Texas curve margin of safety.

DOT National Transportation Integrated Search

2013-01-01

This software can be used to assist with the assessment of margin of safety for a horizontal curve. It is intended for use by engineers and technicians responsible for safety analysis or management of rural highway pavement or traffic control devices...

Light Water Reactor Sustainability Program FY13 Status Update for EPRI - RISMC Collaboration

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

Smith, Curtis

2013-09-01

The purpose of the Risk Informed Safety Margin Characterization (RISMC) Pathway research and development (R&D) is to support plant decisions for risk-informed margins management with the aim to improve economics, reliability, and sustain safety of current NPPs. Goals of the RISMC Pathway are twofold: (1) Develop and demonstrate a risk-assessment method coupled to safety margin quantification that can be used by NPP decision makers as part of their margin recovery strategies. (2) Create an advanced "RISMC toolkit" that enables more accurate representation of NPP safety margin. In order to carry out the R&D needed for the Pathway, the Idaho Nationalmore » Laboratory (INL) is collaborating with the Electric Power Research Institute (EPRI) in order to focus on applications of interest to the U.S. nuclear power industry. This report documents the collaboration activities performed between INL and EPRI during FY2013.« less

Determining the safety of enzymes used in animal feed.

PubMed

Pariza, Michael W; Cook, Mark

2010-04-01

The purpose of this paper is to provide guidance for evaluating the safety of enzyme preparations used in animal feed. Feed enzymes are typically added to animal feed to increase nutrient bioavailability by acting on feed components prior to or after consumption, i.e., within the gastrointestinal tract. In contrast, food processing enzymes are generally used during processing and then inactivated or removed prior to consumption. The enzymes used in both applications are almost always impure mixtures of active enzyme and other metabolites from the production strain, hence similar safety evaluation procedures for both are warranted. We propose that the primary consideration should be the safety of the production strain and that the decision tree mechanism developed previously for food processing enzymes (Pariza and Johnson, 2001) is appropriate for determining the safety of feed enzymes. Thoroughly characterized non-pathogenic, non-toxigenic microbial strains with a history of safe use in enzyme manufacture are also logical candidates for generating safe strain lineages, from which additional strains may be derived via genetic modification by traditional and non-traditional strategies. For new feed enzyme products derived from a safe strain lineage, it is important to ensure a sufficiently high safety margin for the intended use, and that the product complies with appropriate specifications for chemical and microbial contamination. Copyright 2009 Elsevier Inc. All rights reserved.

Study Suggests Smaller Melanoma Excision Margins May Be Option for Some Patients

Cancer.gov

A randomized controlled trial of patients with stage IIA–C cutaneous melanoma thicker than 2-mm found that a 2-cm surgical resection margin is sufficient and is as safe for patients as a 4-cm margin.

Improved Safety Margin Characterization of Risk from Loss of Offsite Power

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

Nelson, Paul

Original intent: The original intent of this task was “support of the Risk-Informed Safety Margin Characteristic (RISMC) methodology in order” “to address … efficiency of computation so that more accurate and cost-effective techniques can be used to address safety margin characterizations” (S. M. Hess et al., “Risk-Informed Safety Margin Characterization,” Procs. ICONE17, Brussels, July 2009, CD format). It was intended that “in Task 1 itself this improvement will be directed toward upon the very important issue of Loss of Offsite Power (LOOP) events,” more specifically toward the challenge of efficient computation of the multidimensional nonrecovery integral that has been discussedmore » by many previous contributors to the theory of nuclear safety. It was further envisioned that “three different computational approaches will be explored,” corresponding to the three subtasks listed below; deliverables were tied to the individual subtasks.« less

Time Safety Margin: Theory and Practice

DTIC Science & Technology

2016-09-01

Basic Dive Recovery Terminology The Simplest Definition of TSM: Time Safety Margin is the time to directly travel from the worst-case vector to an...Safety Margin (TSM). TSM is defined as the time in seconds to directly travel from the worst case vector (i.e. worst case combination of parameters...invoked by this AFI, base recovery planning and risk management upon the calculated TSM. TSM is the time in seconds to di- rectly travel from the worst case

Modeling Precheck Parallel Screening Process in the Face of Strategic Applicants with Incomplete Information and Screening Errors.

PubMed

Song, Cen; Zhuang, Jun

2018-01-01

In security check systems, tighter screening processes increase the security level, but also cause more congestion, which could cause longer wait times. Having to deal with more congestion in lines could also cause issues for the screeners. The Transportation Security Administration (TSA) Precheck Program was introduced to create fast lanes in airports with the goal of expediting passengers who the TSA does not deem to be threats. In this lane, the TSA allows passengers to enjoy fewer restrictions in order to speed up the screening time. Motivated by the TSA Precheck Program, we study parallel queueing imperfect screening systems, where the potential normal and adversary participants/applicants decide whether to apply to the Precheck Program or not. The approved participants would be assigned to a faster screening channel based on a screening policy determined by an approver, who balances the concerns of safety of the passengers and congestion of the lines. There exist three types of optimal normal applicant's application strategy, which depend on whether the marginal payoff is negative or positive, or whether the marginal benefit equals the marginal cost. An adversary applicant would not apply when the screening policy is sufficiently large or the number of utilized benefits is sufficiently small. The basic model is extended by considering (1) applicants' parameters to follow different distributions and (2) applicants to have risk levels, where the approver determines the threshold value needed to qualify for Precheck. This article integrates game theory and queueing theory to study the optimal screening policy and provides some insights to imperfect parallel queueing screening systems. © 2017 Society for Risk Analysis.

Determination of safety margins for whole blood concentrations of alcohol and nineteen drugs in driving under the influence cases.

PubMed

Kristoffersen, Lena; Strand, Dag Helge; Liane, Veronica Horpestad; Vindenes, Vigdis; Tvete, Ingunn Fride; Aldrin, Magne

2016-02-01

Legislative limits for driving under the influence of 20 non-alcohol drugs were introduced in Norway in February 2012. Per se limits corresponding to blood alcohol concentrations (BAC) of 0.2g/kg were established for 20 psychoactive drugs, and limits for graded sanctions corresponding to BACs of 0.5 and 1.2g/kg were determined for 13 of these drugs. This new legislation made it possible for the courts to make sentences based on the analytical results, similar to the situation for alcohol. To ensure that the reported concentration is as least as high as the true concentration, with a 99% safety level, safety margins had to be calculated for each of the substances. Diazepam, tetrahydrocannabinol (THC) and alcohol were used as model substances to establish a new model for estimating the safety margins. The model was compared with a previous used model established several years ago, by a similar yet much simpler model, and they were found to be in agreement. The measurement uncertainties depend on the standard batch used, the work list and the measurements' replicate. A Bayesian modelling approach was used to determine the parameters in the model, using a dataset of 4700 diazepam positive specimens and 5400 THC positive specimens. Different safety margins were considered for low and high concentration levels of diazepam (≤2μM (0.6mg/L) and >2μM) and THC (≤0.01μM (0.003mg/L) and >0.01μM). The safety margins were for diazepam 19.5% (≤2μM) and 34% (>2μM), for THC 19.5% (≤0.01μM) and 24.9% (>0.01μM). Concentration dependent safety margins for BAC were based on a dataset of 29500 alcohol positive specimens, and were in the range 10.4% (0.1g/kg) to 4.0% (4.0g/kg) at a 99% safety level. A simplified approach was used to establish safety margins for the compounds amphetamine, MDMA, methamphetamine, alprazolam, phenazepam, flunitrazepam, clonazepam, nitrazepam, oxazepam, buprenorphine, GHB, methadone, ketamine, cocaine, morphine, zolpidem and zopiclone. The safety margins for these drugs were in the range 34-41%. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Inductionless or limited shock testing is possible in most patients with implantable cardioverter- defibrillators/cardiac resynchronization therapy defibrillators: results of the multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations).

PubMed

Day, John D; Doshi, Rahul N; Belott, Peter; Birgersdotter-Green, Ulrika; Behboodikhah, Mahnaz; Ott, Peter; Glatter, Kathryn A; Tobias, Serge; Frumin, Howard; Lee, Byron K; Merillat, John; Wiener, Isaac; Wang, Samuel; Grogin, Harlan; Chun, Sung; Patrawalla, Rob; Crandall, Brian; Osborn, Jeffrey S; Weiss, J Peter; Lappe, Donald L; Neuman, Stacey

2007-05-08

Implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators have relied on multiple ventricular fibrillation (VF) induction/defibrillation tests at implantation to ensure that the device can reliably sense, detect, and convert VF. The ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations) is the first large, multicenter, prospective trial comparing vulnerability safety margin testing versus defibrillation safety margin testing with a single VF induction/defibrillation. A total of 426 patients receiving an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator underwent vulnerability safety margin or defibrillation safety margin screening at 14 J in a randomized order. After this, patients underwent confirmatory testing, which required 2 VF conversions without failure at < or = 21 J. Patients who passed their first 14-J and confirmatory tests, irrespective of the results of their second 14-J test, had their devices programmed to a 21-J shock for ventricular tachycardia (VT) or VF > or = 200 bpm and were followed up for 1 year. Of 420 patients who underwent 14-J vulnerability safety margin screening, 322 (76.7%) passed. Of these, 317 (98.4%) also passed 21-J confirmatory tests. Of 416 patients who underwent 14-J defibrillation safety margin screening, 343 (82.5%) passed, and 338 (98.5%) also passed 21-J confirmatory tests. Most clinical VT/VF episodes (32 of 37, or 86%) were terminated by the first shock, with no difference in first shock success. In all observed cases in which the first shock was unsuccessful, subsequent shocks terminated VT/VF without complication. Although spontaneous episodes of fast VT/VF were limited, there was no difference in the odds of first shock efficacy between groups. Screening with vulnerability safety margin or defibrillation safety margin may allow for inductionless or limited shock testing in most patients.

Orion MPCV Touchdown Detection Threshold Development and Testing

NASA Technical Reports Server (NTRS)

Daum, Jared; Gay, Robert

2013-01-01

A robust method of detecting Orion Multi-Purpose Crew Vehicle (MPCV) splashdown is necessary to ensure crew and hardware safety during descent and after touchdown. The proposed method uses a triple redundant system to inhibit Reaction Control System (RCS) thruster firings, detach parachute risers from the vehicle, and transition to the post-landing segment of the Flight Software (FSW). An in-depth trade study was completed to determine optimal characteristics of the touchdown detection method resulting in an algorithm monitoring filtered, lever-arm corrected, 200 Hz Inertial Measurement Unit (IMU) vehicle acceleration magnitude data against a tunable threshold using persistence counter logic. Following the design of the algorithm, high fidelity environment and vehicle simulations, coupled with the actual vehicle FSW, were used to tune the acceleration threshold and persistence counter value to result in adequate performance in detecting touchdown and sufficient safety margin against early detection while descending under parachutes. An analytical approach including Kriging and adaptive sampling allowed for a sufficient number of finite element analysis (FEA) impact simulations to be completed using minimal computation time. The combination of a persistence counter of 10 and an acceleration threshold of approximately 57.3 ft/s2 resulted in an impact performance factor of safety (FOS) of 1.0 and a safety FOS of approximately 2.6 for touchdown declaration. An RCS termination acceleration threshold of approximately 53.1 ft/s(exp)2 with a persistence counter of 10 resulted in an increased impact performance FOS of 1.2 at the expense of a lowered under-parachutes safety factor of 2.2. The resulting tuned algorithm was then tested on data from eight Capsule Parachute Assembly System (CPAS) flight tests, showing an experimental minimum safety FOS of 6.1. The formulated touchdown detection algorithm will be flown on the Orion MPCV FSW during the Exploration Flight Test 1 (EFT-1) mission in the second half of 2014.

Light Water Reactor Sustainability Program: Risk-Informed Safety Margins Characterization (RISMC) Pathway Technical Program Plan

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

Smith, Curtis; Rabiti, Cristian; Martineau, Richard

Safety is central to the design, licensing, operation, and economics of Nuclear Power Plants (NPPs). As the current Light Water Reactor (LWR) NPPs age beyond 60 years, there are possibilities for increased frequency of Systems, Structures, and Components (SSCs) degradations or failures that initiate safety-significant events, reduce existing accident mitigation capabilities, or create new failure modes. Plant designers commonly “over-design” portions of NPPs and provide robustness in the form of redundant and diverse engineered safety features to ensure that, even in the case of well-beyond design basis scenarios, public health and safety will be protected with a very high degreemore » of assurance. This form of defense-in-depth is a reasoned response to uncertainties and is often referred to generically as “safety margin.” Historically, specific safety margin provisions have been formulated, primarily based on “engineering judgment.”« less

Station Blackout: A case study in the interaction of mechanistic and probabilistic safety analysis

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

Curtis Smith; Diego Mandelli; Cristian Rabiti

2013-11-01

The ability to better characterize and quantify safety margins is important to improved decision making about nuclear power plant design, operation, and plant life extension. As research and development (R&D) in the light-water reactor (LWR) Sustainability (LWRS) Program and other collaborative efforts yield new data, sensors, and improved scientific understanding of physical processes that govern the aging and degradation of plant SSCs needs and opportunities to better optimize plant safety and performance will become known. The purpose of the Risk Informed Safety Margin Characterization (RISMC) Pathway R&D is to support plant decisions for risk-informed margin management with the aim tomore » improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe the RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario.« less

Forensic implications of the variation in morphology of marginal serrations on the teeth of the great white shark.

PubMed

Nambiar, P; Brown, K A; Bridges, T E

1996-06-01

The teeth of the Great White Shark have been examined to ascertain whether there is any commonality in the arrangement or number of the marginal serrations (peaks) or, indeed, whether individual sharks have a unique pattern of shapes or size of the peaks. The teeth of the White Shark are characteristic in size and shape with serrations along almost the entire mesial and distal margins. This study has revealed no consistent pattern of size or arrangement of the marginal serrations that was sufficiently characteristic within an individual shark to serve as a reliable index of identification of a tooth as originating from that particular shark. Nonetheless, the serrations are sufficiently distinctive to enable the potential identification of an individual tooth as having been the cause of a particular bitemark.

System Guidelines for EMC Safety-Critical Circuits: Design, Selection, and Margin Demonstration

NASA Technical Reports Server (NTRS)

Lawton, R. M.

1996-01-01

Demonstration of safety margins for critical points (circuits) has traditionally been required since it first became a part of systems-level Electromagnetic Compatibility (EMC) requirements of MIL-E-6051C. The goal of this document is to present cost-effective guidelines for ensuring adequate Electromagnetic Effects (EME) safety margins on spacecraft critical circuits. It is for the use of NASA and other government agencies and their contractors to prevent loss of life, loss of spacecraft, or unacceptable degradation. This document provides practical definition and treatment guidance to contain costs within affordable limits.

Utility of Amplatzer Vascular Plug with Preoperative Common Hepatic Artery Embolization for Distal Pancreatectomy with En Bloc Celiac Axis Resection

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

Toguchi, Masafumi, E-mail: e024163@yahoo.co.jp; Tsurusaki, Masakatsu; Numoto, Isao

PurposeTo evaluate the feasibility and safety of the Amplatzer vascular plug (AVP) for preoperative common hepatic embolization (CHA) before distal pancreatectomy with en bloc celiac axis resection (DP-CAR) to redistribute blood flow to the stomach and liver via the superior mesenteric artery (SMA).Materials and MethodsFour patients (3 males, 1 female; median age 69 years) with locally advanced pancreatic body cancer underwent preoperative CHA embolization with AVP. After embolization, SMA arteriography was performed to confirm the alteration of blood flow from the SMA to the proper hepatic artery.ResultsIn three of four patients, technical successes were achieved with sufficient margin from the originmore » of gastroduodenal artery. In one patient, the margin was less than 5 mm, although surgery was successfully performed without any problem. Eventually, all patients underwent the DP-CAR without arterial reconstruction or liver ischemia.ConclusionsAVP application is feasible and safe as an embolic procedure for preoperative CHA embolization of DP-CAR.« less

Statistical issues in the design, conduct and analysis of two large safety studies.

PubMed

Gaffney, Michael

2016-10-01

The emergence, post approval, of serious medical events, which may be associated with the use of a particular drug or class of drugs, is an important public health and regulatory issue. The best method to address this issue is through a large, rigorously designed safety study. Therefore, it is important to elucidate the statistical issues involved in these large safety studies. Two such studies are PRECISION and EAGLES. PRECISION is the primary focus of this article. PRECISION is a non-inferiority design with a clinically relevant non-inferiority margin. Statistical issues in the design, conduct and analysis of PRECISION are discussed. Quantitative and clinical aspects of the selection of the composite primary endpoint, the determination and role of the non-inferiority margin in a large safety study and the intent-to-treat and modified intent-to-treat analyses in a non-inferiority safety study are shown. Protocol changes that were necessary during the conduct of PRECISION are discussed from a statistical perspective. Issues regarding the complex analysis and interpretation of the results of PRECISION are outlined. EAGLES is presented as a large, rigorously designed safety study when a non-inferiority margin was not able to be determined by a strong clinical/scientific method. In general, when a non-inferiority margin is not able to be determined, the width of the 95% confidence interval is a way to size the study and to assess the cost-benefit of relative trial size. A non-inferiority margin, when able to be determined by a strong scientific method, should be included in a large safety study. Although these studies could not be called "pragmatic," they are examples of best real-world designs to address safety and regulatory concerns. © The Author(s) 2016.

Effect of Smaller Left Ventricular Capture Threshold Safety Margins to Improve Device Longevity in Recipients of Cardiac Resynchronization-Defibrillation Therapy.

PubMed

Steinhaus, Daniel A; Waks, Jonathan W; Collins, Robert; Kleckner, Karen; Kramer, Daniel B; Zimetbaum, Peter J

2015-07-01

Device longevity in cardiac resynchronization therapy (CRT) is affected by the pacing capture threshold (PCT) and programmed pacing amplitude of the left ventricular (LV) pacing lead. The aims of this study were to evaluate the stability of LV pacing thresholds in a nationwide sample of CRT defibrillator recipients and to determine potential longevity improvements associated with a decrease in the LV safety margin while maintaining effective delivery of CRT. CRT defibrillator patients in the Medtronic CareLink database were eligible for inclusion. LV PCT stability was evaluated using ≥2 measurements over a 14-day period. Separately, a random sample of 7,250 patients with programmed right atrial and right ventricular amplitudes ≤2.5 V, LV thresholds ≤ 2.5 V, and LV pacing ≥90% were evaluated to estimate theoretical battery longevity improvement using LV safety margins of 0.5 and 1.5 V. Threshold stability analysis in 43,256 patients demonstrated LV PCT stability of <0.5 V in 77% of patients and <1 V in 95%. Device longevity analysis showed that the use of a 0.5-V safety margin increased average battery longevity by 0.62 years (95% confidence interval 0.61 to 0.63) compared with a safety margin of 1.5 V. Patients with LV PCTs >1 V had the greatest increases in battery life (mean increase 0.86 years, 95% confidence interval 0.85 to 0.87). In conclusion, nearly all CRT defibrillator patients had LV PCT stability <1.0 V. Decreasing the LV safety margin from 1.5 to 0.5 V provided consistent delivery of CRT for most patients and significantly improved battery longevity. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparison of a Traditional Probabilistic Risk Assessment Approach with Advanced Safety Analysis

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

Smith, Curtis L; Mandelli, Diego; Zhegang Ma

2014-11-01

As part of the Light Water Sustainability Program (LWRS) [1], the purpose of the Risk Informed Safety Margin Characterization (RISMC) [2] Pathway research and development (R&D) is to support plant decisions for risk-informed margin management with the aim to improve economics, reliability, and sustain safety of current NPPs. In this paper, we describe the RISMC analysis process illustrating how mechanistic and probabilistic approaches are combined in order to estimate a safety margin. We use the scenario of a “station blackout” (SBO) wherein offsite power and onsite power is lost, thereby causing a challenge to plant safety systems. We describe themore » RISMC approach, illustrate the station blackout modeling, and contrast this with traditional risk analysis modeling for this type of accident scenario. We also describe our approach we are using to represent advanced flooding analysis.« less

Estimation Of TMDLs And Margin Of Safety Under Conditions Of Uncertainty

EPA Science Inventory

In TMDL development, an adequate margin of safety (MOS) is required in the calculation process to provide a cushion needed because of uncertainties in the data and analysis. Current practices, however, rarely factor analysis' uncertainty in TMDL development and the MOS is largel...

System Guidelines for EMC Safety-Critical Circuits: Design, Selection, and Margin Demonstration

NASA Technical Reports Server (NTRS)

Lawton, R. M.

1996-01-01

Demonstration of required safety margins on critical electrical/electronic circuits in large complex systems has become an implementation and cost problem. These margins are the difference between the activation level of the circuit and the electrical noise on the circuit in the actual operating environment. This document discusses the origin of the requirement and gives a detailed process flow for the identification of the system electromagnetic compatibility (EMC) critical circuit list. The process flow discusses the roles of engineering disciplines such as systems engineering, safety, and EMC. Design and analysis guidelines are provided to assist the designer in assuring the system design has a high probability of meeting the margin requirements. Examples of approaches used on actual programs (Skylab and Space Shuttle Solid Rocket Booster) are provided to show how variations of the approach can be used successfully.

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

Effect of Neutron Absorbers Mixed in or Coating the Fuel of a 1-MWt Lithium-Cooled Space Reactor

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

Amiri, Benjamin W.; Los Alamos National Laboratory, Los Alamos, NM 87545; Poston, David I.

2005-02-06

The goal of this study was to determine the effect of various neutron poisons (boron, dysprosium, erbium, and gadolinium) on a 1-MWt, lithium-cooled liquid-metal reactor. The isotopes were considered to be in-fuel poisons, as well as poisons coating the fuel. One way to quantify the effectiveness of a poison in meeting accident-condition requirements is by defining the safety margin as the difference between keff at the beginning of life and keff during the accident scenarios. The isotope that showed the most potential in increasing the safety margin for the wet-sand/water case was 157Gd. The safety margin was 10%-20% greater usingmore » 157Gd as an in-fuel poison as opposed to a coating, depending on the poison quantity. However, the most limiting condition (i.e., the accident scenario with the highest keff, thus the lowest safety margin) is when the reactor is submerged in wet sand. None of the isotopes considered significantly affected the safety margin for the dry-sand case. However, the poison isotopes considered may have applicability for meeting the wet-sand/water keff requirements or as burnable poisons in a moderated system. The views expressed in this document are those of the author and do not necessarily reflect agreement by the government.« less

Resilient Propulsion Control Research for the NASA Integrated Resilient Aircraft Control (IRAC) Project

NASA Technical Reports Server (NTRS)

Guo, Ten-Huei; Litt, Jonathan S.

2007-01-01

Gas turbine engines are designed to provide sufficient safety margins to guarantee robust operation with an exceptionally long life. However, engine performance requirements may be drastically altered during abnormal flight conditions or emergency maneuvers. In some situations, the conservative design of the engine control system may not be in the best interest of overall aircraft safety; it may be advantageous to "sacrifice" the engine to "save" the aircraft. Motivated by this opportunity, the NASA Aviation Safety Program is conducting resilient propulsion research aimed at developing adaptive engine control methodologies to operate the engine beyond the normal domain for emergency operations to maximize the possibility of safely landing the damaged aircraft. Previous research studies and field incident reports show that the propulsion system can be an effective tool to help control and eventually land a damaged aircraft. Building upon the flight-proven Propulsion Controlled Aircraft (PCA) experience, this area of research will focus on how engine control systems can improve aircraft safe-landing probabilities under adverse conditions. This paper describes the proposed research topics in Engine System Requirements, Engine Modeling and Simulation, Engine Enhancement Research, Operational Risk Analysis and Modeling, and Integrated Flight and Propulsion Controller Designs that support the overall goal.

Relative oral efficacy and acute toxicity of hydroxypyridin-4-one iron chelators in mice

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

Porter, J.B.; Morgan, J.; Hoyes, K.P.

1990-12-01

The relationship between the oral efficacy and the acute toxicity of hydroxypyridin-4-one iron chelators has been investigated to clarify structure-function relationships of these compounds in vivo and to identify compounds with the maximum therapeutic safety margin. By comparing 59Fe excretion following oral or intraperitoneal administration of increasing doses of each chelator to iron-overloaded mice, the most effective compounds have been identified. These have partition coefficients (Kpart) above 0.3 in the iron-free form with a trend of increasing oral efficacy with increasing Kpart values (r = .6). However, this is achieved at a cost of increasing acute toxicity, as shown bymore » a linear correlation between 59Fe excretion increase per unit dose and 1/LD50 (r = .83). A sharp increase in the LD50 values is observed for compounds with Kpart values above 1.0, suggesting that such compounds are unlikely to possess a sufficient therapeutic safety margin. Below a Kpart of 1.0, acute toxicity is relatively independent of lipid solubility. All the compounds are less toxic by the oral route than by the intraperitoneal route, although iron excretion is not significantly different by these two routes. At least five compounds (CP51, CP94, CP93, CP96, and CP21) are more effective orally than the same dose of intraperitoneal desferrioxamine (DFO) (P less than or equal to .02) or orally administered L1(CP20) (P less than or equal to .02).« less

Revenue Sufficiency and Reliability in a Zero Marginal Cost Future

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

Frew, Bethany A.

Features of existing wholesale electricity markets, such as administrative pricing rules and policy-based reliability standards, can distort market incentives from allowing generators sufficient opportunities to recover both fixed and variable costs. Moreover, these challenges can be amplified by other factors, including (1) inelastic demand resulting from a lack of price signal clarity, (2) low- or near-zero marginal cost generation, particularly arising from low natural gas fuel prices and variable generation (VG), such as wind and solar, and (3) the variability and uncertainty of this VG. As power systems begin to incorporate higher shares of VG, many questions arise about themore » suitability of the existing marginal-cost-based price formation, primarily within an energy-only market structure, to ensure the economic viability of resources that might be needed to provide system reliability. This article discusses these questions and provides a summary of completed and ongoing modelling-based work at the National Renewable Energy Laboratory to better understand the impacts of evolving power systems on reliability and revenue sufficiency.« less

Revenue Sufficiency and Reliability in a Zero Marginal Cost Future: Preprint

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

Frew, Bethany A.; Milligan, Michael; Brinkman, Greg

Features of existing wholesale electricity markets, such as administrative pricing rules and policy-based reliability standards, can distort market incentives from allowing generators sufficient opportunities to recover both fixed and variable costs. Moreover, these challenges can be amplified by other factors, including (1) inelastic demand resulting from a lack of price signal clarity, (2) low- or near-zero marginal cost generation, particularly arising from low natural gas fuel prices and variable generation (VG), such as wind and solar, and (3) the variability and uncertainty of this VG. As power systems begin to incorporate higher shares of VG, many questions arise about themore » suitability of the existing marginal-cost-based price formation, primarily within an energy-only market structure, to ensure the economic viability of resources that might be needed to provide system reliability. This article discusses these questions and provides a summary of completed and ongoing modelling-based work at the National Renewable Energy Laboratory to better understand the impacts of evolving power systems on reliability and revenue sufficiency.« less

Increasing Safety of a Robotic System for Inner Ear Surgery Using Probabilistic Error Modeling Near Vital Anatomy

PubMed Central

Dillon, Neal P.; Siebold, Michael A.; Mitchell, Jason E.; Blachon, Gregoire S.; Balachandran, Ramya; Fitzpatrick, J. Michael; Webster, Robert J.

2017-01-01

Safe and effective planning for robotic surgery that involves cutting or ablation of tissue must consider all potential sources of error when determining how close the tool may come to vital anatomy. A pre-operative plan that does not adequately consider potential deviations from ideal system behavior may lead to patient injury. Conversely, a plan that is overly conservative may result in ineffective or incomplete performance of the task. Thus, enforcing simple, uniform-thickness safety margins around vital anatomy is insufficient in the presence of spatially varying, anisotropic error. Prior work has used registration error to determine a variable-thickness safety margin around vital structures that must be approached during mastoidectomy but ultimately preserved. In this paper, these methods are extended to incorporate image distortion and physical robot errors, including kinematic errors and deflections of the robot. These additional sources of error are discussed and stochastic models for a bone-attached robot for otologic surgery are developed. An algorithm for generating appropriate safety margins based on a desired probability of preserving the underlying anatomical structure is presented. Simulations are performed on a CT scan of a cadaver head and safety margins are calculated around several critical structures for planning of a robotic mastoidectomy. PMID:29200595

Increasing safety of a robotic system for inner ear surgery using probabilistic error modeling near vital anatomy

NASA Astrophysics Data System (ADS)

Dillon, Neal P.; Siebold, Michael A.; Mitchell, Jason E.; Blachon, Gregoire S.; Balachandran, Ramya; Fitzpatrick, J. Michael; Webster, Robert J.

2016-03-01

Safe and effective planning for robotic surgery that involves cutting or ablation of tissue must consider all potential sources of error when determining how close the tool may come to vital anatomy. A pre-operative plan that does not adequately consider potential deviations from ideal system behavior may lead to patient injury. Conversely, a plan that is overly conservative may result in ineffective or incomplete performance of the task. Thus, enforcing simple, uniform-thickness safety margins around vital anatomy is insufficient in the presence of spatially varying, anisotropic error. Prior work has used registration error to determine a variable-thickness safety margin around vital structures that must be approached during mastoidectomy but ultimately preserved. In this paper, these methods are extended to incorporate image distortion and physical robot errors, including kinematic errors and deflections of the robot. These additional sources of error are discussed and stochastic models for a bone-attached robot for otologic surgery are developed. An algorithm for generating appropriate safety margins based on a desired probability of preserving the underlying anatomical structure is presented. Simulations are performed on a CT scan of a cadaver head and safety margins are calculated around several critical structures for planning of a robotic mastoidectomy.

Comparing the Affordable Care Act's Financial Impact on Safety-Net Hospitals in States That Expanded Medicaid and Those That Did Not.

PubMed

Dobson, Allen; DaVanzo, Joan E; Haught, Randy; Phap-Hoa, Luu

2017-11-01

Safety-net hospitals play a vital role in delivering health care to Medicaid enrollees, the uninsured, and other vulnerable patients. By reducing the number of uninsured Americans, the Affordable Care Act (ACA) was also expected to lower these hospitals’ significant uncompensated care costs and shore up their financial stability. To examine how the ACA’s Medicaid expansion affected the financial status of safety-net hospitals in states that expanded Medicaid and in states that did not. Using Medicare hospital cost reports for federal fiscal years 2012 and 2015, the authors compared changes in Medicaid inpatient days as a percentage of total inpatient days, Medicaid revenues as a percentage of total net patient revenues, uncompensated care costs as a percentage of total operating costs, and hospital operating margins. Medicaid expansion had a significant, favorable financial impact on safety-net hospitals. From 2012 to 2015, safety-net hospitals in expansion states, compared to those in nonexpansion states, experienced larger increases in Medicaid inpatient days and Medicaid revenues as well as reduced uncompensated care costs. These changes improved operating margins for safety-net hospitals in expansion states. Margins for safety-net hospitals in nonexpansion states, meanwhile, declined.

A soft-contact model for computing safety margins in human prehension.

PubMed

Singh, Tarkeshwar; Ambike, Satyajit

2017-10-01

The soft human digit tip forms contact with grasped objects over a finite area and applies a moment about an axis normal to the area. These moments are important for ensuring stability during precision grasping. However, the contribution of these moments to grasp stability is rarely investigated in prehension studies. The more popular hard-contact model assumes that the digits exert a force vector but no free moment on the grasped object. Many sensorimotor studies use this model and show that humans estimate friction coefficients to scale the normal force to grasp objects stably, i.e. the smoother the surface, the tighter the grasp. The difference between the applied normal force and the minimal normal force needed to prevent slipping is called safety margin and this index is widely used as a measure of grasp planning. Here, we define and quantify safety margin using a more realistic contact model that allows digits to apply both forces and moments. Specifically, we adapt a soft-contact model from robotics and demonstrate that the safety margin thus computed is a more accurate and robust index of grasp planning than its hard-contact variant. Previously, we have used the soft-contact model to propose two indices of grasp planning that show how humans account for the shape and inertial properties of an object. A soft-contact based safety margin offers complementary insights by quantifying how humans may account for surface properties of the object and skin tissue during grasp planning and execution. Copyright © 2017 Elsevier B.V. All rights reserved.

Hydraulic safety margins and embolism reversal in stems and leaves: Why are conifers and angiosperms so different?

Treesearch

Daniel M. Johnson; Katherine A. McCulloh; David R. Woodruff; Frederick C. Meinzer

2012-01-01

Angiosperm and coniferous tree species utilize a continuum of hydraulic strategies. Hydraulic safety margins (defined as differences between naturally occurring xylem pressures and pressures that would cause hydraulic dysfunction, or differences between pressures resulting in loss of hydraulic function in adjacent organs (e.g., stems vs. leaves) tend to be much greater...

Derivation of improved load transformation matrices for launchers-spacecraft coupled analysis, and direct computation of margins of safety

NASA Technical Reports Server (NTRS)

Klein, M.; Reynolds, J.; Ricks, E.

1989-01-01

Load and stress recovery from transient dynamic studies are improved upon using an extended acceleration vector in the modal acceleration technique applied to structural analysis. Extension of the normal LTM (load transformation matrices) stress recovery to automatically compute margins of safety is presented with an application to the Hubble space telescope.

Quantifying Safety Margin Using the Risk-Informed Safety Margin Characterization (RISMC)

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

Grabaskas, David; Bucknor, Matthew; Brunett, Acacia

2015-04-26

The Risk-Informed Safety Margin Characterization (RISMC), developed by Idaho National Laboratory as part of the Light-Water Reactor Sustainability Project, utilizes a probabilistic safety margin comparison between a load and capacity distribution, rather than a deterministic comparison between two values, as is usually done in best-estimate plus uncertainty analyses. The goal is to determine the failure probability, or in other words, the probability of the system load equaling or exceeding the system capacity. While this method has been used in pilot studies, there has been little work conducted investigating the statistical significance of the resulting failure probability. In particular, it ismore » difficult to determine how many simulations are necessary to properly characterize the failure probability. This work uses classical (frequentist) statistics and confidence intervals to examine the impact in statistical accuracy when the number of simulations is varied. Two methods are proposed to establish confidence intervals related to the failure probability established using a RISMC analysis. The confidence interval provides information about the statistical accuracy of the method utilized to explore the uncertainty space, and offers a quantitative method to gauge the increase in statistical accuracy due to performing additional simulations.« less

Concept and setup for intraoperative imaging of tumorous tissue via Attenuated Total Reflection spectrosocopy with Quantum Cascade Lasers

NASA Astrophysics Data System (ADS)

Geiger, Florian B.; Koerdel, Martin; Schick, Anton; Heimann, Axel; Matiasek, Kaspar; Herkommer, Alois M.

2015-03-01

A major challenge in tumor surgery is the differentiation between normal and malignant tissue. Since an incompletely resected tumor easily leads to recidivism, the gold standard is to remove malignant tissue with a sufficient safety margin and send it to pathology for examination with patho-histological techniques (rapid section diagnosis). This approach, however, exhibits several disadvantages: The removal of additional tissue (safety margin) means additional stress to the patient; the correct interpretation of proper tumor excision relies on the pathologist's experience and the waiting time between resection and pathological result can be more than 45 minutes. This last aspect implies unnecessary occupation of cost-intensive operating room staff as well as longer anesthesia for the patient. Various research groups state that hyperspectral imaging in the mid-infrared, especially in the so called "fingerprint region", allows spatially resolved discrimination between normal and malignant tissue. All these experiments, though, took place in a laboratory environment and were conducted on dried, ex vivo tissue and on a microscopic scale. It is therefore our aim to develop a system incorporating the following properties: Intraoperatively and in vivo applicable, measurement time shorter than one minute, based on mid infrared spectroscopy, providing both spectral and spatial information and no use of external fluorescence markers. Theoretical assessment of different concepts and experimental studies show that a setup based on a tunable Quantum Cascade Laser and Attenuated Total Reflection seems feasible for in vivo tissue discrimination via imaging. This is confirmed by experiments with a first demonstrator.

Predictors of Payer Mix and Financial Performance Among Safety Net Hospitals Prior to the Affordable Care Act.

PubMed

Sommers, Benjamin D; Stone, Juliana; Kane, Nancy

2016-01-01

The objective of this study was to use audited hospital financial statements to identify predictors of payer mix and financial performance in safety net hospitals prior to the Affordable Care Act. We analyzed the 2010 financial statements of 98 large, urban safety net hospital systems in 34 states, supplemented with data on population demographics, hospital features, and state policies. We used multivariate regression to identify independent predictors of three outcomes: 1) Medicaid-reliant payer mix (hospitals for which at least 25% of hospital days are paid for by Medicaid); 2) safety net revenue-to-cost ratio (Medicaid and Medicare Disproportionate Share Hospital payments and local government transfers, divided by charity care costs and Medicaid payment shortfall); and 3) operating margin. Medicaid-reliant payer mix was positively associated with more inclusive state Medicaid eligibility criteria and more minority patients. More inclusive Medicaid eligibility and higher Medicaid reimbursement rates positively predicted safety net revenue-to-cost ratio. University governance was the strongest positive predictor of operating margin. Safety net hospital financial performance varied considerably. Academic hospitals had higher operating margins, while more generous Medicaid eligibility and reimbursement policies improved hospitals' ability to recoup costs. Institutional and state policies may outweigh patient demographics in the financial health of safety net hospitals. © The Author(s) 2015.

In Space Nuclear Power as an Enabling Technology for Deep Space Exploration

NASA Technical Reports Server (NTRS)

Sackheim, Robert L.; Houts, Michael

2000-01-01

Deep Space Exploration missions, both for scientific and Human Exploration and Development (HEDS), appear to be as weight limited today as they would have been 35 years ago. Right behind the weight constraints is the nearly equally important mission limitation of cost. Launch vehicles, upper stages and in-space propulsion systems also cost about the same today with the same efficiency as they have had for many years (excluding impact of inflation). Both these dual mission constraints combine to force either very expensive, mega systems missions or very light weight, but high risk/low margin planetary spacecraft designs, such as the recent unsuccessful attempts for an extremely low cost mission to Mars during the 1998-99 opportunity (i.e., Mars Climate Orbiter and the Mars Polar Lander). When one considers spacecraft missions to the outer heliopause or even the outer planets, the enormous weight and cost constraints will impose even more daunting concerns for mission cost, risk and the ability to establish adequate mission margins for success. This paper will discuss the benefits of using a safe in-space nuclear reactor as the basis for providing both sufficient electric power and high performance space propulsion that will greatly reduce mission risk and significantly increase weight (IMLEO) and cost margins. Weight and cost margins are increased by enabling much higher payload fractions and redundant design features for a given launch vehicle (higher payload fraction of IMLEO). The paper will also discuss and summarize the recent advances in nuclear reactor technology and safety of modern reactor designs and operating practice and experience, as well as advances in reactor coupled power generation and high performance nuclear thermal and electric propulsion technologies. It will be shown that these nuclear power and propulsion technologies are major enabling capabilities for higher reliability, higher margin and lower cost deep space missions design to reliably reach the outer planets for scientific exploration.

Co-ordination of growth, gas exchange and hydraulics define the carbon safety margin in tree species with contrasting drought strategies.

PubMed

Mitchell, P J; O'Grady, A P; Tissue, D T; Worledge, D; Pinkard, E A

2014-05-01

Gas exchange, growth, water transport and carbon (C) metabolism diminish during drought according to their respective sensitivities to declining water status. The timing of this sequence of declining physiological functions may determine how water and C relations compromise plant survival. In this paper, we test the hypothesis that the degree of asynchrony between declining C supply (photosynthesis) and C demand (growth and respiration) determines the rate and magnitude of changes in whole-plant non-structural carbohydrates (NSC) during drought. Two complementary experiments using two tree species (Eucalyptus globulus Labill. and Pinus radiata D. Don) with contrasting drought response strategies were performed to (i) assess changes in radial stem growth, transpiration, leaf water potential and gas exchange in response to chronic drought, and (ii) evaluate the concomitant impacts of these drought responses on the temporal patterns of NSC during terminal drought. The three distinct phases of water stress were delineated by thresholds of growth cessation and stomatal closure that defined the 'carbon safety margin' (i.e., the difference between leaf water potential when growth is zero and leaf water potential when net photosynthesis is zero). A wider C safety margin in E. globulus was defined by an earlier cessation of growth relative to photosynthesis that reduced the demand for NSC while maintaining C acquisition. By contrast, the narrower C safety margin in P. radiata was characterized by a synchronous decline in growth and photosynthesis, whereby growth continued under a declining supply of NSC from photosynthesis. The narrower C safety margin in P. radiata was associated with declines in starch concentrations after ∼ 90 days of chronic drought and significant depletion of starch in all organs at mortality. The observed divergence in the sensitivity of drought responses is indicative of a potential trade-off between maintaining hydraulic safety and adequate C availability. © The Author 2014. Published by Oxford University Press. All rights reserved.

