Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians

PubMed Central

Nappi, Rossella E.; Kaunitz, Andrew M.; Bitzer, Johannes

2016-01-01

ABSTRACT Objectives: The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. Methods: We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. Results: The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Conclusions: Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices. PMID:26572318

Direct oral anticoagulants for extended thromboprophylaxis in medically ill patients: meta-analysis and risk/benefit assessment.

PubMed

Al Yami, Majed S; Kurdi, Sawsan; Abraham, Ivo

2018-01-01

Standard-duration (7-10 days) thromboprophylaxis with low molecular weight heparin, low dose unfractionated heparin, or fondaparinux in hospitalized medically ill patients is associated with ~50% reduction in venous thromboembolism (VTE) risk. However, these patients remain at high risk for VTE post-discharge. The direct oral anticoagulants (DOACs) apixaban, rivaroxaban and betrixaban have been evaluated for extended-duration (30-42 days) thromboprophylaxis in this population. We review the efficacy and safety results from the 3 pivotal trials of extended-duration DOAC thromboprophylaxis in medically ill patients. We performed a meta-analysis of these pivotal trials focusing on 6 VTE (efficacy) and three bleeding outcomes (safety). These results were integrated into a quantitative risk/benefit assessment. The trials evaluating extended-duration DOAC thromboprophylaxis in medically ill patients failed to establish clear efficacy and/or safety signals for each agent. Our meta-analysis shows that, as a class, DOACs have selective and partial extended-duration prophylactic activity in preventing VTE events. However, this is associated with a marked increase in the risk of various bleeding events. The risk/benefit analyses fail to show a consistent net clinical benefit of extended-duration DOAC prophylaxis in medically ill patients. At this time, the evidence of safe and effective extended-duration thromboprophylaxis with DOACs in this population is inconclusive.

75 FR 21990 - Safety Zone; Extended Debris Removal in the Lake Champlain Bridge Construction Zone (Between...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

...-AA00 Safety Zone; Extended Debris Removal in the Lake Champlain Bridge Construction Zone (Between... surrounding the Lake Champlain Bridge construction zone between Chimney Point, VT and Crown Point, NY. This... of debris from the old Crown Point bridge demolition. The debris must be cleared from the navigable...

The Association Between Professional Burnout and Engagement With Patient Safety Culture and Outcomes: A Systematic Review.

PubMed

Mossburg, Sarah E; Dennison Himmelfarb, Cheryl

2018-06-25

In the last 20 years, there have been numerous successful efforts to improve patient safety, although recent research still shows a significant gap. Researchers have begun exploring the impact of individual level factors on patient safety culture and safety outcomes. This review examines the state of the science exploring the impact of professional burnout and engagement on patient safety culture and safety outcomes. A systematic search was conducted in CINAHL, PubMed, and Embase. Studies included reported on the relationships among burnout or engagement and safety culture or safety outcomes. Twenty-two studies met inclusion criteria. Ten studies showed a relationship between both safety culture and clinical errors with burnout. Two of 3 studies reported an association between burnout and patient outcomes. Fewer studies focused on engagement. Most studies exploring engagement and safety culture found a moderately strong positive association. The limited evidence on the relationship between engagement and errors depicts inconsistent findings. Only one study explored engagement and patient outcomes, which failed to find a relationship. The burnout/safety literature should be expanded to a multidisciplinary focus. Mixed results of the relationship between burnout and errors could be due to a disparate relationship with perceived versus observed errors. The engagement/safety literature is immature, although high engagement seems to be associated with high safety culture. Extending this science into safety outcomes would be meaningful, especially in light of the recent focus on an abundance-based approach to safety.

Extending Occupational Health and Safety to Urban Street Vendors: Reflections From a Project in Durban, South Africa.

PubMed

Alfers, Laura; Xulu, Phumzile; Dobson, Richard; Hariparsad, Sujatha

2016-08-01

This article focuses on an action-research project which is attempting to extend occupational health and safety to a group of street traders in Durban, South Africa, using a variety of different (and sometimes unconventional) institutional actors. The article is written from the perspective of key people who have played a role in conceptualizing and administering the project and is intended to deepen the conversation about what it means to extend occupational health to the informal economy. It explores this question through a reflection on three key project activities: the setting up of a trader-led health and safety committee, an occupational health and safety training course, and a clinical health assessment. It concludes with a discussion of the issues that emerge from the reflections of project participants, which include the need to bring occupational health and urban health into closer conversation with one another, the need to be cognizant of local "informal" politics and the impact that has on occupational health and safety interventions, and the need to create greater opportunities for occupational health and safety professionals to interact with workers in the informal economy. © The Author(s) 2016.

Preparedness of fire safety in underground train station: Comparison between train operators in Malaysia with other operators from the developed countries

NASA Astrophysics Data System (ADS)

Tajedi, Noor Aqilah A.; Sukor, Nur Sabahiah A.; Ismail, Mohd Ashraf M.; Shamsudin, Shahrul A.

2017-10-01

The purpose of this paper is to compare the fire evacuation plan and preparation at the underground train stations in the different countries. The methodology for this study was using the extended questionnaire survey to investigate the Rapid Rail Sdn Bhd, Malaysia's fire safety plan and preparation at the underground train stations. There were four sections in the questionnaire which included (i) background of the respondents, (ii) the details on the train stations, safety instruction and fire evacuation exercises (iii) technical systems, installation and equipment at the underground stations and (iv) procedures and technical changes related to fire safety that had been applied by the operators. Previously, the respondents from the different train operator services in the developed countries had completed the questionnaires. This paper extends the response from the Rapid Rail Sdn Bhd to compare the emergency procedures and preparation for fire event with the developed countries. As a result, this study found that the equipment and facilities that provided at the underground train stations that operated by Rapid Rail are relevant for fire safety procedures and needs. The main advantage for Rapid Rail is the underground stations were designed with two or more entrances/exits that may perform better evacuation compare to one main entrance/exit train stations in the other developed countries.

76 FR 21253 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending and expanding the emergency safety zone established on... January 28, 2011. The safety zone is necessary to help ensure the safety of the response workers and...

Pilot Study on the Safety and Tolerability of Extended Release Niacin for HIV-infected Patients with Hypertriglyceridemia

PubMed Central

Souza, Scott A; Walsh, Erica J; Shippey, Ford; Shikuma, Cecilia

2010-01-01

Background To determine the safety and tolerability of extended release niacin (ERN) in HIV-infected patients. Methods This was a pilot, open-label, 36 week study evaluating the safety and tolerability of ERN in HIV-infected patients with hypertriglyceridemia. Subjects with cardiovascular disease, diabetes or liver disease were excluded. Subjects with persistent elevation of triglyceride (TG) >200 after 8 weeks on American Heart Association Step One and Two Diets were started on ERN 500mg once daily, with continuation of the diet and exercise recommendations until the end of the study. ERN was increased by 500mg every 4 weeks, to a maximum of 1500mg/day, depending on subject tolerability. Safety and tolerability of ERN were assessed. Results Ten subjects enrolled received ERN. Dose titration and maintenance to 1500mg/day were achieved in all 10 subjects. No subject required dose adjustment. Mild flushing was experienced in 8 subjects. Asymptomatic hypophosphotemia was noted in 4 subjects; all resolved with oral phosphate supplementation. Median TG was reduced by 254 mg/dL (p<0.05). Non-significant changes were noted in liver enzymes, HDL, LDL, and total cholesterol. Fasting insulin and glucose levels did not change with treatment. Conclusion In this pilot study, ERN was well-tolerated and resulted in reduction of TG. Although the results of this study are promising, the study is limited in the small number of subjects. Further investigation is warranted. PMID:20533755

Crutches and children - proper fit and safety tips

MedlinePlus

... 000640.htm Crutches and children - proper fit and safety tips To use the sharing features on this ... the crutch, then extended when taking a step. Safety Tips Teach your child to: Always keep crutches ...

Effects of Extended-Release Niacin and Extended-Release Niacin/Laropiprant on the Pharmacokinetics of Simvastatin in Healthy Subjects.

PubMed

Lauring, Brett; Dishy, Victor; De Kam, Pieter-Jan; Crumley, Tami; Wenning, Larissa; Liu, Fang; Sisk, Christine; Wagner, John; Lai, Eseng

2015-01-01

The use of multiple lipid-modifying agents with different mechanisms of action is often required to regulate lipid levels in patients with dyslipidemia. During combination therapy, alterations in the pharmacokinetics of any of the drugs used and their metabolites may occur. Three separate open-label, randomized, crossover studies evaluated the potential for pharmacokinetic interaction between extended-release niacin (with and without concomitant laropiprant) and simvastatin in healthy subjects. Study 1 used single doses of extended-release niacin and simvastatin; study 2 used multiple-dose coadministration of extended-release niacin/laropiprant and simvastatin in healthy subjects; and study 3 used single doses of both extended-release niacin and the coadministration of extended-release niacin/laropiprant and simvastatin in healthy Chinese subjects. During each treatment period, plasma samples were collected predose and at prespecified postdose time points for pharmacokinetic analyses. The safety and tolerability of simvastatin with and without coadministered extended-release niacin (or extended-release niacin/laropiprant) were assessed by clinical evaluation of adverse experiences. In 2 studies in healthy subjects, modest increases in exposure to simvastatin acid (by ∼60%) by extended-release niacin and extended-release niacin/laropiprant were observed. Based on the clinical experience with simvastatin, these effects are not believed to be clinically meaningful. In the third study on healthy Chinese subjects, no statistically meaningful increases in exposure to simvastatin by extended-release niacin and extended-release niacin/laropiprant were observed. In all populations examined in these studies, the coadministration of extended-release niacin and simvastatin was generally well tolerated.

78 FR 70858 - Safety Zones; Pacific Northwest Grain Handlers Association Facilities; Columbia and Willamette...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

... 1625-AA00 Safety Zones; Pacific Northwest Grain Handlers Association Facilities; Columbia and... establishing temporary safety zones around the following Pacific Northwest Grain Handlers Association... Commodities facility on the Willamette River in Portland, OR. These safety zones extend approximately between...

Safety climate and mindful safety practices in the oil and gas industry.

PubMed

Dahl, Øyvind; Kongsvik, Trond

2018-02-01

The existence of a positive association between safety climate and the safety behavior of sharp-end workers in high-risk organizations is supported by a considerable body of research. Previous research has primarily analyzed two components of safety behavior, namely safety compliance and safety participation. The present study extends previous research by looking into the relationship between safety climate and another component of safety behavior, namely mindful safety practices. Mindful safety practices are defined as the ability to be aware of critical factors in the environment and to act appropriately when dangers arise. Regression analysis was used to examine whether mindful safety practices are, like compliance and participation, promoted by a positive safety climate, in a questionnaire-based study of 5712 sharp-end workers in the oil and gas industry. The analysis revealed that a positive safety climate promotes mindful safety practices. The regression model accounted for roughly 31% of the variance in mindful safety practices. The most important safety climate factor was safety leadership. The findings clearly demonstrate that mindful safety practices are highly context-dependent, hence, manageable and susceptible to change. In order to improve safety climate in a direction which is favorable for mindful safety practices, the results demonstrate that it is important to give the fundamental features of safety climate high priority and in particular that of safety leadership. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

New drugs: evidence relating to their therapeutic value after introduction to the market.

PubMed

Ujeyl, Mariam; Schlegel, Claudia; Walter, Siegbert; Gundert-Remy, Ursula

2012-02-01

Drug approval is based on three criteria: quality, efficacy, and safety. We investigated the types of study design and statistical methods employed to demonstrate safety and efficacy of proprietary medicinal products (PMPs) that were approved for use in the European Union through the centralized procedure. We retrospectively analyzed the European Public Assessment Reports of PMPs that the European Medicinal Agency approved, either initially or for extended indications, in 2009 and 2010. Data were analyzed for 39 PMPs: 64% of these were new active substances, and 36% were approved for extended indications. 46% of the PMPs had been studied in an active-control trial. In only 28%, superiority of the new PMPs compared to active control had been tested. 46% of the approvals included testing of a patient-relevant primary endpoint. The median size of population used to demonstrate safety was 1700 persons. The centralized procedure does not require comparative information from active-control trials. Accordingly, as our descriptive analysis revealed, this information is often not available at the time of market introduction. Pivotal studies only rarely clearly demonstrate an added therapeutic value of a new PMP compared to existing alternatives.

CloudSat Safety Operations at Vandenberg AFB

NASA Technical Reports Server (NTRS)

Greenberg, Steve

2006-01-01

CloudSat safety operations at Vendenberg AFB is given. The topics include: 1) CloudSat Project Overview; 2) Vandenberg Ground Operations; 3) Delta II Launch Vehicle; 4) The A-Train; 5) System Safety Management; 6) CALIPSO Hazards Assessment; 7) CALIPSO Supplemental Safeguards; 8) Joint System Safety Operations; 9) Extended Stand-down; 10) Launch Delay Safety Concerns; and 11) Lessons Learned.

76 FR 34862 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement of a safety zone established on the... original safety zone was established on January 28, 2011. The safety zone is necessary to help ensure the...

Efficacy and Safety of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder.

PubMed

Childress, Ann C; Wigal, Sharon B; Brams, Matthew N; Turnbow, John M; Pincus, Yulia; Belden, Heidi W; Berry, Sally A

2018-06-01

To determine the efficacy and safety of amphetamine extended-release oral suspension (AMPH EROS) in the treatment of attention-deficit/hyperactivity disorder (ADHD) in a dose-optimized, randomized, double-blind, parallel-group study. Boys and girls aged 6 to 12 years diagnosed with ADHD were enrolled. During a 5-week, open-label, dose-optimization phase, patients began treatment with 2.5 or 5 mg/day of AMPH EROS; doses were titrated until an optimal dose (maximum 20 mg/day) was reached. During the double-blind phase, patients were randomized to receive treatment with either their optimized dose (10-20 mg/day) of AMPH EROS or placebo for 1 week. Efficacy was assessed in a laboratory classroom setting on the final day of double-blind treatment using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale and Permanent Product Measure of Performance (PERMP) test. Safety was assessed measuring adverse events (AEs) and vital signs. The study was completed by 99 patients. The primary efficacy endpoint (change from predose SKAMP-Combined score at 4 hours postdose) and secondary endpoints (change from predose SKAMP-Combined scores at 1, 2, 6, 8, 10, 12, and 13 hours postdose) were statistically significantly improved with AMPH EROS treatment versus placebo at all time points. Onset of treatment effect was present by 1 hour postdosing, the first time point measured, and duration of efficacy lasted 13 hours postdosing. PERMP data mirrored the SKAMP-Combined score data. AEs (>5%) reported during dose optimization were decreased appetite, insomnia, affect lability, upper abdominal pain, mood swings, and headache. AMPH EROS was effective in reducing symptoms of ADHD and had a rapid onset and extended duration of effect. Reported AEs were consistent with those of other extended-release amphetamine products.

The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol.

PubMed

Kroll, Robin; Reape, Kathleen Z; Margolis, Marya

2010-01-01

This clinical trial was conducted to demonstrate the efficacy and safety of a 91-day extended-regimen, low-dose combination oral contraceptive (OC) consisting of 84 days of ethinyl estradiol (EE) 20 mcg/levonorgestrel (LNG) 100 mcg, followed by 7 days of 10 mcg EE in place of placebo. A multicenter open-label, single-treatment, Phase 3 study evaluated women aged 18 through 40 years over a treatment period of up to 1 year (four 91-day extended cycles). All subjects completed daily paper diaries to monitor compliance, bleeding and additional forms of contraception used during the course of the study. A total of 1249 subjects completed the study. The Pearl Index was 2.74 (95% confidence interval, 1.92-3.78), based on 36 pregnancies that occurred after the onset of treatment and within 14 days after the last combination tablet in women aged 18-35 years. Among compliant-use subjects 18-35 years old, the Pearl Index was 1.73 based on 22 on-treatment pregnancies. The life table pregnancy rate for subjects 18-35 years of age was 2.39%. Cycle control and adverse events reported with this regimen were similar to those reported with other low-dose OCs. This study demonstrated effective prevention of pregnancy with a 20-mcg EE, 91-day extended-regimen OC. In addition, the regimen was well tolerated and incidence of adverse events were consistent with what has been reported with other low-dose OCs.

A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study).

PubMed

Krucoff, Mitchell W; Rutledge, David R; Gruberg, Luis; Jonnavithula, Lalitha; Katopodis, John N; Lombardi, William; Mao, Vivian W; Sharma, Samin K; Simonton, Charles A; Tamboli, Hoshedar P; Wang, Jin; Wilburn, Olivia; Zhao, Weiying; Sudhir, Krishnankutty; Hermiller, James B

2011-12-01

The XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System Condition-of-Approval Post-Market study) sought to: 1) evaluate the safety of everolimus-eluting coronary stent systems (EECSS) in a contemporary cohort of real-world subjects; and 2) prospectively test the quality of event reporting with analysis of matched patients from the randomized SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions) trial. Randomized trials have demonstrated the safety and efficacy of EECSS in selected "standard-risk" patients. The XIENCE V USA trial was a prospective, multicenter, single-arm study in unselected patients. The primary endpoint was Academic Research Consortium (ARC)-defined definite and probable stent thrombosis (ST); the co-primary endpoint was the composite of cardiac death and myocardial infarction at 1 year. Secondary analyses included: 1) stratification by standard-risk and extended-risk cohorts; and 2) late ST after dual antiplatelet therapy interruption. Of 5,054 participants (1,875 standard-risk; 3,179 extended-risk), 4,958 (98.1%) reached 1-year follow-up. The rate of ARC-defined definite and probable ST was 0.84% (95% confidence interval [CI]: 0.60% to 1.14%) in the overall population and 0.33% (95% CI: 0.12% to 10.72%) and 1.14% (95% CI: 0.80% to 11.58%) in the standard-risk and extended-risk cohorts, respectively. No late ST was observed after dual antiplatelet therapy interruption in either cohort after 6 months. The composite rate of cardiac death and ARC-defined myocardial infarction was 6.5% (95% CI: 5.79% to 17.17%) in the overall population, 3.8% (95% CI: 2.98% to 14.78%) in the standard-risk cohort, and 8.0% (95% CI: 7.09% to 19.02%) in the extended-risk cohort. This study comprehensively reports ST rates for EECSS in a contemporary real-world population. The absence of ST after dual antiplatelet therapy interruption beyond 6 months in standard-risk and high-risk patients is notable. Consistent safety outcomes between matched standard-risk cohorts from the XIENCE V USA study and the SPIRIT IV randomized trial suggest that this study affords a reliable benchmark for understanding the safety of EECSS in the context of real-world clinical practice. (XIENCE V Everolimus Eluting Coronary Stent System [EECSS] USA Post-Approval Study; NCT00676520). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Safety behavior: Job demands, job resources, and perceived management commitment to safety.

PubMed

Hansez, Isabelle; Chmiel, Nik

2010-07-01

The job demands-resources model posits that job demands and resources influence outcomes through job strain and work engagement processes. We test whether the model can be extended to effort-related "routine" safety violations and "situational" safety violations provoked by the organization. In addition we test more directly the involvement of job strain than previous studies which have used burnout measures. Structural equation modeling provided, for the first time, evidence of predicted relationships between job strain and "routine" violations and work engagement with "routine" and "situational" violations, thereby supporting the extension of the job demands-resources model to safety behaviors. In addition our results showed that a key safety-specific construct 'perceived management commitment to safety' added to the explanatory power of the job demands-resources model. A predicted path from job resources to perceived management commitment to safety was highly significant, supporting the view that job resources can influence safety behavior through both general motivational involvement in work (work engagement) and through safety-specific processes.

Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.

PubMed

Kvalheim, Sverre A; Dahl, Øyvind

2016-12-01

Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

33 CFR 165.112 - Safety Zone: USS CASSIN YOUNG, Boston, Massachusetts.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone: USS CASSIN YOUNG... Safety Zone: USS CASSIN YOUNG, Boston, Massachusetts. (a) Location. The following area is a safety zone... underway. The zone extends 100 yards in all directions in the waters around the USS CASSIN YOUNG and...

76 FR 73511 - Safety Zone; M/V DAVY CROCKETT, Columbia River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

...-AA00 Safety Zone; M/V DAVY CROCKETT, Columbia River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The U.S. Coast Guard is extending the enforcement period of a safety zone established on... sight at approximate river mile 117. The original safety zone was established on January 28, 2011. The...

78 FR 57261 - Safety Zone; Grain-Shipment and Grain-Shipment Assist Vessels, Columbia and Willamette Rivers

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-18

... 1625-AA00 Safety Zone; Grain-Shipment and Grain-Shipment Assist Vessels, Columbia and Willamette Rivers... temporary safety zone around all inbound and outbound grain-shipment and grain-shipment assist vessels... Columbia and Willamette Rivers and their tributaries. For grain- shipment vessels, this safety zone extends...

76 FR 23485 - Safety Zone; Red River

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-27

...-AA00 Safety Zone; Red River AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone for all waters of the Red River in the State of North..., extending the entire width of the river. This safety zone is needed to protect persons and vessels from...

Electron beam processing of fresh produce - A critical review

NASA Astrophysics Data System (ADS)

Pillai, Suresh D.; Shayanfar, Shima

2018-02-01

To meet the increasing global demand for fresh produce, robust processing methods that ensures both the safety and quality of fresh produce are needed. Since fresh produce cannot withstand thermal processing conditions, most of common safety interventions used in other foods are ineffective. Electron beam (eBeam) is a non-thermal technology that can be used to extend the shelf life and ensure the microbiological safety of fresh produce. There have been studies documenting the application of eBeam to ensure both safety and quality in fresh produce, however, there are still unexplored areas that still need further research. This is a critical review on the current literature on the application of eBeam technology for fresh produce.

Once-daily mesalamine granules for ulcerative colitis.

PubMed

Lawlor, Garrett; Ahmed, Awais; Moss, Alan C

2010-07-01

Mesalamine extended-release capsules (Apriso [Salix Pharmaceuticals, Raleigh, NC, USA]) are the first once-daily mesalamine preparation approved by the US FDA for the maintenance of remission of ulcerative colitis (UC). Each mesalamine extended-release capsule contains granules of a mesalamine-polymer matrix that are coated with a pH-sensitive resin. This design begins releasing mesalamine (0.375 g) once the pH is more than 6 in the ileum and colon. Two clinical trials have reported that mesalamine extended-release capsules (1.5 g/day) maintained remission in 79% of patients with UC who were in clinical remission. Reported adherence with mesalamine extended-release capsules once daily was high (>90%) in these studies. This article examines the efficacy and safety of mesalamine extended-release capsules in the maintenance of remission in patients with UC.

Health, Safety, and Environment Division

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wade, C

1992-01-01

The primary responsibility of the Health, Safety, and Environmental (HSE) Division at the Los Alamos National Laboratory is to provide comprehensive occupational health and safety programs, waste processing, and environmental protection. These activities are designed to protect the worker, the public, and the environment. Meeting these responsibilities requires expertise in many disciplines, including radiation protection, industrial hygiene, safety, occupational medicine, environmental science and engineering, analytical chemistry, epidemiology, and waste management. New and challenging health, safety, and environmental problems occasionally arise from the diverse research and development work of the Laboratory, and research programs in HSE Division often stem from thesemore » applied needs. These programs continue but are also extended, as needed, to study specific problems for the Department of Energy. The results of these programs help develop better practices in occupational health and safety, radiation protection, and environmental science.« less

Is There Cultural Safety in Australian Universities?

ERIC Educational Resources Information Center

Rochecouste, Judith; Oliver, Rhonda; Bennell, Debra

2014-01-01

This paper examines the cultural safety offered to Australian Aboriginal and Torres Strait Islander students within their university environments. In the context of this paper, cultural safety includes cultural competency, as recently subscribed by Universities Australia, and "extends beyond (to) cultural awareness and cultural…

77 FR 6856 - Agency Requests Approval To Extend Information Collection(s): Section 410 Alcohol Impaired...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-09

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration [U.S. DOT Docket No. NHTSA-2012-0012] Agency Requests Approval To Extend Information Collection(s): Section 410 Alcohol... extend information collection. The collection involves preparation of certifications, and documents...

Application of modified extended method in CREAM for safety inspector in coal mines

NASA Astrophysics Data System (ADS)

Wang, Jinhe; Zhang, Xiaohong; Zeng, Jianchao

2018-01-01

Safety inspector often performs duties in circumstances contributes to the oc currence of human failures. Therefore, the paper aims at quantifying human failure pro bability (HFP) of safety inspector during the coal mine operation with cognitive reliabi lity and error analysis method (CREAM). Whereas, some shortcomings of this approa ch that lacking considering the applicability of the common performance condition (C PC), and the subjective of evaluating CPC level which weaken the accuracy of the qua ntitative prediction results. A modified extended method in CREAM which is able to a ddress these difficulties with a CPC framework table is proposed, and the proposed me thodology is demonstrated by the virtue of a coal-mine accident example. The results a re expected to be useful in predicting HFP of safety inspector and contribute to the enh ancement of coal mine safety.

Assessment of Contributions to Patient Safety Knowledge by the Agency for Healthcare Research and Quality-Funded Patient Safety Projects

PubMed Central

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-01-01

Objective To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)' patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Data Sources Information abstracted from proposals for projects funded in AHRQ' patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. Study Design This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. Principal Findings The 234 projects funded through AHRQ' patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. Conclusions The projects funded in AHRQ' patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results. PMID:21456108

76 FR 14829 - Safety Zone; 2011 Hylebos Bridge Restoration, Hylebos Waterway, Tacoma, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-18

...-AA00 Safety Zone; 2011 Hylebos Bridge Restoration, Hylebos Waterway, Tacoma, WA AGENCY: Coast Guard... temporary safety zone extending 50 yards to the north and south of the Hylebos Bridge, Tacoma, WA in both directions along the entire length of the Hylebos Bridge to ensure the safety of the boating public during...

Three Reflections on Assessing Safety Training Needs: A Case Study

ERIC Educational Resources Information Center

Sleezer, Catherine M.; Kelsey, Kathleen D.; Wood, Thomas E.

2008-01-01

Needs assessment plays an important role in training and human performance improvement efforts, but the literature contains little research on this topic. This study extended previous research on the Performance Analysis for Training (PAT) model of needs assessment by examining its implementation to determine environmental and occupational health…

Safety leadership: extending workplace safety climate best practices across health care workforces.

PubMed

McCaughey, Deirdre; Halbesleben, Jonathon R B; Savage, Grant T; Simons, Tony; McGhan, Gwen E

2013-01-01

Hospitals within the United States consistently have injury rates that are over twice the national employee injury rate. Hospital safety studies typically investigate care providers rather than support service employees. Compounding the lack of evidence for this understudied population is the scant evidence that is available to examine the relationship of support service employees'perceptions of safety and work-related injuries. To examine this phenomenon, the purpose of this study was to investigate support service employees' perceptions of safety leadership and social support as well as the relationship of safety perception to levels of reported injuries. A nonexperimental survey was conducted with the data collected from hospital support service employees (n = 1,272) and examined. (1) relationships between safety leadership (supervisor and organization) and individual and unit safety perceptions; (2) the moderating effect of social support (supervisor and coworker) on individual and unit safety perceptions; and (3) the relationship of safety perception to reported injury rates. The survey items in this study were based on the items from the AHRQ Patient Safety Culture Survey and the U.S. National Health Care Surveys. Safety leadership (supervisor and organization) was found to be positively related to individual safety perceptions and unit safety grade as was supervisor and coworker support. Coworker support was found to positively moderate the following relationships: supervisor safety leadership and safety perceptions, supervisor safety leadership and unit safety grade, and senior management safety leadership and safety perceptions. Positive employee safety perceptions were found to have a significant relationship with lower reported injury rates. These findings suggest that safety leadership from supervisors and senior management as well as coworker support has positive implications for support service employees' perceptions of safety, which, in turn, are negatively related to lower odds of reporting injuries.

Health, Safety, and Environment Division annual report 1989

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wade, C.

1992-01-01

The primary responsibility of the Health, Safety, and Environment (HSE) Division at the Los Alamos National Laboratory is to provide comprehensive occupational health and safety programs, waste processing, and environmental protection. These activities are designed to protect the worker, the public, and the environment. Meeting the responsibilities involves many disciplines, including radiation protection, industrial hygiene, safety, occupational medicine, environmental science and engineering, analytical chemistry, epidemiology, and waste management. New and challenging health, safety, and environmental problems occasionally arise from the diverse research and development work of the Laboratory, and research programs in the HSE Division often stem from these appliedmore » needs. These programs continue but are also extended, as needed, to study specific problems for the Department of Energy. The result of these programs is to help develop better practices in occupational health and safety, radiation protection, and environmental sciences.« less

78 FR 46258 - Safety Zone; Upper Mississippi River, Mile 662.8 to 663.9

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

...-AA00 Safety Zone; Upper Mississippi River, Mile 662.8 to 663.9 AGENCY: Coast Guard, DHS. ACTION... Upper Mississippi River, from mile 662.8 to 663.9, extending the entire width of the river. This safety... mile 662.8 to 663.9 on the Upper Mississippi River. Anticipated traffic on the river presents safety...

76 FR 73686 - Curtis-Straus LLC; Application for Renewal of Recognition; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2009-0026...: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice; extension of comment period. SUMMARY: The Occupational Safety and Health Administration (OSHA) is extending the comment period for its...

EPA Extends Comment Period for Draft Label Revisions on Respirators

EPA Pesticide Factsheets

Extending Comment Period for Draft Label Revisions on Respirators, Bring the respirator descriptions on pesticide labels into conformance with the current National Institute for Occupational Safety and Health (NIOSH) respirator language

An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies

PubMed Central

Iffland, Kerstin; Grotenhermen, Franjo

2017-01-01

Abstract Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy and psychotic disorders. Here, the most commonly reported side effects were tiredness, diarrhea, and changes of appetite/weight. In comparison with other drugs, used for the treatment of these medical conditions, CBD has a better side effect profile. This could improve patients' compliance and adherence to treatment. CBD is often used as adjunct therapy. Therefore, more clinical research is warranted on CBD action on hepatic enzymes, drug transporters, and interactions with other drugs and to see if this mainly leads to positive or negative effects, for example, reducing the needed clobazam doses in epilepsy and therefore clobazam's side effects. Conclusion: This review also illustrates that some important toxicological parameters are yet to be studied, for example, if CBD has an effect on hormones. Additionally, more clinical trials with a greater number of participants and longer chronic CBD administration are still lacking. PMID:28861514

49 CFR 232.213 - Extended haul trains.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT AND OTHER NON-PASSENGER TRAINS AND... extended haul trains will originate and a description of the trains that will be operated as extended haul.... (5) The train shall have no more than one pick-up and one set-out en route, except for the set-out of...

Safety and tolerability of extended-release niacin-laropiprant: Pooled analyses for 11,310 patients in 12 controlled clinical trials.

PubMed

McKenney, James; Bays, Harold; Gleim, Gilbert; Mitchel, Yale; Kuznetsova, Olga; Sapre, Aditi; Sirah, Waheeda; Maccubbin, Darbie

2015-01-01

The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) showed that adding extended-release niacin-laropiprant (ERN-LRPT) to statin provided no incremental cardiovascular benefit vs placebo (PBO). ERN-LRPT was also associated with an excess of serious adverse experiences (AEs), some of which were unexpected (infections and bleeding). These findings led to the withdrawal of ERN-LRPT from all markets. We examined the safety profile of ERN-LRPT vs the comparators ERN alone and statins in the ERN-LRPT development program to assess whether similar safety signals were observed to those seen in HPS-THRIVE and whether these might be attributed to ERN or LRPT. Postrandomization safety data from 12 clinical studies, 12 to 52 weeks in duration and involving 11,310 patients, were analyzed across 3 treatments: (1) ERN-LRPT; (2) ERN-NSP (ERN, Merck & Co, Inc or Niaspan [NSP], Abbott Laboratories); and (3) statin-PBO (statin or PBO). The safety profiles of ERN-LRPT and ERN-NSP were similar, except for less flushing with ERN-LRPT. Nonflushing AEs reported more frequently with ERN-LRPT or ERN-NSP than with statin-PBO were mostly nonserious and typical of niacin (nausea, diarrhea, and increased blood glucose). There was no evidence for an increased risk of serious AEs related to diabetes, muscle, infection, or bleeding. Pooled data from 11,310 patients revealed that, except for reduced flushing, the safety profile of ERN-LRPT was similar to that of ERN-NSP; LRPT did not appear to adversely affect the side-effect profile of ERN. The inability to replicate the unexpected AE findings in HPS2-THRIVE could be because of the smaller sample size and substantially shorter duration of these studies. Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.

78 FR 9054 - National Institute for Occupational Safety and Health Respiratory Protection for Healthcare...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-07

... program research agenda and (2) assess progress toward better respirators for healthcare workers. This... Observational Studies of Respirator Use & New Educational Resources'', ``Considerations for Extending Respirator Supplies During an Outbreak or Pandemic'', ``Standards & Test Methods for Improved Respirators for...

75 FR 28769 - Safety Zone; Osage River, Mile 016.8 to 017.2

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-24

...-AA00 Safety Zone; Osage River, Mile 016.8 to 017.2 AGENCY: Coast Guard, DHS. ACTION: Notice of proposed... Osage River, Mile 016.8 to 017.2, extending the entire width of the river. This safety zone is needed to... between mile 016.8 and 017.2 on the Osage River. This event presents safety hazards to the navigation of...

Predictors of Cell Phone Use in Distracted Driving: Extending the Theory of Planned Behavior.

PubMed

Tian, Yan; Robinson, James D

2017-09-01

This study examines the predictors of six distracted driving behaviors, and the survey data partially support Ajzen's (1991) Theory of Planned Behavior (TPB). The data suggest that the attitude variable predicted intention to engage in all six distracted driving behaviors (reading and sending text messages, making and answering cell phone calls, reading/viewing social media, and posting on social media while driving). Extending the model to include past experience and the variable perceived safety of technology yielded an improvement in the prediction of the distraction variables. Specifically, past experience predicted all six distracted driving behaviors, and the variable perceived safety of technology predicted intentions to read/view social media and intention to post on social media while driving. The study provides evidence for the importance of incorporating expanded variables into the original TPB model to predict cell phone use behaviors while driving, and it suggests that it is essential to tailor campaign materials for each specific cell phone use behavior to reduce distracted driving.

78 FR 34258 - Safety Zone; Salvage Operations at Marseilles Dam; Illinois River

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

...-AA00 Safety Zone; Salvage Operations at Marseilles Dam; Illinois River AGENCY: Coast Guard, DHS. ACTION... Illinois River starting at Mile Marker 246.9 and extending 600 yards upstream of the Marseilles Dam to Mile... repair efforts at the Marseilles Dam. This safety zone is necessary to protect the general public...

77 FR 7582 - Determination That JENLOGA (Clonidine Hydrochloride) Extended-Release Tablets, 0.1 Milligram and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

..., Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug... sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated... of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for...

78 FR 48631 - Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-09

... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 317 [Docket No. FSIS-2008... AGENCY: Food Safety and Inspection Service, USDA. ACTION: Proposed rule; extension of comment period. SUMMARY: The Food Safety and Inspection Service (FSIS) is extending the comment period for the Federal...

Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial.

PubMed

Buynak, Robert; Rappaport, Stephen A; Rod, Kevin; Arsenault, Pierre; Heisig, Fabian; Rauschkolb, Christine; Etropolski, Mila

2015-11-01

Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain. Patients were enrolled in this 1-year, open-label extension study after completing one of two 15-week, placebo-controlled studies of tapentadol ER and oxycodone controlled release (CR) for osteoarthritis knee pain (NCT00421928) or low back pain (NCT00449176), a 7-week crossover study between tapentadol immediate release and tapentadol ER for low back pain (NCT00594516), or a 1-year safety study of tapentadol ER and oxycodone CR for osteoarthritis or low back pain (NCT00361504). After titrating the drug to an optimal dose, patients received tapentadol ER (100-250 mg BID) for up to 1 year (after finishing treatment in the preceding studies); patients who were previously treated with tapentadol ER in the 1-year safety study received tapentadol ER continuously for up to 2 years in total. Of the 1,154 patients in the safety population, 82.7% were aged >65 years and 57.9% were female; 50.1% had mild baseline pain intensity. Mean (SD) pain intensity scores (11-point numerical rating scale) were 3.9 (2.38) at baseline (end of preceding study) and 3.7 (2.42) at end point, indicating that pain relief was maintained during the extension study. Improvements in measures of quality of life (eg, EuroQol-5 Dimension and the 36-item Short Form Health Survey [SF-36]) health status questionnaires) achieved during the preceding studies were maintained during the open-label extension study. Tapentadol ER was associated with a safety and tolerability profile comparable to that observed in the preceding studies. The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13.1%), nausea (11.8%), and constipation (11.1%). Similar efficacy and tolerability results were shown for patients who received up to 2 years of tapentadol ER treatment. Pain relief and improvements in quality of life achieved during the preceding studies were maintained throughout this extension study, during which tapentadol ER was well tolerated for the long-term treatment of chronic osteoarthritis or low back pain over up to 2 years of treatment. (ClinicalTrials.gov identifier: NCT00487435.). Copyright © 2015. Published by Elsevier Inc.

Efficacy and safety of an ascending-dose, extended-regimen levonorgestrel/ethinyl estradiol combined oral contraceptive.

PubMed

Portman, David J; Kaunitz, Andrew M; Howard, Brandon; Weiss, Herman; Hsieh, Jennifer; Ricciotti, Nancy

2014-04-01

To evaluate the efficacy and safety of an ascending-dose, extended-regimen (ADER) combined oral contraceptive consisting of levonorgestrel (LNG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 42 days, LNG 150 mcg/EE 25 mcg for 21 days, LNG 150 mcg/EE 30 mcg for 21 days and EE 10 mcg for 7 days. This was a multicenter, open-label, phase 3, single-arm study. Sexually active women aged 18-40 years were enrolled and received ADER for up to 1 year (4 consecutive 91-day cycles). Participants kept diaries to record adherence, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index and the life-table method; safety and tolerability were assessed through reported adverse events (AEs). A total of 3701 women were enrolled and 2144 completed the study. The Pearl Index was 3.19 [95% confidence interval (CI), 2.49-4.03], based on 70 pregnancies that occurred after ADER initiation and ≤ 7 days after the last LNG/EE or EE-only pill in women aged 18-35 years, excluding cycles in which another contraceptive method was used. Life-table pregnancy rate was 2.82% (95% CI, 2.23%-3.57%) for all users aged 18-35 years. Unscheduled bleeding/spotting decreased with increasing EE doses within each cycle and decreased after cycle 1. No unexpected AEs or changes in laboratory parameters were reported. This study demonstrated that ADER effectively prevented pregnancy with a favorable safety and tolerability profile. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

The health care work environment and adverse health and safety consequences for nurses.

PubMed

Geiger-Brown, Jeanne; Lipscomb, Jane

2010-01-01

Nurses' working conditions are inextricably linked to the quality of care that is provided to patients and patients' safety. These same working conditions are associated with health and safety outcomes for nurses and other health care providers. This chapter describes aspects of the nursing work environment that have been linked to hazards and adverse exposures for nurses, as well as the most common health and safety outcomes of nursing work. We include studies from 2000 to the present by nurse researchers, studies of nurses as subjects, and studies of workers under similar working conditions that could translate to nurses' work environment. We explore a number of work organization factors including shift work and extended work hours, safety climate and culture, teamwork, and communication. We also describe environmental hazards, including chemical hazards (e.g., waste anesthetics, hazardous drugs, cleaning compounds) and airborne and bloodborne pathogen exposure. Nurses' health and safety outcomes include physical (e.g., musculoskeletal disorders, gastrointestinal, slips, trips and falls, physical assault) and psychosocial outcomes (e.g., burnout, work-family conflict). Finally, we present recommendations for future research to further protect nurses and all health care workers from a range of hazardous working conditions.

Safety Behaviors and Stuttering.

PubMed

Lowe, Robyn; Helgadottir, Fjola; Menzies, Ross; Heard, Rob; O'Brian, Sue; Packman, Ann; Onslow, Mark

2017-05-24

Those who are socially anxious may use safety behaviors during feared social interactions to prevent negative outcomes. Safety behaviors are associated with anxiety maintenance and poorer treatment outcomes because they prevent fear extinction. Social anxiety disorder is often comorbid with stuttering. Speech pathologists reported in a recent publication (Helgadottir, Menzies, Onslow, Packman, & O'Brian, 2014a) that they often recommended procedures for clients that could be safety behaviors. This study investigated the self-reported use of safety behaviors by adults who stutter. Participants were 133 adults who stutter enrolled in an online cognitive-behavior therapy program. Participants completed a questionnaire about their use of potential safety behaviors when anxious during social encounters. Correlations were computed between safety behaviors and pretreatment scores on measures of fear of negative evaluation and negative cognitions. Of 133 participants, 132 reported that they used safety behaviors. Many of the safety behaviors correlated with higher scores for fear of negative evaluation and negative cognitions. Adults who stutter report using safety behaviors, and their use is associated with pretreatment fear of negative evaluation and unhelpful thoughts about stuttering. These results suggest that the negative effects of safety behaviors may extend to those who stutter, and further research is needed.

77 FR 61048 - Distracted Driving Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-05

... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Distracted Driving Grant Program AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of... distracted driving grants on August 24, 2012. In this notice, DOT is extending the application submission...

HPV vaccination impact on a cervical cancer screening program: methods of the FASTER-Tlalpan Study in Mexico.

PubMed

Salmerón, Jorge; Torres-Ibarra, Leticia; Bosch, F Xavier; Cuzick, Jack; Lörincz, Attila; Wheeler, Cosette M; Castle, Philip E; Robles, Claudia; Lazcano-Ponce, Eduardo

2016-04-01

To outline the design of a clinical trial to evaluate the impact of HPV vaccination as part of a hrHPV-based primary screening program to extend screening intervals. A total of 18,000 women aged 25-45 years, attending the regular cervical cancer-screening program in primary health care services in Tlalpan, Mexico City, will be invited to the study. Eligible participants will be assigned to one of three comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening. Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will be conducted to estimate safety profiles at different screening intervals; participants will undergo diagnosis confirmation and treatment as necessary. The FASTER-Tlalpan Study will provide insights into new approaches of cervical cancer prevention programs. It will offer valuable information on potential benefits of combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.

Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies.

PubMed

Rodrigues, Eliana; Barnes, Joanne

2013-01-01

Typically, ethnobotanical/ethnopharmacological (EB/EP) surveys are used to describe uses, doses/dosages, sources and methods of preparation of traditional herbal medicines; their application to date in examining the adverse effects, contraindications and other safety aspects of these preparations is limited. From a pharmacovigilance perspective, numerous challenges exist in applying its existing methods to studying the safety profile of herbal medicines, particularly where used by indigenous cultures. This paper aims to contribute to the methodological aspects of EB/EP field work, and to extend the reach of pharmacovigilance, by proposing a tool comprising a list of questions that could be applied during interview and observational studies. The questions focus on the collection of information on the safety profile of traditional herbal medicines as it is embedded in traditional knowledge, as well as on identifying personal experiences (spontaneous reports) of adverse or undesirable effects associated with the use of traditional herbal medicines. Questions on the precise composition of traditional prescriptions or 'recipes', their preparation, storage, administration and dosing are also included. Strengths and limitations of the tool are discussed. From this interweaving of EB/EP and pharmacovigilance arises a concept of ethnopharmacovigilance for traditional herbal medicines: the scope of EB/EP is extended to include exploration of the potential harmful effects of medicinal plants, and the incorporation of pharmacovigilance questions into EB/EP studies provides a new opportunity for collection of 'general' traditional knowledge on the safety of traditional herbal medicines and, importantly, a conduit for collection of spontaneous reports of suspected adverse effects. Whether the proposed tool can yield data sufficiently rich and of an appropriate quality for application of EB/EP (e.g. data verification and quantitative analysis tools) and pharmacovigilance techniques (e.g. causality assessment and data mining) requires field testing.

75 FR 59620 - Natchez Fireworks Safety Zone; Lower Mississippi River, Mile Marker 365.5 to Mile Marker 363...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

...-AA00 Natchez Fireworks Safety Zone; Lower Mississippi River, Mile Marker 365.5 to Mile Marker 363... establishing a temporary safety zone for all waters of the Lower Mississippi River from mile marker 365.5 to... from mile marker 365.5 to 363 extending the entire width [[Page 59621

76 FR 38011 - Safety Zone; Hylebos Bridge Restoration, Hylebos Waterway, Tacoma, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-29

...-AA00 Safety Zone; Hylebos Bridge Restoration, Hylebos Waterway, Tacoma, WA AGENCY: Coast Guard, DHS... extending 50 yards to the north and south of the Hylebos Bridge, Tacoma, WA in both directions along the entire length of the Hylebos Bridge to ensure the safety of the boating public during the Hylebos Bridge...

Sun Safety Knowledge, Attitudes, and Behaviors among Beachgoing Adolescents

ERIC Educational Resources Information Center

Merten, Julie Williams; Higgins, Sue; Rowan, Alan; Pragle, Aimee

2014-01-01

Background: Skin cancer rates are rising and could be reduced with better sun protection behaviors. Adolescent exposure to ultraviolet (UV) radiation is damaging because it can lead to skin cancer. This descriptive study extends understanding of adolescent sun exposure attitudes, knowledge, and behaviors. Methods: A sample of 423 beachgoing…

The safety, tolerability, and efficacy of once-daily memantine (28 mg): a multinational, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe Alzheimer's disease taking cholinesterase inhibitors.

PubMed

Grossberg, George T; Manes, Facundo; Allegri, Ricardo F; Gutiérrez-Robledo, Luis Miguel; Gloger, Sergio; Xie, Lei; Jia, X Daniel; Pejović, Vojislav; Miller, Michael L; Perhach, James L; Graham, Stephen M

2013-06-01

Immediate-release memantine (10 mg, twice daily) is approved in the USA for moderate-to-severe Alzheimer's disease (AD). This study evaluated the efficacy, safety, and tolerability of a higher-dose, once-daily, extended-release formulation in patients with moderate-to-severe AD concurrently taking cholinesterase inhibitors. In this 24-week, double-blind, multinational study (NCT00322153), outpatients with AD (Mini-Mental State Examination scores of 3-14) were randomized to receive once-daily, 28-mg, extended-release memantine or placebo. Co-primary efficacy parameters were the baseline-to-endpoint score change on the Severe Impairment Battery (SIB) and the endpoint score on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus). The secondary efficacy parameter was the baseline-to-endpoint score change on the 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19); additional parameters included the baseline-to-endpoint score changes on the Neuropsychiatric Inventory (NPI) and verbal fluency test. Data were analyzed using a two-way analysis of covariance model, except for CIBIC-Plus (Cochran-Mantel-Haenszel test). Safety and tolerability were assessed through adverse events and physical and laboratory examinations. A total of 677 patients were randomized to receive extended-release memantine (n = 342) or placebo (n = 335); completion rates were 79.8 and 81.2 %, respectively. At endpoint (week 24, last observation carried forward), memantine-treated patients significantly outperformed placebo-treated patients on the SIB (least squares mean difference [95 % CI] 2.6 [1.0, 4.2]; p = 0.001), CIBIC-Plus (p = 0.008), NPI (p = 0.005), and verbal fluency test (p = 0.004); the effect did not achieve significance on ADCS-ADL19 (p = 0.177). Adverse events with a frequency of ≥5.0 % that were more prevalent in the memantine group were headache (5.6 vs. 5.1 %) and diarrhea (5.0 vs. 3.9 %). Extended-release memantine was efficacious, safe, and well tolerated in this population.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.

PubMed

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Itamura, Rio; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75-225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (-10.76; P=0.031), but not in the flexible-dose (-10.37; P=0.106) group compared with placebo (-9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan

PubMed Central

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75–225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (−10.76; P=0.031), but not in the flexible-dose (−10.37; P=0.106) group compared with placebo (−9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan. PMID:26513202

An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch.

PubMed

Zhang, Chao; Li, Haiyan; Xiong, Xin; Zhai, Suodi; Wei, Yudong; Zhang, Shuang; Zhang, Yuanyuan; Xu, Lin; Liu, Li

2017-01-01

We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE)/gestodene (GSD) transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet ® ) were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS) assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration ( C max ), extended time to reach the C max and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration-time curve (AUCs) of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations.

Assessment of contributions to patient safety knowledge by the Agency for Healthcare Research and Quality-funded patient safety projects.

PubMed

Sorbero, Melony E S; Ricci, Karen A; Lovejoy, Susan; Haviland, Amelia M; Smith, Linda; Bradley, Lily A; Hiatt, Liisa; Farley, Donna O

2009-04-01

To characterize the activities of projects funded in Agency for Healthcare Research and Quality (AHRQ)'s patient safety portfolio and assess their aggregate potential to contribute to knowledge development. Information abstracted from proposals for projects funded in AHRQ's patient safety portfolio, information on safety practices from the AHRQ Evidence Report on Patient Safety Practices, and products produced by the projects. This represented one part of the process evaluation conducted as part of a longitudinal evaluation based on the Context–Input–Process–Product model. The 234 projects funded through AHRQ's patient safety portfolio examined a wide variety of patient safety issues and extended their work beyond the hospital setting to less studied parts of the health care system. Many of the projects implemented and tested practices for which the patient safety evidence report identified a need for additional evidence. The funded projects also generated a substantial body of new patient safety knowledge through a growing number of journal articles and other products. The projects funded in AHRQ's patient safety portfolio have the potential to make substantial contributions to the knowledge base on patient safety. The full value of this new knowledge remains to be confirmed through the synthesis of results

75 FR 41764 - Safety Zone; Mississippi River, Mile 840.0 to 839.8

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-19

...-AA00 Safety Zone; Mississippi River, Mile 840.0 to 839.8 AGENCY: Coast Guard, DHS. ACTION: Temporary... Mississippi River, Mile 840.0 to 839.8, extending the entire width of the river. This safety zone is needed to... Purpose On July 24, 2010 the Red Bull North America will be conducting a flying aircraft regatta at mile...

76 FR 36316 - Safety Zone; Upper Mississippi River, Mile 180.0 to 179.0

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...-AA00 Safety Zone; Upper Mississippi River, Mile 180.0 to 179.0 AGENCY: Coast Guard, DHS. ACTION... Upper Mississippi River, from Mile 180.0 to 179.0, extending the entire width of the river. This safety... combat capabilities between Mile 180.0 and 179.0 on the Upper Mississippi River. This event presents...

33 CFR 165.1332 - Safety Zones; annual firework displays within the Captain of the Port, Puget Sound Area of...

Code of Federal Regulations, 2014 CFR

2014-07-01

... displays within the Captain of the Port, Puget Sound Area of Responsibility. 165.1332 Section 165.1332... within the Captain of the Port, Puget Sound Area of Responsibility. (a) Safety Zones. The following areas are designated safety zones: (1) All waters of Puget Sound, Washington, extending to a 450 yard radius...

33 CFR 165.1332 - Safety Zones; annual firework displays within the Captain of the Port, Puget Sound Area of...

Code of Federal Regulations, 2011 CFR

2011-07-01

... displays within the Captain of the Port, Puget Sound Area of Responsibility. 165.1332 Section 165.1332... within the Captain of the Port, Puget Sound Area of Responsibility. (a) Safety Zones. The following areas are designated safety zones: (1) All waters of Puget Sound, Washington, extending to a 450 yard radius...

33 CFR 165.1332 - Safety Zones; annual firework displays within the Captain of the Port, Puget Sound Area of...

Code of Federal Regulations, 2012 CFR

2012-07-01

... displays within the Captain of the Port, Puget Sound Area of Responsibility. 165.1332 Section 165.1332... within the Captain of the Port, Puget Sound Area of Responsibility. (a) Safety Zones. The following areas are designated safety zones: (1) All waters of Puget Sound, Washington, extending to a 450 yard radius...

33 CFR 165.1332 - Safety Zones; annual firework displays within the Captain of the Port, Puget Sound Area of...

Code of Federal Regulations, 2013 CFR

2013-07-01

... displays within the Captain of the Port, Puget Sound Area of Responsibility. 165.1332 Section 165.1332... within the Captain of the Port, Puget Sound Area of Responsibility. (a) Safety Zones. The following areas are designated safety zones: (1) All waters of Puget Sound, Washington, extending to a 450 yard radius...

Modeling School Violence across Grade Levels in the U.S. Using the Third International Mathematics and Science Study (TIMSS).

ERIC Educational Resources Information Center

Yu, Lei

School violence has increasingly captured public attention due to deadly school shootings. Controversy on school violence is demonstrated by a mixed picture of school safety and the lack of consensus on the definition of violence, which makes comparison of findings across studies difficult. This study extended the application of the Rasch model to…

Another Approach to Enhance Airline Safety: Using Management Safety Tools

NASA Technical Reports Server (NTRS)

Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

2006-01-01

The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

Safety of Carbamazepine Extended-Release Capsules Used in Combination with Other Psychotropic Medications for the Treatment of Bipolar I Disorder

PubMed Central

Weisler, Richard H.; Kalali, Amir H.; Cutler, Andrew J.; Gazda, Thomas D.; Ginsberg, Lawrence

2008-01-01

Objective To evaluate the safety and efficacy of carbamazepine extended-release capsules (CBZ-ERC) in combination with other psychotropic medications for the treatment of bipolar I disorder. Design In this Phase IIIb, open-label, eight-week, observational, polypharmacy study, adult subjects were started on CBZ-ERC 200mg and titrated over four weeks to optimal dose (1600mg/d maximum). Concomitant lithium and atypical antipsychotics (olanzapine, risperidone, quetiapine, aripiprazole) were permitted. Safety assessments included adverse events, laboratory parameters, physical examination, medication history, vital signs, and electrocardiogram. Efficacy measures included the Young Mania Rating Scale (YMRS), Hamilton Rating Scale for Depression (HAM-D), Montgomery-Åsberg Depression Rating Scale (MADRS), and Clinical Global Impressions Scale–Bipolar Version (CGI-BP). All data were summarized using descriptive statistics. Results Overall, 45 (84.9%) subjects reported treatment-emergent adverse events (TEAEs); most were mild or moderate in severity. The most commonly reported TEAEs were somnolence (n=14, 26.4%), sedation (n=12, 22.6%), dizziness (n=11, 20.8%), headache (n=9, 17.0%), and nausea (n=7, 13.2%). There were no clinically significant changes in vital signs, including weight. Mean changes in laboratory parameters were small, with values that were within the normal range for the majority of subjects. Few changes relative to screening for other safety parameters occurred. Mean total YMRS score decreased from baseline at each study visit. HAM-D and MADRS scores decreased from baseline at Weeks 4 and 8, and all three CGI-BP components (overall bipolar disorder, mania, and depression) improved during the study. Conclusion CBZ-ERC appears to be safe and effective for use in combination with atypical antipsychotics and lithium for treatment of bipolar I disorder. PMID:19727252

Outcomes of an extended-infusion piperacillin-tazobactam protocol implementation in a community teaching hospital adult intensive care unit.

PubMed

Schmees, Patrick M; Bergman, Scott J; Strader, Brandi D; Metzke, Megan E; Pointer, Sarah; Valenti, Kristine M

2016-06-01

The purpose of this study is to evaluate the outcome differences between patients receiving piperacillin-tazobactam pre- and post-implementation of an extended infusion dosing protocol in a community teaching hospital adult intensive care unit. On December 19th, 2011, extended infusion dosing of piperacillin-tazobactam was implemented at St. John's Hospital's intensive and cardiac care units (ICU/CCU) following IRB-approval. This is a historical case-control cohort study involving review of electronic medical charts of patients who received traditional or extended infusion therapy. Data was collected for patients that received piperacillin-tazobactam in the ICU/CCU from December 19th, 2010 through March 19th, 2011 for traditional infusion and from December 19th, 2011 through March 19th, 2012 for extended infusion. Primary endpoints were ICU/CCU mortality at discharge and length of stay. The study included 113 patients with 52 in the traditional-infusion group and 61 extended-infusion group. There was no statistically significant difference in the primary end-point of ICU/CCU mortality between the two groups (14.8% vs. 21.1%; p = 0.374). In the extended infusion group, there was a shorter length of ICU and CCU stay (8.32 vs. 12.06 days; p = 0.025) and shorter length of hospital stay (11.32 vs. 19.7 days; p = 0.006). The extended-infusion group showed a decrease in cost of therapy that was statistically significant ($120.21 vs. $155.17; p = 0.035). Adverse drug effects did not differ between the two study groups. This study showed that treatment with extended-infusion piperacillin-tazobactam therapy improved patient outcomes while maintaining patient safety and decreasing costs. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

78 FR 59906 - Pipeline Safety: Class Location Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-30

... 192 [Docket No. PHMSA-2013-0161] Pipeline Safety: Class Location Requirements AGENCY: Pipeline and... Location Requirements,'' seeking comments on whether integrity management program (IMP) requirements, or... for class location requirements. PHMSA has received two requests to extend the comment period to allow...

Role of champions in the implementation of patient safety practice change.

PubMed

Soo, Stephanie; Berta, Whitney; Baker, G Ross

2009-01-01

Practitioners of patient safety practice change agree that champions are central to the success of implementation. The clinical champion role is a concept that has been widely promoted yet empirically underdeveloped in health services literature. Questions remain as to who these champions are, what roles they play in patient safety practice change and what contexts serve to facilitate their efforts. This investigation used a multiple-case study design to critically examine the role of champions in the implementation of rapid response teams (RRTs), an innovative complex patient safety intervention, in two large urban acute care facilities. An analysis of interviews with key individuals involved in the RRT implementation process revealed a typology of the patient safety practice champion that extended beyond clinical personnel to include managerial and executive staff. Champions engaged to a varying extent in a number of core activities, including education, advocacy, relationship building and boundary spanning. Individuals became champions both through informal emergence and a combination of formal appointment and informal emergence. By identifying and elaborating upon specific features of the champion role, this study aims to expand the dialogue about champions for patient safety practice change.

Using Peer-Mediated Literacy-Based Behavioral Interventions to Increase First Aid Safety Skills in Students With Developmental Disabilities.

PubMed

Kearney, Kelly B; Brady, Michael P; Hall, Kalynn; Honsberger, Toby

2017-08-01

Many adolescents with developmental disabilities do not learn the safety skills needed to maintain physical well-being in domestic and community environments. Literacy-based behavioral interventions (LBBIs) that combine print, pictures, and behavioral rehearsal are effective for promoting acquisition and maintenance of self-care skills, but have not been investigated as safety skill intervention. Also, LBBIs have primarily been implemented by teachers and other professionals. In this study, a peer partner was taught to deliver an LBBI story to students so they would learn to perform a basic first aid routine: cleaning and dressing a wound. Results showed that students' accuracy with the first aid routine increased after a peer delivered the LBBI instructional package, and maintained after the peer stopped delivering it. This study demonstrates the effectiveness of the LBBI instructional package for teaching first aid safety skills, and extends previous research showing the efficacy of peers in delivering this intervention.

[Out of hospital emergencies towards a safety culture].

PubMed

Cano-del Pozo, M I; Obón-Azuara, B; Valderrama-Rodríguez, M; Revilla-López, C; Brosed-Yuste, C; Fajardo-Trasobares, E; Garcés-Baquero, P; Mateo-Clavería, J; Molina-Estrada, I; Perona-Flores, N; Salcedo-de Dios, S; Tomé-Rey, A

2014-01-01

The aim of this study is to measure the degree of safety culture (CS) among healthcare professional workers of an out-of-hospital Emergency Medical Service. Most patient safety studies have been conducted in relation to the hospital rather than pre-hospital Emergency Medical Services. The objective is to analyze the dimensions with lower scores in order to plan futures strategies. A descriptive study using the AHRQ (Agency for Healthcare Research and Quality) questionnaire. The questionnaire was delivered to all healthcare professionals workers of 061 Advanced Life Support Units of Aragón, during the month of August 2013. The response rate was 55%. Main strengths detected: an adequate number of staff (96%), good working conditions (89%), tasks supported from immediate superior (77%), teamwork climate (74%), and non-punitive environment to report adverse events (68%). Areas for improvement: insufficient training in patient safety (53%) and lack of feedback of incidents reported (50%). The opportunities for improvement identified focus on the training of professionals in order to ensure safer care, while extending the safety culture. Also, the implementation of a system of notification and registration of adverse events in the service is deemed necessary. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

Leader-member exchange: Moderating the health and safety outcomes of job insecurity.

PubMed

Probst, Tahira M; Jiang, Lixin; Graso, Maja

2016-02-01

Job insecurity has been repeatedly linked with poor employee health and safety outcomes. Although research on high quality leader-member exchange (LMX) has demonstrated many beneficial effects, no research to date has examined the extent to which positive LMX might attenuate those adverse health and safety-related consequences of job insecurity. The current study extends research in this area by specifically examining the buffering impact of LMX on the relationship between job insecurity and safety knowledge, reported accidents, and physical health conditions. Furthermore, the study also examines whether positive LMX mitigates the typically seen negative impact of job insecurity on supervisor satisfaction. The hypotheses were tested using survey data collected from 212 employees of a mine located in southwestern United States. As predicted, job insecurity was related to lower levels of supervisor satisfaction, more health ailments, and more workplace accidents, and was marginally related to lower levels of safety knowledge. Results indicated that LMX significantly attenuated these observed relationships. The quality of the dyadic relationship between supervisor and subordinate has a significant impact on the extent to which job insecurity is associated with adverse health and safety outcomes. Practical implications for supervisor behavior and developing high quality LMX are discussed in light of today's pervasive job insecurity. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

75 FR 55973 - Safety Zone; Illinois River, Mile 000.5 to 001.5

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-15

...-AA00 Safety Zone; Illinois River, Mile 000.5 to 001.5 AGENCY: Coast Guard, DHS. ACTION: Temporary final... River, Mile 000.5 to 001.5, extending the entire width of the river. This safety zone is needed to... 18, 2010 the City of Grafton will be conducting a land based fireworks display at mile 001.0 on the...

49 CFR 385.323 - May FMCSA extend the period under § 385.319(c) for a new entrant to take corrective action to...

Code of Federal Regulations, 2010 CFR

2010-10-01

...) for a new entrant to take corrective action to remedy its safety management practices? 385.323 Section....319(c) for a new entrant to take corrective action to remedy its safety management practices? (a... determines the new entrant is making a good faith effort to remedy its safety management practices. (b) FMCSA...

Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran.

PubMed

Agnelli, G; Eriksson, B I; Cohen, A T; Bergqvist, D; Dahl, O E; Lassen, M R; Mouret, P; Rosencher, N; Andersson, M; Bylock, A; Jensen, E; Boberg, B

2009-01-01

Ximelagatran, the first oral direct thrombin inhibitor, was shown to be an effective antithrombotic agent but was associated with potential liver toxicity after prolonged administration. The aim of the EXTEND study was to assess safety and efficacy of extended administration (35 days) of ximelagatran or enoxaparin for the prevention of venous thromboembolism after elective hip replacement and hip fracture surgery. A follow-up period, including assessment of liver enzymes (in particular alanine aminotransferase; ALAT), until post-operative day 180 was planned, with visits at days 56 and 180. Randomization and administration of study drugs were stopped following a report of serious liver injury occurring 3 weeks after completion of ximelagatran treatment. At the time of study termination, 1158 patients had been randomized and 641 had completed the 35-day treatment; with 303 ximelagatran and 265 enoxaparin patients remaining in the study through to the day 56 follow-up visit. Overall, 58 patients showed an ALAT increase to >2x upper limit of normal: 31 treated with enoxaparin, 27 with ximelagatran. Three ximelagatran patients also showed symptoms potentially related to liver toxicity. Eleven ximelagatran patients showed an ALAT increase after study treatment ended. The clinical development of ximelagatran was terminated and the drug withdrawn from the market. Evaluation of the relative efficacy of the two treatments as specified in the protocol was impossible due to the premature termination of the study. Prolonged administration of ximelagatran was associated with an increased risk of liver toxicity. In a substantial proportion of patients, ALAT increase occurred after treatment withdrawal. The findings seen with ximelagatran should be considered when designing studies with new antithrombotic agents.

Assessing Knowledge Retention of an Immersive Serious Game vs. a Traditional Education Method in Aviation Safety.

PubMed

Chittaro, Luca; Buttussi, Fabio

2015-04-01

Thanks to the increasing availability of consumer head-mounted displays, educational applications of immersive VR could now reach to the general public, especially if they include gaming elements (immersive serious games). Safety education of citizens could be a particularly promising domain for immersive serious games, because people tend not to pay attention to and benefit from current safety materials. In this paper, we propose an HMD-based immersive game for educating passengers about aviation safety that allows players to experience a serious aircraft emergency with the goal of surviving it. We compare the proposed approach to a traditional aviation safety education method (the safety card) used by airlines. Unlike most studies of VR for safety knowledge acquisition, we do not focus only on assessing learning immediately after the experience but we extend our attention to knowledge retention over a longer time span. This is a fundamental requirement, because people need to retain safety procedures in order to apply them when faced with danger. A knowledge test administered before, immediately after and one week after the experimental condition showed that the immersive serious game was superior to the safety card. Moreover, subjective as well as physiological measurements employed in the study showed that the immersive serious game was more engaging and fear-arousing than the safety card, a factor that can contribute to explain the obtained superior retention, as we discuss in the paper.

Australian fly-in, fly-out operations: Impacts on communities, safety, workers and their families.

PubMed

Langdon, Rebecca R; Biggs, Herbert C; Rowland, Bevan

2016-10-17

Australia's mineral, resource and infrastructure sectors continues to expand as operations in rural and remote locations increasingly rely on fly-in, fly-out or drive-in, drive-out workforces in order to become economically competitive. The issues in effectively managing these workforces are becoming more apparent with reported high amounts of turnover and concerns for safety and performance. The issues presented include a range of physical, mental, psychosocial, safety and community challenges. This review aims to consolidate a range of research conducted to communicate potential challenges for industry in relation to a wide variety of issues when engaging and using FIFO/DIDO workforces which includes compressed working schedule design (work schedules), working hours, fatigue, safety performance, employee wellbeing, turnover, psychosocial relationships and community concerns. A comprehensive literature review was performed using EBSCOhost, PubMed and google scholar, with a focus on FIFO or DIDO workforces engaged within the resources sector. Search terms were kept broad in order to capture all national and international research conducted and included: "fly-in, fly-out" "FIFO" "DIDO" "drive-in, drive-out" "mining". There was no date restriction included in the search. Many of the studies were focused on sleep quality, fatigue and the influence of lowered safety performance while at work, presenting an increased risk for health and safety. These issues may be exacerbated for the FIFO workforce when linked to additional research surrounding the extended periods of absence from families influencing workers personal relationships, psychological wellbeing, job satisfaction and the reported high amounts of turnover within the industry. Taken together, this presents a unique implication for the management and continued use of FIFO workforces when considering balancing safety and performance with economic viability of production and operations. The issues of long working hours, fatigue, turnover and job satisfaction are not new to the management of workers. However, FIFO workforces appear to be at an increased risk physically and mentally due to a culmination of other influences, such as extended and frequent periods of absence from friends and families which contribute to feelings of isolation and lowered psychological wellbeing. FIFO workers and their families, engage in a unique lifestyle, rarely are other workers subjected to long hours and compressed work weeks while separated or isolated from their families for extended periods of time. Recently, FIFO interest has shifted to understanding the influences on employee engagement, satisfaction, retention and safety. Considering the management of FIFO workforces from a holistic perspective incorporating all of the issues impacting on these workers may assist to ensure the challenges associated with FIFO employment are understood, addressed and communicated to workers and their families is crucial for safety and health.

Recording and automated analysis of naturalistic bioptic driving.

PubMed

Luo, Gang; Peli, Eli

2011-05-01

People with moderate central vision loss are legally permitted to drive with a bioptic telescope in 39 US states and the Netherlands, but the safety of bioptic driving remains highly controversial. There is no scientific evidence about bioptic use and its impact on safety. We propose searching for evidence by recording naturalistic driving activities in patients' cars. In a pilot study we used an analogue video system to record two bioptic drivers' daily driving activities for 10 and 5 days, respectively. In this technical report, we also describe our novel digital system that collects vehicle manoeuvre information and enables recording over more extended periods, and discuss our approach to analyzing the vast amount of data. Our observations of telescope use by the pilot subjects were quite different from their reports in a previous survey. One subject used the telescope only seven times in nearly 6 h of driving. For the other subject, the average interval between telescope use was about 2 min, and Mobile (cell) phone use in one trip extended the interval to almost 5 min. We demonstrate that computerized analysis of lengthy recordings based on video, GPS, acceleration, and black box data can be used to select informative segments for efficient off-line review of naturalistic driving behaviours. The inconsistency between self reports and objective data as well as infrequent telescope use underscores the importance of recording bioptic driving behaviours in naturalistic conditions over extended periods. We argue that the new recording system is important for understanding bioptic use behaviours and bioptic driving safety. © 2011 The College of Optometrists.

Recording and automated analysis of naturalistic bioptic driving

PubMed Central

Luo, Gang; Peli, Eli

2011-01-01

Purpose People with moderate central vision loss are legally permitted to drive with a bioptic telescope in 39 US states and the Netherlands, but the safety of bioptic driving remains highly controversial. There is no scientific evidence about bioptic use and its impact on safety. We propose searching for evidence by recording naturalistic driving activities in patients' cars. Methods In a pilot study we used an analogue video system to record two bioptic drivers' daily driving activities for 10 and 5 days, respectively. In this technical report, we also describe our novel digital system that collects vehicle maneuver information and enables recording over more extended periods, and discuss our approach to analyzing the vast amount of data. Results Our observations of telescope use by the pilot subjects were quite different from their reports in a previous survey. One subject used the telescope only 7 times in nearly 6 hours of driving. For the other subject, the average interval between telescope use was about 2 minutes, and cell phone use in one trip extended the interval to almost 5 minutes. We demonstrate that computerized analysis of lengthy recordings based on video, GPS, acceleration, and black box data can be used to select informative segments for efficient off-line review of naturalistic driving behaviors. Conclusions The inconsistency between self reports and objective data as well as infrequent telescope use underscores the importance of recording bioptic driving behaviors in naturalistic conditions over extended periods. We argue that the new recording system is important for understanding bioptic use behaviors and bioptic driving safety. PMID:21410498

ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

ClinicalTrials.gov

2012-04-28

The Primary Study Objective is to Assess the Efficacy and; Safety of Extended 4-week Heparin Prophylaxis Compared to; Prophylaxis Given for 8±2 Days After Planned Laparoscopic; Surgery for Colorectal Cancer.; The Clinical Benefit Will be Evaluated as the Difference in; the Incidence of VTE or VTE-related Death Occurring Within 30 Days; From Surgery in the Two Study Groups.

Application of a functional mathematical index (FMI) for predicting effects of the composition of jujube fruit on nutritional quality and health

USDA-ARS?s Scientific Manuscript database

In the present study, we extend the concept of a Functional Mathematical Index (FMI) for the assessment and prediction of food quality and safety of jujube fruit, a medicinal food widely consumed in Asian countries. In this study the index has been applied to one field-grown jujube fruit harvested a...

Influence of safety measures on the risks of transporting dangerous goods through road tunnels.

PubMed

Saccomanno, Frank; Haastrup, Palle

2002-12-01

Quantitative risk assessment (QRA) models are used to estimate the risks of transporting dangerous goods and to assess the merits of introducing alternative risk reduction measures for different transportation scenarios and assumptions. A comprehensive QRA model recently was developed in Europe for application to road tunnels. This model can assess the merits of a limited number of "native safety measures." In this article, we introduce a procedure for extending its scope to include the treatment of a number of important "nonnative safety measures" of interest to tunnel operators and decisionmakers. Nonnative safety measures were not included in the original model specification. The suggested procedure makes use of expert judgment and Monte Carlo simulation methods to model uncertainty in the revised risk estimates. The results of a case study application are presented that involve the risks of transporting a given volume of flammable liquid through a 10-km road tunnel.

Effects of extended work shifts on employee fatigue, health, satisfaction, work/family balance, and patient safety.

PubMed

Estryn-Béhar, Madeleine; Van der Heijden, Beatrice I J M

2012-01-01

12-hour shifts are quickly spreading in Europe. From our multivariate analysis concerning 25,924 European nurses, including twenty explanatory variables simultaneously, we found that work schedule itself is not a major determinant factor. Nurses aim to choose or accept night shifts or 12-hour shift in order to reduce their work/home conflicts, however, at the expense of the patient's safety, as well as their own health and safety. Therefore, it is important to develop measures, such as extended child care, association of nurses to the elaboration of their rota, 9- or 10-hour shifts in the afternoon, allowing naps during night shifts, and reduction of changing shifts with short notice. Work schedules must be organized in order to allow time for shift handover, social support and team building.

Guide for Resurfacing, Restoration and Rehabilitation of Highways and Streets (Other than Freeways)

DOT National Transportation Integrated Search

1995-04-01

The primary purpose of R-R-R projects is to provide a better riding surface, enhance safety, : improve operating conditions, and to preserve and extend the service life of existing non-freeway : facilities. Highway safety is an essential element of R...

Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential.

PubMed

Hale, Martin E; Ma, Yuju; Malamut, Richard

2016-01-01

To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology. Phase 3, multicenter, open-label extension. Fifty-six US centers. Adults with chronic low back pain completing a 12-week placebocontrolled study of abuse-deterrent hydrocodone ER were eligible. One hundred eighty-two patients enrolled and received ≥1 dose of study drug, 170 entered openlabel treatment, and 136 completed the study. Patients receiving hydrocodone ER in the 12-week, placebo-controlled study continued their previous dose unless adjustment was needed; those previously receiving placebo (n=78) underwent dose titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients received 22 weeks of open-label treatment. adverse events (AEs). Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. AEs were reported for 65/182 (36 percent) patients during dose titration/ adjustment and 88/170 (52 percent) during open-label treatment. No treatmentrelated serious AEs were reported. There were no clinically meaningful trends in other safety assessments, including physical examinations and pure tone audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a severe AE of neurosensory deafness that was considered treatment related. Mean WPI and API remained steady throughout open-label treatment. Six (3 percent) patients reported medication loss, and 5 (3 percent) reported diversion. Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258

78 FR 66009 - Determination That INVEGA (Paliperidone) Extended-Release Tablet, 12 Milligrams, Was Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-P-0775... Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that INVEGA (paliperidone) extended-release tablet...

75 FR 24501 - Fatigue Tolerance Evaluation of Metallic Structures; Extension of Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-05

... notice responds to a request from the European Aviation Safety Agency (EASA) to extend the comment period... European Aviation Safety Agency (EASA) addressed the joint interest in this rulemaking objective on the... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 27 [Docket No. FAA-2009...

An original bill to extend National Highway Traffic Safety Administration and Federal Motor Carrier Safety Administration authorizations funded by the Highway Trust Fund, and for other purposes.

THOMAS, 111th Congress

Sen. Rockefeller, John D., IV [D-WV

2009-07-22

Senate - 07/22/2009 Placed on Senate Legislative Calendar under General Orders. Calendar No. 123. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

78 FR 25346 - Petition for Waiver of Compliance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 232, Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment; End-of-Train Devices... five cycle trains and requests to extend the required mileage interval of the Class 1A brake tests of...

Extended acute toxicity study of (188) Re-liposome in rats.

PubMed

Chi-Mou, Liu; Chia-Che, Tsai; Chia-Yu, Yu; Wan-Chi, Lee; Chung-Li, Ho; Tsui-Jung, Chang; Chih-Hsien, Chang; Te-Wei, Lee

2013-09-01

Liposomes can selectively target cancer sites and carry payloads, thereby improving diagnostic and therapeutic effectiveness as well as reducing toxicity. To evaluate therapeutic strategies, it is essential to use animal models reflecting important safety aspects before clinical application. As our previous study found that a high dosage (185 of MBq) of (188) Re-N,N-bis (2-mercaptoethyl)-N',N'-diethylethylenediamine-labeled pegylated liposomes ((188) Re-liposome) induced a decrease in white blood cell (WBC) count in Sprague-Dawley rats 7 days postinjection, the objective of the present study was to investigate extended acute radiotoxicity of (188) Re-liposome. Rats were administered via intravenous (i.v.) injection with (188) Re-liposome (185, 55.5 and 18.5 MBq), normal saline as a blank control or non-radioactive liposome as a vehicle control. Mortality, clinical signs, food consumption, body weights, urinary, biochemical and hematological analyzes were examined. In addition, gross necropsy and histopathological examinations were also performed at the end of the follow-up period. None of the rats died and no clinical sign was observed during the 28-day study period. Only male rats receiving (188) Re-liposome at a high dosage (185 MBq) displayed a slight weight loss compared with the control rats. In both male and female rats, the WBC counts of both high-dose and medium-dose (55.5 MBq) groups reduced significantly 7 days postinjection, but recovered to the normal range on Study Day 29. There was no significant difference in urinary analyzes, biochemical parameters and histopathological assessments between the (188) Re-liposome-treated and control groups. The information generated from the present study on extended acute toxicity of (188) Re-liposome will serve as a safety reference for radiopharmaceuticals in early-phase clinical trials. Copyright © 2012 John Wiley & Sons, Ltd.

The role of quantitative safety evaluation in regulatory decision making of drugs.

PubMed

Chakravarty, Aloka G; Izem, Rima; Keeton, Stephine; Kim, Clara Y; Levenson, Mark S; Soukup, Mat

2016-01-01

Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.

Video-assisted thoracic surgery for left upper lobectomy for complex lesions: how to extend the indication with optimal safety?

PubMed

Bayard, Nathanaël Frank; Barnett, Stephen Arthur; Rinieri, Philippe; Melki, Jean; Peillon, Christophe; Baste, Jean Marc

2016-08-01

The feasibility of extending the VATS approach to locally advanced NSCLC has been described with good clinical outcome. These complex resections are still technically challenging and patient safety must remain the highest priority. In this article, we describe our routine VATS approach for left upper lobectomy in proximal, locally advanced lesions. Both surgical and anaesthesiology teams are trained during simulation sessions to respond rapidly in case of urgent thoracotomy. Encircling arterial and venous vessels allow control of inadvertent bleeding during difficult dissection. Also, whenever needed the double vessel control technique is a time saver waiting for conversion to thoracotomy.

Operational Performance Risk Assessment in Support of A Supervisory Control System

DOE Office of Scientific and Technical Information (OSTI.GOV)

Denning, Richard S.; Muhlheim, Michael David; Cetiner, Sacit M.

Supervisory control system (SCS) is developed for multi-unit advanced small modular reactors to minimize human interventions in both normal and abnormal operations. In SCS, control action decisions made based on probabilistic risk assessment approach via Event Trees/Fault Trees. Although traditional PRA tools are implemented, their scope is extended to normal operations and application is reversed; success of non-safety related system instead failure of safety systems this extended PRA approach called as operational performance risk assessment (OPRA). OPRA helps to identify success paths, combination of control actions for transients and to quantify these success paths to provide possible actions without activatingmore » plant protection system. In this paper, a case study of the OPRA in supervisory control system is demonstrated within the context of the ALMR PRISM design, specifically power conversion system. The scenario investigated involved a condition that the feed water control valve is observed to be drifting to the closed position. Alternative plant configurations were identified via OPRA that would allow the plant to continue to operate at full or reduced power. Dynamic analyses were performed with a thermal-hydraulic model of the ALMR PRISM system using Modelica to evaluate remained safety margins. Successful recovery paths for the selected scenario are identified and quantified via SCS.« less

Tyre-road grip coefficient assessment - Part II: online estimation using instrumented vehicle, extended Kalman filter, and neural network

NASA Astrophysics Data System (ADS)

Luque, Pablo; Mántaras, Daniel A.; Fidalgo, Eloy; Álvarez, Javier; Riva, Paolo; Girón, Pablo; Compadre, Diego; Ferran, Jordi

2013-12-01

The main objective of this work is to determine the limit of safe driving conditions by identifying the maximal friction coefficient in a real vehicle. The study will focus on finding a method to determine this limit before reaching the skid, which is valuable information in the context of traffic safety. Since it is not possible to measure the friction coefficient directly, it will be estimated using the appropriate tools in order to get the most accurate information. A real vehicle is instrumented to collect information of general kinematics and steering tie-rod forces. A real-time algorithm is developed to estimate forces and aligning torque in the tyres using an extended Kalman filter and neural networks techniques. The methodology is based on determining the aligning torque; this variable allows evaluation of the behaviour of the tyre. It transmits interesting information from the tyre-road contact and can be used to predict the maximal tyre grip and safety margin. The maximal grip coefficient is estimated according to a knowledge base, extracted from computer simulation of a high detailed three-dimensional model, using Adams® software. The proposed methodology is validated and applied to real driving conditions, in which maximal grip and safety margin are properly estimated.

Patients' and families' perspectives of patient safety at the end of life: a video-reflexive ethnography study.

PubMed

Collier, Aileen; Sorensen, Ros; Iedema, Rick

2016-02-01

The aim of this study was to investigate patients' and families' perspectives of safety and quality in the setting of a life-limiting illness. Data reported here were generated from a qualitative study using video-reflexive ethnographic methodology. Data were collected over 18 months and generated through participant observation, shadowing of clinicians, field-interviews and semi-structured interviews with patients and families. The study was conducted at two hospital sites in Sydney, Australia and in patients' homes. Patients with an advanced life-limiting illness (n = 29) ranging in age between 27 and 89 years and family members (n = 5) participated in the study. Patient safety remains important to dying patients and families. For dying people, iatrogenic harm is not regarded as 'one off' incidents. Rather, harm is experienced as a result of an unfolding series of negative events. Critically, iatrogenic harm is emotional, social and spiritual and not solely technical-clinical misadventure and is inextricably linked with feeling unsafe. Thus, patient safety extends beyond narrowly defined technical-clinical parameters to include interpersonal safety. Current approaches to patient safety do not address fully the needs of dying patients and their families. Patients and their families regard poor communication with and by health professionals to be harmful in and of itself. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Transport aircraft accident dynamics

NASA Technical Reports Server (NTRS)

Cominsky, A.

1982-01-01

A study was carried out of 112 impact survivable jet transport aircraft accidents (world wide) of 27,700 kg (60,000 lb.) aircraft and up extending over the last 20 years. This study centered on the effect of impact and the follow-on events on aircraft structures and was confined to the approach, landing and takeoff segments of the flight. The significant characteristics, frequency of occurrence and the effect on the occupants of the above data base were studied and categorized with a view to establishing typical impact scenarios for use as a basis of verifying the effectiveness of potential safety concepts. Studies were also carried out of related subjects such as: (1) assessment of advanced materials; (2) human tolerance to impact; (3) merit functions for safety concepts; and (4) impact analysis and test methods.

Extended Safety, Immunogenicity and Efficacy of a Blood-Stage Malaria Vaccine in Malian Children: 24-Month Follow-Up of a Randomized, Double-Blinded Phase 2 Trial

PubMed Central

Laurens, Matthew B.; Thera, Mahamadou A.; Coulibaly, Drissa; Ouattara, Amed; Kone, Abdoulaye K.; Guindo, Ando B.; Traore, Karim; Traore, Idrissa; Kouriba, Bourema; Diallo, Dapa A.; Diarra, Issa; Daou, Modibo; Dolo, Amagana; Tolo, Youssouf; Sissoko, Mahamadou S.; Niangaly, Amadou; Sissoko, Mady; Takala-Harrison, Shannon; Lyke, Kirsten E.; Wu, Yukun; Blackwelder, William C.; Godeaux, Olivier; Vekemans, Johan; Dubois, Marie-Claude; Ballou, W. Ripley; Cohen, Joe; Dube, Tina; Soisson, Lorraine; Diggs, Carter L.; House, Brent; Bennett, Jason W.; Lanar, David E.; Dutta, Sheetij; Heppner, D. Gray; Plowe, Christopher V.; Doumbo, Ogobara K.

2013-01-01

Background The FMP2.1/AS02A candidate malaria vaccine was tested in a Phase 2 study in Mali. Based on results from the first eight months of follow-up, the vaccine appeared well-tolerated and immunogenic. It had no significant efficacy based on the primary endpoint, clinical malaria, but marginal efficacy against clinical malaria in secondary analyses, and high allele-specific efficacy. Extended follow-up was conducted to evaluate extended safety, immunogenicity and efficacy. Methods A randomized, double-blinded trial of safety, immunogenicity and efficacy of the candidate Plasmodium falciparum apical membrane antigen 1 (AMA1) vaccine FMP2.1/AS02A was conducted in Bandiagara, Mali. Children aged 1–6 years were randomized in a 1∶1 ratio to receive FMP2.1/AS02A or control rabies vaccine on days 0, 30 and 60. Using active and passive surveillance, clinical malaria and adverse events as well as antibodies against P. falciparum AMA1 were monitored for 24 months after the first vaccination, spanning two malaria seasons. Findings 400 children were enrolled. Serious adverse events occurred in nine participants in the FMP2.1/AS02A group and three in the control group; none was considered related to study vaccination. After two years, anti-AMA1 immune responses remained significantly higher in the FMP2.1/AS02A group than in the control group. For the entire 24-month follow-up period, vaccine efficacy was 7.6% (p = 0.51) against first clinical malaria episodes and 9.9% (p = 0.19) against all malaria episodes. For the final 16-month follow-up period, vaccine efficacy was 0.9% (p = 0.98) against all malaria episodes. Allele-specific efficacy seen in the first malaria season did not extend into the second season of follow-up. Interpretation Allele-specific vaccine efficacy was not sustained in the second malaria season, despite continued high levels of anti-AMA1 antibodies. This study presents an opportunity to evaluate correlates of partial protection against clinical malaria that waned during the second malaria season. Trial Registration Clinicaltrials.gov NCT00460525 NCT00460525 PMID:24260195

Barriers and facilitators to hospital pharmacists' engagement in medication safety activities: a qualitative study using the theoretical domains framework.

PubMed

Mekonnen, Alemayehu B; McLachlan, Andrew J; Brien, Jo-Anne E; Mekonnen, Desalew; Abay, Zenahebezu

2018-01-01

Hospital pharmacists play a central role in medication safety activities. However, in Ethiopia, this role has been launched recently and little is known regarding the current status of this extended service. Using the Theoretical Domains Framework (TDF), we aimed to identify the barriers and facilitators to hospital pharmacists' engagement in medication safety activities across various public hospitals in the Amhara region of Ethiopia. Eight focus group discussions, using an interview guide that was drawn upon the TDF, were conducted with 44 hospital pharmacists to explore their beliefs regarding their involvement in clinical services. Group discussions were audio-recorded, transcribed verbatim, and analysed using directed content analysis based on the TDF. Relevant domains were identified by applying relevance criteria to each of the domains in the TDF. Content analysis revealed six domains that influence hospital pharmacists' engagement in medication safety activities. These domains included 'Knowledge', 'Skills', 'Environmental context and resources', 'Motivations and goals', 'Social influences' and 'Social/professional role'. Most hospital pharmacists believed knowledge gap was an issue, as was the lack of training and supportive skills although some expressed as they were competent enough for their skills in identifying medication related problems. Most participants were very much enthusiastic for their extended roles and were positive towards the future of the profession; however, competing priorities along with the lack of remuneration and awareness (of other health care professionals) regarding the profession's role were barriers to service delivery. There were also a number of resource constraints, such as staffing, infrastructure and government funding, and acceptance rate of pharmacist's recommendation that were likely to influence the clinical practice of pharmacists. Using the TDF , this study identified a wide range of barriers and facilitators to hospital pharmacists' engagement in medication safety activities in resource-limited settings. There existed considerable interrelationships between domains that were perceived to influence hospital pharmacists' behaviours, and this may assist in designing behaviour change interventions that target common behavioural domains.

76 FR 53820 - Safety Zone; Missouri River From the Border Between Montana and North Dakota

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

..., DHS. ACTION: Temporary final rule; change of effective period. SUMMARY: The Coast Guard is extending... continued and uninterrupted protection of levees and personnel involved in ongoing high water response... personnel involved in ongoing high water response. Failing to extend the effective dates for this rule...

The efficacy and safety of extended-release methylphenidate following traumatic brain injury: a randomised controlled pilot study.

PubMed

Dymowski, Alicia R; Ponsford, Jennie L; Owens, Jacqueline A; Olver, John H; Ponsford, Michael; Willmott, Catherine

2017-06-01

To investigate the feasibility, safety and efficacy of extended-release methylphenidate in enhancing processing speed, complex attentional functioning and everyday attentional behaviour after traumatic brain injury. Seven week randomised, placebo-controlled, double-blind, parallel pilot study. Inpatient and outpatient Acquired Brain Injury Rehabilitation Program. Eleven individuals with reduced processing speed and/or attention deficits following complicated mild to severe traumatic brain injury. Participants were allocated using a blocked randomisation schedule to receive daily extended-release methylphenidate (Ritalin ® LA at a dose of 0.6 mg/kg) or placebo (lactose) in identical capsules. Tests of processing speed and complex attention, and ratings of everyday attentional behaviour were completed at baseline, week 7 (on-drug), week 8 (off-drug) and 9 months follow-up. Vital signs and side effects were monitored from baseline to week 8. Three percent ( n = 11) of individuals screened participated (mean post-traumatic amnesia duration = 63.80 days, SD = 45.15). Results were analysed for six and four individuals on methylphenidate and placebo, respectively. Groups did not differ on attentional test performance or relative/therapist ratings of everyday attentional behaviour. One methylphenidate participant withdrew due to difficulty sleeping. Methylphenidate was associated with trends towards increased blood pressure and reported anxiety. Methylphenidate was not associated with enhanced processing speed, attentional functioning or everyday attentional behaviour after traumatic brain injury. Alternative treatments for attention deficits after traumatic brain injury should be explored given the limited feasibility of methylphenidate in this population.

Unit: Science and Safety, Inspection Set, National Trial Print.

ERIC Educational Resources Information Center

Australian Science Education Project, Toorak, Victoria.

This unit, a trial version prepared by the Australian Science Education Project, is intended to create in students an awareness of the potential hazards of a science room, to help build confidence by teaching safe techniques of apparatus manipulation, and to demonstrate the utility of planning work thoroughly. The safety principles are extended to…

30 CFR 75.1101-21 - Back-up water system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Back-up water system. 75.1101-21 Section 75.1101-21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... water system. One fire hose outlet together with a length of hose capable of extending to the belt drive...

30 CFR 75.1101-21 - Back-up water system.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Back-up water system. 75.1101-21 Section 75.1101-21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... water system. One fire hose outlet together with a length of hose capable of extending to the belt drive...

Extended Editorial: Research and Education in Reliability, Maintenance, Quality Control, Risk and Safety.

ERIC Educational Resources Information Center

Ramalhoto, M. F.

1999-01-01

Introduces a special theme journal issue on research and education in quality control, maintenance, reliability, risk analysis, and safety. Discusses each of these theme concepts and their applications to naval architecture, marine engineering, and industrial engineering. Considers the effects of the rapid transfer of research results through…

33 CFR 165.14-1414 - Safety Zones; Hawaiian Islands Commercial Harbors; HI.

Code of Federal Regulations, 2014 CFR

2014-07-01

... harbors, or all of these harbors, dependent upon details in the tsunami warning. These safety zones extend... period. Paragraph (b) of this section will be enforced when a tsunami warning has been issued for the... Coast Guard's Homeport Web site. Following the passage of the tsunami or tsunami threat and harbor...

30 CFR 75.1101-21 - Back-up water system.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Back-up water system. 75.1101-21 Section 75.1101-21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... water system. One fire hose outlet together with a length of hose capable of extending to the belt drive...

30 CFR 75.1101-21 - Back-up water system.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Back-up water system. 75.1101-21 Section 75.1101-21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... water system. One fire hose outlet together with a length of hose capable of extending to the belt drive...

30 CFR 75.1101-21 - Back-up water system.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Back-up water system. 75.1101-21 Section 75.1101-21 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... water system. One fire hose outlet together with a length of hose capable of extending to the belt drive...

Building the vision, a series of AZTech ITS model deployment success stories for the Phoenix metropolitan area : number eight : rapid response, improving communications between traffic management and emergency SVCS

DOT National Transportation Integrated Search

1998-01-01

Improving safety is an essential element of AZTech's mission. By extending the use of advanced communications technology and integrating individual traffic management systems, AZTech facilitates : safety on the roadways. To improve the management of ...

77 FR 75676 - Standard Review Plan for Review of Fuel Cycle Facility License Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0220] Standard Review Plan for Review of Fuel Cycle... Review of a License Application for a Fuel Cycle Facility.'' The NRC is extending the public comment... of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards. [FR Doc. 2012...

78 FR 19715 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1153] Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and...: The Food and Drug Administration (FDA) is extending the comment period for the notice entitled...

Proceedings of the Sixth NASA Langley Formal Methods (LFM) Workshop

NASA Technical Reports Server (NTRS)

Rozier, Kristin Yvonne (Editor)

2008-01-01

Today's verification techniques are hard-pressed to scale with the ever-increasing complexity of safety critical systems. Within the field of aeronautics alone, we find the need for verification of algorithms for separation assurance, air traffic control, auto-pilot, Unmanned Aerial Vehicles (UAVs), adaptive avionics, automated decision authority, and much more. Recent advances in formal methods have made verifying more of these problems realistic. Thus we need to continually re-assess what we can solve now and identify the next barriers to overcome. Only through an exchange of ideas between theoreticians and practitioners from academia to industry can we extend formal methods for the verification of ever more challenging problem domains. This volume contains the extended abstracts of the talks presented at LFM 2008: The Sixth NASA Langley Formal Methods Workshop held on April 30 - May 2, 2008 in Newport News, Virginia, USA. The topics of interest that were listed in the call for abstracts were: advances in formal verification techniques; formal models of distributed computing; planning and scheduling; automated air traffic management; fault tolerance; hybrid systems/hybrid automata; embedded systems; safety critical applications; safety cases; accident/safety analysis.

The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

PubMed Central

Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

2015-01-01

Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240

Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial.

PubMed

Hull, Russell D; Schellong, Sebastian M; Tapson, Victor F; Monreal, Manuel; Samama, Meyer-Michel; Nicol, Philippe; Vicaut, Eric; Turpie, Alexander G G; Yusen, Roger D

2010-07-06

Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients. To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients. Randomized, parallel, placebo-controlled trial. Randomization was computer-generated. Allocation was centralized. Patients, caregivers, and outcome assessors were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00077753) SETTING: 370 sites in 20 countries across North and South America, Europe, and Asia. Acutely ill medical patients 40 years or older with recently reduced mobility (bed rest or sedentary without [level 1] or with [level 2] bathroom privileges). Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors (age >75 years, history of VTE, or active or previous cancer) after interim analyses suggested lower-than-expected VTE rates. Enoxaparin, 40 mg/d subcutaneously (2975 patients), or placebo (2988 patients), for 28 +/- 4 days after receiving open-label enoxaparin for an initial 10 +/- 4 days. Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose. Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference favoring enoxaparin, -1.53% [95.8% CI, -2.54% to -0.52%]). Enoxaparin increased major bleeding events (0.8% vs. 0.3%; absolute risk difference favoring placebo, 0.51% [95% CI, 0.12% to 0.89%]). The benefits of extended-duration enoxaparin seemed to be restricted to women, patients older than 75 years, and those with level 1 immobility. Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial. Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women. Sanofi-aventis.

Models Extracted from Text for System-Software Safety Analyses

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2010-01-01

This presentation describes extraction and integration of requirements information and safety information in visualizations to support early review of completeness, correctness, and consistency of lengthy and diverse system safety analyses. Software tools have been developed and extended to perform the following tasks: 1) extract model parts and safety information from text in interface requirements documents, failure modes and effects analyses and hazard reports; 2) map and integrate the information to develop system architecture models and visualizations for safety analysts; and 3) provide model output to support virtual system integration testing. This presentation illustrates the methods and products with a rocket motor initiation case.

A Roadmap for Aircraft Engine Life Extending Control

NASA Technical Reports Server (NTRS)

Guo, Ten-Huei

2001-01-01

The concept of Aircraft Engine Life Extending Control is introduced. A brief description of the tradeoffs between performance and engine life are first explained. The overall goal of the life extending controller is to reduce the engine operating cost by extending the on-wing engine life while improving operational safety. The research results for NASA's Rocket Engine life extending control program are also briefly described. Major building blocks of the Engine Life Extending Control architecture are examined. These blocks include: life prediction models, engine operation models, stress and thermal analysis tools, control schemes, and intelligent control systems. The technology areas that would likely impact the successful implementation of an aircraft engine life extending control are also briefly described. Near, intermediate, and long term goals of NASA's activities are also presented.

Effectiveness, safety and feasibility of extended-release naltrexone for opioid dependence: a 9-month follow-up to a 3-month randomized trial.

PubMed

Solli, Kristin Klemmetsby; Latif, Zill-E-Huma; Opheim, Arild; Krajci, Peter; Sharma-Haase, Kamni; Benth, Jūratė Šaltytė; Tanum, Lars; Kunoe, Nikolaj

2018-05-28

This is a follow-up study of a previously published randomized clinical trial conducted in Norway that compared extended-release naltrexone (XR-NTX) to buprenorphine-naloxone (BP-NLX) over 3 months. At the conclusion of the trial, participants were offered their choice of study medication for an additional 9 months. While BP-NLX was available at no cost through opioid maintenance treatment programmes, XR-NTX was available only through study participation, accounting for why almost all participants chose XR-NTX in the follow-up. The aim of this follow-up study was to compare differences in outcome between adults with opioid dependence continuing XR-NTX and those inducted on XR-NTX for a 9-month period, on measures of effectiveness, safety and feasibility. In this prospective cohort study, participants were either continuing XR-NTX, changed from BP-NLX to XR-NTX or re-included into the study and inducted on XR-NTX treatment. Five urban, out-patient addiction clinics in Norway. Opioid-dependent adults continuing (n = 54) or inducted on (n = 63) XR-NTX. XR-NTX administrated as intramuscular injections (380 mg) every fourth week. Data on retention, use of heroin and other illicit substances, opioid craving, treatment satisfaction, addiction-related problems and adverse events were reported every fourth week. Nine-month follow-up completion rates were 51.9% among participants continuing XR-NTX in the follow-up and 47.6% among those inducted on XR-NTX. Opioid abstinence rates were, respectively, 53.7 and 44.4%. No significant group differences were found in use of heroin and other opioids. Opioid-dependent individuals who elect to switch from buprenorphine-naltrexone treatment after 3 months to extended-release naltrexone treatment for 9 months appear to experience similar treatment completion and abstinence rates and similar adverse event profiles to individuals who had been on extended-release naltrexone from the start of treatment. © 2018 Society for the Study of Addiction.

Financial Management: Extending the Financial Statements Audit Requirement of the CFO Act to Additional Federal Agencies

DTIC Science & Technology

2002-05-14

Defense Nuclear Facilities Safety Board has balance-sheet-only audits every 3 to 5 years, most recently for fiscal year 1997. It did not prepare fiscal...associated with the agency’s operations were the most important factors to Have had financial statements audits Defense Nuclear Facilities Safety...audits, the International Trade Commission and the Defense Nuclear Facilities Safety Board, did not have financial statements audits for fiscal year

Sleep and Alertness in Medical Interns and Residents: An Observational Study on the Role of Extended Shifts

PubMed Central

Dinges, David F.; Shea, Judy A.; Small, Dylan S.; Zhu, Jingsan; Norton, Laurie; Ecker, Adrian J.; Novak, Cristina; Bellini, Lisa M.; Volpp, Kevin G.

2017-01-01

Abstract Study Objectives: Fatigue from sleep loss is a risk to physician and patient safety, but objective data on physician sleep and alertness on different duty hour schedules is scarce. This study objectively quantified differences in sleep duration and alertness between medical interns working extended overnight shifts and residents not or rarely working extended overnight shifts. Methods: Sleep–wake activity of 137 interns and 87 PGY-2/3 residents on 2-week Internal Medicine and Oncology rotations was assessed with wrist-actigraphy. Alertness was assessed daily with a brief Psychomotor Vigilance Test (PVT) and the Karolinska Sleepiness Scale. Results: Interns averaged 6.93 hours (95% confidence interval [CI] 6.84–7.03 hours) sleep per 24 hours across shifts, significantly less than residents not working overnight shifts (7.18 hours, 95% CI 7.06–7.30 hours, p = .007). Interns obtained on average 2.19 hours (95% CI 2.02–2.36 hours) sleep during on-call nights (17.5% obtained no sleep). Alertness was significantly lower on mornings after on-call nights compared to regular shifts (p < .001). Naps between 9 am and 6 pm on the first day post‐call were frequent (90.8%) and averaged 2.84 hours (95% CI 2.69–3.00 hours), but interns still slept 1.66 hours less per 24 hours (95% CI 1.56–1.76 hours) compared to regular shift days (p < .001). Sleep inertia significantly affected alertness in the 60 minutes after waking on-call. Conclusions: Extended overnight shifts increase the likelihood of chronic sleep restriction in interns. Reduced levels of alertness after on-call nights need to be mitigated. A systematic comparison of sleep, alertness, and safety outcomes under current and past duty hour rules is encouraged. PMID:28329124

Efficacy of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study.

PubMed

Strowitzki, Thomas; Kirsch, Bodo; Elliesen, Jörg

2012-04-01

The aim of this Phase III, multicentre, open-label, randomised study was to compare the efficacy and safety of ethinylestradiol (EE)/drospirenone (DRSP) in a new flexible extended regimen that allowed the management of intracyclic (breakthrough) bleeding (MIB) with that of EE/DRSP in a conventional 28-day regimen in women with moderate-to-severe primary dysmenorrhoea. Women (aged 18-40 years) with moderate-to-severe primary dysmenorrhoea-related pain received a flexible extended regimen with MIB (flexible(MIB); minimum 24, maximum 120 days of continuous tablet intake for a flexible number of cycles to reach a treatment duration of at least 140 days with 4-day breaks between cycles) or a conventional 28-day regimen (24 active and four placebo tablets for five cycles) of EE/DRSP. The primary outcome was the number of days with dysmenorrhoeic pain over 140 days. Secondary outcomes included other dysmenorrhoea-related pain outcomes, bleeding profile, satisfaction and safety. Overall, 223 patients received study medication. There were significantly fewer days with dysmenorrhoeic pain with the flexible(MIB) regimen than the conventional regimen (difference -4.2 days, 95% CI -6.5 to -2.0; p=0.0003), as well as considerably fewer days with at least moderate dysmenorrhoeic pain (difference -2.5 days, 95% CI -3.7 to -1.3), dysmenorrhoeic pain that interfered with daily activities (difference -2.2 days, 95% CI -4.2 to -0.1) and pelvic pain (difference -3.4 days, 95% CI -5.9 to -0.9). Adverse events were similar with both regimens. Compared with the conventional regimen, the flexible extended regimen of EE/DRSP with MIB was associated with a significantly greater reduction in days with dysmenorrhoeic pain in women with moderate-to-severe primary dysmenorrhoea. The flexible(MIB) regimen was also associated with greater improvements in dysmenorrhea according to the Clinical Global Impression rating scale and was generally well tolerated.

78 FR 263 - Safety Zones; TEMCO Grain Facilities; Columbia and Willamette Rivers

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

...'01'' W. In essence, these boundaries extend from the shoreline of the facility 150 yards onto the...'' N/122-40'28'' W. In essence, these boundaries extend from the shoreline of the facility 150 yards... criminal laws of the United States. (2) Navigable waters of the United States means those waters defined as...

78 FR 47567 - Safety Zones; Pacific Northwest Grain Handlers Association Facilities; Columbia and Willamette...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

... established, corrects an error in the geographic coordinates of two others, and further defines grain-shipment...'' N/122- 46'24'' W. In essence, these boundaries extend from the shoreline of the facility 150 yards.... In essence, these boundaries extend from the shoreline of the facility 150 yards onto the river from...

76 FR 53352 - Proposed Amendment of Class E Airspace; Alice, TX

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... procedures at Old Hoppe Place Airport, Agua Dulce, TX, has made this action necessary for the safety and..., area. Controlled airspace extending upward from 700 feet above the surface is being removed at Old... extending upward from 700 feet or more above the surface of the earth. * * * * * ASW TX E5 Alice, TX...

A Controlled Trial of Extended-Release Guanfacine and Psychostimulants for Attention-Deficit/Hyperactivity Disorder

ERIC Educational Resources Information Center

Wilens, Timothy E.; Bukstein, Oscar; Brams, Matthew; Cutler, Andrew J.; Childress, Ann; Rugino, Thomas; Lyne, Andrew; Grannis, Kara; Youcha, Sharon

2012-01-01

Objective: To examine efficacy, tolerability, and safety of guanfacine extended release (GXR; less than or equal to 4 mg/d) adjunctive to a long-acting psychostimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years of age with suboptimal, but partial, response to psychostimulant…

Review of extended-release formulations of Tramadol for the management of chronic non-cancer pain: focus on marketed formulations

PubMed Central

Kizilbash, Arshi; Ngô-Minh, Cường

2014-01-01

Patients with chronic non-malignant pain report impairments of physical, social, and psychological well-being. The goal of pain management should include reducing pain and improving quality of life. Patients with chronic pain require medications that are able to provide adequate pain relief, have minimum dosing intervals to maintain efficacy, and avoid breakthrough pain. Tramadol has proven efficacy and a favourable safety profile. The positive efficacy and safety profile has been demonstrated historically in numerous published clinical studies as well as from post-marketing experience. It is a World Health Organization “Step 2” opioid analgesic that has been shown to be effective, well-tolerated, and valuable, where treatment with strong opioids is not required. A number of extended release formulations of Tramadol are available in Canada and the United States. An optimal extended release Tramadol formulation would be expected to provide consistent pain control with once daily dosing, few sleep interruptions, flexible dosing schedules, and no limitation on taking with meals. Appropriate treatment options should be based on the above proposed attributes. A comparative review of available extended release Tramadol formulations shows that these medications are not equivalent in their pharmacokinetic profile and this may have implications for selecting the optimal therapy for patients with pain syndromes where Tramadol is an appropriate analgesic agent. Differences in pharmacokinetics amongst the formulations may also translate into varied clinical responses in patients. Selection of the appropriate formulation by the health care provider should therefore be based on the patient’s chronic pain condition, needs, and lifestyle. PMID:24711710

A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.

PubMed

Arora, Samir; Setnik, Beatrice; Michael, Drass; Hudson, John D; Clemmer, Ray; Meisner, Paul; Pixton, Glenn C; Goli, Veeraindar; Sommerville, Kenneth W

2014-01-01

To evaluate the long-term safety of oxycodone-hydrochloride and sequestered naltrexone-hydrochloride (ALO-02) administered for up to 12 months. Open-label, single-arm safety study. Thirty-two US research centers (ClinicalTrials.gov identifier NCT01428583). Three hundred ninety-five adults (opioid experienced and opioid naïve) with moderate-to-severe chronic noncancer pain (CNCP). Open-label, oral ALO-02 capsules, daily dose ranging from 20 to 160 mg oxycodone for up to 12 months. Number and type of adverse events (AEs) and drugrelated AEs, including assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse Measure). A total of 193 (48.9 percent) patients received ALO-02 for ≥181 days and 105 (26.6 percent) patients for ≥361 days. The most common treatment-emergent AEs were nausea (25.3 percent), constipation (21.3 percent), vomiting (13.9 percent), and headache (11.6 percent). The most common drug-related AEs were constipation (18.0 percent), nausea (14.9 percent), somnolence (8.4 percent), fatigue (6.8 percent), dizziness (5.6 percent), and vomiting (5.1 percent). A majority of patients (86.6 percent) had a maximum COWS total score below the level for mild withdrawal symptoms at every visit throughout the study. Pain severity scores as measured by the short Form of the Brief Pain Inventory (BPI-SF) decreased over time. Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naïve patients. ALO-02 demonstrated a safety profile consistent with extended-release opioids and the expected analgesic efficacy. The addition of sequestered naltrexone had no significant clinical effect on patients when taken as directed.

Analysis of electric vehicle extended range misalignment based on rigid-flexible dynamics

NASA Astrophysics Data System (ADS)

Xu, Xiaowei; Lv, Mingliang; Chen, Zibo; Ji, Wei; Gao, Ruiceng

2017-04-01

The safety of the extended range electric vehicle is seriously affected by the misalignment fault. Therefore, this paper analyzed the electric vehicle extended range misalignment based on rigid-flexible dynamics. Through comprehensively applied the hybrid modeling of rigid-flexible and the method of fault diagnosis of machinery and equipment comprehensively, it established a extender hybrid rigid flexible mechanical model by means of the software ADAMS and ANSYS. By setting the relevant parameters to simulate the misalignment of shafting, the failure phenomenon, the spectrum analysis and the evolution rules were analyzed. It concluded that 0.5th and 1 harmonics are considered as the characteristic parameters of misalignment diagnostics for electric vehicle extended range.

Single- and Multiple-dose Pharmacokinetics of a Lorcaserin Extended-release Tablet.

PubMed

Christopher, Ronald; Morgan, Mike; Ferry, Jim; Rege, Bhaskar; Tang, Yong; Kristensen, Allan; Shanahan, William

2016-10-01

Lorcaserin is a serotonin 2C receptor agonist indicated for chronic weight management as an adjunct to diet and exercise. The initial approved formulation is a 10-mg, immediate-release (IR) tablet for administration BID. These studies investigated the single- and multiple-dose pharmacokinetic properties of a new, recently US Food and Drug Administration-approved, extended-release, 20-mg once-daily formulation. We performed 2 separate 2-period, 2-sequence crossover studies in 36 healthy adults: a study comparing the IR formulation to the extended-release formulation under fasting conditions and a study comparing the extended-release formulation under fed and fasted conditions. Compared with lorcaserin IR, the T max after a single dose of lorcaserin extended-release was greater (median, 12 vs 3 hours), and the C max was 26% lower (38.8 vs 52.3 ng/mL). AUC data were bioequivalent for the 2 formulations in both single- and multiple-dose regimens, confirming no formulation effect on lorcaserin bioavailability. In fasted and fed conditions, T max after a single dose was identical (median, 12 hours), but C max was approximately 45% higher in the fed state (mean, 38.5 ng/mL fasted vs 56.1 ng/mL fed). However, at steady state, C max and AUC were determined to be bioequivalent between the fasted and fed states, indicating no clinically relevant food effect on the pharmacokinetic properties of lorcaserin extended-release. The safety profile was consistent between the 2 formulations. Overall, the results indicate that lorcaserin extended-release is a suitable once-daily alternative to the approved IR BID formulation. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Performance and Safety of Lithium Ion Cells

NASA Technical Reports Server (NTRS)

Ratnakumar, B. V.; Smart, M. C.; Whitcanack, L.; Surampudi, S.; Marsh, R.

2001-01-01

This report evaluates the performance and safety of Lithium Ion (Li-Ion) cells when used in batteries. Issues discussed include the cycle life, energy efficiency, tolerance to higher charge voltage, tolerance to extended tapered charge voltage, charge on cycling, specific energy, low temperature discharge, low temperature charge, various charge characteristics, storage characteristics, and more of Li-Ion cells.

78 FR 39592 - Safety Zone, Tennessee River, Mile 625.5 to 626.5

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... Zone, Tennessee River, Mile 625.5 to 626.5 AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone for the waters of the Tennessee River beginning at mile marker 625.5 and ending at mile marker 626.5, extending bank to bank. This zone is...

75 FR 62320 - Safety Zone; Fireworks for USS GRAVELY Commissioning Ceremony, Cape Fear River, Wilmington, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-08

...-AA00 Safety Zone; Fireworks for USS GRAVELY Commissioning Ceremony, Cape Fear River, Wilmington, NC... zone on the navigable waters of Cape Fear River in Wilmington, NC in support of the Fireworks for the... western shore of the Cape Fear River at Battleship Park. The fireworks debris fallout area will extend...

Tornadoes: Nature's Most Violent Storms. A Preparedness Guide Including Safety Information for Schools.

ERIC Educational Resources Information Center

American National Red Cross, Washington, DC.

This preparedness guide explains and describes tornadoes, and includes safety information for schools. A tornado is defined as a violently rotating column of air extending from a thunderstorm to the ground. The guide explains the cause of tornadoes, provides diagrams of how they form, describes variations of tornadoes, and classifies tornadoes by…

76 FR 53908 - Determination That OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 7.5 Milligrams...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This... approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the...

77 FR 38718 - Safety Zone; NOBLE DISCOVERER, Outer Continental Shelf Drillship, Chukchi and/or Beaufort Seas, AK

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

... Beaufort Seas, Alaska (See Table 1). Table 1--Prospect Locations Prospect Well Area Block Lease No... requirements. The planned exploration drilling in the identified lease blocks will be conducted with the NOBLE... outer boundaries of the safety zone to include the anchor chain extending from the OCS facilities; one...

A Review of Safety and Design Requirements of the Artificial Pancreas.

PubMed

Blauw, Helga; Keith-Hynes, Patrick; Koops, Robin; DeVries, J Hans

2016-11-01

As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components-type 1 diabetes, artificial pancreas, and safety or design-and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential.

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Stephen B.

2010-01-01

Software plays an increasingly larger role in all aspects of NASA's science missions. This has been extended to the identification, management and control of faults which affect safety-critical functions and by default, the overall success of the mission. Traditionally, the analysis of fault identification, management and control are hardware based. Due to the increasing complexity of system, there has been a corresponding increase in the complexity in fault management software. The NASA Independent Validation & Verification (IV&V) program is creating processes and procedures to identify, and incorporate safety-critical software requirements along with corresponding software faults so that potential hazards may be mitigated. This Specific to Generic ... A Case for Reuse paper describes the phases of a dependability and safety study which identifies a new, process to create a foundation for reusable assets. These assets support the identification and management of specific software faults and, their transformation from specific to generic software faults. This approach also has applications to other systems outside of the NASA environment. This paper addresses how a mission specific dependability and safety case is being transformed to a generic dependability and safety case which can be reused for any type of space mission with an emphasis on software fault conditions.

Hierarchical Safety Cases

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Whiteside, Iain J.

2012-01-01

We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

Safety profile of levetiracetam.

PubMed

Arroyo, Santiago; Crawford, Pamela

2003-05-01

A good balance between safety and tolerability is necessary for an antiepileptic drug (AED) to be successful in the management of patients with epilepsy. Levetiracetam is one of the new generation of AEDs licensed as an add-on therapy for the treatment of patients with partial-onset seizures. Leveti-racetam's mechanisms of action are not fully understood. Controlled clinical trials, open-label studies, and postmarketing surveillance indicate that leveti-racetam has a favorable safety profile characterized by little effect on vital signs or clinical laboratory values, reported adverse events that are mild to moderate, and no known drug-drug interactions. The tolerability of levetiracetam may extend to both pediatric and elderly patients based on analyses of small numbers of patients. Tolerability is maintained over the long term. Levetirac-etam does not appear to have a different safety profile in learning-disabled patients. Levetiracetam appears to have a good balance between tolerability and efficacy in the treatment of a wide variety of patients with partial epilepsy.

Secondary prevention of recurrent venous thromboembolism after initial oral anticoagulation therapy in patients with unprovoked venous thromboembolism.