Margins of safety provided by COSHH Essentials and the ILO Chemical Control Toolkit.

PubMed

Jones, Rachael M; Nicas, Mark

2006-03-01

COSHH Essentials, developed by the UK Health and Safety Executive, and the Chemical Control Toolkit (Toolkit) proposed by the International Labor Organization, are 'control banding' approaches to workplace risk management intended for use by proprietors of small and medium-sized businesses. Both systems group chemical substances into hazard bands based on toxicological endpoint and potency. COSSH Essentials uses the European Union's Risk-phrases (R-phrases), whereas the Toolkit uses R-phrases and the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals. Each hazard band is associated with a range of airborne concentrations, termed exposure bands, which are to be attained by the implementation of recommended control technologies. Here we analyze the margin of safety afforded by the systems and, for each hazard band, define the minimal margin as the ratio of the minimum airborne concentration that produced the toxicological endpoint of interest in experimental animals to the maximum concentration in workplace air permitted by the exposure band. We found that the minimal margins were always <100, with some ranging to <1, and inversely related to molecular weight. The Toolkit-GHS system generally produced margins equal to or larger than COSHH Essentials, suggesting that the Toolkit-GHS system is more protective of worker health. Although, these systems predict exposures comparable with current occupational exposure limits, we argue that the minimal margins are better indicators of health protection. Further, given the small margins observed, we feel it is important that revisions of these systems provide the exposure bands to users, so as to permit evaluation of control technology capture efficiency.

Nuclear power: Siting and safety

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

Openshaw, S.

1986-01-01

By 2030, half, or even two-thirds, of all electricity may be generated by nuclear power. Major reactor accidents are still expected to be rare occurrences, but nuclear safety is largely a matter of faith. Terrorist attacks, sabotage, and human error could cause a significant accident. Reactor siting can offer an additional, design-independent margin of safety. Remote geographical sites for new plants would minimize health risks, protect the industry from negative changes in public opinion concerning nuclear energy, and improve long-term public acceptance of nuclear power. U.K. siting practices usually do not consider the contribution to safety that could be obtainedmore » from remote sites. This book discusses the present trends of siting policies of nuclear power and their design-independent margin of safety.« less

Coordination of xylem hydraulics and stomatal regulation in keeping the integrity of xylem water transport in shoots of two compound-leaved tree species.

PubMed

Liu, Yan-Yan; Song, Jia; Wang, Miao; Li, Na; Niu, Cun-Yang; Hao, Guang-You

2015-12-01

Hydraulic segmentation between proximal and distal organs has been hypothesized to be an important protective mechanism for plants to minimize the detrimental effects of drought-induced hydraulic failure. Uncertainties still exist regarding the degree of segmentation and the role of stomatal regulation in keeping hydraulic integrity of organs at different hierarchies. In the present study, we measured hydraulic conductivity and vulnerability in stems, compound leaf petioles and leaflet laminas of Fraxinus mandshurica Rupr. and Juglans mandshurica Maxim. growing in Changbai Mountain of Northeast China to identify the main locality where hydraulic segmentation occurs along the shoot water transport pathway. Stomatal conductance in response to leaf water potential change was also measured to investigate the role of stomatal regulation in avoiding extensive transpiration-induced embolism. No major contrasts were found between stems and compound leaf petioles in either hydraulic conductivity or vulnerability to drought-induced embolism, whereas a large difference in hydraulic vulnerability exists between compound leaf petioles and leaflet laminas. Furthermore, in contrast to the relatively large safety margins in stems (4.13 and 2.04 MPa) and compound leaf petioles (1.33 and 1.93 MPa), leaflet lamina hydraulic systems have substantially smaller or even negative safety margins (-0.17 and 0.47 MPa) in F. mandshurica and J. mandshurica. Under unstressed water conditions, gas exchange may be better optimized by allowing leaflet vascular system function with small safety margins. In the meantime, hydraulic safety of compound leaf petioles and stems are guaranteed by their large safety margins. In facing severe drought stress, larger safety margins in stems than in compound leaf petioles would allow plants to minimize the risk of catastrophic embolism in stems by sacrificing the whole compound leaves. A strong coordination between hydraulic and stomatal regulation appears to play a critical role in balancing the competing efficiency and safety requirements for xylem water transport and use in plants. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

ELQ-300 prodrugs for enhanced delivery and single-dose cure of malaria.

PubMed

Miley, Galen P; Pou, Sovitj; Winter, Rolf; Nilsen, Aaron; Li, Yuexin; Kelly, Jane X; Stickles, Allison M; Mather, Michael W; Forquer, Isaac P; Pershing, April M; White, Karen; Shackleford, David; Saunders, Jessica; Chen, Gong; Ting, Li-Min; Kim, Kami; Zakharov, Lev N; Donini, Cristina; Burrows, Jeremy N; Vaidya, Akhil B; Charman, Susan A; Riscoe, Michael K

2015-09-01

ELQ-300 is a preclinical candidate that targets the liver and blood stages of Plasmodium falciparum, as well as the forms that are crucial to transmission of disease: gametocytes, zygotes, and ookinetes. A significant obstacle to the clinical development of ELQ-300 is related to its physicochemical properties. Its relatively poor aqueous solubility and high crystallinity limit absorption to the degree that only low blood concentrations can be achieved following oral dosing. While these low blood concentrations are sufficient for therapy, the levels are too low to establish an acceptable safety margin required by regulatory agencies for clinical development. One way to address the challenging physicochemical properties of ELQ-300 is through the development of prodrugs. Here, we profile ELQ-337, a bioreversible O-linked carbonate ester prodrug of the parent molecule. At the molar equivalent dose of 3 mg/kg of body weight, the delivery of ELQ-300 from ELQ-337 is enhanced by 3- to 4-fold, reaching a maximum concentration of drug in serum (C max) of 5.9 μM by 6 h after oral administration, and unlike ELQ-300 at any dose, ELQ-337 provides single-dose cures of patent malaria infections in mice at low-single-digit milligram per kilogram doses. Our findings show that the prodrug strategy represents a viable approach to overcome the physicochemical limitations of ELQ-300 to deliver the active drug to the bloodstream at concentrations sufficient for safety and toxicology studies, as well as achieving single-dose cures. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Developing Probabilistic Safety Performance Margins for Unknown and Underappreciated Risks

NASA Technical Reports Server (NTRS)

Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris

2015-01-01

Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.

Negative Stress Margins - Are They Real?

NASA Technical Reports Server (NTRS)

Raju, Ivatury S.; Lee, Darlene S.; Mohaghegh, Michael

2011-01-01

Advances in modeling and simulation, new finite element software, modeling engines and powerful computers are providing opportunities to interrogate designs in a very different manner and in a more detailed approach than ever before. Margins of safety are also often evaluated using local stresses for various design concepts and design parameters quickly once analysis models are defined and developed. This paper suggests that not all the negative margins of safety evaluated are real. The structural areas where negative margins are frequently encountered are often near stress concentrations, point loads and load discontinuities, near locations of stress singularities, in areas having large gradients but with insufficient mesh density, in areas with modeling issues and modeling errors, and in areas with connections and interfaces, in two-dimensional (2D) and three-dimensional (3D) transitions, bolts and bolt modeling, and boundary conditions. Now, more than ever, structural analysts need to examine and interrogate their analysis results and perform basic sanity checks to determine if these negative margins are real.

Margin of Safety Definition and Examples Used in Safety Basis Documents and the USQ Process

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

Beaulieu, R. A.

The Nuclear Safety Management final rule, 10 CFR 830, provides an undefined term, margin of safety (MOS). Safe harbors listed in 10 CFR 830, Table 2, such as DOE-STD-3009 use but do not define the term. This lack of definition has created the need for the definition. This paper provides a definition of MOS and documents examples of MOS as applied in a U.S. Department of Energy (DOE) approved safety basis for an existing nuclear facility. If we understand what MOS looks like regarding Technical Safety Requirements (TSR) parameters, then it helps us compare against other parameters that do notmore » involve a MOS. This paper also documents parameters that are not MOS. These criteria could be used to determine if an MOS exists in safety basis documents. This paper helps DOE, including the National Nuclear Security Administration (NNSA) and its contractors responsible for the safety basis improve safety basis documents and the unreviewed safety question (USQ) process with respect to MOS.« less

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

Kiselyov, V.A.; Sokov, L.M.

The LBB regulatory approach adopted in Russia in 1993 as an extra safety barrier is described for advanced WWER 1000 reactor steamline. The application of LBB concept requires the following additional protections. First, the steamline should be a highly qualified piping, performed in accordance with the applicable regulations and guidelines, carefully screened to verify that it is not subjected to any disqualifying failure mechanism. Second, a deterministic fracture mechanics analysis and leak rate evaluation have been performed to demonstrate that postulated through-wall crack that yields 95 1/min at normal operation conditions is stable even under seismic loads. Finally, it hasmore » been verified that the leak detection systems are sufficiently reliable, diverse and sensitive, and that adequate margins exist to detect a through wall crack smaller than the critical size. The obtained results are encouraging and show the possibility of the application of the LBB case to the steamline of advanced WWER 1000 reactor.« less

Portal imaging based definition of the planning target volume during pelvic irradiation for gynecological malignancies.

PubMed

Mock, U; Dieckmann, K; Wolff, U; Knocke, T H; Pötter, R

1999-08-01

Geometrical accuracy in patient positioning can vary substantially during external radiotherapy. This study estimated the set-up accuracy during pelvic irradiation for gynecological malignancies for determination of safety margins (planning target volume, PTV). Based on electronic portal imaging devices (EPID), 25 patients undergoing 4-field pelvic irradiation for gynecological malignancies were analyzed with regard to set-up accuracy during the treatment course. Regularly performed EPID images were used in order to systematically assess the systematic and random component of set-up displacements. Anatomical matching of verification and simulation images was followed by measuring corresponding distances between the central axis and anatomical features. Data analysis of set-up errors referred to the x-, y-,and z-axes. Additionally, cumulative frequencies were evaluated. A total of 50 simulation films and 313 verification images were analyzed. For the anterior-posterior (AP) beam direction mean deviations along the x- and z-axes were 1.5 mm and -1.9 mm, respectively. Moreover, random errors of 4.8 mm (x-axis) and 3.0 mm (z-axis) were determined. Concerning the latero-lateral treatment fields, the systematic errors along the two axes were calculated to 2.9 mm (y-axis) and -2.0 mm (z-axis) and random errors of 3.8 mm and 3.5 mm were found, respectively. The cumulative frequency of misalignments < or =5 mm showed values of 75% (AP fields) and 72% (latero-lateral fields). With regard to cumulative frequencies < or =10 mm quantification revealed values of 97% for both beam directions. During external pelvic irradiation therapy for gynecological malignancies, EPID images on a regular basis revealed acceptable set-up inaccuracies. Safety margins (PTV) of 1 cm appear to be sufficient, accounting for more than 95% of all deviations.

Prediction of Safety Margin and Optimization of Dosing Protocol for a Novel Antibiotic using Quantitative Systems Pharmacology Modeling.

PubMed

Woodhead, Jeffrey L; Paech, Franziska; Maurer, Martina; Engelhardt, Marc; Schmitt-Hoffmann, Anne H; Spickermann, Jochen; Messner, Simon; Wind, Mathias; Witschi, Anne-Therese; Krähenbühl, Stephan; Siler, Scott Q; Watkins, Paul B; Howell, Brett A

2018-06-07

Elevations of liver enzymes have been observed in clinical trials with BAL30072, a novel antibiotic. In vitro assays have identified potential mechanisms for the observed hepatotoxicity, including electron transport chain (ETC) inhibition and reactive oxygen species (ROS) generation. DILIsym, a quantitative systems pharmacology (QSP) model of drug-induced liver injury, has been used to predict the likelihood that each mechanism explains the observed toxicity. DILIsym was also used to predict the safety margin for a novel BAL30072 dosing scheme; it was predicted to be low. DILIsym was then used to recommend potential modifications to this dosing scheme; weight-adjusted dosing and a requirement to assay plasma alanine aminotransferase (ALT) daily and stop dosing as soon as ALT increases were observed improved the predicted safety margin of BAL30072 and decreased the predicted likelihood of severe injury. This research demonstrates a potential application for QSP modeling in improving the safety profile of candidate drugs. © 2018 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

A theory and model of conflict detection in air traffic control: incorporating environmental constraints.

PubMed

Loft, Shayne; Bolland, Scott; Humphreys, Michael S; Neal, Andrew

2009-06-01

A performance theory for conflict detection in air traffic control is presented that specifies how controllers adapt decisions to compensate for environmental constraints. This theory is then used as a framework for a model that can fit controller intervention decisions. The performance theory proposes that controllers apply safety margins to ensure separation between aircraft. These safety margins are formed through experience and reflect the biasing of decisions to favor safety over accuracy, as well as expectations regarding uncertainty in aircraft trajectory. In 2 experiments, controllers indicated whether they would intervene to ensure separation between pairs of aircraft. The model closely predicted the probability of controller intervention across the geometry of problems and as a function of controller experience. When controller safety margins were manipulated via task instructions, the parameters of the model changed in the predicted direction. The strength of the model over existing and alternative models is that it better captures the uncertainty and decision biases involved in the process of conflict detection. (PsycINFO Database Record (c) 2009 APA, all rights reserved).

Final stress analysis report ultraviolet spectrometer S169

NASA Technical Reports Server (NTRS)

Cooper, S.

1971-01-01

The stress analysis report verifies the structural integrity of the Apollo S-169 UV-spectrometer experiment. The methods by which the various members were analyzed are described. A detailed summary of results for the individual structural elements appears in the form of a table of minimum margins of safety. No negative margins of safety were experienced. It is concluded that the component structure is more than adequate to withstand the environmental load conditions given in the design criteria.

Hydraulic safety margins and air-seeding thresholds in roots, trunks, branches and petioles of four northern hardwood trees.

PubMed

Wason, Jay W; Anstreicher, Katherine S; Stephansky, Nathan; Huggett, Brett A; Brodersen, Craig R

2018-04-16

During drought, xylem sap pressures can approach or exceed critical thresholds where gas embolisms form and propagate through the xylem network, leading to systemic hydraulic dysfunction. The vulnerability segmentation hypothesis (VSH) predicts that low-investment organs (e.g. leaf petioles) should be more vulnerable to embolism spread compared to high-investment, perennial organs (e.g. trunks, stems), as a means of mitigating embolism spread and excessive negative pressures in the perennial organs. We tested this hypothesis by measuring air-seeding thresholds using the single-vessel air-injection method and calculating hydraulic safety margins in four northern hardwood tree species of the northeastern United States, in both saplings and canopy height trees, and at five points along the soil-plant-atmosphere continuum. Acer rubrum was the most resistant to air-seeding and generally supported the VSH. However, Fagus grandifolia, Fraxinus americana and Quercus rubra showed little to no variation in air-seeding thresholds across organ types within each species. Leaf-petiole xylem operated at water potentials close to or exceeding their hydraulic safety margins in all species, whereas roots, trunks and stems of A. rubrum, F. grandifolia and Q. rubra operated within their safety margins, even during the third-driest summer in the last 100 yr. © 2018 The Authors. New Phytologist © 2018 New Phytologist Trust.

Limitations and tradeoffs in synchronization of large-scale networks with uncertain links

PubMed Central

Diwadkar, Amit; Vaidya, Umesh

2016-01-01

The synchronization of nonlinear systems connected over large-scale networks has gained popularity in a variety of applications, such as power grids, sensor networks, and biology. Stochastic uncertainty in the interconnections is a ubiquitous phenomenon observed in these physical and biological networks. We provide a size-independent network sufficient condition for the synchronization of scalar nonlinear systems with stochastic linear interactions over large-scale networks. This sufficient condition, expressed in terms of nonlinear dynamics, the Laplacian eigenvalues of the nominal interconnections, and the variance and location of the stochastic uncertainty, allows us to define a synchronization margin. We provide an analytical characterization of important trade-offs between the internal nonlinear dynamics, network topology, and uncertainty in synchronization. For nearest neighbour networks, the existence of an optimal number of neighbours with a maximum synchronization margin is demonstrated. An analytical formula for the optimal gain that produces the maximum synchronization margin allows us to compare the synchronization properties of various complex network topologies. PMID:27067994

[Nitrates (V) in drinking water as factor of a health risk for people in Podlaskie Voivodship].

PubMed

Szczerbiński, Robert; Karczewski, Jan; Fiłon, Joanna

2006-01-01

The aim of this article was to evaluate of a health danger and to estimate the risk due to the presence of nitrates (V) in drinking water used by people in Podlaskie Voivodship. For research I used water specimens taken in 14 poviats (smaller administration districts) in Podlaskie Voivodship as part of drinking water quality monitoring in the years 2001-2003. Evaluation of danger of nitrates (V) taken in with drinking water by the population of Podlaskie Voivodship was carried out by comparing ADI (Acceptable Daily Intake) with value of EDI (Evaluated Daily Intake) and TMDI (Theoretical Maximum Daily Intake) Risk was estimated by calculating safety margin between ADI and EDI. On the basis of the obtained results it was stated that on the territory of Podlaskie Voivodship 1.79% of urban population and 4.86% of rural population, was taking in nitrates (V) with water supplied by waterworks in doses below the safety margin. Nitrates (V) from drinking water in doses below the safety margin were taken in by population of 10 poviats, with the highest percentage of the population noted in the poviats of: Grajewo (10.97%), Augustów (10.77%) and Sejny (10.43%). Among the urban population the highest percentage noted in the Poviat of Augustów (9.46%), and among the rural population--in the Poviat of Grajewo (22.46%). The highest percentage of the population (69.97%) in Podlaskie Voivodship consumed nitrates (V) with drinking water supplied by waterworks in the range of the safety margin from 1 to 10, including 78.86% of urban population and 53.3% of rural population. It seems useful to continue the environmental research on the exposure of Podlaskie Voivodship inhabitants to nitrates by correlating the risk expressed by the safety margin with cancer epidemiology.

Margins Associated with Loss of Assured Safety for Systems with Multiple Time-Dependent Failure Modes.

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

Helton, Jon C.; Brooks, Dusty Marie; Sallaberry, Cedric Jean-Marie.

Representations for margins associated with loss of assured safety (LOAS) for weak link (WL)/strong link (SL) systems involving multiple time-dependent failure modes are developed. The following topics are described: (i) defining properties for WLs and SLs, (ii) background on cumulative distribution functions (CDFs) for link failure time, link property value at link failure, and time at which LOAS occurs, (iii) CDFs for failure time margins defined by (time at which SL system fails) – (time at which WL system fails), (iv) CDFs for SL system property values at LOAS, (v) CDFs for WL/SL property value margins defined by (property valuemore » at which SL system fails) – (property value at which WL system fails), and (vi) CDFs for SL property value margins defined by (property value of failing SL at time of SL system failure) – (property value of this SL at time of WL system failure). Included in this presentation is a demonstration of a verification strategy based on defining and approximating the indicated margin results with (i) procedures based on formal integral representations and associated quadrature approximations and (ii) procedures based on algorithms for sampling-based approximations.« less

Safe insertion of S-2 alar iliac screws: radiological comparison between 2 insertion points using computed tomography and 3D analysis software.

PubMed

Yamada, Kentaro; Abe, Yuichiro; Satoh, Shigenobu

2018-05-01

OBJECTIVE S-2 alar iliac (S2AI) screws are commonly used as anchors for lumbosacral fixation. A serious potential complication of screw insertion is major vascular injury due to anterior or caudal screw deviation. To avoid screw deviation, the pelvic inlet view on intraoperative fluoroscopy images is recommended. However, there has been no detailed investigation of optimal fluoroscopic incline with the pelvic inlet view. The purpose of this study was to investigate the safety margins and to optimize fluoroscopic settings to avoid screw deviation with 2 reported insertion techniques using 3D analysis software and CT. METHODS The study included 50 patients (25 men and 25 women) who underwent abdominal-pelvic CT. With the use of software, the ideal S2AI screws were set from 2 entry points: A) the midpoint between the S-1 dorsal foramen and the S-2 dorsal foramen where they meet the lateral sacral crest, and B) 1 mm inferior and 1 mm lateral to the S-1 dorsal foramen. Anteriorly or caudally deviated screws were defined as deviation of a half thread of the ideal screw by rotation anteriorly or caudally from the entry point. The angular safety margins were compared between the 2 entry points, and patients with small safety margins were investigated. Subsequently, fluoroscopic images were virtualized on ray sum-rendered images. Conditions that provided proper recognition of screw deviation were investigated via lateral and anteroposterior views with the beam tilted caudally. RESULTS The safety margins of S2AI screws were smaller in the anterior direction than in the caudal direction and by entry point A than by entry point B (A: 9.1° ± 1.6° and B: 9.7° ± 1.5° in the anterior direction; A: 10.9° ± 3.8° and B: 13.9° ± 4.1° in the caudal direction). In contrast, patients with a deep-seated L-5 vertebral body tended to have smaller safety margins in the caudal direction. All anteriorly deviated screws were recognized with a 60°-70° inlet view from the S-1 slope. The caudally deviated screws were all recognized on the lateral view, but 31% of screws at entry point A and 21% of screws at entry point B were not recognized on the pelvic inlet view. CONCLUSIONS S2AI screws should be carefully placed to avoid anterior deviation compared with caudal deviation in terms of the safety margin, except in patients with a deep-seated L-5. The difference in safety margins between entry points A and B was negligible. Intraoperative fluoroscopy is recommended with a pelvic inlet view tilted 60°-70° from the S-1 slope to avoid anterior screw deviation. The lateral view is recommended to confirm that the screw is not deviated caudally.

Probabilistic margin evaluation on accidental transients for the ASTRID reactor project

NASA Astrophysics Data System (ADS)

Marquès, Michel

2014-06-01

ASTRID is a technological demonstrator of Sodium cooled Fast Reactor (SFR) under development. The conceptual design studies are being conducted in accordance with the Generation IV reactor objectives, particularly in terms of improving safety. For the hypothetical events, belonging to the accidental category "severe accident prevention situations" having a very low frequency of occurrence, the safety demonstration is no more based on a deterministic demonstration with conservative assumptions on models and parameters but on a "Best-Estimate Plus Uncertainty" (BEPU) approach. This BEPU approach ispresented in this paper for an Unprotected Loss-of-Flow (ULOF) event. The Best-Estimate (BE) analysis of this ULOFt ransient is performed with the CATHARE2 code, which is the French reference system code for SFR applications. The objective of the BEPU analysis is twofold: first evaluate the safety margin to sodium boiling in taking into account the uncertainties on the input parameters of the CATHARE2 code (twenty-two uncertain input parameters have been identified, which can be classified into five groups: reactor power, accident management, pumps characteristics, reactivity coefficients, thermal parameters and head losses); secondly quantify the contribution of each input uncertainty to the overall uncertainty of the safety margins, in order to refocusing R&D efforts on the most influential factors. This paper focuses on the methodological aspects of the evaluation of the safety margin. At least for the preliminary phase of the project (conceptual design), a probabilistic criterion has been fixed in the context of this BEPU analysis; this criterion is the value of the margin to sodium boiling, which has a probability 95% to be exceeded, obtained with a confidence level of 95% (i.e. the M5,95percentile of the margin distribution). This paper presents two methods used to assess this percentile: the Wilks method and the Bootstrap method ; the effectiveness of the two methods is compared on the basis of 500 simulations performed with theCATHARE2 code. We conclude that, with only 100 simulations performed with the CATHARE2 code, which is a number of simulations workable in the conceptual design phase of the ASTRID project where the models and the hypothesis are often modified, it is best in order to evaluate the percentile M5,95 of the margin to sodium boiling to use the bootstrap method, which will provide a slightly conservative result. On the other hand, in order to obtain an accurate estimation of the percentileM5,95, for the safety report for example, it will be necessary to perform at least 300 simulations with the CATHARE2 code. In this case, both methods (Wilks and Bootstrap) would give equivalent results.

Cryptosporidium and Giardia safety margin increase in leafy green vegetables irrigated with treated wastewater.

PubMed

Domenech, Eva; Amorós, Inmaculada; Moreno, Yolanda; Alonso, José L

2018-01-01

The presence of Cryptosporidium and Giardia in waste water is a main concern because water reuse for irrigation can jeopardize human health. Spanish Legislation for water reuse does not oblige to analyze the presence of both pathogens Cryptosporidium and Giardia in reused water for irrigation. Therefore, the objective of this paper is to determine the influence of wastewater treatment in the increase of the consumer safety margin in relation to the presence of Cryptosporidium and Giardia in leafy green vegetables. With this aim in mind, a total of 108 samples from raw (influent) and treated wastewater (effluent) from three wastewater treatment plants in Spain were analysed according to USEPA Method 1623. Effluent results show that Cryptosporidium oocysts average counts ranged from 1.38 to 2.6/L oocysts and Giardia cysts ranged from 0.6 to 1.7/L cysts, which means a removal values of 2.7 log, 2.5 log and 1.8 log for Cryptosporidium oocysts and 1 log, 2 log and 2.2 log for Giardia cysts in the three wastewater treatment plants analysed. In relation to safety margin the highest probability that exposure exceed the dose response was observed for Giardia. In addition, the sensitivity analysis showed that (oo)cysts concentration present in the leafy green vegetables and the human dose-response were the most influential inputs in the safety margin obtained. Copyright © 2017 The Authors. Published by Elsevier GmbH.. All rights reserved.

A quantitative comparison of the safety margins in the european indicative occupational exposure limits and the derived no-effect levels for workers under REACH.

PubMed

Schenk, Linda; Johanson, Gunnar

2011-06-01

The new European Union (EU) REACH legislation requires derived no-effect levels (DNELs) to be calculated for substances produced in quantities above 10 tonnes/year. Meanwhile, the setting of occupational exposure limits (OELs) continues both at the member state and the EU levels. According to REACH, indicative OEL values (IOELVs) from the Commission may under some circumstances be used as worker-DNELs. On the other hand, worker-DNELs will be derived for several thousand substances, far more than the approximately 100 substances for which IOELVs have been established. Thus, the procedure to set health-based OELs may become influential on that of DNELs and vice versa. In this study, we compare the safety margins of 88 Scientific Committee on OELs (SCOEL) recommendations with those of the corresponding worker-DNELs, derived according to the default approach as described in the REACH guidance document. Overall, the REACH safety margins were approximately six times higher than those derived from the SCOEL documentation but varied widely with REACH/SCOEL safety margin ratios ranging by two orders of magnitude, from 0.3 to 58 (n = 88). The discrepancies may create confusion in terms of legal compliance, risk management, and risk communication. We also found that the REACH guidance document, although encompassing detailed advice on many issues, including default assessment factors for species and route extrapolation, gives little quantitative guidance on when and how to depart from defaults.

Lunar Reconnaissance Orbiter K-Band (26 GHz) Signal Analysis: Initial Study Results

NASA Astrophysics Data System (ADS)

Morabito, D. D.; Heckman, D.

2017-11-01

Lower frequency telemetry bands are becoming more limited in bandwidth due to increased competition between flight projects and other entities. Higher frequency bands offer significantly more bandwidth and hence the prospect of much higher data rates. Future or prospective flight projects considering higher frequency bands such as Ka-band (32 GHz) for deep-space and K-band (26 GHz) for near-Earth telemetry links are interested in past flight experience with available received data at these frequencies. Given that there is increased degradation due to the atmosphere at these higher frequencies, there is an effort to retrieve flight data of received signal strength to analyze performance under a variety of factors. Such factors include elevation angle, season, and atmospheric conditions. This article reports on the analysis findings of over 10 million observations of received signal strength of the Lunar Reconnaissance Orbiter (LRO) spacecraft collected between 2014 and 2017. We analyzed these data to characterize link performance over a wide range of weather conditions, season, and as a function of elevation angle. Based on this analysis, we have confirmed the safety of using a 3-dB margin for preflight planning purposes. These results suggest that a 3-dB margin with respect to adverse conditions will ensure a 98 to 99 percent data return under 95 percent weather conditions at 26 GHz (K-band), thus confirming expectations from link budget predictions. The results suggest that this margin should be applicable for all elevation angles above 10 deg. Thus, missions that have sufficient power for their desired data rates may opt to use 10 deg as their minimum elevation angle. Limitations of this study include climate variability and the fact that the observations require removal of hotbody noise in order to perform an adequate cumulative distribution function (CDF) analysis, which is planned for a future comprehensive study. Flight projects may use other link margins depending upon available information, uncertainties of non-atmospheric link parameters, and mission phase.

Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD).

PubMed

2012-11-01

All countries face challenges in making sufficient supplies of blood and blood products available and sustainable, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health. Since 1975, the World Health Assembly (WHA) has highlighted the global need for blood safety and availability. WHA resolutions 63·12, 58·13 and 28·72, The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components and WHO Global Blood Safety Network recommendations have reaffirmed the achievement of 'Self-sufficiency in blood and blood products based on voluntary non-remunerated blood donation (VNRBD)' as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. Despite some successes, self-sufficiency is not yet a reality in many countries. A consultation of experts, convened by the World Health Organization (WHO) in September 2011 in Geneva, Switzerland, addressed the urgent need to establish strategies and mechanisms for achieving self-sufficiency. Information on the current situation, and country perspectives and experiences were shared. Factors influencing the global implementation of self-sufficiency, including safety, ethics, security and sustainability of supply, trade and its potential impact on public health, availability and access for patients, were analysed to define strategies and mechanisms and provide practical guidance on achieving self-sufficiency. Experts developed a consensus statement outlining the rationale and definition of self-sufficiency in safe blood and blood products based on VNRBD and made recommendations to national health authorities and WHO. © 2012 World Health Organization. Vox Sanguinis © 2012 International Society of Blood Transfusion.

Marginal revenue and length of stay in inpatient psychiatry.

PubMed

Pletscher, Mark

2016-09-01

This study examines the changes in marginal revenue during psychiatric inpatient stays in a large Swiss psychiatric hospital after the introduction of a mixed reimbursement system with tariff rates that vary over length of stay. A discrete time duration model with a difference-in-difference specification and time-varying coefficients is estimated to assess variations in policy effects over length of stay. Among patients whose costs are fully reimbursed by the mixed scheme, the model demonstrates a significant effect of marginal revenue on length of stay. No significant policy effects are found among patients for whom only health insurance rates are delivered as mixed tariffs and government contributions are made retrospectively. The results indicate that marginal revenue can affect length of stay in inpatient psychiatry facilities, but that the reduction in marginal revenue must be sufficiently large.

Protection of Workers and Third Parties during the Construction of Linear Structures

NASA Astrophysics Data System (ADS)

Vlčková, Jitka; Venkrbec, Václav; Henková, Svatava; Chromý, Adam

2017-12-01

The minimization of risk in the workplace through a focus on occupational health and safety (OHS) is one of the primary objectives for every construction project. The most serious accidents in the construction industry occur during work on earthworks and linear structures. The character of such structures places them among those posing the greatest threat to the public (referred to as “third parties”). They can be characterized as large structures whose construction may involve the building site extending in a narrow lane alongside previously constructed objects currently in use by the public. Linear structures are often directly connected to existing objects or buildings, making it impossible to guard the whole construction site. However, many OHS problems related to linear structures can be prevented during the design stage. The aim of this article is to introduce a new methodology which has been implemented into a computer program that deals with safety measures at construction sites where work is performed on linear structures. Based on existing experience with the design of such structures and their execution and supervision by safety coordinators, the basic types of linear structures, their location in the terrain, the conditions present during their execution and other marginal conditions and influences were modelled. Basic safety information has been assigned to this elementary information, which is strictly necessary for the construction process. The safety provisions can be grouped according to type, e.g. technical, organizational and other necessary documentation, or into sets of provisions concerning areas such as construction site safety, transport safety, earthworks safety, etc. The selection of the given provisions takes place using multiple criteria. The aim of creating this program is to provide a practical tool for designers, contractors and construction companies. The model can contribute to the sufficient awareness of these participants about technical and organizational provisions that can help them to meet workplace safety requirements. The software for the selection of safety provisions also contains module that can calculate necessary cost estimates using a calculation formula chosen by the user. All software data conform to European standards harmonized for the Czech Republic.

Loss of Coolant Accident (LOCA) / Emergency Core Coolant System (ECCS Evaluation of Risk-Informed Margins Management Strategies for a Representative Pressurized Water Reactor (PWR)

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

Szilard, Ronaldo Henriques

A Risk Informed Safety Margin Characterization (RISMC) toolkit and methodology are proposed for investigating nuclear power plant core, fuels design and safety analysis, including postulated Loss-of-Coolant Accident (LOCA) analysis. This toolkit, under an integrated evaluation model framework, is name LOCA toolkit for the US (LOTUS). This demonstration includes coupled analysis of core design, fuel design, thermal hydraulics and systems analysis, using advanced risk analysis tools and methods to investigate a wide range of results.

The relationship between safety net activities and hospital financial performance

PubMed Central

2010-01-01

Background During the 1990's hospitals in the U.S were faced with cost containment charges, which may have disproportionately impacted hospitals that serve poor patients. The purposes of this paper are to study the impact of safety net activities on total profit margins and operating expenditures, and to trace these relationships over the 1990s for all U.S urban hospitals, controlling for hospital and market characteristics. Methods The primary data source used for this analysis is the Annual Survey of Hospitals from the American Hospital Association and Medicare Hospital Cost Reports for years 1990-1999. Ordinary least square, hospital fixed effects, and two-stage least square analyses were performed for years 1990-1999. Logged total profit margin and operating expenditure were the dependent variables. The safety net activities are the socioeconomic status of the population in the hospital serving area, and Medicaid intensity. In some specifications, we also included uncompensated care burden. Results We found little evidence of negative effects of safety net activities on total margin. However, hospitals serving a low socioeconomic population had lower expenditure raising concerns for the quality of the services provided. Conclusions Despite potentially negative policy and market changes during the 1990s, safety net activities do not appear to have imperiled the survival of hospitals. There may, however, be concerns about the long-term quality of the services for hospitals serving low socioeconomic population. PMID:20074367

Re-irradiation Using Intensity-modulated Radiotherapy for Recurrent and Second Primary Head and Neck Cancer.

PubMed

Choi, Seo Hee; Chang, Jee Suk; Choi, Jinhyun; Park, So Hyun; Keum, Ki Chang; Park, Kyung Ran; Lee, Chang Geol

2018-05-01

Information on re-irradiation (re-RT) for recurrent and second primary head and neck cancer is limited. Herein, a description of our long-term experience of re-RT for previously irradiated head and neck cancer is provided. A retrospective review was performed for 73 consecutive patients re-irradiated for head and neck cancer between 2006 and 2015. Re-RT targets encompassed only the recurrent gross tumor and had tight margins (5-10 mm). Salvage surgery was performed on 28 (38%) patients before re-RT and 53 (73%) patients received chemotherapy concurrent with re-RT. The median interval between initial and re-RT was 31 months and the median cumulative dose of the two irradiations was 126 Gy (biologically equivalent to 2 Gy fractionation). With a median survival of 33 months, locoregional recurrence after re-RT developed in 37 patients (51%; 25 infield, 12 outfield). In multivariate analysis, higher re-RT dose (≥66 Gy), longer time interval (>2 years), and use of concurrent chemotherapy were associated with improved locoregional recurrence-free survival (all p<0.05). Additionally, performance status, additional surgical resection, and longer interval were associated with better overall survival (p=0.006, 0.021, 0.004, respectively). Clinically significant acute and late toxicities occurred in 14% and 22% of evaluable patients, but no grade 5 toxicity was observed. Moderate safety and acceptable toxicity was found after re-RT using tight margins, sufficient radiation dose, and daily image guidance. Encouraging local control and survival were obtained, similar to historical data using 1-2 cm margins. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

No-touch radiofrequency ablation using multiple electrodes: An in vivo comparison study of switching monopolar versus switching bipolar modes in porcine livers

PubMed Central

Chang, Won; Yoon, Jeong Hee; Lee, Dong Ho; Lee, Sang Min; Lee, Kyoung Bun; Kim, Bo Ram; Kim, Tae-Hyung; Lee, Seunghyun; Han, Joon Koo

2017-01-01

Objective To evaluate the in vivo technical feasibility, efficiency, and safety of switching bipolar (SB) and switching monopolar (SM) radiofrequency ablation (RFA) as a no-touch ablation technique in the porcine liver. Materials and methods The animal care and use committee approved this animal study and 16 pigs were used in two independent experiments. In the first experiment, RFA was performed on 2-cm tumor mimickers in the liver using a no-touch technique in the SM mode (2 groups, SM1: 10 minutes, n = 10; SM2: 15 minutes, n = 10) and SB-mode (1 group, SB: 10 minutes, n = 10). The technical success with sufficient safety margins, creation of confluent necrosis, ablation size, and distance between the electrode and ablation zone margin (DEM), were compared between groups. In the second experiment, thermal injury to the adjacent anatomic organs was compared between SM-RFA (15 minutes, n = 13) and SB-RFA modes (10 minutes, n = 13). Results The rates of the technical success and the creation of confluent necrosis were higher in the SB group than in the SM1 groups (100% vs. 60% and 90% vs. 40%, both p < 0.05). The ablation volume in the SM2 group was significantly larger than that in the SB group (59.2±18.7 cm3 vs. 39.8±9.7 cm3, p < 0.05), and the DEM in the SM2 group was also larger than that in the SB group (1.39±0.21 cm vs. 1.07±0.10 cm, p < 0.05). In the second experiment, the incidence of thermal injury to the adjacent organs and tissues in the SB group (23.1%, 3/13) was significantly lower than that in the SM group (69.2%, 8/13) (p = 0.021). Conclusion SB-RFA was more advantageous for a no-touch technique for liver tumors, showing the potential of a better safety profile than SM-RFA. PMID:28445542

Safety Criticality Standards Using the French CRISTAL Code Package: Application to the AREVA NP UO{sub 2} Fuel Fabrication Plant

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

Doucet, M.; Durant Terrasson, L.; Mouton, J.

2006-07-01

Criticality safety evaluations implement requirements to proof of sufficient sub critical margins outside of the reactor environment for example in fuel fabrication plants. Basic criticality data (i.e., criticality standards) are used in the determination of sub critical margins for all processes involving plutonium or enriched uranium. There are several criticality international standards, e.g., ARH-600, which is one the US nuclear industry relies on. The French Nuclear Safety Authority (DGSNR and its advising body IRSN) has requested AREVA NP to review the criticality standards used for the evaluation of its Low Enriched Uranium fuel fabrication plants with CRISTAL V0, the recentlymore » updated French criticality evaluation package. Criticality safety is a concern for every phase of the fabrication process including UF{sub 6} cylinder storage, UF{sub 6}-UO{sub 2} conversion, powder storage, pelletizing, rod loading, assembly fabrication, and assembly transportation. Until 2003, the accepted criticality standards were based on the French CEA work performed in the late seventies with the APOLLO1 cell/assembly computer code. APOLLO1 is a spectral code, used for evaluating the basic characteristics of fuel assemblies for reactor physics applications, which has been enhanced to perform criticality safety calculations. Throughout the years, CRISTAL, starting with APOLLO1 and MORET 3 (a 3D Monte Carlo code), has been improved to account for the growth of its qualification database and for increasing user requirements. Today, CRISTAL V0 is an up-to-date computational tool incorporating a modern basic microscopic cross section set based on JEF2.2 and the comprehensive APOLLO2 and MORET 4 codes. APOLLO2 is well suited for criticality standards calculations as it includes a sophisticated self shielding approach, a P{sub ij} flux determination, and a 1D transport (S{sub n}) process. CRISTAL V0 is the result of more than five years of development work focusing on theoretical approaches and the implementation of user-friendly graphical interfaces. Due to its comprehensive physical simulation and thanks to its broad qualification database with more than a thousand benchmark/calculation comparisons, CRISTAL V0 provides outstanding and reliable accuracy for criticality evaluations for configurations covering the entire fuel cycle (i.e. from enrichment, pellet/assembly fabrication, transportation, to fuel reprocessing). After a brief description of the calculation scheme and the physics algorithms used in this code package, results for the various fissile media encountered in a UO{sub 2} fuel fabrication plant will be detailed and discussed. (authors)« less

Defibrillation threshold testing fails to show clinical benefit during long-term follow-up of patients undergoing cardiac resynchronization therapy defibrillator implantation.

PubMed

Michowitz, Yoav; Lellouche, Nicolas; Contractor, Tahmeed; Bourke, Tara; Wiener, Isaac; Buch, Eric; Boyle, Noel; Bersohn, Malcolm; Shivkumar, Kalyanam

2011-05-01

The utility of defibrillation threshold testing in patients undergoing implantable cardioverter-defibrillator (ICD) implantation is controversial. Higher defibrillation thresholds have been noted in patients undergoing implantation of cardiac resynchronization therapy defibrillators (CRT-D). Since the risks and potential benefits of testing may be higher in this population, we sought to assess the impact of defibrillation safety margin or vulnerability safety margin testing in CRT-D recipients. A total of 256 consecutive subjects who underwent CRT-D implantation between January 2003 and December 2007 were retrospectively reviewed. Subjects were divided into two groups based on whether (n= 204) or not (n= 52) safety margin testing was performed. Patient characteristics, tachyarrhythmia therapies, procedural results, and clinical outcomes were recorded. Baseline characteristics, including heart failure (HF) severity, were comparable between the groups. Four cases of HF exacerbation (2%), including one leading to one death, were recorded in the tested group immediately post-implantation. No complications were observed in the untested group. After a mean follow-up of 32 ± 20 months, the proportion of appropriate shocks in the two groups was similar (31 vs. 25%, P = 0.49). There were three cases of failed appropriate shocks in the tested group, despite adequate safety margins at implantation, whereas no failed shocks were noted in the untested group. Survival was similar in the two groups. Defibrillation efficacy testing during implant of CRT-D was associated with increased morbidity and did not predict the success of future device therapy or improve survival during long-term follow-up.

Manipulation of a fragile object by elderly individuals.

PubMed

Gorniak, Stacey L; Zatsiorsky, Vladimir M; Latash, Mark L

2011-08-01

We investigated strategies of healthy elderly participants (74-84 years old) during prehension and transport of an object with varying degrees of fragility. Fragility was specified as the maximal normal force that the object could withstand without collapsing. Specifically, kinetic and kinematic variables as well as and force covariation indices were quantified and compared to those shown by young healthy persons (19-28 years old). We tested three hypotheses related to age-related changes in two safety margins (slip safety margin and crush safety margin) and indices of force covariation. Compared to young controls, elderly individuals exhibited a decrease in object acceleration and an increase in movement time, an increase in grip force production, a decrease in the correlation between grip and load forces, an overall decrease in indices of multi-digit synergies, and lower safety margin indices computed with respect to both dropping and crushing the object. Elderly participants preferred to be at a relatively lower risk of crushing the object even if this led to a higher risk of dropping it. Both groups showed an increase in the index of synergy stabilizing total normal force produced by the four fingers with increased fragility of the object. Age-related changes are viewed as a direct result of physiological changes due to aging, not adaptation to object fragility. Such changes in overall characteristics of prehension likely reflect diminished synergic control by the central nervous system of finger forces with aging. The findings corroborate an earlier hypothesis on an age-related shift from synergic to element-based control.

Dynamical criterion for a marginally unstable, quasi-linear behavior in a two-layer model

NASA Technical Reports Server (NTRS)

Ebisuzaki, W.

1988-01-01

A two-layer quasi-geostrophic flow forced by meridional variations in heating can be in regimes ranging from radiative equilibrium to forced geostrophic turbulence. Between these extremes is a regime where the time-mean (zonal) flow is marginally unstable. Using scaling arguments, it is concluded that such a marginally unstable state should occur when a certain parameter, measuring the strength of wave-wave interactions relative to the beta effect and advection by the thermal wind, is small. Numerical simulations support this proposal. A transition from the marginally unstable regime to a more nonlinear regime is then examined through numerical simulations with different radiative forcings. It is found that transition is not caused by secondary instability of waves in the marginally unstable regime. Instead, the time-mean flow can support a number of marginally unstable normal modes. These normal modes interact with each other, and if they are of sufficient amplitude, the flow enters a more nonlinear regime.

Ensuring the validity of calculated subcritical limits

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

Clark, H.K.

1977-01-01

The care taken at the Savannah River Laboratory and Plant to ensure the validity of calculated subcritical limits is described. Close attention is given to ANSI N16.1-1975, ''Validation of Calculational Methods for Nuclear Criticality Safety.'' The computer codes used for criticality safety computations, which are listed and are briefly described, have been placed in the SRL JOSHUA system to facilitate calculation and to reduce input errors. A driver module, KOKO, simplifies and standardizes input and links the codes together in various ways. For any criticality safety evaluation, correlations of the calculational methods are made with experiment to establish bias. Occasionallymore » subcritical experiments are performed expressly to provide benchmarks. Calculated subcritical limits contain an adequate but not excessive margin to allow for uncertainty in the bias. The final step in any criticality safety evaluation is the writing of a report describing the calculations and justifying the margin.« less

NAD(P)H: Quinone Oxidoreductase 1 Deficiency Conjoint with Marginal Vitamin C Deficiency Causes Cigarette Smoke Induced Myelodysplastic Syndromes

PubMed Central

Das, Archita; Dey, Neekkan; Ghosh, Arunava; Das, Tanusree; Chatterjee, Indu B.

2011-01-01

Background The etiology of myelodysplastic syndromes (MDS) is largely unknown. Exposure to cigarette smoke (CS) is reported to be associated with MDS risk. There is inconsistent evidence that deficiency of NAD(P)H-quinone: oxidoreductase 1 (NQO1) increases the risk of MDS. Earlier we had shown that CS induces toxicity only in marginal vitamin C-deficient guinea pigs but not in vitamin C-sufficient ones. We therefore considered that NQO1 deficiency along with marginal vitamin C deficiency might produce MDS in CS-exposed guinea pigs. Methodology and Principal Findings Here we show that CS exposure for 21 days produces MDS in guinea pigs having deficiency of NQO1 (fed 3 mg dicoumarol/day) conjoint with marginal vitamin C deficiency (fed 0.5 mg vitamin C/day). As evidenced by morphology, histology and cytogenetics, MDS produced in the guinea pigs falls in the category of refractory cytopenia with unilineage dysplasia (RCUD): refractory anemia; refractory thrombocytopenia that is associated with ring sideroblasts, micromegakaryocytes, myeloid hyperplasia and aneuploidy. MDS is accompanied by increased CD34(+) cells and oxidative stress as shown by the formation of protein carbonyls and 8-oxodeoxyguanosine. Apoptosis precedes MDS but disappears later with marked decrease in the p53 protein. MDS produced in the guinea pigs are irreversible. MDS and all the aforesaid pathophysiological events do not occur in vitamin C-sufficient guinea pigs. However, after the onset of MDS vitamin C becomes ineffective. Conclusions and Significance CS exposure causes MDS in guinea pigs having deficiency of NQO1 conjoint with marginal vitamin C deficiency. The syndromes are not produced in singular deficiency of NQO1 or marginal vitamin C deficiency. Our results suggest that human smokers having NQO1 deficiency combined with marginal vitamin C deficiency are likely to be at high risk for developing MDS and that intake of a moderately large dose of vitamin C would prevent MDS. PMID:21655231

Self-sufficiency, free trade and safety.

PubMed

Rautonen, Jukka

2010-01-01

The relationship between free trade, self-sufficiency and safety of blood and blood components has been a perennial discussion topic in the blood service community. Traditionally, national self-sufficiency has been perceived as the ultimate goal that would also maximize safety. However, very few countries are, or can be, truly self-sufficient when self-sufficiency is understood correctly to encompass the whole value chain from the blood donor to the finished product. This is most striking when plasma derived medicines are considered. Free trade of blood products, or competition, as such can have a negative or positive effect on blood safety. Further, free trade of equipment and reagents and several plasma medicines is actually necessary to meet the domestic demand for blood and blood derivatives in most countries. Opposing free trade due to dogmatic reasons is not in the best interest of any country and will be especially harmful for the developing world. Competition between blood services in the USA has been present for decades. The more than threefold differences in blood product prices between European blood services indicate that competition is long overdue in Europe, too. This competition should be welcomed but carefully and proactively regulated to avoid putting safe and secure blood supply at risk. Copyright 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

The positive inside rule is stronger when followed by a transmembrane helix.

PubMed

Virkki, Minttu T; Peters, Christoph; Nilsson, Daniel; Sörensen, Therese; Cristobal, Susana; Wallner, Björn; Elofsson, Arne

2014-08-12

The translocon recognizes transmembrane helices with sufficient level of hydrophobicity and inserts them into the membrane. However, sometimes less hydrophobic helices are also recognized. Positive inside rule, orientational preferences of and specific interactions with neighboring helices have been shown to aid in the recognition of these helices, at least in artificial systems. To better understand how the translocon inserts marginally hydrophobic helices, we studied three naturally occurring marginally hydrophobic helices, which were previously shown to require the subsequent helix for efficient translocon recognition. We find no evidence for specific interactions when we scan all residues in the subsequent helices. Instead, we identify arginines located at the N-terminal part of the subsequent helices that are crucial for the recognition of the marginally hydrophobic transmembrane helices, indicating that the positive inside rule is important. However, in two of the constructs, these arginines do not aid in the recognition without the rest of the subsequent helix; that is, the positive inside rule alone is not sufficient. Instead, the improved recognition of marginally hydrophobic helices can here be explained as follows: the positive inside rule provides an orientational preference of the subsequent helix, which in turn allows the marginally hydrophobic helix to be inserted; that is, the effect of the positive inside rule is stronger if positively charged residues are followed by a transmembrane helix. Such a mechanism obviously cannot aid C-terminal helices, and consequently, we find that the terminal helices in multi-spanning membrane proteins are more hydrophobic than internal helices. Copyright © 2014 Elsevier Ltd. All rights reserved.

RELAP5 Application to Accident Analysis of the NIST Research Reactor

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

Baek, J.; Cuadra Gascon, A.; Cheng, L.Y.

Detailed safety analyses have been performed for the 20 MW D{sub 2}O moderated research reactor (NBSR) at the National Institute of Standards and Technology (NIST). The time-dependent analysis of the primary system is determined with a RELAP5 transient analysis model that includes the reactor vessel, the pump, heat exchanger, fuel element geometry, and flow channels for both the six inner and twenty-four outer fuel elements. A post-processing of the simulation results has been conducted to evaluate minimum critical heat flux ratio (CHFR) using the Sudo-Kaminaga correlation. Evaluations are performed for the following accidents: (1) the control rod withdrawal startup accidentmore » and (2) the maximum reactivity insertion accident. In both cases the RELAP5 results indicate that there is adequate margin to CHF and no damage to the fuel will occur because of sufficient coolant flow through the fuel channels and the negative scram reactivity insertion.« less

Defense AT and L Magazine. Volume 45, Number 2, March-April 2016

DTIC Science & Technology

2016-03-01

preferred contract type (Fixed Price Incentive Firm and Cost Plus Incentive Fee may be effective) 5. Provide sufficient contract length for the...example would be an incentive on pay- load margin for our medium launch vehicle, where the mini - mum requirement is 100 pounds of margin and the...involving a mini -UAV initiative with Indian industry partners. In discussing the Make in India initiative, U.S. officials note that it requires time

Coordination of stem and leaf hydraulic conductance in southern California shrubs: a test of the hydraulic segmentation hypothesis.

PubMed

Pivovaroff, Alexandria L; Sack, Lawren; Santiago, Louis S

2014-08-01

Coordination of water movement among plant organs is important for understanding plant water use strategies. The hydraulic segmentation hypothesis (HSH) proposes that hydraulic conductance in shorter lived, 'expendable' organs such as leaves and longer lived, more 'expensive' organs such as stems may be decoupled, with resistance in leaves acting as a bottleneck or 'safety valve'. We tested the HSH in woody species from a Mediterranean-type ecosystem by measuring leaf hydraulic conductance (Kleaf) and stem hydraulic conductivity (KS). We also investigated whether leaves function as safety valves by relating Kleaf and the hydraulic safety margin (stem water potential minus the water potential at which 50% of conductivity is lost (Ψstem-Ψ50)). We also examined related plant traits including the operating range of water potentials, wood density, leaf mass per area, and leaf area to sapwood area ratio to provide insight into whole-plant water use strategies. For hydrated shoots, Kleaf was negatively correlated with KS , supporting the HSH. Additionally, Kleaf was positively correlated with the hydraulic safety margin and negatively correlated with the leaf area to sapwood area ratio. Consistent with the HSH, our data indicate that leaves may act as control valves for species with high KS , or a low safety margin. This critical role of leaves appears to contribute importantly to plant ecological specialization in a drought-prone environment. © 2014 The Authors. New Phytologist © 2014 New Phytologist Trust.

Safety assessment of green tea based beverages and dried green tea extracts as nutritional supplements.

PubMed

Dekant, Wolfgang; Fujii, Kenkichi; Shibata, Eiichiro; Morita, Osamu; Shimotoyodome, Akira

2017-08-05

The safety of green tea infusions and green tea extract (GTE)-based products is reviewed regarding catechins. Epigallocatechin 3-gallate (EGCG), the major catechin present in green tea, is suspected of being responsible for liver toxicity reported in humans consuming food supplements. Intake of EGCG with green tea infusions and GTE-based beverages is up to about 450mg EGCG/person/day in Europe and higher in Asia. Consumption of green tea is not associated with liver damage in humans, and green tea infusion and GTE-based beverages are considered safe in the range of historical uses. In animal studies, EGCG's potency for liver effects is highly dependent on conditions of administration. Use of NOAELs from bolus administration to derive a tolerable upper intake level applying the margin of safety concept results in acceptable EGCG-doses lower than those from one cup of green tea. NOAELs from toxicity studies applying EGCG with diet/split of the daily dose are a better point of departure for risk characterization. In clinical intervention studies, liver effects were not observed after intakes below 600mg EGCG/person/day. Thus, a tolerable upper intake level of 300mg EGCG/person/day is proposed for food supplements; this gives a twofold safety margin to clinical studies that did not report liver effects and a margin of safety of 100 to the NOAELs in animal studies with dietary administration of green tea catechins. Copyright © 2017 Elsevier B.V. All rights reserved.

2015 Accomplishments Report

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

None, None

This report covers selected highlights from the four research pathways in the LWRS Program: Materials Aging and Degradation; Risk-Informed Safety Margin Characterization; Advanced Instrumentation, Information, and Control Systems Technologies; and Reactor Safety Technologies, as well as a look-ahead at planned activities for 2017.

2016 Accomplishments Report

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

None, None

This report covers selected highlights from the four research pathways in the LWRS Program: Materials Aging and Degradation; Risk-Informed Safety Margin Characterization; Advanced Instrumentation, Information, and Control Systems Technologies; and Reactor Safety Technologies, as well as a look-ahead at planned activities for 2017.

77 FR 69507 - Proposed Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-19

..., ``Revise Shutdown Margin Definition To Address Advanced Fuel Designs'' AGENCY: Nuclear Regulatory... Shutdown Margin Definition to Address Advanced Fuel Designs.'' DATES: Comment period expires on December 19... address newer BWR fuel designs, which may be more reactive at shutdown temperatures above 68[emsp14][deg]F...

Lung segment geometry study: simulation of largest possible tumours that fit into bronchopulmonary segments.

PubMed

Welter, S; Stöcker, C; Dicken, V; Kühl, H; Krass, S; Stamatis, G

2012-03-01

Segmental resection in stage I non-small cell lung cancer (NSCLC) has been well described and is considered to have similar survival rates as lobectomy but with increased rates of local tumour recurrence due to inadequate parenchymal margins. In consequence, today segmentectomy is only performed when the tumour is smaller than 2 cm. Three-dimensional reconstructions from 11 thin-slice CT scans of bronchopulmonary segments were generated, and virtual spherical tumours were placed over the segments, respecting all segmental borders. As a next step, virtual parenchymal safety margins of 2 cm and 3 cm were subtracted and the size of the remaining tumour calculated. The maximum tumour diameters with a 30-mm parenchymal safety margin ranged from 26.1 mm in right-sided segments 7 + 8 to 59.8 mm in the left apical segments 1-3. Using a three-dimensional reconstruction of lung CT scans, we demonstrated that segmentectomy or resection of segmental groups should be feasible with adequate margins, even for larger tumours in selected cases. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Incidence of ineffective safety margin testing (<10 J) and efficacy of routine subcutaneous array insertion during implantable cardioverter defibrillator implantation.

PubMed

Ohlow, Marc-Alexander; Roos, Marcus; Lauer, Bernward; Geller, J Christoph

2016-01-01

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications. Copyright © 2016 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

Hot compression process for making edge seals for fuel cells

DOEpatents

Dunyak, Thomas J.; Granata, Jr., Samuel J.

1994-01-01

A hot compression process for forming integral edge seals in anode and cade assemblies wherein the assemblies are made to a nominal size larger than a finished size, beads of AFLAS are applied to a band adjacent the peripheral margins on both sides of the assemblies, the assemblies are placed in a hot press and compressed for about five minutes with a force sufficient to permeate the peripheral margins with the AFLAS, cooled and cut to finished size.

Integral throat entrance development, qualification and production for the Antares 3 nozzle

NASA Technical Reports Server (NTRS)

Clayton, F. I.; Dirling, R. B.; Eitman, D. A.; Loomis, W. C.

1982-01-01

Although design analyses of a G-90 graphite integral throat entrance for the Antares 3 solid rocket motor nozzle indicated acceptable margins of safety, the nozzle throat insert suffered a thermostructural failure during the first development firing. Subsequent re-analysis using properties measured on material from the same billet as the nozzle throat insert showed negative margins. Carbon-carbon was investigated and found to result in large positive margins of safety. The G-90 graphite was replaced by SAI fast processed 4-D material which uses Hercules HM 10000 fiber as the reinforcement. Its construction allows powder filling of the interstices after preform fabrication which accelerates the densification process. Allied 15V coal tar pitch is then used to complete densification. The properties were extensively characterized on this material and six nozzles were subjected to demonstration, development and qualification firings.

A multiloop generalization of the circle criterion for stability margin analysis

NASA Technical Reports Server (NTRS)

Safonov, M. G.; Athans, M.

1979-01-01

In order to provide a theoretical tool suited for characterizing the stability margins of multiloop feedback systems, multiloop input-output stability results generalizing the circle stability criterion are considered. Generalized conic sectors with 'centers' and 'radii' determined by linear dynamical operators are employed to specify the stability margins as a frequency dependent convex set of modeling errors (including nonlinearities, gain variations and phase variations) which the system must be able to tolerate in each feedback loop without instability. The resulting stability criterion gives sufficient conditions for closed loop stability in the presence of frequency dependent modeling errors, even when the modeling errors occur simultaneously in all loops. The stability conditions yield an easily interpreted scalar measure of the amount by which a multiloop system exceeds, or falls short of, its stability margin specifications.

Safety margins in zircaloy oxidation and embrittlement criteria for emergency core cooling system acceptance

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

Williford, R.E.

1986-09-01

Current emergency core cooling system acceptance criteria for light water reactors specify that, under loss-of-coolant accident (LOCA) conditions, the Baker-Just (BJ) correlation must be used to calculate Zircaloy-steam oxidation, calculated peak cladding temperatures (PCT) must not exceed 1204/sup 0/C, and calculated oxidation must not exceed 17% equivalent cladding reacted (ECR). An appropriately defined minimum margin of safety was estimated for each of these criteria. The currently required BJ oxidation correlation provides margins only over the 1100 to 1500/sup 0/C temperature range at the 95% confidence level. The PCT margins for thermal shock and handling failures are adequate at oxidation temperaturesmore » above 1204/sup 0/C for up to 210 and 160 s, respectively, at the 95% confidence level. The ECR thermal shock and handling margins at the 50 and 95% confidence levels, respectively, range between 2 and 7% ECR for the BJ correlation, but vanish at temperatures above 1100 to 1160/sup 0/C for the best-estimate Cathcart-Pawel correlation. However, use of the Cathcart Pawel correlation for ''design basis'' LOCA calculations can be justified at the 85 to 88% confidence level if cooling rate effects can be neglected.« less

Multilayer Disk Reduced Interlayer Crosstalk with Wide Disk-Fabrication Margin

NASA Astrophysics Data System (ADS)

Hirotsune, Akemi; Miyauchi, Yasushi; Endo, Nobumasa; Onuma, Tsuyoshi; Anzai, Yumiko; Kurokawa, Takahiro; Ushiyama, Junko; Shintani, Toshimichi; Sugiyama, Toshinori; Miyamoto, Harukazu

2008-07-01

To reduce interlayer crosstalk caused by the ghost spot which appears in a multilayer optical disk with more than three information layers, a multilayer disk structure which reduces interlayer crosstalk with a wide disk-fabrication margin was proposed in which the backward reflectivity of the information layers is sufficiently low. It was confirmed that the interlayer crosstalk caused by the ghost spot was reduced to less than the crosstalk from the adjacent layer by controlling backward reflectivity. The wide disk-fabrication margin of the proposed disk structure was indicated by experimentally confirming that the tolerance of the maximum deviation of the spacer-layer thickness is four times larger than that in the previous multilayer disk.

37 CFR 1.52 - Language, paper, writing, margins, compact disc specifications.

Code of Federal Regulations, 2013 CFR

2013-07-01

... permanent dark ink or its equivalent; and (v) Presented in a form having sufficient clarity and contrast... statement that the replacement compact disc contains no new matter. The compact disc and copy must be...

A robust signalling system for land mobile satellite services

NASA Technical Reports Server (NTRS)

Irish, Dale; Shmith, Gary; Hart, Nick; Wines, Marie

1989-01-01

Presented here is a signalling system optimized to ensure expedient call set-up for satellite telephony services in a land mobile environment. In a land mobile environment, the satellite to mobile link is subject to impairments from multipath and shadowing phenomena, which result in signal amplitude and phase variations. Multipath, caused by signal scattering and reflections, results in sufficient link margin to compensate for these variations. Direct signal attenuation caused by shadowing due to buildings and vegetation may result in attenuation values in excess of 10 dB and commonly up to 20 dB. It is not practical to provide a link with sufficient margin to enable communication when the signal is blocked. When a moving vehicle passes these obstacles, the link will experience rapid changes in signal strength due to shadowing. Using statistical models of attenuation as a function of distance travelled, a communication strategy has been defined for the land mobile environment.

Influence of Passive Stiffness of Hamstrings on Postural Stability

PubMed Central

Kuszewski, Michał; Gnat, Rafał; Sobota, Grzegorz; Myśliwiec, Andrzej

2015-01-01

The aim of the study was to explore whether passive stiffness of the hamstrings influences the strategy of maintaining postural stability. A sample of 50 subjects was selected; the final analyses were based on data of 41 individuals (33 men, 8 women) aged 21 to 29 (mean = 23.3, SD = 1.1) years. A quasi- experimental ex post facto design with repeated measures was used. Categories of independent variables were obtained directly prior to the measurement of the dependent variables. In stage one of the study, passive knee extension was measured in the supine position to assess hamstring stiffness. In stage two, the magnitude of postural sway in antero-posterior direction was measured, while varying the body position on a stabilometric platform, both with and without visual control. The margin of safety was used as a measure of postural control. The magnitude of the margin of safety increased significantly between the open-eye and closed-eye trials. However, although we registered a visible tendency for a larger increase of the margin of safety associated with lower levels of passive hamstrings stiffness, no significant differences were found. Therefore, this study demonstrated that hamstring stiffness did not influence the strategy used to maintain postural stability. PMID:25964809

Influence of passive stiffness of hamstrings on postural stability.

PubMed

Kuszewski, Michał; Gnat, Rafał; Sobota, Grzegorz; Myśliwiec, Andrzej

2015-03-29

The aim of the study was to explore whether passive stiffness of the hamstrings influences the strategy of maintaining postural stability. A sample of 50 subjects was selected; the final analyses were based on data of 41 individuals (33 men, 8 women) aged 21 to 29 (mean = 23.3, SD = 1.1) years. A quasi- experimental ex post facto design with repeated measures was used. Categories of independent variables were obtained directly prior to the measurement of the dependent variables. In stage one of the study, passive knee extension was measured in the supine position to assess hamstring stiffness. In stage two, the magnitude of postural sway in antero-posterior direction was measured, while varying the body position on a stabilometric platform, both with and without visual control. The margin of safety was used as a measure of postural control. The magnitude of the margin of safety increased significantly between the open-eye and closed-eye trials. However, although we registered a visible tendency for a larger increase of the margin of safety associated with lower levels of passive hamstrings stiffness, no significant differences were found. Therefore, this study demonstrated that hamstring stiffness did not influence the strategy used to maintain postural stability.

An empirical assessment of driver motivation and emotional states in perceived safety margins under varied driving conditions.

PubMed

Zhang, Yu; Kaber, David B

2013-01-01

Motivation models in driving behaviour postulate that driver motives and emotional states dictate risk tolerance under various traffic conditions. The present study used time and driver performance-based payment systems to manipulate motivation and risk-taking behaviour. Ten participants drove to a predefined location in a simulated driving environment. Traffic patterns (density and velocity) were manipulated to cause driver behaviour adjustments due to the need to conform with the social norms of the roadway. The driving environment complexity was investigated as a mediating factor in risk tolerance. Results revealed the performance-based payment system to closely relate to risk-taking behaviour as compared with the time-based payment system. Drivers conformed with social norms associated with specific traffic patterns. Higher roadway complexity led to a more conservative safety margins and speeds. This research contributes to the further development of motivational models of driver behaviour. This study provides empirical justification for two motivation factors in driver risk-taking decisions, including compliance with social norm and emotions triggered by incentives. Environment complexity was identified as a mediating factor in motivational behaviour model. This study also recommended safety margin measures sensitive to changes in driver risk tolerance.

Talonavicular joint arthroscopic portals: A cadaveric study of feasibility and safety.

PubMed

Xavier, Gabriel; Oliva, Xavier Martin; Rotinen, Mauri; Monzo, Mariano

2016-09-01

The objectives of the study were to evaluate the safety of hypothetical arthroscopic portals from talonavicular joint and to evaluate their reproducibility and enforceability. 19 cadaveric feet were marked and four arthroscopic portals were made (medial, dorsomedial, dorsolateral and lateral). The specimens were dissected in layers and the distances between neurovascular structures and the trocars were measured. Medial and dorsomedial portals were in average 8.3 and 8.7, respectively, to the saphenous vein and nerve. Dorsolateral portal was in average 8.1mm to the deep peroneal nerve and dorsalis pedis artery, and 9.1mm to the medial dorsal cutaneous branch of the superficial peroneal nerve. Lateral portal was in average 12.3mm to the intermediate dorsal cutaneous branch of the superficial peroneal nerve. Tested portals shown to have a good safety margin for the foot neurovascular deep dorsal structures and an acceptable safety margin for the superficial neurovascular structures. Copyright © 2015 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

Assessment of safety margins in zircaloy oxidation and embrittlement criteria for ECCS acceptance

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

Williford, R.E.

1986-04-01

Current Emergency Core Cooling System (ECCS) Acceptance Criteria for light-water reactors include certain requirements pertaining to calculations of core performance during a Loss of Coolant Accident (LOCA). The Baker-Just correlation must be used to calculate Zircaloy-steam oxidation, calculated peak cladding temperatures (PCT) must not exceed 1204/sup 0/C, and calculated oxidation must not exceed 17% equivalent cladding reacted (17% ECR). The minimum margin of safety was estimated for each of these criteria, based on research performed in the last decade. Margins were defined as the amounts of conservatism over and above the expected extreme values computed from the data base atmore » specified confidence levels. The currently required Baker-Just oxidation correlation provides margins only over the 1100/sup 0/C to 1500/sup 0/C temperature range at the 95% confidence level. The PCT margins for thermal shock and handling failures are adequate at oxidation temperatures above 1204/sup 0/C for 210 and 160 seconds, respectively, at the 95% confidence level. ECR thermal shock and handling margins at the 50% and 95% confidence levels, respectively, range between 2% and 7% ECR for the Baker-Just correlation, but vanish at temperatures between 1100/sup 0/C and 1160/sup 0/C for the best-estimate Cathcart-Pawel correlation. Use of the Cathcart-Pawel correlation for LOCA calculations can be justified at the 85% to 88% confidence level if cooling rate effects can be neglected. 75 refs., 21 figs.« less

INTEGRATION OF RELIABILITY WITH MECHANISTIC THERMALHYDRAULICS: REPORT ON APPROACH AND TEST PROBLEM RESULTS

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

J. S. Schroeder; R. W. Youngblood

The Risk-Informed Safety Margin Characterization (RISMC) pathway of the Light Water Reactor Sustainability Program is developing simulation-based methods and tools for analyzing safety margin from a modern perspective. [1] There are multiple definitions of 'margin.' One class of definitions defines margin in terms of the distance between a point estimate of a given performance parameter (such as peak clad temperature), and a point-value acceptance criterion defined for that parameter (such as 2200 F). The present perspective on margin is that it relates to the probability of failure, and not just the distance between a nominal operating point and a criterion.more » In this work, margin is characterized through a probabilistic analysis of the 'loads' imposed on systems, structures, and components, and their 'capacity' to resist those loads without failing. Given the probabilistic load and capacity spectra, one can assess the probability that load exceeds capacity, leading to component failure. Within the project, we refer to a plot of these probabilistic spectra as 'the logo.' Refer to Figure 1 for a notional illustration. The implications of referring to 'the logo' are (1) RISMC is focused on being able to analyze loads and spectra probabilistically, and (2) calling it 'the logo' tacitly acknowledges that it is a highly simplified picture: meaningful analysis of a given component failure mode may require development of probabilistic spectra for multiple physical parameters, and in many practical cases, 'load' and 'capacity' will not vary independently.« less

Cyclic Symmetry Finite Element Forced Response Analysis of a Distortion-Tolerant Fan with Boundary Layer Ingestion

NASA Technical Reports Server (NTRS)

Min, J. B.; Reddy, T. S. R.; Bakhle, M. A.; Coroneos, R. M.; Stefko, G. L.; Provenza, A. J.; Duffy, K. P.

2018-01-01

Accurate prediction of the blade vibration stress is required to determine overall durability of fan blade design under Boundary Layer Ingestion (BLI) distorted flow environments. Traditional single blade modeling technique is incapable of representing accurate modeling for the entire rotor blade system subject to complex dynamic loading behaviors and vibrations in distorted flow conditions. A particular objective of our work was to develop a high-fidelity full-rotor aeromechanics analysis capability for a system subjected to a distorted inlet flow by applying cyclic symmetry finite element modeling methodology. This reduction modeling method allows computationally very efficient analysis using a small periodic section of the full rotor blade system. Experimental testing by the use of the 8-foot by 6-foot Supersonic Wind Tunnel Test facility at NASA Glenn Research Center was also carried out for the system designated as the Boundary Layer Ingesting Inlet/Distortion-Tolerant Fan (BLI2DTF) technology development. The results obtained from the present numerical modeling technique were evaluated with those of the wind tunnel experimental test, toward establishing a computationally efficient aeromechanics analysis modeling tool facilitating for analyses of the full rotor blade systems subjected to a distorted inlet flow conditions. Fairly good correlations were achieved hence our computational modeling techniques were fully demonstrated. The analysis result showed that the safety margin requirement set in the BLI2DTF fan blade design provided a sufficient margin with respect to the operating speed range.

Inactivation and removal of influenza A virus H1N1 during the manufacture of plasma derivatives.

PubMed

Jeong, Eun Kyo; Sung, Hark Mo; Kim, In Seop

2010-11-01

Although transmission of pandemic influenza A virus H1N1 2009 is still occurring globally, little has been reported about how this outbreak has affected the safety of plasma derivatives. To evaluate the safety of plasma derivatives, dedicated virus clearance processes used during their production were investigated for their effectiveness in eliminating this virus of recent concern. In this study, influenza A virus H1N1 strain A/NWS/33 (H1N1) was chosen as a surrogate. H1N1 was completely inactivated by fraction IV fractionation as well as pasteurization during the manufacture of albumin. H1N1 was also effectively removed into the precipitate by fraction III fractionation and completely inactivated by low pH incubation as well as pasteurization during the manufacture of intravenous immunoglobulin. H1N1 was completely inactivated within 1 min of solvent/detergent treatment using 0.3% tri (n-butyl) phosphate and 1.0% Triton X-100 and also completely inactivated within 10 min of dry-heat treatment at 98 °C during the manufacture of factor VIII. H1N1 was completely removed by virus filtration process using Viresolve NFP filter and also completely inactivated by pasteurization during the manufacture of anti-thrombin III. These results indicate that all the virus clearance processes commonly used have sufficient H1N1 reducing capacity to achieve a high margin of safety. Copyright © 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

School Bus Fleet Safety: Planning and Development.

ERIC Educational Resources Information Center

Bieber, Robert M.

1984-01-01

To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

Acoustic Liner for Turbomachinery Applications

NASA Technical Reports Server (NTRS)

Huff, Dennis L.; Sutliff, Daniel L.; Jones, Michael G.; Hebsur, Mohan G.

2010-01-01

The purpose of this innovation is to reduce aircraft noise in the communities surrounding airports by significantly attenuating the noise generated by the turbomachinery, and enhancing safety by providing a containment barrier for a blade failure. Acoustic liners are used in today's turbofan engines to reduce noise. The amount of noise reduction from an acoustic liner is a function of the treatment area, the liner design, and the material properties, and limited by the constraints of the nacelle or casement design. It is desirable to increase the effective area of the acoustic treatment to increase noise suppression. Modern turbofan engines use wide-chord rotor blades, which means there is considerable treatment area available over the rotor tip. Turbofan engines require containment over the rotors for protection from blade failure. Traditional methods use a material wrap such as Kevlar integrated with rub strips and sometimes metal layers (sandwiches). It is possible to substitute the soft rub-strip material with an open-cell metallic foam that provides noise-reduction benefits and a sacrificial material in the first layer of the containment system. An open-cell foam was evaluated that behaves like a bulk acoustic liner, serves as a tip rub strip, and can be integrated with a rotor containment system. Foams can be integrated with the fan-containment system to provide sufficient safety margins and increased noise attenuation. The major innovation is the integration of the foam with the containment.

Marginal Loss Calculations for the DCOPF

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

Eldridge, Brent; O'Neill, Richard P.; Castillo, Andrea R.

2016-12-05

The purpose of this paper is to explain some aspects of including a marginal line loss approximation in the DCOPF. The DCOPF optimizes electric generator dispatch using simplified power flow physics. Since the standard assumptions in the DCOPF include a lossless network, a number of modifications have to be added to the model. Calculating marginal losses allows the DCOPF to optimize the location of power generation, so that generators that are closer to demand centers are relatively cheaper than remote generation. The problem formulations discussed in this paper will simplify many aspects of practical electric dispatch implementations in use today,more » but will include sufficient detail to demonstrate a few points with regard to the handling of losses.« less

Transoral robotic surgery for neurogenic tumors of the prestyloid parapharyngeal space.

PubMed

Lee, Hyoung Shin; Kim, Jinna; Lee, Hyun Jin; Koh, Yoon Woo; Choi, Eun Chang

2012-08-01

The parapharyngeal space is a difficult area for a surgical approach due to anatomical complexity. We performed a minimally invasive and precise surgical technique to remove neurogenic tumors of the prestyloid parapharyngeal space using transoral robotic instrumentation. The mass was successfully removed in the two cases with three-dimensional visualization providing an excellent view of the resection margin and the dissection plane preserving the vital structures. An adequate resection margin was acquired, and no violation of the tumor capsule occurred. No significant complications were noted. Transoral robotic surgery was feasible for neurogenic tumors of the prestyloid parapharyngeal space, providing a sufficient resection margin and delicate dissection through excellent surgical views and instrumentation. Copyright © 2012. Published by Elsevier Ireland Ltd.

Orientational preferences of neighboring helices can drive ER insertion of a marginally hydrophobic transmembrane helix

PubMed Central

Öjemalm, Karin; Halling, Katrin K.; Nilsson, IngMarie; von Heijne, Gunnar

2013-01-01

Summary α-helical integral membrane proteins critically depend on the correct insertion of their transmembrane α-helices into the lipid bilayer for proper folding, yet a surprisingly large fraction of the transmembrane α-helices in multispanning integral membrane proteins are not sufficiently hydrophobic to insert into the target membrane by themselves. How can such marginally hydrophobic segments nevertheless form transmembrane helices in the folded structure? Here, we show that a transmembrane helix with a strong orientational preference (Ncyt-Clum or Nlum-Ccyt) can both increase and decrease the hydrophobicity threshold for membrane insertion of a neighboring, marginally hydrophobic helix. This effect helps explain the ‘missing hydrophobicity’ in polytopic membrane proteins. PMID:22281052

Safety of High Speed Ground Transportation Systems : Analytical Methodology for Safety Validation of Computer Controlled Subsystems : Volume 2. Development of a Safety Validation Methodology

DOT National Transportation Integrated Search

1995-01-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety cortical functions in high-speed rail or magnetic levitation ...

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

Kristine Barrett; Shannon Bragg-Sitton

The Advanced Light Water Reactor (LWR) Nuclear Fuel Development Research and Development (R&D) Pathway encompasses strategic research focused on improving reactor core economics and safety margins through the development of an advanced fuel cladding system. To achieve significant operating improvements while remaining within safety boundaries, significant steps beyond incremental improvements in the current generation of nuclear fuel are required. Fundamental improvements are required in the areas of nuclear fuel composition, cladding integrity, and the fuel/cladding interaction to allow power uprates and increased fuel burn-up allowance while potentially improving safety margin through the adoption of an “accident tolerant” fuel system thatmore » would offer improved coping time under accident scenarios. With a development time of about 20 – 25 years, advanced fuel designs must be started today and proven in current reactors if future reactor designs are to be able to use them with confidence.« less

A Worst-Case Approach for On-Line Flutter Prediction

NASA Technical Reports Server (NTRS)

Lind, Rick C.; Brenner, Martin J.

1998-01-01

Worst-case flutter margins may be computed for a linear model with respect to a set of uncertainty operators using the structured singular value. This paper considers an on-line implementation to compute these robust margins in a flight test program. Uncertainty descriptions are updated at test points to account for unmodeled time-varying dynamics of the airplane by ensuring the robust model is not invalidated by measured flight data. Robust margins computed with respect to this uncertainty remain conservative to the changing dynamics throughout the flight. A simulation clearly demonstrates this method can improve the efficiency of flight testing by accurately predicting the flutter margin to improve safety while reducing the necessary flight time.

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

Unwin, Stephen D.; Lowry, Peter P.; Layton, Robert F.

This is a working report drafted under the Risk-Informed Safety Margin Characterization pathway of the Light Water Reactor Sustainability Program, describing statistical models of passives component reliabilities.

Analysis of a Preloaded Bolted Joint in a Ceramic Composite Combustor

NASA Technical Reports Server (NTRS)

Hissam, D. Andy; Bower, Mark V.

2003-01-01

This paper presents the detailed analysis of a preloaded bolted joint incorporating ceramic materials. The objective of this analysis is to determine the suitability of a joint design for a ceramic combustor. The analysis addresses critical factors in bolted joint design including preload, preload uncertainty, and load factor. The relationship between key joint variables is also investigated. The analysis is based on four key design criteria, each addressing an anticipated failure mode. The criteria are defined in terms of margin of safety, which must be greater than zero for the design criteria to be satisfied. Since the proposed joint has positive margins of safety, the design criteria are satisfied. Therefore, the joint design is acceptable.

Perceived Safety at Work in the Wake of Terror: The Importance of Security Measures and Emergency Preparedness.

PubMed

Nissen, Alexander; Heir, Trond

2016-12-01

We aimed to explore how perceived safety after terrorism is connected to views on security measures and emergency preparedness in a workplace setting. Using a questionnaire-based, cross-sectional study of ministerial employees in Norway who were targeted in a terrorist attack in 2011 (n=3344), we investigated how employees' perceived safety at work 9 to 10 months after the attack was associated with their perceptions of whether security measures were sufficiently prioritized at work, whether there had been sufficient escape and evacuation training, and whether they were confident with evacuation procedures. We found strong evidence of increasing perceived safety at work the more employees believed security measures were sufficiently prioritized at work (partially confounded by post-traumatic stress disorder), and the better their knowledge of evacuation procedures (modified by gender and education). The present study suggests that employers may enhance perceived safety at work for terror-exposed employees by showing a commitment to security measures and by ensuring employees know evacuation procedures well. More research is needed to investigate causality patterns behind the associations found in this cross-sectional study. (Disaster Med Public Health Preparedness. 2016;10:805-811).