PubMed

Robertson, Lindsay; Yeoh, Su Ern; Ramli, Ahmad

2017-12-15

Currently, little evidence is available on the length and type of anticoagulation used for extended treatment for prevention of recurrent venous thromboembolism (VTE) in patients with unprovoked VTE who have completed initial oral anticoagulation therapy. To compare the efficacy and safety of available oral therapeutic options (aspirin, warfarin, direct oral anticoagulants (DOACs)) for extended thromboprophylaxis in adults with a first unprovoked VTE, to prevent VTE recurrence after completion of an acceptable initial oral anticoagulant treatment period, as defined in individual studies. For this review, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (March 2017) as well as the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2). We also searched trials registries (March 2017) and reference lists of relevant articles. We included randomised controlled trials in which patients with a first, symptomatic, objectively confirmed, unprovoked VTE, who had been initially treated with anticoagulants, were randomised to extended prophylaxis (vitamin K antagonists (VKAs), antiplatelet agents, or DOACs) versus no prophylaxis or placebo. We also included trials that compared one type of extended prophylaxis versus another type of extended prophylaxis. Two review authors independently selected studies, assessed quality, and extracted data. We resolved disagreements by discussion. Six studies with a combined total of 3436 participants met the inclusion criteria. Five studies compared extended prophylaxis versus placebo: three compared warfarin versus placebo, and two compared aspirin versus placebo. One study compared one type of extended prophylaxis (rivaroxaban) versus another type of extended prophylaxis (aspirin). For extended prophylaxis versus placebo, we downgraded the quality of the evidence for recurrent VTE and all-cause mortality to moderate owing to concerns arising from risks of selection and performance bias in individual studies. For all other outcomes in this review, we downgraded the quality of the evidence to low owing to concerns arising from risk of bias for the studies stated above, combined with concerns over imprecision. For extended prophylaxis versus other extended prophylaxis, we downgraded the quality of the evidence for recurrent VTE and major bleeding to moderate owing to concerns over imprecision. Risk of bias in the individual study was low.Meta-analysis showed that extended prophylaxis was no more effective than placebo in preventing VTE-related mortality (odds ratio (OR) 0.98, 95% confidence interval (CI) 0.14 to 6.98; 1862 participants; 4 studies; P = 0.98; low-quality evidence), recurrent VTE (OR 0.63, 95% CI 0.38 to 1.03; 2043 participants; 5 studies; P = 0.07; moderate-quality evidence), major bleeding (OR 1.84, 95% CI 0.87 to 3.85; 2043 participants; 5 studies; P = 0.86; low-quality evidence), all-cause mortality (OR 1.00, 95% CI 0.63 to 1.57; 2043 participants; 5 studies; P = 0.99; moderate-quality evidence), clinically relevant non-major bleeding (OR 1.78, 95% CI 0.59 to 5.33; 1672 participants; 4 studies; P = 0.30; low-quality evidence), stroke (OR 1.15, 95% CI 0.39 to 3.46; 1224 participants; 2 studies; P = 0.80; low-quality evidence), or myocardial infarction (OR 1.00, 95% CI 0.35 to 2.87; 1495 participants; 3 studies; P = 1.00; low-quality evidence).One study showed that the novel oral anticoagulant rivaroxaban was associated with fewer recurrent VTEs than aspirin (OR 0.28, 95% CI 0.15 to 0.54; 1389 participants; P = 0.0001; moderate-quality evidence). Data show no clear differences in the incidence of major bleeding between rivaroxaban and aspirin (OR 3.06, 95% CI 0.37 to 25.51; 1389 participants; P = 0.30; moderate-quality evidence) nor in the incidence of clinically relevant non-major bleeding (OR 0.84, 95% CI 0.37 to 1.94; 1389 participants; 1 study; P = 0.69; moderate-quality evidence). Data on VTE-related mortality, all-cause mortality, stroke, and myocardial infarction were not yet available for participants with unprovoked VTE and will be incorporated in future versions of the review. Evidence is currently insufficient to permit definitive conclusions concerning the effectiveness and safety of extended thromboprophylaxis in prevention of recurrent VTE after initial oral anticoagulation therapy among participants with unprovoked VTE. Additional good-quality large-scale randomised controlled trials are required before firm conclusions can be reached.

Exploring extended scope of practice in dietetics: A systems approach.

PubMed

Ryan, Dominique; Pelly, Fiona; Purcell, Elizabeth

2017-09-01

The aim of this study was to explore health professionals' perceptions of an extended scope of a practice clinic, and develop a framework using a systems approach to facilitate extended scope models across various health settings. A qualitative investigation using semi-structured interviews with four health professionals involved in an extended scope dietitian-led gastroenterology clinic in a hospital in regional Queensland was conducted. A case study design was utilised to investigate interviewees' perceptions of the clinic. Participants were conveniently, purposively sampled. Transcript analysis involved a descriptive analytical approach. Interviewee responses were coded and categorised into themes, and investigator triangulation was used to ensure consistency between individual analyses. A secondary interpretative analysis was conducted where relationships between key themes were mapped to the Systems Engineering Initiative for Patient Safety work system model. Interviewees identified various factors as vital inputs to the work system. These were categorised into the four key elements: stakeholder support, resources, planning and the dietitian. Clinic outcomes were categorised into the impact on four key groups: patients, the dietitian, the multidisciplinary team and the health system. Mapping of the relationships between inputs and outcomes resulted in an implementation framework for extended scope of practice. Extended scope of practice in dietetics may provide positive outcomes for various stakeholders. However, further development of extended scope roles for dietitians requires increased advocacy and support from governments, professional bodies, training institutions and dietitians. We have developed an implementation framework which can be utilised by health professionals interested in embracing an extended scope model of care. © 2016 Dietitians Association of Australia.

Overview of extended release tacrolimus in solid organ transplantation

PubMed Central

Patel, Neha; Cook, Abigail; Greenhalgh, Elizabeth; Rech, Megan A; Rusinak, Joshua; Heinrich, Lynley

2016-01-01

Tacrolimus (Prograf©, Astellas Pharma Europe Ltd, Staines, United Kingdom; referred to as tacrolimus-BID) is an immunosuppressive agent to prevent and treat allograft rejection in kidney transplant recipients in combination with mycophenolate mofetil, corticosteroids, with or without basiliximab induction. The drug has also been studied in liver, heart and lung transplant; however, these are currently off-label indications. An extended release tacrolimus formulation (Advagraf©, Astagraf XL©) allows for once-daily dosing, with the potential to improve adherence. Extended release tacrolimus has similar absorption, distribution, metabolism and excretion to tacrolimus-BID. Phase I pharmacokinetic trials comparing extended release tacrolimus and tacrolimus-BID have demonstrated a decreased maximum concentration (Cmax) and delayed time to maximum concentration (tmax) with the extended release formulation; however, AUC0-24 was comparable between formulations. Overall extended release tacrolimus has a very similar safety and efficacy profile to tacrolimus-BID. It is not recommended in the use of liver transplant patient’s due to the increased risk of mortality in female recipients. There has been minimal data regarding the use of extended release tacrolimus in heart and lung transplant recipients. With the current data available for all organ groups the extended release tacrolimus should be dosed in a 1:1 fashion, the exception may be the cystic fibrosis population where their initial dose may need to be higher. PMID:27011912

Overview of extended release tacrolimus in solid organ transplantation.

PubMed

Patel, Neha; Cook, Abigail; Greenhalgh, Elizabeth; Rech, Megan A; Rusinak, Joshua; Heinrich, Lynley

2016-03-24

Tacrolimus (Prograf(©), Astellas Pharma Europe Ltd, Staines, United Kingdom; referred to as tacrolimus-BID) is an immunosuppressive agent to prevent and treat allograft rejection in kidney transplant recipients in combination with mycophenolate mofetil, corticosteroids, with or without basiliximab induction. The drug has also been studied in liver, heart and lung transplant; however, these are currently off-label indications. An extended release tacrolimus formulation (Advagraf(©), Astagraf XL(©)) allows for once-daily dosing, with the potential to improve adherence. Extended release tacrolimus has similar absorption, distribution, metabolism and excretion to tacrolimus-BID. Phase I pharmacokinetic trials comparing extended release tacrolimus and tacrolimus-BID have demonstrated a decreased maximum concentration (Cmax) and delayed time to maximum concentration (tmax) with the extended release formulation; however, AUC0-24 was comparable between formulations. Overall extended release tacrolimus has a very similar safety and efficacy profile to tacrolimus-BID. It is not recommended in the use of liver transplant patient's due to the increased risk of mortality in female recipients. There has been minimal data regarding the use of extended release tacrolimus in heart and lung transplant recipients. With the current data available for all organ groups the extended release tacrolimus should be dosed in a 1:1 fashion, the exception may be the cystic fibrosis population where their initial dose may need to be higher.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

When policy meets physiology: the challenge of reducing resident work hours.

PubMed

Lockley, Steven W; Landrigan, Christopher P; Barger, Laura K; Czeisler, Charles A

2006-08-01

Considerable controversy exists regarding optimal work hours for physicians and surgeons in training. In a series of studies, we assessed the effect of extended work hours on resident sleep and health as well as patient safety. In a validated nationwide survey, we found that residents who had worked 24 hours or longer were 2.3 times more likely to have a motor vehicle crash following that shift than when they worked < 24 hours, and that the monthly risk of a crash increased by 16.2% after each extended duration shift. We also found in a randomized trial that interns working a traditional on-call schedule slept 5.8 hours less per week, had twice as many attentional failures on duty overnight, and made 36% more serious medical errors and nearly six times more serious diagnostic errors than when working on a schedule that limited continuous duty to 16 hours. While numerous opinions have been published opposing reductions in extended work hours due to concerns regarding continuity of patient care, reduced educational opportunities, and traditionally-defined professionalism, there are remarkably few objective data in support of continuing to schedule medical trainees to work shifts > 24 hours. An evidence-based approach is needed to minimize the well-documented risk that current work hour practices confer on resident health and patient safety while optimizing education and continuity of care.

Current Practices for Providing School Field Trip Meals: Perspectives of School Nutrition Managers and Teachers

ERIC Educational Resources Information Center

Sneed, Jeannie; Vaterlaus Patten, Emily

2015-01-01

Purpose/Objectives: The Healthy, Hunger Free Kids Act of 2010 extended the requirements for a school food safety program to wherever food is stored, prepared, or served, including meals for field trips. The purpose of this study was to determine what foods are used for field trip meals, how those foods are transported and stored, and what standard…

Effectiveness and safety of morphine sulfate extended-release capsules in patients with chronic, moderate-to-severe pain in a primary care setting

PubMed Central

Brown, James; Setnik, Beatrice; Lee, Keung; Cleveland, Jody M; Roland, Carl L; Wase, Linda; Webster, Lynn

2011-01-01

Background The purpose of this study was to determine the effectiveness and safety of morphine sulfate extended-release capsules among primary care patients with chronic, moderate-to-severe pain using a universal precautions approach that assessed and monitored risk for opioid misuse and abuse. Methods This open-label, uncontrolled, multicenter, prospective study was conducted in primary care centers (n = 281) and included opioid-naïve and opioid-experienced patients with either a pain score ≥4 (0 = no pain, 10 = pain as bad as you can imagine), or with unacceptable side effects while taking opioids. The patients were treated with morphine sulfate extendedrelease capsules for up to four months. Patient-rated pain intensity (worst, least, average) over the past 24 hours (0–10 scale), pain interference with seven activities of daily living (0 = no interference, 10 = completely interferes), and adverse events were recorded. Results Of 1487 patients who filled at least one prescription, 561 (38%) completed the study. Patients were primarily white (87%) and female (57%); 92% had pain for more than one year; and 79% were opioid-experienced. Median age was 52 years. Decreases in mean (± standard deviation) average pain scores (baseline 6.2 ± 2.3) were −0.8 ± 2.2 at visit 2 (5–14 days later), and −1.6 ± 2.3 and −1.7 ± 2.2 at visits 3 and 4 (spaced 3–4 weeks apart), respectively, and −1.1 ± 2.4 at visit 5 (included patients withdrawn from the study who were no longer taking the study drug). A similar trend was observed for worst pain and least pain scores and for pain interference with activities. Fifty-one percent of the safety population patients and 81% in the completer population reported being satisfied or very satisfied with the study treatment. Most common adverse events were typical of opioids, ie, constipation (14%), nausea (11%), vomiting (5%), and somnolence (5%). Conclusion The results suggest that pain outcomes improved in patients with chronic, moderate-to-severe pain receiving morphine sulfate extended-release capsules within the context of a structured universal precautions approach in the primary care setting. PMID:22090806

Expert opinion on a flexible extended regimen of drospirenone/ethinyl estradiol contraceptive.

PubMed

Han, Leo; Jensen, Jeffrey T

2014-10-01

Oral contraceptives are often prescribed in extended or continuous forms in order to manage menstrual bleeding and menstrual-related side effects. However, with extended regimens, unscheduled intracycle bleeding can become problematic. Flexible extended dosing of a contraceptive containing drospirenone (DRSP) and ethinyl estradiol (EE) was designed to improve bleeding profiles during extended cycles through active management of bleeding symptoms. We examine the rationale for flexible extended dosing as well as review the dosing regimen. We will focus on the findings of the two most important clinical trials regarding flexible extended DRSP/EE (3 mg/20 μg), including the bleeding profiles of women in those trials. Pharmacology, mechanisms of action, efficacy as well as safety of DRSP containing pills will also be reviewed. Flexible extended dosing of DRSP/EE (3 mg/20 μg) has similar pharmacokinetics and contraceptive efficacy of both conventional and fixed extended regimens. However, it has the added benefit of fewer days of bleeding/spotting compared to conventional and fixed extended regimens.

Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes.

PubMed

Apovian, Caroline M

2016-03-01

Contrave(®) is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Its safety and efficacy were assessed in four randomized, double-blind, placebo-controlled, 56-week Phase III clinical trials in 4536 adult subjects: COR-1, COR-II, COR-BMOD and COR-DM. All four studies demonstrated statistically significant and clinically meaningful weight loss following up to 52 weeks of treatment with naltrexone/bupropion compared with placebo. The average weight loss from baseline across the four studies was approximately 11-22 lbs (5-9 kg). Results show the efficacy of Contrave for weight loss, as well as significant improvements in cardiometabolic markers. This review focuses on the four studies, their outcomes and the mechanism of action of Contrave.

A Semantic Approach with Decision Support for Safety Service in Smart Home Management

PubMed Central

Huang, Xiaoci; Yi, Jianjun; Zhu, Xiaomin; Chen, Shaoli

2016-01-01

Research on smart homes (SHs) has increased significantly in recent years because of the convenience provided by having an assisted living environment. The functions of SHs as mentioned in previous studies, particularly safety services, are seldom discussed or mentioned. Thus, this study proposes a semantic approach with decision support for safety service in SH management. The focus of this contribution is to explore a context awareness and reasoning approach for risk recognition in SH that enables the proper decision support for flexible safety service provision. The framework of SH based on a wireless sensor network is described from the perspective of neighbourhood management. This approach is based on the integration of semantic knowledge in which a reasoner can make decisions about risk recognition and safety service. We present a management ontology for a SH and relevant monitoring contextual information, which considers its suitability in a pervasive computing environment and is service-oriented. We also propose a rule-based reasoning method to provide decision support through reasoning techniques and context-awareness. A system prototype is developed to evaluate the feasibility, time response and extendibility of the approach. The evaluation of our approach shows that it is more effective in daily risk event recognition. The decisions for service provision are shown to be accurate. PMID:27527170

A Semantic Approach with Decision Support for Safety Service in Smart Home Management.

PubMed

Huang, Xiaoci; Yi, Jianjun; Zhu, Xiaomin; Chen, Shaoli

2016-08-03

Research on smart homes (SHs) has increased significantly in recent years because of the convenience provided by having an assisted living environment. The functions of SHs as mentioned in previous studies, particularly safety services, are seldom discussed or mentioned. Thus, this study proposes a semantic approach with decision support for safety service in SH management. The focus of this contribution is to explore a context awareness and reasoning approach for risk recognition in SH that enables the proper decision support for flexible safety service provision. The framework of SH based on a wireless sensor network is described from the perspective of neighbourhood management. This approach is based on the integration of semantic knowledge in which a reasoner can make decisions about risk recognition and safety service. We present a management ontology for a SH and relevant monitoring contextual information, which considers its suitability in a pervasive computing environment and is service-oriented. We also propose a rule-based reasoning method to provide decision support through reasoning techniques and context-awareness. A system prototype is developed to evaluate the feasibility, time response and extendibility of the approach. The evaluation of our approach shows that it is more effective in daily risk event recognition. The decisions for service provision are shown to be accurate.

Quantitative safety assessment of air traffic control systems through system control capacity

NASA Astrophysics Data System (ADS)

Guo, Jingjing

Quantitative Safety Assessments (QSA) are essential to safety benefit verification and regulations of developmental changes in safety critical systems like the Air Traffic Control (ATC) systems. Effectiveness of the assessments is particularly desirable today in the safe implementations of revolutionary ATC overhauls like NextGen and SESAR. QSA of ATC systems are however challenged by system complexity and lack of accident data. Extending from the idea "safety is a control problem" in the literature, this research proposes to assess system safety from the control perspective, through quantifying a system's "control capacity". A system's safety performance correlates to this "control capacity" in the control of "safety critical processes". To examine this idea in QSA of the ATC systems, a Control-capacity Based Safety Assessment Framework (CBSAF) is developed which includes two control capacity metrics and a procedural method. The two metrics are Probabilistic System Control-capacity (PSC) and Temporal System Control-capacity (TSC); each addresses an aspect of a system's control capacity. And the procedural method consists three general stages: I) identification of safety critical processes, II) development of system control models and III) evaluation of system control capacity. The CBSAF was tested in two case studies. The first one assesses an en-route collision avoidance scenario and compares three hypothetical configurations. The CBSAF was able to capture the uncoordinated behavior between two means of control, as was observed in a historic midair collision accident. The second case study compares CBSAF with an existing risk based QSA method in assessing the safety benefits of introducing a runway incursion alert system. Similar conclusions are reached between the two methods, while the CBSAF has the advantage of simplicity and provides a new control-based perspective and interpretation to the assessments. The case studies are intended to investigate the potential and demonstrate the utilities of CBSAF and are not intended for thorough studies of collision avoidance and runway incursions safety, which are extremely challenging problems. Further development and thorough validations are required to allow CBSAF to reach implementation phases, e.g. addressing the issues of limited scalability and subjectivity.

Are Older Adults Prepared to Ensure Food Safety during Extended Power Outages and Other Emergencies?: Findings from a National Survey

ERIC Educational Resources Information Center

Kosa, Katherine M.; Cates, Sheryl C.; Karns, Shawn; Godwin, Sandria L.; Coppings, Richard J.

2012-01-01

Natural disasters and other emergencies can cause an increased risk of foodborne illness. We conducted a nationally representative survey to understand consumers' knowledge and use of recommended practices during/after extended power outages and other emergencies. Because older adults are at an increased risk for foodborne illness, this paper…

77 FR 50417 - Proposed Amendment of Class D and Class E Airspace; Lewiston, ID

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... Class E airspace extending upward from 700 feet above the surface and 1,200 feet above the surface, and...,200 feet above the surface area to enhance safety in the Lewiston-Nez Pearce County Airport, Lewiston... extending upward from 700 feet above the surface at Lewiston-Nez Perce County Airport, Lewiston, ID (77 FR...

77 FR 9944 - Determination That REQUIP XL (Ropinerole Hydrochloride) Extended-Release Tablets, 3 Milligrams...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

... Parkinson's disease. REQUIP XL (ropinerole hydrochloride) extended-release tablets, 3 mg, are currently... amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j... suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines...

76 FR 44650 - Motor Carrier Safety Advisory Committee Public Subcommittee Meeting; Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

... extends the meeting time. The meeting will be held at the Sheraton Crystal City in Arlington, VA. The... 1-2, 2011, MCSAC subcommittee meeting had not been made at the time the June 29, 2011, notice was... meeting time is being extended on the first day of the August 1-2, 2011, meeting. FOR FURTHER INFORMATION...

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.

PubMed

Weitz, Jeffrey I; Bauersachs, Rupert; Beyer-Westendorf, Jan; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Davidson, Bruce L; Holberg, Gerlind; Kakkar, Ajay; Lensing, Anthonie W A; Prins, Martin; Haskell, Lloyd; van Bellen, Bonno; Verhamme, Peter; Wells, Philip S; Prandoni, Paolo

2015-08-31

Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6-12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

Rationales for home safety promotion in the Iranian primary healthcare system: results from a pilot study.

PubMed

Mohammadi, R; Ekman, R; Svanström, L; Gooya, M M

2006-01-01

To analyse the prerequisites for a nationwide primary healthcare (PHC) home safety promotion programme in Iran. Injury is a major public health problem throughout the world, currently accounting for one-seventh of all premature deaths and disabilities. Within 20 years, it is estimated that the proportion will increase to one-fifth. The present healthcare system in Iran was started in 1979, with a major focus on easy access to services and prevention. The system is based on the 'health house', which is run by community health workers. A survey shows that 36% of injuries occur in the home environment. A pilot phase of the Home Safety Promotion Programme was initiated in 1994, and included safety checking at home for fences, kitchens, drugs and poisons, heaters, electricity, and stairs and ladders. The pilot study covered 478,551 households out of the 12 million (approximately) in Iran. Sixty-nine supervisors were involved individually, assembled into eight focus groups. Household safety increased by 10-20% over the 4 years of the study. The frequency of home visits changed from annual to seasonal, since all participants agreed that there were seasonal differences in safety problems. The supervisors showed a high level of knowledge of injury as a public health problem, and also positive attitudes towards doing something about safety on the basis of a PHC scheme. The role of a surveillance system was highlighted, and it was suggested that such a system should be added to the programme. Based on our preliminary findings, there were reasons to obtain a policy decision concerning a national programme for safety promotion before extending the pilot scheme to the whole country. A national safety programme was decided upon following completion of the pilot study. It includes a home-related-injury surveillance system that is mandatory in rural areas and voluntary in some cities.

75 FR 53193 - Safety Zone; Mississippi River, Mile 427.3 to 427.5

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-31

... Zone; Mississippi River, Mile 427.3 to 427.5 AGENCY: Coast Guard, DHS. ACTION: Temporary final rule... River, Mile 427.3 to 427.5, extending the entire width of the river. This safety zone is needed to... 5, 2010 the City of Keithsburg will be conducting a fireworks display at mile 427.4 on the Upper...

75 FR 55272 - Safety Zone; Mississippi River, Mile 212.0 to 214.5

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-10

...-AA00 Safety Zone; Mississippi River, Mile 212.0 to 214.5 AGENCY: Coast Guard, DHS. ACTION: Temporary... Mississippi River, Mile 212.0 to 214.5, extending West of Portage Island to the right descending bank of the... based fireworks display between mile 212.0 to 214.5 on the Upper Mississippi River. This event presents...

33 CFR 165.1330 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, Washington.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., Seattle, Washington. (a) Location. The following area is a safety zone: All waters extending 100 yards... minutes following the conclusion of the Parade of Ships. For the purpose of this rule, the Parade of Ships includes both the pass and review of the ships near Pier 66 and the aerial demonstrations immediately...

33 CFR 165.1330 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, Washington.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., Seattle, Washington. (a) Location. The following area is a safety zone: All waters extending 100 yards... minutes following the conclusion of the Parade of Ships. For the purpose of this rule, the Parade of Ships includes both the pass and review of the ships near Pier 66 and the aerial demonstrations immediately...

33 CFR 165.1330 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, Washington.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., Seattle, Washington. (a) Location. The following area is a safety zone: All waters extending 100 yards... minutes following the conclusion of the Parade of Ships. For the purpose of this rule, the Parade of Ships includes both the pass and review of the ships near Pier 66 and the aerial demonstrations immediately...

33 CFR 165.1330 - Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay, Seattle, Washington.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., Seattle, Washington. (a) Location. The following area is a safety zone: All waters extending 100 yards... minutes following the conclusion of the Parade of Ships. For the purpose of this rule, the Parade of Ships includes both the pass and review of the ships near Pier 66 and the aerial demonstrations immediately...

77 FR 44468 - Safety Zone; Fireworks for NC NENA/APCO Conference, Cape Fear River; Wilmington, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-30

... 1625-AA00 Safety Zone; Fireworks for NC NENA/APCO Conference, Cape Fear River; Wilmington, NC AGENCY... on the navigable waters of Cape Fear River; Wilmington, NC in support of the Fireworks display for... shore of the Cape Fear River at Battleship Park. The fireworks debris fallout area will extend over the...

Advanced Range Safety System for High Energy Vehicles

NASA Technical Reports Server (NTRS)

Claxton, Jeffrey S.; Linton, Donald F.

2002-01-01

The advanced range safety system project is a collaboration between the National Aeronautics and Space Administration and the United States Air Force to develop systems that would reduce costs and schedule for safety approval for new classes of unmanned high-energy vehicles. The mission-planning feature for this system would yield flight profiles that satisfy the mission requirements for the user while providing an increased quality of risk assessment, enhancing public safety. By improving the speed and accuracy of predicting risks to the public, mission planners would be able to expand flight envelopes significantly. Once in place, this system is expected to offer the flexibility of handling real-time risk management for the high-energy capabilities of hypersonic vehicles including autonomous return-from-orbit vehicles and extended flight profiles over land. Users of this system would include mission planners of Space Launch Initiative vehicles, space planes, and other high-energy vehicles. The real-time features of the system could make extended flight of a malfunctioning vehicle possible, in lieu of an immediate terminate decision. With this improved capability, the user would have more time for anomaly resolution and potential recovery of a malfunctioning vehicle.

The second “time-out”: a surgical safety checklist for lengthy robotic surgeries

PubMed Central

2013-01-01

Robotic surgeries of long duration are associated with both increased risks to patients as well as distinct challenges for care providers. We propose a surgical checklist, to be completed during a second “time-out”, aimed at reducing peri-operative complications and addressing obstacles presented by lengthy robotic surgeries. A review of the literature was performed to identify the most common complications of robotic surgeries with extended operative times. A surgical checklist was developed with the goal of addressing these issues and maximizing patient safety. Extended operative times during robotic surgery increase patient risk for position-related complications and other adverse events. These cases also raise concerns for surgical, anesthesia, and nursing staff which are less common in shorter, non-robotic operations. Key elements of the checklist were designed to coordinate operative staff in verifying patient safety while addressing the unique concerns within each specialty. As robotic surgery is increasingly utilized, operations with long surgical times may become more common due to increased case complexity and surgeons overcoming the learning curve. A standardized surgical checklist, conducted three to four hours after the start of surgery, may enhance perioperative patient safety and quality of care. PMID:23731776

High Energy Density Additives for Hybrid Fuel Rockets to Improve Performance and Enhance Safety

NASA Technical Reports Server (NTRS)

Jaffe, Richard L.

2014-01-01

We propose a conceptual study of prototype strained hydrocarbon molecules as high energy density additives for hybrid rocket fuels to boost the performance of these rockets without compromising safety and reliability. Use of these additives could extend the range of applications for which hybrid rockets become an attractive alternative to conventional solid or liquid fuel rockets. The objectives of the study were to confirm and quantify the high enthalpy of these strained molecules and to assess improvement in rocket performance that would be expected if these additives were blended with conventional fuels. We confirmed the chemical properties (including enthalpy) of these additives. However, the predicted improvement in rocket performance was too small to make this a useful strategy for boosting hybrid rocket performance.

Safety lock-out device for electrical appliances

DOEpatents

Cliff, Jr., Paul L.

1996-01-01

A safety lock-out device prevents the insertion of an electrical power cord into an electrical power cord receptacle of an electrical appliance. The devise comprises a mounting plate fastened to the appliance and a cover plate hingedly attached to the appliance. The cover plate is movable between a first position and a second position such that, in the first position, the cover plate covers and prevents insertion of a power cord into the appliance receptacle. In said second position, the appliance receptacle is uncovered to permit insertion of a power cord into the receptacle. Extending a lock shank through aligned openings formed in flange members extending from the mounting plate and the cover plate locks the cover plate in the first position.

Safety lock-out device for electrical appliances

DOEpatents

Cliff, P.L. Jr.

1996-07-09

A safety lock-out device prevents the insertion of an electrical power cord into an electrical power cord receptacle of an electrical appliance. The device comprises a mounting plate fastened to the appliance and a hinged cover plate attached to the appliance. The cover plate is movable between a first position and a second position such that, in the first position, the cover plate covers and prevents insertion of a power cord into the appliance receptacle. In said second position, the appliance receptacle is uncovered to permit insertion of a power cord into the receptacle. Extending a lock shank through aligned openings formed in flange members extending from the mounting plate, the cover plate locks the cover plate in the first position. 15 figs.

Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day—A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia

PubMed Central

Coppola, Danielle; Melkote, Rama; Lannie, Caroline; Singh, Jaskaran; Nuamah, Isaac; Gopal, Srihari; Hough, David; Palumbo, Joseph

2011-01-01

Background Paliperidone extended-release (paliperidone ER) is an approved oral antipsychotic medication (dosing range 3–12 mg/day) for treatment of schizophrenia and schizoaffective disorder in adults. Methods In this 3-arm, double-blind, placebo- and active-controlled, parallel-group study, paliperidone ER 1.5 mg was assessed to determine the lowest efficacious dose in patients (N = 201) with acute schizophrenia. Paliperidone ER 6 mg was included for assay sensitivity. Results Patients (intent-to-treat analysis set) had a mean age of 39.4 years; 74% were men, 43% Asian, and 40% black. The baseline mean (SD) Positive and Negative Syndrome Scale (PANSS) total score was 92.6 (13.02) and the mean (SD) change from baseline to endpoint was: placebo group, –11.4 (20.81); paliperidone ER 1.5 mg group, –8.9 (23.31); and paliperidone ER 6 mg group, –15.7 (26.25). Differences between paliperidone groups versus placebo were not significant (paliperidone ER 1.5 mg [p = 0.582], paliperidone ER 6 mg, [p = 0.308]). Safety results of paliperidone ER 1.5 mg and placebo were comparable. The most frequently reported treatment emergent adverse events (≥10%) were: placebo group—headache (15.6%) and psychotic disorder (14.1%); paliperidone ER 1.5 mg group—insomnia (13.6%); and paliperidone ER 6 mg group—headache (11.4%), insomnia (10%), and tremor (10%). Conclusions In this study, paliperidone ER 1.5 mg did not demonstrate efficacy in patients with acute schizophrenia. A markedly high placebo response was noted. Assay sensitivity with the 6 mg dose was not established. Paliperidone ER 1.5 mg was generally tolerable with a safety profile comparable to placebo. PMID:27738355

Steady-state pharmacokinetics of fluvastatin in healthy subjects following a new extended release fluvastatin tablet, Lescol XL.

PubMed

Barilla, Denise; Prasad, Pratapa; Hubert, Martine; Gumbhir-Shah, Kavita

2004-03-01

This was an open-label, randomized, three-period, three-treatment, multiple dose, crossover study in 12 healthy male and female subjects. This study evaluated single dose and steady-state pharmacokinetics of fluvastatin following single and multiple dose administrations of a new extended release fluvastatin 8 h matrix tablet, Lescol XL 80 mg and 160 mg doses once a day. The study also included a twice a day administration of an immediate release (IR) form of fluvastatin capsule, Lescol, for comparative purposes. All doses were administered for 7 days. The safety and tolerability were also assessed. The pharmacokinetics of fluvastatin were evaluated on days 1 and 7 following each treatment. Fluvastatin systemic exposure was 50% less when administered as Lescol XL 80 mg qd compared with Lescol IR 40 mg bid. Conversely, fluvastatin systemic exposure was 22% higher when administered as Lescol XL 160 mg qd compared with Lescol IR 40 mg bid. Single doses of Lescol XL 80 mg and 160 mg were dose proportional but, deviation (30%) from dose proportionality was observed for the Lescol XL 160 mg at steady-state. There appeared to be moderate (20%-40%) accumulation of serum fluvastatin maximal concentrations and exposure after multiple doses of Lescol XL tablets. Both Lescol XL 80 mg and 160 mg showed delayed absorption and longer apparent elimination half-life compared with fluvastatin IR capsule. Single and multiple doses of fluvastatin were generally well tolerated in this healthy volunteer population. Adverse event profiles were consistent with the published safety profile of the marketed formulations. Aside from one incidence of creatine phosphokinase (CPK) elevation (following Lescol XL 160 mg qd treatment), there were no safety concerns with any of the treatments when administered acutely (7 days). Copyright 2004 John Wiley & Sons, Ltd.

Efficacy and Safety of Paliperidone Extended Release 1.5 mg/day-A Double-blind, Placebo- and Active-Controlled, Study in the Treatment of Patients with Schizophrenia.

PubMed

Coppola, Danielle; Melkote, Rama; Lannie, Caroline; Singh, Jaskaran; Nuamah, Isaac; Gopal, Srihari; Hough, David; Palumbo, Joseph

2011-05-15

Paliperidone extended-release (paliperidone ER) is an approved oral antipsychotic medication (dosing range 3-12 mg/day) for treatment of schizophrenia and schizoaffective disorder in adults. In this 3-arm, double-blind, placebo- and active-controlled, parallel-group study, paliperidone ER 1.5 mg was assessed to determine the lowest efficacious dose in patients (N = 201) with acute schizophrenia. Paliperidone ER 6 mg was included for assay sensitivity. Patients (intent-to-treat analysis set) had a mean age of 39.4 years; 74% were men, 43% Asian, and 40% black. The baseline mean (SD) Positive and Negative Syndrome Scale (PANSS) total score was 92.6 (13.02) and the mean (SD) change from baseline to endpoint was: placebo group, -11.4 (20.81); paliperidone ER 1.5 mg group, -8.9 (23.31); and paliperidone ER 6 mg group, -15.7 (26.25). Differences between paliperidone groups versus placebo were not significant (paliperidone ER 1.5 mg [p = 0.582], paliperidone ER 6 mg, [p = 0.308]). Safety results of paliperidone ER 1.5 mg and placebo were comparable. The most frequently reported treatment emergent adverse events (≥10%) were: placebo group-headache (15.6%) and psychotic disorder (14.1%); paliperidone ER 1.5 mg group-insomnia (13.6%); and paliperidone ER 6 mg group-headache (11.4%), insomnia (10%), and tremor (10%). In this study, paliperidone ER 1.5 mg did not demonstrate efficacy in patients with acute schizophrenia. A markedly high placebo response was noted. Assay sensitivity with the 6 mg dose was not established. Paliperidone ER 1.5 mg was generally tolerable with a safety profile comparable to placebo.

Safety and pharmacokinetics of veliparib extended-release in patients with advanced solid tumors: a phase I study.

PubMed

Werner, Theresa L; Sachdev, Jasgit; Swisher, Elizabeth M; Gutierrez, Martin; Kittaneh, Muaiad; Stein, Mark N; Xiong, Hao; Dunbar, Martin; Sullivan, Danielle; Komarnitsky, Philip; McKee, Mark; Tan, Antoinette R

2018-05-07

The poly(ADP-ribose) polymerase-1/2 inhibitor veliparib is active against tumors deficient in homologous DNA damage repair. The pharmacokinetics and safety of veliparib extended-release (ER) were evaluated in patients with advanced solid tumors. This phase I study assessed veliparib-ER up to 800 mg once daily or 600 mg twice daily. Dose-limiting toxicities (DLTs), recommended phase II dose (RP2D), and maximum tolerated dose (MTD) were assessed in cycle 1 and safety/tolerability during continuous administration (28-day cycles). Seventy-one patients (n = 53 ovarian, n = 17 breast, n = 1 prostate carcinoma) received veliparib; 50 had deleterious breast cancer susceptibility (BRCA) gene mutations. Single-dose veliparib-ER 200 mg (fasting) led to 58% lower peak concentration and similar area under the concentration-time curve compared with veliparib immediate-release (IR). Three patients experienced DLTs (grade 2: asthenia; grade 3: nausea/vomiting, seizure). RP2D and MTD for veliparib-ER were 400 mg BID. The most frequent adverse events (AEs) were nausea (78.9%) and vomiting (50.7%). The most common grade 3/4 treatment-related AEs were as follows: thrombocytopenia (7.0%), nausea, and anemia (4.2% each). Overall, 12 (27.3%) patients with ovarian and 10 (62.5%) patients with breast carcinoma had a partial response. Veliparib-ER, versus veliparib-IR, exhibited an improved pharmacokinetic profile and was well tolerated in patients with ovarian and BRCA-mutated breast cancers. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Novel food packaging systems with natural antimicrobial agents.

PubMed

Irkin, Reyhan; Esmer, Ozlem Kizilirmak

2015-10-01

A new type of packaging that combines food packaging materials with antimicrobial substances to control microbial surface contamination of foods to enhance product microbial safety and to extend shelf-life is attracting interest in the packaging industry. Several antimicrobial compounds can be combined with different types of packaging materials. But in recent years, since consumer demand for natural food ingredients has increased because of safety and availability, these natural compounds are beginning to replace the chemical additives in foods and are perceived to be safer and claimed to alleviate safety concerns. Recent research studies are mainly focused on the application of natural antimicrobials in food packaging system. Biologically derived compounds like bacteriocins, phytochemicals, enzymes can be used in antimicrobial food packaging. The aim of this review is to give an overview of most important knowledge about application of natural antimicrobial packagings with model food systems and their antimicrobial effects on food products.

[Evaluation of the risk of delayed adverse effects of chronic combined exposure to radiation and chemical factors with the purpose to ensure safety in orbital and exploration space missions].

PubMed

Shafirkin, A V; Mukhamedieva, L N; Tatarkin, S V; Barantseva, M Iu

2012-01-01

The work had the aim to anatomize the existing issues with providing safety in extended orbital and exploration missions for ensuing estimation of actual values of the total radiation risk for the crew, and risks of other delayed effects of simultaneous exposure to ionizing radiation and chemical pollutants in cabin air, and a number of other stressful factors inevitable in space flight. The flow of chronic experiments for separate and combined studies with reproduction of air makeup and radiation doses in actual orbital and predicted exploration missions is outlined. To set safety limits, new approaches should be applied to the description of gradual norm degradation to pathologies in addition to several generalized quantitative indices of adaptation and straining of the regulatory systems, as well as of effectiveness of the compensatory body reserve against separate and combined exposure.

Ensuring Food Security Through Enhancing Microbiological Food Safety

NASA Astrophysics Data System (ADS)

Mikš-Krajnik, Marta; Yuk, Hyun-Gyun; Kumar, Amit; Yang, Yishan; Zheng, Qianwang; Kim, Min-Jeong; Ghate, Vinayak; Yuan, Wenqian; Pang, Xinyi

2015-10-01

Food safety and food security are interrelated concepts with a profound impact on the quality of human life. Food security describes the overall availability of food at different levels from global to individual household. While, food safety focuses on handling, preparation and storage of foods in order to prevent foodborne illnesses. This review focuses on innovative thermal and non-thermal technologies in the area of food processing as the means to ensure food security through improving food safety with emphasis on the reduction and control of microbiological risks. The antimicrobial efficiency and mechanism of new technologies to extend the shelf life of food product were also discussed.

High prevalence of intracranial aneurysms in patients with aortic dissection or aneurysm: feasibility of extended aorta CT angiography with involvement of intracranial arteries.

PubMed

Lee, Dahye; Ahn, Sung Jun; Cho, Eun-Suk; Kim, Yong Bae; Song, Suk-Won; Jung, Woo Sang; Suh, Sang Hyun

2017-10-01

Previous studies have suggested a higher prevalence of intracranial aneurysms (IAs) in patients with aortic aneurysms (AAs). To carry out a preliminary study to evaluate the prevalence of IAs in these patients and the diagnostic feasibility of extended aorta CT angiography (CTA), including intracranial arteries as well as the aorta. We retrospectively reviewed all patients with a clinical diagnosis of AA or aortic dissection (AD) who had undergone aorta CTA as well as MR angiography, CTA, and/or DSA of the brain between 2009 and 2014. Since 2012, the extended aorta CTA protocol has been applied in these patients. Characteristics of IAs were classified with baseline clinical data. For quantitative and qualitative assessment by two independent raters, brain images obtained by extended aorta CTA and brain CTA were compared. The radiation dose of the two aorta protocols was compared. The prevalence of IA was 22.2% (35/158). All IAs were detected by extended aorta CTA, except one small aneurysm (<3 mm). The mean vascular attenuation value between brain images showed no difference (p=0.83), but the contrast-to-noise ratio was significantly lower in extended aorta CTA (p<0.001). In qualitative assessment, the interobserver agreement was substantial (k=0.79). For the radiation dose, the dose-length product of the extended aorta CTA increased with increment of the scan range (p=0.048). With a high prevalence of IAs in patients with ADs or AAs, extended aorta CTA could be used to evaluate aorta disease and IA in a single session. However, further prospective studies are needed to prove efficacy and safety of the extended aorta CTA protocol in patients with AAs or ADs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Sleep and Alertness in Medical Interns and Residents: An Observational Study on the Role of Extended Shifts.

PubMed

Basner, Mathias; Dinges, David F; Shea, Judy A; Small, Dylan S; Zhu, Jingsan; Norton, Laurie; Ecker, Adrian J; Novak, Cristina; Bellini, Lisa M; Volpp, Kevin G

2017-04-01

Fatigue from sleep loss is a risk to physician and patient safety, but objective data on physician sleep and alertness on different duty hour schedules is scarce. This study objectively quantified differences in sleep duration and alertness between medical interns working extended overnight shifts and residents not or rarely working extended overnight shifts. Sleep-wake activity of 137 interns and 87 PGY-2/3 residents on 2-week Internal Medicine and Oncology rotations was assessed with wrist-actigraphy. Alertness was assessed daily with a brief Psychomotor Vigilance Test (PVT) and the Karolinska Sleepiness Scale. Interns averaged 6.93 hours (95% confidence interval [CI] 6.84-7.03 hours) sleep per 24 hours across shifts, significantly less than residents not working overnight shifts (7.18 hours, 95% CI 7.06-7.30 hours, p = .007). Interns obtained on average 2.19 hours (95% CI 2.02-2.36 hours) sleep during on-call nights (17.5% obtained no sleep). Alertness was significantly lower on mornings after on-call nights compared to regular shifts (p < .001). Naps between 9 am and 6 pm on the first day post-call were frequent (90.8%) and averaged 2.84 hours (95% CI 2.69-3.00 hours), but interns still slept 1.66 hours less per 24 hours (95% CI 1.56-1.76 hours) compared to regular shift days (p < .001). Sleep inertia significantly affected alertness in the 60 minutes after waking on-call. Extended overnight shifts increase the likelihood of chronic sleep restriction in interns. Reduced levels of alertness after on-call nights need to be mitigated. A systematic comparison of sleep, alertness, and safety outcomes under current and past duty hour rules is encouraged. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

A study comparing changes in loading conditions of an extended service life system using aluminum 2024-T351

NASA Astrophysics Data System (ADS)

Beal, Roger Zack

The current fiscally austere environment prevalent in the military and industry is driving extreme measures to save money. In the United States Air Force, this has driven enormous efforts to trim sustainment spending on extended life aircraft. The challenge to the aerospace engineer is to ensure flight safety in the midst of this economic pressure. One method of cutting costs is to increase the time an aircraft is in service by delaying the point when the aircraft is taken out of service for depot maintenance. To ensure flight safety, in depth fatigue and fracture analysis needs to be accomplished to assess increasing the inspection interval. The purpose of this study was to determine the sensitivity of Aluminum 2024-T351 alloy, a common material used in tension dominated aerospace applications, to two different loading spectra---one that is aggressive and the other that is benign. This was accomplished by conducting five different combinations of the two spectra, developing computer simulations using the AFGROW software and comparing with the measured data. The results showed that the material demonstrated significantly different behavior between the two spectra. These results provide a valuable tool for the aerospace engineer for fatigue life prediction and inspection interval evaluation.

77 FR 74781 - Safety Zones; Columbia Grain and United Grain Corporation Facilities; Columbia and Willamette Rivers

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-18

... 45-38'30'' N/122- 46'25'' W. In essence, these boundaries extend from the shoreline of the facility.../122-41'31'' W. In essence, these boundaries extend from the shoreline of the facility 150 yards onto... waters of the United States means those waters defined as such in 33 CFR part 2. (3) Navigation Rules...

Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

PubMed

Sekulic, Aleksandar; Migden, Michael R; Lewis, Karl; Hainsworth, John D; Solomon, James A; Yoo, Simon; Arron, Sarah T; Friedlander, Philip A; Marmur, Ellen; Rudin, Charles M; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel

2015-06-01

Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. An efficacy and safety analysis was conducted 12 months after primary analysis. This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Extended time-to-collision measures for road traffic safety assessment.

PubMed

Minderhoud, M M; Bovy, P H

2001-01-01

This article describes two new safety indicators based on the time-to-collision notion suitable for comparative road traffic safety analyses. Such safety indicators can be applied in the comparison of a do-nothing case with an adapted situation, e.g. the introduction of intelligent driver support systems. In contrast to the classical time-to-collision value, measured at a cross section, the improved safety indicators use vehicle trajectories collected over a specific time horizon for a certain roadway segment to calculate the overall safety indicator value. Vehicle-specific indicator values as well as safety-critical probabilities can easily be determined from the developed safety measures. Application of the derived safety indicators is demonstrated for the assessment of the potential safety impacts of driver support systems from which it appears that some Autonomous Intelligent Cruise Control (AICC) designs are more safety-critical than the reference case without these systems. It is suggested that the indicator threshold value to be applied in the safety assessment has to be adapted when advanced AICC-systems with safe characteristics are introduced.

75 FR 33692 - Safety Zone; Tacoma Freedom Fair Air Show, Commencement Bay, Tacoma, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-15

... this rule encompasses all waters within the points 47[deg]-17.63' N., 122[deg]-28.724' W.; 47[deg]-17... Ruston Way and extending approximately 1100 yards into Commencement Bay. Floating markers will be placed... designated safety zone: All waters within the points 47[deg]-17.63' N., 122[deg]-28.724' W.; 47[deg]-17.059...

76 FR 77901 - Safety Zone; Upper Mississippi River, Mile 389.4 to 403.1

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-15

...-AA00 Safety Zone; Upper Mississippi River, Mile 389.4 to 403.1 AGENCY: Coast Guard, DHS. ACTION... Upper Mississippi River, from Mile 389.4 to 403.1, extending the entire width of the river located on... 389.4 to 403.1 on the Upper Mississippi River. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that...

Safety and Efficacy of Methotrexate in Psoriasis: A Meta-Analysis of Published Trials

PubMed Central

West, Jonathan; Ogston, Simon; Foerster, John

2016-01-01

Background Methotrexate (MTX) has been used to treat psoriasis for over half a century. Even so, clinical data characterising its efficacy and safety are sparse. Objective In order to enhance the available evidence, we conducted two meta-analyses, one for efficacy and one for safety outcomes, respectively, according to PRISMA checklist. (Data sources, study criteria, and study synthesis methods are detailed in Methods). Results In terms of efficacy, only eleven studies met criteria for study design and passed a Cochrane risk of bias analysis. Based on this limited dataset, 45.2% [95% confidence interval 34.1–60.0] of patients achieve PASI75 at primary endpoint (12 or 16 weeks, respectively, n = 705 patients across all studies), compared to a calculated PASI75 of 4.4 [3.5–5.6] for placebo, yielding a relative risk of 10.2 [95% C.I. 7.1–14.7]. For safety outcomes, we extended the meta-analysis to include studies employing the same dose range of MTX for other chronic inflammatory conditions, e.g. rheumatoid arthritis, in order not to maximise capture of relevant safety data. Based on 2763 patient safety years, adverse events (AEs) were found treatment limiting in 6.9 ± 1.4% (mean ± s.e.) of patients treated for six months, with an adverse effect profile largely in line with that encountered in clinical practice. Finally, in order to facilitate prospective clinical audit and to help generate long-term treatment outcomes under real world conditions, we also developed an easy to use documentation form to be completed by patients without requirement for additional staff time. Limitations Meta-analyses for efficacy and safety, respectively, employed non-identical selection criteria. Conclusions These meta-analyses summarise currently available evidence on MTX in psoriasis and should be of use to gauge whether local results broadly fall within outcomes. PMID:27168193

Driver characteristics associated with child safety seat usage in Malaysia: a cross-sectional study.

PubMed

Kulanthayan, S; Razak, Ahmad; Schenk, Ellen

2010-03-01

The rapidly motorizing environment in Malaysia has made child occupant safety a current public health concern. The usage of child safety seats (CSS) is a widely regarded intervention to enhance child occupant safety, yet no study has been conducted on CSS in Malaysia. This study aims to determine the CSS usage rates in Malaysia and to assess driver characteristics that are associated with CSS usage. Nine variables - urban versus rural study location, age, gender, marital status, educational status, monthly family income, number of children present in the vehicle, distance traveled to the study location, and attitude - were examined through a cross-sectional study of interviewing drivers of 230 vehicles transporting at least one child <10 years of age at the time of the study. The vehicles were also observed for whether or not there was a CSS present. The interviews were conducted at six sampling locations - three urban and three rural - in the state of Melaka. 27.4% of the drivers were found to be using at least one CSS at the time of the survey. Among the nine variables studied, three of the driver characteristics showed statistical significance (p<0.05) with CSS usage: age (p=0.047), educational status (p=0.009), and attitude (p=0.009). This study begins to create knowledge on child occupant safety in Malaysia. The results indicate that interventional efforts should focus on educational programs geared toward drivers that are less educated or extended family members who inconsistently transport young children. Furthermore, any educational efforts could be strongly enhanced by legislation mandating the use of CSS. Every effort should be made to thoroughly assess the effectiveness of any educational or legislative activities that are implemented. Copyright 2009 Elsevier Ltd. All rights reserved.

Safety with surgical lasers.

PubMed

McKenzie, A L

1984-01-01

As the sales of surgical lasers continue to grow, the problem of laser safety in hospitals becomes increasingly more urgent. This article considers both the principles and the practice of laser safety, and indicates how safety codes should be organized within a hospital. Eye safety is of paramount importance, and the effects of different wavelengths of laser radiation on the eye are described, both for intrabeam and extended-source exposure. An account is given of the concept of Maximum Permissible Exposure (MPE) and how it depends upon wavelength and exposure duration. The standard laser classification is developed in relation to MPE. The use of laser protective eyewear is discussed for the surgeon, other theatre staff and the patient. Finally, the role of the Laser Protection Supervisor and of the Laser Protection Adviser are explained in the context of establishing a local laser safety code.

Comparison of the efficacy of extended-release clarithromycin tablets and amoxicillin/clavulanate tablets in the treatment of acute exacerbation of chronic bronchitis.

PubMed

Anzueto, A; Fisher, C L; Busman, T; Olson, C A

2001-01-01

Clarithromycin has established efficacy and safety in the treatment of respiratory infections. This study examined the efficacy and safety of a new extended-release formulation of clarithromycin compared with amoxicillin/clavulanate in the treatment of acute exacerbation of chronic bronchitis (AECB). This phase IIIB, multicenter, randomized, parallel-group, investigator-blinded study in patients with AECB and productive cough with purulent sputum compared treatment with extended-release clarithromycin (two 500-mg tablets once daily for 7 days) and amoxicillin/clavulanate (one 875-mg tablet twice daily for 10 days). Assessments were performed before treatment, between study days 10 and 12 (or within 48 hours after premature discontinuation), and between study days 17 and 21 (test of cure). Of 287 patients randomized and treated, 270 were clinically evaluable (137 clarithromycin, 133 amoxicillin/clavulanate). Treatment groups were well matched in terms of demographic characteristics, medical condition, and history. Among clinically evaluable patients at test of cure, 85% and 87% of clarithromycin- and amoxicillin/clavulanate-treated patients, respectively, demonstrated clinical cure (as defined in 1998 draft US Food and Drug Administration guidelines); among clinically and bacteriologically evaluable patients, 92% versus 89%, respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were similar in the 2 groups (88% clarithromycin, 89% amoxicillin/clavulanate). Rates of premature discontinuation of study drug for any reason differed between treatments: 3% (4/142) of clarithromycin-treated patients versus 12% (17/145) of amoxicillin/clavulanate-treated patients (P = 0.005). One percent (2/142) and 6% (8/145) of the respective treatment groups discontinued study drug because of adverse events. Adverse events generally occurred with a similar frequency in the 2 groups; however, taste alteration was more common with clarithromycin (9/142 [6%]) than with amoxicillin/clavulanate (1/145 [1%]; P = 0.01). Mean severity scores for gastrointestinal adverse events showed a significant difference between groups (1.16 for clarithromycin-treated patients and 1.58 for amoxicillin/clavulanate-treated patients: P = 0.016). The results of this study demonstrate the clinical and bacteriologic equivalence and improved gastrointestinal tolerability of a 7-day course of once-daily extended-release clarithromycin relative to a 10-day course of twice-daily amoxicillin/clavulanate in the treatment of AECB.

Exposure plus response prevention versus exposure plus safety behaviours in reducing feelings of contamination, fear, danger and disgust. An extended replication of Rachman, Shafran, Radomsky & Zysk (2011).

PubMed

van den Hout, Marcel A; Engelhard, Iris M; Toffolo, Marieke B J; van Uijen, Sophie L

2011-09-01

Safety behaviours are widely held to impede the beneficial effects of exposure, certainly in OCD. Recently, Rachman, Radomsky, Shafran, and Zysk (2011) challenged this view. Healthy volunteers repeatedly touched a contaminant in two sessions. Half of the participants did not engage in safety behaviours after touching (exposure + response prevention), while the other half did (exposure + safety behaviours, i.e., cleaning hands with a hygienic wipe). Scores of contamination, fear, danger, and disgust decreased in both sessions and the effects were not impeded by safety behaviours. Three potential artefacts were identified in the Rachman et al. study: a no-treatment control group was lacking, the stop rules for ending exposure differed between conditions, and positive expectations may have been induced in the safety behaviours group. We tried to critically replicate the main findings. The Rachman et al. (2011) study was replicated, with 44 volunteers but stop rules and expectations were similar between treatments, and effects were also assessed in a no-intervention control group. Relative to the control condition, both exposure interventions induced reliable decreases in feelings of contamination, fear, danger, and disgust. The decline followed an exponential curve with the largest gains at the first trials of each session. Findings were obtained from a non-clinical sample. The findings attest to the robustness of the Rachman et al. findings, and challenge the notion that safety behaviours should be dismissed categorically in exposure treatments. Copyright © 2011 Elsevier Ltd. All rights reserved.

Demonstration of fully coupled simplified extended station black-out accident simulation with RELAP-7

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhao, Haihua; Zhang, Hongbin; Zou, Ling

2014-10-01

The RELAP-7 code is the next generation nuclear reactor system safety analysis code being developed at the Idaho National Laboratory (INL). The RELAP-7 code develop-ment effort started in October of 2011 and by the end of the second development year, a number of physical components with simplified two phase flow capability have been de-veloped to support the simplified boiling water reactor (BWR) extended station blackout (SBO) analyses. The demonstration case includes the major components for the primary system of a BWR, as well as the safety system components for the safety relief valve (SRV), the reactor core isolation cooling (RCIC)more » system, and the wet well. Three scenar-ios for the SBO simulations have been considered. Since RELAP-7 is not a severe acci-dent analysis code, the simulation stops when fuel clad temperature reaches damage point. Scenario I represents an extreme station blackout accident without any external cooling and cooling water injection. The system pressure is controlled by automatically releasing steam through SRVs. Scenario II includes the RCIC system but without SRV. The RCIC system is fully coupled with the reactor primary system and all the major components are dynamically simulated. The third scenario includes both the RCIC system and the SRV to provide a more realistic simulation. This paper will describe the major models and dis-cuss the results for the three scenarios. The RELAP-7 simulations for the three simplified SBO scenarios show the importance of dynamically simulating the SRVs, the RCIC sys-tem, and the wet well system to the reactor safety during extended SBO accidents.« less

Under the radar: community safety nets for AIDS-affected households in sub-Saharan Africa.

PubMed

Foster, G

2007-01-01

Safety nets are mechanisms to mitigate the effects of poverty on vulnerable households during times of stress. In sub-Saharan Africa, extended families, together with communities, are the most effective responses enabling access to support for households facing crises. This paper reviews literature on informal social security systems in sub-Saharan Africa, analyses changes taking place in their functioning as a result of HIV/AIDS and describes community safety net components including economic associations, cooperatives, loan providers, philanthropic groups and HIV/AIDS initiatives. Community safety nets target households in greatest need, respond rapidly to crises, are cost efficient, based on local needs and available resources, involve the specialized knowledge of community members and provide financial and psycho-social support. Their main limitations are lack of material resources and reliance on unpaid labour of women. Changes have taken place in safety net mechanisms because of HIV/AIDS, suggesting the resilience of communities rather than their impending collapse. Studies are lacking that assess the value of informal community-level transfers, describe how safety nets assist the poor or analyse modifications in response to HIV/AIDS. The role of community safety nets remains largely invisible under the radar of governments, non-governmental organizations and international bodies. External support can strengthen this system of informal social security that provides poor HIV/AIDS-affected households with significant support.

Shuttle: forever young?

PubMed

Sietzen, Frank

2002-01-01

NASA has started a 4-phase program of upgrades designed to increase safety and extend use of the space shuttles through the year 2020. Phase I is aimed at improving vehicle safety and supporting the space station. Phase II is aimed at combating obsolescence and includes a checkout launch and control system and protection from micrometeoroids and orbital debris. Phase III is designed to expand or enhance the capabilities of the shuttle and includes development of an auxiliary power unit, avionics, a channel-wall nozzle, extended nose landing gear, long-life fuel cells, a nontoxic orbital maneuvering system/reaction control system, and a water membrane evaporator. Phase IV is aimed at design of system changes that would alter the shuttle mold line and configuration; projects include a five-segment solid rocket booster, liquid flyback boosters, and a crew escape module.

[The possibility of local control of cancer by neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma].

PubMed

Nakagawa, Kei; Katayose, Yu; Rikiyama, Toshiki; Okaue, Adoru; Unno, Michiaki

2009-11-01

Surgical resection is the gold standard of treatment for cholangiocarcinoma. However, there are also many recurrences after operation, because of the anatomical background and the tendency of invasion. We thought that eliminating the remnant of the cancer could yield a better prognosis. Therefore, an introduction of the neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patient (NACRAC) was planned. The safety of NACRAC was confirmed by a pilot study. The recommended dose of gemcitabine (600 mg/m2) was determined by a phase I study. A phase II study is now being performed for evaluating the effectiveness and safety. NACRAC may control the frontal part of the tumor with difficult distinctions made by MDCT, and abolishing the cancer remnant is expected. The possibility of extended prognosis by NACRAC can be considered.

Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain.

PubMed

Taber, Louise; Lynch, Shau Yu; He, Ellie; Ripa, Steven R

2016-01-01

To evaluate long-term use of Hysingla(®) ER (HYD), a single-entity, extended-release, once-daily hydrocodone bitartrate tablet with abuse-deterrent properties in patients with moderate-to-severe chronic noncancer and nonneuropathic pain. This open-label study consisted of a dose-titration period (up to 45 days), a 52-week maintenance period and a 24-week extension period. Opioid-naïve or opioid-experienced patients with controlled or uncontrolled chronic pain conditions were treated with HYD 20-120 mg daily. Supplemental nonopioid and short-acting opioid analgesics were permitted. This paper presents the results of 106 patients who continued HYD treatment for up to 76 weeks. Primary safety measures included the incidence of adverse events, as well as audiologic, clinical laboratory and electrocardiogram measurements. Effectiveness was measured by the change between baseline and the overall 76-week treatment period in "average pain over the last 24 h" (0 = no pain, 10 = pain as bad as you can imagine), Brief Pain Inventory-Short Form survey, Medical Outcomes Study 36-Item Short Form Health Survey, Medical Outcomes Study Sleep Scale-Revised and concomitant nonstudy opioid analgesic use. Among 410 patients who completed the maintenance period, 106 continued into the extension. Of these, 83 (78%) completed the entire 76-week treatment period. Treatment-emergent adverse events were typical of those observed with μ-opioid agonists. No study drug abuse or diversion was reported. Clinically important analgesia and functional improvement were achieved during the dose-titration period and were maintained in most patients throughout 76 weeks without the need for continued HYD dose increases or changes in concomitant nonstudy opioid analgesics. The mean pain score was 6.1 at baseline, 3.8 at the end of the dose titration period and 3.8 through 76 weeks. HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of treatment.

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.

PubMed

Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Hansen, Richard

2016-04-01

Modified-release drugs may provide clinical advantages compared to immediate-release forms and improve convenience to the patient and health outcomes. Concerns have been raised regarding interchangeability, efficacy, and safety of modified-release formulations. This study analyses all US Food and Drug Administration (FDA)-approved modified-release formulations and market trends, and illustrates how bioequivalence and safety of generic modified-release products compare to their respective brand name drugs and other generic drugs with different formulation design characteristics. This study also examines major concerns related to modified-release formulations: safety of opioids and bioequivalence of generic bupropion and methylphenidate. Study data were derived from the FDA electronic versions of the FDA's Orange Book (OB) and the FDA safety communications web page. Medicare Part D utilization and expenditures data were extracted from the Centers for Medicare and Medicaid. In May 2015, 276 (11.9 %) of the 2325 active ingredients and fixed-dose combinations listed in the FDA's Orange Book had at least one modified-release form approved by the FDA. The number of approvals increased over time; 52.5 % of modified releases were approved in the period 2000-May 2015. The FDA required a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of extended-release opioids outweighed its risks of overdose and abuse. The REMS involved 16 new drug applications and 25 abbreviated new drug applications. The FDA addressed interchangeability problems with generic modified-release alternatives of bupropion and methylphenidate including lack of bioequivalence, reduced efficacy, and increased incidence of adverse events. Systematic post-marketing surveillance studies are needed to assess differences in safety, interchangeability, and efficacy of drugs with modified- and immediate-release formulations.

U.S. pharmacy policy: a public health perspective on safety and cost.

PubMed

Rosenau, Pauline Vaillancourt; Lal, Lincy S; Glasser, Jay H

2009-01-01

A public health perspective based on social justice and a population health point of view emphasizes pharmacy policy innovations regarding safety and costs. Such policies that effectively reduce costs include controlling profits, establishing profit targets, extending prescription providers, revising prescription classification schemes, emphasizing generic medications, and establishing formularies. Public education and universal programs may reduce costs, but co-pays and "cost-sharing" do not. Switching medications to over-the-counter (OTC) status, pill splitting, and importing medication from abroad are poor substitutes for authentic public health pharmacy policy. Where policy changes yield savings, public health insists that these savings should be used to increase access and improve population health. In the future, pharmacy policies may emphasize public health accountability more than individual liberty because of potential cost savings to society. Fear of litigation, as an informal mechanism of focusing manufacturer's attention on safety, is inefficient; public health pharmacy policy regarding safety looks toward a more active regulatory role on the part of government. A case study of direct-to-consumer advertising illustrates the complexity of public health pharmacy policy.

Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation.

PubMed

Oh, Chang-Kwon; Huh, Kyu Ha; Lee, Jong Soo; Cho, Hong Rae; Kim, Yu Seun

2014-09-01

The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction. This prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared. Sixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35). Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.

Feasibility and safety of endoscopic submucosal dissection for lower rectal tumors with hemorrhoids.

PubMed

Tanaka, Shinwa; Toyonaga, Takashi; Morita, Yoshinori; Hoshi, Namiko; Ishida, Tsukasa; Ohara, Yoshiko; Yoshizaki, Tetsuya; Kawara, Fumiaki; Umegaki, Eiji; Azuma, Takeshi

2016-07-21

To evaluate the feasibility and safety of endoscopic submucosal dissection (ESD) for lower rectal lesions with hemorrhoids. The outcome of ESD for 23 lesions with hemorrhoids (hemorrhoid group) was compared with that of 48 lesions without hemorrhoids extending to the dentate line (non-hemorrhoid group) during the same study period. Median operation times (ranges) in the hemorrhoid and non-hemorrhoid groups were 121 (51-390) and 130 (28-540) min. The en bloc resection rate and the curative resection rate in the hemorrhoid group were 96% and 83%, and they were 100% and 90% in the non-hemorrhoid group, respectively. In terms of adverse events, perforation and postoperative bleeding did not occur in both groups. In terms of the clinical course of hemorrhoids after ESD, the rate of complete recovery of hemorrhoids after ESD in lesions with resection of more than 90% was significantly higher than that in lesions with resection of less than 90%. ESD on lower rectal lesions with hemorrhoids could be performed safely, similarly to that on rectal lesions extending to the dentate line without hemorrhoids. In addition, all hemorrhoids after ESD improved to various degrees, depending on the resection range.

Feasibility and safety of endoscopic submucosal dissection for lower rectal tumors with hemorrhoids

PubMed Central

Tanaka, Shinwa; Toyonaga, Takashi; Morita, Yoshinori; Hoshi, Namiko; Ishida, Tsukasa; Ohara, Yoshiko; Yoshizaki, Tetsuya; Kawara, Fumiaki; Umegaki, Eiji; Azuma, Takeshi

2016-01-01

AIM: To evaluate the feasibility and safety of endoscopic submucosal dissection (ESD) for lower rectal lesions with hemorrhoids. METHODS: The outcome of ESD for 23 lesions with hemorrhoids (hemorrhoid group) was compared with that of 48 lesions without hemorrhoids extending to the dentate line (non-hemorrhoid group) during the same study period. RESULTS: Median operation times (ranges) in the hemorrhoid and non-hemorrhoid groups were 121 (51-390) and 130 (28-540) min. The en bloc resection rate and the curative resection rate in the hemorrhoid group were 96% and 83%, and they were 100% and 90% in the non-hemorrhoid group, respectively. In terms of adverse events, perforation and postoperative bleeding did not occur in both groups. In terms of the clinical course of hemorrhoids after ESD, the rate of complete recovery of hemorrhoids after ESD in lesions with resection of more than 90% was significantly higher than that in lesions with resection of less than 90%. CONCLUSION: ESD on lower rectal lesions with hemorrhoids could be performed safely, similarly to that on rectal lesions extending to the dentate line without hemorrhoids. In addition, all hemorrhoids after ESD improved to various degrees, depending on the resection range. PMID:27468216

[24-hour work: the interaction of stress and changes in the sleep-wake cycle in the police force].

PubMed

Garbarino, Sergio

2014-01-01

Disruption in police officers. In recent years there has been a widespread growth in services, available regardless of time or day organization (24/7 service) and a diffuse increase in their use, both in work and private lives, generally ignoring the importance of a regular sleep organization. Police officers - often need to work extended shifts and long hours under highly stressful conditions, which results in reduced levels of safety and operational effectiveness. In numerous studies, perceived stress has been found to correlate with both subjective and objective disturbances in sleep. Consequently, excessive daytime sleepiness is one of the most frequent health and safety hazards that police officers have to deal with. Sleep deprivation affects performance outcomes through a wide range of cognitive domains. Sleepiness and fatigue, caused by sleep loss, extended work and wakefulness, circadian misalignment and sleep disorders are major causes of workplace human errors, incidents, and accidents. Therefore, prevention of sleep loss, high levels of stress and fatigue is a key factor to consider when assessing emergency intervention. In order to combat fatigue and sleepiness, a 30-90 minutes nap before night shift could be a viable option.

A novel method for deriving thresholds of toxicological concern for vaccine constituents.

PubMed

White, Jennifer; Wrzesinski, Claudia; Green, Martin; Johnson, Giffe T; McCluskey, James D; Abritis, Alison; Harbison, Raymond D

2016-05-01

Safety assessment evaluating the presence of impurities, residual materials, and contaminants in vaccines is a focus of current research. Thresholds of toxicological concern (TTCs) are mathematically modeled levels used for assessing the safety of many food and medication constituents. In this study, six algorithms are selected from the open-access ToxTree software program to derive a method for calculating TTCs for vaccine constituents: In Vivo Rodent Micronucleus assay/LD50, Benigni-Bossa/LD50, Cramer Extended/LD50, In Vivo Rodent Micronucleus assay/TDLo, Benigni-Bossa/TDLo, and the Cramer Extended/TDLo. Using an initial dataset (n = 197) taken from INCHEM, RepDose, RTECS, and TOXNET, the chemicals were divided into two families: "positive" - based on the presence of structures associated with adverse outcomes, or "negative" - no such structures or having structures that appear to be protective of health. The final validation indicated that the Benigni-Bossa/LD50 method is the most appropriate for calculating TTCs for vaccine constituents. Final TTCs were designated as 18.06 μg/person and 20.61 μg/person for the Benigni-Bossa/LD50 positive and negative structural families, respectively.

75 FR 71543 - Safety Zone; Gulf Intracoastal Waterway, Mile Marker 49.0 to 50.0, west of Harvey Locks, Bank to...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

...-AA00 Safety Zone; Gulf Intracoastal Waterway, Mile Marker 49.0 to 50.0, west of Harvey Locks, Bank to Bank, Bayou Blue Pontoon Bridge, Lafourche Parish, LA AGENCY: Coast Guard, DHS. ACTION: Temporary Final... Waterway extending from Mile Marker 49.0 to Mile Marker 50.0, bank to bank, West of Harvey Locks, Lafourche...

Bioequivalence of Dapagliflozin/Metformin Extended-release Fixed-combination Drug Product and Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Russian Subjects.

PubMed

Khomitskaya, Yunona; Tikhonova, Nadezhda; Gudkov, Konstantin; Erofeeva, Svetlana; Holmes, Victoria; Dayton, Brian; Davies, Nigel; Boulton, David W; Tang, Weifeng

2018-04-01

Fixed-combination drug products (FCDPs) combining dapagliflozin and metformin extended release (XR) may provide patients with type 2 diabetes mellitus with an alternative antihyperglycemic treatment, which could improve adherence by reducing tablet burden. This study evaluated the bioequivalence of dapagliflozin/metformin XR FCDP versus the co-administration of the individual monotherapy tablets currently available for use in the Russian Federation. Healthy subjects aged 18 to 45 years were enrolled in this randomized, open-label, 2-period crossover study, conducted in a single Russian center. Pharmacokinetic parameters (AUC 0-t , C max , and C max /AUC 0-t ) were used to assess bioequivalence of dapagliflozin/metformin XR (10/1000 mg) FCDP to the individual component tablets (dapagliflozin [10 mg] plus metformin XR [2 × 500 mg]) under standard fed conditions. Safety and tolerability were also assessed. Forty healthy subjects were included (47.5% male; mean age, 30 years; and mean body mass index, 24.2 kg/m 2 ). Dapagliflozin and metformin XR in the FCDP were bioequivalent to the individual component tablets marketed in the Russian Federation, with the 90% CIs of the geometric least-squares mean ratios for all key pharmacokinetic parameters being contained within the 80% to 125% bioequivalence limits. Both FCDP and the individual component formulations were well tolerated, with no serious adverse events. Bioequivalence of dapagliflozin/metformin XR FCDP and the individual components was established without any new safety concerns, presenting a safe alternative for patients currently receiving regimens including each component individually. ClinicalTrials.gov identifier: NCT02722239. Copyright © 2018 Elsevier HS Journals, Inc. All rights reserved.

Efficacy of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study

PubMed Central

Strowitzki, Thomas; Kirsch, Bodo; Elliesen, Jörg

2012-01-01

Objectives The aim of this Phase III, multicentre, open-label, randomised study was to compare the efficacy and safety of ethinylestradiol (EE)/drospirenone (DRSP) in a new flexible extended regimen that allowed the management of intracyclic (breakthrough) bleeding (MIB) with that of EE/DRSP in a conventional 28-day regimen in women with moderate-to-severe primary dysmenorrhoea. Methods Women (aged 18–40 years) with moderate-to-severe primary dysmenorrhoea-related pain received a flexible extended regimen with MIB (flexibleMIB; minimum 24, maximum 120 days of continuous tablet intake for a flexible number of cycles to reach a treatment duration of at least 140 days with 4-day breaks between cycles) or a conventional 28-day regimen (24 active and four placebo tablets for five cycles) of EE/DRSP. The primary outcome was the number of days with dysmenorrhoeic pain over 140 days. Secondary outcomes included other dysmenorrhoea-related pain outcomes, bleeding profile, satisfaction and safety. Results Overall, 223 patients received study medication. There were significantly fewer days with dysmenorrhoeic pain with the flexibleMIB regimen than the conventional regimen (difference −4.2 days, 95% CI −6.5 to −2.0; p=0.0003), as well as considerably fewer days with at least moderate dysmenorrhoeic pain (difference −2.5 days, 95% CI −3.7 to −1.3), dysmenorrhoeic pain that interfered with daily activities (difference −2.2 days, 95% CI −4.2 to −0.1) and pelvic pain (difference −3.4 days, 95% CI −5.9 to −0.9). Adverse events were similar with both regimens. Conclusions Compared with the conventional regimen, the flexible extended regimen of EE/DRSP with MIB was associated with a significantly greater reduction in days with dysmenorrhoeic pain in women with moderate-to-severe primary dysmenorrhoea. The flexibleMIB regimen was also associated with greater improvements in dysmenorrhea according to the Clinical Global Impression rating scale and was generally well tolerated. PMID:22454006

A randomized, double-blind, parallel-group, multicenter, placebo-controlled study of the safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for symptom relief as an adjunctive therapy to antibiotic treatment of acute respiratory infections.

PubMed

LaForce, Craig; Gentile, Deborah A; Skoner, David P

2008-07-01

This study assessed the efficacy and safety of guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bilayer tablets in providing relief of acute respiratory symptoms when used as an adjunct to antibiotics in patients with an acute respiratory infection (ARI). Adult patients experiencing symptoms of ARI and meeting the physician's usual diagnostic criteria for oral antibiotic treatment were prescribed an antibiotic and randomized to adjunctive guaifenesin/pseudoephedrine hydrochloride or matching placebo twice daily for 7 days. Patients completed symptom diaries and treatment assessments twice daily and attended office visits on Days 4 and 8. The safety/intent-to-treat (ITT) population analysis included 601 patients (guaifenesin/pseudoephedrine, n = 303; placebo, n = 298). Mean symptom scores were lower with guaifenesin/pseudoephedrine from Day 3 for every symptom assessed, with statistically significant improvements in total symptom score from Day 3 (P = 0.026). The greatest effects of treatment with guaifenesin/pseudoephedrine were observed for nasal congestion and sinus headache. Time to overall relief was shorter with guaifenesin/pseudoephedrine (P = 0.038). Significantly more patients reported "the medication was helping during the day" on Day 2 with guaifenesin/pseudoephedrine (P = 0.002). Patient assessments of symptom relief showed a significant preference for guaifenesin/pseudoephedrine versus placebo (P = 0.021). Treatment with guaifenesin/pseudoephedrine was well tolerated. Insomnia (2.6%), nausea (2.3%), and headache (1.3%) were the most common treatment-related adverse effects. As adjunctive therapy for symptom relief for patients taking antibiotics for ARIs, guaifenesin/pseudoephedrine shortened time to relief and improved bothersome respiratory symptoms better than placebo, with greatest effects seen for nasal congestion and sinus headache.

Tokamak Operation with Safety Factor q 95 < 2 via Control of MHD Stability

DOE PAGES

Piovesan, Paolo; Hanson, Jeremy M.; Martin, Piero; ...

2014-07-24

Magnetic feedback control of the resistive-wall mode has enabled DIII-D to access stable operation at safety factor q95 = 1:9 in divertor plasmas for 150 instability growth times. Magnetohydrodynamic stability sets a hard, disruptive limit on the minimum edge safety factor achievable in a tokamak, or on the maximum plasma current at given toroidal magnetic eld. In tokamaks with a divertor, the limit occurs at q95 = 2, as con rmed in DIII-D. Since the energy con cement time scales linearly with current, this also bounds the performance of a fusion reactor. DIII-D has overcome this limit, opening a wholemore » new high-current regime not accessible before. This result brings signi cant possible bene ts in terms of fusion performance, but it also extends resistive wall mode physics and its control to conditions never explored before. In present experiments, q95 < 2 operation is eventually halted by voltage limits reached in the feedback power supplies, not by intrinsic physics issues. Improvements to power supplies and to control algorithms have the potential to further extend this regime.« less

Advanced Analgesic Drug Delivery and Nanobiotechnology.

PubMed

Stoicea, Nicoleta; Fiorda-Diaz, Juan; Joseph, Nicholas; Shabsigh, Muhammad; Arias-Morales, Carlos; Gonzalez-Zacarias, Alicia A; Mavarez-Martinez, Ana; Marjoribanks, Stephen; Bergese, Sergio D

2017-07-01

Transdermal administration of analgesic medications offers several benefits over alternative routes of administration, including a decreased systemic drug load with fewer side effects, and avoidance of drug degradation by the gastrointestinal tract. Transdermal administration also offers a convenient mode of drug administration over an extended period of time, particularly desirable in pain medicine. A transdermal administration route may also offer increased safety for drugs with a narrow therapeutic window. The primary barrier to transdermal drug absorption is the skin itself. Transdermal nanotechnology offers a novel method of achieving enhanced dermal penetration with an extended delivery profile for analgesic drugs, due to their small size and relatively large surface area. Several materials have been used to enhance drug duration and transdermal penetration. The application of nanotechnology in transdermal delivery of analgesics has raised new questions regarding safety and ethical issues. The small molecular size of nanoparticles enables drug delivery to previously inaccessible body sites. To ensure safety, the interaction of nanoparticles with the human body requires further investigation on an individual drug basis, since different formulations have unique properties and side effects.

Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

NASA Technical Reports Server (NTRS)

Hill, Janice; Victor, Daniel

2008-01-01

When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

Efficacy and safety of Meriva®, a curcumin-phosphatidylcholine complex, during extended administration in osteoarthritis patients.

PubMed

Belcaro, Gianni; Cesarone, Maria Rosaria; Dugall, Mark; Pellegrini, Luciano; Ledda, Andrea; Grossi, Maria Giovanna; Togni, Stefano; Appendino, Giovanni

2010-12-01

In a previous three-month study of Meriva, a proprietary curcumin-phosphatidylcholine phytosome complex, decreased joint pain and improvement in joint function were observed in 50 osteoarthritis (OA) patients. Since OA is a chronic condition requiring prolonged treatment, the long-term efficacy and safety of Meriva were investigated in a longer (eight months) study involving 100 OA patients. The clinical end points (Western Ontario and McMaster Universities [WOMAC] score, Karnofsky Performance Scale Index, and treadmill walking performance) were complemented by the evaluation of a series of inflammatory markers (interleukin [IL]-1beta, IL-6, soluble CD40 ligand [sCD40L], soluble vascular cell adhesion molecule (sVCAM)-1, and erythrocyte sedimentation rate [ESR]). This represents the most ambitious attempt, to date, to evaluate the clinical efficacy and safety of curcumin as an anti-inflammatory agent. Significant improvements of both the clinical and biochemical end points were observed for Meriva compared to the control group. This, coupled with an excellent tolerability, suggests that Meriva is worth considering for the long-term complementary management of osteoarthritis.

Leveraging Safety Programs to Improve and Support Security Programs

DOE Office of Scientific and Technical Information (OSTI.GOV)

Leach, Janice; Snell, Mark K.; Pratt, R.

2015-10-01

There has been a long history of considering Safety, Security, and Safeguards (3S) as three functions of nuclear security design and operations that need to be properly and collectively integrated with operations. This paper specifically considers how safety programmes can be extended directly to benefit security as part of an integrated facility management programme. The discussion will draw on experiences implementing such a programme at Sandia National Laboratories’ Annular Research Reactor Facility. While the paper focuses on nuclear facilities, similar ideas could be used to support security programmes at other types of high-consequence facilities and transportation activities.

Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy.

PubMed

Moradi, Amir; Palm, Melanie

2015-09-01

Currently there are many non-invasive radiofrequency (RF) devices on the market that are utilized in the field of aesthetic medicine. At this time, there is only one FDA cleared device on the market that emits RF energy using a non-contact delivery system for circumferential reduction by means of adipocyte disruption. Innovation of treatment protocols is an integral part of aesthetic device development. However, when protocol modifications are made it is important to look at the safety as well as the potential for improved efficacy before initiating change. The purpose of this study was to evaluate the safety and efficacy of a newly designed extended treatment protocol using an operator independent selective non-contact RF device for the improvement in the contour and circumferential reduction of the abdomen and flanks (love handles). Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits. Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment photographs to determine which photo was the after photo. The evaluators were able to correctly identify the post treatment photos with an 88% accuracy rate. Treatments were well tolerated by all subjects. No study related adverse events were reported. This study found that an extended treatment protocol using a selective RF device is a safe and effective method for the reduction of circumference and improved contouring of the abdomen and love handles.

[Surveillance of health care errors. An overview of the published data in Argentina].

PubMed

Codermatz, Marcela A; Trillo, Carolina; Berenstein, Graciela; Ortiz, Zulma

2006-01-01

In the last decades, public health surveillance extended its scope of study to new fields, such as medical errors, in order to improve patient safety. This study was aimed to review all the evidence produced in Argentina about the surveillance of medical errors. An exhaustive literature search was performed. A total of 4656 abstracts were assessed (150 MEDLINE, 145 LILACS, and 4361 hand searched abstracts). Of them, 52 were analysed and 8 were considered relevant for health care error surveillance. Different approaches were used to study medical errors. Some of them have focused on patient safety and others on medical malpractice. There is still a need to improve the surveillance of this type of event. Mainly, the quality reports of study design and surveillance attributes were unclear. A critical appraisal and synthesis of all relevant studies on health care errors may help to understand not only the state of the art, but also to define research priorities.

Efficacy and safety of a combined oral contraceptive containing estradiol valerate/dienogest: results from a clinical study conducted in North America.

PubMed

Nelson, Anita; Parke, Susanne; Mellinger, Uwe; Zampaglione, Edio; Schmidt, Anja

2014-03-01

This study investigated the efficacy and safety of a combined oral contraceptive (COC) containing estradiol valerate/dienogest (E2V/DNG). This was a multicenter, noncomparative, 13-cycle (extended to 28 cycles) study conducted in the United States and Canada. Contraceptive efficacy was calculated as a Pearl Index for 13 cycles, based on all on-treatment pregnancies; bleeding patterns were calculated based on bleeding and spotting information recorded daily in diary cards. Safety events during a 16-month extension study were added to the 1-year data. In total, 499 women, aged 18-35 years, were enrolled, and 490 of them were included in the full analysis set for contraceptive efficacy. Five pregnancies occurred in the first year (unadjusted Pearl Index=1.64). In cycles 1-12, an average 23.5% of women had absent scheduled (withdrawal) bleeding. Among women with scheduled (withdrawal) bleeding, bleeding started after a median of 2 days after intake of the last DNG-containing pill. For safety, data included from 147 women followed over an additional 16 months were added to the original 13-cycle data set. Treatment-related adverse events (AEs) occurred in 51.8% of women; 14.9% discontinued because of AEs over the entire 28-month study period. A COC with E2V and DNG was shown to provide effective contraception in women aged 18-35 years in North America.

76 FR 55261 - Safety Zone; Corporate Party on Hornblower Yacht, San Francisco, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... loaded onto a barge at Pier 50 near position 37[deg]46'28'' N, 122[deg]23'06'' W (NAD 83). From 7:45...]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83). The temporary safety zone will extend 100 feet from the... position 37[deg]46'38.46'' N, 122[deg]23'01.67'' W (NAD 83). The fireworks display will occur from 8:45...

An exploration of workplace social capital as an antecedent of occupational safety and health climate and outcomes in the Chinese education sector.

PubMed

Tang, Jessica Janice; Leka, Stavroula; Hunt, Nigel; MacLennan, Sara

2014-07-01

It is widely acknowledged that teachers are at greater risk of work-related health problems. At the same time, employee perceptions of different dimensions of organizational climate can influence their attitudes, performance, and well-being at work. This study applied and extended a safety climate model in the context of the education sector in Hong Kong. Apart from safety considerations alone, the study included occupational health considerations and social capital and tested their relationships with occupational safety and health (OSH) outcomes. Seven hundred and four Hong Kong teachers completed a range of questionnaires exploring social capital, OSH climate, OSH knowledge, OSH performance (compliance and participation), general health, and self-rated health complaints and injuries. Structural equation modeling (SEM) was used to analyze the relationships between predictive and outcome variables. SEM analysis revealed a high level of goodness of fit, and the hypothesized model including social capital yielded a better fit than the original model. Social capital, OSH climate, and OSH performance were determinants of both positive and negative outcome variables. In addition, social capital not only significantly predicted general health directly, but also had a predictive effect on the OSH climate-behavior-outcome relationship. This study makes a contribution to the workplace social capital and OSH climate literature by empirically assessing their relationship in the Chinese education sector.

2011 Annual Meeting of the Safety Pharmacology Society: an overview.

PubMed

Cavero, Icilio

2012-03-01

The keynote address of 2011 Annual Meeting of the Safety Pharmacology Society examined the known and the still to be known on drug-induced nephrotoxicity. The nominee of the Distinguished Service Award Lecture gave an account of his career achievements particularly on the domain of chronically instrumented animals for assessing cardiovascular safety. The value of Safety Pharmacology resides in the benefits delivered to Pharma organizations, regulators, payers and patients. Meticulous due diligence concerning compliance of Safety Pharmacology studies to best practices is an effective means to ensure that equally stringent safety criteria are applied to both in-licensed and in-house compounds. Innovative technologies of great potential for Safety Pharmacology presented at the meeting are organs on chips (lung, heart, intestine) displaying mechanical and biochemical features of native organs, electrical field potential (MEA) or impedance (xCELLigence Cardio) measurements in human induced pluripotent stem cell-derived cardiomyocytes for unveiling cardiac electrophysiological and mechanical liabilities, functional human airway epithelium (MucilAir™) preparations with unique 1-year shelf-life for acute and chronic in vitro evaluation of drug efficacy and toxicity. Custom-designed in silico and in vitro assay platforms defining the receptorome space occupied by chemical entities facilitate, throughout the drug discovery phase, the selection of candidates with optimized safety profile on organ function. These approaches can now be complemented by advanced computational analysis allowing the identification of compounds with receptorome, or clinically adverse effect profiles, similar to those of the drug candidate under scrutiny for extending the safety assessment to potential liability targets not captured by classical approaches. Nonclinical data supporting safety can be quite reassuring for drugs with a discovered signal of risk. However, for marketing authorization this information should be complemented by a clear clinical proof of safety. The ongoing outsourcing process of Regulatory Safety Pharmacology activities from large Pharmas to contract research organizations should be taken as an opportunity to establish long-overdue in-house Exploratory Safety Pharmacology units fully dedicated to the optimization of clinical candidates on organ safety.

Pharmacokinetics and Safety of High-Dose and Extended-Interval Regimens of Levofloxacin in Human Immunodeficiency Virus-Infected Patients

PubMed Central

Piscitelli, Stephen C.; Spooner, Katherine; Baird, Barbara; Chow, Andrew T.; Fowler, Cynthia L.; Williams, Rex R.; Natarajan, Jaya; Masur, Henry; Walker, Robert E.

1999-01-01

The pharmacokinetics of levofloxacin, administered in high doses and with extended dosing intervals, was studied in human immunodeficiency virus (HIV)-infected patients. Thirty patients received either 750 mg of the drug or a placebo once daily for 14 days, followed by 750 mg or 1,000 mg of the drug or a placebo three times weekly for an additional 14 days. Levofloxacin disposition was characterized by rapid oral absorption, with peak concentrations occurring approximately 1.5 h after dosing and elimination half-lives from 7.2 to 9.4 h. The overall incidence of any adverse effect was 70% (1,000 mg) to 95% (750 mg) for levofloxacin-treated patients and 71% for those taking the placebo. Levofloxacin pharmacokinetic parameters for HIV-infected patients were consistent with those observed in studies of healthy volunteers. PMID:10471591

Middle East food safety perspectives.

PubMed

Idriss, Atef W; El-Habbab, Mohammad S

2014-08-01

Food safety and quality assurance are increasingly a major issue with the globalisation of agricultural trade, on the one hand, and intensification of agriculture, on the other. Consumer protection has become a priority in policy-making amongst the large economies of the Middle East and North Africa (MENA) countries following a number of food safety incidents. To enhance food safety, it is necessary to establish markets underpinned by knowledge and resources, including analysis of international rejections of food products from MENA countries, international laboratory accreditation, improved reporting systems and traceability, continued development and validation of analytical methods, and more work on correlating sensory evaluation with analytical results. MENA countries should develop a national strategy for food safety based on a holistic approach that extends from farm-to-fork and involves all the relevant stakeholders. Accordingly, food safety should be a regional programme, raising awareness among policy- and decision-makers of the importance of food safety and quality for consumer protection, food trade and economic development. © 2014 Society of Chemical Industry.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Logan, Jeffrey S.; Paranhos, Elizabeth; Kozak, Tracy G.

This study focuses on onshore natural gas operations and examines the extent to which oil and gas firms have embraced certain organizational characteristics that lead to 'high reliability' - understood here as strong safety and reliability records over extended periods of operation. The key questions that motivated this study include whether onshore oil and gas firms engaged in exploration and production (E&P) and midstream (i.e., natural gas transmission and storage) are implementing practices characteristic of high reliability organizations (HROs) and the extent to which any such practices are being driven by industry innovations and standards and/or regulatory requirements.

Extended cold snare polypectomy for small colorectal polyps increases the R0 resection rate.

PubMed

Abe, Yasuhiro; Nabeta, Haruaki; Koyanagi, Ryota; Nakamichi, Taro; Hirashima, Hayato; Lefor, Alan Kawarai; Shinozaki, Satoshi

2018-02-01

 Despite widespread use of cold snare polypectomy (CSP), the R0 resection rate is not well documented. We perform extended CSP, resecting polyps with a > 1 mm circumferential margin. The aim of this study is to compare the R0 resection rate of extended CSP with conventional CSP and to assess safety. From April 2014 to September 2016, 712 non-pedunculated colorectal polyps, < 10 mm in size, resected using CSP from 316 patients were retrospectively analyzed.  We divided lesions into conventional CSP (n = 263) and extended CSP groups (n = 449). The baseline characteristics of these two groups were not significantly different in univariate or multivariate analyses. Sessile polyps comprised 94 % (668/712), and the remaining were flat-elevated polyps. Mean size of polyps (±standard deviation) was 4.2 ± 1.5 mm. The most frequent pathology was low grade adenoma (97 %, 689/712). The R0 resection rate was significantly higher in the extended CSP group (439/449 [98 %]) than in the conventional CSP group (222/263 [84 %], P  < 0.001). There was no delayed bleeding or perforation in either group (conventional CSP group, 0/263, 95 % confidence interval: 0.0 - 1.4 % and extended CSP group, 0/449, 95 % confidence interval: 0.0 - 0.8 %).  Extended CSP results in a higher R0 resection rate compared with conventional CSP. Extended CSP did not result in a higher rate of delayed bleeding or perforation. Extended CSP is a safe and promising procedure for endoscopic resection of non-pedunculated colorectal polyps < 10 mm in size.

Estimation of Inherent Safety Margins in Loaded Commercial Spent Nuclear Fuel Casks

DOE PAGES

Banerjee, Kaushik; Robb, Kevin R.; Radulescu, Georgeta; ...

2016-06-15

We completed a novel assessment to determine the unquantified and uncredited safety margins (i.e., the difference between the licensing basis and as-loaded calculations) available in as-loaded spent nuclear fuel (SNF) casks. This assessment was performed as part of a broader effort to assess issues and uncertainties related to the continued safety of casks during extended storage and transportability following extended storage periods. Detailed analyses crediting the actual as-loaded cask inventory were performed for each of the casks at three decommissioned pressurized water reactor (PWR) sites to determine their characteristics relative to regulatory safety criteria for criticality, thermal, and shielding performance.more » These detailed analyses were performed in an automated fashion by employing a comprehensive and integrated data and analysis tool—Used Nuclear Fuel-Storage, Transportation & Disposal Analysis Resource and Data System (UNF-ST&DARDS). Calculated uncredited criticality margins from 0.07 to almost 0.30 Δk eff were observed; calculated decay heat margins ranged from 4 to almost 22 kW (as of 2014); and significant uncredited transportation dose rate margins were also observed. The results demonstrate that, at least for the casks analyzed here, significant uncredited safety margins are available that could potentially be used to compensate for SNF assembly and canister structural performance related uncertainties associated with long-term storage and subsequent transportation. The results also suggest that these inherent margins associated with how casks are loaded could support future changes in cask licensing to directly or indirectly credit the margins. Work continues to quantify the uncredited safety margins in the SNF casks loaded at other nuclear reactor sites.« less

The value of materials R&D in the fast track development of fusion power

NASA Astrophysics Data System (ADS)

Ward, D. J.; Taylor, N. P.; Cook, I.

2007-08-01

The objective of the international fusion program is the creation of power plants with attractive safety and environmental features and viable economics. There is a range of possible plants that can meet these objectives, as studied for instance in the recent EU studies of power plant concepts. All of the concepts satisfy safety and environmental objectives but the economic performance is interpreted differently in different world regions according to the perception of future energy markets. This leads to different materials performance targets and the direction and timescales of the materials development programme needed to meet those targets. In this paper, the implications for materials requirements of a fast track approach to fusion development are investigated. This includes a quantification of the overall benefits of more advanced materials: including the effect of trading off an extended development time against a reduced cost of electricity for resulting power plants.

Estimation of integrated public risks for nonseismic external events affecting the Savannah River Site

DOE Office of Scientific and Technical Information (OSTI.GOV)

Durant, W.S.; robinette, R.J.; Kirchner, J.R.

1994-03-01

In essence, this study was envisioned as the ``combination`` of existing accident dose and risk calculations from safety analyses of individual facilities. However, because of the extended time period over which the safety analyses were prepared, calculational assumptions and methodologies differed between the analyses. The scope of this study therefore included the standardization of assumptions and calculations as necessary to insure that the analytical logic was consistent for all the facilities. Each of the nonseismic external events considered in the analyses are addressed in individual sections in this report. In Section 2, extreme straight-line winds are examined. Section 3 addressesmore » tornadoes, and Section 4 addresses other external events [floods, other extreme weather events (lightning, hail, and extremes in temperature or precipitation), vehicle impact, accidents involving adjacent facilities, aircraft impact, and meteorite impact]. Section 5 provides a summary of the general conclusions of the report.« less

Airflow Hazard Visualization for Helicopter Pilots: Flight Simulation Study Results

NASA Technical Reports Server (NTRS)

Aragon, Cecilia R.; Long, Kurtis R.

2005-01-01

Airflow hazards such as vortices or low level wind shear have been identified as a primary contributing factor in many helicopter accidents. US Navy ships generate airwakes over their decks, creating potentially hazardous conditions for shipboard rotorcraft launch and recovery. Recent sensor developments may enable the delivery of airwake data to the cockpit, where visualizing the hazard data may improve safety and possibly extend ship/helicopter operational envelopes. A prototype flight-deck airflow hazard visualization system was implemented on a high-fidelity rotorcraft flight dynamics simulator. Experienced helicopter pilots, including pilots from all five branches of the military, participated in a usability study of the system. Data was collected both objectively from the simulator and subjectively from post-test questionnaires. Results of the data analysis are presented, demonstrating a reduction in crash rate and other trends that illustrate the potential of airflow hazard visualization to improve flight safety.

Analytical methods in multivariate highway safety exposure data estimation

DOT National Transportation Integrated Search

1984-01-01

Three general analytical techniques which may be of use in : extending, enhancing, and combining highway accident exposure data are : discussed. The techniques are log-linear modelling, iterative propor : tional fitting and the expectation maximizati...

78 FR 40484 - Determination That METADATE ER (Methylphenidate Hydrochloride) Extended-Release Tablet, 10...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-05

..., educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the... marketing for reasons other than safety or effectiveness. ANDAs that refer to METADATE ER (methylphenidate...

Student midwives' duty hours: risks, standards, and recommendations.

PubMed

Lawrence, Rachel; Kantrowitz-Gordon, Ira; Landis, Andrea

2014-01-01

A growing body of literature has emerged describing the risks of extended-duty shifts and sleep deprivation. Worldwide, midwifery organizations have not adopted standards for practitioner or student duty shifts. This project reviews the literature related to extended-duty shifts in an effort to develop evidence-based recommendations for student nurse-midwives/student midwives (SNMs/SMs). A comprehensive literature search was conducted through electronic databases, major journals, and reference lists published in English since January 2001. Primary research studies evaluating sleep deprivation and shift duration were included. Studies that did not include the target population (shift workers) and those that formed conclusions related to extended-duty shifts greater than 30 hours were excluded. In addition, an extensive worldwide review of duty-hour recommendations from more than 300 health care organizations was conducted. A total of 40 studies met the inclusion criteria. Extended-duty shifts (those greater than 12 hours) increased the risk for cognitive and physical functional errors, safety concerns, and decreased quality of life from sleep deprivation. Cognitive function errors included attention lapses, visual tracking errors, decreased mentation and immediate recall, and decreased learning capacity. Physical errors included decreased motor skills and slowed reaction times in clinical simulations. These deficits led to an increased risk of motor vehicle accidents, needle sticks, and performance equivalent to unsafe blood alcohol concentrations. An overall decrease in quality of life and job satisfaction was linked to extended-duty shifts. Seven organizations for medical residents or advanced practice nurses have developed policy statements on duty shifts, with extended-duty shift limitations between 12 and 24 hours. The risks associated with extended-duty shifts may inhibit the development of SNMs/SMs into competent practitioners and place patients at risk. It is recommended that midwifery education programs adopt evidence-based limitations for the duty shifts of SNMs/SMs. © 2014 by the American College of Nurse-Midwives.

Old Age, Life Extension, and the Character of Medical Choice

PubMed Central

Kaufman, Sharon R.; Shim, Janet K.; Russ, Ann J.

2008-01-01

Objectives This qualitative, ethnographic study explores the character and extent of medical choice for life-extending procedures on older adults. It examines the sociomedical features of treatment that shape health care provider understandings of the nature of choice, and it illustrates the effects of treatment patterns on patients’ perspectives of their options for life extension. Methods By using participant observation in outpatient clinics and face-to-face interviews, we spoke with a convenience sample of 38 health professionals and 132 patients aged 70 or older who had undergone life-extending medical procedures. We asked providers and patients open-ended questions about their understandings of medical choice for cardiac procedures, dialysis, and kidney transplant. Results Neither patients nor health professionals made choices about the start or continuation of life-extending interventions that were uninformed by the routine pathways of treatment; the pressures of the technological imperative; or the growing normalization, ease, and safety of treating ever older patients. We found a difference among cardiac, dialysis, and transplant procedures regarding the locus of responsibility for maintaining and extending life. Discussion Provider and patient practices together reveal how the standard use of medical procedures at ever older ages trumps patient-initiated decision making. PMID:16855038

An early assessment of silicone hydrogel safety: pearls and pitfalls, and current status.

PubMed

Keay, Lisa; Edwards, Katie; Stapleton, Fiona

2007-11-01

The contact lens industry has evolved and now provides many choices, including continuous wear, overnight orthokeratology, frequent-replacement lenses, daily-disposable lenses, and many alternatives in systems of care and maintenance. Epidemiologic studies to date have shown that how a lens is worn, particularly if worn overnight, can increase the risk of microbial keratitis. However, the risk of silicone hydrogel contact lenses worn on a continuous-wear basis has been evaluated only recently. This article summarizes the recent research data on extended-wear silicone hydrogel lenses and discusses the challenges of early evaluations of silicone hydrogel lens safety. Finally, the relevance of this information is discussed to practitioners and contact lens wearers making choices about the risks and benefits of different products and how they are used.

Minimum Equipment Lists, Flight Rules and ... Past, Present and Future of Safety Pre-Determined Decisions for Operations

NASA Astrophysics Data System (ADS)

Herd, A.; Wolff, M.

2012-01-01

Extended mission operations, such as human spaceflight to Mars provide an opportunity for take current human exploration beyond Low Earth Orbit, such as the operations undertaken on the International Space Station (ISS). This opportunity also presents a challenge in terms of extending what we currently understand as "remote operations" performed on ISS, offering learning beyond that gained from the successful moon- lander expeditions. As such there is a need to assess how the existing operations concept of ground support teams directing (and supporting) on-orbit ISS operations can be applied in the extended mission concept. The current mission support concept involves three interacting operations products - a short term plan, crew procedures and flight rules. Flight rules (for ISS operations) currently provide overall planning, engineering and operations constraints (including those derived from a safety perspective) in the form of a rule book. This paper will focus specifically on flight rules, and describe the current use of them, and assess the future role of flight rules to support exploration, including the deployment of decision support tools (DSTs) to ensure flight rule compliancy for missions with minimal ground support. Taking consideration of the historical development of pre-planned decisions, and their manifestation within the operations environment, combined with the extended remoteness of human exploration missions, we will propose a future development of this product and a platform on which it could be presented.

Effects of approach and services under differential response on long term child safety and welfare.

PubMed

Loman, L Anthony; Siegel, Gary L

2015-01-01

An outcome analysis was conducted based on an extended follow-up of the implementation of differential response program reforms in Child Protective Services offices in 10 counties in a Midwestern U.S. State. Random assignment was conducted of families that were first determined to be appropriate for family assessments. Experimental families (n=2,382) were each assigned to a non-forensic family assessment, and control families (n=2,247) each received a forensic investigation. Families were assigned continuously over a 15-month period and then tracked from 45 to 60 months from the date of assignment. Detailed information on services provided and family responses was obtained via two subsamples of experimental and control families. Measures of family engagement and service reception and utilization were utilized to determine instrumental outcomes introduced through family assessments. Improved family engagement and increased and broadened services were found to have occurred, and it was theorized that these changes mediated extended outcomes. Extended outcomes included reductions of rates of subsequent screened-in reports of child maltreatment, proportions of families that experienced child removals, and instances of new safety threats and problems in parenting. Differences in outcomes were found among the participating counties with 4 counties accounting for most outcome differences. The relationships between instrumental and extended outcomes were discussed with suggestions for further research. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Validating and Extending the Three Process Model of Alertness in Airline Operations

PubMed Central

Ingre, Michael; Van Leeuwen, Wessel; Klemets, Tomas; Ullvetter, Christer; Hough, Stephen; Kecklund, Göran; Karlsson, David; Åkerstedt, Torbjörn

2014-01-01

Sleepiness and fatigue are important risk factors in the transport sector and bio-mathematical sleepiness, sleep and fatigue modeling is increasingly becoming a valuable tool for assessing safety of work schedules and rosters in Fatigue Risk Management Systems (FRMS). The present study sought to validate the inner workings of one such model, Three Process Model (TPM), on aircrews and extend the model with functions to model jetlag and to directly assess the risk of any sleepiness level in any shift schedule or roster with and without knowledge of sleep timings. We collected sleep and sleepiness data from 136 aircrews in a real life situation by means of an application running on a handheld touch screen computer device (iPhone, iPod or iPad) and used the TPM to predict sleepiness with varying level of complexity of model equations and data. The results based on multilevel linear and non-linear mixed effects models showed that the TPM predictions correlated with observed ratings of sleepiness, but explorative analyses suggest that the default model can be improved and reduced to include only two-processes (S+C), with adjusted phases of the circadian process based on a single question of circadian type. We also extended the model with a function to model jetlag acclimatization and with estimates of individual differences including reference limits accounting for 50%, 75% and 90% of the population as well as functions for predicting the probability of any level of sleepiness for ecological assessment of absolute and relative risk of sleepiness in shift systems for safety applications. PMID:25329575

Applying an extended theory of planned behavior to predicting violations at automated railroad crossings.

PubMed

Palat, Blazej; Paran, Françoise; Delhomme, Patricia

2017-01-01

Based on an extended Theory of Planned Behavior (TPB, Ajzen, 1985, 1991), we conducted surveys in order to explain and predict violations at a railroad crossing, among pedestrians (n=153) and car drivers (n=151). Measures were made with respect to three chronologically related railroad crossing situations that varied in risk level. The situations were described in scenarios and depicted on photographs. The participants were recruited in the suburbs of Paris, at two automated railroad crossings with four half-barriers. We found that the pedestrians had stronger crossing intentions than did car drivers, especially at the more congested crossing of the two under study. For both categories of road users, intentions and the amount of intention variance explained by the extended TPB factors decreased significantly with risk level. In the most dangerous situations, risk-taking was the most unlikely and the least predictable Self-reported past frequency of crossing against safety warning devices was the main predictor of the intention to commit this violation again, especially among males, followed by the attitude and the injunctive norm in favor the violation. Moreover, car drivers were influenced in their crossing intentions by the descriptive norm. The presence of another vehicle on the tracks when the safety warning devices were activated was perceived not as facilitating, but as an additional risk factor. The discussion addresses the importance of taking into account these determinants of violations in conceiving countermeasures. Our findings could be especially useful for conceiving risk-communication campaigns. Copyright © 2016 Elsevier Ltd. All rights reserved.

School safe driving climate: Theoretical and practical considerations for promoting teen driver safety in school settings.

PubMed

Mirman, Jessica H; Roche, Brianne; Higgins-D'Alessandro, Ann

2018-06-21

The aims of this study were to extend the current literature on school climate that is focused on understanding how teacher, administrator, and student perceptions about driving-focused aspects of the social, educational, and institutional climate of schools can affect students' achievement, behavior, and adjustment towards the development of the concept of school safe driving climate (SSDC) and initiate the development of tools and processes for assessing SSDC. A mixed-methods approach was used to develop an initial version of a survey-based measure of SSDC that involved self-report surveys (students) and in-depth interviews (teachers). Exploratory factor analytic procedures identified SSDC constructs and a regression framework was used to examine associations among SSDC constructs and self-reported driver behaviors. Qualitative data were subjected to inductive analysis, with a goal of elucidating teachers' perspectives on SSDC and an SSDC intervention. The study sample consisted of 947 adolescents (48% male) from one large high school and 44 teacher advisors. Participants were recruited from a school participating in a state-wide effort to promote transportation safety through peer-led programming. Two SSDC factors were identified: Administrative Contributions to School Safety and Value of School Safety, which were associated with adolescents' perceptions of their driving behaviors. Adolescents' perceived that the intervention affected administrative safety. Teacher interviews contextualized these results and provided guidance on program revisions. Safe driving climate may be an important, modifiable, and measurable aspect of school climate. Additional research is needed to refine the assessment tool and to use it in longitudinal and experimental studies.

Orbital Transfer Vehicle (OTV) engine study. Phase A: Extension

NASA Technical Reports Server (NTRS)

Sobin, A. J.

1980-01-01

The current Phase A-Extension of the OTV engine study program aims to provide additional expander and staged combustion cycle data that will lead to design definition of the OTV engine. The proposed program effort seeks to optimize the expander cycle engine concept (consistent with identified OTV engine requirements), investigate the feasibility of kitting the staged combustion cycle engine to provide extended thrust operation, and conduct in-depth analysis of development risk, crew safety, and reliability for both cycles. Additional tasks address the costing of a 10/K thrust expander cycle engine and support of OTV systems study contractors.

Regulations as Prevention Strategies for Shiftwork Problems.

PubMed

Jeppesen; Bøggild; Larsen

1997-07-01

The study examines how the Danish system of regulations stemming from collective agreements and legislation and its associated participatory structures operate at the local level in relation to shiftwork and health and safety issues in a regional hospital system consisting of seven hospitals. The study analyzed ward reports of each employee's employment and working hours, local agreements about working time for deviations from legislation, and accounts from meetings in Co-operation Committees and Health and Safety Committees with respect to shiftwork issues from 1980 to 1994. The results showed that part-time employment, especially for those working on fixed evening and night shifts, was a dominant feature in the shiftwork arrangements. A majority of wards were found to have mixtures of employees working rotating or fixed shifts. Each hospital had local agreements that extended the number of work days between periods with days off and reduced the daily resting period to its minimum. None of the meetings of the Health and Safety Committees dealt with shiftwork, and when shiftwork and working time were on the agendas of the Co-operation Committees, health and safety aspects did not feature in the conclusions. The absence of consideration of health and safety aspects is discussed in relation to the uncertainty of the general regulatory principles for work organization and scheduling. The paper concludes that in order to utilize the potential af the participatory structures in developing prevention strategies for shiftwork problems, it is important to clarify responsibilities and cooperation between the two participatory committees.

Inspection In Overhead Spaces Containing Asbestos

NASA Technical Reports Server (NTRS)

Bell, Jacque; Hartwick, George; Hutcherson, Jerry

1989-01-01

Procedure for inspection in spaces above dropped ceilings that contain asbestos saves time and effort without sacrificing safety. With new method, only items of safety equipment needed are glove bag, storage bag, and roll of adhesive tape. Inspector tapes glove bag tightly to support grid around ceiling tile to be removed. With hands in gloves inspector lifts tile gently and places it aside. Extending head and shoulders into bag, inspector examines space above ceiling with help of flashlight.

76 FR 77125 - Safety Zone; Sausalito Yacht Club's Annual Lighted Boat Parade and Fireworks Display, Sausalito, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-12

..., pyrotechnics will be loaded onto a barge at Pier 50 near position 37[deg]46'28'' N, 122[deg]23'06'' W (NAD 83... position 37[deg]51'30.92'' N, 122[deg]28'27.97'' W (NAD 83). The temporary safety zone will extend 100 feet... Pier 50 to position 37[deg]51'30.92'' N, 122[deg]28'27.97'' W (NAD 83). The fireworks display is...

Model-Based Safety Analysis

NASA Technical Reports Server (NTRS)

Joshi, Anjali; Heimdahl, Mats P. E.; Miller, Steven P.; Whalen, Mike W.

2006-01-01

System safety analysis techniques are well established and are used extensively during the design of safety-critical systems. Despite this, most of the techniques are highly subjective and dependent on the skill of the practitioner. Since these analyses are usually based on an informal system model, it is unlikely that they will be complete, consistent, and error free. In fact, the lack of precise models of the system architecture and its failure modes often forces the safety analysts to devote much of their effort to gathering architectural details about the system behavior from several sources and embedding this information in the safety artifacts such as the fault trees. This report describes Model-Based Safety Analysis, an approach in which the system and safety engineers share a common system model created using a model-based development process. By extending the system model with a fault model as well as relevant portions of the physical system to be controlled, automated support can be provided for much of the safety analysis. We believe that by using a common model for both system and safety engineering and automating parts of the safety analysis, we can both reduce the cost and improve the quality of the safety analysis. Here we present our vision of model-based safety analysis and discuss the advantages and challenges in making this approach practical.

Results from a phase 1 study of nusinersen (ISIS-SMN(Rx)) in children with spinal muscular atrophy.

PubMed

Chiriboga, Claudia A; Swoboda, Kathryn J; Darras, Basil T; Iannaccone, Susan T; Montes, Jacqueline; De Vivo, Darryl C; Norris, Daniel A; Bennett, C Frank; Bishop, Kathie M

2016-03-08

To examine safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of intrathecal nusinersen (previously ISIS-SMNRx), an antisense oligonucleotide designed to alter splicing of SMN2 mRNA, in patients with childhood spinal muscular atrophy (SMA). Nusinersen was delivered by intrathecal injection to medically stable patients with type 2 and type 3 SMA aged 2-14 years in an open-label phase 1 study and its long-term extension. Four ascending single-dose levels (1, 3, 6, and 9 mg) were examined in cohorts of 6-10 participants. Participants were monitored for safety and tolerability, and CSF and plasma pharmacokinetics were measured. Exploratory efficacy endpoints included the Hammersmith Functional Motor Scale Expanded (HFMSE) and Pediatric Quality of Life Inventory. A total of 28 participants enrolled in the study (n = 6 in first 3 dose cohorts; n = 10 in the 9-mg cohort). Intrathecal nusinersen was well-tolerated with no safety/tolerability concerns identified. Plasma and CSF drug levels were dose-dependent, consistent with preclinical data. Extended pharmacokinetics indicated a prolonged CSF drug half-life of 4-6 months after initial clearance. A significant increase in HFMSE scores was observed at the 9-mg dose at 3 months postdose (3.1 points; p = 0.016), which was further increased 9-14 months postdose (5.8 points; p = 0.008) during the extension study. Results from this study support continued development of nusinersen for treatment of SMA. This study provides Class IV evidence that in children with SMA, intrathecal nusinersen is not associated with safety or tolerability concerns. © 2016 American Academy of Neurology.

Asphalt surface treatment practice in southeastern United States.

DOT National Transportation Integrated Search

2014-07-01

It costs less to maintain roads in good condition than in poor condition. Pavement preservation is a set of : activities to extend pavement life, improve safety, and meet road user expectations. Surface treatments are : pavement preservation treatmen...

In the Line of Fire.

ERIC Educational Resources Information Center

Kennedy, Mike

2001-01-01

Highlights the importance of using sprinkler systems in school residence halls to prevent fire fatalities. Understanding the risks involved, retrofitting schools to meet these risks, and realizing the need to extend safety education to off-campus housing are discussed. (GR)

Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women

PubMed Central

Konno, Ryo; Yoshikawa, Hiroyuki; Okutani, Marie; Quint, Wim; V Suryakiran, Pemmaraju; Lin, Lan; Struyf, Frank

2014-01-01

In this open, extended follow-up study (NCT00929526, Clinicaltrials.gov), we evaluated the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine efficacy, immunogenicity and safety up to 4 years after first vaccination in Japanese women aged 20–25 years. In the initial randomized, double-blind study (NCT00316693), 1040 women received the study vaccine or hepatitis A control vaccine; 752 women were included in the follow-up study. In women from the according-to-protocol efficacy cohort (ATP-E), who were initially seronegative for the HPV type analyzed, no cervical intraepithelial neoplasia (CIN) grade 1 or greater (CIN1+) cases associated with HPV-16/18 were reported in the HPV group, while in the control group, 5 cases were identified in extended follow-up analyses (vaccine efficacy [VE] 100% [95% CI: −3.7–100]) and 8 cases in combined initial and follow-up studies analyses (VE 100% [42.2–100]). In the ATP-E, VE against CIN1+ and CIN2+ associated with high-risk HPV types reached 66.4% (21.6–87.1) and 83.0% (22.1–98.2) in extended follow-up analyses, and 63.4% (28.8–82.3) and 77.3% (30.4–94.4) in analyses of combined studies, respectively. During the 4-year period, protection against CIN1+ and CIN2+, irrespective of the HPV type, was 56.7% (32.8–72.6) and 54.9% (20.5–75.3) in women receiving ≥1 vaccine dose, regardless of baseline serostatus (total vaccinated cohort [TVC]) and 61.0% (11.8–84.2) and 73.9% (1.1–95.3) in women naïve to HPV infection at baseline (TVC-naïve), respectively. The high VE observed in Japanese women, accompanied by a sustained immune response and a clinically acceptable safety profile, support findings of large, international trials. PMID:25424783

Scraping by: Income and Program Participation After the Loss of Extended Unemployment Benefits.

PubMed

Rothstein, Jesse; Valletta, Robert G

Many Unemployment Insurance (UI) recipients do not find new jobs before exhausting their benefits, even when benefits are extended during recessions. Using Survey of Income and Program Participation (SIPP) panel data covering the 2001 and 2007 to 2009 recessions and their aftermaths, we identify individuals whose jobless spells outlasted their UI benefits (exhaustees) and examine household income, program participation, and health-related outcomes during the six months following UI exhaustion. For the average exhaustee, the loss of UI benefits is only slightly offset by increased participation in other safety net programs (e.g., food stamps), and family poverty rates rise substantially. Self-reported disability also rises following UI exhaustion. These patterns do not vary dramatically across household demographic groups, broad income level prior to job loss, or the two business cycles. The results highlight the unique, important role of UI in the U.S. social safety net.

A Comparative Study of Natural Antimicrobial Delivery Systems for Microbial Safety and Quality of Fresh-Cut Lettuce.

PubMed

Hill, Laura E; Oliveira, Daniela A; Hills, Katherine; Giacobassi, Cassie; Johnson, Jecori; Summerlin, Harvey; Taylor, T Matthew; Gomes, Carmen L

2017-05-01

Nanoencapsulation can provide a means to effectively deliver antimicrobial compounds and enhance the safety of fresh produce. However, to date there are no studies which directly compares how different nanoencapsulation systems affect fresh produce safety and quality. This study compared the effects on quality and safety of fresh-cut lettuce treated with free and nanoencapsulated natural antimicrobial, cinnamon bark extract (CBE). A challenge study compared antimicrobial efficacy of 3 different nanoencapsulated CBE systems. The most effective antimicrobial treatment against Listeria monocytogenes was chitosan-co-poly-N-isopropylacrylamide (chitosan-PNIPAAM) encapsulated CBE, with a reduction on bacterial load up to 2 log 10 CFU/g (P < 0.05) compared to the other encapsulation systems when fresh-cut lettuce was stored at 5 °C and 10 °C for 15 d. Subsequently, chitosan-PNIPAAM-CBE nanoparticles (20, 40, and 80 mg/mL) were compared to a control and free CBE (400, 800, and 1600 μg/mL) for its effects on fresh-cut lettuce quality over 15 d at 5 °C. By the 10th day, the most effective antimicrobial concentration was 80 mg/mL for chitosan-PNIPAAM-CBE, up to 2 log 10 CFU/g reduction (P < 0.05), compared with the other treatments. There was no significant difference between control and treated samples up to day 10 for the quality attributes evaluated. Chitosan-PNIPAAM-CBE nanoparticles effectively inhibited spoilage microorganisms' growth and extended fresh-cut lettuce shelf-life. Overall, nanoencapsulation provided a method to effectively deliver essential oil and enhanced produce safety, while creating little to no detrimental quality changes on the fresh-cut lettuce. © 2017 Institute of Food Technologists®.