Consumer and farmer safety evaluation of application of botanical pesticides in black pepper crop protection.

PubMed

Hernández-Moreno, David; Soffers, Ans E M F; Wiratno; Falke, Hein E; Rietjens, Ivonne M C M; Murk, Albertinka J

2013-06-01

This study presents a consumer and farmer safety evaluation on the use of four botanical pesticides in pepper berry crop protection. The pesticides evaluated include preparations from clove, tuba root, sweet flag and pyrethrum. Their safety evaluation was based on their active ingredients being eugenol, rotenone, β-asarone and pyrethrins, respectively. Botanical pesticides from Acorus calamus are of possible concern because of the genotoxic and carcinogenic ingredient β-asarone although estimated margins of exposure (MOE) for consumers indicate a low priority for risk management. For the other three botanical pesticides the margin of safety (MOS) between established acute reference doses and/or acceptable daily intake values and intake estimates for the consumer, resulting from their use as a botanical pesticide are not of safety concern, with the exception for levels of rotenone upon use of tuba root extracts on stored berries. Used levels of clove and pyrethrum as botanical pesticides in pepper berry crop production is not of safety concern for consumers or farmers, whereas for use of tuba root and sweet flag some risk factors were defined requiring further evaluation and/or risk management. It seems prudent to look for alternatives for use of sweet flag extracts containing β-asarone. Copyright © 2013 Elsevier Ltd. All rights reserved.

30 CFR 56.4530 - Exits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control... a sufficient number of exits to permit prompt escape in case of fire. ...

The risks of radiation

NASA Astrophysics Data System (ADS)

Miettenen, Jorma K.

1988-01-01

The risks of radioactivity are a really complicated matter, yet they are much better known than are the risks relating to thousands of chemical poisons that occur in our environment. The greatest mistakes are probably made in the definition of safety margins. Except for the bombs dropped in Japan and one other case in the Marshall Islands, there has always—luckily—been a wide safety margin between fallout radiation and doses dangerous to health; the margin has actually been about 1000-fold. The Chernobyl dose of 0.5 mGy/year that we received is only 1/1000 of the acute dose of 0.5 Gy which would cause a slight and nonpermanent change in the blood picture. There is no such safety margin with respect to many air pollutants. The safety standards for sulfuric or nitric oxides, ozone and so on, have been set only just below the level that already causes a health hazard, and these standards are exceeded once in a while. Otherwise, traffic would have to be forbidden and many industrial plants, especially power stations using coal, would have to stop working whenever a low-temperature inversion occurred. Environmental radioactivity does not represent a likely health risk in Finland unless a nuclear war breaks out. Air pollutants, on the contrary, are a real and almost daily health risk that should be carefully considered when decisions about our energy production are being made. In spite of what happened at Chernobyl, global consumption of nuclear power will double by the year 2000, since there are about 140 nuclear power plants presently under construction. It is not likely that another catastrophe like Chernobyl will happen, yet nuclear plant accidents are of course possible, even if their likelihood is diminished by improving reactor safety and even if any eventual damage could be expected to be smaller. If a reactor is hooded by a containment structure, no significant release of radioactive materials should be possible even in case of an accident. However, we must be prepared to protect the population with carefully planned civil defense and radiation protection measures.

Long-term study of ovine pulmonary adenocarcinogenesis in sheep with marginal vs. sufficient nutritional selenium supply: results from computed tomography, pathology, immunohistochemistry, JSRV-PCR and lung biochemistry.

PubMed

Humann-Ziehank, Esther; Renko, Kostja; Bruegmann, Michael L; Devi, Vemuri Rama; Hewicker-Trautwein, Marion; Andreae, Arnim; Ganter, Martin

2013-10-01

The impact of selenium (Se) in carcinogenesis is still debatable due to inconsistent results of observational studies, recent suspicion of diabetic side effects and e.g. dual roles of glutathione peroxidases (GPx). Previously, our group introduced long-term studies on lung carcinogenesis using the jaagtsiekte sheep retrovirus (JSRV) induced ovine pulmonary adenocarcinoma (OPA) as an innovative animal model. The present report describes the results of sufficient (0.2 mg Se/kg dry weight (dw)) vs. marginal (<0.05 mg Se/kg dw) nutritional Se supply on cancer progression over a two-year period in 16 animals. Computed tomography (CT) evaluation of lung cancer progression, final pathological examination, evidence of pro-viral JSRV-DNA in lung, lymph nodes and broncho-alveolar lavage cells as well as biochemical analysis of Se, GPx1 and thioredoxin reductase (TrxR) activity in lung tissue were recorded. Additionally, immunohistochemical determination of GPx1 expression in unaffected and neoplastic lung cells was implemented. The feeding regime caused significant differences in Se concentration and GPx1 activity in lung tissue between groups, whereas TrxR activity remained unaffected. JSRV was evident in broncho-alveolar lavage cells, lung tissue and lung lymph nodes. Quarterly executed CT could not demonstrate differences in lung cancer proliferation intensity. Necropsy and histopathology substantiated CT findings. Immunohistochemical analysis of GPx1 in lung tissue suggested a coherency of GPx1 immunolabelling intensity in dependence of tumour size. It was concluded that the model proved to be suitable for long-term studies of lung cancer proliferation including the impact of modifiable nutritional factors. Proliferation of OPA was unaffected by marginal vs. sufficient nutritional Se supply. Copyright © 2013 Elsevier GmbH. All rights reserved.

Dosimetric Implications of Residual Tracking Errors During Robotic SBRT of Liver Metastases

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

Chan, Mark; Tuen Mun Hospital, Hong Kong; Grehn, Melanie

Purpose: Although the metric precision of robotic stereotactic body radiation therapy in the presence of breathing motion is widely known, we investigated the dosimetric implications of breathing phase–related residual tracking errors. Methods and Materials: In 24 patients (28 liver metastases) treated with the CyberKnife, we recorded the residual correlation, prediction, and rotational tracking errors from 90 fractions and binned them into 10 breathing phases. The average breathing phase errors were used to shift and rotate the clinical tumor volume (CTV) and planning target volume (PTV) for each phase to calculate a pseudo 4-dimensional error dose distribution for comparison with themore » original planned dose distribution. Results: The median systematic directional correlation, prediction, and absolute aggregate rotation errors were 0.3 mm (range, 0.1-1.3 mm), 0.01 mm (range, 0.00-0.05 mm), and 1.5° (range, 0.4°-2.7°), respectively. Dosimetrically, 44%, 81%, and 92% of all voxels differed by less than 1%, 3%, and 5% of the planned local dose, respectively. The median coverage reduction for the PTV was 1.1% (range in coverage difference, −7.8% to +0.8%), significantly depending on correlation (P=.026) and rotational (P=.005) error. With a 3-mm PTV margin, the median coverage change for the CTV was 0.0% (range, −1.0% to +5.4%), not significantly depending on any investigated parameter. In 42% of patients, the 3-mm margin did not fully compensate for the residual tracking errors, resulting in a CTV coverage reduction of 0.1% to 1.0%. Conclusions: For liver tumors treated with robotic stereotactic body radiation therapy, a safety margin of 3 mm is not always sufficient to cover all residual tracking errors. Dosimetrically, this translates into only small CTV coverage reductions.« less

Invasive vulvar carcinoma and the question of the surgical margin.

PubMed

Palaia, Innocenza; Bellati, Filippo; Calcagno, Marco; Musella, Angela; Perniola, Giorgia; Panici, Pierluigi B

2011-08-01

To assess the discrepancy between width of surgical margin measured with the naked eye/ruler by a surgeon before removing an invasive vulvar carcinoma, and width of margin measured under microscope by pathologist after fixation of the resected lesion with formalin. Potential relationships between discrepancy and disease recurrence were also investigated. This prospective study was conducted with resected lesions from 86 women who underwent surgery for primary/recurrent invasive vulvar carcinoma. After the surgeon removed the lesions surrounded by 1-2-cm margins, the pathologist determined margin width at the 4 cardinal points of 86 lesions (for a total of 344 margin assessments), first macroscopically and then under the microscope. A safety margin of 0.8 cm on microscopic view was achieved in 83% of cases (112 of 135) when the macroscopic measurement was 1cm, in 91% of cases (58 of 64) when it was 1.5 cm, and 98% of cases (105 of 107) when it was 2 cm. There was a small discrepancy between the surgeon's intent and the microscopic margin measurement, mostly related to tissue shrinkage. A 1-cm surgical margin corresponded to a 0.8-cm margin in microscopic view (the "safe margin") in most cases. Copyright © 2011 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Operating without a Safety Net: Gay Male Adolescents and Emerging Adults' Experiences of Marginalization and Migration, and Implications for Theory of Syndemic Production of Health Disparities

ERIC Educational Resources Information Center

Bruce, Douglas; Harper, Gary W.

2011-01-01

Health disparities among gay men (HIV, substance use, depression) have been described as a mutually occurring "syndemic" that is socially produced through two overarching dynamics: marginalization and migration. Although the syndemic theory proposes a developmental trajectory, it has been largely based on epidemiological studies of adult gay men…

Feminist Heuristics: Transforming the Foundation of Food Quality and Safety Assurance Systems

ERIC Educational Resources Information Center

Kimura, Aya Hirata

2012-01-01

Food safety and quality assurance systems have emerged as a key mechanism of food governance in recent years and are also popular among alternative agrofood movements, such as the organic and fair trade movements. Rural sociologists have identified many problems with existing systems, including corporate cooptation, the marginalization of small…

30 CFR 77.207 - Illumination.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS, SURFACE COAL MINES AND SURFACE WORK AREAS OF UNDERGROUND COAL MINES Surface Installations § 77.207 Illumination. Illumination sufficient to provide safe working conditions shall be...

29 CFR 1952.104 - Final approval determination.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... Assistant Secretary determined that, in operation, Oregon's occupational safety and health program (with the... accordance with 29 CFR part 1953; to allocate sufficient safety and health enforcement staff to meet the...

Development of remote crane system for use inside small argon hot-cell

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

Lee, Jong Kwang; Park, Byung Suk; Yu, Seung-Nam

2013-07-01

In this paper, we describe the design of a novel crane system for the use in a small argon hot-cell where only a pair of master-slave manipulators (MSM) is available for the remote maintenance of the crane. To increase the remote maintainability in the space-limited environment, we devised a remote actuation mechanism in which electrical parts consisting of a servo-motor, a position sensor, and two limit switches located inside the workspace of the MSM transmit power to the mechanical parts located in the ceiling. Even though the design concept does not provide thoroughly sufficient solution because the mechanical parts aremore » placed out of the MSM's workspace, the durability of mechanical parts can be easily increased if they have a high safety margin. Therefore, the concept may be one of the best solutions for our special crane system. In addition, we developed a servo-control system based on absolute positioning technology; therefore, it is possible for us to perform the given tasks more safely through an automatic operation. (authors)« less

40 CFR 230.41 - Wetlands.

Code of Federal Regulations, 2011 CFR

2011-07-01

... surface or ground water at a frequency and duration sufficient to support, and that under normal...) Where wetlands are adjacent to open water, they generally constitute the transition to upland. The margin between wetland and open water can best be established by specialists familiar with the local...

Food insufficiency in the households of reproductive-age Ecuadorian women: association with food and nutritional status indicators.

PubMed

Weigel, M Margaret; Armijos, Maria Mercedes

2015-01-01

Data from a nationally representative survey of Ecuadorian households with reproductive-aged women (n = 10,784) were used to analyze the prevalence of household food insufficiency (HFI) and its association with sociodemographic characteristics, food acquisition and expenditure patterns, dietary diversity, and anthropometric indicators. Fifteen percent of households had food insufficiency and 15% had marginal food sufficiency. HFI was associated with poverty-linked indicators. Marginally food sufficient households reported social and economic capital than food which appeared protective against HFI. Food insufficiency was associated with reduced household acquisition/expenditures on high quality protein and micronutrient-rich food sources. HFI was not associated with adult or adolescent female overweight/obesity but was associated with short adult stature (< 1.45 m). The ongoing nutrition transition in Ecuador is expected to continue to modify population food security, diet, and nutrition. Systematic surveillance of household level food security is needed to inform recent food-related policies and programs implemented by the Ecuadorian government.

Centrifugal Compressor Surge Margin Improved With Diffuser Hub Surface Air Injection

NASA Technical Reports Server (NTRS)

Skoch, Gary J.

2002-01-01

Aerodynamic stability is an important parameter in the design of compressors for aircraft gas turbine engines. Compression system instabilities can cause compressor surge, which may lead to the loss of an aircraft. As a result, engine designers include a margin of safety between the operating line of the engine and the stability limit line of the compressor. The margin of safety is typically referred to as "surge margin." Achieving the highest possible level of surge margin while meeting design point performance objectives is the goal of the compressor designer. However, performance goals often must be compromised in order to achieve adequate levels of surge margin. Techniques to improve surge margin will permit more aggressive compressor designs. Centrifugal compressor surge margin improvement was demonstrated at the NASA Glenn Research Center by injecting air into the vaned diffuser of a 4:1-pressure-ratio centrifugal compressor. Tests were performed using injector nozzles located on the diffuser hub surface of a vane-island diffuser in the vaneless region between the impeller trailing edge and the diffuser-vane leading edge. The nozzle flow path and discharge shape were designed to produce an air stream that remained tangent to the hub surface as it traveled into the diffuser passage. Injector nozzles were located near the leading edge of 23 of the 24 diffuser vanes. One passage did not contain an injector so that instrumentation located in that passage would be preserved. Several orientations of the injected stream relative to the diffuser vane leading edge were tested over a range of injected flow rates. Only steady flow (nonpulsed) air injection was tested. At 100 percent of the design speed, a 15-percent improvement in the baseline surge margin was achieved with a nozzle orientation that produced a jet that was bisected by the diffuser vane leading edge. Other orientations also improved the baseline surge margin. Tests were conducted at speeds below the design speed, and similar results were obtained. In most cases, the greatest improvement in surge margin occurred at fairly low levels of injected flow rate. Externally supplied injection air was used in these experiments. However, the injected flow rates that provided the greatest benefit could be produced using injection air that is recirculating between the diffuser discharge and nozzles located in the diffuser vaneless region. Future experiments will evaluate the effectiveness of recirculating air injection.

Analytical methodology for safety validation of computer controlled subsystems. Volume 1 : state-of-the-art and assessment of safety verification/validation methodologies

DOT National Transportation Integrated Search

1995-09-01

This report describes the development of a methodology designed to assure that a sufficiently high level of safety is achieved and maintained in computer-based systems which perform safety critical functions in high-speed rail or magnetic levitation ...

17 CFR 40.10 - Special certification procedures for submission of rules by systemically important derivatives...

Code of Federal Regulations, 2012 CFR

2012-04-01

... affect financial resources, participant and product eligibility, risk management (including matters relating to margin and stress testing), daily or intraday settlement procedures, default procedures, system... settlement activities and the sufficiency of any proposed risk management techniques. (d) Notice of objection...

17 CFR 40.10 - Special certification procedures for submission of rules by systemically important derivatives...

Code of Federal Regulations, 2013 CFR

2013-04-01

... affect financial resources, participant and product eligibility, risk management (including matters relating to margin and stress testing), daily or intraday settlement procedures, default procedures, system... settlement activities and the sufficiency of any proposed risk management techniques. (d) Notice of objection...

17 CFR 40.10 - Special certification procedures for submission of rules by systemically important derivatives...

Code of Federal Regulations, 2014 CFR

2014-04-01

... affect financial resources, participant and product eligibility, risk management (including matters relating to margin and stress testing), daily or intraday settlement procedures, default procedures, system... settlement activities and the sufficiency of any proposed risk management techniques. (d) Notice of objection...

Walking stability during cell phone use in healthy adults.

PubMed

Kao, Pei-Chun; Higginson, Christopher I; Seymour, Kelly; Kamerdze, Morgan; Higginson, Jill S

2015-05-01

The number of falls and/or accidental injuries associated with cellular phone use during walking is growing rapidly. Understanding the effects of concurrent cell phone use on human gait may help develop safety guidelines for pedestrians. It was shown previously that older adults had more pronounced dual-task interferences than younger adults when concurrent cognitive task required visual information processing. Thus, cell phone use might have greater impact on walking stability in older than in younger adults. This study examined gait stability and variability during a cell phone dialing task (phone) and two classic cognitive tasks, the Paced Auditory Serial Addition Test (PASAT) and Symbol Digit Modalities Test (SDMT). Nine older and seven younger healthy adults walked on a treadmill at four different conditions: walking only, PASAT, phone, and SDMT. We computed short-term local divergence exponent (LDE) of the trunk motion (local stability), dynamic margins of stability (MOS), step spatiotemporal measures, and kinematic variability. Older and younger adults had similar values of short-term LDE during all conditions, indicating that local stability was not affected by the dual-task. Compared to walking only, older and younger adults walked with significantly greater average mediolateral MOS during phone and SDMT conditions but significantly less ankle angle variability during all dual-tasks and less knee angle variability during PASAT. The current findings demonstrate that healthy adults may try to control foot placement and joint kinematics during cell phone use or another cognitive task with a visual component to ensure sufficient dynamic margins of stability and maintain local stability. Copyright © 2015 Elsevier B.V. All rights reserved.

Walking Stability during Cell Phone Use in Healthy Adults

PubMed Central

Kao, Pei-Chun; Higginson, Christopher I.; Seymour, Kelly; Kamerdze, Morgan; Higginson, Jill S.

2015-01-01

The number of falls and/or accidental injuries associated with cellular phone use during walking is growing rapidly. Understanding the effects of concurrent cell phone use on human gait may help develop safety guidelines for pedestrians. It was shown previously that older adults had more pronounced dual-task interferences than younger adults when concurrent cognitive task required visual information processing. Thus, cell phone use might have greater impact on walking stability in older than in younger adults. This study examined gait stability and variability during a cell phone dialing task (phone) and two classic cognitive tasks, the Paced Auditory Serial Addition Test (PASAT) and Symbol Digit Modalities Test (SDMT). Nine older and seven younger healthy adults walked on a treadmill at four different conditions: walking only, PASAT, phone, and SDMT. We computed short-term local divergence exponent (LDE) of the trunk motion (local stability), dynamic margins of stability (MOS), step spatiotemporal measures, and kinematic variability. Older and younger adults had similar values of short-term LDE during all conditions, indicating that local stability was not affected by the dual-task. Compared to walking only, older and younger adults walked with significantly greater average mediolateral MOS during phone and SDMT conditions but significantly less ankle angle variability during all dual-tasks and less knee angle variability during PASAT. The current findings demonstrate that healthy adults may try to control foot placement and joint kinematics during cell phone use or another cognitive task with a visual component to ensure sufficient dynamic margins of stability and maintain local stability. PMID:25890490

29 CFR 1910.26 - Portable metal ladders.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Walking-Working Surfaces § 1910.26 Portable metal ladders. (a... material for the safety of the user. (viii) A metal spreader or locking device of sufficient size and...

Modeling of a Flooding Induced Station Blackout for a Pressurized Water Reactor Using the RISMC Toolkit

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

Mandelli, Diego; Prescott, Steven R; Smith, Curtis L

2011-07-01

In the Risk Informed Safety Margin Characterization (RISMC) approach we want to understand not just the frequency of an event like core damage, but how close we are (or are not) to key safety-related events and how might we increase our safety margins. The RISMC Pathway uses the probabilistic margin approach to quantify impacts to reliability and safety by coupling both probabilistic (via stochastic simulation) and mechanistic (via physics models) approaches. This coupling takes place through the interchange of physical parameters and operational or accident scenarios. In this paper we apply the RISMC approach to evaluate the impact of amore » power uprate on a pressurized water reactor (PWR) for a tsunami-induced flooding test case. This analysis is performed using the RISMC toolkit: RELAP-7 and RAVEN codes. RELAP-7 is the new generation of system analysis codes that is responsible for simulating the thermal-hydraulic dynamics of PWR and boiling water reactor systems. RAVEN has two capabilities: to act as a controller of the RELAP-7 simulation (e.g., system activation) and to perform statistical analyses (e.g., run multiple RELAP-7 simulations where sequencing/timing of events have been changed according to a set of stochastic distributions). By using the RISMC toolkit, we can evaluate how power uprate affects the system recovery measures needed to avoid core damage after the PWR lost all available AC power by a tsunami induced flooding. The simulation of the actual flooding is performed by using a smooth particle hydrodynamics code: NEUTRINO.« less

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2013 CFR

2013-07-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2012 CFR

2012-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2014 CFR

2014-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

41 CFR 102-80.115 - Is there more than one option for establishing that an equivalent level of safety exists?

Code of Federal Regulations, 2011 CFR

2011-01-01

..., complete sprinkler protection can be expected to prevent flashover in the room of fire origin, limit fire... the times required for egress. If a combination of fire protection systems provides a margin of safety... Contracts and Property Management Federal Property Management Regulations System (Continued) FEDERAL...

One-millimeter cancer-free margin is curative for colorectal liver metastases: a propensity score case-match approach.

PubMed

Hamady, Zaed Z R; Lodge, J Peter A; Welsh, Fenella K; Toogood, Giles J; White, Alan; John, Timothy; Rees, Myrddin

2014-03-01

To investigate the influence of clear surgical resection margin width on disease recurrence rate after intentionally curative resection of colorectal liver metastases. There is consensus that a histological positive resection margin is a predictor of disease recurrence after resection of colorectal liver metastases. The dispute, however, over the width of cancer-free resection margin required is ongoing. Analysis of observational prospectively collected data for 2715 patients who underwent primary resection of colorectal liver metastases from 2 major hepatobiliary units in the United Kingdom. Histological cancer-free resection margin was classified as positive (if cancer cells present at less than 1 mm from the resection margin) or negative (if the distance between the cancer and the margin is 1 mm or more). The negative margin was further classified according to the distance from the tumor in millimeters. Predictors of disease-free survival were analyzed in univariate and multivariate analyses. A case-match analysis by a propensity score method was undertaken to reduce bias. A 1-mm cancer-free resection margin was sufficient to achieve 33% 5-year overall disease-free survival. Extra margin width did not add disease-free survival advantage (P > 0.05). After the propensity case-match analysis, there is no statistical difference in disease-free survival between patients with negative narrow and wider margin clearance [hazard ratio (HR) 1.0; 95% (confidence interval) CI: 0.9-1.2; P = 0.579 at 5-mm cutoff and HR 1.1; 95% CI: 0.96-1.3; P = 0.149 at 10-mm cutoff]. Patients with extrahepatic disease and positive lymph node primary tumor did not have disease-free survival advantage despite surgical margin clearance (9 months for <1-mm vs 12 months for ≥1-mm margin clearance; P = 0.062). One-mm cancer-free resection margin achieved in patients with colorectal liver metastases should now be considered the standard of care.

Marginal Cost Pricing in a World without Perfect Competition: Implications for Electricity Markets with High Shares of Low Marginal Cost Resources

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

Frew, Bethany A.; Clark, Kara; Bloom, Aaron P.

A common approach to regulating electricity is through auction-based competitive wholesale markets. The goal of this approach is to provide a reliable supply of power at the lowest reasonable cost to the consumer. This necessitates market structures and operating rules that ensure revenue sufficiency for all generators needed for resource adequacy purposes. Wholesale electricity markets employ marginal-cost pricing to provide cost-effective dispatch such that resources are compensated for their operational costs. However, marginal-cost pricing alone cannot guarantee cost recovery outside of perfect competition, and electricity markets have at least six attributes that preclude them from functioning as perfectly competitive markets.more » These attributes include market power, externalities, public good attributes, lack of storage, wholesale price caps, and ineffective demand curve. Until (and unless) these failures are ameliorated, some form of corrective action(s) will be necessary to improve market efficiency so that prices can correctly reflect the needed level of system reliability. Many of these options necessarily involve some form of administrative or out-of-market actions, such as scarcity pricing, capacity payments, bilateral or other out-of-market contracts, or some hybrid combination. A key focus with these options is to create a connection between the electricity market and long-term reliability/loss-of-load expectation targets, which are inherently disconnected in the native markets because of the aforementioned market failures. The addition of variable generation resources can exacerbate revenue sufficiency and resource adequacy concerns caused by these underlying market failures. Because variable generation resources have near-zero marginal costs, they effectively suppress energy prices and reduce the capacity factors of conventional generators through the merit-order effect in the simplest case of a convex market; non-convexities can also suppress prices.« less

Safety and Suitability for Service Assessment Testing for Aircraft Launched Munitions

DTIC Science & Technology

2013-07-01

2013 12 benefits in terms of cost and test efficiency that tend to associate the Analytical S3 Test Approach with complex missile systems and the... systems containing expensive, non-safety related components. c. When using the Analytical S3 Test Approach for aircraft launched bombs, full BTCA is...establish safety margin of the system . Details of the Empirical Test Flow with full and reduced BTCA options are provided in Appendix B, Annexes 3 and

29 CFR 1926.105 - Safety nets.

Code of Federal Regulations, 2014 CFR

2014-07-01

... be hung with sufficient clearance to prevent user's contact with the surfaces or structures below... shall provide a minimum breaking strength of 5,000 pounds. (e) Forged steel safety hooks or shackles...

29 CFR 1926.105 - Safety nets.

Code of Federal Regulations, 2013 CFR

2013-07-01

... be hung with sufficient clearance to prevent user's contact with the surfaces or structures below... shall provide a minimum breaking strength of 5,000 pounds. (e) Forged steel safety hooks or shackles...

29 CFR 1926.105 - Safety nets.

Code of Federal Regulations, 2011 CFR

2011-07-01

... be hung with sufficient clearance to prevent user's contact with the surfaces or structures below... shall provide a minimum breaking strength of 5,000 pounds. (e) Forged steel safety hooks or shackles...

29 CFR 1926.105 - Safety nets.

Code of Federal Regulations, 2012 CFR

2012-07-01

... be hung with sufficient clearance to prevent user's contact with the surfaces or structures below... shall provide a minimum breaking strength of 5,000 pounds. (e) Forged steel safety hooks or shackles...

Development, fabrication and test of a high purity silica heat shield

NASA Technical Reports Server (NTRS)

Rusert, E. L.; Drennan, D. N.; Biggs, M. S.

1978-01-01

A highly reflective hyperpure ( 25 ppm ion impurities) slip cast fused silica heat shield material developed for planetary entry probes was successfully scaled up. Process development activities for slip casting large parts included green strength improvements, casting slip preparation, aggregate casting, strength, reflectance, and subscale fabrication. Successful fabrication of a one-half scale Saturn probe (shape and size) heat shield was accomplished while maintaining the silica high purity and reflectance through the scale-up process. However, stress analysis of this original aggregate slip cast material indicated a small margin of safety (MS. = +4%) using a factor of safety of 1.25. An alternate hyperpure material formulation to increase the strength and toughness for a greater safety margin was evaluated. The alternate material incorporates short hyperpure silica fibers into the casting slip. The best formulation evaluated has a 50% by weight fiber addition resulting in an 80% increase in flexural strength and a 170% increase in toughness over the original aggregate slip cast materials with comparable reflectance.

A risk assessment of topical tretinoin as a potential human developmental toxin based on animal and comparative human data.

PubMed

Johnson, E M

1997-03-01

Although topically applied all-trans-retinoic acid (tretinoin) undergoes minimal absorption and adds negligibly to normal endogenous levels, its safety in humans is occasionally questioned because oral ingestion of retinoids at therapeutic levels is known to entail teratogenic risks. To assess the actual potential for developmental toxicity from treatment with topical tretinoin. Risk assessments were conducted on four known human developmental toxicants (valproic acid, methotrexate, thalidomide, and isotretinoin) and a potential developmental toxicant (acetylsalicylic acid). The margin of safety for each chemical was calculated from the ratio of animal no-observed adverse effect levels to human lowest-observed adverse effect levels or estimated exposure doses. The derived safety margin of more than 100 for topical tretinoin (with 2% absorption) contrasted sharply with the near unity values for valproic acid, methotrexate, thalidomide, and isotretinoin and was larger than that for acetylsalicylic acid. These data support other epidemiologic and animal data that topical tretinoin is not a potential human developmental toxicant.

Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

NASA Technical Reports Server (NTRS)

Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

2013-01-01

NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

17 CFR 240.17Ad-22 - Standards for clearing agencies.

Code of Federal Regulations, 2013 CFR

2013-04-01

... of the clearing agency's risk management procedures. (9) Provide market participants with sufficient... to its participants that would be expected to breach margin requirements or other risk control... net capital as defined in § 240.15c3-1 for broker-dealers or any similar risk adjusted capital...

Design and analysis of lifting tool assemblies to lift different engine block

NASA Astrophysics Data System (ADS)

Sawant, Arpana; Deshmukh, Nilaj N.; Chauhan, Santosh; Dabhadkar, Mandar; Deore, Rupali

2017-07-01

Engines block are required to be lifted from one place to another while they are being processed. The human effort required for this purpose is more and also the engine block may get damaged if it is not handled properly. There is a need for designing a proper lifting tool which will be able to conveniently lift the engine block and place it at the desired position without any accident and damage to the engine block. In the present study lifting tool assemblies are designed and analyzed in such way that it may lift different categories of engine blocks. The lifting tool assembly consists of lifting plate, lifting ring, cap screws and washers. A parametric model and assembly of Lifting tool is done in 3D modelling software CREO 2.0 and analysis is carried out in ANSYS Workbench 16.0. A test block of weight equivalent to that of an engine block is considered for the purpose of analysis. In the preliminary study, without washer the stresses obtained on the lifting tool were more than the safety margin. In the present design, washers were used with appropriate dimensions which helps to bring down the stresses on the lifting tool within the safety margin. Analysis is carried out to verify that tool design meets the ASME BTH-1 required safety margin.

Stratal stacking patterns and tectono-sedimentary evolution of hyperextended magma-poor rifted margins

NASA Astrophysics Data System (ADS)

Ribes, C.; Gillard, M.; Epin, M. E.; Ghienne, J. F.; Manatschal, G.; Karner, G. D.; Johnson, C. A.

2016-12-01

Research on the formation and evolution of deep-water rifted margins has undergone a major paradigm shift in recent years. An increasing number of studies of present-day and fossil rifted margins allow us to identify and characterize the structural architecture of the most distal parts of rifted margins, the so-called hyperextended, magma-poor rifted margins. However, at present, little is known about the depositional environments, sedimentary facies, stacking patterns, subsidence and thermal history within these domains. In this context, characterizing the stratal stacking patterns and understanding their spatial and temporal evolution is a new challenge. The major difficulty comes from the fact that the observed stratigraphic geometries and facies relationships are a result of the complex interplay between sediment supply and available accommodation, which is controlled by not only the regional generation of accommodation, but also by local tectono-magmatic processes. These parameters are poorly constrained or even sufficiently known in these tectonic settings. Indeed, the complex structural evolution of hyperextended magma-poor rifted margins, including the development of poly-phase in-sequence and out of sequence extensional detachment faults and associated mantle exhumation and magmatic activity, can generate complex accommodation patterns over a highly structured top basement. The presentation summarizes early results concerning the controlling parameters on ultra-deep water stratigraphic stacking patterns and to provide a conceptual framework. This observation-driven approach combines fieldwork from fossil Alpine Tethys margins exposed in the Alps and the analysis of seismic reflection data from present-day deep water rifted margins such as the Australian-Antarctic, East India and Iberia-Newfoundland margins.

Hyperspectral imaging for cancer surgical margin delineation: registration of hyperspectral and histological images

NASA Astrophysics Data System (ADS)

Lu, Guolan; Halig, Luma; Wang, Dongsheng; Chen, Zhuo G.; Fei, Baowei

2014-03-01

The determination of tumor margins during surgical resection remains a challenging task. A complete removal of malignant tissue and conservation of healthy tissue is important for the preservation of organ function, patient satisfaction, and quality of life. Visual inspection and palpation is not sufficient for discriminating between malignant and normal tissue types. Hyperspectral imaging (HSI) technology has the potential to noninvasively delineate surgical tumor margin and can be used as an intra-operative visual aid tool. Since histological images provide the ground truth of cancer margins, it is necessary to warp the cancer regions in ex vivo histological images back to in vivo hyperspectral images in order to validate the tumor margins detected by HSI and to optimize the imaging parameters. In this paper, principal component analysis (PCA) is utilized to extract the principle component bands of the HSI images, which is then used to register HSI images with the corresponding histological image. Affine registration is chosen to model the global transformation. A B-spline free form deformation (FFD) method is used to model the local non-rigid deformation. Registration experiment was performed on animal hyperspectral and histological images. Experimental results from animals demonstrated the feasibility of the hyperspectral imaging method for cancer margin detection.

Development of anaesthetic protocols for lumpfish (Cyclopterus lumpus L.): Effect of anaesthetic concentrations, sea water temperature and body weight

PubMed Central

Skår, Malene W.; Powell, Mark D.; Wergeland, Heidrun I.; Samuelsen, Ole B.

2017-01-01

In recent years, use of lumpfish (Cyclopterus lumpus L.) as cleaner-fish to remove sea-lice have been chosen by many salmon farmers in Europe and Canada as an alternative to medical treatment, which has led to large scale production of lumpfish. At present, there is limited knowledge of how lumpfish respond upon anaesthesia, which anaesthetics and concentrations that are efficient and conditions for euthanasia. We have therefore tested and developed protocols for bath immersion for three commonly used anaesthetics metacaine (Finquel, buffered tricaine methanesulfonate, MS-222 and Tricaine Pharmaq), benzocaine (Benzoak vet) and isoeugenol (Aqui-S), determined concentration for normal and fast anaesthesia and evaluated safety margin for each condition. Also, a behavioral matrix has been developed. We have examined the effect of fish size (10–20 g, 200–400 g and 600–1300 g) and sea water temperature (6°C and 12°C). We found that 200 mg L-1 metacaine is an efficient dose for deep narcosis independently for fish size and temperature due to good safety margins with regards to both exposure times and doses. However, for many tasks lighter anaesthesia is sufficient, and then 100 mg L-1 metacaine can be used. Benzocaine is less efficient than metacaine, but can be used as anaesthetic of fish < 400 g. The optimal doses of benzocaine were 100–200 mg L-1 for small fish (10–20 g) and 200 mg L-1 for medium sized fish (200–400 g). For larger fish (> 600 g), benzocaine is not suitable. Isoeugenol cannot be recommended for full anesthesia of lumpfish. The conditions for lethal doses varied with chosen anaesthetic, fish size and temperature. For small fish (10–20 g), exposure to 1600 mgL-1 of metacaine in 10 minutes it lethal. Guided protocols for non-lethal anaesthesia will contribute to ensure safe treatment of lumpfish according to an ethical standard for good fish welfare. PMID:28678815

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...

30 CFR 56.4000 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... sufficient vapor is released by a liquid to form a flammable vapor-air mixture near the surface of the liquid... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control § 56.4000...

30 CFR 56.4000 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... sufficient vapor is released by a liquid to form a flammable vapor-air mixture near the surface of the liquid... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control § 56.4000...

30 CFR 56.4000 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... sufficient vapor is released by a liquid to form a flammable vapor-air mixture near the surface of the liquid... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control § 56.4000...

30 CFR 56.4000 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... sufficient vapor is released by a liquid to form a flammable vapor-air mixture near the surface of the liquid... Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control § 56.4000...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2013-01-01 2013-01-01 false Contents of applications; technical information in final...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2012-01-01 2012-01-01 false Contents of applications; technical information in final...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2014-01-01 2014-01-01 false Contents of applications; technical information in final...

10 CFR 52.157 - Contents of applications; technical information in final safety analysis report.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; technical information in final safety analysis report. The application must contain a final safety analysis...) Information sufficient to demonstrate compliance with the applicable requirements regarding testing, analysis... 10 Energy 2 2011-01-01 2011-01-01 false Contents of applications; technical information in final...

Caught in the competitive crossfire: safety-net providers balance margin and mission in a profit-driven health care market.

PubMed

Cunningham, Peter J; Bazzoli, Gloria J; Katz, Aaron

2008-01-01

This paper describes how intensifying competitive pressures in the health system are simultaneously driving increased demand for safety-net care and taxing safety-net providers' ability to maintain the mission of serving all, regardless of ability to pay. Although safety-net providers adapted to previous challenges arising from managed care, health system pressures have been more intense and more generalized across different sectors in recent years than in the past. Providers are adopting some of the same strategies being used in the private sector to attract higher-paying patients and changing their "image" as a safety-net provider.

Test and model correlation of the atmospheric emission photometric imager fiberglass pedestal

NASA Technical Reports Server (NTRS)

Lee, H. M., III; Barker, L. A.

1990-01-01

The correlation is presented of the static loads testing and finite element modeling for the fiberglass pedestal used on the Atmospheric Emission Photometric Imaging (AEPI) experiment. This payload is to be launched in the space shuttle as part of the ATLAS-1 experiment. Strain gauge data from rosettes around the highly loaded base are compared to the same load case run for the Spacelab 1 testing done in 1981. Correlation of the model and test data was accomplished through comparison of the composite stress invariant using the expected flight loads for the ATLAS-1 mission. Where appropriate, the Tsai-Wu failure criteria was used in the development of the key margins of safety. Margins of safety are all positive for the pedestal and are reported.

DETERMINATION OF THE APPROPRIATE FQPA SAFETY FACTOR(S) IN THE ORGANOPHOSPHOROUS PESTICIDE CUMULATIVE RISK ASSESSMENT: SUSCEPTIBILITY AND SENSITIVITY TO THE COMMON MECHANISM, ACETYLCHOLINESTERASE INHIBITION

EPA Science Inventory

The Food Quality Protection Act of 1996 (FQPA) directs EPA, in setting pesticide tolerances, to use an additional tenfold margin of safety to protect infants and children taking into account the potential for pre- and postnatal toxicity and the completeness of the toxicology and ...

Orion MPCV Touchdown Detection Threshold Development and Testing

NASA Technical Reports Server (NTRS)

Daum, Jared; Gay, Robert

2013-01-01

A robust method of detecting Orion Multi ]Purpose Crew Vehicle (MPCV) splashdown is necessary to ensure crew and hardware safety during descent and after touchdown. The proposed method uses a triple redundant system to inhibit Reaction Control System (RCS) thruster firings, detach parachute risers from the vehicle, and transition to the post ]landing segment of the Flight Software (FSW). The vehicle crew is the prime input for touchdown detection, followed by an autonomous FSW algorithm, and finally a strictly time based backup timer. RCS thrusters must be inhibited before submersion in water to protect against possible damage due to firing these jets under water. In addition, neglecting to declare touchdown will not allow the vehicle to transition to post ]landing activities such as activating the Crew Module Up ]righting System (CMUS), resulting in possible loss of communication and difficult recovery. A previous AIAA paper gAssessment of an Automated Touchdown Detection Algorithm for the Orion Crew Module h concluded that a strictly Inertial Measurement Unit (IMU) based detection method using an acceleration spike algorithm had the highest safety margins and shortest detection times of other methods considered. That study utilized finite element simulations of vehicle splashdown, generated by LS ]DYNA, which were expanded to a larger set of results using a Kriging surface fit. The study also used the Decelerator Systems Simulation (DSS) to generate flight dynamics during vehicle descent under parachutes. Proto ]type IMU and FSW MATLAB models provided the basis for initial algorithm development and testing. This paper documents an in ]depth trade study, using the same dynamics data and MATLAB simulations as the earlier work, to further develop the acceleration detection method. By studying the combined effects of data rate, filtering on the rotational acceleration correction, data persistence limits and values of acceleration thresholds, an optimal configuration was determined. The lever arm calculation, which removes the centripetal acceleration caused by vehicle rotation, requires that the vehicle angular acceleration be derived from vehicle body rates, necessitating the addition of a 2nd order filter to smooth the data. It was determined that using 200 Hz data directly from the vehicle IMU outperforms the 40 Hz FSW data rate. Data persistence counter values and acceleration thresholds were balanced in order to meet desired safety and performance. The algorithm proved to exhibit ample safety margin against early detection while under parachutes, and adequate performance upon vehicle splashdown. Fall times from algorithm initiation were also studied, and a backup timer length was chosen to provide a large safety margin, yet still trigger detection before CMUS inflation. This timer serves as a backup to the primary acceleration detection method. Additionally, these parameters were tested for safety on actual flight test data, demonstrating expected safety margins.

Digital Filters for Digital Phase-locked Loops

NASA Technical Reports Server (NTRS)

Simon, M.; Mileant, A.

1985-01-01

An s/z hybrid model for a general phase locked loop is proposed. The impact of the loop filter on the stability, gain margin, noise equivalent bandwidth, steady state error and time response is investigated. A specific digital filter is selected which maximizes the overall gain margin of the loop. This filter can have any desired number of integrators. Three integrators are sufficient in order to track a phase jerk with zero steady state error at loop update instants. This filter has one zero near z = 1.0 for each integrator. The total number of poles of the filter is equal to the number of integrators plus two.

Medical abortion: understanding perspectives of rural and marginalized women from rural South India.

PubMed

Sri, B Subha; Ravindran, T K Sundari

2012-09-01

To understand how rural and other groups of marginalized women define safe abortion; their perspectives and concerns regarding medical abortion (MA); and what factors affect their access to safe abortion. Focus group discussions were held with various groups of rural and marginalized women in Tamil Nadu to understand their perspectives and concerns on abortion, especially MA. Nearly a decade after mifepristone was approved for abortion in India, most study participants had never heard of MA. When they learned of the method, most preferred it over other methods of abortion. The women also had questions and concerns about the method and recommendations on how services should be provided. Their definition of a "safe abortion" included criteria beyond medical safety. They placed a high priority on "social safety," including confidentiality and privacy. In their view, factors affecting access to safe abortion and choice of provider included cost, assurance of secrecy, promptness of service provision, and absence of provider gatekeeping and provider-imposed conditions for receiving services. Women's preference for MA shows the potential of this technology to address the problem of unsafe abortion in India. Women need better access to information and services to realize this potential, however. Women's preferences regarding information dissemination and service provision need to be taken into account if policies and programs are to be truly responsive to the needs of marginalized women. Copyright © 2012. Published by Elsevier Ireland Ltd.

Real-world effects of using a phone while driving on lateral and longitudinal control of vehicles.

PubMed

Dozza, Marco; Flannagan, Carol A C; Sayer, James R

2015-12-01

Technologies able to augment human communication, such as smartphones, are increasingly present during all daily activities. Their use while driving, in particular, is of great potential concern, because of the high risk that distraction poses during this activity. Current countermeasures to distraction from phone use are considerably different across countries and not always widely accepted/adopted by the drivers. This study utilized naturalistic driving data collected from 108 drivers in the Integrated Vehicle-Based Safety Systems (IVBSS) program in 2009 and 2010 to assess the extent to which using a phone changes lateral or longitudinal control of a vehicle. The IVBSS study included drivers from three age groups: 20–30 (younger), 40–50 (middle-aged), and 60–70 (older). Results from this study show that younger drivers are more likely to use a phone while driving than older and middle-aged drivers. Furthermore, younger drivers exhibited smaller safety margins while using a phone. Nevertheless, younger drivers did not experience more severe lateral/longitudinal threats than older and middle-aged drivers, probably because of faster reaction times. While manipulating the phone (i.e., dialing, texting), drivers exhibited larger lateral safety margins and experienced less severe lateral threats than while conversing on the phone. Finally, longitudinal threats were more critical soon after phone interaction, suggesting that drivers terminate phone interactions when driving becomes more demanding. These findings suggest that drivers are aware of the potential negative effect of phone use on their safety. This awareness guides their decision to engage/disengage in phone use and to increase safety margins (self-regulation). This compensatory behavior may be a natural countermeasure to distraction that is hard to measure in controlled studies. Practical Applications: Intelligent systems able to amplify this natural compensatory behavior may become a widely accepted/adopted countermeasure to the potential distraction from phone operation while driving.

Patient positioning in head and neck cancer : Setup variations and safety margins in helical tomotherapy.

PubMed

Leitzen, Christina; Wilhelm-Buchstab, Timo; Müdder, Thomas; Heimann, Martina; Koch, David; Schmeel, Christopher; Simon, Birgit; Stumpf, Sabina; Vornholt, Susanne; Garbe, Stephan; Röhner, Fred; Schoroth, Felix; Schild, Hans Heinz; Schüller, Heinrich

2018-05-01

To evaluate the interfractional variations of patient positioning during intensity-modulated radiotherapy (IMRT) with helical tomotherapy in head and neck cancer and to calculate the required safety margins (sm) for bony landmarks resulting from the necessary table adjustments. In all, 15 patients with head and neck cancer were irradiated using the Hi-Art II tomotherapy system between April and September 2016. Before therapy sessions, patient position was frequently checked by megavolt computed tomography (MV-CT). Necessary table adjustments (ta) in the right-left (rl), superior-inferior (si) and anterior-posterior (ap) directions were recorded for four anatomical points: second, fourth and sixth cervical vertebral body (CVB), anterior nasal spine (ANS). Based upon these data sm were calculated for non-image-guided radiotherapy, image-guided radiotherapy (IGRT) and image guidance limited to a shortened area (CVB 2). Based upon planning CT the actual treatment required ta from -0.05 ± 1.31 mm for CVB 2 (ap) up to 2.63 ± 2.39 mm for ANS (rl). Considering the performed ta resulting from image control (MV-CT) we detected remaining ta from -0.10 ± 1.09 mm for CVB 4 (rl) up to 1.97 ± 1.64 mm for ANS (si). After theoretical adjustment of patients position to CVB 2 the resulting ta ranged from -0.11 ± 2.44 mm for CVB6 (ap) to 2.37 ± 2.17 mm for ANS (si). These data imply safety margins: uncorrected patient position: 3.63-9.95 mm, corrected positioning based upon the whole target volume (IGRT): 1.85-6.63 mm, corrected positioning based upon CVB 2 (IGRT): 3.13-6.66 mm. The calculated safety margins differ between anatomic regions. Repetitive and frequent image control of patient positioning is necessary that, however, possibly may be focussed on a limited region.

Power in urban social-ecological systems: Processes and practices of governance and marginalization

Treesearch

Lindsay K. Campbell; Nate Gabriel

2016-01-01

Historically, the urban forestry literature, including the workfeatured in Urban Forestry and Urban Greening, has focused primarily on either quantitative, positivistic analyses of human-environment dynamics, or applied research to inform the management of natural resources, without sufficiently problematizing the effects of power within these processes (Bentsen et al...

Global Convergence of the EM Algorithm for Unconstrained Latent Variable Models with Categorical Indicators

ERIC Educational Resources Information Center

Weissman, Alexander

2013-01-01

Convergence of the expectation-maximization (EM) algorithm to a global optimum of the marginal log likelihood function for unconstrained latent variable models with categorical indicators is presented. The sufficient conditions under which global convergence of the EM algorithm is attainable are provided in an information-theoretic context by…

17 CFR 240.17Ad-22 - Standards for clearing agencies.

Code of Federal Regulations, 2014 CFR

2014-04-01

... of the clearing agency's risk management procedures. (9) Provide market participants with sufficient... agency's exposures to its participants that would be expected to breach margin requirements or other risk... section means net capital as defined in § 240.15c3-1 for broker-dealers or any similar risk adjusted...

[Soft tissue sarcoma of the upper extremities. Analysis of factors relevant for prognosis in 160 patients].

PubMed

Lehnhardt, M; Hirche, C; Daigeler, A; Goertz, O; Ring, A; Hirsch, T; Drücke, D; Hauser, J; Steinau, H U

2012-02-01

Soft tissue sarcomas (STS) are a rare entity with reduced prognosis due to their aggressive biology. For an optimal treatment of STS identification of independent prognostic factors is crucial in order to reduce tumor-related mortality and recurrence rates. The surgical oncological concept includes wide excisions with resection safety margins >1 cm which enables acceptable functional results and reduced rates of amputation of the lower extremities. In contrast, individual anatomy of the upper extremities, in particular of the hand, leads to an intentional reduction of resection margins in order to preserve the extremity and its function with the main intention of tumor-free resection margins. In this study, the oncological safety and outcome as well as functional results were validated by a retrospective analysis of survival rate, recurrence rate and potential prognostic factors. A total of 160 patients who had been treated for STS of the upper extremities were retrospectively included. Independent prognostic factors were analyzed (primary versus recurrent tumor, tumor size, resection status, grade of malignancy, additional therapy, localization in the upper extremity). Kaplan-Meier analyses for survival rate and local control were calculated. Further outcome measures were functional results validated by the DASH score and rate of amputation. In 130 patients (81%) wide tumor excision (R0) was performed and in 19 patients (12%) an amputation was necessary. The 5-year overall survival rate was 70% and the 5-year survival rate in primary tumors was 81% whereas in recurrences 55% relapsed locally. The 10-year overall survival rate was 45% and the 5-year recurrence rate was 18% for primary STS and 43% for recurrent STS. Variance analysis revealed primary versus recurrent tumor, tumor size, resection status and grade of malignancy as independent prognostic factors. Analysis of functional results showed a median DASH score of 37 (0-100; 0=contralateral extremity). The 5-year survival and local recurrence rates are comparable to STS wide resections with safety margins >1 cm for the lower extremities and the trunk. Analysis of prognostic factors revealed resection status and the tumor-free resection margins to be the main goals in STS resection of upper extremity.

A review of inherent safety characteristics of metal alloy sodium-cooled fast reactor fuel against postulated accidents

DOE PAGES

Sofu, Tanju

2015-04-01

The thermal, mechanical, and neutronic performance of the metal alloy fast reactor fuel design complements the safety advantages of the liquid metal cooling and the pool-type primary system. Together, these features provide large safety margins in both normal operating modes and for a wide range of postulated accidents. In particular, they maximize the measures of safety associated with inherent reactor response to unprotected, double-fault accidents, and to minimize risk to the public and plant investment. High thermal conductivity and high gap conductance play the most significant role in safety advantages of the metallic fuel, resulting in a flatter radial temperaturemore » profile within the pin and much lower normal operation and transient temperatures in comparison to oxide fuel. Despite the big difference in melting point, both oxide and metal fuels have a relatively similar margin to melting during postulated accidents. When the metal fuel cladding fails, it typically occurs below the coolant boiling point and the damaged fuel pins remain coolable. Metal fuel is compatible with sodium coolant, eliminating the potential of energetic fuel--coolant reactions and flow blockages. All these, and the low retained heat leading to a longer grace period for operator action, are significant contributing factors to the inherently benign response of metallic fuel to postulated accidents. This paper summarizes the past analytical and experimental results obtained in past sodium-cooled fast reactor safety programs in the United States, and presents an overview of fuel safety performance as observed in laboratory and in-pile tests.« less

A review of inherent safety characteristics of metal alloy sodium-cooled fast reactor fuel against postulated accidents

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

Sofu, Tanju

2015-04-01

The thermal, mechanical, and neutronic performance of the metal alloy fast reactor fuel design complements the safety advantages of the liquid metal cooling and the pool-type primary system. Together, these features provide large safety margins in both normal operating modes and for a wide range of postulated accidents. In particular, they maximize the measures of safety associated with inherent reactor response to unprotected, double-fault accidents, and to minimize risk to the public and plant investment. High thermal conductivity and high gap conductance play the most significant role in safety advantages of the metallic fuel, resulting in a flatter radial temperaturemore » profile within the pin and much lower normal operation and transient temperatures in comparison to oxide fuel. Despite the big difference in melting point, both oxide and metal fuels have a relatively similar margin to melting during postulated accidents. When the metal fuel cladding fails, it typically occurs below the coolant boiling point and the damaged fuel pins remain cool-able. Metal fuel is compatible with sodium coolant, eliminating the potential of energetic fuel coolant reactions and flow blockages. All these, and the low retained heat leading to a longer grace period for operator action, are significant contributing factors to the inherently benign response of metallic fuel to postulated accidents. This paper summarizes the past analytical and experimental results obtained in past sodium-cooled fast reactor safety programs in the United States, and presents an overview of fuel safety performance as observed in laboratory and in-pile tests.« less

Novel safety floors do not influence early compensatory balance reactions in older adults.

PubMed

Wright, Alexander D; Heckman, George A; McIlroy, William E; Laing, Andrew C

2014-01-01

Novel safety flooring systems are a promising approach for reducing fall-related injuries in seniors, as they have been demonstrated to substantially reduce impact severity during falls, while minimally impairing balance control in community-dwelling older women. This pilot study aimed to characterize the potential effects of flooring conditions on dynamic balance control in retirement home-dwellers with more limited mobility. A tether-release paradigm was used to simulate a trip-type perturbation in 15 seniors across five flooring surfaces (three novel safety floors and one carpet compared to institutional-grade resilient rolled-sheeting). Kinetic and kinematic data tracked the displacement profiles of the underfoot centre-of-pressure and whole-body centre-of-mass, which were used to characterize compensatory balance reactions. Difference tests (ANOVA) found that the onset of the compensatory balance reaction was not associated with floor condition, nor were the timing and magnitude of peak centre-of-pressure excursion (minimum margin of safety) and velocity. Accordingly, the minimum margin of safety of the centre-of-mass was not significantly different across floors. Equivalence tests supported these findings. This study provides evidence that the carpet and novel safety floors tested do not negatively influence characteristics of initial dynamic balance responses following a lean-and-release perturbation compared to an institutional-grade resilient rolled-sheeting surface. In combination with reports of substantial force attenuative properties during fall-related impacts, these findings support the promise of novel safety floors as a biomechanically effective strategy for reducing fall-related injuries. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

On the initiation of subduction

NASA Technical Reports Server (NTRS)

Mueller, Steve; Phillips, Roger J.

1991-01-01

Estimates of shear resistance associated with lithospheric thrusting and convergence represent lower bounds on the force necessary to promote trench formation. Three environments proposed as preferential sites of incipient subduction are investigated: passive continental margins, transform faults/fracture zones, and extinct ridges. None of these are predicted to convert into subduction zones simply by the accumulation of local gravitational stresses. Subduction cannot initiate through the foundering of dense oceanic lithosphere immediately adjacent to passive continental margins. The attempted subduction of buoyant material at a mature trench can result in large compressional forces in both subducting and overriding plates. This is the only tectonic force sufficient to trigger the nucleation of a new subduction zone. The ubiquitous distribution of transform faults and fracture zones, combined with the common proximity of these features to mature subduction complexes, suggests that they may represent the most likely sites of trench formation if they are even marginally weaker than normal oceanic lithosphere.

Development of CO2 laser Doppler instrumentation for detection of clear air turbulence, volume 2: Appendices

NASA Technical Reports Server (NTRS)

Harris, C. E.; Jelalian, A. V.

1979-01-01

Analyses of the mounting and mount support systems of the clear air turbulence transmitters verify that satisfactory shock and vibration isolation are attained. The mount support structure conforms to flight crash safety requirements with high margins of safety. Restraint cables reinforce the mounts in the critical loaded forward direction limiting maximum forward system deflection to 1 1/4 inches.

Los Alamos Novel Rocket Design Flight Tested

ScienceCinema

Tappan, Bryce

2018-04-16

Los Alamos National Laboratory scientists recently flight tested a new rocket design that includes a high-energy fuel and a motor design that also delivers a high degree of safety. Researchers will now work to scale-up the design, as well as explore miniaturization of the system, in order to exploit all potential applications that would require high-energy, high-velocity, and correspondingly high safety margins.

Los Alamos Novel Rocket Design Flight Tested

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

Tappan, Bryce

Los Alamos National Laboratory scientists recently flight tested a new rocket design that includes a high-energy fuel and a motor design that also delivers a high degree of safety. Researchers will now work to scale-up the design, as well as explore miniaturization of the system, in order to exploit all potential applications that would require high-energy, high-velocity, and correspondingly high safety margins.

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

Turley, Jessica; Claridge Mackonis, Elizabeth

To evaluate in-field megavoltage (MV) imaging of simultaneously integrated boost (SIB) breast fields to determine its feasibility in treatment verification for the SIB breast radiotherapy technique, and to assess whether the current-imaging protocol and treatment margins are sufficient. For nine patients undergoing SIB breast radiotherapy, in-field MV images of the SIB fields were acquired on days that regular treatment verification imaging was performed. The in-field images were matched offline according to the scar wire on digitally reconstructed radiographs. The offline image correction results were then applied to a margin recipe formula to calculate safe margins that account for random andmore » systematic uncertainties in the position of the boost volume when an offline correction protocol has been applied. After offline assessment of the acquired images, 96% were within the tolerance set in the current department-imaging protocol. Retrospectively performing the maximum position deviations on the Eclipse™ treatment planning system demonstrated that the clinical target volume (CTV) boost received a minimum dose difference of 0.4% and a maximum dose difference of 1.4% less than planned. Furthermore, applying our results to the Van Herk margin formula to ensure that 90% of patients receive 95% of the prescribed dose, the calculated CTV margins were comparable to the current departmental procedure used. Based on the in-field boost images acquired and the feasible application of these results to the margin formula the current CTV-planning target volume margins used are appropriate for the accurate treatment of the SIB boost volume without additional imaging.« less

Impact of Market Behavior, Fleet Composition, and Ancillary Services on Revenue Sufficiency

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

Frew, Bethany; Gallo, Giulia; Brinkman, Gregory

Revenue insufficiency, or the missing money problem, occurs when the revenues that generators earn from the market are not sufficient to cover both fixed and variable costs to remain in the market and/or justify investments in new capacity, which may be needed for reliability. The near-zero marginal cost of variable renewable generators further exacerbates these revenue challenges. Estimating the extent of the missing money problem in current electricity markets is an important, nontrivial task that requires representing both how the power system operates and how market participants behave. This paper explores the missing money problem using a production cost modelmore » that represented a simplified version of the Electric Reliability Council of Texas (ERCOT) energy-only market for the years 2012-2014. We evaluate how various market structures -- including market behavior, ancillary services, and changing fleet compositions -- affect net revenues in this ERCOT-like system. In most production cost modeling exercises, resources are assumed to offer their marginal capabilities at marginal costs. Although this assumption is reasonable for feasibility studies and long-term planning, it does not adequately consider the market behaviors that impact revenue sufficiency. In this work, we simulate a limited set of market participant strategic bidding behaviors by means of different sets of markups; these markups are applied to the true production costs of all gas generators, which are the most prominent generators in ERCOT. Results show that markups can help generators increase their net revenues overall, although net revenues may increase or decrease depending on the technology and the year under study. Results also confirm that conventional, variable-cost-based production cost simulations do not capture prices accurately, and this particular feature calls for proxies for strategic behaviors (e.g., markups) and more accurate representations of how electricity markets work. The analysis also shows that generators face revenue sufficiency challenges in this ERCOT-like energy-only market model; net revenues provided by the market in all base markup cases and sensitivity scenarios (except when a large fraction of the existing coal fleet is retired) are not sufficient to justify investments in new capacity for thermal and nuclear power units. Overall, the work described in this paper points to the need for improved behavioral models of electricity markets to more accurately study current and potential market design issues that could arise in systems with high penetrations of renewable generation.« less

Structural design/margin assessment

NASA Technical Reports Server (NTRS)

Ryan, R. S.

1993-01-01

Determining structural design inputs and the structural margins following design completion is one of the major activities in space exploration. The end result is a statement of these margins as stability, safety factors on ultimate and yield stresses, fracture limits (fracture control), fatigue lifetime, reuse criteria, operational criteria and procedures, stability factors, deflections, clearance, handling criteria, etc. The process is normally called a load cycle and is time consuming, very complex, and involves much more than structures. The key to successful structural design is the proper implementation of the process. It depends on many factors: leadership and management of the process, adequate analysis and testing tools, data basing, communications, people skills, and training. This process and the various factors involved are discussed.

Airframe/TPS Session

NASA Technical Reports Server (NTRS)

Welch, Sharon; Bowles, David

2000-01-01

This viewgraph presentation gives an overview of the second generation Reusable Launch Vehicle (RLV) airframe configuration, including details on the structures and materials, tanks, airframe/cryotank demonstrations, internal assemblies, weight growth and margin, and safety and cost requirements.

Gross mismatch between thermal tolerances and environmental temperatures in a tropical freshwater snail: climate warming and evolutionary implications.

PubMed

Polgar, Gianluca; Khang, Tsung Fei; Chua, Teddy; Marshall, David J

2015-01-01

The relationship between acute thermal tolerance and habitat temperature in ectotherm animals informs about their thermal adaptation and is used to assess thermal safety margins and sensitivity to climate warming. We studied this relationship in an equatorial freshwater snail (Clea nigricans), belonging to a predominantly marine gastropod lineage (Neogastropoda, Buccinidae). We found that tolerance of heating and cooling exceeded average daily maximum and minimum temperatures, by roughly 20°C in each case. Because habitat temperature is generally assumed to be the main selective factor acting on the fundamental thermal niche, the discordance between thermal tolerance and environmental temperature implies trait conservation following 'in situ' environmental change, or following novel colonisation of a thermally less-variable habitat. Whereas heat tolerance could relate to an historical association with the thermally variable and extreme marine intertidal fringe zone, cold tolerance could associate with either an ancestral life at higher latitudes, or represent adaptation to cooler, higher-altitudinal, tropical lotic systems. The broad upper thermal safety margin (difference between heat tolerance and maximum environmental temperature) observed in this snail is grossly incompatible with the very narrow safety margins typically found in most terrestrial tropical ectotherms (insects and lizards), and hence with the emerging prediction that tropical ectotherms, are especially vulnerable to environmental warming. A more comprehensive understanding of climatic vulnerability of animal ectotherms thus requires greater consideration of taxonomic diversity, ecological transition and evolutionary history. Copyright © 2014 Elsevier Ltd. All rights reserved.

Excess Capacity in China’s Power Systems: A Regional Analysis

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

Lin, Jiang; Liu, Xu; Karl, Fredrich

2016-11-01

This paper examines China’s regional electricity grids using a reliability perspective, which is commonly measured in terms of a reserve margin. Our analysis shows that at the end of 2014, the average reserve margin for China as a whole was roughly 28%, almost twice as high as a typical planning reserve margin in the U.S. However, this national average masks huge variations in reserve margins across major regional power grid areas: the northeastern region has the highest reserve margin of over 60%, followed by the northwestern region at 49%, and the southern grid area at 35%. In this analysis, wemore » also examined future reserve margins for regional electricity grids in China under two scenarios: 1) a low scenario of national annual electricity consumption growth rates of 1.5% between 2015 and 2020 and 1.0% between 2020 and 2025, and 2) a high scenario of annual average growth rates of 3.0% and 2.0%, respectively. Both scenarios suggest that the northeastern, northwestern, and southern regions have significant excess generation capacity, and that this excess capacity situation will continue over the next decade without regulatory intervention. The northern and central regions could have sufficient generation capacity to 2020, but may require additional resources in a higher growth scenario. The eastern region requires new resources by 2020 in both scenarios.« less

An integrated policy framework for the sustainable exploitation of biomass for bioenergy from marginal lands

NASA Astrophysics Data System (ADS)

Panoutsou, Calliope

2017-04-01

Currently, there are not sufficiently tailored policies focusing on biomass and bioenergy from marginal lands. This paper will provide an integrated policy framework and recommendations to facilitate understanding for the market sectors involved and the key principles which can be used to form future sustainable policies for this issue. The work will focus at EU level policy recommendations and discuss how these can interrelate with national and regional level policies to promote the usage of marginal lands for biomass and bioenergy. Recommended policy measures will be based on the findings of the Biomass Policies (www.biomasspolicies.eu) and S2Biom (www.s2biom.eu) projects and will be prepared taking into account the key influencing factors (technical, environmental, social and economic) on biomass and bioenergy from marginal lands: • across different types of marginality (biophysical such as: low temperature, dryness, excess soil moisture, poor chemical properties, steep slope, etc., and socio-economic resulting from lack of economic competitiveness in certain regions and crops, abandonment or rural areas, etc.) • across the different stages of the biomass value chain (supply, logistics, conversion, distribution and end-use). The aim of recommendations will be to inform policy makers on how to distinguish key policy related attributes across biomass and bioenergy from marginal lands, measure them and prioritise actions with a 'system' based approach.

Solo-Surgeon Single-Port Laparoscopic Anterior Resection for Sigmoid Colon Cancer: Comparative Study.

PubMed

Choi, Byung Jo; Jeong, Won Jun; Kim, Say-June; Lee, Sang Chul

2018-03-01

To report our experience with solo-surgeon, single-port laparoscopic anterior resection (solo SPAR) for sigmoid colon cancer. Data from sigmoid colon cancer patients who underwent anterior resections (ARs) using the single-port, solo surgery technique (n = 31) or the conventional single-port laparoscopic technique (n = 45), between January 2011 and July 2016, were retrospectively analyzed. In the solo surgeries, making the transumbilical incision into the peritoneal cavity was facilitated through the use of a self-retaining retractor system. After establishing a single port through the umbilicus, an adjustable mechanical camera holder replaced the human scope assistant. Patient and tumor characteristics and operative, pathologic, and postoperative outcomes were compared. The operative times and estimated blood losses were similar for the patients in both treatment groups. In addition, most of the postoperative variables were comparable between the two groups, including postoperative complications and hospital stays. In the solo SPAR group, comparable lymph nodes were attained, and sufficient proximal and distal cut margins were obtained. The difference in the proximal cut margin significantly favored the solo SPAR, compared with the conventional AR group (P = .000). This study shows that solo SPAR, using a passive camera system, is safe and feasible for use in sigmoid colon cancer surgery, if performed by an experienced laparoscopic surgeon. In addition to reducing the need for a surgical assistant, the oncologic requirements, including adequate margins and sufficient lymph node harvesting, could be fulfilled. Further evaluations, including prospective randomized studies, are warranted.

Hand in Hand: Media Literacy and Internet Safety

ERIC Educational Resources Information Center

Gallagher, Frank

2011-01-01

Internet safety cannot be effectively taught without also teaching media literacy. The two go hand in hand, and both are necessary, but neither is sufficient. To understand why, it is important to first appreciate what the real risks to children are. Many of the early Internet safety programs were based on a fear of predators. Predators turned out…

77 FR 47284 - Safety Zone; Dredge Arthur J, Lake Huron, Lakeport, MI

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-08

...-AA00 Safety Zone; Dredge Arthur J, Lake Huron, Lakeport, MI AGENCY: Coast Guard, DHS. ACTION: Temporary... preparation for and salvage operations of the Arthur J. dredge vessel. This temporary safety zone is necessary... sinking of the dredge vessel Arthur J. precluded the Coast Guard from having sufficient time to publish an...

Hospital financial performance in the recent recession and implications for institutions that remain financially weak.

PubMed

Bazzoli, Gloria J; Fareed, Naleef; Waters, Teresa M

2014-05-01

The recent recession had a profound effect on all sectors of the US economy, including health care. We examined how private hospitals fared through the recession and considered how changes in their financial health may affect their ability to respond to future industry challenges. We categorized 2,971 private short-term general medical or surgical hospitals (both nonprofit and for-profit) according to their pre-recession financial health and safety-net status, and we examined their operational status changes and operating and total financial margins during 2006-11. We found that hospitals that were financially weak before the recession remained so during and after the recession. The total margins of nonprofit hospitals (both safety-net and other institutions) declined in 2008 but returned to their pre-recession levels by 2011. The recession did not create additional fiscal pressure on hospitals that were previously financially weak or in safety-net roles. However, both groups continue to have notable financial deficiencies that could limit their abilities to meet the growing demands on the industry.

Heat removal capability of divertor coaxial tube assembly

NASA Astrophysics Data System (ADS)

Shibui, Masanao; Nakahira, Masataka; Tada, Eisuke; Takatsu, Hideyuki

1994-05-01

To deal with high power flowing in the divertor region, an advanced divertor concept with gas target has been proposed for use in ITER/EDA. The concept uses a divertor channel to remove the radiated power while allowing neutrals to recirculate. Candidate channel wall designs include a tube array design where many coaxial tubes are arranged in the toroidal direction to make louver. The coaxial tube consists of a Be protection tube encases many supply tubes wound helically around a return tube. V-alloy and hardened Cu-alloy have been proposed for use in the supply and return tubes. Some coolants have also been proposed for the design including pressurized He and liquid metals, because these coolants are consistent with the selection of coolants for the blanket and also meet the requirement of high temperature operation. In the coaxial tube design, the coolant area is restricted and brittle Be material is used under severe thermal cyclings. Thus, to obtain the coaxial tube with sufficient safety margin for the expected fusion power excursion, it is essential to understand its applicability limit. The paper discusses heat removal capability of the coaxial tube and recommends some design modifications.

CFD Analysis and Design of Detailed Target Configurations for an Accelerator-Driven Subcritical System

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

Kraus, Adam; Merzari, Elia; Sofu, Tanju

2016-08-01

High-fidelity analysis has been utilized in the design of beam target options for an accelerator driven subcritical system. Designs featuring stacks of plates with square cross section have been investigated for both tungsten and uranium target materials. The presented work includes the first thermal-hydraulic simulations of the full, detailed target geometry. The innovative target cooling manifold design features many regions with complex flow features, including 90 bends and merging jets, which necessitate three-dimensional fluid simulations. These were performed using the commercial computational fluid dynamics code STAR-CCM+. Conjugate heat transfer was modeled between the plates, cladding, manifold structure, and fluid. Steady-statemore » simulations were performed but lacked good residual convergence. Unsteady simulations were then performed, which converged well and demonstrated that flow instability existed in the lower portion of the manifold. It was established that the flow instability had little effect on the peak plate temperatures, which were well below the melting point. The estimated plate surface temperatures and target region pressure were shown to provide sufficient margin to subcooled boiling for standard operating conditions. This demonstrated the safety of both potential target configurations during normal operation.« less

Responding to the challenge of untreatable gonorrhea: ETX0914, a first-in-class agent with a distinct mechanism-of-action against bacterial Type II topoisomerases.

PubMed

Basarab, Gregory S; Kern, Gunther H; McNulty, John; Mueller, John P; Lawrence, Kenneth; Vishwanathan, Karthick; Alm, Richard A; Barvian, Kevin; Doig, Peter; Galullo, Vincent; Gardner, Humphrey; Gowravaram, Madhusudhan; Huband, Michael; Kimzey, Amy; Morningstar, Marshall; Kutschke, Amy; Lahiri, Sushmita D; Perros, Manos; Singh, Renu; Schuck, Virna J A; Tommasi, Ruben; Walkup, Grant; Newman, Joseph V

2015-07-14

With the diminishing effectiveness of current antibacterial therapies, it is critically important to discover agents that operate by a mechanism that circumvents existing resistance. ETX0914, the first of a new class of antibacterial agent targeted for the treatment of gonorrhea, operates by a novel mode-of-inhibition against bacterial type II topoisomerases. Incorporating an oxazolidinone on the scaffold mitigated toxicological issues often seen with topoisomerase inhibitors. Organisms resistant to other topoisomerase inhibitors were not cross-resistant with ETX0914 nor were spontaneous resistant mutants to ETX0914 cross-resistant with other topoisomerase inhibitor classes, including the widely used fluoroquinolone class. Preclinical evaluation of ETX0914 pharmacokinetics and pharmacodynamics showed distribution into vascular tissues and efficacy in a murine Staphylococcus aureus infection model that served as a surrogate for predicting efficacious exposures for the treatment of Neisseria gonorrhoeae infections. A wide safety margin to the efficacious exposure in toxicological evaluations supported progression to Phase 1. Dosing ETX0914 in human volunteers showed sufficient exposure and minimal adverse effects to expect a highly efficacious anti-gonorrhea therapy.

Responding to the challenge of untreatable gonorrhea: ETX0914, a first-in-class agent with a distinct mechanism-of-action against bacterial Type II topoisomerases

PubMed Central

Basarab, Gregory S.; Kern, Gunther H.; McNulty, John; Mueller, John P.; Lawrence, Kenneth; Vishwanathan, Karthick; Alm, Richard A.; Barvian, Kevin; Doig, Peter; Galullo, Vincent; Gardner, Humphrey; Gowravaram, Madhusudhan; Huband, Michael; Kimzey, Amy; Morningstar, Marshall; Kutschke, Amy; Lahiri, Sushmita D.; Perros, Manos; Singh, Renu; Schuck, Virna J. A.; Tommasi, Ruben; Walkup, Grant; Newman, Joseph V.

2015-01-01

With the diminishing effectiveness of current antibacterial therapies, it is critically important to discover agents that operate by a mechanism that circumvents existing resistance. ETX0914, the first of a new class of antibacterial agent targeted for the treatment of gonorrhea, operates by a novel mode-of-inhibition against bacterial type II topoisomerases. Incorporating an oxazolidinone on the scaffold mitigated toxicological issues often seen with topoisomerase inhibitors. Organisms resistant to other topoisomerase inhibitors were not cross-resistant with ETX0914 nor were spontaneous resistant mutants to ETX0914 cross-resistant with other topoisomerase inhibitor classes, including the widely used fluoroquinolone class. Preclinical evaluation of ETX0914 pharmacokinetics and pharmacodynamics showed distribution into vascular tissues and efficacy in a murine Staphylococcus aureus infection model that served as a surrogate for predicting efficacious exposures for the treatment of Neisseria gonorrhoeae infections. A wide safety margin to the efficacious exposure in toxicological evaluations supported progression to Phase 1. Dosing ETX0914 in human volunteers showed sufficient exposure and minimal adverse effects to expect a highly efficacious anti-gonorrhea therapy. PMID:26168713

Gamma processing of Arabic bread for immune system-compromised cancer patients

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

Grecz, N.; Brannon, R.; Jaw, R.

Arabic bread prepared from local Saudi flour contained a total of up to 105/sup 4/ organisms per g. Most of these were bacterial spores that survived the baking process (1.3 x 10/sup 2/ to 3.5 x 10/sup 3/) and a small number of yeasts and molds (10 to 40 cells per g). The organisms in Arabic bread appear to be harmless to healthy individuals. However, for immune system-compromised cancer patients and bone marrow transplant recipients, it is prudent to irradiate the bread to reduce microbial contamination. The decimal reduction doses (10% survival) for the most radiation-resistant organisms (spore formers) inmore » bread were 0.11 to 0.15 Mrad. Accordingly, 0.6 Mrad was sufficient to reduce the number of spores in Arabic bread by a factor of 10,000, i.e., to <1/g. This treatment constitutes radiation pasteurization (radicidation), and to this extent, provides a margin of microbiological safety. Sensory evaluation by the nine-point hedonic scale showed no detectable loss of organoleptic quality of bread up to 0.6 Mrad, while irradiation to 2.5 Mrad induced unacceptable organoleptic changes.« less

Generalized Tumor Dose for Treatment Planning Decision Support

NASA Astrophysics Data System (ADS)

Zuniga, Areli A.

Modern radiation therapy techniques allow for improved target conformity and normal tissue sparing. These highly conformal treatment plans have allowed dose escalation techniques increasing the probability of tumor control. At the same time this conformation has introduced inhomogeneous dose distributions, making delivered dose characterizations more difficult. The concept of equivalent uniform dose (EUD) characterizes a heterogeneous dose distribution within irradiated structures as a single value and has been used in biologically based treatment planning (BBTP); however, there are no substantial validation studies on clinical outcome data supporting EUD's use and therefore has not been widely adopted as decision-making support. These highly conformal treatment plans have also introduced the need for safety margins around the target volume. These margins are designed to minimize geometrical misses, and to compensate for dosimetric and treatment delivery uncertainties. The margin's purpose is to reduce the chance of tumor recurrence. This dissertation introduces a new EUD formulation designed especially for tumor volumes, called generalized Tumor Dose (gTD). It also investigates, as a second objective, margins extensions for potential improvements in local control while maintaining or minimizing toxicity. The suitability of gTD to rank LC was assessed by means of retrospective studies in a head and neck (HN) squamous cell carcinoma (SCC) and non-small cell lung cancer (NSCLC) cohorts. The formulation was optimized based on two datasets (one of each type) and then, model validation was assessed on independent cohorts. The second objective of this dissertation was investigated by ranking the probability of LC of the primary disease adding different margin sizes. In order to do so, an already published EUD formula was used retrospectively in a HN and a NSCLC datasets. Finally, recommendations for the viability to implement this new formulation into a routine treatment planning process as well as the revision of safety margins to improve local tumor control maximizing normal tissue sparing in SCC of the HN and NSCLC are discussed.

Plutonium Critical Mass Curve Comparison to Mass at Upper Subcritical Limit (USL) Using Whisper

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

Alwin, Jennifer Louise; Zhang, Ning

Whisper is computational software designed to assist the nuclear criticality safety analyst with validation studies with the MCNP ® Monte Carlo radiation transport package. Standard approaches to validation rely on the selection of benchmarks based upon expert judgment. Whisper uses sensitivity/uncertainty (S/U) methods to select relevant benchmarks to a particular application or set of applications being analyzed. Using these benchmarks, Whisper computes a calculational margin. Whisper attempts to quantify the margin of subcriticality (MOS) from errors in software and uncertainties in nuclear data. The combination of the Whisper-derived calculational margin and MOS comprise the baseline upper subcritical limit (USL), tomore » which an additional margin may be applied by the nuclear criticality safety analyst as appropriate to ensure subcriticality. A series of critical mass curves for plutonium, similar to those found in Figure 31 of LA-10860-MS, have been generated using MCNP6.1.1 and the iterative parameter study software, WORM_Solver. The baseline USL for each of the data points of the curves was then computed using Whisper 1.1. The USL was then used to determine the equivalent mass for plutonium metal-water system. ANSI/ANS-8.1 states that it is acceptable to use handbook data, such as the data directly from the LA-10860-MS, as it is already considered validated (Section 4.3 4) “Use of subcritical limit data provided in ANSI/ANS standards or accepted reference publications does not require further validation.”). This paper attempts to take a novel approach to visualize traditional critical mass curves and allows comparison with the amount of mass for which the k eff is equal to the USL (calculational margin + margin of subcriticality). However, the intent is to plot the critical mass data along with USL, not to suggest that already accepted handbook data should have new and more rigorous requirements for validation.« less

Differential Impact of Close Surgical Margin on Local Recurrence According to Primary Tumor Size in Oral Squamous Cell Carcinoma.

PubMed

Jang, Jeon Yeob; Choi, Nayeon; Ko, Young-Hyeh; Chung, Man Ki; Son, Young-Ik; Baek, Chung-Hwan; Baek, Kwan-Hyuck; Jeong, Han-Sin

2017-06-01

The extent of surgical safety margin (gross tumor border to resection margin) in oral cancer surgery remains unclear, and no study has determined the differential impact of close surgical margin and microscopic extension according to primary tumor size in oral cancers. We retrospectively analyzed the clinical data of 325 patients with surgically treated oral cavity squamous cell carcinomas to determine the effect of a close surgical margin (<5 mm) (cSM 5 ) on local recurrence. In addition, the depth of microscopic tumor infiltration was determined in 90 available surgical specimens. The cSM 5 was not related to the risk of local tumor recurrence in early-stage oral cancer, while it significantly increased the rate of local tumor recurrence in resectable advanced-stage oral cancers (hazard ratio 3.157, 95 % confidence interval 1.050-9.407, p = 0.041). Addition of postoperative adjuvant radiation to early-stage tumors with cSM 5 did not further reduce the local recurrence rate compared to surgery alone. The depth of microscopic tumor extension from the gross tumor border was significantly associated with primary tumor thickness (ρ = 0.390, p < 0.001) and tumor sizes (ρ = 0.308, p = 0.003), which was a median (range) of 0.84 (0.14-2.32) mm in T1, 1.06 (0.20-4.34) mm in T2, and 1.77 (0.13-4.70) mm in T3-4. The cSM 5 was a significant risk factor for local recurrence only in advanced oral cancers, but not in early-stage tumors, where microscopic tumor extension was not beyond 3 mm in T1 tumors. Thus, the extent of surgical safety margin can be redefined according to the primary tumor size.

Speed-Accuracy Response Models: Scoring Rules Based on Response Time and Accuracy

ERIC Educational Resources Information Center

Maris, Gunter; van der Maas, Han

2012-01-01

Starting from an explicit scoring rule for time limit tasks incorporating both response time and accuracy, and a definite trade-off between speed and accuracy, a response model is derived. Since the scoring rule is interpreted as a sufficient statistic, the model belongs to the exponential family. The various marginal and conditional distributions…

Safety and economic impact of Texas travel information centers.

DOT National Transportation Integrated Search

2014-12-01

The overall goal of this research was to develop a methodology and gather sufficient data to quantify the : impact of Texas Travel Information Center staff and services on the safety of travelers on Texas roadways. : Researchers used data and analyti...

49 CFR 238.201 - Scope/alternative compliance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... equivalent safety and compliance with this subpart, other than § 238.203, based upon a submission of data and analysis sufficient to support that determination. The petition shall include: (i) The information required..., sufficient to describe the actual construction of the equipment of special design; (iii) Engineering analysis...

44 CFR 60.22 - Planning considerations for flood-prone areas.

Code of Federal Regulations, 2012 CFR

2012-10-01

... community shall consider— (1) Preservation of the flood-prone areas for open space purposes; (2) Relocation... debris, to provide an added margin of safety against floods having a magnitude greater than the base...