The European ASAMPSA_E project : towards guidance to model the impact of high amplitude natural hazards in the probabilistic safety assessment of nuclear power plants. Information on the project progress and needs from the geosciences.

NASA Astrophysics Data System (ADS)

Raimond, Emmanuel; Decker, Kurt; Guigueno, Yves; Klug, Joakim; Loeffler, Horst

2015-04-01

The Fukushima nuclear accident in Japan resulted from the combination of two correlated extreme external events (earthquake and tsunami). The consequences, in particular flooding, went beyond what was considered in the initial engineering design design of nuclear power plants (NPPs). Such situations can in theory be identified using probabilistic safety assessment (PSA) methodology. PSA results may then lead industry (system suppliers and utilities) or Safety Authorities to take appropriate decisions to reinforce the defence-in-depth of the NPP for low probability event but high amplitude consequences. In reality, the development of such PSA remains a challenging task. Definitions of the design basis of NPPs, for example, require data on events with occurrence probabilities not higher than 10-4 per year. Today, even lower probabilities, down to 10-8, are expected and typically used for probabilistic safety analyses (PSA) of NPPs and the examination of so-called design extension conditions. Modelling the combinations of natural or man-made hazards that can affect a NPP and affecting some meaningful probability of occurrence seems to be difficult. The European project ASAMPSAE (www.asampsa.eu) gathers more than 30 organizations (industry, research, safety control) from Europe, US and Japan and aims at identifying some meaningful practices to extend the scope and the quality of the existing probabilistic safety analysis developed for nuclear power plants. It offers a framework to discuss, at a technical level, how "extended PSA" can be developed efficiently and be used to verify if the robustness of Nuclear Power Plants (NPPs) in their environment is sufficient. The paper will present the objectives of this project, some first lessons and introduce which type of guidance is being developed. It will explain the need of expertise from geosciences to support the nuclear safety assessment in the different area (seismotectonic, hydrological, meteorological and biological hazards, …).

Controlled-release of Chlorine Dioxide in a Perforated Packaging System to Extend the Storage Life and Improve the Safety of Grape Tomatoes.

PubMed

Sun, Xiuxiu; Baldwin, Elizabeth; Plotto, Anne; Narciso, Jan; Ference, Christopher; Ritenour, Mark; Harrison, Ken; Gangemi, Joseph; Bai, Jinhe

2017-04-07

A controlled-release chlorine dioxide (ClO2) pouch was developed by sealing a slurry form of ClO2 into semipermeable polymer film; the release properties of the pouch were monitored in containers with or without fruit. The pouch was affixed to the inside of a perforated clamshell containing grape tomatoes, and the effect on microbial population, firmness, and weight loss was evaluated during a 14 day storage period at 20 °C. Within 3 days, the ClO2 concentration in the clamshells reached 3.5 ppm and remained constant until day 10. Thereafter, it decreased to 2 ppm by day 14. The ClO2 pouch exhibited strong antimicrobial activity, reducing Escherichia coli populations by 3.08 log CFU/g and Alternaria alternata populations by 2.85 log CFU/g after 14 days of storage. The ClO2 treatment also reduced softening and weight loss and extended the overall shelf life of the tomatoes. Our results suggest that ClO2 treatment is useful for extending the shelf life and improving the microbial safety of tomatoes during storage without impairing their quality.

Total energy food plant 21 million gallon ethanol facility

NASA Astrophysics Data System (ADS)

1981-10-01

The Phase I Engineering study includes the following: process description, waste water treatment plant, material summary, energy chart, capital cost estimate, equipment list, personnel requirements, drawings list, specifications list, and project schedule. The economic and financial feasibility of the technical process, and environmental, health, safety, and socio-economic assessments for the project are reported. The costs for extending the following utilities to the property line of the selected site are presented: potable water, sewer system, electricity, roads for truck traffic, and rail service.

A Review of Environmental and Engineering Studies Concerning Effects of Extended Season Navigation on the Great Lakes-St. Lawrence Seaway System

DTIC Science & Technology

1988-10-01

hydroelectric power companies set across the St. Lawrence River in early winter to ensure dependable electric power generation in winter. One scheme was to...leave part of the boom open, but connected, and pull it closed after the last ship passed through using an electric winch mounted on a cell structure...needing a supplemntal safety loop. It was electrically operated, submersible, sensitive, and fairly light. Eventually the tension link design, including

Challenges to overcome: energy supply for remote consumers in the Russian Arctic

NASA Astrophysics Data System (ADS)

Morgunova, M. O.; Solovyev, D. A.

2017-11-01

The paper explores challenges of power supply for remote users through the case of the Northern Sea Route (NSR) supportive infrastructure development and specially nature protected areas (NPA) of the Russian Arctic. The study is based on a comprehensive analysis of relevant data of the state of renewable energy in the Russian Arctic. The paper gives policy recommendations on how to extend the use of renewable energy power plants in the region, optimize their input and increase cost-effectiveness and safety.

An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.

PubMed

Hunt, Sheena; Stebbings, Simon; McNamara, Debra

2016-10-28

This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.

Safety control circuit for a neutronic reactor

DOEpatents

Ellsworth, Howard C.

2004-04-27

A neutronic reactor comprising an active portion containing material fissionable by neutrons of thermal energy, means to control a neutronic chain reaction within the reactor comprising a safety device and a regulating device, a safety device including means defining a vertical channel extending into the reactor from an aperture in the upper surface of the reactor, a rod containing neutron-absorbing materials slidably disposed within the channel, means for maintaining the safety rod in a withdrawn position relative to the active portion of the reactor including means for releasing said rod on actuation thereof, a hopper mounted above the active portion of the reactor having a door disposed at the bottom of the hopper opening into the vertical channel, a plurality of bodies of neutron-absorbing materials disposed within the hopper, and means responsive to the failure of the safety rod on actuation thereof to enter the active portion of the reactor for opening the door in the hopper.

Multi-criteria framework as an innovative tradeoff approach to determine the shelf-life of high pressure-treated poultry.

PubMed

Guillou, S; Lerasle, M; Simonin, H; Anthoine, V; Chéret, R; Federighi, M; Membré, J-M

2016-09-16

A multi-criteria framework combining safety, hygiene and sensorial quality was developed to investigate the possibility of extending the shelf-life and/or removing lactate by applying High Hydrostatic Pressure (HHP) in a ready-to-cook (RTC) poultry product. For this purpose, Salmonella and Listeria monocytogenes were considered as safety indicators and Escherichia coli as hygienic indicator. Predictive modeling was used to determine the influence of HHP and lactate concentration on microbial growth and survival of these indicators. To that end, probabilistic assessment exposure models developed in a previous study (Lerasle, M., Guillou, S., Simonin, H., Anthoine, V., Chéret, R., Federighi, M., Membré, J.M. 2014. Assessment of Salmonella and L. monocytogenes level in ready-to-cook poultry meat: Effect of various high pressure treatments and potassium lactate concentrations. International Journal of Food Microbiology 186, 74-83) were used for L. monocytogenes and Salmonella. Besides, for E. coli, an exposure assessment model was built by modeling data from challenge-test experiments. Finally, sensory tests and color measurements were performed to evaluate the effect of HHP on the organoleptic quality of an RTC product. Quantitative rules of decision based on safety, hygienic and organoleptic criteria were set. Hygienic and safety criteria were associated with probability to exceed maximum contamination levels of L. monocytogenes, Salmonella and E. coli at the end of the shelf-life whereas organoleptic criteria corresponded to absence of statistical difference between pressurized and unpressurized products. A tradeoff between safety and hygienic risk, color and taste, was then applied to define process and formulation enabling shelf-life extension. In the resulting operating window, one condition was experimentally assayed on naturally contaminated RTC products to validate the multi-criteria approach. As a conclusion, the framework was validated; it was possible to extend the shelf-life of an RTC poultry product containing 1.8% (w/w) lactate by one week, despite slight color alteration. This approach could be profitably implemented by food processors as a decision support tool for shelf-life determination. Copyright © 2016 Elsevier B.V. All rights reserved.

Local properties of magnetic reconnection in nonlinear resistive- and extended-magnetohydrodynamic toroidal simulations of the sawtooth crash

DOE PAGES

Beidler, M. T.; Cassak, P. A.; Jardin, S. C.; ...

2016-12-15

We diagnose local properties of magnetic reconnection during a sawtooth crash employing the three-dimensional toroidal, extended-magnetohydrodynamic (MHD) code M3D-C 1. To do so, we sample simulation data in the plane in which reconnection occurs, the plane perpendicular to the helical (m, n) = (1, 1) mode at the q = 1 surface, where m and n are the poloidal and toroidal mode numbers and q is the safety factor. We study the nonlinear evolution of a particular test equilibrium in a non-reduced field representation using both resistive-MHD and extended-MHD models. We find growth rates for the extended-MHD reconnection process exhibitmore » a nonlinear acceleration and greatly exceed that of the resistive-MHD model, as is expected from previous experimental, theoretical, and computational work. We compare the properties of reconnection in the two simulations, revealing the reconnecting current sheets are locally different in the two models and we present the first observation of the quadrupole out-of-plane Hall magnetic field that appears during extended-MHD reconnection in a 3D toroidal simulation (but not in resistive-MHD). We also explore the dependence on toroidal angle of the properties of reconnection as viewed in the plane perpendicular to the helical magnetic field, finding qualitative and quantitative effects due to changes in the symmetry of the reconnection process. Furthermore, this study is potentially important for a wide range of magnetically confined fusion applications, from confirming simulations with extended-MHD effects are sufficiently resolved to describe reconnection, to quantifying local reconnection rates for purposes of understanding and predicting transport, not only at the q = 1 rational surface for sawteeth, but also at higher order rational surfaces that play a role in disruptions and edge-confinement degradation.« less

University education and nuclear criticality safety professionals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wilson, R.E.; Stachowiak, R.V.; Knief, R.A.

1996-12-31

The problem of developing a productive criticality safety specialist at a nuclear fuel facility has long been with us. The normal practice is to hire a recent undergraduate or graduate degree recipient and invest at least a decade in on-the-job training. In the early 1980s, the U.S. Department of Energy (DOE) developed a model intern program in an attempt to speed up the process. The program involved working at assigned projects for extended periods at a working critical mass laboratory, a methods development group, and a fuel cycle facility. This never gained support as it involved extended time away frommore » the job. At the Rocky Flats Environmental Technology Site, the training method is currently the traditional one involving extensive experience. The flaw is that the criticality safety staff turnover has been such that few individuals continue for the decade some consider necessary for maturity in the discipline. To maintain quality evaluations and controls as well as interpretation decisions, extensive group review is used. This has proved costly to the site and professionally unsatisfying to the current staff. The site contractor has proposed a training program to remedy the basic problem.« less

[Progress of low-energy shockwave therapy in clinical application].

PubMed

Xin, Zhong-cheng; Liu, Jing; Wang, Lin; Li, Hui-xi

2013-08-18

A shock wave is a transient pressure disturbance that propagates rapidly in three-dimensional space. It is associated with a sudden rise from ambient pressure to its maximum pressure. Shock wave therapy in urology is primarily used to disintegrate urolithiasis. Recently, low-energy shock wave therapy (LESWT), which is a novel convenient and cost-effective therapeutic modality, is extended to treat other pathological conditions including coronary heart disease, musculoskeletal disorders and erectile dysfunction. However, the exact therapeutic mechanisms and clinical safety and efficacy of LESWT remain to be investigated. Based on the results of previous studies, it is suggested that LESWT could regulate angiogenesis-related growth factors expression including endothelial nitric oxide synthase (eNOS), vessel endothelial growth factor (VEGF) and proliferating cell nuclear antigen (PCNA), which might induce the ingrowth of neovascularization that improves blood supply and increases cell proliferation and eventual tissue regeneration for restore pathological changes. The further studies on cellular and molecular biological changes by LESWT for clarification its mechanism and clinical safety and efficacy studies are recommended.

A case of industrial safety appraisal for extension of service life of GTK-10-4 gas turbines used at gas transmission stations

NASA Astrophysics Data System (ADS)

Rybnikov, A. I.; Kovalev, A. G.; Kryukov, I. I.; Leont'ev, S. A.; Moshnikov, A. V.

2017-04-01

It is shown that the extended life and enhanced operational reliability of parts and subassemblies of the most popular GTK-10-4 gas transmission plants are determined by the enhanced efficiency of the control over technical condition and operational safety of turbine plants in conformity with industrial safety requirements imposed on gas pipeline compressor stations. It has been established that the materials of parts and subassemblies of gas turbine plants with different, especially with maximal operating time, shall be exposed to NDT for the purpose of determining the actual mechanical characteristics of these materials with different operating time and calculating residual life. The analysis of damageability and operating conditions has helped to identify parts and subassemblies for repair or replacement with the highest frequency of unacceptable defects. These parts and subassemblies have been shown to include base members of the axial compressor (AC), a turbine housing, an axial compressor rotor, high- and low-pressure turbine (HPT and LPT) discs, a 12-part holder, the housing of the holder of HPT and LPT guiding blades, a sealed baffler, and working and guiding AC, LPT and HPT blades. The most typical operational defects have been enumerated and analyzed. It has been determined that the primary task of the industrial safety appraisal for extending the life of GTK-10-4 with limit-exceeding operating time is to thoroughly examine HPT and LPT discs with more than 130,000 hours of operating time and establish by DT methods characteristics of materials for evaluation, taking account of their degradation, and residual life of critical turbine elements. In addition, it has been shown that the service life of HP turbine discs can be extended by replacing the disc material (EP-428 12% chromium steel) with a material with a higher linear expansion factor that somewhat exceeds the expansion factor of EI-893 nickel alloy used to melt out working blades.

Safety modelling and testing of lithium-ion batteries in electrified vehicles

NASA Astrophysics Data System (ADS)

Deng, Jie; Bae, Chulheung; Marcicki, James; Masias, Alvaro; Miller, Theodore

2018-04-01

To optimize the safety of batteries, it is important to understand their behaviours when subjected to abuse conditions. Most early efforts in battery safety modelling focused on either one battery cell or a single field of interest such as mechanical or thermal failure. These efforts may not completely reflect the failure of batteries in automotive applications, where various physical processes can take place in a large number of cells simultaneously. In this Perspective, we review modelling and testing approaches for battery safety under abuse conditions. We then propose a general framework for large-scale multi-physics modelling and experimental work to address safety issues of automotive batteries in real-world applications. In particular, we consider modelling coupled mechanical, electrical, electrochemical and thermal behaviours of batteries, and explore strategies to extend simulations to the battery module and pack level. Moreover, we evaluate safety test approaches for an entire range of automotive hardware sets from cell to pack. We also discuss challenges in building this framework and directions for its future development.

Effect of Concomitant Medications on the Safety and Efficacy of Extended-Release Carbidopa-Levodopa (IPX066) in Patients With Advanced Parkinson Disease: A Post Hoc Analysis.

PubMed

LeWitt, Peter A; Verhagen Metman, Leo; Rubens, Robert; Khanna, Sarita; Kell, Sherron; Gupta, Suneel

Extended-release (ER) carbidopa-levodopa (CD-LD) (IPX066/RYTARY/NUMIENT) produces improvements in "off" time, "on" time without troublesome dyskinesia, and Unified Parkinson Disease Rating Scale scores compared with immediate-release (IR) CD-LD or IR CD-LD plus entacapone (CLE). Post hoc analyses of 2 ER CD-LD phase 3 trials evaluated whether the efficacy and safety of ER CD-LD relative to the respective active comparators were altered by concomitant medications (dopaminergic agonists, monoamine oxidase B [MAO-B] inhibitors, or amantadine). ADVANCE-PD (n = 393) assessed safety and efficacy of ER CD-LD versus IR CD-LD. ASCEND-PD (n = 91) evaluated ER CD-LD versus CLE. In both studies, IR- and CLE-experienced patients underwent a 6-week, open-label dose-conversion period to ER CD-LD prior to randomization. For analysis, the randomized population was divided into 3 subgroups: dopaminergic agonists, rasagiline or selegiline, and amantadine. For each subgroup, changes from baseline in PD diary measures ("off" time and "on" time with and without troublesome dyskinesia), Unified Parkinson Disease Rating Scale Parts II + III scores, and adverse events were analyzed, comparing ER CD-LD with the active comparator. Concomitant dopaminergic agonist or MAO-B inhibitor use did not diminish the efficacy (improvement in "off" time and "on" time without troublesome dyskinesia) of ER CD-LD compared with IR CD-LD or CLE, whereas the improvement with concomitant amantadine failed to reach significance. Safety and tolerability were similar among the subgroups, and ER CD-LD did not increase troublesome dyskinesia. For patients on oral LD regimens and taking a dopaminergic agonist, and/or a MAO-B inhibitor, changing from an IR to an ER CD-LD formulation provides approximately an additional hour of "good" on time.

Effect of Concomitant Medications on the Safety and Efficacy of Extended-Release Carbidopa-Levodopa (IPX066) in Patients With Advanced Parkinson Disease: A Post Hoc Analysis

PubMed Central

LeWitt, Peter A.; Verhagen Metman, Leo; Rubens, Robert; Khanna, Sarita; Kell, Sherron; Gupta, Suneel

2018-01-01

Objectives Extended-release (ER) carbidopa-levodopa (CD-LD) (IPX066/RYTARY/NUMIENT) produces improvements in “off” time, “on” time without troublesome dyskinesia, and Unified Parkinson Disease Rating Scale scores compared with immediate-release (IR) CD-LD or IR CD-LD plus entacapone (CLE). Post hoc analyses of 2 ER CD-LD phase 3 trials evaluated whether the efficacy and safety of ER CD-LD relative to the respective active comparators were altered by concomitant medications (dopaminergic agonists, monoamine oxidase B [MAO-B] inhibitors, or amantadine). Methods ADVANCE-PD (n = 393) assessed safety and efficacy of ER CD-LD versus IR CD-LD. ASCEND-PD (n = 91) evaluated ER CD-LD versus CLE. In both studies, IR- and CLE-experienced patients underwent a 6-week, open-label dose-conversion period to ER CD-LD prior to randomization. For analysis, the randomized population was divided into 3 subgroups: dopaminergic agonists, rasagiline or selegiline, and amantadine. For each subgroup, changes from baseline in PD diary measures (“off” time and “on” time with and without troublesome dyskinesia), Unified Parkinson Disease Rating Scale Parts II + III scores, and adverse events were analyzed, comparing ER CD-LD with the active comparator. Results and Conclusions Concomitant dopaminergic agonist or MAO-B inhibitor use did not diminish the efficacy (improvement in “off” time and “on” time without troublesome dyskinesia) of ER CD-LD compared with IR CD-LD or CLE, whereas the improvement with concomitant amantadine failed to reach significance. Safety and tolerability were similar among the subgroups, and ER CD-LD did not increase troublesome dyskinesia. For patients on oral LD regimens and taking a dopaminergic agonist, and/or a MAO-B inhibitor, changing from an IR to an ER CD-LD formulation provides approximately an additional hour of “good” on time. PMID:29432286

TH-E-19A-01: Quality and Safety in Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ford, E; Ezzell, G; Miller, B

2014-06-15

Clinical radiotherapy data clearly demonstrate the link between the quality and safety of radiation treatments and the outcome for patients. The medical physicist plays an essential role in this process. To ensure the highest quality treatments, the medical physicist must understand and employ modern quality improvement techniques. This extends well beyond the duties traditionally associated with prescriptive QA measures. This session will review the current best practices for improving quality and safety in radiation therapy. General elements of quality management will be reviewed including: what makes a good quality management structure, the use of prospective risk analysis such as FMEA,more » and the use of incident learning. All of these practices are recommended in society-level documents and are incorporated into the new Practice Accreditation program developed by ASTRO. To be effective, however, these techniques must be practical in a resource-limited environment. This session will therefore focus on practical tools such as the newly-released radiation oncology incident learning system, RO-ILS, supported by AAPM and ASTRO. With these general constructs in mind, a case study will be presented of quality management in an SBRT service. An example FMEA risk assessment will be presented along with incident learning examples including root cause analysis. As the physicist's role as “quality officer” continues to evolve it will be essential to understand and employ the most effective techniques for quality improvement. This session will provide a concrete overview of the fundamentals in quality and safety. Learning Objectives: Recognize the essential elements of a good quality management system in radiotherapy. Understand the value of incident learning and the AAPM/ASTRO ROILS incident learning system. Appreciate failure mode and effects analysis as a risk assessment tool and its use in resource-limited environments. Understand the fundamental principles of good error proofing that extends beyond traditional prescriptive QA measures.« less

Effectiveness and Safety of an Extended ICU Visitation Model for Delirium Prevention: A Before and After Study.

PubMed

Rosa, Regis Goulart; Tonietto, Tulio Frederico; da Silva, Daiana Barbosa; Gutierres, Franciele Aparecida; Ascoli, Aline Maria; Madeira, Laura Cordeiro; Rutzen, William; Falavigna, Maicon; Robinson, Caroline Cabral; Salluh, Jorge Ibrain; Cavalcanti, Alexandre Biasi; Azevedo, Luciano Cesar; Cremonese, Rafael Viegas; Haack, Tarissa Ribeiro; Eugênio, Cláudia Severgnini; Dornelles, Aline; Bessel, Marina; Teles, José Mario Meira; Skrobik, Yoanna; Teixeira, Cassiano

2017-10-01

To evaluate the effect of an extended visitation model compared with a restricted visitation model on the occurrence of delirium among ICU patients. Prospective single-center before and after study. Thirty-one-bed medical-surgical ICU. All patients greater than or equal to 18 years old with expected length of stay greater than or equal to 24 hours consecutively admitted to the ICU from May 2015 to November 2015. Change of visitation policy from a restricted visitation model (4.5 hr/d) to an extended visitation model (12 hr/d). Two hundred eighty-six patients were enrolled (141 restricted visitation model, 145 extended visitation model). The primary outcome was the cumulative incidence of delirium, assessed bid using the confusion assessment method for the ICU. Predefined secondary outcomes included duration of delirium/coma; any ICU-acquired infection; ICU-acquired bloodstream infection, pneumonia, and urinary tract infection; all-cause ICU mortality; and length of ICU stay. The median duration of visits increased from 133 minutes (interquartile range, 97.7-162.0) in restricted visitation model to 245 minutes (interquartile range, 175.0-272.0) in extended visitation model (p < 0.001). Fourteen patients (9.6%) developed delirium in extended visitation model compared with 29 (20.5%) in restricted visitation model (adjusted relative risk, 0.50; 95% CI, 0.26-0.95). In comparison with restricted visitation model patients, extended visitation model patients had shorter length of delirium/coma (1.5 d [interquartile range, 1.0-3.0] vs 3.0 d [interquartile range, 2.5-5.0]; p = 0.03) and ICU stay (3.0 d [interquartile range, 2.0-4.0] vs 4.0 d [interquartile range, 2.0-6.0]; p = 0.04). The rate of ICU-acquired infections and all-cause ICU mortality did not differ significantly between the two study groups. In this medical-surgical ICU, an extended visitation model was associated with reduced occurrence of delirium and shorter length of delirium/coma and ICU stay.

GPS Status and Modernization

DTIC Science & Technology

2010-03-10

Economic Growth, and Public Safety • Extends across all domains -- air, land, sea, space, cyberspace • Effects transcend national and military boundaries...KwajaleinEcuador Argentina South Africa Tahiti Australia 5 New Zealand SPS Signal in Space Performance t e r s N/A N/A N/A N/A N/A (RMS over all SPS SIS URE) 2008...transportation safety-of-life • 1st launch: ~ 2010 (GPS IIF); 24 satellites: ~ 2018 • Fourth civil signal “L1C” • Designed with international partners

Safety Grooving

NASA Technical Reports Server (NTRS)

1985-01-01

Safety grooving, the cutting of grooves in concrete to increase traction and prevent injury, was first developed to reduce aircraft accidents on wet runways. Represented by the International Grooving and Grinding Association (IG&GA), the industry expanded into highway and pedestrian applications. The technique originated at Langley, which assisted in testing the grooving at airports and on highways. Skidding was reduced, stopping distance decreased, and a vehicle's cornering ability on curves was increased. The process has been extended to animal holding pens, steps, parking lots and other potentially slippery surfaces.

Reaching teen farm workers with health and safety information: an evaluation of a high school ESL curriculum.

PubMed

Teran, S; Strochlic, R; Bush, D; Baker, R; Meyers, J

2008-04-01

While childhood agricultural injury has long been recognized as an important public health issue, most research has focused on family farms and there have not been many interventions targeting hired youth. This study evaluated the impact of a high school English as a Second Language (ESL) curriculum, designed to provide teen agricultural workers with the knowledge and tools to protect their health and safety in the fields. Using a quasi-experimental design, the research consisted of two intervention groups and a comparison group, and included over 2,000 students from communities that lead California in agricultural production. The research findings revealed that the curriculum had significant impact in terms of increases in knowledge and attitudes, and nearly half of those interviewed after a summer of working in the fields reported implementing new behaviors to protect their health and safety. The curriculum also had extended effects in the broader community, as the majority of students reported sharing the new information with others. The study found that a school-based ESL curriculum is an effective intervention to reach and educate teen farm workers and that ESL classes can serve as a much-needed access point for young farm workers.

The role of paediatric nurses in medication safety prior to the implementation of electronic prescribing: a qualitative case study.

PubMed

Farre, Albert; Heath, Gemma; Shaw, Karen; Jordan, Teresa; Cummins, Carole

2017-04-01

Objectives To explore paediatric nurses' experiences and perspectives of their role in the medication process and how this role is enacted in everyday practice. Methods A qualitative case study on a general surgical ward of a paediatric hospital in England, one year prior to the planned implementation of ePrescribing. Three focus groups and six individual semi-structured interviews were conducted, involving 24 nurses. Focus groups and interviews were audio-recorded, transcribed, anonymized and subjected to thematic analysis. Results Two overarching analytical themes were identified: the centrality of risk management in nurses' role in the medication process and the distributed nature of nurses' medication risk management practices. Nurses' contribution to medication safety was seen as an intrinsic feature of a role that extended beyond just preparing and administering medications as prescribed and placed nurses at the heart of a dynamic set of interactions, practices and situations through which medication risks were managed. These findings also illustrate the collective nature of patient safety. Conclusions Both the recognized and the unrecognized contributions of nurses to the management of medications needs to be considered in the design and implementation of ePrescribing systems.

[Combined hormonal contraception in cycles artificially extended].

PubMed

Bustillos-Alamilla, Edgardo; Zepeda-Zaragoza, J; Hernández-Ruiz, M A; Briones-Landa, Carlos Humberto

2010-01-01

To compare the bleeding patterns, satisfaction and tolerability of 3 different contraceptive in an extended regimens in the service of Family Planning of the North Central Hospital of PEMEX. Healthy, adult women with desire of contraception for one year (N 120) were randomly assigned to receive oral contraceptive drospirenone/ethinyl E2 (group1), the norelgestromin/ethinyl E2 transdermal patch (group 2) and vaginal ring etonogestrel/ ethinyl E2 (group 3) in an extended regimen (42 consecutive days, 1 hormone-free week). Study assessments were conducted at scheduled visits at the time of initial screening, at baseline after 1, 3, 6, and 12 months. Subjects recorded menstrual associated symptoms bleeding data and completed satisfaction questionnaires. Subjects and investigators provided overall assessments of the regimens. Extended use of 3 different contraceptive resulted in fewer bleeding days in every group (66.6%, 55% and 58.3% P 0.0024), and less mastalgia and menstrual pain. Subjects were highly satisfied with three regimens (93.3%, 96.6% and 91.6% P 0.00421). Although not mayor adverse events were reported with this regimen, there was an increase in spotting days; it decreased with each successive cycle of therapy. Efficacy and safety were similar to those reported for traditional cycle. Extended-contraceptive regimen delays menses and reduces bleeding, a profile that may be preferred by women who seek flexibility with their contraceptive method.

Maintaining remission in ulcerative colitis – role of once daily extended-release mesalamine

PubMed Central

Oliveira, Lilliana; Cohen, Russell D

2011-01-01

The aminosalicylates (5-ASA; also referred to as mesalamine-based agents) are considered as first-line in the maintenance of remission of mild to moderate ulcerative colitis (UC). Traditionally these agents have required a large pill burden and multiple daily dosing regimens which may account for the low adherence rates, especially in patients in remission. Extended-release mesalamine is the first once daily mesalamine product approved by the Food and Drug Administration for the maintenance of UC remission. This review will examine the pharmacokinetics, dosing, efficacy, and safety data of extended-release mesalamine, and discuss the potential role of improving medication compliance and decreasing costs in UC maintenance. PMID:21448448

Maintaining remission in ulcerative colitis--role of once daily extended-release mesalamine.

PubMed

Oliveira, Lilliana; Cohen, Russell D

2011-02-27

The aminosalicylates (5-ASA; also referred to as mesalamine-based agents) are considered as first-line in the maintenance of remission of mild to moderate ulcerative colitis (UC). Traditionally these agents have required a large pill burden and multiple daily dosing regimens which may account for the low adherence rates, especially in patients in remission. Extended-release mesalamine is the first once daily mesalamine product approved by the Food and Drug Administration for the maintenance of UC remission. This review will examine the pharmacokinetics, dosing, efficacy, and safety data of extended-release mesalamine, and discuss the potential role of improving medication compliance and decreasing costs in UC maintenance.

Extended GTST-MLD for aerospace system safety analysis.

PubMed

Guo, Chiming; Gong, Shiyu; Tan, Lin; Guo, Bo

2012-06-01

The hazards caused by complex interactions in the aerospace system have become a problem that urgently needs to be settled. This article introduces a method for aerospace system hazard interaction identification based on extended GTST-MLD (goal tree-success tree-master logic diagram) during the design stage. GTST-MLD is a functional modeling framework with a simple architecture. Ontology is used to extend the ability of system interaction description in GTST-MLD by adding the system design knowledge and the past accident experience. From the level of functionality and equipment, respectively, this approach can help the technician detect potential hazard interactions. Finally, a case is used to show the method. © 2011 Society for Risk Analysis.

Drug policy: making effective drugs available without bankrupting the healthcare system.

PubMed

Laupacis, Andreas; Anderson, Geoffrey; O'Brien, Bernie

2002-01-01

To the extent possible, drug policy should be based upon good quality evidence. This must extend beyond the traditional focus on efficacy and safety in carefully selected patients, to evidence about real-world effectiveness, cost-effectiveness and safety of drugs. This paper will consider methods of improving the quality of the evidence currently available, and the implications of requiring that evidence. Historically, there has been a direct link between research evidence and policy at the level of licensing - drugs are only made available after they have been shown to be safe and efficacious in well-designed and independently assessed research studies. We propose that this reliance on evidence be logically extended to cover the formulary inclusion and post-marketing surveillance aspects of modern prescription drug policy. More specifically we propose that the decision to initially list a drug on a benefit formulary be based on evidence from relevant head-to-head comparisons and well-designed cost-effectiveness analyses. This evidence would be produced by industry in cooperation with independent peer-reviewed funding agencies. Drugs could only be added to a formulary if they met specific predetermined criteria, and drugs could be removed as superior alternatives became available. The provincial governments are monopsony buyers of medicines, and they wield the power to determine public payer "market access'for medicines. This power (within and across provinces) could be used more effectively to negotiate price in the context of reimbursement. The effect of different methods of influencing prescribing (e.g., 'limited access?) upon drug utilization and patient outcomes should be rigorously assessed, including the randomization of groups of patients or communities to different strategies. We also propose that all drugs on the formulary would be subject to a well-designed post-marketing surveillance program. This program would build on the existing passive reporting of adverse events by adding a proactive system that would systematically describe the use and impact of drugs. The notion of drug safety would be extended to include not only adverse events, but also inappropriate use of drugs that results inpatients receiving drugs that do not benefit them. Inappropriate use wastes resources and can put patients and populations at risk.

Mothers' Concerns for Personal Safety and Privacy While Breastfeeding: An Unexplored Phenomenon.

PubMed

Rosen-Carole, Casey; Allen, Katherine; Fagnano, Maria; Dozier, Ann; Halterman, Jill

2018-04-01

Preliminary qualitative research in upstate NY shows new mothers are worried about safety while breastfeeding. Little is known regarding prevalence of these concerns and their effect on breastfeeding outcomes. (1) Determine frequency of breastfeeding safety and privacy concerns; (2) Explore their association with breastfeeding outcomes. Mothers were surveyed immediately and 1-month postpartum about breastfeeding goals; both surveys addressed privacy and safety concerns at home, work, and in public. Outcome data included breastfeeding intent, exclusivity, and duration. Breastfeeding/non-breastfeeding mothers were compared using Chi-square and multivariate analyses. A total of 279 women enrolled. Of these 82.8% initiated breastfeeding; at 1-month 72% provided any breast milk, and 44% were exclusively breastfeeding. About 99% felt safe breastfeeding at home; 25% reported privacy concerns; and 5% felt "vulnerable or unsafe" while breastfeeding. At 1-month, 49% agreed there was a safe place to breastfeed/express milk at work (20% unsure). Non-breastfeeding mothers expressed more safety concerns outside home/at work: 18% breastfeeding versus 28% non-breastfeeding outside home; 27% breastfeeding versus 40% non-breastfeeding at work. Nearly 54% who reported feeling vulnerable/unsafe with breastfeeding initiated breastfeeding, compared with 86% not reporting this concern (p = 0.008). Fewer women initiating breastfeeding reported vulnerability/safety (3% breastfeeding versus 14% non-breastfeeding, p = 0.008) or privacy (22% breastfeeding versus 40% non-breastfeeding, p = 0.19) concerns. Associations held after controlling for age, race, parity, insurance, geography, and marital-status. Significant associations between initiation, privacy, and safety concerns did not extend to duration or exclusivity. Many breastfeeding women reported safety and privacy concerns, especially outside the home and at work, which may influence breastfeeding initiation. Further study may identify methods to address these issues, potentially increasing breastfeeding rates.

Single-Lever Power Control for General Aviation Aircraft Promises Improved Efficiency and Simplified Pilot Controls

NASA Technical Reports Server (NTRS)

Musgrave, Jeffrey L.

1997-01-01

General aviation research is leading to major advances in internal combustion engine control systems for single-engine, single-pilot aircraft. These advances promise to increase engine performance and fuel efficiency while substantially reducing pilot workload and increasing flight safety. One such advance is a single-lever power control (SLPC) system, a welcome departure from older, less user-friendly, multilever engine control systems. The benefits of using single-lever power controls for general aviation aircraft are improved flight safety through advanced engine diagnostics, simplified powerplant operations, increased time between overhauls, and cost-effective technology (extends fuel burn and reduces overhaul costs). The single-lever concept has proven to be so effective in preliminary studies that general aviation manufacturers are making plans to retrofit current aircraft with the technology and are incorporating it in designs for future aircraft.

Extended International Normalized Ratio testing intervals for warfarin-treated patients.

PubMed

Barnes, G D; Kong, X; Cole, D; Haymart, B; Kline-Rogers, E; Almany, S; Dahu, M; Ekola, M; Kaatz, S; Kozlowski, J; Froehlich, J B

2018-05-15

Essentials Warfarin typically requires International Normalized Ratio (INR) testing at least every 4 weeks. We implemented extended INR testing for stable warfarin patients in six anticoagulation clinics. Use of extended INR testing increased from 41.8% to 69.3% over the 3 year study. Use of extended INR testing appeared safe and effective. Background A previous single-center randomized trial suggested that patients with stable International Normalized Ratio (INR) values could safely receive INR testing as infrequently as every 12 weeks. Objective To test the success of implementation of an extended INR testing interval for stable warfarin patients in a practice-based, multicenter collaborative of anticoagulation clinics. Methods At six anticoagulation clinics, patients were identified as being eligible for extended INR testing on the basis of prior INR value stability and minimal warfarin dose changes between 2014 and 2016. We assessed the frequency with which anticoagulation clinic providers recommended an extended INR testing interval (> 5 weeks) to eligible patients. We also explored safety outcomes for eligible patients, including next INR values, bleeding events, and emergency department visits. Results At least one eligible period for extended INR testing was identified in 890 of 3362 (26.5%) warfarin-treated patients. Overall, the use of extended INR testing in eligible patients increased from 41.8% in the first quarter of 2014 to 69.3% in the fourth quarter of 2016. The number of subsequent out-of-range next INR values were similar between eligible patients who did and did not have an extended INR testing interval (27.3% versus 28.4%, respectively). The numbers of major bleeding events were not different between the two groups, but rates of clinically relevant non-major bleeding (0.02 per 100 patient-years versus 0.09 per 100 patient-years) and emergency department visits (0.07 per 100 patient-years versus 0.19 per 100 patient-years) were lower for eligible patients with extended INR testing intervals than for those with non-extended INR testing intervals. Conclusions Extended INR testing for stable warfarin patients can be successfully and safely implemented in diverse, practice-based anticoagulation clinic settings. © 2018 International Society on Thrombosis and Haemostasis.

Approaches to the safety assessment of engineered nanomaterials (ENM) in food.

PubMed

Cockburn, Andrew; Bradford, Roberta; Buck, Neil; Constable, Anne; Edwards, Gareth; Haber, Bernd; Hepburn, Paul; Howlett, John; Kampers, Frans; Klein, Christoph; Radomski, Marek; Stamm, Hermann; Wijnhoven, Susan; Wildemann, Tanja

2012-06-01

A systematic, tiered approach to assess the safety of engineered nanomaterials (ENMs) in foods is presented. The ENM is first compared to its non-nano form counterpart to determine if ENM-specific assessment is required. Of highest concern from a toxicological perspective are ENMs which have potential for systemic translocation, are insoluble or only partially soluble over time or are particulate and bio-persistent. Where ENM-specific assessment is triggered, Tier 1 screening considers the potential for translocation across biological barriers, cytotoxicity, generation of reactive oxygen species, inflammatory response, genotoxicity and general toxicity. In silico and in vitro studies, together with a sub-acute repeat-dose rodent study, could be considered for this phase. Tier 2 hazard characterisation is based on a sentinel 90-day rodent study with an extended range of endpoints, additional parameters being investigated case-by-case. Physicochemical characterisation should be performed in a range of food and biological matrices. A default assumption of 100% bioavailability of the ENM provides a 'worst case' exposure scenario, which could be refined as additional data become available. The safety testing strategy is considered applicable to variations in ENM size within the nanoscale and to new generations of ENM. Copyright © 2012 Elsevier Ltd. All rights reserved.

Clinical safety assessment of oral higenamine supplementation in healthy, young men.

PubMed

Bloomer, R J; Schriefer, J M; Gunnels, T A

2015-10-01

Higenamine, an herbal agent also known as norcoclaurine, is thought to stimulate β-androgenic receptors and possess lipolytic activity. It is currently making its way into the dietary supplement market. To our knowledge, no studies have been conducted to determine the safety profile of oral higenamine when used alone and in conjunction with other commonly used lipolytic agents. Forty-eight men were assigned to ingest either a placebo, higenamine, caffeine, or higenamine + caffeine + yohimbe bark extract daily for a period of 8 weeks. Before and after 4 and 8 weeks of supplementation, the following variables were measured: resting respiratory rate, heart rate, blood pressure, urinalysis, complete blood count, metabolic panel, liver enzyme activity, and lipid panel. No interaction effects were noted for any variable (p > 0.05), with no changes of statistical significance occurring across time for any of the four conditions (p > 0.05). This is the first study to determine the safety profile of oral higenamine intake in human subjects. Our data indicate that 8 weeks of daily higenamine supplementation, either alone or in conjunction with caffeine and yohimbe bark extract, does not result in a statistically significant change in any of the measured outcome variables. Additional studies, inclusive of a larger sample size, are needed to extend these initial findings. © The Author(s) 2015.

Fermented and Acidified Vegetables

USDA-ARS?s Scientific Manuscript database

Vegetables may be preserved by fermentation, direct acidification, or a combination of these along with pasteurization or refrigeration and selected additives to yield products with an extended shelf life and enhanced safety. Organic acids such as lactic, acetic, sorbic and benzoic acids along with ...

METHOD AND APPARATUS FOR REACTOR SAFETY CONTROL

DOEpatents

Huston, N.E.

1961-06-01

A self-contained nuclear reactor fuse controlled device tron absorbing material, normally in a compact form but which can be expanded into an extended form presenting a large surface for neutron absorption when triggered by an increase in neutron flux, is described.

Asphalt surface treatment practice in southeastern United States : [tech summary].

DOT National Transportation Integrated Search

2014-09-01

Pavement preservation is an approach in enhancing pavement performance using a set of practices that extends the life : of the pavement and improves safety and ride quality. According to the World Banks Pavement Deterioration Model, the : cost of ...

Prediction of thermal behavior of pervious concrete pavements in winter.

DOT National Transportation Integrated Search

2017-05-15

Because application of pervious concrete pavement (PCPs) has extended to cold-climate regions of the United States, the safety and : mobility of PCP installations during the winter season need to be maintained. Timely application of salt, anti-icing,...

A Model for Occupational Safety and Health Intervention Diffusion to Small Businesses

PubMed Central

Sinclair, Raymond C.; Cunningham, Thomas R.; Schulte, Paul A.

2015-01-01

Background Smaller businesses differ from their larger counterparts in having higher rates of occupational injuries and illnesses and fewer resources for preventing those losses. Intervention models developed outside the United States have addressed the resource deficiency issue by incorporating intermediary organizations such as trade associations. Methods This paper extends previous models by using exchange theory and by borrowing from the diffusion of innovations model. It emphasizes that occupational safety and health (OSH) organizations must understand as much about intermediary organizations as they do about small businesses. OSH organizations (“initiators”) must understand how to position interventions and information to intermediaries as added value to their relationships with small businesses. Examples from experiences in two midwestern states are used to illustrate relationships and types of analyses implied by the extended model. Results The study found that intermediary organizations were highly attuned to providing smaller businesses with what they want, including OSH services. The study also found that there are opinion leader organizations and individual champions within intermediaries who are key to decisions and actions about OSH programming. Conclusions The model places more responsibility on both initiators and intermediaries to develop and market interventions that will be valued in the competitive small business environment where the resources required to adopt each new business activity could always be used in other ways. The model is a candidate for empirical validation, and it offers some encouragement that the issue of sustainable OSH assistance to small businesses might be addressed. PMID:24115112

A variational dynamic programming approach to robot-path planning with a distance-safety criterion

NASA Technical Reports Server (NTRS)

Suh, Suk-Hwan; Shin, Kang G.

1988-01-01

An approach to robot-path planning is developed by considering both the traveling distance and the safety of the robot. A computationally-efficient algorithm is developed to find a near-optimal path with a weighted distance-safety criterion by using a variational calculus and dynamic programming (VCDP) method. The algorithm is readily applicable to any factory environment by representing the free workspace as channels. A method for deriving these channels is also proposed. Although it is developed mainly for two-dimensional problems, this method can be easily extended to a class of three-dimensional problems. Numerical examples are presented to demonstrate the utility and power of this method.

Using signals associated with safety in avoidance learning: computational model of sex differences

PubMed Central

Beck, Kevin D.; Pang, Kevin C.H.; Myers, Catherine E.

2015-01-01

Avoidance behavior involves learning responses that prevent upcoming aversive events; these responses typically extinguish when the aversive events stop materializing. Stimuli that signal safety from aversive events can paradoxically inhibit extinction of avoidance behavior. In animals, males and females process safety signals differently. These differences help explain why women are more likely to be diagnosed with an anxiety disorder and exhibit differences in symptom presentation and course compared to men. In the current study, we extend an existing model of strain differences in avoidance behavior to simulate sex differences in rats. The model successfully replicates data showing that the omission of a signal associated with a period of safety can facilitate extinction in females, but not males, and makes novel predictions that this effect should depend on the duration of the period, the duration of the signal itself, and its occurrence within that period. Non-reinforced responses during the safe period were also found to be important in the expression of these patterns. The model also allowed us to explore underlying mechanisms for the observed sex effects, such as whether safety signals serve as occasion setters for aversive events, to determine why removing them can facilitate extinction of avoidance. The simulation results argue against this account, and instead suggest the signal may serve as a conditioned reinforcer of avoidance behavior. PMID:26213650

Clinical and economic benefits of extended treatment with apixaban for the treatment and prevention of recurrent venous thromboembolism in Canada.

PubMed

Quon, Peter; Le, Hoa H; Raymond, Vincent; Mtibaa, Mondher; Moshyk, Andriy

2016-06-01

Background and objective Venous thromboembolism (VTE) is associated with long-term clinical and economic burden. Clinical guidelines generally recommend at least 3 months of anticoagulation, but, in clinical practice, concerns over bleeding risk often limit extended treatment. Apixaban was studied for extended VTE treatment in the AMPLIFY-EXT trial, demonstrating superiority to placebo in VTE reduction without increasing risk of major bleeding. This study assessed the long-term clinical and economic benefits of extending treatment with apixaban when clinical equipoise exists compared to standard of care with enoxaparin/warfarin and other novel oral anti-coagulants (NOACs) for the treatment and prevention of recurrent VTE in Canada. Methods A Markov model was developed to follow patients with VTE over their lifetimes. Efficacy and safety for apixaban and enoxaparin/warfarin were based on AMPLIFY and AMPLIFY-EXT, while relative efficacy to other NOACs was synthesized by network meta-analysis (NMA). Dosages for NOACs and enoxaparin/warfarin were based on their respective trials and were given up to 18 months and up to 6 months, followed by no treatment, respectively. Patient quality adjusted life years (QALYs) were based on published studies, and costs for resource utilization were from a Ministry of Health perspective, expressed as 2014 CAD ($). Results Extended treatment with apixaban compared to enoxaparin/warfarin resulted in fewer recurrent VTEs, VTE-related deaths, and bleeding events, but at slightly increased cost. The incremental cost-effectiveness ratio was $4828 per QALY gained. Compared to other NOACs, apixaban had the fewest bleeding events, similar recurrent VTE events, and the lowest overall cost, which was driven by the strong bleeding profile. In scenario analyses of acute and lifetime treatments, apixaban was cost-effective against all strategies. Conclusions Extended treatment with apixaban can offer substantial clinical benefits and is a cost-effective alternative to enoxaparin/warfarin and other NOACs.

A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain.

PubMed

Lee, Jae Hyup; Lee, Chong-Suh

2013-11-01

Chronic low back pain is a common condition that is often difficult to treat. The combination of tramadol hydrochloride and acetaminophen in an extended-release formulation has been shown to provide rapid and long-lasting analgesic effects resulting from the synergistic activity of these 2 active ingredients. The goal of this study was to evaluate the efficacy and safety of extended-release tramadol hydrochloride 75-mg/acetaminophen 650-mg fixed-dose combination tablets (TA-ER) for the treatment of chronic low back pain. This Phase III, double-blind, placebo-controlled, parallel-group study enrolled 245 patients with moderate to severe (≥4 cm on a 10-cm visual analog scale) chronic (≥3 months') low back pain insufficiently controlled by previous NSAIDs or cyclooxygenase-2-selective inhibitors and randomly assigned them to receive 4 weeks of either TA-ER or placebo. The primary efficacy end point was the percentage of patients with a pain intensity change rate ≥30% from baseline to final evaluation. Secondary end points included quality of life (Korean Short Form-36), functionality (Korean Oswestry Disability Index), and adverse events. The percentage of patients with a pain intensity change rate ≥30% was significantly higher (P < 0.05) in the TA-ER group than in the placebo group for both the full analysis set and the per-protocol population. Pain relief success rate from baseline was significantly higher with TA-ER versus placebo at days 8 and 15 but not at the final visit. Patients in the TA-ER group had significant improvements versus placebo in role-physical, general health, and reported health transition domains of the Korean Short Form-36 and significantly higher functional improvements in the personal care section of the Korean Oswestry Disability Index. Patient assessment of overall pain control as "very good" was also significantly higher with TA-ER than with placebo. Adverse events were reported more frequently with TA-ER than with placebo; the most common adverse events reported were nausea, dizziness, constipation, and vomiting. TA-ER was significantly more effective than placebo in providing pain relief, functional improvements, and improved quality of life. It exhibited a predictable safety profile in patients with chronic low back pain. ClinicalTrials.gov identifier: NCT01112267. © 2013 The Authors. Published by Elsevier HS Journals, Inc. All rights reserved.

The Human Performance Envelope: Past Research, Present Activities and Future Directions

NASA Technical Reports Server (NTRS)

Edwards, Tamsyn

2017-01-01

Air traffic controllers (ATCOs) must maintain a consistently high level of human performance in order to maintain flight safety and efficiency. In current control environments, performance-influencing factors such as workload, fatigue and situation awareness can co-occur, and interact, to effect performance. However, multifactor influences and the association with performance are under-researched. This study utilized a high fidelity human in the loop enroute air traffic control simulation to investigate the relationship between workload, situation awareness and ATCO performance. The study aimed to replicate and extend Edwards, Sharples, Wilson and Kirwans (2012) previous study and confirm multifactor interactions with a participant sample of ex-controllers. The study also aimed to extend Edwards et als previous research by comparing multifactor relationships across 4 automation conditions. Results suggest that workload and SA may interact to produce a cumulative impact on controller performance, although the effect of the interaction on performance may be dependent on the context and amount of automation present. Findings have implications for human-automation teaming in air traffic control, and the potential prediction and support of ATCO performance.

Inviscid Analysis of Extended Formation Flight

NASA Technical Reports Server (NTRS)

Kless, James; Aftosmis, Michael J.; Ning, Simeon Andrew; Nemec, Marian

2012-01-01

Flying airplanes in extended formations, with separation distances of tens of wingspans, significantly improves safety while maintaining most of the fuel savings achieved in close formations. The present study investigates the impact of roll trim and compressibility at fixed lift coefficient on the benefits of extended formation flight. An Euler solver with adjoint-based mesh refinement combined with a wake propagation model is used to analyze a two-body echelon formation at a separation distance of 30 spans. Two geometries are examined: a simple wing and a wing-body geometry. Energy savings, quantified by both formation drag fraction and span efficiency factor, are investigated at subsonic and transonic speeds for a matrix of vortex locations. The results show that at fixed lift and trimmed for roll, the optimal location of vortex impingement is about 10% inboard of the trailing airplane s wing-tip. Interestingly, early results show the variation in drag fraction reduction is small in the neighborhood of the optimal position. Over 90% of energy benefits can be obtained with a 5% variation in transverse and 10% variation in crossflow directions. Early results suggest control surface deflections required to achieve trim reduce the benefits of formation flight by 3-5% at subsonic speeds. The final paper will include transonic effects and trim on extended formation flight drag benefits.

Evolved atmospheric entry corridor with safety factor

NASA Astrophysics Data System (ADS)

Liang, Zixuan; Ren, Zhang; Li, Qingdong

2018-02-01

Atmospheric entry corridors are established in previous research based on the equilibrium glide condition which assumes the flight-path angle to be zero. To get a better understanding of the highly constrained entry flight, an evolved entry corridor that considers the exact flight-path angle is developed in this study. Firstly, the conventional corridor in the altitude vs. velocity plane is extended into a three-dimensional one in the space of altitude, velocity, and flight-path angle. The three-dimensional corridor is generated by a series of constraint boxes. Then, based on a simple mapping method, an evolved two-dimensional entry corridor with safety factor is obtained. The safety factor is defined to describe the flexibility of the flight-path angle for a state within the corridor. Finally, the evolved entry corridor is simulated for the Space Shuttle and the Common Aero Vehicle (CAV) to demonstrate the effectiveness of the corridor generation approach. Compared with the conventional corridor, the evolved corridor is much wider and provides additional information. Therefore, the evolved corridor would benefit more to the entry trajectory design and analysis.

Para-aortic lymphadenectomy in advanced stage cervical cancer, a protocol for comparing safety, feasibility and diagnostic accuracy of surgical staging versus PET-CT; PALDISC trial.

PubMed

Tax, Casper; Abbink, Karin; Rovers, Maroeska M; Bekkers, Ruud L M; Zusterzeel, Petra L M

2018-01-01

Currently, a PET-CT is used to assess the need for extended field radiotherapy of para-aortic lymph nodes (PALN) in International Federation of Gynaecology and Obstetrics (FIGO) stage IB2, IIA2-IVA (locally advanced stage) cervical cancer. A small study established a sensitivity and specificity estimate for PALN metastases of 50% (95% CI; 7-93%) and 83% (95% CI; 52-98%), respectively. Surgical staging of PALN may lead to a higher diagnostic accuracy. However, surgical staging of para-aortic lymph nodes in locally advanced stage cervical cancer is not common practice. Therefore, a phase 2 randomised controlled trial is needed to assess its safety and feasibility. In addition to standard imaging (MRI or CT scan) with PET-CT, 30 adult women with FIGO stage IB2, IIA2-IVA cervical cancer will be randomised to receive either surgical staging or usual PET-CT staging. Administering extended field radiotherapy will be based on lymphadenectomy results for the intervention group and on the PET-CT results for the control group. Follow-up visits at 0, 3, 6, 9 and 12 months will assess health-related quality of life and progression-free survival.Primary safety and feasibility outcomes of surgical staging will be assessed by calculating means with 95% confidence intervals for duration of surgery, number of complications, blood loss, nodal yield after para-aortic lymphadenectomy and treatment delay due to surgical staging. Secondary patient-centred outcomes on quality of life and first year survival will be documented and compared between the two groups. Estimates of sensitivity, specificity and negative and positive predictive values of MRI, PET-CT and surgical staging will be presented with 95% CI.. All analysis will be performed according to the intention to treat principle. This study will assess safety and feasibility, expressed as the number and severity of complications, effect on quality of life and the treatment delay due to surgically staging para-aortic lymph nodes in locally advanced cervical cancer. It will provide insight in the diagnostic accuracy of the PET-CT and detection rate of missed (micro)metastases due to surgical staging. This information will be used to assess the necessity for a phase 3 study on the diagnostic accuracy of the PET-CT and surgical staging. If a phase 3 study is deemed necessary, current data can be used for sample size calculation of such a phase 3 study. Nederlands Trial Register/Dutch Trial Registry (www.trialregister.nl), NTR4922. Registered on 24 November 2014.

Two-year Efficacy and Safety of Etanercept in Pediatric Patients with Extended Oligoarthritis, Enthesitis-related Arthritis, or Psoriatic Arthritis.

PubMed

Constantin, Tamas; Foeldvari, Ivan; Vojinovic, Jelena; Horneff, Gerd; Burgos-Vargas, Ruben; Nikishina, Irina; Akikusa, Jonathan D; Avcin, Tadej; Chaitow, Jeffrey; Koskova, Elena; Lauwerys, Bernard R; Calvo Penades, Inmaculada; Flato, Berit; Gamir, Maria Luz; Huppertz, Hans-Iko; Jaller Raad, Juan Jose; Jarosova, Katerina; Anton, Jordi; Macku, Marie; Otero Escalante, William J; Rutkowska-Sak, Lidia; Trauzeddel, Ralf; Velez-Sanchez, Patricia J; Wouters, Carine; Wajdula, Joseph; Zang, Chuanbo; Bukowski, Jack; Woodworth, Deborah; Vlahos, Bonnie; Martini, Alberto; Ruperto, Nicolino

2016-04-01

The main objective was to determine the 2-year clinical benefit and safety of etanercept (ETN) in children with the juvenile idiopathic arthritis (JIA) categories of extended oligoarthritis (eoJIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA). CLIPPER was a 96-week, phase IIIb, open-label, multicenter study. Patients with eoJIA, ERA, or PsA received ETN 0.8 mg/kg once weekly (50 mg max) for up to 96 weeks. The proportions of patients reaching the JIA American College of Rheumatology (ACR) 30/50/70/90/100 and inactive disease responses at Week 96 were calculated. Adverse events (AE) were collected throughout the study (intention-to-treat sample). There were 127 patients (eoJIA n = 60, ERA n = 38, PsA n = 29) who received ≥ 1 dose of ETN. The mean disease duration was 31.6 (eoJIA), 23.0 (ERA), and 21.8 (PsA) months. At Week 96, JIA ACR 30/50/70/90/100/inactive disease responses (95% CI) were achieved by 84.3% (76.7, 90.1), 83.5% (75.8, 89.5), 78.7% (70.6, 85.5), 55.1% (46.0, 63.9), 45.7% (36.8, 54.7), and 27.6% (20.0, 36.2) of patients, respectively. The most common AE (no. events, events per 100 patient-yrs) overall were headache (23, 10.7), pyrexia (12, 5.6), and diarrhea (10, 4.6). The most common infections were upper respiratory tract infection (83, 38.6), pharyngitis (50, 23.2), gastroenteritis (22, 10.2), bronchitis (19, 8.8), and rhinitis (17, 7.9). No cases of malignancy, active tuberculosis, demyelinating disorders, or death were reported. Over 96 weeks of therapy, ETN demonstrated sustained efficacy at treating the clinical symptoms of all 3 JIA categories, with no major safety issues.

A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment.

PubMed

Rauck, Richard L; Hale, Martin E; Bass, Almasa; Bramson, Candace; Pixton, Glenn; Wilson, Jacquelyn G; Setnik, Beatrice; Meisner, Paul; Sommerville, Kenneth W; Malhotra, Bimal K; Wolfram, Gernot

2015-09-01

The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain. An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n = 134, placebo; n = 147, ALO-02). Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P = 0.0114). Forty-four percent of patients treated with placebo and 57.5% of patients treated with ALO-02 reported ≥30% improvement in weekly average NRS-Pain scores from screening to the final 2 weeks of the treatment period (P = 0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with chronic low back pain and has a safety profile similar to other opioids.