44 CFR 60.22 - Planning considerations for flood-prone areas.

Code of Federal Regulations, 2013 CFR

2013-10-01

... community shall consider— (1) Preservation of the flood-prone areas for open space purposes; (2) Relocation... debris, to provide an added margin of safety against floods having a magnitude greater than the base...

44 CFR 60.22 - Planning considerations for flood-prone areas.

Code of Federal Regulations, 2014 CFR

2014-10-01

... community shall consider— (1) Preservation of the flood-prone areas for open space purposes; (2) Relocation... debris, to provide an added margin of safety against floods having a magnitude greater than the base...

Flow of material under compression in weak lower continental crust can cause post-rift uplift of passive continental margins

NASA Astrophysics Data System (ADS)

Chalmers, James

2014-05-01

There are mountain ranges up to more than 2 km high along many passive continental margins (e.g. Norway, eastern Australia, eastern Brazil, SE and SW Africa, east and west Greenland etc.), dubbed Elevated Passive Continental Margins (EPCMs). EPCMs contain several features in common and observations indicate that uplift of these margins took place after continental break-up. There are many explanations for their formation but none that satisfy all the observations. Lack of a geodynamical mechanism has meant that there has been difficulty in getting the community to accept the observational evidence. Formation of a passive continental margin must take place under conditions of tension. After rifting ceases, however, the margin can come under compression from forces originating elsewhere on or below its plate, e.g. orogeny elsewhere in the plate or sub-lithospheric drag. The World Stress Map (www.world-stress-mp.org) shows that, where data exists, all EPCMs are currently under compression. Under sufficient compression, crust and/or lithosphere can fold, and Cloetingh & Burov (2010) showed that many continental areas may have folded in this way. The wavelengths of folding observed by Cloetingh & Burov (2010) imply that the lower crust is likely to be of intermediate composition; granitic lower crust would fold with a shorter wavelength and basic lower crust would mean that the whole lithosphere would have to fold as a unit resulting in a much longer wavelength. Continental crust more than 20 km thick would be separated from the mantle by a weak layer. However, crust less thick than that would contain no weak layers would become effectively annealed to the underlying strong mantle. Under sufficient horizontal compression stress, material can flow in the lower weak layer towards a continental margin from the continental side. The annealed extended crust and mantle under the rift means, however, that flow cannot continue towards the ocean. Mid- and lower crustal material therefore accumulates in the proximal rift and rift margin, thickening them and lifting them by isostatic response to the thickening. Flow into the rift margin is opposed by uplift and folding of the upper, strong crust, which imposes an additional normal stress, until crust thickens no more. However, flow continues through this thickened crust, thickening and uplifting the area "downstream", so widening the thickened area. Flow and uplift can continue until a reduction in imposed far-field compressive stress causes a consequent large reduction in inflow, thereby 'freezing' the thickened crust in place. Erosion of the uplifted area will lead to further uplift of the uneroded material because of the isostatic response to the erosion. Reference Cloetingh, S. & Burov, E. 2010: Lithospheric folding and sedimentary basin evolution: a review and analysis of formation mechanisms. Basin Research 22, 1365-2117. doi:10.1111/j.1365-2117.2010.00490.x.

On-Board Chemical Propulsion

NASA Technical Reports Server (NTRS)

Schneider, Steven J.

1997-01-01

NASA Lewis Research Center's On-Board Propulsion program (OBP) is developing low-thrust chemical propulsion technologies for both satellite and vehicle reaction control applications. There is a vigorous international competition to develop new, highperformance bipropellant engines. High-leverage bipropellant systems are critical to both commercial competitiveness in the international communications market and to cost-effective mission design in government sectors. To significantly improve bipropellant engine performance, we must increase the thermal margin of the chamber materials. Iridium-coated rhenium (Ir/Re) engines, developed and demonstrated under OBP programs, can operate at temperatures well above the constraints of state-of-practice systems, providing a sufficient margin to maximize performance with the hypergolic propellants used in most satellite propulsion systems.

Tri-modal confocal margin screening for the presence of residual squamous cell carcinoma in Mohs surgical excisions

NASA Astrophysics Data System (ADS)

Bar, Anna; Snavely, Nicholas; Chen, Nathaniel; Jacques, Steven; Gareau, Daniel S.

2012-03-01

Screening cancer in excision margins may be done with confocal microscopy to save time and cost over the gold standard histopathology (H&E). However, diagnostic accuracy requires sufficient contrast. Reflectance mode enables detection of large (>500um) nodular tumors. Enhanced nuclear contrast with acridine orange fluorescence mode additionally enables detection of tiny (<50um) basal cell carcinomas. Here, we present a novel combination of three modes to detect squamous cell carcinoma (SCC). Accurate screening of SCC requires eosin fluorescence, reflectance and acridine orange fluorescence to enable contrast for cytoplasm, collagen and nuclei respectively. Combining these signals replicates H&E for rapid clinical translation.

Assessment of the stability of a multimachine power system by the transient energy margin

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

Stanton, S.E.

1982-01-01

This reasearch develops a tool for the direct assessment of the transient stability of a multimachine electric power system that is subject to a large disturbance. The tool is the Transient Energy Margin. The transient of interest is the first swing (or inertial) transient. The Transient Energy Margin is computed by evaluating an energy function using the relevant unstable equilibrium point and the system states at the instant the disturbance is removed. In evaluating the function, a significant portion of the fault kinetic energy is identified as not contributing to system instability. The resulting energy value is a measure ofmore » the margin-of-safety for the disturbed system. A distinction is proposed between assessing system stability and assessing system security. The Transient Energy Margin is used first to assess the stability of the system. This profile ranks various distrubances to display the strengths and weaknesses of the system. A modified Transient Energy Margin is then proposed as an assessment of security; the transient energy margin profile is repeated to evaluate the system response in terms of the local minimum energy conditions approached by the critical trajectories. Both techniques are applied to a practical, 17 generator test system.« less

Comparing vaccines: a systematic review of the use of the non-inferiority margin in vaccine trials.

PubMed

Donken, R; de Melker, H E; Rots, N Y; Berbers, G; Knol, M J

2015-03-17

Non-inferiority (NI) randomized controlled trials (RCTs) aim to demonstrate that a new treatment is no worse than a comparator that has already shown its efficacy over placebo within a pre-specified margin. However, clear guidelines on how the NI margin should be determined are lacking for vaccine trials. A difference (seroprevalence/risk) of 10% or a geometric mean titre/concentration (GMT) ratio of 1.5 or 2.0 in antibody levels is implicitly recommended for vaccine trials. We aimed to explore which NI margins were used in vaccine RCTs and how they were determined. A systematic search for NI vaccine RCTs yielded 177 eligible articles. Data were extracted from these articles using a standardized form and included general characteristics and characteristics specific for NI trials. Relations between the study characteristics and the NI margin used were explored. Among the 143 studies using an NI margin based on difference (n=136 on immunogenicity, n=2 on efficacy and n=5 on safety), 66% used a margin of 10%, 23% used margins lower than 10% (range 1-7.5%) and 11% used margins larger than 10% (range 11.5-25%). Of the 103 studies using a NI margin based on the GMT ratio, 50% used a margin of 0.67/1.5 and 49% used 0.5/2.0. As observed, 85% of the studies did not discuss the method of margin determination; and 19% of the studies lacked a confidence interval or p-value for non-inferiority. Most NI vaccine RCTs used an NI margin of 10% for difference or a GMT ratio of 1.5 or 2.0 without a clear rationale. Most articles presented enough information for the reader to make a judgement about the NI margin used and the conclusions. The reporting on the design, margins used and results of NI vaccine trials could be improved; more explicit guidelines may help to achieve this end. Copyright © 2015 Elsevier Ltd. All rights reserved.

SU-E-T-573: The Robustness of a Combined Margin Recipe for Uncertainties During Radiotherapy

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

Stroom, J; Vieira, S; Greco, C

2014-06-01

Purpose: To investigate the variability of a safety margin recipe that combines CTV and PTV margins quadratically, with several tumor, treatment, and user related factors. Methods: Margin recipes were calculated by monte-carlo simulations in 5 steps. 1. A spherical tumor with or without isotropic microscopic was irradiated with a 5 field dose plan2. PTV: Geometric uncertainties were introduced using systematic (Sgeo) and random (sgeo) standard deviations. CTV: Microscopic disease distribution was modelled by semi-gaussian (Smicro) with varying number of islets (Ni)3. For a specific uncertainty set (Sgeo, sgeo, Smicro(Ni)), margins were varied until pre-defined decrease in TCP or dose coveragemore » was fulfilled. 4. First, margin recipes were calculated for each of the three uncertainties separately. CTV and PTV recipes were then combined quadratically to yield a final recipe M(Sgeo, sgeo, Smicro(Ni)).5. The final M was verified by simultaneous simulations of the uncertainties.Now, M has been calculated for various changing parameters like margin criteria, penumbra steepness, islet radio-sensitivity, dose conformity, and number of fractions. We subsequently investigated A: whether the combined recipe still holds in all these situations, and B: what the margin variation was in all these cases. Results: We found that the accuracy of the combined margin recipes remains on average within 1mm for all situations, confirming the correctness of the quadratic addition. Depending on the specific parameter, margin factors could change such that margins change over 50%. Especially margin recipes based on TCP-criteria are more sensitive to more parameters than those based on purely geometric Dmin-criteria. Interestingly, measures taken to minimize treatment field sizes (by e.g. optimizing dose conformity) are counteracted by the requirement of larger margins to get the same tumor coverage. Conclusion: Margin recipes combining geometric and microscopic uncertainties quadratically are accurate under varying circumstances. However margins can change up to 50% for different situations.« less

Safety of fenbendazole in common peafowl (Pavo cristatus).

PubMed

Umar, Sajid; Abbas, Seema; Khan, Muhammad Irfan; Nisa, Qamarun; Younus, Muhammad; Aqil, Kiran; Qayyum, Rizwan; Yaqoob, Muhammad; Ali, Asif; Yaseen, Muhammad Asif; Shah, Muhammad Ali

2018-01-01

The present study was undertaken to find out the safety levels of fenbendazole in common peafowl. This bird, raised on aviaries and zoos, can be severely parasitized with Ascaridia galli (enteric worms) and Syngamus trachea (gapeworm) along with other parasitic worms. Fenbendazole is a highly effective benzimidazole-class anthelmintic in animals. The objective of this work was to provide target animal safety data in young peafowl and to demonstrate reproductive safety in adult birds. During the experimental study, diets containing fenbendazole at 0, 100, 200 and 300 ppm were fed for 21 days (three times the normal treatment duration). Data for feed consumption, feed conversion rate, and body weights were recorded for each bird in each group. Drug concentrations in different tissues of birds were determined to correlate concentrations with clinical observations, clinical pathology, and histologic findings. There were no morbidities or mortalities after study day 21. Additionally, there were no statistically significant treatment-related differences among above mentioned parameters. Analysis of fenbendazole concentrations in kidney, liver, leg/thigh, and breast muscle and skin with associated fat revealed that, even at the highest dose level used and with no feed withdrawal, fenbendazole concentrations were relatively low in these tissues. These findings indicate that fenbendazole has a relatively wide margin of safety in young peafowl and that the proposed dose of 100 ppm in the feed for 7 consecutive days is well within the margin of safety. In the reproductive safety study, five breeder peafowl farms fed fendbendazole at 100ppm for 7 days and collected data on hatching percentage of peahen eggs before and after treatment. Reproductive performance in peahen was not adversely affected.

Assessment of the Impact of Scheduled Postmarketing Safety Summary Analyses on Regulatory Actions

PubMed Central

Sekine, S; Pinnow, EE; Wu, E; Kurtzig, R; Hall, M; Dal Pan, GJ

2016-01-01

In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug Administration (FDA) to conduct a summary analysis of adverse event reports to identify risks of a drug or biologic product 18 months after product approval, or after 10,000 patients have used the product, whichever is later. We assessed the extent to which these analyses identified new safety signals and resultant safety-related label changes. Among 458 newly approved products, 300 were the subjects of a scheduled analysis; a new safety signal that resulted in a safety-related label change was found for 11 of these products. Less than 2% of 713 safety-related label changes were based on the scheduled analyses. Our study suggests that the safety summary analyses provide only marginal value over other pharmacovigilance activities. PMID:26853718

Flight-determined stability analysis of multiple-input-multiple-output control systems

NASA Technical Reports Server (NTRS)

Burken, John J.

1992-01-01

Singular value analysis can give conservative stability margin results. Applying structure to the uncertainty can reduce this conservatism. This paper presents flight-determined stability margins for the X-29A lateral-directional, multiloop control system. These margins are compared with the predicted unscaled singular values and scaled structured singular values. The algorithm was further evaluated with flight data by changing the roll-rate-to-aileron command-feedback gain by +/- 20 percent. Minimum eigenvalues of the return difference matrix which bound the singular values are also presented. Extracting multiloop singular values from flight data and analyzing the feedback gain variations validates this technique as a measure of robustness. This analysis can be used for near-real-time flight monitoring and safety testing.

Flight-determined stability analysis of multiple-input-multiple-output control systems

NASA Technical Reports Server (NTRS)

Burken, John J.

1992-01-01

Singular value analysis can give conservative stability margin results. Applying structure to the uncertainty can reduce this conservatism. This paper presents flight-determined stability margins for the X-29A lateral-directional, multiloop control system. These margins are compared with the predicted unscaled singular values and scaled structured singular values. The algorithm was further evaluated with flight data by changing the roll-rate-to-aileron-command-feedback gain by +/- 20 percent. Also presented are the minimum eigenvalues of the return difference matrix which bound the singular values. Extracting multiloop singular values from flight data and analyzing the feedback gain variations validates this technique as a measure of robustness. This analysis can be used for near-real-time flight monitoring and safety testing.

The margination propensity of spherical particles for vascular targeting in the microcirculation

PubMed Central

Gentile, Francesco; Curcio, Antonio; Indolfi, Ciro; Ferrari, Mauro; Decuzzi, Paolo

2008-01-01

The propensity of circulating particles to drift laterally towards the vessel walls (margination) in the microcirculation has been experimentally studied using a parallel plate flow chamber. Fluorescent polystyrene particles, with a relative density to water of just 50 g/cm3comparable with that of liposomal or polymeric nanoparticles used in drug delivery and bio-imaging, have been used with a diameter spanning over three order of magnitudes from 50 nm up to 10 μm. The number n∼s of particles marginating per unit surface have been measured through confocal fluorescent microscopy for a horizontal chamber, and the corresponding total volume V∼s of particles has been calculated. Scaling laws have been derived as a function of the particle diameter d. In horizontal capillaries, margination is mainly due to the gravitational force for particles with d > 200 nm and V∼s increases with d4; whereas for smaller particles V∼s increases with d3. In vertical capillaries, since the particles are heavier than the fluid they would tend to marginate towards the walls in downward flows and towards the center in upward flows, with V∼s increasing with d9/2. However, the margination in vertical capillaries is predicted to be much smaller than in horizontal capillaries. These results suggest that, for particles circulating in an external field of volume forces (gravitation or magnetic), the strategy of using larger particles designed to marginate and adhere firmly to the vascular walls under flow could be more effective than that of using particles sufficiently small (d < 200 nm) to hopefully cross a discontinuous endothelium. PMID:18702833

Treatment selection for patients with ductal carcinoma in situ (DCIS) of the breast using the University of Southern California/Van Nuys (USC/VNPI) prognostic index.

PubMed

Silverstein, Melvin J; Lagios, Michael D

2015-01-01

The University of Southern California/Van Nuys Prognostic Index (USC/VNPI) is an algorithm that quantifies five measurable prognostic factors known to be important in predicting local recurrence in conservatively treated patients with ductal carcinoma in situ (DCIS) (tumor size, margin width, nuclear grade, age, and comedonecrosis). With five times as many patients since originally developed, sufficient numbers now exist for analysis by individual scores rather than groups of scores. To achieve a local recurrence rate of less than 20% at 12 years, these data support excision alone for all patients scoring 4, 5, or 6 and patients who score 7 but have margin widths ≥3 mm. Excision plus RT achieves the less than 20% local recurrence threshold at 12 years for patients who score 7 and have margins <3 mm, patients who score 8 and have margins ≥3 mm, and for patients who score 9 and have margins ≥5 mm. Mastectomy is required for patients who score 8 and have margins <3 mm, who score 9 and have margins <5 mm and for all patients who score 10, 11, or 12 to keep the local recurrence rate less than 20% at 12 years. DCIS is a highly favorable disease. There is no difference in mortality rate regardless of which treatment is chosen. The USC/VNPI is a numeric tool that can be used to aid the treatment decision-making process. © 2015 Wiley Periodicals, Inc.

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

ClinicalTrials.gov

2017-04-03

Acute Myelocytic Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Marginal Zone Lymphoma; Follicular Lymphomas; Large-cell Lymphoma; Lymphoblastic Lymphoma; Burkitt's Lymphoma; High Grade Lymphomas; Mantle-cell Lymphoma; Lymphoplasmacytic Lymphoma

Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators.

PubMed

Bates, Jonathan; Parzynski, Craig S; Dhruva, Sanket S; Coppi, Andreas; Kuntz, Richard; Li, Shu-Xia; Marinac-Dabic, Danica; Masoudi, Frederick A; Shaw, Richard E; Warner, Frederick; Krumholz, Harlan M; Ross, Joseph S

2018-06-12

To estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. We conducted repeated sample size estimates to calculate the medical device utilization needed, systematically varying device-specific safety event rate ratios and significance levels while maintaining 80% power, testing 3 average adverse event rates (3.9, 6.1, and 12.6 events per 100 person-years) estimated from the American College of Cardiology's 2006 to 2010 National Cardiovascular Data Registry of ICDs. We then compared with actual medical device utilization. At significance level 0.05 and 80% power, 34% or fewer ICD models accrued sufficient utilization in practice to detect safety differences for rate ratios <1.15 and an average event rate of 12.6 events per 100 person-years. For average event rates of 3.9 and 12.6 events per 100 person-years, 30% and 50% of ICD models, respectively, accrued sufficient utilization for a rate ratio of 1.25, whereas 52% and 67% for a rate ratio of 1.50. Because actual ICD utilization was not uniformly distributed across ICD models, the proportion of individuals receiving any ICD that accrued sufficient utilization in practice was 0% to 21%, 32% to 70%, and 67% to 84% for rate ratios of 1.05, 1.15, and 1.25, respectively, for the range of 3 average adverse event rates. Small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates. Copyright © 2018 John Wiley & Sons, Ltd.

Guaranteeing safety in spatially situated agents

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

Kohout, R.C.; Hendler, J.A.; Musliner, D.J.

1996-12-31

{open_quote}Mission-critical{close_quotes} systems, which include such diverse applications as nuclear power plant controllers, {open_quotes}fly-by-wire{close_quotes} airplanes, medical care and monitoring systems, and autonomous mobile vehicles, are characterized by the fact that system failure is potentially catastrophic. The high cost of failure justifies the expenditure of considerable effort at design-time in order to guarantee the correctness of system behavior. This paper examines the problem of guaranteeing safety in a well studied class of robot motion problems known as the {open_quotes}asteroid avoidance problem.{close_quotes} We establish necessary and sufficient conditions for ensuring safety in the simple version of this problem which occurs most frequently inmore » the literature, as well as sufficient conditions for a more general and realistic case. In doing so, we establish functional relationships between the number, size and speed of obstacles, the robot`s maximum speed and the conditions which must be maintained in order to ensure safety.« less

The influence of novel compliant floors on balance control in elderly women--A biomechanical study.

PubMed

Wright, Alexander D; Laing, Andrew C

2011-07-01

Novel compliant floors aim to decrease the risk for fall-related injury by providing substantial force attenuation during the impact phase of falls. Certain models of compliant flooring have been shown to have limited influence on postural sway and successful completion of dynamic balance tasks. However, the effects of these products on balance recovery mechanisms following an externally induced perturbation have yet to be quantified. We used a floor translation paradigm to induce a balance perturbation to thirteen elderly community-dwelling women. Outcome measures included the displacement rates and margins of safety for both the underfoot centre-of-pressure and whole-body centre-of-mass across two novel compliant floors (SmartCell, SofTile), two basic foam surfaces (Firm-Foam, Soft-Foam) and a standard 'Rigid' floor as a control condition. The centre-of-mass and centre-of-pressure margins of safety, and all centre-of-mass displacement rates, were not significantly lower for the two novel compliant flooring systems compared to the control floor. The centre-of-pressure displacement rates were similar to the control floor for the SmartCell floor condition. The majority of the margin of safety and displacement rate variables for the foam floors were significantly lower than the control condition. This study illustrates that the SmartCell and SofTile novel compliant floors have minimal influences on balance and balance control responses following externally induced perturbations in older community-dwelling women, and supports pilot installations of these floors to inform decisions regarding the development of clinical trials. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

The influence of novel compliant floors on balance control in elderly women—A biomechanical study

PubMed Central

Wright, Alexander D.; Laing, Andrew C.

2012-01-01

Novel compliant floors aim to decrease the risk for fall-related injury by providing substantial force attenuation during the impact phase of falls. Certain models of compliant flooring have been shown to have limited influence on postural sway and successful completion of dynamic balance tasks. However, the effects of these products on balance recovery mechanisms following an externally induced perturbation have yet to be quantified. We used a floor translation paradigm to induce a balance perturbation to thirteen elderly community-dwelling women. Outcome measures included the displacement rates and margins of safety for both the underfoot centre-of-pressure and whole-body centre-of-mass across two novel compliant floors (Smart-Cell, SofTile), two basic foam surfaces (Firm-Foam, Soft-Foam) and a standard ‘Rigid’ floor as a control condition. The centre-of-mass and centre-of-pressure margins of safety, and all centre-of-mass displacement rates, were not significantly lower for the two novel compliant flooring systems compared to the control floor. The centre-of-pressure displacement rates were similar to the control floor for the SmartCell floor condition. The majority of the margin of safety and displacement rate variables for the foam floors were significantly lower than the control condition. This study illustrates that the SmartCell and SofTile novel compliant floors have minimal influences on balance and balance control responses following externally induced perturbations in older community-dwelling women, and supports pilot installations of these floors to inform decisions regarding the development of clinical trials. PMID:21545881

Hydraulic safety margins and embolism reversal in stems and leaves: why are conifers and angiosperms so different?

PubMed

Johnson, Daniel M; McCulloh, Katherine A; Woodruff, David R; Meinzer, Frederick C

2012-10-01

Angiosperm and coniferous tree species utilize a continuum of hydraulic strategies. Hydraulic safety margins (defined as differences between naturally occurring xylem pressures and pressures that would cause hydraulic dysfunction, or differences between pressures resulting in loss of hydraulic function in adjacent organs (e.g., stems vs. leaves) tend to be much greater in conifers than angiosperms and serve to prevent stem embolism. However, conifers tend to experience embolism more frequently in leaves and roots than angiosperms. Embolism repair is thought to occur by active transport of sugars into empty conduits followed by passive water movement. The most likely source of sugar for refilling is from nonstructural carbohydrate depolymerization in nearby parenchyma cells. Compared to angiosperms, conifers tend to have little parenchyma or nonstructural carbohydrates in their wood. The ability to rapidly repair embolisms may rely on having nearby parenchyma cells, which could explain the need for greater safety margins in conifer wood as compared to angiosperms. The frequent embolisms that occur in the distal portions of conifers are readily repaired, perhaps due to the abundant parenchyma in leaves and roots, and these distal tissues may act as hydraulic circuit breakers that prevent tension-induced embolisms in the attached stems. Frequent embolisms in conifer leaves may also be due to weaker stomatal response to changes in ambient humidity. Although there is a continuum of hydraulic strategies among woody plants, there appear to be two distinct 'behaviors' at the extremes: (1) embolism prevention and (2) embolism occurrence and subsequent repair. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Lateral spread of heat during thyroidectomy using different haemostatic devices.

PubMed

Adamczewski, Zbigniew; Król, Aleksander; Kałużna-Markowska, Karolina; Brzeziński, Jan; Lewiński, Andrzej; Dedecjus, Marek

2015-01-01

The presented study is an attempt to comprehensively analyze the lateral spread of heat during thyroidectomy. Obtained results may be valuable in other surgical disciplines in which thermal analysis is difficult or impossible. The aim of the study was to evaluate the temperature distribution in the operating field during thyroidectomy performed with the use of modern haemostatic instruments, and to define the safety margin for the investigated devices. Ninety-three patients were thyroidectomised due to thyroid neoplasm. During all the operations the thermovisual measurements were carried out along with continuous intraoperative neuromonitoring of the recurrent laryngeal nerve (CIONM). Investigated patients were divided into 5 groups, named according to the applied haemostatic technique: LigaSure (N=17); ThermoStapler (N=20); Focus (N=19); SonoSurg (N=17) and Monopolar (N=20). At maximal performance settings, the highest working temperature was observed for the ThermoStapler, while the lowest temperature was recorded for the Monopolar. Safety margin and working time were increased in Focus and SonoSurg, compared to LigaSure and ThermoStapler. The differences in the necrosis thickness were negligible. The largest distance of the midline of the active blade from isotherm of 42ºC observed in the study was 5.51 mm; none of investigated devices used at a bigger distance had influence on the morphology of the electric signal of CIONM. The thermo-visual camera allows non-invasive, safe, and real-time monitoring and analysis of temperature distribution in the operation area during thyroidectomy. Proposed minimal safety margin for the analysed devices is 5.51 mm.

Dopamine Reward Prediction Error Responses Reflect Marginal Utility

PubMed Central

Stauffer, William R.; Lak, Armin; Schultz, Wolfram

2014-01-01

Summary Background Optimal choices require an accurate neuronal representation of economic value. In economics, utility functions are mathematical representations of subjective value that can be constructed from choices under risk. Utility usually exhibits a nonlinear relationship to physical reward value that corresponds to risk attitudes and reflects the increasing or decreasing marginal utility obtained with each additional unit of reward. Accordingly, neuronal reward responses coding utility should robustly reflect this nonlinearity. Results In two monkeys, we measured utility as a function of physical reward value from meaningful choices under risk (that adhered to first- and second-order stochastic dominance). The resulting nonlinear utility functions predicted the certainty equivalents for new gambles, indicating that the functions’ shapes were meaningful. The monkeys were risk seeking (convex utility function) for low reward and risk avoiding (concave utility function) with higher amounts. Critically, the dopamine prediction error responses at the time of reward itself reflected the nonlinear utility functions measured at the time of choices. In particular, the reward response magnitude depended on the first derivative of the utility function and thus reflected the marginal utility. Furthermore, dopamine responses recorded outside of the task reflected the marginal utility of unpredicted reward. Accordingly, these responses were sufficient to train reinforcement learning models to predict the behaviorally defined expected utility of gambles. Conclusions These data suggest a neuronal manifestation of marginal utility in dopamine neurons and indicate a common neuronal basis for fundamental explanatory constructs in animal learning theory (prediction error) and economic decision theory (marginal utility). PMID:25283778

RISMC Toolkit and Methodology Research and Development Plan for External Hazards Analysis

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

Coleman, Justin Leigh

This report includes the description and development plan for a Risk Informed Safety Margins Characterization (RISMC) toolkit and methodology that will evaluate multihazard risk in an integrated manner to support the operating nuclear fleet.

Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

USDA-ARS?s Scientific Manuscript database

Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to ...

Setting the most robust effluent level under severe uncertainty: application of information-gap decision theory to chemical management.

PubMed

Yokomizo, Hiroyuki; Naito, Wataru; Tanaka, Yoshinari; Kamo, Masashi

2013-11-01

Decisions in ecological risk management for chemical substances must be made based on incomplete information due to uncertainties. To protect the ecosystems from the adverse effect of chemicals, a precautionary approach is often taken. The precautionary approach, which is based on conservative assumptions about the risks of chemical substances, can be applied selecting management models and data. This approach can lead to an adequate margin of safety for ecosystems by reducing exposure to harmful substances, either by reducing the use of target chemicals or putting in place strict water quality criteria. However, the reduction of chemical use or effluent concentrations typically entails a financial burden. The cost effectiveness of the precautionary approach may be small. Hence, we need to develop a formulaic methodology in chemical risk management that can sufficiently protect ecosystems in a cost-effective way, even when we do not have sufficient information for chemical management. Information-gap decision theory can provide the formulaic methodology. Information-gap decision theory determines which action is the most robust to uncertainty by guaranteeing an acceptable outcome under the largest degree of uncertainty without requiring information about the extent of parameter uncertainty at the outset. In this paper, we illustrate the application of information-gap decision theory to derive a framework for setting effluent limits of pollutants for point sources under uncertainty. Our application incorporates a cost for reduction in pollutant emission and a cost to wildlife species affected by the pollutant. Our framework enables us to settle upon actions to deal with severe uncertainty in ecological risk management of chemicals. Copyright © 2013 Elsevier Ltd. All rights reserved.

Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial.

PubMed

Chin, Joseph L; Billia, Michele; Relle, James; Roethke, Matthias C; Popeneciu, Ionel V; Kuru, Timur H; Hatiboglu, Gencay; Mueller-Wolf, Maya B; Motsch, Johann; Romagnoli, Cesare; Kassam, Zahra; Harle, Christopher C; Hafron, Jason; Nandalur, Kiran R; Chronik, Blaine A; Burtnyk, Mathieu; Schlemmer, Heinz-Peter; Pahernik, Sascha

2016-09-01

Magnetic resonance imaging-guided transurethral ultrasound ablation (MRI-TULSA) is a novel minimally invasive technology for ablating prostate tissue, potentially offering good disease control of localized cancer and low morbidity. To determine the clinical safety and feasibility of MRI-TULSA for whole-gland prostate ablation in a primary treatment setting of localized prostate cancer (PCa). A single-arm prospective phase 1 study was performed at three tertiary referral centers in Canada, Germany, and the United States. Thirty patients (median age: 69 yr; interquartile range [IQR]: 67-71 yr) with biopsy-proven low-risk (80%) and intermediate-risk (20%) PCa were treated and followed for 12 mo. MRI-TULSA treatment was delivered with the therapeutic intent of conservative whole-gland ablation including 3-mm safety margins and 10% residual viable prostate expected around the capsule. Primary end points were safety (adverse events) and feasibility (technical accuracy and precision of conformal thermal ablation). Exploratory outcomes included quality of life, prostate-specific antigen (PSA), and biopsy at 12 mo. Median treatment time was 36min (IQR: 26-44) and prostate volume was 44ml (IQR: 38-48). Spatial control of thermal ablation was ±1.3mm on MRI thermometry. Common Terminology Criteria for Adverse Events included hematuria (43% grade [G] 1; 6.7% G2), urinary tract infections (33% G2), acute urinary retention (10% G1; 17% G2), and epididymitis (3.3% G3). There were no rectal injuries. Median pretreatment International Prostate Symptom Score 8 (IQR: 5-13) returned to 6 (IQR: 4-10) at 3 mo (mean change: -2; 95% confidence interval [CI], -4 to 1). Median pretreatment International Index of Erectile Function 13 (IQR: 6-28) recovered to 13 (IQR: 5-25) at 12 mo (mean change: -1; 95% CI, -5 to 3). Median PSA decreased 87% at 1 mo and was stable at 0.8 ng/ml (IQR: 0.6-1.1) to 12 mo. Positive biopsies showed 61% reduction in total cancer length, clinically significant disease in 9 of 29 patients (31%; 95% CI, 15-51), and any disease in 16 of 29 patients (55%; 95% CI, 36-74). MRI-TULSA was feasible, safe, and technically precise for whole-gland prostate ablation in patients with localized PCa. Phase 1 data are sufficiently compelling to study MRI-TULSA further in a larger prospective trial with reduced safety margins. We used magnetic resonance imaging-guided transurethral ultrasound to heat and ablate the prostate in men with prostate cancer. We showed that the treatment can be targeted within a narrow range (1mm) and has a well-tolerated side effect profile. A larger study is under way. NCT01686958, DRKS00005311. Copyright © 2016. Published by Elsevier B.V.

The potential impact of global warming on the efficacy of field margins sown for the conservation of bumble-bees.

PubMed

Memmott, Jane; Carvell, Claire; Pywell, Richard F; Craze, Paul G

2010-07-12

Climate change is expected to drive species extinct by reducing their survival, reproduction and habitat. Less well appreciated is the possibility that climate change could cause extinction by changing the ecological interactions between species. If ecologists, land managers and policy makers are to manage farmland biodiversity sustainably under global climate change, they need to understand the ways in which species interact with each other as this will affect the way they respond to climate change. Here, we consider the ability of nectar flower mixtures used in field margins to provide sufficient forage for bumble-bees under future climate change. We simulated the effect of global warming on the network of plant-pollinator interactions in two types of field margin: a four-species pollen and nectar mix and a six-species wildflower mix. While periods without flowering resources and periods with no food were rare, curtailment of the field season was very common for the bumble-bees in both mixtures. The effect of this, however, could be ameliorated by adding extra species at the start and end of the flowering season. The plant species that could be used to future-proof margins against global warming are discussed.

Rain Fade Compensation for Ka-Band Communications Satellites

NASA Technical Reports Server (NTRS)

Mitchell, W. Carl; Nguyen, Lan; Dissanayake, Asoka; Markey, Brian; Le, Anh

1997-01-01

This report provides a review and evaluation of rain fade measurement and compensation techniques for Ka-band satellite systems. This report includes a description of and cost estimates for performing three rain fade measurement and compensation experiments. The first experiment deals with rain fade measurement techniques while the second one covers the rain fade compensation techniques. The third experiment addresses a feedback flow control technique for the ABR service (for ATM-based traffic). The following conclusions were observed in this report; a sufficient system signal margin should be allocated for all carriers in a network, that is a fixed clear-sky margin should be typically in the range of 4-5 dB and should be more like 15 dB in the up link for moderate and heavy rain zones; to obtain a higher system margin it is desirable to combine the uplink power control technique with the technique that implements the source information rate and FEC code rate changes resulting in a 4-5 dB increase in the dynamic part of the system margin. The experiments would assess the feasibility of the fade measurements and compensation techniques, and ABR feedback control technique.

Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma.

PubMed

Davids, Matthew S; Roberts, Andrew W; Seymour, John F; Pagel, John M; Kahl, Brad S; Wierda, William G; Puvvada, Soham; Kipps, Thomas J; Anderson, Mary Ann; Salem, Ahmed Hamed; Dunbar, Martin; Zhu, Ming; Peale, Franklin; Ross, Jeremy A; Gressick, Lori; Desai, Monali; Kim, Su Young; Verdugo, Maria; Humerickhouse, Rod A; Gordon, Gary B; Gerecitano, John F

2017-03-10

Purpose B-cell leukemia/lymphoma-2 (BCL-2) overexpression is common in many non-Hodgkin lymphoma (NHL) subtypes. A phase I trial in patients with NHL was conducted to determine safety, pharmacokinetics, and efficacy of venetoclax, a selective, potent, orally bioavailable BCL-2 inhibitor. Patients and Methods A total of 106 patients with relapsed or refractory NHL received venetoclax once daily until progressive disease or unacceptable toxicity at target doses from 200 to 1,200 mg in dose-escalation and safety expansion cohorts. Treatment commenced with a 3-week dose ramp-up period for most patients in dose-escalation cohorts and for all patients in safety expansion. Results NHL subtypes included mantle cell lymphoma (MCL; n = 28), follicular lymphoma (FL; n = 29), diffuse large B-cell lymphoma (DLBCL; n = 34), DLBCL arising from chronic lymphocytic leukemia (Richter transformation; n = 7), Waldenström macroglobulinemia (n = 4), and marginal zone lymphoma (n = 3). Venetoclax was generally well tolerated. Clinical tumor lysis syndrome was not observed, whereas laboratory tumor lysis syndrome was documented in three patients. Treatment-emergent adverse events were reported in 103 patients (97%), a majority of which were grade 1 to 2 in severity. Grade 3 to 4 events were reported in 59 patients (56%), and the most common were hematologic, including anemia (15%), neutropenia (11%), and thrombocytopenia (9%). Overall response rate was 44% (MCL, 75%; FL, 38%; DLBCL, 18%). Estimated median progression-free survival was 6 months (MCL, 14 months; FL, 11 months; DLBCL, 1 month). Conclusion Selective targeting of BCL-2 with venetoclax was well tolerated, and single-agent activity varied among NHL subtypes. We determined 1,200 mg to be the recommended single-agent dose for future studies in FL and DLBCL, with 800 mg being sufficient to consistently achieve durable response in MCL. Additional investigations including combination therapy to augment response rates and durability are ongoing.

Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

PubMed Central

Roberts, Andrew W.; Seymour, John F.; Pagel, John M.; Kahl, Brad S.; Wierda, William G.; Puvvada, Soham; Kipps, Thomas J.; Anderson, Mary Ann; Salem, Ahmed Hamed; Dunbar, Martin; Zhu, Ming; Peale, Franklin; Ross, Jeremy A.; Gressick, Lori; Desai, Monali; Kim, Su Young; Verdugo, Maria; Humerickhouse, Rod A.; Gordon, Gary B.; Gerecitano, John F.

2017-01-01

Purpose B-cell leukemia/lymphoma-2 (BCL-2) overexpression is common in many non-Hodgkin lymphoma (NHL) subtypes. A phase I trial in patients with NHL was conducted to determine safety, pharmacokinetics, and efficacy of venetoclax, a selective, potent, orally bioavailable BCL-2 inhibitor. Patients and Methods A total of 106 patients with relapsed or refractory NHL received venetoclax once daily until progressive disease or unacceptable toxicity at target doses from 200 to 1,200 mg in dose-escalation and safety expansion cohorts. Treatment commenced with a 3-week dose ramp-up period for most patients in dose-escalation cohorts and for all patients in safety expansion. Results NHL subtypes included mantle cell lymphoma (MCL; n = 28), follicular lymphoma (FL; n = 29), diffuse large B-cell lymphoma (DLBCL; n = 34), DLBCL arising from chronic lymphocytic leukemia (Richter transformation; n = 7), Waldenström macroglobulinemia (n = 4), and marginal zone lymphoma (n = 3). Venetoclax was generally well tolerated. Clinical tumor lysis syndrome was not observed, whereas laboratory tumor lysis syndrome was documented in three patients. Treatment-emergent adverse events were reported in 103 patients (97%), a majority of which were grade 1 to 2 in severity. Grade 3 to 4 events were reported in 59 patients (56%), and the most common were hematologic, including anemia (15%), neutropenia (11%), and thrombocytopenia (9%). Overall response rate was 44% (MCL, 75%; FL, 38%; DLBCL, 18%). Estimated median progression-free survival was 6 months (MCL, 14 months; FL, 11 months; DLBCL, 1 month). Conclusion Selective targeting of BCL-2 with venetoclax was well tolerated, and single-agent activity varied among NHL subtypes. We determined 1,200 mg to be the recommended single-agent dose for future studies in FL and DLBCL, with 800 mg being sufficient to consistently achieve durable response in MCL. Additional investigations including combination therapy to augment response rates and durability are ongoing. PMID:28095146

Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design.

PubMed

Meybohm, Patrick; Herrmann, Eva; Steinbicker, Andrea U; Wittmann, Maria; Gruenewald, Matthias; Fischer, Dania; Baumgarten, Georg; Renner, Jochen; Van Aken, Hugo K; Weber, Christian F; Mueller, Markus M; Geisen, Christof; Rey, Julia; Bon, Dimitra; Hintereder, Gudrun; Choorapoikayil, Suma; Oldenburg, Johannes; Brockmann, Christian; Geissler, Raoul G; Seifried, Erhard; Zacharowski, Kai

2016-08-01

To determine whether the implementation of patient blood management (PBM) is effective to decrease the use of red blood cell without impairment of patient's safety. The World Health Organization encouraged all member states to implement PBM programs employing multiple combined strategies to increase and preserve autologous erythrocyte volume to minimize red blood cell transfusions. Data regarding safety issues are not sufficiently available. In this prospective, multicenter study, surgical inpatients from four German University Hospitals were analyzed before (pre-PBM) and after the implementation of PBM. PBM program included multiple measures (ie, preoperative optimization of hemoglobin levels, blood-sparing techniques, and standardization of transfusion practice). Primary aim was to show noninferiority of the PBM cohort with a margin of 0.5%. Secondary endpoints included red blood cell utilization. A total of 129,719 patients discharged between July 2012 and June 2015 with different inclusion periods for pre-PBM (54,513 patients) and PBM (75,206 patients) were analyzed. The primary endpoint was 6.53% in the pre-PBM versus 6.34% in the PBM cohort. The noninferiority aim was achieved (P < 0.001). Incidence of acute renal failure decreased in the PBM cohort (2.39% vs 1.67%; P < 0.001, regression model). The mean number of red blood cell transfused per patient was reduced from 1.21 ± 0.05 to 1.00 ± 0.05 (relative change by 17%, P < 0.001). The data presented show that implementation of PBM with a more conscious handling of transfusion practice can be achieved even in large hospitals without impairment of patient's safety. Further studies should elucidate which PBM measures are most clinically and cost effective. PBM-Study ClinicalTrials.gov, NCT01820949.