Small molecule SIRT1 activators for the treatment of aging and age-related diseases

PubMed Central

Hubbard, Basil P.; Sinclair, David A.

2014-01-01

Recent studies in mice have identified single molecules that can delay multiple diseases of aging and extend lifespan. In theory, such molecules could prevent dozens of diseases simultaneously, significantly extending healthy years of life. In this review we discuss recent advances, controversies, opportunities, and challenges surrounding the development of SIRT1 activators, molecules with the potential to delay aging and age-related diseases. Sirtuins comprise a family of NAD+-dependent deacylases that are central to the body’s response to diet and exercise. New studies indicate that both natural and synthetic sirtuin activating compounds (STACs) work via a common allosteric mechanism to stimulate sirtuin activity, thereby conferring broad health benefits in rodents, primates, and possibly humans. The fact that the two-thirds of people in the USA who consume multiple dietary supplements consume resveratrol, a SIRT1 activator, underscores the importance of understanding the biochemical mechanism, physiological effects, and safety of STACs. PMID:24439680

American Society of Nephrology

MedlinePlus

... heart failure https://t.co/PkE9xXgnUF – @ASNKidney on Twitter #Amish mutation protects against #diabetes and may extend life | @NYTimes https://t.co/7wnc2AhBdO – @ASNKidney on Twitter .@US_FDA issues safety alert for #gout medication | @ ...

An Update on the Progress of the Extended One-Generation Reproductive Protocol

EPA Science Inventory

Consistent with a more science-based approach assessing potential adverse effects of pesticides, the ILSI-HESI Agricultural Chemical Safety Assessment (ACSA) Technical Committee, proposed a new tiered toxicity testing strategy. This approach utilizes fewer animals and provides an...

Self-awareness of impairment and the decision to drive after an extended period of wakefulness.

PubMed

Jones, Christopher B; Dorrian, Jillian; Jay, Sarah M; Lamond, Nicole; Ferguson, Sally; Dawson, Drew

2006-01-01

Fatigue is an increasingly noted factor in road accidents. The ability to predict and be aware of impairment in terms of driving capability is important for potential legal liability and road safety. However, to date, there have been few studies that have investigated the accuracy of individuals in predicting how safely they could drive during conditions of sleep loss. Research has demonstrated that individuals rate themselves as better than the population average in a number of domains, including driving-related skills. Therefore, this study also aimed to investigate self-ratings of predicted driving ability during extended wakefulness and compare them to ratings made of a hypothetical other person under the same conditions. Thirty-two participants remained awake for a period of 40 h. Every 2 h, they completed the Psychomotor Vigilance Task (PVT) and rated on a seven-point scale how well they thought they could drive safely, react quickly in an emergency, and stay in their own lane. They were also asked to assess how they thought someone else in their own position could drive. The participants rated their driving ability as becoming significantly poorer at the same time that their PVT performance became significantly slower. Self-ratings indicating a qualitative assessment of poorer than neutral driving occurred at 03:00 h for both the "drive safely" and "react quickly" questions, after 19 h of continuous wakefulness (starting at 08:00 h). This occurred at 05:00 h for the "keep in my lane" question. Previous studies with a similar protocol demonstrated that under these conditions, individuals exhibit a performance decrements equivalent to someone with a blood alcohol concentration of 0.05% (the legal driving limit in Australia). Participants consistently rated the ability of others to drive as poorer than their own. The main implication from this study for road safety and legal liability is that it is reasonable to focus on a person's perception of the situation, as it does align with objective reality to a certain extent. A concern in terms of road safety is potential overconfidence, indicated by rating others consistently poorer than themselves.

Optimal Surgery for Mid-Transverse Colon Cancer: Laparoscopic Extended Right Hemicolectomy Versus Laparoscopic Transverse Colectomy.

PubMed

Matsuda, Takeru; Sumi, Yasuo; Yamashita, Kimihiro; Hasegawa, Hiroshi; Yamamoto, Masashi; Matsuda, Yoshiko; Kanaji, Shingo; Oshikiri, Taro; Nakamura, Tetsu; Suzuki, Satoshi; Kakeji, Yoshihiro

2018-04-02

Although the feasibility and safety of laparoscopic surgery for transverse colon cancer have been shown by the recent studies, the optimal laparoscopic approach for mid-transverse colon cancer is controversial. We retrospectively analyzed the data of patients with the mid-transverse colon cancer at our institutions between January 2007 and April 2017. Thirty-eight and 34 patients who received extended right hemicolectomy and transverse colectomy, respectively, were enrolled. There were no significant differences in operating time, blood loss, and hospital stay between the two groups. Postoperative complications developed in 10 of 34 patients (29.4%; wound infection: 2 cases, anastomotic leakage: 2 cases, bowel obstruction: 1 case, incisional hernia: 2 cases, others: 3 cases) for the transverse colectomy group and in 4 of 38 patients (10.5%; wound infection: 1 case, anastomotic leakage: 0 case, bowel obstruction: 2 cases, incisional hernia: 0 case, others: 1 case) for the extended right hemicolectomy group (P = 0.014). Although the median number of harvested #221 and #222 LNs was similar between the two groups (6 vs. 8, P = 0.710, and 3 vs. 2, P = 0.256, respectively), that of #223 was significantly larger in extended right hemicolectomy than in transverse colectomy (3 vs. 1, P = 0.038). The 5-year disease-free and overall survival rates were 92.4 and 90.3% for the extended right hemicolectomy group, and 95.7 and 79.6% for the transverse colectomy group (P = 0.593 and P = 0.638, respectively). Laparoscopic extended right hemicolectomy and laparoscopic transverse colectomy offer similar oncological outcomes for mid-transverse colon cancer. Laparoscopic extended right hemicolectomy might be associated with fewer postoperative complications.

Perioperative Nurses' Work Experience With Robotic Surgery: A Focus Group Study.

PubMed

Kang, Min Jung; De Gagne, Jennie C; Kang, Hee Sun

2016-04-01

The aim of this study was to explore the work experience of perioperative nurses involved in robotic surgery. A qualitative descriptive study was conducted. Participants were 15 nurses who had been on a robotic surgery team at one of five major university hospitals in Seoul, South Korea. Participants were one male and 14 female nurses (mean age, 31.33 [SD, 4.19] years; range, 25-41 years). Their experience as robotic surgery nurses ranged from 8 months to 6 years. Nurses' experiences with robotic surgery were categorized within four main themes: (1) constant checking on patients' safety and the robot's functions; (2) unexpected robotic machine errors or malfunctions; (3) feelings of burden in a robotic surgical team; and (4) need and desire for more information and education. This study showed that there are common concerns about patient safety and the possibility of emergencies related to robot system failure among nurses. Offering more support for nurses involved in robotic surgery should be a priority to empower them to play an extended role in robotic surgery.

First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A.

PubMed

Hampton, K; Chowdary, P; Dunkley, S; Ehrenforth, S; Jacobsen, L; Neff, A; Santagostino, E; Sathar, J; Takedani, H; Takemoto, C M; Négrier, C

2017-09-01

N8-GP (turoctocog alfa pegol) is an extended half-life glycoPEGylated recombinant factor VIII (FVIII) product developed for the prevention and treatment of bleeds in haemophilia A patients. This is a planned interim analysis of pathfinder™3, an international, open-label, Phase 3 trial evaluating the efficacy and safety (including immunogenicity) of N8-GP administered before, during and after major surgery in severe haemophilia A patients aged ≥12 years. Sixteen patients who underwent 18 major surgical procedures (including synovectomy, joint replacement and ankle arthrodesis) were included here. Postoperative assessments were conducted daily for days 1-6, and once for days 7-14. Primary endpoint was N8-GP haemostatic efficacy, assessed after completion of surgery using a four-point scale ('excellent', 'good', 'moderate', 'none'). Haemostasis was successful (rated 'excellent' or 'good') on completion of surgery in 17 (94.4%) procedures and rated as 'moderate' (5.6%) for one surgery in a patient with multiple comorbidities who needed an intraoperative N8-GP dose (20.7 IU kg -1 ). In the postoperative period, three bleeds occurred (one during days 1-6; two during days 7-14); all were successfully treated with N8-GP. Mean N8-GP consumption on day of surgery was 80.0 IU kg -1 ; patients received a mean of 1.7 doses (median: 2, range: 1-3). No safety concerns were identified. The data showed that N8-GP was effective and well tolerated for the prevention and treatment of bleeds during major surgery; such FVIII products with extended half-lives may modify current treatment schedules, enabling fewer infusions and earlier patient discharge. © 2017 John Wiley & Sons Ltd.

2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study.

PubMed

Wei, Mingwei; Meng, Fanyue; Wang, Shiyuan; Li, Jingxin; Zhang, Yuntao; Mao, Qunying; Hu, Yuemei; Liu, Pei; Shi, Nianmin; Tao, Hong; Chu, Kai; Wang, Yuxiao; Liang, Zhenglun; Li, Xiuling; Zhu, Fengcai

2017-01-01

 This study evaluated the 2-year efficacy, immunogenicity, and safety of the Vigoo enterovirus 71 (EV71) vaccine.  In an initial phase 3 study, we randomly assigned healthy infants and children aged 6-35 months (ratio, 1:1) to receive 2 doses of either EV71 vaccine (5120 participants) or placebo (5125 participants) at days 0 and 28, and followed them for 12 months after vaccination. In this extended follow-up study, we continued to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine for up to 2 years.  Overall efficacy was 94.84% (95% confidence interval [CI], 83.53%-98.38%) during the 2-year follow-up period (P < .0001), and the vaccine efficacy during the second year was 100.00% (95% CI, 84.15%-100.00%) against EV71-associated hand-foot-and-mouth disease (HFMD; P < .0001). Geometric mean titers of neutralizing antibody in participants remained high during the 2-year follow-up period, and no vaccine-related serious adverse events were recorded.  Two doses of Vigoo EV71 vaccine could provide sustained protection against EV71-associated HFMD in healthy Chinese children.  NCT01508247. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

A Longitudinal Analysis of the Causal Factors in Major Maritime Accidents in the USA and Canada (1996-2006)

NASA Technical Reports Server (NTRS)

Johnson, C. W.; Holloway, C, M.

2007-01-01

Accident reports provide important insights into the causes and contributory factors leading to particular adverse events. In contrast, this paper provides an analysis that extends across the findings presented over ten years investigations into maritime accidents by both the US National Transportation Safety Board (NTSB) and Canadian Transportation Safety Board (TSB). The purpose of the study was to assess the comparative frequency of a range of causal factors in the reporting of adverse events. In order to communicate our findings, we introduce J-H graphs as a means of representing the proportion of causes and contributory factors associated with human error, equipment failure and other high level classifications in longitudinal studies of accident reports. Our results suggest the proportion of causal and contributory factors attributable to direct human error may be very much smaller than has been suggested elsewhere in the human factors literature. In contrast, more attention should be paid to wider systemic issues, including the managerial and regulatory context of maritime operations.

Tolerability of extended-release quetiapine fumarate compared with immediate-release quetiapine fumarate in older patients with Alzheimer's disease with symptoms of psychosis and/or agitation: a randomised, double-blind, parallel-group study.

PubMed

De Deyn, Peter Paul; Eriksson, Hans; Svensson, Hanna

2012-03-01

The objective of this study was to assess the safety and tolerability of extended-release quetiapine fumarate (quetiapine XR) compared with quetiapine immediate-release (quetiapine IR) in older patients with Alzheimer's disease with symptoms of psychosis and/or agitation. This was a 6-week, double-blind, double-dummy, randomised study. Of the 109 patients screened, 100 were randomised to receive quetiapine XR (n = 68) or quetiapine IR (n = 32), at doses of 50 and 25 mg/day, respectively. Treatment was escalated to 100 mg/day by Day 4. At Day 8, a flexible-dose (50-300 mg/day) period began when dose adjustment was made at the investigator's discretion. The primary variable was incidence and type of adverse events (AEs). Secondary variables included efficacy and other safety assessments. Mean daily doses were 143.6 and 142.0 mg in the quetiapine XR and quetiapine IR groups, respectively. Ninety patients completed the study; only one withdrew (in the quetiapine XR group) because of an AE. Laboratory evaluations identified severe neutropaenia (one patient), mild neutropaenia (three patients) and eosinophilia (five patients); however, these were not reported, as AEs and confounding factors, such as patient age, concomitant illness and medication, made it difficult to determine any relationship to quetiapine treatment. Numerical improvements from baseline were seen across both treatment groups in Neuropsychiatric Inventory frequency × severity total, Neuropsychiatric Inventory-Nursing Home version, Cohen-Mansfield Agitation Inventory, Clinical Global Impression-Severity of Illness and Clinical Global Impression-Improvement scores. Quetiapine XR dosed up to 300 mg/day was generally well tolerated, with a similar profile to that of quetiapine IR. Copyright © 2011 John Wiley & Sons, Ltd.

A novel once-daily fixed-dose combination of memantine extended release and donepezil for the treatment of moderate to severe Alzheimer's disease: two phase I studies in healthy volunteers.

PubMed

Boinpally, Ramesh; Chen, Laishun; Zukin, Stephen R; McClure, Natalie; Hofbauer, Robert K; Periclou, Antonia

2015-07-01

Combining two standard-of-care medications for Alzheimer's disease (AD) into a single once-daily dosage unit may improve treatment adherence, facilitate drug administration, and reduce caregiver burden. A new fixed-dose combination (FDC) capsule containing 28 mg memantine extended release (ER) and 10 mg donepezil was evaluated for bioequivalence with co-administered commercially available memantine ER and donepezil, and for bioavailability with regard to food intake. Two phase I, single-dose, randomized, open-label, crossover studies were conducted in 18- to 45-year-old healthy individuals. In MDX-PK-104 study, fasting participants (N = 38) received co-administered memantine ER and donepezil or the FDC. In MDX-PK-105 study, participants (N = 36) received three treatments: intact FDC taken while fasting or after a high-fat meal, or FDC contents sprinkled on applesauce while fasting. Standard pharmacokinetic parameters for memantine and donepezil were calculated from the plasma concentration time-curve using non-compartmental analyses. Linear mixed-effects models were used to compare: (a) FDC versus co-administered individual drugs; (b) FDC fasted versus with food; and (c) FDC sprinkled on applesauce versus FDC intact, both fasted. Safety parameters were also evaluated. The FDC capsule was bioequivalent to co-administered memantine ER and donepezil. There was no significant food effect on the bioavailability of the FDC components. There were no clinically relevant differences in time to maximum plasma concentration or safety profiles across treatments. An FDC capsule containing 28 mg memantine ER and 10 mg donepezil is bioequivalent to commercially available memantine ER and donepezil, and bioavailability is not affected by food intake or sprinkling of capsule contents on applesauce.

Safety sans Frontières: An International Safety Culture Model.

PubMed

Reader, Tom W; Noort, Mark C; Shorrock, Steven; Kirwan, Barry

2015-05-01

The management of safety culture in international and culturally diverse organizations is a concern for many high-risk industries. Yet, research has primarily developed models of safety culture within Western countries, and there is a need to extend investigations of safety culture to global environments. We examined (i) whether safety culture can be reliably measured within a single industry operating across different cultural environments, and (ii) if there is an association between safety culture and national culture. The psychometric properties of a safety culture model developed for the air traffic management (ATM) industry were examined in 17 European countries from four culturally distinct regions of Europe (North, East, South, West). Participants were ATM operational staff (n = 5,176) and management staff (n = 1,230). Through employing multigroup confirmatory factor analysis, good psychometric properties of the model were established. This demonstrates, for the first time, that when safety culture models are tailored to a specific industry, they can operate consistently across national boundaries and occupational groups. Additionally, safety culture scores at both regional and national levels were associated with country-level data on Hofstede's five national culture dimensions (collectivism, power distance, uncertainty avoidance, masculinity, and long-term orientation). MANOVAs indicated safety culture to be most positive in Northern Europe, less so in Western and Eastern Europe, and least positive in Southern Europe. This indicates that national cultural traits may influence the development of organizational safety culture, with significant implications for safety culture theory and practice. © 2015 Society for Risk Analysis.

Evaluation of safety and quality impact of extractable and leachable substances in therapeutic biologic protein products: a risk-based perspective.

PubMed

Markovic, Ingrid

2007-09-01

Leachables are chemical entities that migrate spontaneously from the final container closure system, packaging components and/or processing equipment under recommended conditions of product use and storage. Unlike leachables, extractables are generated under exaggerated temperature and time conditions in the presence of an appropriate solvent. Increasing evidence suggests that leachables may pose a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine dysregulation. These substances may also alter product physico-chemical properties via interaction with the active pharmaceutical ingredient or the excipients in product vehicle, thereby adversely affecting the final product quality. The evaluation of leachable compounds begins with a thorough identification of extractable compounds released from the production and packaging components under exaggerated conditions. The set of observed extractables helps to identify possible targets to be monitored in a subsequent leachables study over extended time periods. Although extractables and leachables also present a challenge for the safe use of device components (e.g., metered dose inhalers, dry powder inhalers, nasal spray devices or various implants), this review focusses on a safety risk assessment for specified therapeutic biological protein products. Regulatory, safety and scientific considerations in evaluating extractables and leachables are discussed, along with strategies for the analytical identification, quantification and monitoring.

Extended-release mesalamine granules for ulcerative colitis.

PubMed

Love, Bryan L; Miller, April D

2012-11-01

To evaluate the efficacy and safety of extended-release mesalamine granules in the maintenance of remission in ulcerative colitis (UC). Literature was obtained through searches of MEDLINE (1990-June 2012) using the terms mesalamine granules, ulcerative colitis, Apriso, and Salofalk. Bibliographies from retrieved articles were searched for additional citations. All English-language articles reporting on use of extended-release mesalamine granules in humans identified through the search were evaluated and included. The preferred initial treatment for induction and maintenance of remission in mild to moderate UC is agents from the 5-aminosalicylate class (balsalazide, mesalamine, olsalazine, sulfasalazine). Mesalamine granules are available as an encapsulated product in the US and as a nonencapsulated formulation in Europe. Data evaluating encapsulated mesalamine granules for induction of remission are lacking; however, the European mesalamine granule formulation has been evaluated for induction of remission. Patients receiving mesalamine granules for induction achieved clinical and endoscopic remission more frequently than those receiving placebo. Two pivotal, randomized, double-blind, placebo-controlled, multicenter studies have evaluated encapsulated mesalamine granules for maintenance in 562 adults in remission from UC. In both studies, the proportion of patients who remained relapse-free at 6 months was higher for those receiving encapsulated mesalamine granules than placebo. Mesalamine granules are well tolerated, with headache, nausea, and upper respiratory infections being the most frequently reported adverse effects. Current evidence supports the use of extended-release mesalamine granules for maintenance of remission in mild to moderate UC. Further studies are necessary to examine the ideal dose and regimen of encapsulated mesalamine granules for induction of remission in UC.

Delayed release dexlansoprazole in the treatment of GERD and erosive esophagitis

PubMed Central

Wittbrodt, Eric T; Baum, Charles; Peura, David A

2009-01-01

Although proton pump inhibitors (PPI) have a record of remarkable effectiveness and safety in the management of gastroesophageal reflux disease (GERD), several treatment challenges with PPI have emerged. Dexlansoprazole MR is the (R)-enantiomer of lansoprazole contained in a formulation that produces two distinct releases of drug and significantly extends the duration of active plasma concentrations and % time pH > 4 beyond that of conventional single-release PPI. Dexlansoprazole MR can be administered without regard to meals or the timing of meals in most patients. Dexlansoprazole MR 60 mg demonstrated similar efficacy for healing of erosive esophagitis at 8 weeks compared with lansoprazole 30 mg, and dexlansoprazole MR 30 mg was superior to placebo for maintenance of healed erosive esophagitis at 6 months with 99% of nights and 96% of days heartburn-free over 6 months in patients taking dexlansoprazole MR 30 mg. Superior relief of heartburn occurred in patients taking dexlansoprazole MR 30 mg (55% heartburn-free 24-hour periods) vs placebo (14%) for symptomatic nonerosive GERD. The safety profile of dexlansoprazole MR is similar to that of lansoprazole. The extended pharmacodynamic effects, added convenience, and efficacy and safety of dexlansoprazole MR offer a novel approach to gastric pH control in patients with acid-related disorders. PMID:21694835

Long pulse operation of the Kamaboko negative ion source on the MANTIS test bed

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tramham, R.; Jacquot, C.; Riz, D.

1998-08-20

Advanced Tokamak concepts and steady state plasma scenarios require external plasma heating and current drive for extended time periods. This poses several problems for the neutral beam injection systems that are currently in use. The power loading of the ion source and accelerator are especially problematic. The Kamaboko negative ion source, a small scale model of the ITER arc source, is being prepared for extended operation of deuterium beams for up to 1000 seconds. The operating conditions of the plasma grid prove to be important for reducing electron power loading of the accelerator. Operation of deuterium beams for extended periodsmore » also poses radiation safety risks which must be addressed.« less

Buckling analysis of the quadripod structure for the NASA 70-meter antenna

NASA Technical Reports Server (NTRS)

Chian, Chian T.

1987-01-01

As part of the effort to extend the diameter of three Deep Space Network large earth antennas from 64 meters to 70 meters, a slim profiled quadripod structure was designed to support a 7.7 meter diameter subreflector for the 70 meter antenna. The new quadripod design, which particularly emphasizes reduced radio frequency blockage, is achieved by means of a narrow cross sectional profile of the legs. Buckling analysis, using NASTRAN, was conducted in this study to verify the safety margin for the quadripod structural stability.

Ad hoc versus standardized admixtures for continuous infusion drugs in neonatal intensive care: cognitive task analysis of safety at the bedside.

PubMed

Brannon, Timothy S

2006-01-01

Continuous infusion intravenous (IV) drugs in neonatal intensive care are usually prepared based on patient weight so that the dose is readable as a simple multiple of the infusion pump rate. New safety guidelines propose that hospitals switch to using standardized admixtures of these drugs to prevent calculation errors during ad hoc preparation. Extended hierarchical task analysis suggests that switching to standardized admixtures may lead to more errors in programming the pump at the bedside.

Ad Hoc versus Standardized Admixtures for Continuous Infusion Drugs in Neonatal Intensive Care: Cognitive Task Analysis of Safety at the Bedside

PubMed Central

Brannon, Timothy S.

2006-01-01

Continuous infusion intravenous (IV) drugs in neonatal intensive care are usually prepared based on patient weight so that the dose is readable as a simple multiple of the infusion pump rate. New safety guidelines propose that hospitals switch to using standardized admixtures of these drugs to prevent calculation errors during ad hoc preparation. Extended hierarchical task analysis suggests that switching to standardized admixtures may lead to more errors in programming the pump at the bedside. PMID:17238482

Chemotherapy safety in clinical veterinary oncology.

PubMed

Klahn, Shawna

2014-09-01

Exposure to chemotherapy is a health hazard for all personnel in facilities that store, prepare, or administer antineoplastic agents. Contamination levels have been measured as much as 15 times higher in the veterinary medicine sector than in human facilities. Recent publications in human and veterinary medicine indicate that exposure extends beyond the clinic walls to affect the patient's home and family. This article provides an update on the advances in chemotherapy safety, the current issues, and the impact on cancer management in veterinary medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

Use of Oxycodone in Pain Management

PubMed Central

Moradi, Mohammad; Esmaeili, Sara; Shoar, Saeed; Safari, Saeid

2012-01-01

Oxycodone is widely used to alleviate moderate-to severe acute pain, It is an effective analgesic for many types of pain, and is especially useful for paroxysmal spontaneous pain, steady pain, allodynia associated with postherpetic neuralgia, and it is also increasingly used in the management of cancer-related and chronic pain, oxycodone has been found to improve the quality of life of patients with many types of pain. In 2011, following chemical and physical manipulation, an extended-release form of oxycodone was developed in order to maintain its rate-controlling mechanism. This new formulation significantly improved analgesia among patients with moderate-to-severe chronic osteoarthritis pain with an adverse event profile similar to that of other opioids. The long-term safety and efficacy of extended-release form of oxycodone in relieving moderate-to-severe chronic pain has been demonstrated. In this study we discussed about different aspects of this drug in managing of various types of pain. PMID:24904812

Extended and continuous use of hormonal contraceptives to reduce menstruation.

PubMed

Wiegratz, Inka; Kissler, Stefan; Kuhl, Herbert; Kaufmann, Manfred

2006-09-01

During the use of long-cycle regimens of monophasic oral contraceptives, the total number of bleeding and cycle-dependent complaints is considerably lower than during conventional treatment with oral contraceptives. Despite an initially higher rate of irregular bleeding, the majority of women prefer the long-cycle treatment since it may improve quality of life. As this regimen provides an enhanced ovarian suppression, it may prevent pregnancies, especially in noncompliant women or patients who are concomitantly treated with drugs that may impair the efficacy of oral contraceptives. Postponement or suppression of withdrawal bleeding also reduces menses-associated disorders such as menorrhagia and dysmenorrhea, and has beneficial effects in patients with hemorrhagic diathesis, endometriosis, uterine leiomyomas and polycystic ovary syndrome. Long-term studies are necessary to assess the impact of long-term use of extended regimens of oral contraceptives on safety, for example, the risk of cancer and cardiovascular disease, and on fertility after discontinuation of treatment.

78 FR 32085 - Amendment of Class E Airspace; Eureka, NV

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-29

... instrument approach procedures at the airport. This improves the safety and management of Instrument Flight... aircraft using the RNAV (GPS) standard instrument approach procedures at Eureka Airport. Class E airspace...) standard instrument approach procedures at the airport. Additional controlled airspace extending upward...

78 FR 67294 - Amendment of Class E Airspace; Wadena, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... Approach Procedures at Wadena Municipal Airport. The airport's geographic coordinates are also adjusted. This action enhances the safety and management of Instrument Flight Rule (IFR) operations at the... extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures...

75 FR 54859 - Agency Information Collection Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

... DEPARTMENT OF ENERGY Agency Information Collection Extension AGENCY: U.S. Department of Energy... Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request (ICR... Safety and Health Policy uses the information collected from the contractors to evaluate the adequacy of...

78 FR 62609 - Agency Information Collection Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

... DEPARTMENT OF ENERGY Agency Information Collection Extension AGENCY: U.S. Department of Energy... Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request (ICR... Safety and Health Policy uses the information collected from the contractors to evaluate the adequacy of...

Illuminating e-beam processing

USDA-ARS?s Scientific Manuscript database

This month's Processing column will explore electronic beam (e-beam) processing. E-beam processing uses a low energy form of irradiation and has emerged as a highly promising treatment for both food safety and quarantine purposes. It is also used to extend food shelf life. This column will review...

Morphine sulfate and naltrexone hydrochloride extended-release capsules: naltrexone release, pharmacodynamics, and tolerability.

PubMed

Johnson, Franklin; Setnik, Beatrice

2011-01-01

Morphine sulfate and naltrexone hydrochloride extended-release capsules (EMBEDA, King Pharmaceuticals, Inc., Bristol, TN), indicated for management of chronic, moderate-to-severe pain, contain pellets of extended-release morphine sulfate with a sequestered naltrexone core (MS-sNT). Taken as directed, morphine provides analgesia while naltrexone remains sequestered; if tampered with by crushing, naltrexone is released to mitigate morphine-induced euphoric effects. While it is necessary to establish that formulations intended to reduce attractiveness for abuse are successful in doing so, it is also necessary to demonstrate that product therapeutic integrity is maintained for patients. Data were reviewed from 3 studies to determine: 1) the quantity of naltrexone released when MS-sNT pellets are crushed (MS-sNTC) for at least 2 minutes with mortar and pestle); 2) the extent to which the naltrexone released upon crushing mitigated morphine-induced subjective effects; and 3) whether sequestered naltrexone precipitates opioid withdrawal when MS-sNT is taken as directed. The naltrexone bioavailability study compared naltrexone release from MS-sNTC with that from whole intact MS-sNT capsules (MS-sNTW) and an equal naltrexone solution (NS) dose. Equivalent bioavailability was established if 90% confidence intervals (CIs) for geometric mean ratios (maximum plasma naltrexone concentration [Cmax] and area under the concentration-time curve extrapolated to infinity [AUC∞]) fell between 80% and 125%. The oral pharmacodynamic study assessed drug liking and euphoria and pharmacokinetic properties of MS-sNTC and MS-sNTW compared with morphine sulfate solution (MSS) and placebo. The 12-month, open-label (OL) safety study evaluated safety of MS-sNT administered orally as directed in patients with chronic, moderate-to-severe pain. Safety assessments included withdrawal symptoms based on the Clinical Opiate Withdrawal Scale (COWS). Naltrexone from MS-sNTC met criteria for equivalent bioavailability to NS. Although morphine relative bioavailability was similar for MS-sNTC and MSS, mean peak (Emax) visual analog scale (VAS) scores for drug liking and Cole/Addiction Research Center Inventory Stimulation-Euphoria were significantly reduced for MS-sNTC vs MSS (p < 0.001). In these 2 studies, a total of 6 participants had one measurement of plasma naltrexone after MS-sNTW that was above the lower limit of quantification. In the OL safety study, 72/93 participants (77%) had no quantifiable naltrexone concentrations. There was neither evidence of naltrexone accumulation for any participant nor any significant correlation with MS-sNT dose, age, or sex. Of 4 participants with the highest naltrexone concentrations, none had COWS scores consistent with moderate opioid withdrawal symptoms. Only 5 participants had COWS scores consistent with moderate opioid withdrawal; all 5 had not taken MS-sNT as directed. Study populations may not be fully representative of patients receiving opioid therapy for the management of chronic, moderate-to-severe pain and of opioid abusers. When MS-sNT capsules are crushed, all of the sequestered naltrexone (relative to oral NS) is released and immediately available to mitigate morphine-induced effects. When MS-sNT was crushed, the naltrexone released abated drug liking and euphoria relative to that from an equal dose of immediate-release morphine from MSS administration in a majority of participants. Naltrexone concentrations were low over a period of 12 months without evidence of accumulation, and there were no observable opioid withdrawal symptoms when MS-sNT was taken as directed.

Behaving safely under pressure: The effects of job demands, resources, and safety climate on employee physical and psychosocial safety behavior.

PubMed

Bronkhorst, Babette

2015-12-01

Previous research has shown that employees who experience high job demands are more inclined to show unsafe behaviors in the workplace. In this paper, we examine why some employees behave safely when faced with these demands while others do not. We add to the literature by incorporating both physical and psychosocial safety climate in the job demands and resources (JD-R) model and extending it to include physical and psychosocial variants of safety behavior. Using a sample of 6230 health care employees nested within 52 organizations, we examined the relationship between job demands and (a) resources, (b) safety climate, and (c) safety behavior. We conducted multilevel analyses to test our hypotheses. Job demands (i.e., work pressure), job resources (i.e., job autonomy, supervisor support, and co-worker support) and safety climate (both physical and psychosocial safety climate) are directly associated with, respectively, lower and higher physical and psychosocial safety behavior. We also found some evidence that safety climate buffers the negative impact of job demands (i.e., work-family conflict and job insecurity) on safety behavior and strengthens the positive impact of job resources (i.e., co-worker support) on safety behavior. Regardless of whether the focus is physical or psychological safety, our results show that strengthening the safety climate within an organization can increase employees' safety behavior. Practical implication: An organization's safety climate is an optimal target of intervention to prevent and ameliorate negative physical and psychological health and safety outcomes, especially in times of uncertainty and change. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

PubMed

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The orthopaedic error index: development and application of a novel national indicator for assessing the relative safety of hospital care using a cross-sectional approach.

PubMed

Panesar, Sukhmeet S; Netuveli, Gopalakrishnan; Carson-Stevens, Andrew; Javad, Sundas; Patel, Bhavesh; Parry, Gareth; Donaldson, Liam J; Sheikh, Aziz

2013-11-21

The Orthopaedic Error Index for hospitals aims to provide the first national assessment of the relative safety of provision of orthopaedic surgery. Cross-sectional study (retrospective analysis of records in a database). The National Reporting and Learning System is the largest national repository of patient-safety incidents in the world with over eight million error reports. It offers a unique opportunity to develop novel approaches to enhancing patient safety, including investigating the relative safety of different healthcare providers and specialties. We extracted all orthopaedic error reports from the system over 1 year (2009-2010). The Orthopaedic Error Index was calculated as a sum of the error propensity and severity. All relevant hospitals offering orthopaedic surgery in England were then ranked by this metric to identify possible outliers that warrant further attention. 155 hospitals reported 48 971 orthopaedic-related patient-safety incidents. The mean Orthopaedic Error Index was 7.09/year (SD 2.72); five hospitals were identified as outliers. Three of these units were specialist tertiary hospitals carrying out complex surgery; the remaining two outlier hospitals had unusually high Orthopaedic Error Indexes: mean 14.46 (SD 0.29) and 15.29 (SD 0.51), respectively. The Orthopaedic Error Index has enabled identification of hospitals that may be putting patients at disproportionate risk of orthopaedic-related iatrogenic harm and which therefore warrant further investigation. It provides the prototype of a summary index of harm to enable surveillance of unsafe care over time across institutions. Further validation and scrutiny of the method will be required to assess its potential to be extended to other hospital specialties in the UK and also internationally to other health systems that have comparable national databases of patient-safety incidents.

The effect of adopting new storage methods for extending product validity periods on manufacturers expected inventory costs.

PubMed

Chen, Po-Yu

2014-01-01

The validness of the expiration dates (validity period) that manufacturers provide on food product labels is a crucial food safety problem. Governments must study how to use their authority by implementing fair awards and punishments to prompt manufacturers into adopting rigorous considerations, such as the effect of adopting new storage methods for extending product validity periods on expected costs. Assuming that a manufacturer sells fresh food or drugs, this manufacturer must respond to current stochastic demands at each unit of time to determine the purchase amount of products for sale. If this decision maker is capable and an opportunity arises, new packaging methods (e.g., aluminum foil packaging, vacuum packaging, high-temperature sterilization after glass packaging, or packaging with various degrees of dryness) or storage methods (i.e., adding desiccants or various antioxidants) can be chosen to extend the validity periods of products. To minimize expected costs, this decision maker must be aware of the processing costs of new storage methods, inventory standards, inventory cycle lengths, and changes in relationships between factors such as stochastic demand functions in a cycle. Based on these changes in relationships, this study established a mathematical model as a basis for discussing the aforementioned topics.

Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial.

PubMed

Bunnapradist, S; Ciechanowski, K; West-Thielke, P; Mulgaonkar, S; Rostaing, L; Vasudev, B; Budde, K

2013-03-01

Phase III noninferiority trial examining efficacy and safety of converting stable renal transplant recipients from twice-daily tacrolimus to a novel extended-release once-daily tacrolimus formulation (LCPT) with a controlled agglomeration technology. Controls maintained tacrolimus twice daily. The primary efficacy endpoint was proportion of patients with efficacy failures (death, graft failure, locally read biopsy-proven acute rejection [BPAR], or loss to follow-up) within 12 months. Starting LCPT dose was 30% lower (15% for blacks) than preconversion tacrolimus dose; target trough levels were 4-15 ng/mL. A total of 326 patients were randomized; the mITT population (n = 162 each group) was similar demographically in the two groups. Mean daily dose of LCPT was significantly (p < 0.0001) lower than preconversion tacrolimus dose at each visit; mean trough levels between groups were similar. There were four efficacy failures in each group; safety outcomes were similar between groups. Frequency of premature study drug discontinuation was LCPT: 12% versus tacrolimus twice daily: 5% (p = 0.028). LCPT demonstrated noninferiority to tacrolimus twice daily in efficacy failure rates. LCPT may offer a safe and effective alternative for converting patients to a once-daily formulation. Compared to currently available tacrolimus formulation, LCPT requires lower doses to achieve target trough levels. © Copyright 2012 The American Society of Transplantation and the American Society of Transplant Surgeons.

What you don't know can hurt you: household products and events.

PubMed

Leonard, S D; Wogalter, M S

2000-05-01

Product safety is affected by product design and by the knowledge of the user, either through the user's own background or through instructions and warnings presented with the product. Given adequate knowledge, warnings can serve primarily to remind individuals of the hazards and precautions that can be taken. This study examined people in the USA (represented by two diverse samples) to evaluate their knowledge about the hazards associated with common household products and situations using both multiple choice and open-ended surveys. The results indicated that the respondents were aware of a substantial number of hazards, but their knowledge often did not extend to the specific circumstances that could produce personal injury and property damage. Further, comparisons of cued and non-cued responses suggested some hazards are not well recognized without the cue. The results indicate warnings are needed both as reminders and to provide safety information.

Beyond engagement in working with children in eight Nairobi slums to address safety, security, and housing: Digital tools for policy and community dialogue.

PubMed

Mitchell, Claudia; Chege, Fatuma; Maina, Lucy; Rothman, Margot

2016-01-01

This article studies the ways in which researchers working in the area of health and social research and using participatory visual methods might extend the reach of participant-generated creations such as photos and drawings to engage community leaders and policy-makers. Framed as going 'beyond engagement', the article explores the idea of the production of researcher-led digital dialogue tools, focusing on one example, based on a series of visual arts-based workshops with children from eight slums in Nairobi addressing issues of safety, security, and well-being in relation to housing. The authors conclude that there is a need for researchers to embark upon the use of visual tools to expand the life and use of visual productions, and in particular to ensure meaningful participation of communities in social change.

Anomaly Analysis: NASA's Engineering and Safety Center Checks Recurring Shuttle Glitches

NASA Technical Reports Server (NTRS)

Morring, Frank, Jr.

2004-01-01

The NASA Engineering and Safety Center (NESC), set up in the wake of the Columbia accident to backstop engineers in the space shuttle program, is reviewing hundreds of recurring anomalies that the program had determined don't affect flight safety to see if in fact they might. The NESC is expanding its support to other programs across the agency, as well. The effort, which will later extend to the International Space Station (ISS), is a principal part of the attempt to overcome the normalization of deviance--a situation in which organizations proceeded as if nothing was wrong in the face of evidence that something was wrong--cited by sociologist Diane Vaughn as contributing to both space shuttle disasters.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beidler, M. T.; Cassak, P. A.; Jardin, S. C.

We diagnose local properties of magnetic reconnection during a sawtooth crash employing the three-dimensional toroidal, extended-magnetohydrodynamic (MHD) code M3D-C 1. To do so, we sample simulation data in the plane in which reconnection occurs, the plane perpendicular to the helical (m, n) = (1, 1) mode at the q = 1 surface, where m and n are the poloidal and toroidal mode numbers and q is the safety factor. We study the nonlinear evolution of a particular test equilibrium in a non-reduced field representation using both resistive-MHD and extended-MHD models. We find growth rates for the extended-MHD reconnection process exhibitmore » a nonlinear acceleration and greatly exceed that of the resistive-MHD model, as is expected from previous experimental, theoretical, and computational work. We compare the properties of reconnection in the two simulations, revealing the reconnecting current sheets are locally different in the two models and we present the first observation of the quadrupole out-of-plane Hall magnetic field that appears during extended-MHD reconnection in a 3D toroidal simulation (but not in resistive-MHD). We also explore the dependence on toroidal angle of the properties of reconnection as viewed in the plane perpendicular to the helical magnetic field, finding qualitative and quantitative effects due to changes in the symmetry of the reconnection process. Furthermore, this study is potentially important for a wide range of magnetically confined fusion applications, from confirming simulations with extended-MHD effects are sufficiently resolved to describe reconnection, to quantifying local reconnection rates for purposes of understanding and predicting transport, not only at the q = 1 rational surface for sawteeth, but also at higher order rational surfaces that play a role in disruptions and edge-confinement degradation.« less

Synthesizing Safety Conditions for Code Certification Using Meta-Level Programming

NASA Technical Reports Server (NTRS)

Eusterbrock, Jutta

2004-01-01

In code certification the code consumer publishes a safety policy and the code producer generates a proof that the produced code is in compliance with the published safety policy. In this paper, a novel viewpoint approach towards an implementational re-use oriented framework for code certification is taken. It adopts ingredients from Necula's approach for proof-carrying code, but in this work safety properties can be analyzed on a higher code level than assembly language instructions. It consists of three parts: (1) The specification language is extended to include generic pre-conditions that shall ensure safety at all states that can be reached during program execution. Actual safety requirements can be expressed by providing domain-specific definitions for the generic predicates which act as interface to the environment. (2) The Floyd-Hoare inductive assertion method is refined to obtain proof rules that allow the derivation of the proof obligations in terms of the generic safety predicates. (3) A meta-interpreter is designed and experimentally implemented that enables automatic synthesis of proof obligations for submitted programs by applying the modified Floyd-Hoare rules. The proof obligations have two separate conjuncts, one for functional correctness and another for the generic safety obligations. Proof of the generic obligations, having provided the actual safety definitions as context, ensures domain-specific safety of program execution in a particular environment and is simpler than full program verification.

Anticipatory vigilance: A grounded theory study of minimising risk within the perioperative setting.

PubMed

O'Brien, Brid; Andrews, Tom; Savage, Eileen

2018-01-01

To explore and explain how nurses minimise risk in the perioperative setting. Perioperative nurses care for patients who are having surgery or other invasive explorative procedures. Perioperative care is increasingly focused on how to improve patient safety. Safety and risk management is a global priority for health services in reducing risk. Many studies have explored safety within the healthcare settings. However, little is known about how nurses minimise risk in the perioperative setting. Classic grounded theory. Ethical approval was granted for all aspects of the study. Thirty-seven nurses working in 11 different perioperative settings in Ireland were interviewed and 33 hr of nonparticipant observation was undertaken. Concurrent data collection and analysis was undertaken using theoretical sampling. Constant comparative method, coding and memoing and were used to analyse the data. Participants' main concern was how to minimise risk. Participants resolved this through engaging in anticipatory vigilance (core category). This strategy consisted of orchestrating, routinising and momentary adapting. Understanding the strategies of anticipatory vigilance extends and provides an in-depth explanation of how nurses' behaviour ensures that risk is minimised in a complex high-risk perioperative setting. This is the first theory situated in the perioperative area for nurses. This theory provides a guide and understanding for nurses working in the perioperative setting on how to minimise risk. It makes perioperative nursing visible enabling positive patient outcomes. This research suggests the need for training and education in maintaining safety and minimising risk in the perioperative setting. © 2017 John Wiley & Sons Ltd.

Determinants of work injuries in mines - an application of structural equation modelling.

PubMed

Maiti, J; Chatterjee, S; Bangdiwala, S I

2004-03-01

In spite of stringent regulations and much attention towards reducing risks in the physical environment, the mining industry continues to be associated with high levels of accidents, injuries and illnesses. Only engineering solutions to accident prevention are inappropriate unless coupled with focused attention to the attitudes and behaviours of the mineworkers in coping with the inherent physical, technical and situational risks. The present study identified these various risk factors and analysed their influences on work injury in a causal framework. Data were collected from an underground coalmine of India. The pattern and strength of relationships of 16 causal factors with work injuries were assessed through structural equation modelling. The case study results showed that negatively personified individuals are of major concern for safety improvement in the mine studied. They not only fail to avoid work injuries, they are unable to extend safe work behaviours in their work. The variable safety environment is negatively affected by personality, whereas social support has a positive relationship with safety environment. The variable job hazards appeared to have a significant relationship with job involvement, which has a negative relationship with work injury. Elimination of negative behaviours must be focused and committed by the mine safety management. Long term planning through (i) identification of negative individuals, (ii) proper councelling of adverse effects of negative behaviours, and (iii) special training with psychological treatment is highly required. Identification may begin while recruiting new workers through interview. Proper allocation of jobs (right person for right job) may be a judicial solution to this end.

Lurasidone for the acute treatment of adults with schizophrenia: what is the number needed to treat, number needed to harm, and likelihood to be helped or harmed?

PubMed

Citrome, Leslie

2012-07-01

To describe the efficacy, safety and tolerability of lurasidone for the acute treatment of schizophrenia using the metrics number needed to treat (NNT) and number needed to harm (NNH). Study data were pooled from six Phase II and III, 6-week, randomized, placebo-controlled trials that were conducted to test the efficacy and safety of lurasidone for the acute treatment of schizophrenia. Included were the following interventions: fixed doses of lurasidone 20, 40, 80, 120 and 160 mg/d; haloperidol 10 mg/d; olanzapine 15 mg/d; quetiapine extended-release 600 mg/d; placebo. The following outcomes were assessed: responder rates as defined by a reduction of ≥20, 30, 40 or 50% from baseline on the Positive and Negative Syndrome Scale (PANSS) total score; study completion; discontinuation due to an adverse event (AE); weight gain ≥7% from baseline; incidence of spontaneously reported AEs; incidence of total cholesterol ≥240 mg/dL, low-density lipoprotein cholesterol ≥160 mg/dL, fasting triglycerides ≥200 mg/dL and glucose ≥126 mg/dL at endpoint. NNT for the efficacy outcomes were calculated after excluding one failed study. NNH for the safety/tolerability outcomes were calculated using all six studies. Likelihood of being helped or harmed (LHH) was also calculated to illustrate trade-offs between outcomes of improvement ≥30% on the PANSS vs. incidence of akathisia, nausea, sedation, somnolence and parkinsonism. NNT vs. placebo for PANSS reductions ≥30% were 6, 6, 7 and 4 for lurasidone doses of 40, 80, 120 and 160 mg/d, respectively, and 4 and 3 for olanzapine 15 mg/d and quetiapine extended-release 600 mg/d, respectively. Lurasidone was not associated with any statistically significant disadvantages over placebo for weight gain or metabolic abnormalities; NNH vs. placebo for weight gain ≥7% from baseline was 4 for olanzapine and 9 for quetiapine extended-release in contrast to a NNH for this outcome ranging from 43 to 150 for lurasidone 40-160 mg/d. The 5 most consistently encountered adverse events attributable to lurasidone were akathisia, nausea, sedation, somnolence and parkinsonism, with NNH vs. placebo for lurasidone 40-120 mg/d ranging from 6 (akathisia with 120 mg/d) to 30 (parkinsonism with 80 mg/d). Lurasidone 160 mg/d appeared better tolerated than doses of 40, 80 or 120 mg/d for akathisia, nausea, sedation or somnolence, with no NNH values for these adverse events for 160 mg/d vs. placebo being statistically significant. LHH was favorable for lurasidone when contrasting PANSS reductions vs. adverse events. NNT and NNH can help quantify efficacy, safety and tolerability outcomes and place lurasidone into clinical perspective. Advantages for lurasidone include a low propensity for weight gain and metabolic abnormalities. More commonly encountered adverse events include akathisia, nausea, sedation, somnolence and parkinsonism, but NNH values are generally in the double digits, reflecting an overall tolerable profile. Individual patient characteristics, values and preferences will need to be considered when selecting lurasidone over other antipsychotics.

The role of psychological determinants and demographic factors in consumer demand for farm-to-fork traceability systems.

PubMed

Myae, Aye Chan; Goddard, Ellen; Aubeeluck, Ashwina

2011-01-01

Traceability systems are an important tool (1) for tracking, monitoring, and managing product flows through the supply chain for better efficiency and profitability of suppliers, and (2) to improve consumer confidence in the face of serious food safety incidents. After the global bovine spongiform encephalopathy (BSE) crisis affected producers, consumers, trade, and the health status of animals and humans, new systems to help confirm the status of cattle products along the supply chain from farm to fork were implemented in many countries (Trautman et al. 2008 ). In this study, people's overall food safety beliefs are explored with the main objective of measuring the link between their food safety beliefs and their attitudes toward traceability. A comparison is made among English-speaking Canadians, French-speaking Canadians, and Japanese consumers. In the study, an Internet-based survey was used to collect data from nationally representative samples of the population in Canada-English (1275), Canada-French (343), and Japanese (1940) in the summer of 2009. Respondents' interests in traceability systems are clearly linked to their sense that the industry is primarily responsible for any food safety outbreaks. Moreover, it is clear that certain segments of the population in all samples feel strongly about the importance of farm to fork traceability in beef; thus, policymakers may wish to consider extending traceability beyond the point of slaughter as a way of encouraging beef sales in Canada.

Identifying medication error chains from critical incident reports: a new analytic approach.

PubMed

Huckels-Baumgart, Saskia; Manser, Tanja

2014-10-01

Research into the distribution of medication errors usually focuses on isolated stages within the medication use process. Our study aimed to provide a novel process-oriented approach to medication incident analysis focusing on medication error chains. Our study was conducted across a 900-bed teaching hospital in Switzerland. All reported 1,591 medication errors 2009-2012 were categorized using the Medication Error Index NCC MERP and the WHO Classification for Patient Safety Methodology. In order to identify medication error chains, each reported medication incident was allocated to the relevant stage of the hospital medication use process. Only 25.8% of the reported medication errors were detected before they propagated through the medication use process. The majority of medication errors (74.2%) formed an error chain encompassing two or more stages. The most frequent error chain comprised preparation up to and including medication administration (45.2%). "Non-consideration of documentation/prescribing" during the drug preparation was the most frequent contributor for "wrong dose" during the administration of medication. Medication error chains provide important insights for detecting and stopping medication errors before they reach the patient. Existing and new safety barriers need to be extended to interrupt error chains and to improve patient safety. © 2014, The American College of Clinical Pharmacology.

Efficacy and safety of rituximab in pemphigus: experience of the German Registry of Autoimmune Diseases.

PubMed

Kasperkiewicz, Michael; Eming, Rüdiger; Behzad, Melika; Hunzelmann, Nicolas; Meurer, Michael; Schulze-Koops, Hendrik; von Wussow, Peter; Hertl, Michael; Zillikens, Detlef; Freivogel, Klaus; Dörner, Thomas; Schmidt, Enno

2012-10-01

Rituximab has been reported to be effective in various small case series of patients with severe and/or refractory pemphigus. However, no systematic evaluation is available to corroborate this observation. The aim of this study was to systematically determine efficacy and safety of rituximab in treatment-resistant pemphigus. Multicenter retrospective, observational study of 36 patients with severe pemphigus vulgaris (n = 33) and pemphigus foliaceus (n = 3) treated with rituximab before August 31(st) , 2008 and enrolled in a national observational registery between December 2008 and June 2009. Within a mean period of observation of 11 (1-37) months, 21 (58 %) pemphigus patients showed complete, 13 (36 %) partial, and 2 (6 %) no response to rituximab treatment. This correlates with a mean improvement of the visual analog scale for well-being of 34 (20-60) at baseline to 75 (40-95) at the last control visit. In 4 (11 %) patients, severe adverse events were recorded including 1 (3 %) serious infection. Data collected in this systematic registry indicate that rituximab is an effective and relatively safe adjuvant treatment option for refractory pemphigus. To further extend our knowledge on efficacy and safety of this drug, controlled prospective trials are required. © The Authors • Journal compilation © Blackwell Verlag GmbH, Berlin.

Results of an Analysis of Field Studies of the Intrinsic Dynamic Characteristics Important for the Safety of Nuclear Power Plant Equipment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kaznovsky, A. P., E-mail: kaznovskyap@atech.ru; Kasiyanov, K. G.; Ryasnyj, S. I.

2015-01-15

A classification of the equipment important for the safety of nuclear power plants is proposed in terms of its dynamic behavior under seismic loading. An extended bank of data from dynamic tests over the entire range of thermal and mechanical equipment in generating units with VVER-1000 and RBMK-1000 reactors is analyzed. Results are presented from a study of the statistical behavior of the distribution of vibrational frequencies and damping decrements with the “small perturbation” factor that affects the measured damping decrements taken into account. A need to adjust the regulatory specifications for choosing the values of the damping decrements withmore » specified inertial loads on equipment owing to seismic effects during design calculations is identified. Minimum values of the decrements are determined and proposed for all types of equipment as functions of the directions and natural vibration frequencies of the dynamic interactions to be adopted as conservative standard values in the absence of actual experimental data in the course of design studies of seismic resistance.« less

Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study.

PubMed

Momoeda, Mikio; Kondo, Masami; Elliesen, Joerg; Yasuda, Masanobu; Yamamoto, Shigetomo; Harada, Tasuku

2017-01-01

Dysmenorrhea is a common condition in women, which is characterized by menstrual pain. Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms, and a 28-day cyclic regimen of ethinylestradiol/drospirenone (28d regimen) is approved for this indication in Japan. The aim of this study was to assess the safety and efficacy of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen) in Japanese women with dysmenorrhea. This multicenter, open-label study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 μg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24-120 days followed by a 4-day tablet-free interval) or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles). The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140-day evaluation period. Dysmenorrhea scores, bleeding patterns, and other pain-related parameters were also assessed. A total of 216 women (mean age 29.7 years) were randomized to the flexible regimen (n=108) or 28d regimen (n=108) and 212 were included in the full analysis sets (flexible regimen, n=105; 28d regimen, n=107). Women in the flexible-regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d-regimen group, with similar decreases in disease severity reported in both treatment groups. According to the investigators, 64.8% and 59.4% of women in the flexible-regimen and 28d-regimen treatment groups had "very much improved" or "much improved" disease, while 54.3% and 50.9% of patients reported being "very much satisfied" or "much satisfied" with their treatment, respectively. In Japanese women with dysmenorrhea, a flexible extended regimen of ethinylestradiol/drospirenone decreased the number of days with dysmenorrheic pain versus the traditional 28d regimen.

Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

PubMed Central

Momoeda, Mikio; Kondo, Masami; Elliesen, Joerg; Yasuda, Masanobu; Yamamoto, Shigetomo; Harada, Tasuku

2017-01-01

Background Dysmenorrhea is a common condition in women, which is characterized by menstrual pain. Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms, and a 28-day cyclic regimen of ethinylestradiol/drospirenone (28d regimen) is approved for this indication in Japan. Aim The aim of this study was to assess the safety and efficacy of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen) in Japanese women with dysmenorrhea. Methods This multicenter, open-label study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 μg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24–120 days followed by a 4-day tablet-free interval) or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles). The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140-day evaluation period. Dysmenorrhea scores, bleeding patterns, and other pain-related parameters were also assessed. Results A total of 216 women (mean age 29.7 years) were randomized to the flexible regimen (n=108) or 28d regimen (n=108) and 212 were included in the full analysis sets (flexible regimen, n=105; 28d regimen, n=107). Women in the flexible-regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d-regimen group, with similar decreases in disease severity reported in both treatment groups. According to the investigators, 64.8% and 59.4% of women in the flexible-regimen and 28d-regimen treatment groups had “very much improved” or “much improved” disease, while 54.3% and 50.9% of patients reported being “very much satisfied” or “much satisfied” with their treatment, respectively. Conclusion In Japanese women with dysmenorrhea, a flexible extended regimen of ethinylestradiol/drospirenone decreased the number of days with dysmenorrheic pain versus the traditional 28d regimen. PMID:28496369

Final report evaluation of bond retainage in Portland cement concrete overlays using infrared thermography and ground penetrating radar.

DOT National Transportation Integrated Search

1989-01-01

When concrete deterioration begins to occur in highway pavement, : repairs become necessary to assure the rider safety, extend its : useful life and restore its riding qualities. One rehabilitation : technique used to restore the pavement to acceptab...

78 FR 52083 - Amendment of Class E Airspace; Fort Polk, LA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

...) Standard Instrument Approach Procedures at Polk Army Airfield (AAF). The airport's geographic coordinates are also adjusted. This action enhances the safety and management of Instrument Flight Rule (IFR... extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures...

75 FR 80374 - Mine Safety Disclosure

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-22

... cases deal with civil penalties proposed by MSHA to be assessed against mine operators and address... the same disclosure requirements as those proposed for issuers that are not foreign private issuers... implementing the requirements of the Act and, therefore, do not extend to foreign mines, to the extent mine...

Design of an extended architecture for degraded modes of operation of AHS

DOT National Transportation Integrated Search

1995-04-01

In June 1998, Congress passed the Transportation Equity Act for the 21st Century (TEA-21) authorizing Federal surface transportation programs for highways, highway safety, and transit for 1998-2003. We are now at the midpoint of TEA-21, and this is a...

The AP1000{sup R} nuclear power plant innovative features for extended station blackout mitigation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vereb, F.; Winters, J.; Schulz, T.

2012-07-01

Station Blackout (SBO) is defined as 'a condition wherein a nuclear power plant sustains a loss of all offsite electric power system concurrent with turbine trip and unavailability of all onsite emergency alternating current (AC) power system. Station blackout does not include the loss of available AC power to buses fed by station batteries through inverters or by alternate AC sources as defined in this section, nor does it assume a concurrent single failure or design basis accident...' in accordance with Reference 1. In this paper, the innovative features of the AP1000 plant design are described with their operation inmore » the scenario of an extended station blackout event. General operation of the passive safety systems are described as well as the unique features which allow the AP1000 plant to cope for at least 7 days during station blackout. Points of emphasis will include: - Passive safety system operation during SBO - 'Fail-safe' nature of key passive safety system valves; automatically places the valve in a conservatively safe alignment even in case of multiple failures in all power supply systems, including normal AC and battery backup - Passive Spent Fuel Pool cooling and makeup water supply during SBO - Robustness of AP1000 plant due to the location of key systems, structures and components required for Safe Shutdown - Diverse means of supplying makeup water to the Passive Containment Cooling System (PCS) and the Spent Fuel Pool (SFP) through use of an engineered, safety-related piping interface and portable equipment, as well as with permanently installed onsite ancillary equipment. (authors)« less

Efficacy, Safety, and Tolerability of an Extended-Release Orally Disintegrating Methylphenidate Tablet in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder in the Laboratory Classroom Setting.

PubMed

Childress, Ann C; Kollins, Scott H; Cutler, Andrew J; Marraffino, Andrea; Sikes, Carolyn R

2017-02-01

Methylphenidate extended-release orally disintegrating tablets (MPH XR-ODTs) represent a new technology for MPH delivery. ODTs disintegrate in the mouth without water and provide a pharmacokinetic profile that is consistent with once-daily dosing. This study sought to determine the efficacy, safety, and tolerability of this novel MPH XR-ODT formulation in school-age children with attention-deficit/hyperactivity disorder (ADHD) in a laboratory classroom setting. Children aged 6-12 years with ADHD (n = 87) were enrolled in this randomized, multicenter, double-blind, placebo-controlled, parallel, laboratory classroom study. The MPH XR-ODT dose was titrated to an optimized dose during a 4-week open-label period and maintained on that dose for 1 week. Participants (n = 85) were then randomized to receive their optimized dose of MPH XR-ODT or placebo once daily for 1 week (double blind), culminating in a laboratory classroom testing day. Efficacy was evaluated using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Attention, Deportment, and Combined scores along with Permanent Product Measure of Performance (PERMP; Attempted and Correct) assessments. Onset and duration of drug action were also evaluated as key secondary endpoints. Safety assessments included adverse events (AEs), physical examinations, electrocardiograms (ECGs), and the Columbia Suicide Severity Rating Scale (C-SSRS). The average SKAMP-Combined score on the classroom study day was significantly better for the MPH XR-ODT group (n = 43) than for the placebo group (n = 39; p < 0.0001). The effect was evident at 1 hour and lasted through 12 hours postdose. The average SKAMP-Attention, SKAMP-Deportment, PERMP-A, and PERMP-C scores were indicative of significantly greater ADHD symptom control for the MPH XR-ODT group. The most common AEs reported were decreased appetite, upper abdominal pain, headache, insomnia, upper respiratory tract infection, affect lability, irritability, cough, and vomiting. MPH XR-ODT was effective and well tolerated for the treatment of children with ADHD in a laboratory classroom setting. Clinical Trial Registry: NCT01835548 ( ClinicalTrials.gov ).

Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial.

PubMed

Strawn, Jeffrey R; Compton, Scott N; Robertson, Brigitte; Albano, Anne Marie; Hamdani, Mohamed; Rynn, Moira A

2017-02-01

This is a feasibility study evaluating the safety, tolerability, and potential anxiolytic efficacy of the α 2 agonist guanfacine extended-release (GXR) in children and adolescents with generalized anxiety disorder (GAD), separation anxiety disorder (SAD), or social phobia/social anxiety disorder. Youth aged 6-17 years with a primary diagnosis of GAD, SAD, and/or social anxiety disorder were treated with flexibly dosed GXR (1-6 mg daily, n = 62) or placebo (n = 21) for 12 weeks. The primary aim of this study was to determine the safety and tolerability of GXR in youth with anxiety disorders, which involved the analysis of treatment-emergent adverse events (TEAEs), the emergence of suicidal ideation and behaviors, vital signs, and electrocardiographic/laboratory parameters. Exploratory efficacy measures included dimensional anxiety scales (Pediatric Anxiety Rating Scale [PARS] and Screen for Child Anxiety Related Emotional Disorders [SCARED]), as well as the Clinical Global Impression-Improvement (CGI-I) scale. As this was an exploratory study, no inferential statistical analyses were performed. GXR was safe and well tolerated. Treatment-related mean ± standard deviation changes in heart rate (GXR: 1.8 ± 12 beats per minute [bpm] decrease; placebo: 0.5 ± 11 bpm decrease), systolic blood pressure (GXR: 2.3 ± 11 mm Hg decrease; placebo: 1.7 ± 11 mm Hg decrease), or diastolic blood pressure (GXR: 1.3 ± 9 mm Hg decrease; placebo: 0.9 ± 7 mm Hg increase) were similar between treatment groups. TEAEs, including headache, somnolence/fatigue, abdominal pain, and dizziness, were consistent with the known safety profile of GXR. No differences were observed between treatment groups for PARS and SCARED scores, although at endpoint, a higher proportion of subjects receiving GXR versus placebo demonstrated CGI-I scores ≤2 (54.2% vs. 31.6%), as rated by the clinician investigator. GXR was well tolerated in pediatric subjects with GAD, SAD, and/or social anxiety disorder. ClinicalTrials.gov Identifier: NCT01470469.

Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial

PubMed Central

Compton, Scott N.; Robertson, Brigitte; Albano, Anne Marie; Hamdani, Mohamed; Rynn, Moira A.

2017-01-01

Abstract Objective: This is a feasibility study evaluating the safety, tolerability, and potential anxiolytic efficacy of the α2 agonist guanfacine extended-release (GXR) in children and adolescents with generalized anxiety disorder (GAD), separation anxiety disorder (SAD), or social phobia/social anxiety disorder. Methods: Youth aged 6–17 years with a primary diagnosis of GAD, SAD, and/or social anxiety disorder were treated with flexibly dosed GXR (1–6 mg daily, n = 62) or placebo (n = 21) for 12 weeks. The primary aim of this study was to determine the safety and tolerability of GXR in youth with anxiety disorders, which involved the analysis of treatment-emergent adverse events (TEAEs), the emergence of suicidal ideation and behaviors, vital signs, and electrocardiographic/laboratory parameters. Exploratory efficacy measures included dimensional anxiety scales (Pediatric Anxiety Rating Scale [PARS] and Screen for Child Anxiety Related Emotional Disorders [SCARED]), as well as the Clinical Global Impression–Improvement (CGI-I) scale. As this was an exploratory study, no inferential statistical analyses were performed. Results: GXR was safe and well tolerated. Treatment-related mean ± standard deviation changes in heart rate (GXR: 1.8 ± 12 beats per minute [bpm] decrease; placebo: 0.5 ± 11 bpm decrease), systolic blood pressure (GXR: 2.3 ± 11 mm Hg decrease; placebo: 1.7 ± 11 mm Hg decrease), or diastolic blood pressure (GXR: 1.3 ± 9 mm Hg decrease; placebo: 0.9 ± 7 mm Hg increase) were similar between treatment groups. TEAEs, including headache, somnolence/fatigue, abdominal pain, and dizziness, were consistent with the known safety profile of GXR. No differences were observed between treatment groups for PARS and SCARED scores, although at endpoint, a higher proportion of subjects receiving GXR versus placebo demonstrated CGI-I scores ≤2 (54.2% vs. 31.6%), as rated by the clinician investigator. Conclusions: GXR was well tolerated in pediatric subjects with GAD, SAD, and/or social anxiety disorder. ClinicalTrials.govIdentifier: NCT01470469. PMID:28165762

Hypnotics in insomnia: the experience of zolpidem.

PubMed

MacFarlane, James; Morin, Charles M; Montplaisir, Jacques

2014-11-01

One of the most commonly prescribed medications to treat insomnia is zolpidem, a nonbenzodiazepine compound that is available as an immediate-release oral tablet formulation, an extended-release oral formulation, an oral spray formulation, and as sublingual formulations. The purpose of this review was to summarize the data currently available on the efficacy and safety of zolpidem in the treatment of insomnia among adults. Published studies on the use of zolpidem in the treatment of insomnia were identified by using combinations of relevant search terms in PubMed and Google Scholar. Studies were included if they were placebo- or active comparator-controlled studies, with the exception of trials on the long-term use of zolpidem. Studies were limited to those conducted in adults. Studies were not included if the patient population was small, if the study was not designed or powered to assess the efficacy or safety of zolpidem, if insomniac patients had a medical condition in addition to insomnia (with the exception of comorbid depression or anxiety for studies on comorbid insomnia), or if zolpidem was given concomitantly with any other therapy (with the exception of selective serotonin reuptake inhibitors for studies on comorbid insomnia). Twenty-five studies designed to evaluate the efficacy of zolpidem in insomnia and 51 studies reporting the safety of zolpidem in insomnia were included in this review. The studies discussed in this review report the efficacy and safety of zolpidem in both young adults and the elderly. It can be used for either bedtime or middle-of-the-night administration, over the short or long term, with minimal risk of withdrawal or abuse. The use of zolpidem is associated with rebound insomnia, complex sleep-related behaviors, and next-day residual effects (after middle-of-the-night dosing) on driving ability, memory, and psychomotor performance. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Development of a generalized perturbation theory method for sensitivity analysis using continuous-energy Monte Carlo methods

DOE PAGES

Perfetti, Christopher M.; Rearden, Bradley T.

2016-03-01

The sensitivity and uncertainty analysis tools of the ORNL SCALE nuclear modeling and simulation code system that have been developed over the last decade have proven indispensable for numerous application and design studies for nuclear criticality safety and reactor physics. SCALE contains tools for analyzing the uncertainty in the eigenvalue of critical systems, but cannot quantify uncertainty in important neutronic parameters such as multigroup cross sections, fuel fission rates, activation rates, and neutron fluence rates with realistic three-dimensional Monte Carlo simulations. A more complete understanding of the sources of uncertainty in these design-limiting parameters could lead to improvements in processmore » optimization, reactor safety, and help inform regulators when setting operational safety margins. A novel approach for calculating eigenvalue sensitivity coefficients, known as the CLUTCH method, was recently explored as academic research and has been found to accurately and rapidly calculate sensitivity coefficients in criticality safety applications. The work presented here describes a new method, known as the GEAR-MC method, which extends the CLUTCH theory for calculating eigenvalue sensitivity coefficients to enable sensitivity coefficient calculations and uncertainty analysis for a generalized set of neutronic responses using high-fidelity continuous-energy Monte Carlo calculations. Here, several criticality safety systems were examined to demonstrate proof of principle for the GEAR-MC method, and GEAR-MC was seen to produce response sensitivity coefficients that agreed well with reference direct perturbation sensitivity coefficients.« less

A novel approach to enhance food safety: industry-academia-government partnership for applied research.

PubMed

Osterholm, Michael T; Ostrowsky, Julie; Farrar, Jeff A; Gravani, Robert B; Tauxe, Robert V; Buchanan, Robert L; Hedberg, Craig W

2009-07-01

An independent collaborative approach was developed for stimulating research on high-priority food safety issues. The Fresh Express Produce Safety Research Initiative was launched in 2007 with $2 million in unrestricted funds from industry and independent direction and oversight from a scientific advisory panel consisting of nationally recognized food safety experts from academia and government agencies. The program had two main objectives: (i) to fund rigorous, innovative, and multidisciplinary research addressing the safety of lettuce, spinach, and other leafy greens and (ii) to share research findings as widely and quickly as possible to support the development of advanced safeguards within the fresh-cut produce industry. Sixty-five proposals were submitted in response to a publicly announced request for proposals and were competitively evaluated. Nine research projects were funded to examine underlying factors involved in Escherichia coli O157:H7 contamination of lettuce, spinach, and other leafy greens and potential strategies for preventing the spread of foodborne pathogens. Results of the studies, published in the Journal of Food Protection, help to identify promising directions for future research into potential sources and entry points of contamination and specific factors associated with harvesting, processing, transporting, and storing produce that allow contaminants to persist and proliferate. The program provides a model for leveraging the strengths of industry, academia, and government to address high-priority issues quickly and directly through applied research. This model can be productively extended to other pathogens and other leafy and nonleafy produce.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population.

PubMed

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population

PubMed Central

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

Background The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Methods Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Results Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Conclusion Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding. PMID:28553116

A service life extension (SLEP) approach to operating aging aircraft beyond their original design lives

NASA Astrophysics Data System (ADS)

Pentz, Alan Carter

With today's uncertain funding climate (including sequestration and continuing budget resolutions), decision makers face severe budgetary challenges to maintain dominance through all aspects of the Department of Defense (DoD). To meet war-fighting capabilities, the DoD continues to extend aircraft programs beyond their design service lives by up to ten years, and occasionally much more. The budget requires a new approach to traditional extension strategies (i.e., reuse, reset, and reclamation) for structural hardware. While extending service life without careful controls can present a safety concern, future operations planning does not consider how much risk is present when operating within sound structural principles. Traditional structural hardware extension methods drive increased costs. Decision makers often overlook the inherent damage tolerance and fatigue capability of structural components and rely on simple time- and flight-based cycle accumulation when determining aircraft retirement lives. This study demonstrates that decision makers should consider risk in addition to the current extension strategies. Through an evaluation of eight military aircraft programs and the application and simulation of F-18 turbine engine usage data, this dissertation shows that insight into actual aircraft mission data, consideration of fatigue capability, and service extension length are key factors to consider. Aircraft structural components, as well as many critical safety components and system designs, have a predefined level of conservatism and inherent damage tolerance. The methods applied in this study would apply to extensions of other critical structures such as bridges. Understanding how much damage tolerance is built into the design compared to the original design usage requirements presents the opportunity to manage systems based on risk. The study presents the sensitivity of these factors and recommends avenues for further research.

Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study.

PubMed

Jensen, Jeffrey T; Garie, Sona Grossova; Trummer, Dietmar; Elliesen, Jörg

2012-08-01

Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive (OC) regimens. The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen. This was a 1-year, open-label, active-controlled, Phase 3 study conducted in the USA. Healthy women (18-45 years) received an ethinylestradiol (EE) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 (i.e., 28-day) regimen. The primary regimen [management of intracyclic bleeding (flexible(MIB)) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting. An alternative extended regimen [active period control (flexible(APC)) regimen] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding. Bleeding profiles were compared between treatments. Efficacy and safety outcomes were also assessed. The full analysis set comprised 1864 women (flexible(MIB), N=1406; flexible(APC), N=232; conventional 24/4, N=226). Over 1 year, subjects in the flexible(MIB) group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). The corresponding value in the flexible(APC) group was 47±33 days. The pregnancy rate in the flexible(MIB) group was 1.65 per 100 woman-years (95% confidence interval, 0.96-2.65). All three regimens were well tolerated. A flexible(MIB) dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen. Copyright © 2012 Elsevier Inc. All rights reserved.

The Effect of a Novel form of Extended-Release Gabapentin on Pain and Sleep in Fibromyalgia Subjects: An Open-Label Pilot Study.

PubMed

North, James M; Hong, Kyung-Soo J; Rauck, Richard L

2016-07-01

We assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM). Subjects with documented diagnosis of FM were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS). A total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8. Small sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group. Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep. © 2015 World Institute of Pain.

Double stenting with silicone and metallic stents for malignant airway stenosis.

PubMed

Matsumoto, Keitaro; Yamasaki, Naoya; Tsuchiya, Tomoshi; Miyazaki, Takuro; Kamohara, Ryotaro; Hatachi, Go; Nagayasu, Takeshi

2017-08-01

For severe malignant airway stenosis, there are several types of commercially available airway stents, and each has its own advantages and disadvantages. We herein describe the safety and efficacy of combination stenting with silicone and metallic stents for patients with extended malignant airway stenosis. Seven patients with malignant airway stenosis were treated via combination stenting with a silicone stent and a metallic stent for extended airway stenosis from the central to peripheral airways. Five patients were diagnosed with advanced esophageal cancer, two of whom had tracheoesophageal fistulas. One patient had adenoid cystic carcinoma, and another had mediastinal tumor. There were no specific complications related to the double stenting. Combination stenting with silicone and metallic stents proved to be a safe option for patients with severe, extended, and complicated malignant airway stenosis.

76 FR 8780 - Standard on the Control of Hazardous Energy (Lockout/Tagout); Extension of the Office of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

... Budget's (OMB) Approval of Information Collection (Paperwork) Requirements AGENCY: Occupational Safety... public comments concerning its proposal to extend OMB approval of the information collection requirements... number for the Information Collection Request (ICR) (OSHA- 2011-0033). All comments, including any...

48 CFR 50.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2010 CFR

2010-10-01

... identifying the risks insured against and the coverage extended to persons or property, or both; (C) Dollar... unusually hazardous or nuclear risks. 50.104-3 Section 50.104-3 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS AND THE SAFETY ACT...

78 FR 18262 - Proposed Amendment of Class E Airspace; Ogallala, NE

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... accommodate new Standard Instrument Approach Procedures (SIAP) at Searle Field Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the... standard instrument approach procedures at Searle Field Airport, Ogallala, NE. A small segment would extend...

77 FR 29872 - Establishment of Class E Airspace; Pender, NE

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... Instrument Approach Procedures at Pender Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport. DATES: Effective date... extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures...

77 FR 7581 - Determination That KAPVAY (Clonidine Hydrochloride) Extended-Release Tablets, 0.2 Milligram, Was...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-P-0292... From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that KAPVAY (clonidine...

In Defense of Snow Days

ERIC Educational Resources Information Center

Goodman, Joshua

2015-01-01

In snowy climates, school superintendents must frequently decide whether an impending storm warrants closing schools for the day. Concerns about student and teacher safety must be weighed against the loss of student learning time, along with state requirements for days of instruction and the cost and inconvenience of extending the school year into…

Student Data Privacy Communications Toolkit

ERIC Educational Resources Information Center

Foundation for Excellence in Education, 2016

2016-01-01

Parents expect school districts and schools to keep their children safe while they are in school. That expectation of safety and security also extends to the protection of their children's learning data. Therefore, it is critical that school districts and schools are open and transparent about their student data privacy practices, and that those…

78 FR 782 - Energy Northwest; Columbia Generating Station; Exemption

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-04

... health or safety, and are consistent with the common defense and security; and (2) when special... temporary relief from the applicable regulation and the licensee or applicant has made good faith efforts to... Common Defense and Security The proposed exemption would extend the time interval between the 2011 and...

78 FR 50328 - Safety Standard for Play Yards

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-19

... safe sleep environment for an infant, and when the result of misassembly could be severe, such as an... sleeping environment for children. It may fold for storage or travel.'' Play yards are intended for... sleeping environment, and infants are meant to be left unsupervised in them for extended periods of time...

78 FR 28987 - Revisions to Transportation Safety Requirements and Harmonization With International Atomic...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Transportation Requirements; Establishing Quality Assurance Programs for Packaging Used in Transport of... would make the regulation of quality assurance programs more efficient by allowing changes that do not change quality assurance approval holder commitments to be made without prior NRC approval, and extending...

77 FR 41259 - Modification of Class E Airspace; Plentywood, MT

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... Plentywood Sher-Wood Airport, Plentywood, MT. Controlled airspace is necessary to accommodate aircraft using... Plentywood Sher-Wood Airport. This improves the safety and management of Instrument Flight Rules (IFR... modifying Class E airspace extending upward from 700 feet above the surface at Plentywood Sher-Wood Airport...

29 CFR 2205.170 - Compliance procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... Complaints may be sent to Executive Director, Occupational Safety and Health Review Commission, One Lafayette Centre, 1120-20th Street NW., 9th Floor, Washington, DC 20036-3419. (d) The agency shall accept and... within 180 days of the alleged act of discrimination. The agency may extend this time period for good...

75 FR 60480 - Concrete and Masonry Construction; Extension of the Office of Management and Budget's (OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-30

... Information Collection (Paperwork) Requirements AGENCY: Occupational Safety and Health Administration (OSHA... proposal to extend the Office of Management and Budget's (OMB) approval of the information collection... OSHA docket number (OSHA-2010-0040) for the Information Collection Request (ICR). All comments...

Application of the IBERDROLA RETRAN Licensing Methodology to the Confrentes BWR-6 110% Extended Power Uprate

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fuente, Rafael de la; Iglesias, Javier; Sedano, Pablo G.

IBERDROLA (Spanish utility) and IBERDROLA INGENIERIA (engineering branch) have been developing during the last 2 yr the 110% Extended Power Uprate Project for Cofrentes BWR-6. IBERDROLA has available an in-house design and licensing reload methodology that has been approved in advance by the Spanish Nuclear Regulatory Authority. This methodology has been applied to perform the nuclear design and the reload licensing analysis for Cofrentes cycles 12 and 13 and to develop a significant number of safety analyses of the Cofrentes Extended Power.Because the scope of the licensing process of the Cofrentes Extended Power Uprate exceeds the range of analysis includedmore » in the Cofrentes generic reload licensing process, it has been required to extend the applicability of the Cofrentes RETRAN model to the analysis of new transients. This is the case of the total loss of feedwater (TLFW) transient.The content of this paper shows the benefits of having an in-house design and licensing methodology and describes the process to extend the applicability of the Cofrentes RETRAN model to the analysis of new transients, particularly in this paper the TLFW transient.« less

Antimicrobial Packaging for Extending the Shelf Life of Bread-A Review.

PubMed

Jideani, V A; Vogt, K

2016-06-10

Antimicrobial packaging is an important form of active packaging that can release antimicrobial substances for enhancing the quality and safety of food during extended storage. It is in response to consumers demand for preservative-free food as well as more natural, disposable, biodegradable, and recyclable food-packaging materials. The potential of a combination of allyl isothiocyanate and potassium sorbate incorporated into polymers in providing the needed natural antimicrobial protection for bread products is discussed. The role of double extrusion process as a means for obtaining a homogeneous mix of the sorbate into the polymer (polyethylene or ethylenevinyalcohol), is highlighted.

Quality and safety aspects of meat products as affected by various physical manipulations of packaging materials.

PubMed

Lee, Keun Taik

2010-09-01

This article explores the effects of physically manipulated packaging materials on the quality and safety of meat products. Recently, innovative measures for improving quality and extending the shelf-life of packaged meat products have been developed, utilizing technologies including barrier film, active packaging, nanotechnology, microperforation, irradiation, plasma and far-infrared ray (FIR) treatments. Despite these developments, each technology has peculiar drawbacks which will need to be addressed by meat scientists in the future. To develop successful meat packaging systems, key product characteristics affecting stability, environmental conditions during storage until consumption, and consumers' packaging expectations must all be taken into consideration. Furthermore, the safety issues related to packaging materials must also be taken into account when processing, packaging and storing meat products.

Community Campaigns, Supply Chains, and Protecting the Health and Well-Being of Workers

PubMed Central

Quinlan, Michael

2009-01-01

The growth of contingent work (also known as precarious employment), the informal sector, and business practices that diffuse employer responsibility for worker health and safety (such as outsourcing and the development of extended national and international contracting networks [supply chains]) pose a serious threat to occupational health and safety that disproportionately affects low-wage, ethnic minority, and immigrant workers. Drawing on cases from the United States and Australia, we examine the role that community-based campaigns can play in meeting these challenges, including several successful campaigns that incorporate supply chain regulation. PMID:19890154

Community campaigns, supply chains, and protecting the health and well-being of workers.

PubMed

Quinlan, Michael; Sokas, Rosemary K

2009-11-01

The growth of contingent work (also known as precarious employment), the informal sector, and business practices that diffuse employer responsibility for worker health and safety (such as outsourcing and the development of extended national and international contracting networks [supply chains]) pose a serious threat to occupational health and safety that disproportionately affects low-wage, ethnic minority, and immigrant workers. Drawing on cases from the United States and Australia, we examine the role that community-based campaigns can play in meeting these challenges, including several successful campaigns that incorporate supply chain regulation.

Bayesian hierarchical modeling for detecting safety signals in clinical trials.

PubMed

Xia, H Amy; Ma, Haijun; Carlin, Bradley P

2011-09-01

Detection of safety signals from clinical trial adverse event data is critical in drug development, but carries a challenging statistical multiplicity problem. Bayesian hierarchical mixture modeling is appealing for its ability to borrow strength across subgroups in the data, as well as moderate extreme findings most likely due merely to chance. We implement such a model for subject incidence (Berry and Berry, 2004 ) using a binomial likelihood, and extend it to subject-year adjusted incidence rate estimation under a Poisson likelihood. We use simulation to choose a signal detection threshold, and illustrate some effective graphics for displaying the flagged signals.

Hospitals should be exemplars of healthy workplaces.

PubMed

Russell, Lesley M; Anstey, Matthew H R; Wells, Susan

2015-05-04

As major employers and flagship health care organisations, hospitals can influence the norms of the communities they serve by adopting model policies and practices that promote the health of patients, visitors, employees, students and trainees. Hospitals must become healthy workplaces in every sense and extend their role to focus on health and wellness, not just illness. Reorienting hospital policies can: ensure the provision and stewardship of healthy, ecologically sound and sustainable environments; increase the focus on promoting health and prevention; foster interpersonal safety; and improve workplace safety. Such efforts deliver improvements in health outcomes and savings in hospital budgets.

Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR™) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial

PubMed Central

French, JA; Baroldi, P; Brittain, ST; Johnson, JK

2014-01-01

Objective To evaluate the efficacy, tolerability, and safety of once-daily 1200 mg and 2400 mg SPN-804 (Oxtellar XR™, Supernus Pharmaceuticals), an extended-release tablet formulation of oxcarbazepine (OXC), added to 1-3 concomitant antiepileptic drugs (AEDs) in adults with refractory partial-onset seizures, with or without secondary generalization. Methods The Prospective, Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory (PROSPER) study was a multinational, randomized, double-blind, parallel-group Phase 3 study. The primary efficacy endpoint was median percent reduction from baseline in monthly (28-day) seizure frequency for the 16-week double-blind treatment period in the intent-to-treat (ITT) population with analyzable seizure data. Other efficacy analyses included proportion of patients with ≥ 50% seizure reduction, proportion of patients seizure free, and the relationship between clinical response and plasma concentration. Results Median percent reduction was -28.7% for placebo, −38.2% (P = 0.08 vs placebo) for once-daily SPN-804 1200 mg, and −42.9% (P = 0.003) for SPN-804 2400 mg. Responder rates were 28.1%, 36.1% (P = 0.08), and 40.7% (P = 0.02); 16-week seizure-free rates in a pragmatic ITT analysis were 3.3%, 4.9% (P = 0.59), and 11.4% (P = 0.008), respectively. When data were analyzed separately for study site clusters, a post hoc analysis demonstrated that both SPN-804 dosages were significantly superior to placebo in median percent seizure reduction (placebo: −13.3%; 1200 mg: −34.5%, P = 0.02; 2400 mg: −52.7%, P = 0.006) in the North American study site cluster. A concentration–response analysis also supported a clinically meaningful effect for 1200 mg. Adverse event types reflected the drug's established profile. Adverse event frequency was consistent with a pharmacokinetic profile in which SPN-804 produces lower peak plasma concentrations vs immediate-release OXC. Once-daily dosing was not associated with any new safety signals. Conclusions Adjunctive once-daily SPN-804 improved seizure control in patients with inadequately controlled partial-onset seizures. Adverse event occurrence and discontinuations due to adverse events suggest improved tolerability vs previously published data with immediate-release OXC. PMID:24359313

A 12-Month Open-Label Extension Study of the Safety and Tolerability of Lisdexamfetamine Dimesylate for Major Depressive Disorder in Adults.

PubMed

Richards, Cynthia; Iosifescu, Dan V; Mago, Rajnish; Sarkis, Elias; Geibel, Brooke; Dauphin, Matthew; McIntyre, Roger S; Weisler, Richard; Brawman-Mintzer, Olga; Gu, Joan; Madhoo, Manisha

2018-06-16

Psychostimulant augmentation is considered a potential treatment strategy for individuals with major depressive disorder who do not adequately respond to antidepressant monotherapy. The primary objective of this 12-month open-label extension study was to evaluate the safety and tolerability of lisdexamfetamine dimesylate (LDX) as augmentation therapy to an antidepressant in adults with major depressive disorder. Eligible adults who completed 1 of 3 short-term antecedent LDX augmentation of antidepressant monotherapy studies were treated with dose-optimized LDX (20-70 mg) for up to 52 weeks while continuing on the index antidepressant (escitalopram, sertraline, venlafaxine extended-release, or duloxetine) assigned during the antecedent short-term studies. Safety and tolerability assessments included the occurrence of treatment-emergent adverse events and vital sign changes. All 3 antecedent studies failed to meet the prespecified primary efficacy endpoint, so this open-label study was terminated early. Headache (15.5% [241/1559]), dry mouth (13.6% [212/1559]), insomnia (13.1% [204/1559]), and decreased appetite (12.1% [189/1559]) were the most frequently reported treatment-emergent adverse events. The greatest mean ± SD increases observed for systolic and diastolic blood pressure and for pulse were 2.6 ± 10.85 and 1.7 ± 7.94 mm Hg and 6.9 ± 10.27 bpm, respectively. Monitoring determined that less than 1% of participants experienced potentially clinically important changes in systolic blood pressure (10 [0.6%]), diastolic blood pressure (8 [0.5%]), or pulse (6 [0.4%]). The overall safety and tolerability of long-term LDX augmentation of antidepressant monotherapy was consistent with the profiles of the short-term antecedent studies, with no evidence of new safety signals.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Extending the Human Papillomavirus Vaccination Programme to Include Males in High-Income Countries: A Systematic Review of the Cost-Effectiveness Studies.

PubMed

Ben Hadj Yahia, Mohamed-Béchir; Jouin-Bortolotti, Anaïs; Dervaux, Benoît

2015-08-01

Giving the human papillomavirus (HPV) vaccination to females has been shown to be cost-effective in most countries. The epidemiological evidence and economic burden of HPV-related diseases have gradually been shown to be gender neutral. Randomized clinical trials report high efficacy, immunogenicity and safety of the HPV vaccine in males aged 16-26 years. Some pioneering countries extended their HPV vaccination programme to include males, regardless of the cost-effectiveness analysis results. Nevertheless, decision makers need evidence provided by modelling and economic studies to justify the funding of mass vaccination. This systematic review aims to assess the cost-effectiveness of extending the HPV vaccination programme to include males living in high-income countries. A systematic review of the cost-effectiveness analyses of HPV vaccination in males was performed. Data were extracted and analysed using a checklist adapted from the Consolidated Health Economic Evaluation Reporting Standards Statement. Seventeen studies and 12 underlying mathematical models were identified. Model filiation showed evolution in time from aggregate models (static and dynamic) to individual-based models. When considering the health outcomes HPV vaccines are licensed for, regardless of modelling approaches and assumptions, extending vaccinations to males is rarely found to be cost-effective in heterosexual populations. Cost-effectiveness ratios become more attractive when all HPV-related diseases are considered and when vaccine coverage in females is below 40%. Targeted vaccination of men who have sex with men (MSM) seems to be the best cost-effectiveness option. The feasibility of this strategy is still an open question, since early identification of this specific population remains difficult.

Classification of antecedents towards safety use of health information technology: A systematic review.

PubMed

Salahuddin, Lizawati; Ismail, Zuraini

2015-11-01

This paper provides a systematic review of safety use of health information technology (IT). The first objective is to identify the antecedents towards safety use of health IT by conducting systematic literature review (SLR). The second objective is to classify the identified antecedents based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model and an extension of DeLone and McLean (D&M) information system (IS) success model. A systematic literature review (SLR) was conducted from peer-reviewed scholarly publications between January 2000 and July 2014. SLR was carried out and reported based on the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The related articles were identified by searching the articles published in Science Direct, Medline, EMBASE, and CINAHL databases. Data extracted from the resultant studies included are to be analysed based on the work system in Systems Engineering Initiative for Patient Safety (SEIPS) model, and also from the extended DeLone and McLean (D&M) information system (IS) success model. 55 articles delineated to be antecedents that influenced the safety use of health IT were included for review. Antecedents were identified and then classified into five key categories. The categories are (1) person, (2) technology, (3) tasks, (4) organization, and (5) environment. Specifically, person is attributed by competence while technology is associated to system quality, information quality, and service quality. Tasks are attributed by task-related stressor. Organisation is related to training, organisation resources, and teamwork. Lastly, environment is attributed by physical layout, and noise. This review provides evidence that the antecedents for safety use of health IT originated from both social and technical aspects. However, inappropriate health IT usage potentially increases the incidence of errors and produces new safety risks. The review cautions future implementation and adoption of health IT to carefully consider the complex interactions between social and technical elements propound in healthcare settings. Copyright © 2015. Published by Elsevier Ireland Ltd.

[Study of Flexible Doses of Paliperidone ER in Pacients with Schizophrenia who Have Undergone Inefficient Treatment with other Antipsychotics].

PubMed

Córdoba, Rodrigo; Cano, Juan Fernando; Arango-Dávila, César Augusto; Miranda, Carlos; Holguín, Jorge; Fernández, Darío; Márquez, Miguel; Lupo, Christian; Gargoloff, Pedro; Petracca, Gustavo; Lucchetti, César

2012-06-01

Extended-release (ER) paliperidone is an innovative atypical antipsychotic that allows minimal peak-to-through fluctuations with once-daily dosing. To evaluate effectiveness, safety and tolerability of flexible, once-daily doses of paliperidone ER (3-12 mg/day) in patients with schizophrenia from Argentina and Colombia who had previously failed treatment with other antipsychotic agents. The authors conducted a 6-month, open-label, prospective and multicentric study. Effectiveness was assessed with Positive and Negative Syndrome Scale (PANSS) and Personal and Social Performance scale (PSP). Other measures of effectiveness, safety and tolerability, were also conducted. Paliperidone ER 3-12 mg/day improved Positive and Negative Syndrome Scale (PANSS) total scores (primary endpoint) from baseline to study end (p < 0,001). In the PANSS total score, the mean change from baseline (83, 9 units) to end point (53,7 units) was significant (p < 0,001). Flexible doses of paliperidone ER demonstrated a ≥20% reduction in the PANSS total score (p<0.001) in almost two-thirds of patients. PSP mean change from baseline (52 units) to end point (85 units) was significant (p < 0,001). Secondary effectiveness assessments, as well as safety and tolerability measures, demonstrated favourable results throughout the study. Flexible doses of paliperidone ER over 6 months were effective, safe and well tolerated in patients with schizophrenia from Argentina and Colombia. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Long-term (5 years), high daily dosage of dietary agmatine--evidence of safety: a case report.

PubMed

Gilad, Gad M; Gilad, Varda H

2014-11-01

There is presently a great interest in the therapeutic potential of agmatine, decarboxylated arginine, for various diseases. Recent clinical studies have already shown that oral agmatine sulfate given for up to 3 weeks provides a safe and, as compared with current therapeutics, more effective treatment for neuropathic pain. These studies have ushered in the use of dietary agmatine as a nutraceutical. However, in view of information paucity, assessment of long-term safety of oral agmatine treatment is now clearly required. The authors of this report undertook to assess their own health status during ongoing consumption of a high daily dosage of oral agmatine over a period of 4-5 years. A daily dose of 2.67 g agmatine sulfate was encapsulated in gelatin capsules; the regimen consists of six capsules daily, each containing 445 mg, three in the morning and three in the evening after meals. Clinical follow-up consists of periodic physical examinations and laboratory blood and urine analyses. All measurements thus far remain within normal values and good general health status is sustained throughout the study period, up to 5 years. This case study shows for the first time that the recommended high dosage of agmatine may be consumed for at least 5 years without evidence of any adverse effects. These initial findings are highly important as they provide significant evidence for the extended long-term safety of a high daily dosage of dietary agmatine--a cardinal advantage for its utility as a nutraceutical.

Psychosocial safety climate as a lead indicator of workplace bullying and harassment, job resources, psychological health and employee engagement.

PubMed

Law, Rebecca; Dollard, Maureen F; Tuckey, Michelle R; Dormann, Christian

2011-09-01

Psychosocial safety climate (PSC) is defined as shared perceptions of organizational policies, practices and procedures for the protection of worker psychological health and safety, that stem largely from management practices. PSC theory extends the Job Demands-Resources (JD-R) framework and proposes that organizational level PSC determines work conditions and subsequently, psychological health problems and work engagement. Our sample was derived from the Australian Workplace Barometer project and comprised 30 organizations, and 220 employees. As expected, hierarchical linear modeling showed that organizational PSC was negatively associated with workplace bullying and harassment (demands) and in turn psychological health problems (health impairment path). PSC was also positively associated with work rewards (resources) and in turn work engagement (motivational path). Accordingly, we found that PSC triggered both the health impairment and motivational pathways, thus justifying extending the JD-R model in a multilevel way. Further we found that PSC, as an organization-based resource, moderated the positive relationship between bullying/harassment and psychological health problems, and the negative relationship between bullying/harassment and engagement. The findings provide evidence for a multilevel model of PSC as a lead indicator of workplace psychosocial hazards (high demands, low resources), psychological health and employee engagement, and as a potential moderator of psychosocial hazard effects. PSC is therefore an efficient target for primary and secondary intervention. Copyright © 2011 Elsevier Ltd. All rights reserved.

Mobile health requires mobile security: challenges, solutions, and standardization.

PubMed

Pharow, Peter; Blobel, Bernd

2008-01-01

Extended communication and advanced cooperation in a permanently growing healthcare and welfare domain require a well-defined set of security services provided by an interoperable security infrastructure based on international and European standards. Any communication and collaboration procedure requires a purpose. But such legal purpose-binding is definitely not the only aspect to carefully be observed and investigated. More and more, aspects of security, safety, privacy, ethics, and quality reach importance while discussing about future-proof health information systems and health networks - regardless whether local, regional or even pan-European networks. During the course of the current paradigm change from an organization-centered to a process-related and to a person-centered health system, different new technologies including mobile solutions need to be applied in order to meet challenges arising from both legal and technical circumstances. Beside the typical Information and Communication Technology systems and applications, the extended use of modern technologies includes large medical devices like, e.g., MRI and CT but also small devices like sensors worn by a person or included in clothing. Security and safety are on top of the priority list. The paper addresses the identification of some specific aspects like mobile technology and safety when moving both IT and people towards mobile health aiming at increasing citizens and patients awareness, confidence, and acceptance in future mobile care - a world often still beyond the horizon.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bourham, Mohamed A.; Gilligan, John G.

Safety considerations in large future fusion reactors like ITER are important before licensing the reactor. Several scenarios are considered hazardous, which include safety of plasma-facing components during hard disruptions, high heat fluxes and thermal stresses during normal operation, accidental energy release, and aerosol formation and transport. Disruption events, in large tokamaks like ITER, are expected to produce local heat fluxes on plasma-facing components, which may exceed 100 GW/m{sup 2} over a period of about 0.1 ms. As a result, the surface temperature dramatically increases, which results in surface melting and vaporization, and produces thermal stresses and surface erosion. Plasma-facing componentsmore » safety issues extends to cover a wide range of possible scenarios, including disruption severity and the impact of plasma-facing components on disruption parameters, accidental energy release and short/long term LOCA's, and formation of airborne particles by convective current transport during a LOVA (water/air ingress disruption) accident scenario. Study, and evaluation of, disruption-induced aerosol generation and mobilization is essential to characterize database on particulate formation and distribution for large future fusion tokamak reactor like ITER. In order to provide database relevant to ITER, the SIRENS electrothermal plasma facility at NCSU has been modified to closely simulate heat fluxes expected in ITER.« less

Development of a Bayesian Belief Network Runway Incursion and Excursion Model

NASA Technical Reports Server (NTRS)

Green, Lawrence L.

2014-01-01

In a previous work, a statistical analysis of runway incursion (RI) event data was conducted to ascertain the relevance of this data to the top ten Technical Challenges (TC) of the National Aeronautics and Space Administration (NASA) Aviation Safety Program (AvSP). The study revealed connections to several of the AvSP top ten TC and identified numerous primary causes and contributing factors of RI events. The statistical analysis served as the basis for developing a system-level Bayesian Belief Network (BBN) model for RI events, also previously reported. Through literature searches and data analysis, this RI event network has now been extended to also model runway excursion (RE) events. These RI and RE event networks have been further modified and vetted by a Subject Matter Expert (SME) panel. The combined system-level BBN model will allow NASA to generically model the causes of RI and RE events and to assess the effectiveness of technology products being developed under NASA funding. These products are intended to reduce the frequency of runway safety incidents/accidents, and to improve runway safety in general. The development and structure of the BBN for both RI and RE events are documented in this paper.

Psychosocial safety climate buffers effects of job demands on depression and positive organizational behaviors.

PubMed

Hall, Garry B; Dollard, Maureen F; Winefield, Anthony H; Dormann, Christian; Bakker, Arnold B

2013-01-01

In a general population sample of 2343 Australian workers from a wide ranging employment demographic, we extended research testing the buffering role of psychosocial safety climate (PSC) as a macro-level resource within the health impairment process of the Job Demands-Resources (JD-R) model. Moderated structural equation modeling was used to test PSC as a moderator between emotional and psychological job demands and worker depression compared with control and social support as alternative moderators. We also tested PSC as a moderator between depression and positive organizational behaviors (POB; engagement and job satisfaction) compared with control and social support as moderators. As expected we found PSC moderated the effects of job demands on depression and further moderated the effects of depression on POB with fit to the data that was as good as control and social support as moderators. This study has shown that PSC is a macro-level resource and safety signal for workers acting to reduce demand-induced depression. We conclude that organizations need to focus on the development of a robust PSC that will operate to buffer the effects of workplace psychosocial hazards and to build environments conducive to worker psychological health and positive organizational behaviors.

Advanced Vibration Analysis Tool Developed for Robust Engine Rotor Designs

NASA Technical Reports Server (NTRS)

Min, James B.

2005-01-01

The primary objective of this research program is to develop vibration analysis tools, design tools, and design strategies to significantly improve the safety and robustness of turbine engine rotors. Bladed disks in turbine engines always feature small, random blade-to-blade differences, or mistuning. Mistuning can lead to a dramatic increase in blade forced-response amplitudes and stresses. Ultimately, this results in high-cycle fatigue, which is a major safety and cost concern. In this research program, the necessary steps will be taken to transform a state-of-the-art vibration analysis tool, the Turbo- Reduce forced-response prediction code, into an effective design tool by enhancing and extending the underlying modeling and analysis methods. Furthermore, novel techniques will be developed to assess the safety of a given design. In particular, a procedure will be established for using natural-frequency curve veerings to identify ranges of operating conditions (rotational speeds and engine orders) in which there is a great risk that the rotor blades will suffer high stresses. This work also will aid statistical studies of the forced response by reducing the necessary number of simulations. Finally, new strategies for improving the design of rotors will be pursued.

SEAL Studies of Variant Blanket Concepts and Materials

NASA Astrophysics Data System (ADS)

Cook, I.; Taylor, N. P.; Forty, C. B. A.; Han, W. E.

1997-09-01

Within the European SEAL ( Safety and Environmental Assessment of fusion power, Long-term) program, safety and environmental assessments have been performed which extend the results of the earlier SEAFP (Safety and Environmental Assessment of Fusion Power) program to a wider range of blanket designs and material choices. The four blanket designs analysed were those which had been developed within the Blanket program of the European Fusion Programme. All four are based on martensitic steel as structural material, and otherwise may be summarized as: water-cooled lithium-lead; dual-cooled lithium-lead; helium-cooled lithium silicate (BOT geometry); helium-cooled lithium aluminate (or zirconate) (BIT geometry). The results reveal that all the blankets show the favorable S&E characteristics of fusion, though there are interesting and significant differences between them. The key results are described. Assessments have also been performed of a wider range of materials than was considered in SEAFP. These were: an alternative vanadium alloy, an alternative low-activation martensitic steel, titanium-aluminum intermetallic, and SiC composite. Assessed impurities were included in the compositions, and these had very important effects upon some of the results. Key results impacting upon accident characteristics, recycling, and waste management are described.

A red-flag-based approach to risk management of EHR-related safety concerns.

PubMed

Sittig, Dean F; Singh, Hardeep

2013-01-01

Although electronic health records (EHRs) have a significant potential to improve patient safety, EHR-related safety concerns have begun to emerge. Based on 369 responses to a survey sent to the memberships of the American Society for Healthcare Risk Management and the American Health Lawyers Association and supplemented by our previous work in EHR-related patient safety, we identified the following common EHR-related safety concerns: (1) incorrect patient identification; (2) extended EHR unavailability (either planned or unplanned); (3) failure to heed a computer-generated warning or alert; (4) system-to-system interface errors; (5) failure to identify, find, or use the most recent patient data; (6) misunderstandings about time; (7) incorrect item selected from a list of items; and (8) open or incomplete orders. In this article, we present a "red-flag"-based approach that can be used by risk managers to identify potential EHR safety concerns in their institutions. An organization that routinely conducts EHR-related surveillance activities, such as the ones proposed here, can significantly reduce risks associated with EHR implementation and use. © 2013 American Society for Healthcare Risk Management of the American Hospital Association.

Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

PubMed

Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

2014-08-01

The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have been made for xenobiotics by the pharmaceutical industry worldwide, extending them to food-related products, especially FSs. We encourage regulatory agencies to adopt globally harmonized safety assessment procedures, regulatory guidelines, and review practices for FSs to foster global trade and to reduce costs and laboratory animal use. © 2013 by The Author(s).

Marginal lung donors: A diminishing margin of safety?

PubMed

Botha, Phil; Fisher, Andrew J; Dark, John H

2006-11-27

Lung donor shortages have resulted in the critical appraisal of cadaveric donor acceptability criteria and the gradual relaxation of once strict guidelines. Many centers have reported their results with these "extended criteria" donors and an increasing number of multicenter registry studies have also been published. The results have been contradictory and leave many questions unanswered. Important new data has however come to light since the last review of the subject by the International Society for Heart and Lung Transplantation Pulmonary Council. We review the current literature focusing on recent developments in the pursuit of an expanded lung donor pool with acceptable outcomes.

[Therapy with recombinant growth hormone].

PubMed

Wabitsch, Martin

2007-06-07

Therapy with recombinant growth hormone is currently approved for the indications growth hormone deficiency,Turner syndrome, chronic renal failure, small for gestational age (SGA) and Prader-Willi syndrome. Positive experience from on-going clinical studies (e.g. on obesity, type 2 diabetes, Crohn's disease) support an extended range of applications for recombinant growth hormone. However, growth hormone therapy is very expensive. On the other hand, biosimilars are already available that are significantly lower in price. During the coming years, research must show whether the efficacy and safety of biosimilars (including possible new indications) are equal to that of the established preparations.

The risk of injury to children in compact pickup trucks.

PubMed

Winston, Flaura K; Durbin, Dennis

2002-01-01

Nearly one million compact pickup trucks were sold last year in the US. Manufacturers now produce extended-cab models of pickups such as the Ford Ranger, Chevrolet S-10, Dodge Dakota, and Toyota Tacoma that can accommodate at least two rear-seated passengers, making them attractive to families with children. However, the safety of these rear seats for children has not been determined. This Issue Brief summarizes a new study that examines and quantifies the risk of injury to children riding in compact pickup trucks. Based on these findings, parents should be advised against using these vehicles as family transportation.

Further study of the intrinsic safety of internally shorted lithium and lithium-ion cells within methane-air

PubMed Central

Dubaniewicz, Thomas H.; DuCarme, Joseph P.

2015-01-01

National Institute for Occupational Safety and Health (NIOSH) researchers continue to study the potential for lithium and lithium-ion battery thermal runaway from an internal short circuit in equipment for use in underground coal mines. Researchers conducted cell crush tests using a plastic wedge within a 20-L explosion-containment chamber filled with 6.5% CH4-air to simulate the mining hazard. The present work extends earlier findings to include a study of LiFePO4 cells crushed while under charge, prismatic form factor LiCoO2 cells, primary spiral-wound constructed LiMnO2 cells, and crush speed influence on thermal runaway susceptibility. The plastic wedge crush was a more severe test than the flat plate crush with a prismatic format cell. Test results indicate that prismatic Saft MP 174565 LiCoO2 and primary spiral-wound Saft FRIWO M52EX LiMnO2 cells pose a CH4-air ignition hazard from internal short circuit. Under specified test conditions, A123 systems ANR26650M1A LiFePO4 cylindrical cells produced no chamber ignitions while under a charge of up to 5 A. Common spiral-wound cell separators are too thin to meet intrinsic safety standards provisions for distance through solid insulation, suggesting that a hard internal short circuit within these cells should be considered for intrinsic safety evaluation purposes, even as a non-countable fault. Observed flames from a LiMnO2 spiral-wound cell after a chamber ignition within an inert atmosphere indicate a sustained exothermic reaction within the cell. The influence of crush speed on ignitions under specified test conditions was not statistically significant. PMID:26139958

On the use of naturalistic methods to examine safety-relevant behaviours amongst children and evaluate a cycling education program.

PubMed

Hatfield, J; Dozza, M; Patton, D A; Maharaj, P; Boufous, S; Eveston, T

2017-11-01

School-based cycling education programs aim to improve cycling safety and participation amongst children. Available research suggests that typical programs, which focus on bicycle manoeuvring skills, have limited effects on behaviour observed on a track or planned route. The current study uses theoretically more valid, naturalistic cycling data, to evaluate Safe Cycle, a program that incorporates hazard and self-awareness training. Soon after Safe Cycle was delivered at treatment schools, research bicycles instrumented with a rearward- and a forward-facing camera were loaned to six children from treatment schools and six children from (waitlist) control schools. In each group half the children were in Year 6, and half were in Year 7/8. Each child was instructed to ride the research bicycle instead of their own bicycle for the 1-2 weeks that they had a research bicycle. Video data were reduced using a purpose-designed coding scheme that identified whether participants performed specific safety-relevant behaviours in appropriate circumstances. While the participants controlled their bicycles well, gave way appropriately to traffic at intersections, and stopped at red lights, participants frequently removed one or both hands from the handlebars, and seldom signalled turns, conducted over-shoulder-checks when changing lanes, or looked in multiple directions at intersections (except when crossing a road). While aspects of design and small sample sizes limited evaluation findings, this research demonstrated the feasibility and potential of naturalistic data to support cycling education program evaluation. Further, the study substantially extended available naturalistic study of children's cycling behaviour to highlight behaviours which might be targeted by cycling safety initiatives. Copyright © 2017 Elsevier Ltd. All rights reserved.

Further study of the intrinsic safety of internally shorted lithium and lithium-ion cells within methane-air.

PubMed

Dubaniewicz, Thomas H; DuCarme, Joseph P

2014-11-01

National Institute for Occupational Safety and Health (NIOSH) researchers continue to study the potential for lithium and lithium-ion battery thermal runaway from an internal short circuit in equipment for use in underground coal mines. Researchers conducted cell crush tests using a plastic wedge within a 20-L explosion-containment chamber filled with 6.5% CH 4 -air to simulate the mining hazard. The present work extends earlier findings to include a study of LiFePO 4 cells crushed while under charge, prismatic form factor LiCoO 2 cells, primary spiral-wound constructed LiMnO 2 cells, and crush speed influence on thermal runaway susceptibility. The plastic wedge crush was a more severe test than the flat plate crush with a prismatic format cell. Test results indicate that prismatic Saft MP 174565 LiCoO 2 and primary spiral-wound Saft FRIWO M52EX LiMnO 2 cells pose a CH 4 -air ignition hazard from internal short circuit. Under specified test conditions, A123 systems ANR26650M1A LiFePO 4 cylindrical cells produced no chamber ignitions while under a charge of up to 5 A. Common spiral-wound cell separators are too thin to meet intrinsic safety standards provisions for distance through solid insulation, suggesting that a hard internal short circuit within these cells should be considered for intrinsic safety evaluation purposes, even as a non-countable fault. Observed flames from a LiMnO 2 spiral-wound cell after a chamber ignition within an inert atmosphere indicate a sustained exothermic reaction within the cell. The influence of crush speed on ignitions under specified test conditions was not statistically significant.

Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process.

PubMed

Martinón-Torres, Federico; Greenberg, David; Varman, Meera; Killar, John A; Hille, Darcy; Strable, Erica L; Stek, Jon E; Kaplan, Susan S

2017-04-01

Rotavirus is the leading cause of severe diarrhea in infants and young children. The current formulation of pentavalent rotavirus vaccine (RV5) must be stored refrigerated at 2-8°C. A modified formulation of RV5 (RV5mp) has been developed with stability at 37°C for 7 days and an expiry extended to 36 months when stored at 2-8°C. This study (ClinicalTrials.gov identifier: NCT01600092; EudraCT number: 2012-001611-23) evaluated the safety, tolerability and immunogenicity of RV5mp versus the currently marketed RV5 in infants. To maintain blinding, both vaccine formulations were stored refrigerated at 2-8°C for the duration of the study. Immunogenicity endpoints were (1) serum neutralizing antibody titers to human rotavirus serotypes G1, G2, G3, G4 and P1A[8] and (2) proportion of subjects with a ≥3-fold rise from baseline for serum neutralizing antibody to human rotavirus serotypes G1, G2, G3, G4 and P1A[8] and serum antirotavirus immunoglobulin A. The RV5mp group (n = 505) and RV5 group (n = 509) had comparable safety profiles. There were no deaths and no vaccine-related serious adverse events in this study. With respect to immunogenicity, RV5mp was noninferior compared with RV5. Serum neutralizing antibody responses by country and breast-feeding status were generally consistent with the overall results. RV5mp enhances storage requirements while maintaining the immunogenicity and safety profile of the currently licensed RV5. A vaccine that is stable at room temperature may be more convenient for vaccinators, particularly in places where the cold chain is unreliable, and ultimately will permit more widespread use.

A phase 1, multicentre, open-label study to evaluate ovarian follicular activity and hormone levels with an extended-regimen combined oral contraceptive with low-dose ethinyl estradiol supplementation.

PubMed

Kroll, Robin; Seidman, Larry; Ricciotti, Nancy; Howard, Brandon; Weiss, Herman

2015-01-01

To evaluate the effect on ovarian follicular activity of the 91-day extended-regimen combined oral contraceptive (COC), consisting of 84 days of levonorgestrel (LNG)/ethinylestradiol (EE) 150 μg/30 μg tablets plus seven days of EE 10 μg tablets in place of placebo. This was a phase 1, open-label study. Ovarian follicular activity was classified via the Hoogland and Skouby method. Safety and tolerability as well as return to ovulation were assessed. Of the 35 subjects included in the efficacy analysis, luteinized, unruptured follicles, or ovulation were detected in 0 of 35 cycles during the first 28-day interval; 1 of 35 cycles (2.9%) in the second 28-day interval; and 2 of 35 cycles (5.7%) in the final 35-day interval. The ovarian activity rate over the entire 91-day treatment period was 2.9%. There was a low incidence of treatment-emergent adverse events. Ovulation returned in most subjects (77.1%, 27/35) within 32 days following the last dose of COC. The 91-day extended-regimen COC with low-dose EE supplementation was found to be effective in suppressing ovarian activity and inhibiting ovulation and was well tolerated. Return to ovulation was rapid, occurring within approximately one month after discontinuation of COC.

75 FR 63730 - Proposed Establishment of Class E Airspace; Panguitch, UT

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... include a portion extending upward from 1,200 feet above the surface at Panguitch Municipal Airport... controlled airspace from 700 feet above the surface. The FAA has reassessed the proposal to include Class E airspace 700 feet and 1,200 feet above the surface to further the safety and management of Instrument...

50 CFR 218.14 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (i.e., the circumference of the area from the border of the exclusion zone extending 2,000 yards... determine if marine mammals are in the area before and/or after a detonation event. (iv) When conducting a... participation shall take into account safety, logistics, and operational concerns. (iv) MMOs shall observe from...

50 CFR 218.5 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (i.e., the circumference of the area from the border of the exclusion zone extending 2,000 yards... determine if marine mammals are in the area before and/or after a detonation event. (iv) When conducting a... participation shall take into account safety, logistics, and operational concerns. (iv) MMOs shall observe from...

50 CFR 218.5 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (i.e., the circumference of the area from the border of the exclusion zone extending 2,000 yards... determine if marine mammals are in the area before and/or after a detonation event. (iv) When conducting a... participation shall take into account safety, logistics, and operational concerns. (iv) MMOs shall observe from...

50 CFR 218.14 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (i.e., the circumference of the area from the border of the exclusion zone extending 2,000 yards... determine if marine mammals are in the area before and/or after a detonation event. (iv) When conducting a... participation shall take into account safety, logistics, and operational concerns. (iv) MMOs shall observe from...

11 CFR 4.7 - Requests for records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the event the time is extended, the requestor shall be notified of the reasons for the extension and... the amount of work and/or time involved in processing requests. Requests for records are processed in... to pose an imminent threat to the life or physical safety of an individual; or (ii) With respect to a...

Yakama Nation Head Start Early Childhood Education Program

ERIC Educational Resources Information Center

Butterfly, Rose

2012-01-01

As a Program Director, every day requires decisions regarding children, parents, extended families, what curriculum to use, and of course, managing the finances. Making the day-to-day decisions and ensuring the overall health, safety, and well-being of each child served by the Yakama Nation Head Start is made easier by continually reflecting on…

25 CFR 170.806 - What is an IRR Transportation Facilities Maintenance Management System?

Code of Federal Regulations, 2013 CFR

2013-04-01

... facility maintenance activities. It will be used to extend the service life of an IRR transportation facility, ensure safety, and report future funding needs to the Secretary. BIA will develop the IRR TFMMS. ... Management System? 170.806 Section 170.806 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND...

25 CFR 170.806 - What is an IRR Transportation Facilities Maintenance Management System?

Code of Federal Regulations, 2014 CFR

2014-04-01

... facility maintenance activities. It will be used to extend the service life of an IRR transportation facility, ensure safety, and report future funding needs to the Secretary. BIA will develop the IRR TFMMS. ... Management System? 170.806 Section 170.806 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND...

25 CFR 170.806 - What is an IRR Transportation Facilities Maintenance Management System?

Code of Federal Regulations, 2012 CFR

2012-04-01

... facility maintenance activities. It will be used to extend the service life of an IRR transportation facility, ensure safety, and report future funding needs to the Secretary. BIA will develop the IRR TFMMS. ... Management System? 170.806 Section 170.806 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR LAND...

Preventing Violence and Promoting Safety in Higher Education Settings: Overview of a Comprehensive Approach

ERIC Educational Resources Information Center

Langford, Linda

2004-01-01

Institutions of higher education (IHEs) are often regarded as sanctuaries, protected environments where young people explore great ideas in a collegial atmosphere and make lifelong friendships. Consequently, incidents of violence on campus are particularly shocking for the extended campus community, evoking questions about whether there is any…

33 CFR 165.1315 - Safety Zones: Fireworks displays in the Captain of the Port Portland Zone.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... One day in early May. (2) Portland Rose Festival Fireworks Display, Portland, OR: (i) Location. Waters...) Oregon Food Bank Blues Festival Fireworks, Portland, OR (i) Location. Waters on the Willamette River...) Splash Aberdeen Waterfront Festival, Aberdeen, WA (i) Location. All water of the Chehalis River extending...

77 FR 62473 - Safety Zone, Seafair Blue Angels Air Show Performance, Seattle, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

....1319 has been determined to be inadequate to accommodate the anticipated flight pattern of the Blue.... [Datum: NAD 1983]'' However, the participating aircraft have a flight pattern that will extend past the... summarize our analyses based on a number of these statutes or executive orders. 1. Regulatory Planning and...