Sea-level-induced seismicity and submarine landslide occurrence

USGS Publications Warehouse

Brothers, Daniel S.; Luttrell, Karen M.; Chaytor, Jason D.

2013-01-01

The temporal coincidence between rapid late Pleistocene sea-level rise and large-scale slope failures is widely documented. Nevertheless, the physical mechanisms that link these phenomena are poorly understood, particularly along nonglaciated margins. Here we investigate the causal relationships between rapid sea-level rise, flexural stress loading, and increased seismicity rates along passive margins. We find that Coulomb failure stress across fault systems of passive continental margins may have increased more than 1 MPa during rapid late Pleistocene–early Holocene sea-level rise, an amount sufficient to trigger fault reactivation and rupture. These results suggest that sea-level–modulated seismicity may have contributed to a number of poorly understood but widely observed phenomena, including (1) increased frequency of large-scale submarine landslides during rapid, late Pleistocene sea-level rise; (2) emplacement of coarse-grained mass transport deposits on deep-sea fans during the early stages of marine transgression; and (3) the unroofing and release of methane gas sequestered in continental slope sediments.

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

Gougar, Hans

This document outlines the development of a high fidelity, best estimate nuclear power plant severe transient simulation capability that will complement or enhance the integral system codes historically used for licensing and analysis of severe accidents. As with other tools in the Risk Informed Safety Margin Characterization (RISMC) Toolkit, the ultimate user of Enhanced Severe Transient Analysis and Prevention (ESTAP) capability is the plant decision-maker; the deliverable to that customer is a modern, simulation-based safety analysis capability, applicable to a much broader class of safety issues than is traditional Light Water Reactor (LWR) licensing analysis. Currently, the RISMC pathway’s majormore » emphasis is placed on developing RELAP-7, a next-generation safety analysis code, and on showing how to use RELAP-7 to analyze margin from a modern point of view: that is, by characterizing margin in terms of the probabilistic spectra of the “loads” applied to systems, structures, and components (SSCs), and the “capacity” of those SSCs to resist those loads without failing. The first objective of the ESTAP task, and the focus of one task of this effort, is to augment RELAP-7 analyses with user-selected multi-dimensional, multi-phase models of specific plant components to simulate complex phenomena that may lead to, or exacerbate, severe transients and core damage. Such phenomena include: coolant crossflow between PWR assemblies during a severe reactivity transient, stratified single or two-phase coolant flow in primary coolant piping, inhomogeneous mixing of emergency coolant water or boric acid with hot primary coolant, and water hammer. These are well-documented phenomena associated with plant transients but that are generally not captured in system codes. They are, however, generally limited to specific components, structures, and operating conditions. The second ESTAP task is to similarly augment a severe (post-core damage) accident integral analyses code with high fidelity simulations that would allow investigation of multi-dimensional, multi-phase containment phenomena that are only treated approximately in established codes.« less

Robust Adaptation? Assessing the sensitivity of safety margins in flood defences to uncertainty in future simulations - a case study from Ireland.

NASA Astrophysics Data System (ADS)

Murphy, Conor; Bastola, Satish; Sweeney, John

2013-04-01

Climate change impact and adaptation assessments have traditionally adopted a 'top-down' scenario based approach, where information from different Global Climate Models (GCMs) and emission scenarios are employed to develop impacts led adaptation strategies. Due to the tradeoffs in the computational cost and need to include a wide range of GCMs for fuller characterization of uncertainties, scenarios are better used for sensitivity testing and adaptation options appraisal. One common approach to adaptation that has been defined as robust is the use of safety margins. In this work the sensitivity of safety margins that have been adopted by the agency responsible for flood risk management in Ireland, to the uncertainty in future projections are examined. The sensitivity of fluvial flood risk to climate change is assessed for four Irish catchments using a large number of GCMs (17) forced with three emissions scenarios (SRES A1B, A2, B1) as input to four hydrological models. Both uncertainty within and between hydrological models is assessed using the GLUE framework. Regionalisation is achieved using a change factor method to infer changes in the parameters of a weather generator using monthly output from the GCMs, while flood frequency analysis is conducted using the method of probability weighted moments to fit the Generalised Extreme Value distribution to ~20,000 annual maxima series. The sensitivity of design margins to the uncertainty space considered is visualised using risk response surfaces. The hydrological sensitivity is measured as the percentage change in flood peak for specified recurrence intervals. Results indicate that there is a considerable residual risk associated with allowances of +20% when uncertainties are accounted for and that the risk of exceedence of design allowances is greatest for more extreme, low frequency events with considerable implication for critical infrastructure, e.g., culverts, bridges, flood defences whose designs are normally associated with such return periods. Sensitivity results show that the impact of climate change is not as great for flood peaks with higher return periods. The average width of the uncertainty range and the size of the range for each catchment reveals that the uncertainties in low frequency events are greater than high frequency events. In addition, the uncertainty interval, estimated as the average width of the uncertainty range of flow for the five return periods, grows wider with a decrease in the runoff coefficient and wetness index of each catchment, both of which tend to increase the nonlinearity in the rainfall response. A key management question that emerges is the acceptability of residual risk where high exposure of vulnerable populations and/or critical infrastructure coincide with high costs of additional capacity in safety margins.

Thermal-safety margins and the necessity of thermoregulatory behavior across latitude and elevation

PubMed Central

Sunday, Jennifer M.; Bates, Amanda E.; Kearney, Michael R.; Colwell, Robert K.; Dulvy, Nicholas K.; Longino, John T.; Huey, Raymond B.

2014-01-01

Physiological thermal-tolerance limits of terrestrial ectotherms often exceed local air temperatures, implying a high degree of thermal safety (an excess of warm or cold thermal tolerance). However, air temperatures can be very different from the equilibrium body temperature of an individual ectotherm. Here, we compile thermal-tolerance limits of ectotherms across a wide range of latitudes and elevations and compare these thermal limits both to air and to operative body temperatures (theoretically equilibrated body temperatures) of small ectothermic animals during the warmest and coldest times of the year. We show that extreme operative body temperatures in exposed habitats match or exceed the physiological thermal limits of most ectotherms. Therefore, contrary to previous findings using air temperatures, most ectotherms do not have a physiological thermal-safety margin. They must therefore rely on behavior to avoid overheating during the warmest times, especially in the lowland tropics. Likewise, species living at temperate latitudes and in alpine habitats must retreat to avoid lethal cold exposure. Behavioral plasticity of habitat use and the energetic consequences of thermal retreats are therefore critical aspects of species’ vulnerability to climate warming and extreme events. PMID:24616528

Evaluation of Margins of Safety in Brazed Joints

NASA Technical Reports Server (NTRS)

Flom, Yury; Wang, Len; Powell, Mollie M.; Soffa, Matthew A.; Rommel, Monica L.

2009-01-01

One of the essential steps in assuring reliable performance of high cost critical brazed structures is the assessment of the Margin of Safety (MS) of the brazed joints. In many cases the experimental determination of the failure loads by destructive testing of the brazed assembly is not practical and cost prohibitive. In such cases the evaluation of the MS is performed analytically by comparing the maximum design loads with the allowable ones and incorporating various safety or knock down factors imposed by the customer. Unfortunately, an industry standard methodology for the design and analysis of brazed joints has not been developed. This paper provides an example of an approach that was used to analyze an AlBeMet 162 (38%Be-62%Al) structure brazed with the AWS BAlSi-4 (Al-12%Si) filler metal. A practical and conservative interaction equation combining shear and tensile allowables was developed and validated to evaluate an acceptable (safe) combination of tensile and shear stresses acting in the brazed joint. These allowables are obtained from testing of standard tensile and lap shear brazed specimens. The proposed equation enables the assessment of the load carrying capability of complex brazed joints subjected to multi-axial loading.

Using translational medicine to understand clinical differences between botulinum toxin formulations.

PubMed

Aoki, K R; Ranoux, D; Wissel, J

2006-12-01

When using botulinum toxin-based products, the physician must decide the optimal location and dose required to alleviate symptoms and improve the patient's quality of life. To deliver effective treatment, the physician needs to understand the importance of accurate target muscle selection and localization and the implications of each product's migration properties when diluted in different volumes. Pre-clinical mouse models of efficacy and safety have been utilized to compare local and distal muscle relaxation effects following defined intramuscular administration. Data from the model allow the products to be ranked based on their propensity for local efficacy versus their distal migration properties. Using standardized dilutions, the non-parallel dose-response curves for the various formulations demonstrate that they have different efficacy profiles. Distal effects were also noted at different treatment doses, which are reflected in the different safety and/or therapeutic margins. Based on these pre-clinical data, the safety and therapeutic margin rankings are ordered, largest to smallest, as BOTOX, Dysport and Myobloc. The results of subsequent clinical trials are variable and dose comparisons are inconclusive, thus supporting the regulatory position that the dose units of the individual preparations are unique and cannot be simply converted between products.

Thermal-safety margins and the necessity of thermoregulatory behavior across latitude and elevation.

PubMed

Sunday, Jennifer M; Bates, Amanda E; Kearney, Michael R; Colwell, Robert K; Dulvy, Nicholas K; Longino, John T; Huey, Raymond B

2014-04-15

Physiological thermal-tolerance limits of terrestrial ectotherms often exceed local air temperatures, implying a high degree of thermal safety (an excess of warm or cold thermal tolerance). However, air temperatures can be very different from the equilibrium body temperature of an individual ectotherm. Here, we compile thermal-tolerance limits of ectotherms across a wide range of latitudes and elevations and compare these thermal limits both to air and to operative body temperatures (theoretically equilibrated body temperatures) of small ectothermic animals during the warmest and coldest times of the year. We show that extreme operative body temperatures in exposed habitats match or exceed the physiological thermal limits of most ectotherms. Therefore, contrary to previous findings using air temperatures, most ectotherms do not have a physiological thermal-safety margin. They must therefore rely on behavior to avoid overheating during the warmest times, especially in the lowland tropics. Likewise, species living at temperate latitudes and in alpine habitats must retreat to avoid lethal cold exposure. Behavioral plasticity of habitat use and the energetic consequences of thermal retreats are therefore critical aspects of species' vulnerability to climate warming and extreme events.

Tumor response and negative distal resection margins of rectal cancer after hyperthermochemoradiation therapy.

PubMed

Tsutsumi, Soichi; Tabe, Yuichi; Fujii, Takaaki; Yamaguchi, Satoru; Suto, Toshinaga; Yajima, Reina; Morita, Hiroki; Kato, Toshihide; Shioya, Mariko; Saito, Jun-Ichi; Asao, Takayuki; Nakano, Takashi; Kuwano, Hiroyuki

2011-11-01

The safety of regional hyperthermia has been tested in locally advanced rectal cancer. The aim of this study was to assess the effects of shorter distal margins on local control and survival in rectal cancer patients who were treated with preoperative hyperthermochemoradiation therapy (HCRT) and underwent rectal resection by using the total mesorectal excision (TME) method. Ninety-three patients with rectal adenocarcinoma who received neoadjuvant HCRT (total radiation: 50 Gy) were included in this study. Surgery was performed 8 weeks after HCRT, and each resected specimen was evaluated histologically. Length of distal surgical margins, status of circumferential margins, pathological response, and tumor node metastasis stage were examined for their effects on recurrence and survival. Fifty-eight (62.4%) patients had tumor regression, and 20 (21.5%) had a pathological complete response. Distal margin length ranged from 1 to 55 mm (median, 21 mm) and did not correlate with local recurrence (p=0.57) or survival (p=0.75) by univariate analysis. Kaplan-Meier estimates of recurrence-free survival and local recurrence for the <10 mm versus ≥10 mm groups were not significantly different. Positive circumferential margins and failure of tumors to respond were unfavorable factors in survival. Distal resection margins that are shorter than 10 mm but are not positive appear to be equivalent to longer margins in patients who undergo HCRT followed by rectal resection with TME. To improve the down-staging rate, additional studies are needed.

Close Margins Less Than 2 mm Are Not Associated With Higher Risks of 10-Year Local Recurrence and Breast Cancer Mortality Compared With Negative Margins in Women Treated With Breast-Conserving Therapy.

PubMed

Tyler, Susan; Truong, Pauline T; Lesperance, Mary; Nichol, Alan; Baliski, Chris; Warburton, Rebecca; Tyldesley, Scott

2018-03-13

The 2014 Society of Surgical Oncology-American Society for Radiation Oncology consensus suggested "no ink on tumor" is a sufficient surgical margin for invasive breast cancer treated with breast-conserving surgery (BCS). Whether close margins <2 mm are associated with inferior outcomes remains controversial. This study evaluated 10-year outcomes by margin status in a population-based cohort treated with BCS and adjuvant radiation therapy (RT). The subjects were 10,863 women with invasive cancer categorized as pT1 to T3, any N, and M0 referred from 2001 to 2011, an era in which the institutional policy was to re-excise close or positive margins, except in select cases. All women underwent BCS and whole-breast RT with or without boost RT. Local recurrence (LR) and breast cancer-specific survival (BCSS) were examined using competing-risk analysis in cohorts with negative (≥2 mm; n = 9241, 85%), close (<2 mm; n = 1310, 12%), or positive (tumor touching ink; n = 312, 3%) margins. Multivariable analysis and matched-pair analysis were performed. The median follow-up period was 8 years. Systemic therapy was used in 87% of patients. Boost RT was used in 34.1%, 76.9%, and 79.5% of patients with negative, close, and positive margins, respectively. In the negative, close, and positive margin cohorts, the 10-year cumulative incidence of LR was 1.8%, 2.0%, and 1.1%, respectively (P = .759). Corresponding BCSS estimates were 93.9%, 91.8%, and 87.9%, respectively (P < .001). On multivariable analysis, close margins were not associated with increased LR (hazard ratio, 1.25; 95% confidence interval 0.79-1.97; P = .350) or reduced BCSS (hazard ratio, 1.25; 95% confidence interval 0.98-1.58, P = .071) relative to negative margins. On matched-pair analysis, close margin cases had similar LR (P = .114) and BCSS (P = .100) to negative margin controls. Select cases with close or positive margins in this population-based analysis had similar LR and BCSS to cases with negative margins. While these findings do not endorse omitting re-excision for all cases, the data support a policy of accepting carefully selected cases with close margins for adjuvant RT without re-excision. Copyright © 2018 Elsevier Inc. All rights reserved.

Cholecystokinin-Assisted Hydrodissection of the Gallbladder Fossa during FDG PET/CT-guided Liver Ablation

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

Tewari, Sanjit O., E-mail: tewaris@mskcc.org; Petre, Elena N., E-mail: petree@mskcc.org; Osborne, Joseph, E-mail: osbornej@mskcc.org

2013-12-15

A 68-year-old female with colorectal cancer developed a metachronous isolated fluorodeoxyglucose-avid (FDG-avid) segment 5/6 gallbladder fossa hepatic lesion and was referred for percutaneous ablation. Pre-procedure computed tomography (CT) images demonstrated a distended gallbladder abutting the segment 5/6 hepatic metastasis. In order to perform ablation with clear margins and avoid direct puncture and aspiration of the gallbladder, cholecystokinin was administered intravenously to stimulate gallbladder contraction before hydrodissection. Subsequently, the lesion was ablated successfully with sufficient margins, of greater than 1.0 cm, using microwave with ultrasound and FDG PET/CT guidance. The patient tolerated the procedure very well and was discharged home themore » next day.« less

Safety and Suitability for Service Assessment Testing for Surface and Underwater Launched Munitions

DTIC Science & Technology

2014-12-05

test efficiency that tend to associate the Analytical S3 Test Approach with large, complex munition systems and the Empirical S3 Test Approach with...the smaller, less complex munition systems . 8.1 ANALYTICAL S3 TEST APPROACH. The Analytical S3 test approach, as shown in Figure 3, evaluates...assets than the Analytical S3 Test approach to establish the safety margin of the system . This approach is generally applicable to small munitions

10 CFR 72.122 - Overall requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... natural phenomena. (1) Structures, systems, and components important to safety must be designed to... effects of natural phenomena such as earthquakes, tornadoes, lightning, hurricanes, floods, tsunami, and... severe of the natural phenomena reported for the site and surrounding area, with appropriate margins to...

14 CFR 33.62 - Stress analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.62 Stress analysis. A stress analysis must be performed on each turbine engine showing the design safety margin of each turbine...

14 CFR 33.62 - Stress analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.62 Stress analysis. A stress analysis must be performed on each turbine engine showing the design safety margin of each turbine...

Multiphysics Object-Oriented Simulation Environment (MOOSE)

ScienceCinema

None

2017-12-09

Nuclear reactor operators can expand safety margins with more precise information about how materials behave inside operating reactors. INL's new simulation platform makes such studies easier & more informative by letting researchers "plug-n-play" their mathematical models, skipping years of computer code development.

Reliability-based evaluation of bridge components for consistent safety margins.

DOT National Transportation Integrated Search

2010-10-01

The Load and Resistant Factor Design (LRFD) approach is based on the concept of structural reliability. The approach is more : rational than the former design approaches such as Load Factor Design or Allowable Stress Design. The LRFD Specification fo...

30 CFR 75.513-1 - Electric conductor; size.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Electric conductor; size. 75.513-1 Section 75.513-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... Electric conductor; size. An electric conductor is not of sufficient size to have adequate carrying...

30 CFR 75.513-1 - Electric conductor; size.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Electric conductor; size. 75.513-1 Section 75.513-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY... Electric conductor; size. An electric conductor is not of sufficient size to have adequate carrying...

46 CFR 195.30-5 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

... apparatus must be of the pressure-demand, open-circuit type, approved by the Mine Safety and Health Administration (MSHA) and by the National Institute for Occupational Safety and Health (NIOSH), and have at a... ascertain that a sufficient number of the crew are familiar with the operation of the equipment. ...

46 CFR 96.30-5 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

... apparatus must be of the pressure-demand, open-circuit type, approved by the Mine Safety and Health Administration (MSHA) and by the National Institute for Occupational Safety and Health (NIOSH), and have at a... ascertain that a sufficient number of the crew are familiar with the operation of the equipment. [CGD 86-036...

76 FR 62044 - Alternative Testing Requirements for Small Batch Manufacturers

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... every manufacturer of a children's product that is subject to a children's product safety rule shall submit sufficient samples of the children's product, or samples that are identical in all material... compliance with such children's product safety rule. Further, section 14(i)(2) requires continued testing of...

A tiered approach to incorporate exposure and pharmacokinetics considerations in in vitro based safety assessment

EPA Science Inventory

Application of in vitro based safety assessment requires reconciling chemical concentrations sufficient to produce bioactivity in vitro with those that trigger a molecular initiating event at the relevant in vivo target site. To address such need, computational tools such as phy...

10 CFR 52.137 - Contents of applications; technical information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... limits on its operation, and presents a safety analysis of the structures, systems, and components and of... products. The description shall be sufficient to permit understanding of the system designs and their relationship to the safety evaluations. Items such as the reactor core, reactor coolant system, instrumentation...

Sharing good NEWS across the world: developing comparable scores across 12 countries for the Neighborhood Environment Walkability Scale (NEWS).

PubMed

Cerin, Ester; Conway, Terry L; Cain, Kelli L; Kerr, Jacqueline; De Bourdeaudhuij, Ilse; Owen, Neville; Reis, Rodrigo S; Sarmiento, Olga L; Hinckson, Erica A; Salvo, Deborah; Christiansen, Lars B; Macfarlane, Duncan J; Davey, Rachel; Mitáš, Josef; Aguinaga-Ontoso, Ines; Sallis, James F

2013-04-08

The IPEN (International Physical Activity and Environment Network) Adult project seeks to conduct pooled analyses of associations of perceived neighborhood environment, as measured by the Neighborhood Environment Walkability Scale (NEWS) and its abbreviated version (NEWS-A), with physical activity using data from 12 countries. As IPEN countries used adapted versions of the NEWS/NEWS-A, this paper aimed to develop scoring protocols that maximize cross-country comparability in responses. This information is also highly relevant to non-IPEN studies employing the NEWS/NEWS-A, which is one of the most popular measures of perceived environment globally. The following countries participated in the IPEN Adult study: Australia, Belgium, Brazil, Colombia, Czech Republic, Denmark, Hong Kong, Mexico, New Zealand, Spain, the United Kingdom, and the United States. Participants (N = 14,305) were recruited from neighborhoods varying in walkability and socio-economic status. Countries collected data on the perceived environment using a self- or interviewer-administered version of the NEWS/NEWS-A. Confirmatory Factor Analysis (CFA) was used to derive comparable country-specific measurement models of the NEWS/NEWS-A. The level of correspondence between standard and alternative versions of the NEWS/NEWS-A factor-analyzable subscales was determined by estimating the correlations and mean standardized difference (Cohen's d) between them using data from countries that had included items from both standard and alternative versions of the subscales. Final country-specific measurement models of the NEWS/NEWS-A provided acceptable levels of fit to the data and shared the same factorial structure with six latent factors and two single items. The correspondence between the standard and alternative versions of subscales of Land use mix - access, Infrastructure and safety for walking/cycling, and Aesthetics was high. The Brazilian version of the Traffic safety subscale was highly, while the Australian and Belgian versions were marginally, comparable to the standard version. Single-item versions of the Street connectivity subscale used in Australia and Belgium showed marginally acceptable correspondence to the standard version. We have proposed country-specific modifications to the original scoring protocol of the NEWS/NEWS-A that enhance inter-country comparability. These modifications have yielded sufficiently equivalent measurement models of the NEWS/NEWS-A. Some inter-country discrepancies remain. These need to be considered when interpreting findings from different countries.

Sharing good NEWS across the world: developing comparable scores across 12 countries for the neighborhood environment walkability scale (NEWS)

PubMed Central

2013-01-01

Background The IPEN (International Physical Activity and Environment Network) Adult project seeks to conduct pooled analyses of associations of perceived neighborhood environment, as measured by the Neighborhood Environment Walkability Scale (NEWS) and its abbreviated version (NEWS-A), with physical activity using data from 12 countries. As IPEN countries used adapted versions of the NEWS/NEWS-A, this paper aimed to develop scoring protocols that maximize cross-country comparability in responses. This information is also highly relevant to non-IPEN studies employing the NEWS/NEWS-A, which is one of the most popular measures of perceived environment globally. Methods The following countries participated in the IPEN Adult study: Australia, Belgium, Brazil, Colombia, Czech Republic, Denmark, Hong Kong, Mexico, New Zealand, Spain, the United Kingdom, and the United States. Participants (N = 14,305) were recruited from neighborhoods varying in walkability and socio-economic status. Countries collected data on the perceived environment using a self- or interviewer-administered version of the NEWS/NEWS-A. Confirmatory Factor Analysis (CFA) was used to derive comparable country-specific measurement models of the NEWS/NEWS-A. The level of correspondence between standard and alternative versions of the NEWS/NEWS-A factor-analyzable subscales was determined by estimating the correlations and mean standardized difference (Cohen’s d) between them using data from countries that had included items from both standard and alternative versions of the subscales. Results Final country-specific measurement models of the NEWS/NEWS-A provided acceptable levels of fit to the data and shared the same factorial structure with six latent factors and two single items. The correspondence between the standard and alternative versions of subscales of Land use mix – access, Infrastructure and safety for walking/cycling, and Aesthetics was high. The Brazilian version of the Traffic safety subscale was highly, while the Australian and Belgian versions were marginally, comparable to the standard version. Single-item versions of the Street connectivity subscale used in Australia and Belgium showed marginally acceptable correspondence to the standard version. Conclusions We have proposed country-specific modifications to the original scoring protocol of the NEWS/NEWS-A that enhance inter-country comparability. These modifications have yielded sufficiently equivalent measurement models of the NEWS/NEWS-A. Some inter-country discrepancies remain. These need to be considered when interpreting findings from different countries. PMID:23566032

Nuclear power plant cable materials :

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

Celina, Mathias C.; Gillen, Kenneth T; Lindgren, Eric Richard

2013-05-01

A selective literature review was conducted to assess whether currently available accelerated aging and original qualification data could be used to establish operational margins for the continued use of cable insulation and jacketing materials in nuclear power plant environments. The materials are subject to chemical and physical degradation under extended radiationthermal- oxidative conditions. Of particular interest were the circumstances under which existing aging data could be used to predict whether aged materials should pass loss of coolant accident (LOCA) performance requirements. Original LOCA qualification testing usually involved accelerated aging simulations of the 40-year expected ambient aging conditions followed by amore » LOCA simulation. The accelerated aging simulations were conducted under rapid accelerated aging conditions that did not account for many of the known limitations in accelerated polymer aging and therefore did not correctly simulate actual aging conditions. These highly accelerated aging conditions resulted in insulation materials with mostly inert aging processes as well as jacket materials where oxidative damage dropped quickly away from the air-exposed outside jacket surface. Therefore, for most LOCA performance predictions, testing appears to have relied upon heterogeneous aging behavior with oxidation often limited to the exterior of the cable cross-section a situation which is not comparable with the nearly homogenous oxidative aging that will occur over decades under low dose rate and low temperature plant conditions. The historical aging conditions are therefore insufficient to determine with reasonable confidence the remaining operational margins for these materials. This does not necessarily imply that the existing 40-year-old materials would fail if LOCA conditions occurred, but rather that unambiguous statements about the current aging state and anticipated LOCA performance cannot be provided based on original qualification testing data alone. The non-availability of conclusive predictions for the aging conditions of 40-year-old cables implies that the same levels of uncertainty will remain for any re-qualification or extended operation of these cables. The highly variable aging behavior of the range of materials employed also implies that simple, standardized aging tests are not sufficient to provide the required aging data and performance predictions for all materials. It is recommended that focused studies be conducted that would yield the material aging parameters needed to predict aging behaviors under low dose, low temperature plant equivalent conditions and that appropriately aged specimens be prepared that would mimic oxidatively-aged 40- to 60- year-old materials for confirmatory LOCA performance testing. This study concludes that it is not sufficient to expose materials to rapid, high radiation and high temperature levels with subsequent LOCA qualification testing in order to predictively quantify safety margins of existing infrastructure with regard to LOCA performance. We need to better understand how cable jacketing and insulation materials have degraded over decades of power plant operation and how this aging history relates to service life prediction and the performance of existing equipment to withstand a LOCA situation.« less

76 FR 40222 - Airworthiness Directives; Turbomeca S.A. ARRIEL 2B and 2B1 Turboshaft Engines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-08

... sufficient to reduce the stress margin of the blade to a level consistent with the rate of occurrences of... stress. Comments We gave the public the opportunity to participate in developing this AD. We received no... would take about 60 work-hours per product to comply with this AD. The average labor rate is $85 per...

Updated evidence-based clinical practice guidelines for the diagnosis and management of melanoma: definitive excision margins for primary cutaneous melanoma.

PubMed

Sladden, Michael J; Nieweg, Omgo E; Howle, Julie; Coventry, Brendon J; Thompson, John F

2018-02-19

Definitive management of primary cutaneous melanoma consists of surgical excision of the melanoma with the aim of curing the patient. The melanoma is widely excised together with a safety margin of surrounding skin and subcutaneous tissue, after the diagnosis and Breslow thickness have been established by histological assessment of the initial excision biopsy specimen. Sentinel lymph node biopsy should be discussed for melanomas ≥ 1 mm thickness (≥ 0.8 mm if other high risk features) in which case lymphoscintigraphy must be performed before wider excision of the primary melanoma site. The 2008 evidence-based clinical practice guidelines for the management of melanoma (http://www.cancer.org.au/content/pdf/HealthProfessionals/ClinicalGuidelines/ClinicalPracticeGuidelines-ManagementofMelanoma.pdf) are currently being revised and updated in a staged process by a multidisciplinary working party established by Cancer Council Australia. The guidelines for definitive excision margins for primary melanomas have been revised as part of this process. Main recommendations: The recommendations for definitive wide local excision of primary cutaneous melanoma are: melanoma in situ: 5-10 mm margins invasive melanoma (pT1) ≤ 1.0 mm thick: 1 cm margins invasive melanoma (pT2) 1.01-2.00 mm thick: 1-2 cm margins invasive melanoma (pT3) 2.01-4.00 mm thick: 1-2 cm margins invasive melanoma (pT4) > 4.0 mm thick: 2 cm margins Changes in management as a result of the guideline: Based on currently available evidence, excision margins for invasive melanoma have been left unchanged compared with the 2008 guidelines. However, melanoma in situ should be excised with 5-10 mm margins, with the aim of achieving complete histological clearance. Minimum clearances from all margins should be assessed and stated. Consideration should be given to further excision if necessary; positive or close histological margins are unacceptable.

ORNL Evaluation of Electrabel Safety Cases for Doel 3 / Tihange 2: Final Report

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

Bass, Bennett Richard; Dickson, Terry L.; Gorti, Sarma B.

Oak Ridge National Laboratory (ORNL) performed a detailed technical review of the 2015 Electrabel (EBL) Safety Cases prepared for the Belgium reactor pressure vessels (RPVs) at Doel 3 and Tihange 2 (D3/T2). The Federal Agency for Nuclear Control (FANC) in Belgium commissioned ORNL to provide a thorough assessment of the existing safety margins against cracking of the RPVs due to the presence of almost laminar flaws found in each RPV. Initial efforts focused on surveying relevant literature that provided necessary background knowledge on the issues related to the quasilaminar flaws observed in D3/T2 reactors. Next, ORNL proceeded to develop anmore » independent quantitative assessment of the entire flaw population in the two Belgian reactors according to the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code, Section XI, Appendix G, Fracture Toughness Criteria for Protection Against Failure, New York (1992 and 2004). That screening assessment of all EBL-characterized flaws in D3/T2 used ORNL tools, methodologies, and the ASME Code Case N-848, Alternative Characterization Rules for QuasiLaminar Flaws . Results and conclusions from the ORNL flaw acceptance assessments of D3/T2 were compared with those from the 2015 EBL Safety Cases. Specific findings of the ORNL evaluation of that part of the EBL structural integrity assessment focusing on stability of the flaw population subjected to primary design transients include the following: ORNL s analysis results were similar to those of EBL in that very few characterized flaws were found not compliant with the ASME (1992) acceptance criterion. ORNL s application of the more recent ASME Section XI (2004) produced only four noncompliant flaws, all due to LOCAs. The finding of a greater number of non-compliant flaws in the EBL screening assessment is due principally to a significantly more restrictive (conservative) criterion for flaw size acceptance used by EBL. ORNL s screening assessment results (obtained using an analysis methodology different from that of EBL) are interpreted herein as confirming the EBL screening results for D3/T2. ORNL s independent refined analysis demonstrated the EBL-characterized flaw 1660, which is non-compliant in the ORNL and EBL screening assessment, is rendered compliant when modeled as a more realistic individual quasi-laminar flaw using a 3-D XFEM analysis approach. ORNL s and EBL s refined analyses are in good agreement for the flaw 1660 close to the clad/base metal interface; ORNL is not persuaded that repeating this exercise for more than one non-compliant flaw is necessary to accept the EBL conclusions derived from the aggregate of EBL refined analysis results. ORNL General Conclusions Regarding the Structural Integrity Assessment (SIA) Conducted by EBL for D3/T2 Based on comparative evaluations of ORNL and EBL SIA analyses and on consideration of other results, ORNL is in agreement with the general conclusions reported by Electrabel in their RPV D3/T2 Technical Summary Note of April 14, 2015: More than 99 percent of flaws in D3/T2 meet the defined screening criterion, rendering them benign with respect to initiation in the event of a design transient. Refined analyses of non-compliant flaws from the screening assessment indicate that only 11 of the 16196 detected flaws have a critical reference-temperature material index (designated RTNDT) that implies the possibility of the initiation of cleavage fracture at some future time. For those 11 2 flaws, the calculated margin in RTNDT (a measure of acceptable embrittlement relative to end-ofservice-life conditions) is significant, being greater than 80 C. Fatigue crack growth is not a concern in the flaw-acceptability analyses. Primary stress re-evaluation confirms that the collapse pressure is more than 1.5 times the design pressure in the presence of defects detected in D3/T2. Sufficient conservatisms are built into the input data and into the different steps of the SIA; in some cases, those conservatisms are quantified and imply that additional margins exist in the SIA. Taken as a whole, the foregoing results and conclusions confirm the structural integrity of Doel 3 and Tihange 2 under all design transients with ample margin in the presence of the 16196 detected flaws.« less

Aviation safety and maintenance under major organizational changes, investigating non-existing accidents.

PubMed

Herrera, Ivonne A; Nordskag, Arve O; Myhre, Grete; Halvorsen, Kåre

2009-11-01

The objective of this paper is to discuss the following questions: Do concurrent organizational changes have a direct impact on aviation maintenance and safety, if so, how can this be measured? These questions were part of the investigation carried out by the Accident Investigation Board, Norway (AIBN). The AIBN investigated whether Norwegian aviation safety had been affected due to major organizational changes between 2000 and 2004. The main concern was the reduction in safety margins and its consequences. This paper presents a summary of the techniques used and explains how they were applied in three airlines and by two offshore helicopter operators. The paper also discusses the development of safety related indicators in the aviation industry. In addition, there is a summary of the lessons learned and safety recommendations. The Norwegian Ministry of Transport has required all players in the aviation industry to follow up the findings and recommendations of the AIBN study.

Evaluation of the setup margins for cone beam computed tomography–guided cranial radiosurgery: A phantom study

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

Calvo Ortega, Juan Francisco, E-mail: jfcdrr@yahoo.es; Wunderink, Wouter; Delgado, David

The aim of this study is to evaluate the setup margins from the clinical target volume (CTV) to planning target volume (PTV) for cranial stereotactic radiosurgery (SRS) treatments guided by cone beam computed tomography (CBCT). We designed an end-to-end (E2E) test using a skull phantom with an embedded 6mm tungsten ball (target). A noncoplanar plan was computed (E2E plan) to irradiate the target. The CBCT-guided positioning of the skull phantom on the linac was performed. Megavoltage portal images were acquired after 15 independent deliveries of the E2E plan. The displacement 2-dimensional (2D) vector between the centers of the square fieldmore » and the ball target on each portal image was used to quantify the isocenter accuracy. Geometrical margins on each patient's direction (left-right or LR, anterior-posterior or AP, superior-inferior or SI) were calculated. Dosimetric validation of the margins was performed in 5 real SRS cases: 3-dimesional (3D) isocenter deviations were mimicked, and changes in CTV dose coverage and organs-at-risk (OARs) dosage were analyzed. The CTV-PTV margins of 1.1 mm in LR direction, and 0.7 mm in AP and SI directions were derived from the E2E tests. The dosimetric analysis revealed that a 1-mm uniform margin was sufficient to ensure the CTV dose coverage, without compromising the OAR dose tolerances. The effect of isocenter uncertainty has been estimated to be 1 mm in our CBCT-guided SRS approach.« less

Towards intraoperative assessment of tumor margins in breast surgery using optical coherence elastography (Conference Presentation)

NASA Astrophysics Data System (ADS)

Kennedy, Brendan F.; Wijesinghe, Philip; Allen, Wes M.; Chin, Lixin; Latham, Bruce; Saunders, Christobel M.; Sampson, David D.

2016-03-01

Surgical excision of tumor is a critical factor in the management of breast cancer. The most common surgical procedure is breast-conserving surgery. The surgeon's goal is to remove the tumor and a rim of healthy tissue surrounding the tumor: the surgical margin. A major issue in breast-conserving surgery is the absence of a reliable tool to guide the surgeon in intraoperatively assessing the margin. A number of techniques have been proposed; however, the re-excision rate remains high and has been reported to be in the range 30-60%. New tools are needed to address this issue. Optical coherence elastography (OCE) shows promise as a tool for intraoperative tumor margin assessment in breast-conserving surgery. Further advances towards clinical translation are limited by long scan times and small fields of view. In particular, scanning over sufficient areas to assess the entire margin in an intraoperative timeframe has not been shown to be feasible. Here, we present a protocol allowing ~75% of the surgical margins to be assessed within 30 minutes. To achieve this, we have incorporated a 65 mm-diameter (internal), wide-aperture annular piezoelectric transducer, allowing the entire surface of the excised tumor mass to be automatically imaged in an OCT mosaic comprised of 10 × 10 mm tiles. As OCT is effective in identifying adipose tissue, our protocol uses the wide-field OCT to selectively guide subsequent local OCE scanning to regions of solid tissue which often present low contrast in OCT images. We present promising examples from freshly excised human breast tissue.

Dopamine reward prediction error responses reflect marginal utility.

PubMed

Stauffer, William R; Lak, Armin; Schultz, Wolfram

2014-11-03

Optimal choices require an accurate neuronal representation of economic value. In economics, utility functions are mathematical representations of subjective value that can be constructed from choices under risk. Utility usually exhibits a nonlinear relationship to physical reward value that corresponds to risk attitudes and reflects the increasing or decreasing marginal utility obtained with each additional unit of reward. Accordingly, neuronal reward responses coding utility should robustly reflect this nonlinearity. In two monkeys, we measured utility as a function of physical reward value from meaningful choices under risk (that adhered to first- and second-order stochastic dominance). The resulting nonlinear utility functions predicted the certainty equivalents for new gambles, indicating that the functions' shapes were meaningful. The monkeys were risk seeking (convex utility function) for low reward and risk avoiding (concave utility function) with higher amounts. Critically, the dopamine prediction error responses at the time of reward itself reflected the nonlinear utility functions measured at the time of choices. In particular, the reward response magnitude depended on the first derivative of the utility function and thus reflected the marginal utility. Furthermore, dopamine responses recorded outside of the task reflected the marginal utility of unpredicted reward. Accordingly, these responses were sufficient to train reinforcement learning models to predict the behaviorally defined expected utility of gambles. These data suggest a neuronal manifestation of marginal utility in dopamine neurons and indicate a common neuronal basis for fundamental explanatory constructs in animal learning theory (prediction error) and economic decision theory (marginal utility). Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Flood hazard assessment for french NPPs

NASA Astrophysics Data System (ADS)

Rebour, Vincent; Duluc, Claire-Marie; Guimier, Laurent

2015-04-01

This paper presents the approach for flood hazard assessment for NPP which is on-going in France in the framework of post-Fukushima activities. These activities were initially defined considering both European "stress tests" of NPPs pursuant to the request of the European Council, and the French safety audit of civilian nuclear facilities in the light of the Fukushima Daiichi accident. The main actors in that process are the utility (EDF is, up to date, the unique NPP's operator in France), the regulatory authority (ASN) and its technical support organization (IRSN). This paper was prepared by IRSN, considering official positions of the other main actors in the current review process, it was not officially endorsed by them. In France, flood hazard to be considered for design basis definition (for new NPPs and for existing NPPs in periodic safety reviews conducted every 10 years) was revised before Fukushima-Daichi accident, due to le Blayais NPP December 1999 experience (partial site flooding and loss of some safety classified systems). The paper presents in the first part an overview of the revised guidance for design basis flood. In order to address design extension conditions (conditions that could result from natural events exceeding the design basis events), a set of flooding scenarios have been defined by adding margins on the scenarios that are considered for the design. Due to the diversity of phenomena to be considered for flooding hazard, the margin assessment is specific to each flooding scenario in terms of parameter to be penalized and of degree of variation of this parameter. The general approach to address design extension conditions is presented in the second part of the paper. The next parts present the approach for five flooding scenarios including design basis scenario and additional margin to define design extension scenarios.

Treatment response assessment of radiofrequency ablation for hepatocellular carcinoma: usefulness of virtual CT sonography with magnetic navigation.