Alternative Fuels Data Center: Natural Gas Vehicle Maintenance and Safety

Science.gov Websites

and delivery systems for road vehicles. Oil-Change Intervals Cleaner-burning fuels have a direct impact on extending the useful life of the engine's lubricating oil. In conventionally fueled vehicles , engine oil degrades as a result of soot and other impurities from the combustion process that get

Thermally stable, plastic-bonded explosives

DOEpatents

Benziger, Theodore M.

1979-01-01

By use of an appropriate thermoplastic rubber as the binder, the thermal stability and thermal stress characteristics of plastic-bonded explosives may be greatly improved. In particular, an HMX-based explosive composition using an oil-extended styrene-ethylenebutylene-styrene block copolymer as the binder exhibits high explosive energy and thermal stability and good handling safety and physical properties.

Quality Characteristics of Precooked Catfish Fillets during 10 months of Frozen Storage

USDA-ARS?s Scientific Manuscript database

Frozen storage is one of the major ways to maintain product quality and safety for an extended period of time. Frozen products can include preheated or precooked seafood products that will be reheated often in a microwave prior to being served. Product quality slowly deteriorates with time during ...

Single-dose evaluation of safety, tolerability and pharmacokinetics of newly formulated hydromorphone immediate-release and hydrophilic matrix extended-release tablets in healthy Japanese subjects without co-administration of an opioid antagonist.

PubMed

Toyama, Kaoru; Uchida, Naoki; Ishizuka, Hitoshi; Sambe, Takehiko; Kobayashi, Shinichi

2015-09-01

This single dose, open-label study investigated the safety, tolerability and pharmacokinetics of single oral doses of newly formulated immediate-release (IR) and hydrophilic matrix extended-release (ER) hydromorphone tablets in healthy Japanese subjects without co-administration of an opioid antagonist under fasting and fed conditions. Plasma and urinary concentrations of hydromorphone and metabolites were measured by liquid-chromatography tandem mass-spectroscopy. Following administration of the ER tablet, plasma concentrations of hydromorphone slowly increased with a median tmax of 5.0 h and the Cmax decreased to 37% of the IR tablet, while the AUC0-inf was comparable with that of the IR tablet when administered at the same dose. The degree of fluctuation in the plasma concentration for the ER tablet was much lower than that of the IR tablet and certain levels of plasma concentrations were maintained after 24 h of ER dosing. The AUC0-inf and Cmax increased with food for both IR and ER tablets. The AUC0-inf of hydromorphone-3-glucoside was one-tenth of that of hydromorphone-3-glucuronide. A single oral administration of the hydromorphone tablets would be well-tolerated in healthy Japanese subjects despite a lack of co-administration of an opioid antagonist and the newly developed ER hydromorphone tablets may have the appropriate PK characteristics for once-daily dosing. © 2015, The American College of Clinical Pharmacology.

Tailoring of the care concept for practicality, safety and robustness

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kawamura, Hideki; McKinley, Ian G

2013-07-01

The Cavern Retrievable (CARE) concept was originally developed to provide flexibility in tailoring disposal of vitrified HLW to small volunteer host sites, where high emplacement density leads to significant challenges in terms of the management of radiogenic heat. Including an extended storage period in underground caverns prior to sealing solved the heat issue, but also provided benefits in terms of a slow decision-making process that provided more opportunities to engage stakeholders. Recently, direct disposal of spent fuel is being considered in Japan and this gives more severe challenges for heat management, even for conventional disposal concepts. Due to great uncertaintiesmore » in the future of nuclear power in Japan, this may also be associated with a desire to preserve the option of retrieval for extended periods. The basic CARE concept has thus been re-assessed to consider these aspects - and also the need to be able to develop a robust safety case that can be readily communicated to stakeholders, who are more sensitive to nuclear issues than they were in the past. (authors)« less

NGNP Project 2011 Status and Path Forward

DOE Office of Scientific and Technical Information (OSTI.GOV)

L.E. Demick

2011-12-01

High Temperature Gas Reactor (HTGR) technology can play an important role in the United States’ energy future by extending the use of nuclear energy for non-electricity energy production missions as well as continuing to provide a considerable base load electric power generation capability. Extending nuclear energy into the industrial and transportation sectors through the co-production of process heat and electricity provides safe and reliable energy for these sectors in an environmentally responsible manner. The safety case for the modular HTGR provides a substantial improvement in nuclear plant safety for the protection of the public and the environment, and supports collocationmore » of the HTGR with major industrial facilities. The NGNP Project at the Idaho National Laboratory has been working toward an objective of commercializing the HTGR technology under DOE direction since 2006. The Project is undergoing a quantum shift in direction and scope as a result of recent DOE decisions. This paper summarizes where the Project has been, where it is at the time of this writing and what is needed in future activities to commercialize HTGR technology.« less

Emerging Treatment Options in Mild to Moderate Ulcerative Colitis

PubMed Central

Lichtenstein, Gary R.; Hanauer, Stephen B.; Sandborn, William J.

2015-01-01

Ulcerative colitis (UC) is a chronic inflammatory condition associated with rectal bleeding and urgency, tenesmus, and diarrhea. Several medical therapies can be used in the treatment of UC. Aminosalicylates are widely used based on their efficacy in the induction and maintenance of remission. Although corticosteroids are effective in patients with more severe disease, systemic use is associated with significant safety concerns. The newer corticosteroid budesonide has lower systemic bioavailability and, consequently, a more favorable safety profile. A budesonide extended-release formulation allows once-daily dosing and delivers the agent locally throughout the colon. Biologic agents used for the treatment of moderate to severe UC include the tumor necrosis factor inhibitors infliximab, adalimumab, and golimumab, and the integrin inhibitor vedolizumab. Rectally administered therapy can also be useful in the treatment of UC. In October 2014, the US Food and Drug Administration approved a budesonide foam formulation for inducing remission in patients with active mild to moderate distal UC extending up to 40 cm from the anal verge. Budesonide foam rapidly distributes to the sigmoid colon and the rectum and avoids some of the drawbacks of suppositories and enemas. PMID:26491415

Outcome evaluation results of school-based cybersafety promotion and cyberbullying prevention intervention for middle school students.

PubMed

Roberto, Anthony J; Eden, Jen; Savage, Matthew W; Ramos-Salazar, Leslie; Deiss, Douglas M

2014-01-01

Guided largely by the Extended Parallel Process Model, the Arizona Attorney General's Social Networking Safety Promotion and Cyberbullying Prevention presentation attempts to shape, change, and reinforce middle school students' perceptions, attitudes, and intentions related to these important social issues. This study evaluated the short-term effects of this presentation in a field experiment using a posttest-only control-group design with random assignment to conditions. A total of 425 sixth, seventh, and eighth graders at a public middle school in a large Southwestern city participated in this study. Results reveal several interesting trends across grade levels regarding cyberbullying perpetration and victimization, and concerning access to various communication technologies. The intervention had the hypothesized main effect on eight of the dependent variables under investigation. Examination of condition by grade interaction effects offered further support for an additional four hypotheses (i.e., the intervention positively affected or reversed a negative trend on four dependent variables in at least one grade). Ideas and implications for future social networking safety promotion and cyberbullying prevention interventions are discussed.

Once daily, extended release ciprofloxacin for complicated urinary tract infections and acute uncomplicated pyelonephritis.

PubMed

Talan, David A; Klimberg, Ira W; Nicolle, Lindsay E; Song, James; Kowalsky, Steven F; Church, Deborah A

2004-02-01

We assessed the efficacy and safety of 1,000 mg extended release ciprofloxacin orally once daily vs conventional 500 mg ciprofloxacin orally twice daily, each for 7 to 14 days, in patients with a complicated urinary tract infection (cUTI) or acute uncomplicated pyelonephritis (AUP). In this prospective, randomized, double-blind, North American multicenter clinical trial adults were stratified based on clinical presentation of cUTI or AUP and randomized to extended release ciprofloxacin or ciprofloxacin twice daily. Efficacy valid patients had positive pretherapy urine cultures (105 or greater cFU/ml) and pyuria within 48 hours of study entry. Bacteriological and clinical outcomes were assessed at the test of cure visit (5 to 11 days after therapy) and the late followup visit (28 to 42 days after therapy). The intent to treat population comprised 1,035 patients (extended release ciprofloxacin in 517 and twice daily in 518), of whom 435 were efficacy valid (cUTI in 343 and AUP in 92). For efficacy valid patients (cUTI and AUP combined) bacteriological eradication rates at test of cure were 89% (183 of 206) vs 85% (195 of 229) (95% CI -2.4%, 10.3%) and clinical cure rates were 97% (198 of 205) vs 94% (211 of 225) (95% CI -1.2%, 6.9%) for extended release vs twice daily ciprofloxacin. Late followup outcomes were consistent with test of cure findings. Eradication rates for Escherichia coli, which accounted for 58% of pathogens, were 97% or greater per group. Drug related adverse event rates were similar for extended release and twice daily ciprofloxacin (13% and 14%, respectively). Extended release ciprofloxacin at a dose of 1,000 mg once daily was as safe and effective as conventional treatment with 500 mg ciprofloxacin twice daily, each given orally for 7 to 14 days in adults with cUTI or AUP. It provides a convenient, once daily, empirical treatment option.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Touati, Said; Chennai, Salim; Souli, Aissa

The increased requirements on supervision, control, and performance in modern power systems make power quality monitoring a common practise for utilities. Large databases are created and automatic processing of the data is required for fast and effective use of the available information. Aim of the work presented in this paper is the development of tools for analysis of monitoring power quality data and in particular measurements of voltage and currents in various level of electrical power distribution. The study is extended to evaluate the reliability of the electrical system in nuclear plant. Power Quality is a measure of how wellmore » a system supports reliable operation of its loads. A power disturbance or event can involve voltage, current, or frequency. Power disturbances can originate in consumer power systems, consumer loads, or the utility. The effect of power quality problems is the loss power supply leading to severe damage to equipments. So, we try to track and improve system reliability. The assessment can be focused on the study of impact of short circuits on the system, harmonics distortion, power factor improvement and effects of transient disturbances on the Electrical System during motor starting and power system fault conditions. We focus also on the review of the Electrical System design against the Nuclear Directorate Safety Assessment principles, including those extended during the last Fukushima nuclear accident. The simplified configuration of the required system can be extended from this simple scheme. To achieve these studies, we have used a demo ETAP power station software for several simulations. (authors)« less

Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study.

PubMed

Ye, Xiaobu; Itzoe, MariaLisa; Sarabia-Estrada, Rachel; DeTolla, Louis; Tyler, Betty M; Guarnieri, Michael

2018-01-01

Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg) showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug.

Suspected Lonely Mouse Syndrome as a Cage Effect in a Drug Safety Study

PubMed Central

Ye, Xiaobu; Itzoe, MariaLisa; Sarabia-Estrada, Rachel; DeTolla, Louis

2018-01-01

Studies have demonstrated that buprenorphine, a front line drug for veterinary analgesia, may alleviate symptoms of chronic pain. A cage side observation protocol was used to record behavioral signs in a mouse clinical trial of extended release buprenorphine. A retrospective review of the observations for signs of pain and stress revealed that mice given a fivefold overdose of buprenorphine (16.25 mg/kg) showed lethargy and facial signs associated with stress. However, similar signs were observed in the drug-free control mice as early as Day 3 of single-cage housing. This appears to be the first report of cage effects in a clinical trial for a veterinary drug. PMID:29854826

Hazard analysis and critical control point systems in the United States Department of Agriculture regulatory policy.

PubMed

Billy, T J; Wachsmuth, I K

1997-08-01

Recent outbreaks of foodborne illness and studies by expert groups have established the need for fundamental change in the United States meat and poultry inspection programme to reduce the risk of foodborne illness. The Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) has embarked on a broad effort to bring about such change, with particular emphasis on the reduction of pathogenic micro-organisms in raw meat and poultry products. The publication on 25 July 1996 of the Final Rule on pathogen reduction and hazard analysis and critical control point (HACCP) systems was a major milestone in the FSIS strategy for change. The Final Rule provides a framework for change and clarifies the respective roles of industry and government in ensuring the safety of meat and poultry products. With the implementation of this Final Rule underway, the FSIS has been exploring ways in which slaughter inspection carried out under an HACCP-based system can be changed so that food safety risks are addressed more adequately and the allocation of inspection resources is improved further. In addition, the FSIS is broadening the focus of food safety activities to extend beyond slaughter and processing plants by working with industry, academia and other government agencies. Such co-operation should lead to the development of measures to improve food safety before animals reach the slaughter plant and after products leave the inspected establishment for distribution to the retail level. For the future, the FSIS believes that quantitative risk assessments will be at the core of food safety activities. Risk assessments provide the most effective means of identifying how specific pathogens and other hazards may be encountered throughout the farm-to-table chain and of measuring the potential impact of various interventions. In addition, these assessments will be used in the development and evaluation of HACCP systems. The FSIS is currently conducting a quantitative risk assessment for eggs, and several surveys and studies are being performed to supply data needed to conduct other risk assessments. The FSIS has established a food safety research agenda which will fill data gaps.

Combustion Safety Simplified Test Protocol Field Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brand, L; Cautley, D.; Bohac, D.

2015-11-05

"9Combustions safety is an important step in the process of upgrading homes for energy efficiency. There are several approaches used by field practitioners, but researchers have indicated that the test procedures in use are complex to implement and provide too many false positives. Field failures often mean that the house is not upgraded until after remediation or not at all, if not include in the program. In this report the PARR and NorthernSTAR DOE Building America Teams provide a simplified test procedure that is easier to implement and should produce fewer false positives. A survey of state weatherization agencies onmore » combustion safety issues, details of a field data collection instrumentation package, summary of data collected over seven months, data analysis and results are included. The project provides several key results. State weatherization agencies do not generally track combustion safety failures, the data from those that do suggest that there is little actual evidence that combustion safety failures due to spillage from non-dryer exhaust are common and that only a very small number of homes are subject to the failures. The project team collected field data on 11 houses in 2015. Of these homes, two houses that demonstrated prolonged and excessive spillage were also the only two with venting systems out of compliance with the National Fuel Gas Code. The remaining homes experienced spillage that only occasionally extended beyond the first minute of operation. Combustion zone depressurization, outdoor temperature, and operation of individual fans all provide statistically significant predictors of spillage.« less

Efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae: an open-label randomized controlled trial.

PubMed

Rattanaumpawan, Pinyo; Werarak, Peerawong; Jitmuang, Anupop; Kiratisin, Pattarachai; Thamlikitkul, Visanu

2017-03-01

Carbapenem antibiotics are considered the treatment of choice for serious extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria (GNB) infections. The study objectives were to evaluate efficacy and safety of de-escalation therapy to ertapenem for treatment of infections caused by extended-spectrum-β-lactamase-producing Enterobacteriaceae. We conducted a randomized controlled trial of adult patients with documented ESBL-producing Enterobacteriaceae infections who had received any group 2 carbapenem for less than 96 h. In the intervention group, the previously-prescribed group 2 carbapenem was de-escalated to ertapenem. In the control group, the group 2 carbapenem was continued. During June 2011-December 2014, 32 patients were randomized to the de-escalation group and 34 to the control group. Most common sites of infection were urinary tract infection (42%). Characteristics of both groups were comparable. By using a 15% predefined margin, ertapenem was non-inferior to control group regarding the clinical cure rate (%Δ = 14.0 [95% confidence interval: -2.4 to 31.1]), the microbiological eradication rate (%Δ = 4.1 [-5.0 to 13.4]), and the superimposed infection rate (%Δ = -16.5 [-38.4 to 5.3]). Patients in the de-escalation group had a significantly lower 28-day mortality rate (9.4% vs. 29.4%; P = .05), a significantly shorter median length of stay (16.5 days [4.0-73.25] vs. 20.0 days [1.0-112.25]; P = .04), and a significantly lower defined daily dose of carbapenem use (12.9 ± 8.9 vs. 18.4 ± 12.6; P = .05). Ertapenem could be safely used as de-escalation therapy for ESBL-producing Enterobacteriaceae infections, once the susceptibility profiles are known. Future studies are needed to investigate ertapenem efficacy against ESBL-producing Enterobacteriaceae pneumonia to determine its applicability in life-threatening conditions. ClinicalTrials.gov identifier: NCT01297842 . Registered on 14 February 2011. First patient enrolled on 27 June 2011.

Reporting the incidence of school violence across grade levels in the U.S. using the Third International Mathematics and Science Study (TIMSS).

PubMed

Yu, Lei

2004-01-01

School violence has increasingly captured public attention due to deadly school shootings. Controversy on school violence is demonstrated by a mixed picture of school safety and the lack of consensus on the definitions of violence, which makes comparison of findings across studies difficult. This study extended the application of the Rasch model to school violence research using TIMSS data. The results show that school violence occurred at a level much lower than the predictions of the measurement model. Across all grade levels the most frequently reported type of violence is intimidation or verbal abuse of students and the least frequently reported physical injury to teachers or staff. Copyright 2004

Bioequivalence of cyclobenzaprine hydrochloride extended-release capsule taken intact or sprinkled over applesauce
.

PubMed

Adar, Liat; Zarycranski, William; Conner, Jill B; Dragone, Jeffrey; Janka, Lindsay; Rabinovich-Guilatt, Laura

2017-12-01

Difficulty swallowing pills can compromise pain control in painful musculoskeletal disorders. This open-label, 2-period crossover study assessed pharmacokinetics and safety of cyclobenzaprine extended-release (CER) 30-mg capsule contents sprinkled over applesauce compared with intact capsules in healthy subjects. 32 subjects were randomized to treatment sequences AB or BA (A = single CER intact capsule; B = single CER capsule contents sprinkled over applesauce (15 mL)). Treatments were separated by a ≥ 14-day washout. Pharmacokinetic assessments included maximum observed plasma drug concentration (C_max), time to C_max (t_max), time to first quantifiable plasma drug concentration (t_lag), and area under the plasma drug concentration-vs.-time curve from time 0 to the last measurable drug concentration (AUC_0-t) and extrapolated to infinity (AUC_0-∞). Bioequivalence was established if the 90% confidence intervals (CIs) of the geometric least squares (LS) means ratios of B:A of C_max, AUC_0-t, and AUC_0-∞ were 80 - 125%. Safety was also assessed. Mean plasma drug concentration-vs.-time profiles were similar for CER intact and sprinkled over applesauce. The 90% CIs of LS means ratios indicated bioequivalence: C_max 91.96 - 100.76%, AUC_0-t 96.18 - 103.50%, and AUC_0-∞ 95.70 - 103.07%. Median t_max was not significantly different (p > 0.05), and median t_lag was the same (1 hour). All adverse effects were mild and resolved during the study. No clinically meaningful changes were noted for clinical laboratory values. CER capsules intact and sprinkled over applesauce are bioequivalent. Sprinkling CER capsule contents is not expected to affect efficacy or safety and can, therefore, be an option for patients with musculoskeletal pain and difficulty swallowing capsules.
.

Green Chemistry: Progress and Barriers

NASA Astrophysics Data System (ADS)

Green, Sarah A.

2016-10-01

Green chemistry can advance both the health of the environment and the primary objectives of the chemical enterprise: to understand the behavior of chemical substances and to use that knowledge to make useful substances. We expect chemical research and manufacturing to be done in a manner that preserves the health and safety of workers; green chemistry extends that expectation to encompass the health and safety of the planet. While green chemistry may currently be treated as an independent branch of research, it should, like safety, eventually become integral to all chemistry activities. While enormous progress has been made in shifting from "brown" to green chemistry, much more effort is needed to effect a sustainable economy. Implementation of new, greener paradigms in chemistry is slow because of lack of knowledge, ends-justify-the-means thinking, systems inertia, and lack of financial or policy incentives.

An Overview of the NASA Aviation Safety Program (AVSP) Systemwide Accident Prevention (SWAP) Human Performance Modeling (HPM) Element

NASA Technical Reports Server (NTRS)

Foyle, David C.; Goodman, Allen; Hooley, Becky L.

2003-01-01

An overview is provided of the Human Performance Modeling (HPM) element within the NASA Aviation Safety Program (AvSP). Two separate model development tracks for performance modeling of real-world aviation environments are described: the first focuses on the advancement of cognitive modeling tools for system design, while the second centers on a prescriptive engineering model of activity tracking for error detection and analysis. A progressive implementation strategy for both tracks is discussed in which increasingly more complex, safety-relevant applications are undertaken to extend the state-of-the-art, as well as to reveal potential human-system vulnerabilities in the aviation domain. Of particular interest is the ability to predict the precursors to error and to assess potential mitigation strategies associated with the operational use of future flight deck technologies.

Current and prospective safety issues at the HFBR

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tichler, P.R.

The Brookhaven High Flux Beam Reactor (HFBR) was designed primarily to produce external neutron beams for experimental research. It is cooled, moderated and reflected by heavy water and uses MTR-ETR type fuel elements containing enriched uranium. The reactor power when operation began in 19965 was 40 MW, was raised to 60 MW in 1982 after a number of plant modifications, and operated at that level until 1989. Since that time safety questions have been raised which resulted in extended shutdowns and a reduction in operating power to 30 MW. This paper will discuss the principle safety issues, plans for theirmore » resolution and return to 60 MW operation. In addition, radiation embrittlement of the reactor vessel and thermal shield and its affect on the life of the facility will be briefly discussed.« less

Current and prospective safety issues at the HFBR

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tichler, P.R.

The Brookhaven high-flux beam reactor (HFBR) was designed primarily to produce external neutron beams for experimental research. It is cooled, moderated, and reflected by heavy water and uses materials test reactor and engineering test reactor type of fuel elements containing enriched uranium. The reactor power when operation began in 1965 was 40 MW, was raised to 60 MW in 1982 after a number of plant modifications, and operated at that level until 1989. Since that time, safety questions have been raised that resulted in extended shutdowns and a reduction in operating power to 30 MW. This paper discusses the principalmore » safety issues and plans for their resolution and return to 60-MW operation. In addition, radiation embrittlement of the reactor vessel and thermal shield and its effect on the life of the facility are briefly discussed.« less

Surface-enhanced Raman spectroscopy applied to food safety.

PubMed

Craig, Ana Paula; Franca, Adriana S; Irudayaraj, Joseph

2013-01-01

Surface-enhanced Raman spectroscopy (SERS) is an advanced Raman technique that enhances the vibrational spectrum of molecules adsorbed on or in the vicinity of metal particles and/or surfaces. Because of its readiness, sensitivity, and minimum sample preparation requirements, SERS is being considered as a powerful technique for food inspection. Key aspects of food-safety assurance, spectroscopy methods, and SERS are briefly discussed in an extended introduction of this review. The recent and potential advances in SERS are highlighted in sections that deal with the (a) detection of food-borne pathogenic microorganisms and (b) the detection of food contaminants and adulteration, concentrated specifically on antibiotics, drugs, hormones, melamine, and pesticides. This review provides an outlook of the work done and a perspective on the future directions of SERS as a reliable tool for food-safety assessment.

The Development of Dynamic Human Reliability Analysis Simulations for Inclusion in Risk Informed Safety Margin Characterization Frameworks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jeffrey C. Joe; Diego Mandelli; Ronald L. Boring

2015-07-01

The United States Department of Energy is sponsoring the Light Water Reactor Sustainability program, which has the overall objective of supporting the near-term and the extended operation of commercial nuclear power plants. One key research and development (R&D) area in this program is the Risk-Informed Safety Margin Characterization pathway, which combines probabilistic risk simulation with thermohydraulic simulation codes to define and manage safety margins. The R&D efforts to date, however, have not included robust simulations of human operators, and how the reliability of human performance or lack thereof (i.e., human errors) can affect risk-margins and plant performance. This paper describesmore » current and planned research efforts to address the absence of robust human reliability simulations and thereby increase the fidelity of simulated accident scenarios.« less

Description of extended pre-harvest pig Salmonella surveillance-and-control programme and its estimated effect on food safety related to pork.

PubMed

Alban, L; Barfod, K; Petersen, J V; Dahl, J; Ajufo, J C; Sandø, G; Krog, H H; Aabo, S

2010-11-01

Salmonella in pork can be combated during pre- or post-harvest. For large slaughterhouses, post-harvest measures like decontamination might be cost-effective while this is less likely with small-to-medium sized slaughterhouses. In this study, pre-harvest measures might be more relevant. We describe an extended surveillance-and-control programme for Salmonella in finisher pigs, which, to establish equivalence to the Swedish control programme, is intended for implementation on the Danish island, Bornholm. The effect of the programme on food safety was estimated by analysing Salmonella data from pig carcasses originating from herds that would have qualified for the programme during 2006-2008. Food safety was interpreted as prevalence of Salmonella on carcasses as well as the estimated number of human cases of salmonellosis related to pork produced within the programme. Data from the Danish Salmonella programme were obtained from Bornholm. We used a simulation model developed to estimate the number of human cases based on the prevalence of Salmonella on carcass swabs. Herds are only accepted in the programme if they have one or less seropositive sample within the previous 6 months. In this way, the Salmonella load is kept to a minimum. The programme is not yet in operation and pigs that qualify for the programme are currently mixed at slaughter with those that do not qualify. Therefore, we had to assess the impact on the carcass prevalence indirectly. The prevalence of Salmonella in carcass swabs among qualifying herds was 0.46% for the 3 years as a whole, with 2006 as the year with highest prevalence. According to the simulation the expected number of human cases relating to pork produced within the programme was below 10. When the programme is in operation, an extra effect of separating pigs within the programme from those outside is expected to lower the prevalence of Salmonella even further. © 2010 Blackwell Verlag GmbH.

Intelligent Life-Extending Controls for Aircraft Engines

NASA Technical Reports Server (NTRS)

Guo, Ten-Huei; Chen, Philip; Jaw, Link

2005-01-01

Aircraft engine controllers are designed and operated to provide desired performance and stability margins. The purpose of life-extending-control (LEC) is to study the relationship between control action and engine component life usage, and to design an intelligent control algorithm to provide proper trade-offs between performance and engine life usage. The benefit of this approach is that it is expected to maintain safety while minimizing the overall operating costs. With the advances of computer technology, engine operation models, and damage physics, it is necessary to reevaluate the control strategy fro overall operating cost consideration. This paper uses the thermo-mechanical fatigue (TMF) of a critical component to demonstrate how an intelligent engine control algorithm can drastically reduce the engine life usage with minimum sacrifice in performance. A Monte Carlo simulation is also performed to evaluate the likely engine damage accumulation under various operating conditions. The simulation results show that an optimized acceleration schedule can provide a significant life saving in selected engine components.

Safety and economic impacts of photo radar program.

PubMed

Chen, Greg

2005-12-01

Unsafe speed is one of the major traffic safety challenges facing motorized nations. In 2003, unsafe speed contributed to 31 percent of all fatal collisions, causing a loss of 13,380 lives in the United States alone. The economic impact of speeding is tremendous. According to NHTSA, the cost of unsafe speed related collisions to the American society exceeds 40 billion US dollars per year. In response, automated photo radar speed enforcement programs have been implemented in many countries. This study assesses the economic impacts of a large-scale photo radar program in British Columbia. The knowledge generated from this study could inform policy makers and project managers in making informed decisions with regard to this highly effective and efficient, yet very controversial program. This study establishes speed and safety effects of photo radar programs by summarizing two physical impact investigations in British Columbia. It then conducts a cost-benefit analysis to assess the program's economic impacts. The cost-benefit analysis takes into account both societal and funding agency's perspectives. It includes a comprehensive account of major impacts. It uses willingness to pay principle to value human lives saved and injuries avoided. It incorporates an extended sensitivity analysis to quantify the robustness of base case conclusions. The study reveals an annual net benefit of approximately 114 million in year 2001 Canadian dollars to British Columbians. The study also finds a net annual saving of over 38 million Canadian dollars for the Insurance Corporation of British Columbia (ICBC) that funded the program. These results are robust under almost all alternative scenarios tested. The only circumstance under which the net benefit of the program turns negative is when the real safety effects were one standard deviation below the estimated values, which is possible but highly unlikely. Automated photo radar traffic safety enforcement can be an effective and efficient means to manage traffic speed, reduce collisions and injuries, and combat the huge resulting economic burden to society. The cost-effectiveness of the program takes on special meaning and urgency when considering the present and future government funding constraints. The application of the program, however, should be planned and implemented with caution. Every effort should be made to focus on and to promote the program on safety improvement grounds. The program can be easily terminated because of political considerations, if the public perceives it as a cash cow to enhance government revenue.

The breakdown of coordinated decision making in distributed systems.

PubMed

Bearman, Christopher; Paletz, Susannah B F; Orasanu, Judith; Thomas, Matthew J W

2010-04-01

This article aims to explore the nature and resolution of breakdowns in coordinated decision making in distributed safety-critical systems. In safety-critical domains, people with different roles and responsibilities often must work together to make coordinated decisions while geographically distributed. Although there is likely to be a large degree of overlap in the shared mental models of these people on the basis of procedures and experience, subtle differences may exist. Study 1 involves using Aviation Safety Reporting System reports to explore the ways in which coordinated decision making breaks down between pilots and air traffic controllers and the way in which the breakdowns are resolved. Study 2 replicates and extends those findings with the use of transcripts from the Apollo 13 National Aeronautics and Space Administration space mission. Across both studies, breakdowns were caused in part by different types of lower-level breakdowns (or disconnects), which are labeled as operational, informational, or evaluative. Evaluative disconnects were found to be significantly harder to resolve than other types of disconnects. Considering breakdowns according to the type of disconnect involved appears to capture useful information that should assist accident and incident investigators. The current trend in aviation of shifting responsibilities and providing increasingly more information to pilots may have a hidden cost of increasing evaluative disconnects. The proposed taxonomy facilitates the investigation of breakdowns in coordinated decision making and draws attention to the importance of considering subtle differences between participants' mental models when considering complex distributed systems.

Safety evaluation of right-turn smart channels using automated traffic conflict analysis.

PubMed

Autey, Jarvis; Sayed, Tarek; Zaki, Mohamed H

2012-03-01

This paper presents the results of a before-after (BA) safety evaluation of a newly proposed design for channelized right-turn lanes. The new design, termed "Smart Channels", decreases the angle of the channelized right turn to approximately 70°. The implementation of these modified right-turn channels is usually advocated to allow for safer pedestrian crossing. However, the benefits also extend to vehicle-vehicle interactions since the new approach angle affords drivers a better view of the traffic stream they are to merge with. The evaluation is conducted using a video-based automated traffic conflict analysis. There are several advantages that support the adoption of traffic conflict techniques in BA safety studies. Traffic conflicts are more frequent than road collisions and are of marginal social cost, they provide insight into the failure mechanism that leads to road collisions, and BA studies based on traffic conflicts can be conducted over shorter periods. As well, the use of automated conflict analysis overcomes the reliability and repeatability problems usually associated with manual conflict observations. Data for three treatment intersections and one control intersection in Penticton, British Columbia, are used in this study. The results of the evaluation show that the implementation of the right-turn treatment has resulted in a considerable reduction in the severity and frequency of merging, rear-end, and total conflicts. The total average hourly conflict was reduced by about 51% while the average conflict severity was reduced by 41%. Copyright © 2011 Elsevier Ltd. All rights reserved.

Test Rack Development for Extended Operation of Advanced Stirling Convertors at NASA Glenn Research Center

NASA Technical Reports Server (NTRS)

Dugala, Gina M.

2009-01-01

The U.S. Department of Energy (DOE), Lockheed Martin Space Company (LMSC), Sun power Inc., and NASA Glenn Research Center (GRC) have been developing an Advanced Stirling Radioisotope Generator (ASRG) for use as a power system on space science missions. This generator will make use of free-piston Stirling convertors to achieve higher conversion efficiency than currently available alternatives. NASA GRC's support of ASRG development includes extended operation testing of Advanced Stirling Convertors (ASCs) developed by Sunpower Inc. In the past year, NASA GRC has been building a test facility to support extended operation of a pair of engineering level ASCs. Operation of the convertors in the test facility provides convertor performance data over an extended period of time. Mechanical support hardware, data acquisition software, and an instrumentation rack were developed to prepare the pair of convertors for continuous extended operation. Short-term tests were performed to gather baseline performance data before extended operation was initiated. These tests included workmanship vibration, insulation thermal loss characterization, low-temperature checkout, and fUll-power operation. Hardware and software features are implemented to ensure reliability of support systems. This paper discusses the mechanical support hardware, instrumentation rack, data acquisition software, short-term tests, and safety features designed to support continuous unattended operation of a pair of ASCs.

Pharmacology of the glucagon-like peptide-1 analog exenatide extended-release in healthy cats.

PubMed

Rudinsky, A J; Adin, C A; Borin-Crivellenti, S; Rajala-Schultz, P; Hall, M J; Gilor, C

2015-04-01

Exenatide extended-release (ER) is a microencapsulated formulation of the glucagon-like peptide 1-receptor agonist exenatide. It has a protracted pharmacokinetic profile that allows a once-weekly injection with comparable efficacy to insulin with an improved safety profile in type II diabetic people. Here, we studied the pharmacology of exenatide ER in 6 healthy cats. A single subcutaneous injection of exenatide ER (0.13 mg/kg) was administered on day 0. Exenatide concentrations were measured for 12 wk. A hyperglycemic clamp (target = 225 mg/dL) was performed on days -7 (clamp I) and 21 (clamp II) with measurements of insulin and glucagon concentrations. Glucose tolerance was defined as the amount of glucose required to maintain hyperglycemia during the clamp. Continuous glucose monitoring was performed on weeks 0, 2, and 6 after injection. Plasma concentrations of exenatide peaked at 1 h and 4 wk after injection. Comparing clamp I with clamp II, fasting blood glucose decreased (mean ± standard deviation = -11 ± 8 mg/dL, P = 0.02), glucose tolerance improved (median [range] +33% [4%-138%], P = 0.04), insulin concentrations increased (+36.5% [-9.9% to 274.1%], P = 0.02), and glucagon concentrations decreased (-4.7% [0%-12.1%], P = 0.005). Compared with preinjection values on continuous glucose monitoring, glucose concentrations decreased and the frequency of readings <50 mg/dL increased at 2 and 6 wk after injection of exenatide ER. This did not correspond to clinical hypoglycemia. No other side effects were observed throughout the study. Exenatide ER was safe and effective in improving glucose tolerance 3 wk after a single injection. Further evaluation is needed to determine its safety, efficacy, and duration of action in diabetic cats. Copyright © 2015 Elsevier Inc. All rights reserved.

A model for occupational safety and health intervention diffusion to small businesses.

PubMed

Sinclair, Raymond C; Cunningham, Thomas R; Schulte, Paul A

2013-12-01

Smaller businesses differ from their larger counterparts in having higher rates of occupational injuries and illnesses and fewer resources for preventing those losses. Intervention models developed outside the United States have addressed the resource deficiency issue by incorporating intermediary organizations such as trade associations. This paper extends previous models by using exchange theory and by borrowing from the diffusion of innovations model. It emphasizes that occupational safety and health (OSH) organizations must understand as much about intermediary organizations as they do about small businesses. OSH organizations ("initiators") must understand how to position interventions and information to intermediaries as added value to their relationships with small businesses. Examples from experiences in two midwestern states are used to illustrate relationships and types of analyses implied by the extended model. The study found that intermediary organizations were highly attuned to providing smaller businesses with what they want, including OSH services. The study also found that there are opinion leader organizations and individual champions within intermediaries who are key to decisions and actions about OSH programming. The model places more responsibility on both initiators and intermediaries to develop and market interventions that will be valued in the competitive small business environment where the resources required to adopt each new business activity could always be used in other ways. The model is a candidate for empirical validation, and it offers some encouragement that the issue of sustainable OSH assistance to small businesses might be addressed. Am. J. Ind. Med. 56:1442-1451, 2013. Published 2013. This article is a U.S. Government work and is in the public domain in the USA. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

Creating an Oversight Infrastructure for Electronic Health Record-Related Patient Safety Hazards

PubMed Central

Singh, Hardeep; Classen, David C.; Sittig, Dean F.

2013-01-01

Electronic health records (EHRs) have potential quality and safety benefits. However, reports of EHR-related safety hazards are now emerging. The Office of the National Coordinator (ONC) for Health Information Technology (HIT) recently sponsored an Institute of Medicine committee to evaluate how HIT use affects patient safety. In this paper, we propose the creation of a national EHR oversight program to provide dedicated surveillance of EHR-related safety hazards and to promote learning from identified errors, close calls, and adverse events. The program calls for data gathering, investigation/analysis and regulatory components. The first two functions will depend on institution-level EHR safety committees that will investigate all known EHR-related adverse events and near-misses and report them nationally using standardized methods. These committees should also perform routine safety self-assessments to proactively identify new risks. Nationally, we propose the long-term creation of a centralized, non-partisan board with an appropriate legal and regulatory infrastructure to ensure the safety of EHRs. We discuss the rationale of the proposed oversight program and its potential organizational components and functions. These include mechanisms for robust data collection and analyses of all safety concerns using multiple methods that extend beyond reporting; multidisciplinary investigation of selected high-risk safety events; and enhanced coordination with other national agencies in order to facilitate broad dissemination of hazards information. Implementation of this proposed infrastructure can facilitate identification of EHR-related adverse events and errors and potentially create a safer and more effective EHR-based health care delivery system. PMID:22080284

[Sleepiness, safety on the road and management of risk].

PubMed

Garbarino, S; Traversa, F; Spigno, F

2012-01-01

Public health studies have shown that sleepiness at the wheel and other risks associated with sleep are responsible for 5% to 30% of road accidents, depending on the type of driver and/or road. In industrialized countries one-fifth of all traffic accidents can be ascribed to sleepiness behind the wheel. Sleep disorders and various common acute and chronic medical conditions together with lifestyles, extended work hours and prolonged wakefulness directly or indirectly affect the quality and quantity of one's sleep increasing the number of workers with sleep debt and staggered hours. These conditions may increase the risk of road accidents. Strategies to reduce this risk of both commercial and non-commercial drivers related to sleepiness include reliable diagnosis and treatment of sleep disorders, management of chronobiological conflicts, adequate catch-up sleep, and countermeasures against sleepiness at the wheel. Road transport safety requires the adoption of occupational health measures, including risk assessment, health education, technical-environmental prevention and health surveillance.

SEIPS 2.0: a human factors framework for studying and improving the work of healthcare professionals and patients.

PubMed

Holden, Richard J; Carayon, Pascale; Gurses, Ayse P; Hoonakker, Peter; Hundt, Ann Schoofs; Ozok, A Ant; Rivera-Rodriguez, A Joy

2013-01-01

Healthcare practitioners, patient safety leaders, educators and researchers increasingly recognise the value of human factors/ergonomics and make use of the discipline's person-centred models of sociotechnical systems. This paper first reviews one of the most widely used healthcare human factors systems models, the Systems Engineering Initiative for Patient Safety (SEIPS) model, and then introduces an extended model, 'SEIPS 2.0'. SEIPS 2.0 incorporates three novel concepts into the original model: configuration, engagement and adaptation. The concept of configuration highlights the dynamic, hierarchical and interactive properties of sociotechnical systems, making it possible to depict how health-related performance is shaped at 'a moment in time'. Engagement conveys that various individuals and teams can perform health-related activities separately and collaboratively. Engaged individuals often include patients, family caregivers and other non-professionals. Adaptation is introduced as a feedback mechanism that explains how dynamic systems evolve in planned and unplanned ways. Key implications and future directions for human factors research in healthcare are discussed.

Participatory approach to identify interventions to improve the health, safety, and work productivity of smallholder women vegetable farmers in the Gambia.

PubMed

Vanderwal, Londa; Rautiainen, Risto; Ramirez, Marizen; Kuye, Rex; Peek-Asa, Corinne; Cook, Thomas; Culp, Kennith; Donham, Kelley

2011-03-01

This paper describes the qualitative, community-based participatory approach used to identify culturally-acceptable and sustainable interventions to improve the occupational health, safety, and productivity of smallholder women vegetable farmers in The Gambia (West Africa). This approach was used to conduct: 1) analysis of the tasks and methods traditionally used in vegetable production, and 2) selection of interventions. The most arduous garden tasks that were amenable to interventions were identified, and the interventions were selected through a participatory process for further evaluation. Factors contributing to the successful implementation of the participatory approach used in this study included the following: 1) ensuring that cultural norms were respected and observed; 2) working closely with the existing garden leadership structure; and 3) research team members working with the subjects for an extended period of time to gain first-hand understanding of the selected tasks and to build credibility with the subjects.

Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

PubMed Central

Iborra, Marisa; Álvarez-Sotomayor, Diego; Nos, Pilar

2014-01-01

Ulcerative colitis (UC) is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon). Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide’s usefulness in treating active mild to moderate ileocecal Crohn’s disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide’s efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX) to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide’s long-term safety and efficacy in treating UC. PMID:24523594

[Spanish drivers' beliefs about speed. Speeding is a major issue of road safety].

PubMed

Montoro González, Luis; Roca Ruiz, Javier; Lucas-Alba, Antonio

2010-11-01

Extending and updating our knowledge concerning drivers' motivational and cognitive processes is of essential importance if we are to apply policies with long-lasting effects. This study presents data from a representative national survey analyzing the Spanish drivers' beliefs about speed, the risks of speeding, the degree of violation of speed-limits and the reasons for speeding. Results indicate that Spanish drivers rate speeding as a serious offence, yet not among the most dangerous ones. All in all, they claim to comply mostly with the speed limits. However, some interesting violation patterns emerge: observance is lower for generic speed limits according to road type (vs. specific limits shown by certain road signs), and particularly in motorways (vs. single carriageways and urban areas). Risk perception and reasons for speeding emerge as the main factors predicting the levels of speed violations reported. Results suggest that any effective intervention strategy should consider such factors, namely the link between speed, road safety, and drivers' specific reasons for speeding.

The use of mental models in chemical risk protection: developing a generic workplace methodology.

PubMed

Cox, Patrick; Niewöhmer, Jörg; Pidgeon, Nick; Gerrard, Simon; Fischhoff, Baruch; Riley, Donna

2003-04-01

We adopted a comparative approach to evaluate and extend a generic methodology to analyze the different sets of beliefs held about chemical hazards in the workplace. Our study mapped existing knowledge structures about the risks associated with the use of perchloroethylene and rosin-based solder flux in differing workplaces. "Influence diagrams" were used to represent beliefs held by chemical experts; "user models" were developed from data elicited from open-ended interviews with the workplace users of the chemicals. The juxtaposition of expert and user understandings of chemical risks enabled us to identify knowledge gaps and misunderstandings and to reinforce appropriate sets of safety beliefs and behavior relevant to chemical risk communications. By designing safety information to be more relevant to the workplace context of users, we believe that employers and employees may gain improved knowledge about chemical hazards in the workplace, such that better chemical risk management, self-protection, and informed decision making develop over time.

Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine.

PubMed

Gould, A Lawrence; Wang, William B

2017-01-15

The development of drugs and biologicals whose mechanisms of action may extend beyond their target indications has led to a need to identify unexpected potential toxicities promptly even while blinded clinical trials are under way. One component of recently issued FDA rules regarding safety reporting requirements raises the possibility of breaking the blind for pre-identified serious adverse events that are not the clinical endpoints of a blinded study. Concern has been expressed that unblinding individual cases of frequently occurring adverse events could compromise the overall validity of the study. However, if external information is available about adverse event rates among patients not receiving the test product in populations similar to the study population, then it may be possible to address the potential for elevated risk without unblinding the trial. This article describes a Bayesian approach for determining the likelihood of elevated risk suitable binomial or Poisson likelihoods that applies regardless of the metric used to express the difference. The method appears to be particularly appropriate for routine monitoring of safety information for project development programs that include large blinded trials. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

The efficacy and safety of aripiprazole for tic disorders in children and adolescents: A systematic review and meta-analysis.

PubMed

Wang, Shuai; Wei, Yan-Zhao; Yang, Jian-Hong; Zhou, Yu-Ming; Cheng, Yu-Hang; Yang, Chao; Zheng, Yi

2017-08-01

The aims are to evaluate the efficacy and safety of aripiprazole for tic disorders (TDs) in children and adolescents. We searched PubMed, Embase, PsychINFO, Cochrane database as well as Chinese databases of CNKI, VIP, CBM and Wanfang from the database inception to October 2016, and 17 full-text studies (N=1305) were included in our article. The meta-analysis of 10 studies (N=817) showed that there was no significant difference in the reduction of total YGTSS score between aripiprazole and other drugs, and meta-analysis of 7 studies (n=324) which used tic symptom control ≧30% as outcome measure showed that there was no significant difference between aripiprazole and other treatments. The most common AEs of aripiprazole were the drowsiness, nausea/vomiting and increased appetite, and meta analysis which used the TESS scale as the outcome measurement showed that there was a significant difference between aripiprazole and haloperidol. In conclusion, these data provide moderate quality evidence that aripiprazole could be an effective and safe treatment option for TDs, and results from further trials are urgently needed to extend this evidence base. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Hypo-fractionated stereotactic radiotherapy of five fractions with linear accelerator for vestibular schwannomas: A systematic review and meta-analysis.

PubMed

Nguyen, Thien; Duong, Courtney; Sheppard, John P; Lee, Seung Jin; Kishan, Amar U; Lee, Percy; Tenn, Stephen; Chin, Robert; Kaprealian, Tania B; Yang, Isaac

2018-03-01

Vestibular schwannomas (VS) are benign tumors stemming from the eighth cranial nerve. Treatment options for VS include conservative management, microsurgery, stereotactic radiosurgery, and fractionated radiotherapy. Though microsurgery has been the standard of care for larger lesions, hypo-fractionated stereotactic radiotherapy (hypo-FSRT) is an emerging modality. However, its clinical efficacy and safety have yet to be established. We conducted a systematic review and meta-analysis of manuscripts indexed in PubMed, Scopus, Web of Science, Embase, and Cochrane databases reporting outcomes of VS cases treated with hypo-FSRT. Five studies representing a total of 228 patients were identified. Across studies, the pooled rates of tumor control, hearing, facial nerve, and trigeminal nerve preservation were 95%, 37%, 97%, and 98%. No instances of malignant induction were observed at median follow-up of 34.8 months. Complications included trigeminal neuropathy (n = 3), maxillary paresthesia (n = 1), neuralgia (n = 1), vestibular dysfunction (n = 1), radionecrosis (n = 1), and hydrocephalus (n = 1). Hypo-FSRT may be another useful approach to manage VS, but studies with extended follow-up times are required to establish long-term safety. Copyright © 2018. Published by Elsevier B.V.

Safe anesthesia: some general considerations.

PubMed

Smalhout, B

1978-01-01

Most of the articles on safety in anesthesia take the mortality as the criterion. This is fallacious. The anesthetist's area of responsibility must be clearly defined before his contribution to any given mortality can be assessed. The development of the field of anesthesiology has extended this area enormously. As a result, the techniques employed and the results obtained need to be reviewed and reconsidered. Outdated attitudes must be resolutely abandoned, particularly with regard to monitoring. The use of a coding system for anesthetic complications helps towards an objective assessment of the degree of safety achieved. The results obtained by this means in the Institute of Anesthesiology in Utrecht are reported.

50 CFR 216.165 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2012 CFR

2012-10-01

... which case post-test survey dates must be extended, and (v) for a period of 7 days after the last..., of marine mammals in the Safety Range at the time of detonation based on post-test aerial monitoring... area off Mayport, FL. (2) The test area must be monitored by aerial and shipboard monitoring for the...

50 CFR 216.165 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2010 CFR

2010-10-01

... which case post-test survey dates must be extended, and (v) for a period of 7 days after the last..., of marine mammals in the Safety Range at the time of detonation based on post-test aerial monitoring... area off Mayport, FL. (2) The test area must be monitored by aerial and shipboard monitoring for the...

50 CFR 216.165 - Requirements for monitoring and reporting.

Code of Federal Regulations, 2011 CFR

2011-10-01

... which case post-test survey dates must be extended, and (v) for a period of 7 days after the last..., of marine mammals in the Safety Range at the time of detonation based on post-test aerial monitoring... area off Mayport, FL. (2) The test area must be monitored by aerial and shipboard monitoring for the...

23 CFR 1200.31 - Extension of the right to incur costs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Extension of the right to incur costs. 1200.31 Section... HIGHWAY SAFETY PROGRAMS Closeout § 1200.31 Extension of the right to incur costs. Upon written request by the State, specifying the reasons therefor, the Approving Official may extend the right to incur costs...

Using Parents in a Defined Role in Alcohol Education: Parents as Prevention Specialists

ERIC Educational Resources Information Center

Wheeler, Wendy Neifeld; Kennedy, Jelane A.

2009-01-01

Parents of today's college students bring unique experiences to the academic journey. They support extended parenting into the college years, demonstrate commitment and knowledge as prevention specialists with regards to their son or daughter's safety, and value the opportunity for partnerships to be developed with the institution of their child's…

School-Sponsored Before, After and Extended School Year Programs: The Role of the School Nurse. Position Statement

ERIC Educational Resources Information Center

Clark, Elizabeth; Buswell, Sue Ann; Morgitan, Judith; Compton, Linda; Westendorf, Georgene; Chau, Elizabeth

2014-01-01

It is the position of the National Association of School Nurses (NASN) that the registered professional school nurse (hereinafter referred to as school nurse) has the educational and clinical background to coordinate the necessary school health services to provide students with the same health, nutrition, and safety needs while attending…

An Evaluation of a Classroom Science Intervention Designed to Extend the Bicycle Helmet Safety Message

ERIC Educational Resources Information Center

McPherson, Moira N.; Marsh, Pamela K.; Montelpare, William J.; Van Barneveld, Christina; Zerpa, Carlos E.

2009-01-01

Background: Wizards of Motion is a program of curriculum delivery through which experts in Kinesiology introduce grade 7 students to applications of physics for human movement. The program is linked closely to Ministry of Education curriculum requirements but includes human movement applications and data analysis experiences. Purpose: The purpose…

78 FR 22413 - Amendment of Class E Airspace; Omak, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... upward from 4,500 feet Mean Sea Level (MSL). This improves the safety and management of Instrument Flight... airspace extending upward from 4,500 feet MSL be rewritten for clarity. With the exception of editorial... 700 feet above the surface and 1,200 feet above the surface at Omak Airport, Omak, WA. The Omak NDB...

Safety and efficacy of extended-release guaifenesin/pseudoephedrine hydrochloride for adjunctive symptom relief of acute respiratory infections.

PubMed

Kikano, George

2009-05-01

Acute bacterial respiratory infections (ABRIs) require treatment with antibiotics. Although antibiotics may address the underlying pathogenic factors, over-the-counter (OTC) agents can play an adjuvant role in relieving mucus-related symptoms. This complimentary role contributes to the healing process and is supported by current clinical guidelines.

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution. (section 2(b), Pub. L. 91-596; U.S. Constitution, Art. I, Sec. 8, Cl. 3; “United States v. Darby,” 312 U.S. 100.) The reach of the Commerce Clause extends beyond Federal regulation of the channels and...

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution. (section 2(b), Pub. L. 91-596; U.S. Constitution, Art. I, Sec. 8, Cl. 3; “United States v. Darby,” 312 U.S. 100.) The reach of the Commerce Clause extends beyond Federal regulation of the channels and...

75 FR 81854 - Safety Zone; New Year's Celebration for the City of San Francisco, Fireworks Display, San...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-29

... the loading, transit, and arrival of the pyrotechnics, and will extend 1,000 feet from the nearest... participants and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels... process would be completed. Because of the dangers posed by the pyrotechnics used in these fireworks...

78 FR 18302 - Fisheries in the Western Pacific; 5-Year Extension of Moratorium on Harvest of Gold Corals

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... by high equipment and operating costs, continued safety concerns and other logistical constraints... impact on a substantial number of small entities. The analysis follows: The proposed rule would extend... initial regulatory flexibility analysis is not required and none has been prepared. List of Subjects in 50...

75 FR 39938 - Notice of Public Information Collection(s) Being Reviewed by the Federal Communications...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-13

... controlled by the utility; and 4) extended to antennas that receive and transmit telecommunications and other..., maintenance or use of certain video antennas on property within the exclusive use or control of the antenna... subscriber antennas are labeled to give notice of potential radio frequency safety hazards of these antennas...

Venlafaxine ER for the Treatment of Pediatric Subjects with Depression: Results of Two Placebo-Controlled Trials

ERIC Educational Resources Information Center

Emslie, Graham J.; Findling, Robert L.; Yeung, Paul P.; Kunz, Nadia R.; Li, Yunfeng

2007-01-01

Objective: The safety, efficacy, and tolerability of venlafaxine extended release (ER) in subjects ages 7 to 17 years with major depressive disorder were evaluated in two multicenter, randomized, double-blind, placebo-controlled trials conducted between October 1997 and August 2001. Method: Participants received venlafaxine ER (flexible dose,…

Guidelines for Releasing Children: Part 2

ERIC Educational Resources Information Center

McGinnis, Michelle H.; Getskow, Veronica; Dicker, Brian S.

2012-01-01

An intoxicated father is picking up his daughter from school, in his condition he must be prevented from driving away with his daughter, but what obligations and options guide school owner Sonia Hernandez? The duty to protect the safety of children in the care of a preschool is paramount. However, the laws in most states do not extend to dangers…

76 FR 52356 - Indiana Michigan Power Company, Donald C. Cook Nuclear Plant, Unit 1; Environmental Assessment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... adversely affect plant safety, and would have no adverse effect on the probability of any accident. For the accidents that involve damage or melting of the fuel in the reactor core, fuel rod integrity has been shown to be unaffected by extended burnup under consideration; therefore, the probability of an accident...

77 FR 51071 - Indiana Michigan Power Company, Donald C. Cook Nuclear Plant, Unit 2, Environmental Assessment...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

... adversely affect plant safety, and would have no adverse effect on the probability of any accident. For the accidents that involve damage or melting of the fuel in the reactor core, fuel rod integrity has been shown to be unaffected by extended burnup under consideration; therefore, the consequences of an accident...

Applying extender devices in patients with penile dysmorphophobia: assessment of tolerability, efficacy, and impact on erectile function.

PubMed

Nowroozi, Mohammad Reza; Amini, Erfan; Ayati, Mohsen; Jamshidian, Hassan; Radkhah, Kayvan; Amini, Shahab

2015-05-01

Most men seeking penile enhancement techniques have a normal penile size. They are either misinformed or suffer from penile dysmorphophobia and should be discouraged from undergoing invasive procedures. Less invasive techniques including penile extenders are not associated with major complications and may be beneficial from a psychological perspective. We conducted this study to assess the efficacy and safety of AndroPenis (Andromedical, Madrid, Spain) penile extender. Between December 2010 and December 2013, 163 men presented to our institution complaining of small penile length and/or girth. All patients received structured psychosexual counseling. Fifty-four patients were willing to use the AndroPenis penile extender after counseling. Patients with major psychiatric disorders were excluded from enrollment. The patients were instructed to wear the device between 4 and 6 hours per day for 6 months. Penile dimensions including flaccid stretched and erected lengths were measured at baseline and after 1, 3, 6, and 9 months. Erectile function was assessed at baseline and 9 months after treatment using the simplified International Index of Erectile Function (IIEF-5). An institutional nonstandardized questionnaire was used to evaluate patient satisfaction at the end of study. Penile length and girth enhancement as well as satisfaction rate and improvement in erectile function were assessed during follow-up. At 6-month follow-up, a mean gain of 1.7 ± 0.8, 1.3 ± 0.4, and 1.2 ± 0.4 cm was noted for the flaccid, stretched, and erected penile lengths, respectively (all P values < 0.001). During the off treatment period, there were no significant changes in penile lengths. No effect on penile girth was observed. Patient satisfaction survey revealed modest satisfaction. From 13 patients with mild baseline erectile dysfunction, nine patients reported normal erectile function after 9 months. Penile extender as a minimally invasive technique is safe and provides modest benefits and patient satisfaction. © 2015 International Society for Sexual Medicine.

Environmental exposure scenarios: development, challenges and possible solutions.

PubMed

Ahrens, Andreas; Traas, Theo P

2007-12-01

Under the new REACH system, companies importing, producing and marketing chemical substances will be obliged to register the single substances and to carry out a safety assessment for all identified uses during the life cycle of the substance. This duty will apply to about 10,000 existing substances in the EU market exceeding an annual production or import volume of 10 t per company. If the substance is already known to be dangerous or turns out to be dangerous(1) during the hazard assessment, the registrant is obliged to carry out an exposure assessment and a risk characterisation for all identified uses. The goal of the safety assessment is to define the conditions of use that allow for adequate control of risk with regard to health and safety at the work place, consumer safety and protection of the environment. Once the registrant has established and documented these conditions in the Chemicals Safety Report (CSR), that information is to be communicated down the supply chain by means of the Extended Safety Data Sheet (eSDS). The ultimate aim of the new legislation is to establish duties and mechanisms that systematically prevent or limit exposure to dangerous industrial chemicals. The current paper explains this concept with regard to environmental exposure and highlights the challenges and possible solutions.

Recommendation for standardization of haematology reporting units used in the extended blood count.

PubMed

Brereton, M; McCafferty, R; Marsden, K; Kawai, Y; Etzell, J; Ermens, A

2016-10-01

It is desirable in the interest of patient safety that the reporting of laboratory results should be standardized where no valid reason for diversity exists. This study considers the reporting units used for the extended blood cell count and makes a new ICSH recommendation to encourage standardization worldwide. This work is based on a literature review that included the original ICSH recommendations and on data gathered from an international survey of current practice completed by 18 countries worldwide. The survey results show that significant diversity in the use of reporting units for the blood count exists worldwide. The use of either non-SI or other units not recommended by the ICSH in the early 1980s has persisted despite the guidance from that time. The diversity in use of reporting units occurs in three areas: the persistence in use of non-SI units for RBC, WBC and platelet counts, the use of three different units for haemoglobin concentration and the manual reporting of WBC differential, reticulocytes and nucleated RBCs when the latter are available from automated analysis or can be expressed as absolute numbers by calculation. A new recommendation with a rationale for each parameter is made for standardization of the reporting units used for the extended blood count. © 2016 John Wiley & Sons Ltd.