PubMed

Minami, Yasunori; Kitai, Satoshi; Kudo, Masatoshi

2012-03-01

Virtual CT sonography using magnetic navigation provides cross sectional images of CT volume data corresponding to the angle of the transducer in the magnetic field in real-time. The purpose of this study was to clarify the value of this virtual CT sonography for treatment response of radiofrequency ablation for hepatocellular carcinoma. Sixty-one patients with 88 HCCs measuring 0.5-1.3 cm (mean±SD, 1.0±0.3 cm) were treated by radiofrequency ablation. For early treatment response, dynamic CT was performed 1-5 days (median, 2 days). We compared early treatment response between axial CT images and multi-angle CT images using virtual CT sonography. Residual tumor stains on axial CT images and multi-angle CT images were detected in 11.4% (10/88) and 13.6% (12/88) after the first session of RFA, respectively (P=0.65). Two patients were diagnosed as showing hyperemia enhancement after the initial radiofrequency ablation on axial CT images and showed local tumor progression shortly because of unnoticed residual tumors. Only virtual CT sonography with magnetic navigation retrospectively showed the residual tumor as circular enhancement. In safety margin analysis, 10 patients were excluded because of residual tumors. The safety margin more than 5 mm by virtual CT sonographic images and transverse CT images were determined in 71.8% (56/78) and 82.1% (64/78), respectively (P=0.13). The safety margin should be overestimated on axial CT images in 8 nodules. Virtual CT sonography with magnetic navigation was useful in evaluating the treatment response of radiofrequency ablation therapy for hepatocellular carcinoma. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Improved safety margin for embryotoxicity in rats for the new endoperoxide artefenomel (OZ439) as compared to artesunate.

PubMed

Clark, Robert L; Edwards, Tammye L; Longo, Monica; Kinney, Joseph; Walker, Don K; Rhodes, Jon; Clode, Sally A; Rückle, Thomas; Wells, Timothy; Andenmatten, Nicole; Huber, Anna Christine

2018-04-17

Combination medicines including an artemisinin are the mainstay of antimalarial therapy. Artemisinins are potent embryotoxicants in animal species due to their trioxane moiety. As part of its development, the new synthetic trioxolane antimalarial artefenomel (OZ439) was tested in rat whole embryo culture and in rat embryo-fetal toxicity studies with dosing throughout organogenesis or with a single dose on Gestational Day (GD) 12. The single-dose studies included groups treated with artesunate to allow a direct comparison of the embryotoxicity of the two antimalarials and included toxicokinetics hematology and histological examination of embryos. In addition, the distribution of artefenomel-related material in plasma was determined after the administration of 14 C-artefenomel. Artefenomel and artesunate showed similar patterns of embryotoxicity including cardiovascular defects and resorption with a steep dose-response. They both also caused a depletion of circulating embryonic erythroblasts both in vitro and in vivo and decreases in maternal reticulocyte count. However, artefenomel was ∼250-fold less potent than the active metabolite of artesunate (dihydroartemisinin) as an embryotoxicant in vitro. The safety margin (based on AUC) for artefenomel administered on GD 12 was approximately 100-fold greater than that for artesunate. Also, unlike artesunate, artefenomel was not a selective developmental toxicant. The lesser embryotoxicity of artefenomel is likely linked to its original design which included two blocking side groups that had been introduced to lower the reactivity with ferrous iron. Our data support the hypothesis that artefenomel's improved safety margin is linked to a lower potential for inhibiting heme biosynthesis in embryonic erythroblasts. © 2017 The Authors. Birth Defects Research Published by Wiley Periodicals, Inc.

Chronic warm exposure impairs growth performance and reduces thermal safety margins in the common triplefin fish (Forsterygion lapillum).

PubMed

McArley, Tristan J; Hickey, Anthony J R; Herbert, Neill A

2017-10-01

Intertidal fish species face gradual chronic changes in temperature and greater extremes of acute thermal exposure through climate-induced warming. As sea temperatures rise, it has been proposed that whole-animal performance will be impaired through oxygen and capacity limited thermal tolerance [OCLTT; reduced aerobic metabolic scope (MS)] and, on acute exposure to high temperatures, thermal safety margins may be reduced because of constrained acclimation capacity of upper thermal limits. Using the New Zealand triplefin fish ( Forsterygion lapillum ), this study addressed how performance in terms of growth and metabolism (MS) and upper thermal tolerance limits would be affected by chronic exposure to elevated temperature. Growth was measured in fish acclimated (12 weeks) to present and predicted future temperatures and metabolic rates were then determined in fish at acclimation temperatures and with acute thermal ramping. In agreement with the OCLTT hypothesis, chronic exposure to elevated temperature significantly reduced growth performance and MS. However, despite the prospect of impaired growth performance under warmer future summertime conditions, an annual growth model revealed that elevated temperatures may only shift the timing of high growth potential and not the overall annual growth rate. While the upper thermal tolerance (i.e. critical thermal maxima) increased with exposure to warmer temperatures and was associated with depressed metabolic rates during acute thermal ramping, upper thermal tolerance did not differ between present and predicted future summertime temperatures. This suggests that warming may progressively decrease thermal safety margins for hardy generalist species and could limit the available habitat range of intertidal populations. © 2017. Published by The Company of Biologists Ltd.

SU-F-BRD-09: Is It Sufficient to Use Only Low Density Tissue-Margin to Compensate Inter-Fractionation Setup Uncertainties in Lung Treatment?

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

Nie, K; Yue, N; Chen, T

2014-06-15

Purpose: In lung radiation treatment, PTV is formed with a margin around GTV (or CTV/ITV). Although GTV is most likely of water equivalent density, the PTV margin may be formed with the surrounding low-density tissues, which may lead to unreal dosimetric plan. This study is to evaluate whether the concern of dose calculation inside the PTV with only low density margin could be justified in lung treatment. Methods: Three SBRT cases were analyzed. The PTV from the original plan (Plan-O) was created with a 5–10 mm margin outside the ITV to incorporate setup errors and all mobility from 10 respiratorymore » phases. Test plans were generated with the GTV shifted to the PTV edge to simulate the extreme situations with maximum setup uncertainties. Two representative positions as the very posterior-superior (Plan-PS) and anterior-inferior (Plan-AI) edge were considered. The virtual GTV was assigned a density of 1.0 g.cm−3 and surrounding lung, including the PTV margin, was defined as 0.25 g.cm−3. Also, additional plan with a 1mm tissue-margin instead of full lung-margin was created to evaluate whether a composite-margin (Plan-Comp) has a better approximation for dose calculation. All plans were generated on the average CT using Analytical Anisotropic Algorithm with heterogeneity correction on and all planning parameters/monitor unites remained unchanged. DVH analyses were performed for comparisons. Results: Despite the non-static dose distribution, the high-dose region synchronized with tumor positions. This might due to scatter conditions as greater doses were absorbed in the solid-tumor than in the surrounding low-density lungtissue. However, it still showed missing target coverage in general. Certain level of composite-margin might give better approximation for the dosecalculation. Conclusion: Our exploratory results suggest that with the lungmargin only, the planning dose of PTV might overestimate the coverage of the target during treatment. The significance of this overestimation might warrant further investigation.« less

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.

Environmental Assessment/Baseline Survey to Establish New Drop Zone (DZ) in Cadiz, Ohio

DTIC Science & Technology

2009-03-01

Force, along with other available information, to: • Develop sufficient information to assess the health and safety risks on the property surveyed and...Environmental Health Risks and Safety Risks . This EO directs federal agencies to identify and assess environmental health and safety risks that may...or prediction or forecast of, any environmental risk for any property. Only a Phase I Environmental Site Assessment performed by an environmental

76 FR 50748 - Information Collection Activity: Production Safety Systems, Revision of a Collection; Submitted...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... Production Safety Systems. OMB Control Number: 1010-0059. Abstract: The Outer Continental Shelf (OCS) Lands..., precautions, and techniques sufficient to prevent or minimize the likelihood of blowouts, loss of well control... an identifiable non-Federal recipient above and beyond those which accrue to the public at large...

Preparedness for practice: a systematic cross-specialty evaluation of the alignment between postgraduate medical education and independent practice.

PubMed

Dijkstra, Ids S; Pols, Jan; Remmelts, Pine; Brand, Paul L P

2015-02-01

Postgraduate medical education training programs strive to prepare their trainees optimally for independent practice. Several studies have shown, however, that new consultants feel inadequately prepared for practice, and that this increases the risk of stress and burnout. To analyze across specialties for which tasks and themes new consultants feel inadequately prepared. And, to identify themes that need improved attention in postgraduate medical education programs or after registration. 330 New consultants from all hospital specialities with accredited training programs who completed their training in the north-eastern educational region of The Netherlands between 2004 and 2010 received a questionnaire which was based on a previously validated generic task inventory. 143 respondents (43%) returned the questionnaire. They felt excellently prepared for 40 tasks, well prepared for 25 tasks, marginally sufficiently prepared for 18 tasks and insufficiently prepared for 8 tasks. Preparedness scores were lowest for tasks concerning management administration and leadership, research, end-of-life care, and patient safety-related communication. Surgical specialists felt better prepared for practice than medical specialists, which could not be explained by differences in general self-efficacy. Although new consultants felt well prepared for medical tasks, the scores of more generic tasks indicate that the alignment between the different phases of the medical education continuum and independent practice needs improvement.

Electroshock weapons can be lethal!

NASA Astrophysics Data System (ADS)

Lundquist, Marjorie

2008-03-01

Electroshock weapons (EWs)-stun guns, tasers, riot shields-are electroconductive devices designed to safely incapacitate healthy men neuromuscularly, so they are called nonlethal or less-lethal. EW firms seeking large nonmilitary markets targeted law enforcement and corrections personnel, who began using EWs in prisons/jails and on public patrol in 1980 in the USA. This shifted the EW-shocked population from healthy soldiers to a heterogeneous mix of both sexes, ages 6-92, in a wide variety of health conditions! An EW operates by disrupting normal physiological processes, producing transient effects in healthy people. But if a person's health is sufficiently compromised, the margin of safety can be lost, resulting in death or permanent health problems. 325 people have died after EW shock since 1980. Did the EW cause these deaths? Evidence indicates that EWs do play a causal role in most such deaths. EWs can be lethal for people in diabetic shock^1 (hypoglycemia), which may be why Robert Dziekanski-a Polish immigrant to Canada-died so quickly after he was tasered at Vancouver Airport: not having eaten for over 10 hours, he likely was severely hypoglycemic. The EW death rate in North America is 30 times higher than need be, because EW users have not been properly trained to use EWs on a heterogeneous population safely! ^1J. Clinical Engineering 30(3):111(2005).

Inhibition Of Washed Sludge With Sodium Nitrite

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

Congdon, J. W.; Lozier, J. S.

2012-09-25

This report describes the results of electrochemical tests used to determine the relationship between the concentration of the aggressive anions in washed sludge and the minimum effective inhibitor concentration. Sodium nitrate was added as the inhibitor because of its compatibility with the DWPF process. A minimum of 0.05M nitrite is required to inhibit the washed sludge simulant solution used in this study. When the worst case compositions and safety margins are considered, it is expected that a minimum operating limit of nearly 0.1M nitrite will be specified. The validity of this limit is dependent on the accuracy of the concentrationsmore » and solubility splits previously reported. Sodium nitrite additions to obtain 0.1M nitrite concentrations in washed sludge will necessitate the additional washing of washed precipitate in order to decrease its sodium nitrite inhibitor requirements sufficiently to remain below the sodium limits in the feed to the DWPF. Nitrite will be the controlling anion in "fresh" washed sludge unless the soluble chloride concentration is about ten times higher than predicted by the solubility splits. Inhibition of "aged" washed sludge will not be a problem unless significant chloride dissolution occurs during storage. It will be very important tomonitor the composition of washed sludge during processing and storage.« less

Risk-based flood protection planning under climate change and modeling uncertainty: a pre-alpine case study

NASA Astrophysics Data System (ADS)

Dittes, Beatrice; Kaiser, Maria; Špačková, Olga; Rieger, Wolfgang; Disse, Markus; Straub, Daniel

2018-05-01

Planning authorities are faced with a range of questions when planning flood protection measures: is the existing protection adequate for current and future demands or should it be extended? How will flood patterns change in the future? How should the uncertainty pertaining to this influence the planning decision, e.g., for delaying planning or including a safety margin? Is it sufficient to follow a protection criterion (e.g., to protect from the 100-year flood) or should the planning be conducted in a risk-based way? How important is it for flood protection planning to accurately estimate flood frequency (changes), costs and damage? These are questions that we address for a medium-sized pre-alpine catchment in southern Germany, using a sequential Bayesian decision making framework that quantitatively addresses the full spectrum of uncertainty. We evaluate different flood protection systems considered by local agencies in a test study catchment. Despite large uncertainties in damage, cost and climate, the recommendation is robust for the most conservative approach. This demonstrates the feasibility of making robust decisions under large uncertainty. Furthermore, by comparison to a previous study, it highlights the benefits of risk-based planning over the planning of flood protection to a prescribed return period.

Design and optimization of integrated gas/condensate plants

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

Root, C.R.; Wilson, J.L.

1995-11-01

An optimized design is demonstrated for combining gas processing and condensate stabilization plants into a single integrated process facility. This integrated design economically provides improved condensate recovery versus use of a simple stabilizer design. A selection matrix showing likely application of this integrated process is presented for use on future designs. Several methods for developing the fluid characterization and for using a process simulator to predict future design compositions are described, which could be useful in other designs. Optimization of flowsheet equipment choices and of design operating pressures and temperatures is demonstrated including the effect of both continuous and discretemore » process equipment size changes. Several similar designs using a turboexpander to provide refrigeration for liquids recovery and stabilizer reflux are described. Operating overthrust and from the P/15-D platform in the Dutch sector of the North Sea has proven these integrated designs are effective. Concerns do remain around operation near or above the critical pressure that should be addressed in future work including providing conservative separator designs, providing sufficient process design safety margin to meet dew point specifications, selecting the most conservative design values of predicted gas dew point and equipment size calculated with different Equations-of-State, and possibly improving the accuracy of PVT calculations in the near critical area.« less

The impact of surgery on survival of patients with cutaneous melanoma: revisiting the role of primary tumor excision margins.

PubMed

Mocellin, Simone; Pasquali, Sandro; Nitti, Donato

2011-02-01

To quantify the impact of excision margins on disease-specific survival of patients with primary cutaneous melanoma. Current guidelines recommend narrow margins for the treatment of primary melanoma, although available evidence on this subject is not unequivocal and not always appropriately analyzed. A systematic review of randomized controlled trials (RCT) addressing the issue of wide versus narrow excision margins was performed. Meta-analysis methods for time-to-event data were used to extract hazard ratios(HR) and their 95% confidence intervals (CI) from eligible studies, and ultimately to estimate the summary effect of excision margins on patients' survival. The 5 eligible RCT enrolled a total of 3295 patients who were allocated to wide (3-5 cm) or narrow (1-2 cm) excision of their primary tumor. The data of locoregional disease-free (LDFS), disease-free (DFS),disease-specific (DSS), and overall (OS) survival were available for 3, 5, 3, and 5 RCT, respectively. The meta-analysis suggested that narrow margins might be associated with an increased risk of both locoregional disease recurrence (HR: 1.30, CI: 1.07-1.57; P = 0.01) and death by disease (HR: 1.28, CI:1.07-1.53, P = 0.01). As regards DFS, the borderline disadvantage (HR:1.13, CI: 0.995-1.28; P = 0.06) becomes significant when considering RCT that enrolled patients with thicker melanoma (HR: 1.19, CI: 1.02-1.39, P =0.03). When death by any cause (OS) was analyzed, no risk difference was found. The lack of DSS data from all the available RCT does not allow to draw definitive conclusions. However, current evidence appears sufficient to question the common belief that narrow excision margins are as safe as wide margins in the management of primary melanoma, that calls for further investigation in this field.

Methodology Development for Passive Component Reliability Modeling in a Multi-Physics Simulation Environment

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

Aldemir, Tunc; Denning, Richard; Catalyurek, Umit

Reduction in safety margin can be expected as passive structures and components undergo degradation with time. Limitations in the traditional probabilistic risk assessment (PRA) methodology constrain its value as an effective tool to address the impact of aging effects on risk and for quantifying the impact of aging management strategies in maintaining safety margins. A methodology has been developed to address multiple aging mechanisms involving large numbers of components (with possibly statistically dependent failures) within the PRA framework in a computationally feasible manner when the sequencing of events is conditioned on the physical conditions predicted in a simulation environment, suchmore » as the New Generation System Code (NGSC) concept. Both epistemic and aleatory uncertainties can be accounted for within the same phenomenological framework and maintenance can be accounted for in a coherent fashion. The framework accommodates the prospective impacts of various intervention strategies such as testing, maintenance, and refurbishment. The methodology is illustrated with several examples.« less

Scaled centrifugal compressor, collector and running gear program

NASA Technical Reports Server (NTRS)

Kenehan, J. G.

1983-01-01

The Scaled Centrifugal Compressor, Collector and Running gear Program was conducted in support of an overall NASA strategy to improve small-compressor performance, durability, and reliability while reducing initial and life-cycle costs. Accordingly, Garrett designed and provided a test rig, gearbox coupling, and facility collector for a new NASA facility, and provided a scaled model of an existing, high-performance impeller for evaluation scaling effects on aerodynamic performance and for obtaining other performance data. Test-rig shafting was designed to operate smoothly throughout a speed range up to 60,000 rpm. Pressurized components were designed to operate at pressures up to 300 psia and at temperatures to 1000 F. Nonrotating components were designed to provide a margin-of-safety of 0.05 or greater; rotating components, for a margin-of-safety based on allowable yield and ultimate strengths. Design activities were supported by complete design analysis, and the finished hardware was subjected to check-runs to confirm proper operation. The test rig will support a wide range of compressor tests and evaluations.

Nozzle extension design status report

NASA Technical Reports Server (NTRS)

Classen, L. B.

1972-01-01

Twenty possible concepts of a possible nozzle/nozzle extension interface were originated. Not all of the concepts were considered worthy of analysis time. Six of them were thermally analyzed and three were stress analyzed. These analyses were done to determine which of the concepts would have the best chance of succeeding, that is, they were a screening process which was to allow rating of one concept against another. This was done because adequate material properties to determine absolute stress levels were not available at the time of the analyses. Through all of the concepts still exhibit some areas of negative margin of safety, concept no. 1 shows good promise that, with slight modifications, it could have all positive margins of safety. Another significant question, regarding these designs, has to do with the Grafoil seals and insulators. Some additional data was just recently received on Grafoil properties, but it was too late to incorporate in the analyses. The new data were not significantly different from the properties which were used.

18 CFR Appendix A to Part 380 - Minimum Filing Requirements for Environmental Reports Under the Natural Gas Act

Code of Federal Regulations, 2010 CFR

2010-04-01

... provide sufficient comparative data to justify the selection of the proposed route. (§ 380.12(l)(2)(ii)) 5... sufficient comparative data to justify the selection of the proposed site. (§ 380.12(l)(2)(ii)) Resource Report 11—Reliability and Safety Describe how the project facilities would be designed, constructed...

18 CFR Appendix A to Part 380 - Minimum Filing Requirements for Environmental Reports Under the Natural Gas Act

Code of Federal Regulations, 2012 CFR

2012-04-01

... provide sufficient comparative data to justify the selection of the proposed route. (§ 380.12(l)(2)(ii)) 5... sufficient comparative data to justify the selection of the proposed site. (§ 380.12(l)(2)(ii)) Resource Report 11—Reliability and Safety Describe how the project facilities would be designed, constructed...

18 CFR Appendix A to Part 380 - Minimum Filing Requirements for Environmental Reports Under the Natural Gas Act

Code of Federal Regulations, 2014 CFR

2014-04-01

... provide sufficient comparative data to justify the selection of the proposed route. (§ 380.12(l)(2)(ii)) 5... sufficient comparative data to justify the selection of the proposed site. (§ 380.12(l)(2)(ii)) Resource Report 11—Reliability and Safety Describe how the project facilities would be designed, constructed...

18 CFR Appendix A to Part 380 - Minimum Filing Requirements for Environmental Reports Under the Natural Gas Act

Code of Federal Regulations, 2013 CFR

2013-04-01

... provide sufficient comparative data to justify the selection of the proposed route. (§ 380.12(l)(2)(ii)) 5... sufficient comparative data to justify the selection of the proposed site. (§ 380.12(l)(2)(ii)) Resource Report 11—Reliability and Safety Describe how the project facilities would be designed, constructed...

18 CFR Appendix A to Part 380 - Minimum Filing Requirements for Environmental Reports Under the Natural Gas Act

Code of Federal Regulations, 2011 CFR

2011-04-01

... provide sufficient comparative data to justify the selection of the proposed route. (§ 380.12(l)(2)(ii)) 5... sufficient comparative data to justify the selection of the proposed site. (§ 380.12(l)(2)(ii)) Resource Report 11—Reliability and Safety Describe how the project facilities would be designed, constructed...

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. 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/.

Marginal kidney donor

PubMed Central

Gopalakrishnan, Ganesh; Gourabathini, Siva Prasad

2007-01-01

Renal transplantation is the treatment of choice for a medically eligible patient with end stage renal disease. The number of renal transplants has increased rapidly over the last two decades. However, the demand for organs has increased even more. This disparity between the availability of organs and waitlisted patients for transplants has forced many transplant centers across the world to use marginal kidneys and donors. We performed a Medline search to establish the current status of marginal kidney donors in the world. Transplant programs using marginal deceased renal grafts is well established. The focus is now on efforts to improve their results. Utilization of non-heart-beating donors is still in a plateau phase and comprises a minor percentage of deceased donations. The main concern is primary non-function of the renal graft apart from legal and ethical issues. Transplants with living donors outnumbered cadaveric transplants at many centers in the last decade. There has been an increased use of marginal living kidney donors with some acceptable medical risks. Our primary concern is the safety of the living donor. There is not enough scientific data available to quantify the risks involved for such donation. The definition of marginal living donor is still not clear and there are no uniform recommendations. The decision must be tailored to each donor who in turn should be actively involved at all levels of the decision-making process. In the current circumstances, our responsibility is very crucial in making decisions for either accepting or rejecting a marginal living donor. PMID:19718332

75 FR 78676 - De Facto Criteria for Establishing a Separate Rate in Antidumping Proceedings Involving Non...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-16

...In antidumping proceedings involving non-market economy (``NME'') countries,\\1\\ the Department of Commerce (``the Department'') has a rebuttable presumption that the export activities of all companies within the country are subject to government control and, thus, should be assessed a single antidumping duty rate (i.e., the NME- Entity rate). It is the Department's policy to assign to all exporters of merchandise subject to investigation in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a ``separate rate'' (i.e., a dumping margin separate from the margin assigned to the NME-Entity). Exporters can demonstrate this independence through the absence of both de jure and de facto governmental control over their export activities. ---------------------------------------------------------------------------

Minireview on the toxicity of dietary acrylamide.

PubMed

Parzefall, Wolfram

2008-04-01

Acrylamide is a commodity chemical with many industrial and laboratory uses. It is also formed from carbohydrate and amino acid containing food by heating (primarily in fried potato products, bread, coffee). Neurotoxicity was detected as the primary toxic effect after occupational exposure. In rats and mice AA is toxic for reproduction and development and to male germ cells, is genotoxic through a reactive metabolite, glycidamide, and carcinogenic to several organs. Epidemiological studies did not point to an association between either occupational or dietary exposure and an excess of cancer incidence. Health risks of the general population are based on an average exposure to 1 microg/kg bw/day increasing for high consumers to 4 microg/kg bw/day. For average consumers a margin of exposure of 200 for neurotoxicity can be regarded as sufficiently protective. However, a margin of 300 for carcinogenic risks appears not sufficient when applying a precautionary principle. This is also illustrated when the benchmark dose lower confidence limit for cancer is divided by an uncertainty factor of 300, which arrives at a tolerable daily intake of 1 microg/kg bw/day, and thus is in the range of average consumption. Further measures to minimize acrylamide formation in food should therefore be explored to reduce human exposure.

Fewer specialists support using medical marijuana and CBD in treating epilepsy patients compared with other medical professionals and patients: result of Epilepsia's survey.

PubMed

Mathern, Gary W; Beninsig, Laurie; Nehlig, Astrid

2015-01-01

From May 20 to September 1 2014, Epilepsia conducted an online survey seeking opinions about the use of medical marijuana and cannabidiol (CBD) for people with epilepsy. This study reports the findings of that poll. The survey consisted of eight questions. Four questions asked if there were sufficient safety and efficacy data, whether responders would advise trying medical marijuana in cases of severe refractory epilepsy, and if pharmacologic grade compounds containing CBD should be available. Four questions addressed occupation, geographic region of residence, if responders had read the paper, and if they were International League Against Epilepsy/International Bureau for Epilepsy (ILAE/IBE) members. Of 776 who started or completed the survey, 58% were patients from North America, and 22% were epileptologists and general neurologists from Europe and North America. A minority of epileptologists and general neurologists said that there were sufficient safety (34%) and efficacy (28%) data, and 48% would advise using medical marijuana in severe cases of epilepsy. By comparison, nearly all patients and the public said there were sufficient safety (96%) and efficacy (95%) data, and 98% would recommend medical marijuana in cases of severe epilepsy. General physicians, basic researchers, nurses, and allied health professions sided more with patients, saying that there were sufficient safety (70%) and efficacy (71%) data, and 83% would advise using marijuana in severe cases. A majority (78%) said there should be pharmacologic grade compounds containing CBD, and there were no differences between specialists, general medical personal, and patients and the public. This survey indicates that there is a wide disparity in opinion on the use of medical marijuana and CBD in the treatment of people with epilepsy, which varied substantially, with fewer medical specialists supporting its use compared with general medical personal, and patients and the public. Wiley Periodicals, Inc. © 2014 International League Against Epilepsy.

The impact of generic substitution on the turnover and gross margin of pharmaceutical companies a survey 1 year and 5 years after the introduction of generic substitution in Finland.

PubMed

Timonen, Johanna; Karttunen, Pekka; Bengtström, Marina; Ahonen, Riitta

2009-10-01

To explore and compare the impact of generic substitution (GS) on the turnover and gross margin per cent of pharmaceutical companies representing mainly original or generic products in Finland. A mail survey to pharmaceutical companies with an office in Finland and substitutable medicines in the Finnish pharmaceutical market 1 year (2004) and nearly 5 years (2008) after GS. The questionnaire were answered by 16 original and 7 generic product companies in 2004 (response rate 56%, n=41) and by 16 original and 6 generic product companies in 2008 (response rate 56%, n=39). Turnover had decreased in the original product companies and increased in the generic product companies. The gross margin per cent had decreased in the original and generic product companies, and the companies had also compensated for it in many ways. The study suggests that GS has promoted the sales of generic product companies in Finland. However, price competition caused by GS has generally decreased the proportion of profit from turnover in the original and generic product companies. The companies have also compensated for their decreased gross margin, which suggests that the profit in euros has not been sufficient to cover fixed costs in the companies.

The High Stability Engine Control (HISTEC) Program: Flight Demonstration Phase

NASA Technical Reports Server (NTRS)

DeLaat, John C.; Southwick, Robert D.; Gallops, George W.; Orme, John S.

1998-01-01

Future aircraft turbine engines, both commercial and military, must be able to accommodate expected increased levels of steady-state and dynamic engine-face distortion. The current approach of incorporating sufficient design stall margin to tolerate these increased levels of distortion would significantly reduce performance. The objective of the High Stability Engine Control (HISTEC) program is to design, develop, and flight-demonstrate an advanced, integrated engine control system that uses measurement-based estimates of distortion to enhance engine stability. The resulting distortion tolerant control reduces the required design stall margin, with a corresponding increase in performance and decrease in fuel burn. The HISTEC concept has been developed and was successfully flight demonstrated on the F-15 ACTIVE aircraft during the summer of 1997. The flight demonstration was planned and carried out in two phases, the first to show distortion estimation, and the second to show distortion accommodation. Post-flight analysis shows that the HISTEC technologies are able to successfully estimate and accommodate distortion, transiently setting the stall margin requirement on-line and in real-time. This allows the design stall margin requirement to be reduced, which in turn can be traded for significantly increased performance and/or decreased weight. Flight demonstration of the HISTEC technologies has significantly reduced the risk of transitioning the technology to tactical and commercial engines.

An evaluation of two conducted electrical weapons and two probe designs using a swine comparative cardiac safety model.

PubMed

Dawes, Donald Murray; Ho, Jeffrey D; Moore, Johanna C; Miner, James R

2013-09-01

Despite human laboratory and field studies that have demonstrated a reasonable safety profile for TASER brand conducted electrical weapons (CEW), the results of some swine studies and arrest related deaths temporal to the use of the CEWs continue to raise questions regarding cardiac safety. TASER International, Inc., has released a new CEW, the TASER X2, touted to have a better safety profile than its long-standing predecessor, the TASER X26. We have developed a model to assess the relative cardiac safety of CEWs and used it to compare the TASER X2 and the TASER X26. This safety model was also used to assess the relative safety of an experimental probe design as compared to the standard steel probe. Our results suggest that the TASER X2 has an improved safety margin over the TASER X26. The new probe design also has promise for enhanced cardiac safety, although may have some disadvantages when compared to the existing design which would make field use impractical.

The flammability of lip, face and hair preparations in the presence of 100% oxygen.

DOT National Transportation Integrated Search

1963-11-01

The effects of high concentrations and pressures of oxygen and static sparks upon lip, face and hair preparations were determined because of questions that frequently arise and apprehension that exists. A wide margin of safety was found for their use...

National Defense on the High Frontier.

ERIC Educational Resources Information Center

Graham, Daniel O.

1983-01-01

A new American defense policy based on satellites which can track down and destroy Soviet missiles is less expensive and more workable than is commonly believed. Such a policy would provide a greater margin of safety than the present policy of deterence based on mutually assured destruction. (IS)

Isocyanate and total inhalable particulate air measurements in the European wood panel industry.

PubMed

Vangronsveld, E; Berckmans, S; Verbinnen, K; Van Leeuw, C; Bormans, C

2010-11-01

It is well known that the use of MDI (methylene diphenyldiisocyanate) as an alternative for formaldehyde-based resins is seen as a responsible option to reduce formaldehyde emissions for CWP (Composite Wood Products) in buildings. However, there are concerns raised regarding the exposure risk of workers. The purpose of this article is to provide the reader with factual information to demonstrate that the use of MDI compared to other agents used in CWP production processes does not pose increased inhalation exposure risks for workers. Personal and area air measurements were carried out at nine Composite Wood Panel plants throughout Europe to assess potential inhalation exposures to MDI and wood dust as Total Inhalable Particulates (TIP). In total, 446 pairs of samples were collected for MDI and TIP of which 283 pairs were personal samples and the remaining 163 pairs were area samples collected at key locations along the production line. This data together with published formaldehyde exposure data has been used to evaluate the exposure safety margin opposite what are considered relevant occupational exposure limits. The methods used for sampling and analysing MDI and TIP are based on internationally accepted methods, i.e. MDHS 25/3 (or ISO 16702) for MDI, and MDHS 14/3 for TIP. The job functions with an increased exposure profile for TIP were the cleaners, drying operators and quality control staff, and for MDI, the cleaners and quality control staff. The areas with an increased exposure profile for TIP are the conveyor area from OSB blender to former area and the OSB press infeed, and for MDI the OSB weigh belt and OSB former bin area. The exposure safety margin opposite the selected exposure limits can be ranked as MDI>TIP>formaldehyde (high margin of safety to low margin of safety), indicating that the use of MDI also reduces the exposure risks to workers during production of CWP compared to formaldehyde. By reducing the airborne TIP concentrations, a respiratory sensitiser, MDI workplace concentrations in general can be reduced further. This can be achieved by improving design and/or maintenance and testing programmes of existing control measures, which should be in place already to effectively control exposure to TIP and formaldehyde. The airborne concentration of MDI at workstations situated after pressing (curing) is regarded as extremely low and likely mainly constituted by workplace emissions from elsewhere in the plant. Copyright © 2010 Elsevier GmbH. All rights reserved.

BRIEF REPORT: Screening Items to Identify Patients with Limited Health Literacy Skills

PubMed Central

Wallace, Lorraine S; Rogers, Edwin S; Roskos, Steven E; Holiday, David B; Weiss, Barry D

2006-01-01

BACKGROUND Patients with limited literacy skills are routinely encountered in clinical practice, but they are not always identified by clinicians. OBJECTIVE To evaluate 3 candidate questions to determine their accuracy in identifying patients with limited or marginal health literacy skills. METHODS We studied 305 English-speaking adults attending a university-based primary care clinic. Demographic items, health literacy screening questions, and the Rapid Estimate of Adult Literacy in Medicine (REALM) were administered to patients. To determine the accuracy of the candidate questions for identifying limited or marginal health literacy skills, we plotted area under the receiver operating characteristic (AUROC) curves for each item, using REALM scores as a reference standard. RESULTS The mean age of subjects was 49.5; 67.5% were female, 85.2% Caucasian, and 81.3% insured by TennCare and/or Medicare. Fifty-four (17.7%) had limited and 52 (17.0%) had marginal health literacy skills. One screening question, “How confident are you filling out medical forms by yourself?” was accurate in detecting limited (AUROC of 0.82; 95% confidence interval [CI]=0.77 to 0.86) and limited/marginal (AUROC of 0.79; 95% CI=0.74 to 0.83) health literacy skills. This question had significantly greater AUROC than either of the other questions (P<.01) and also a greater AUROC than questions based on demographic characteristics. CONCLUSIONS One screening question may be sufficient for detecting limited and marginal health literacy skills in clinic populations. PMID:16881950

Can basal cell carcinoma lateral border be determined by fluorescence diagnosis?: Verification by Mohs micrographic surgery.

PubMed

El Hoshy, Khaled; Bosseila, Manal; El Sharkawy, Dina; Sobhi, Rehab

2016-06-01

The preferential accumulation of 5-aminolaevulinic acid (ALA)-induced protoporphyrin IX (PpIX) in neoplastic cells supports its potential use in the photodetection of epithelial tumours through porphyrin fluorescence. To assess the validity of fluorescence diagnosis (FD) as an efficient pre-surgical in vivo imaging tool for defining the lateral boundaries of various types of basal cell carcinomas (BCCs). The BCC tumour area was determined for 27 patients using FD digitalized imaging system, where the accumulation of PpIX in tumour tissue in relation to normal tissue was measured. Subsequently, BCCs were excised according to the complete area defined by FD using Mohs micrographic surgery (MMS). Of the 27 BCCs, the FD margin of the lesion coincided with the histopathological picture in 12 BCCs (44.44%). The mean value of accumulation factor (AF) was 2.7. Although 17 pigmented BCCs showed attenuated or absent fluorescence in the center, fluorescence at their periphery was used as a guide for excision, and statistically, the pigmentation of the BCCs showed no effect on the results of the FD efficacy (p=1.0). Fluorescence diagnosis of BCC may be beneficial as a guide to the safety margin needed before MMS. The safety margin is decided according to the FD tumour diameter in relation to the clinical tumour diameter. Copyright © 2016 Elsevier B.V. All rights reserved.

Safety and efficacy of LigaSure usage in pancreaticoduodenectomy.

PubMed

Eng, Oliver S; Goswami, Julie; Moore, Dirk; Chen, Chunxia; Brumbaugh, Jennifer; Gannon, Christopher J; August, David A; Carpizo, Darren R

2013-10-01

Over recent years, use of the LigaSure™ vessel sealing device has increased in major abdominal surgery to include pancreaticoduodenectomy (PD). LigaSure™ use during PD has expanded to include all steps of the procedure, including the division of the uncinate margin. This introduces the potential for thermal major vascular injury or margin positivity. The aim of the present study was to evaluate the safety and efficacy of LigaSure™ usage in PD in comparison to established dissection techniques. One hundred and forty-eight patients who underwent PD from 2007 to 2012 at Robert Wood Johnson University Hospital were identified from a retrospective database. Two groups were recognized: those in which the LigaSure™ device was used (N = 114), and in those it was not (N = 34). Peri-operative outcomes were compared. Vascular intra-operative complications directly caused by thermal injury from LigaSure™ use occurred in 1.8% of patients. Overall vascular intra-operative complications, uncinate margin positivity, blood loss, length of stay, and complication severity were not significantly different between groups. The mean operative time was 77 min less (P < 0.010) in the LigaSure™ group. Savings per case where the LigaSure™ was used amounted to $1776.73. LigaSure™ usage during PD is safe and effective. It is associated with decreased operative times, which may decrease operative costs in PD. © 2013 International Hepato-Pancreato-Biliary Association.

Safety and efficacy of LigaSure usage in pancreaticoduodenectomy

PubMed Central

Eng, Oliver S; Goswami, Julie; Moore, Dirk; Chen, Chunxia; Brumbaugh, Jennifer; Gannon, Christopher J; August, David A; Carpizo, Darren R

2013-01-01

Background Over recent years, use of the LigaSure™ vessel sealing device has increased in major abdominal surgery to include pancreaticoduodenectomy (PD). LigaSure™ use during PD has expanded to include all steps of the procedure, including the division of the uncinate margin. This introduces the potential for thermal major vascular injury or margin positivity. The aim of the present study was to evaluate the safety and efficacy of LigaSure™ usage in PD in comparison to established dissection techniques. Methods One hundred and forty-eight patients who underwent PD from 2007 to 2012 at Robert Wood Johnson University Hospital were identified from a retrospective database. Two groups were recognized: those in which the LigaSure™ device was used (N = 114), and in those it was not (N = 34). Peri-operative outcomes were compared. Results Vascular intra-operative complications directly caused by thermal injury from LigaSure™ use occurred in 1.8% of patients. Overall vascular intra-operative complications, uncinate margin positivity, blood loss, length of stay, and complication severity were not significantly different between groups. The mean operative time was 77 min less (P < 0.010) in the LigaSure™ group. Savings per case where the LigaSure™ was used amounted to $1776.73. Conclusion LigaSure™ usage during PD is safe and effective. It is associated with decreased operative times, which may decrease operative costs in PD. PMID:23782268

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.

29 CFR 1926.907 - Use of safety fuse.

Code of Federal Regulations, 2014 CFR

2014-07-01

... separated sufficiently to prevent one charge from dislodging other shots in the blast. (m) When blasting... ignition. (g) No one shall be permitted to carry detonators or primers of any kind on his person. (h) The... lighting devices are used. However, when two or more safety fuses in a group are lighted as one by means of...

29 CFR 1926.907 - Use of safety fuse.

Code of Federal Regulations, 2013 CFR

2013-07-01

... separated sufficiently to prevent one charge from dislodging other shots in the blast. (m) When blasting... ignition. (g) No one shall be permitted to carry detonators or primers of any kind on his person. (h) The... lighting devices are used. However, when two or more safety fuses in a group are lighted as one by means of...

29 CFR 1926.907 - Use of safety fuse.

Code of Federal Regulations, 2011 CFR

2011-07-01

... separated sufficiently to prevent one charge from dislodging other shots in the blast. (m) When blasting... ignition. (g) No one shall be permitted to carry detonators or primers of any kind on his person. (h) The... lighting devices are used. However, when two or more safety fuses in a group are lighted as one by means of...

29 CFR 1926.907 - Use of safety fuse.

Code of Federal Regulations, 2012 CFR

2012-07-01

... separated sufficiently to prevent one charge from dislodging other shots in the blast. (m) When blasting... ignition. (g) No one shall be permitted to carry detonators or primers of any kind on his person. (h) The... lighting devices are used. However, when two or more safety fuses in a group are lighted as one by means of...

29 CFR 1926.907 - Use of safety fuse.

Code of Federal Regulations, 2010 CFR

2010-07-01

... separated sufficiently to prevent one charge from dislodging other shots in the blast. (m) When blasting... ignition. (g) No one shall be permitted to carry detonators or primers of any kind on his person. (h) The... lighting devices are used. However, when two or more safety fuses in a group are lighted as one by means of...

ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

PubMed

de Dianous, Valérie; Fiévez, Cécile

2006-03-31

Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

RAVEN Theory Manual

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

Alfonsi, Andrea; Rabiti, Cristian; Mandelli, Diego

2016-06-01

RAVEN is a software framework able to perform parametric and stochastic analysis based on the response of complex system codes. The initial development was aimed at providing dynamic risk analysis capabilities to the thermohydraulic code RELAP-7, currently under development at Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose stochastic and uncertainty quantification platform, capable of communicating with any system code. In fact, the provided Application Programming Interfaces (APIs) allow RAVEN to interact with any code as long as all the parameters that need to be perturbed are accessible by input filesmore » or via python interfaces. RAVEN is capable of investigating system response and explore input space using various sampling schemes such as Monte Carlo, grid, or Latin hypercube. However, RAVEN strength lies in its system feature discovery capabilities such as: constructing limit surfaces, separating regions of the input space leading to system failure, and using dynamic supervised learning techniques. The development of RAVEN started in 2012 when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework arose. RAVEN’s principal assignment is to provide the necessary software and algorithms in order to employ the concepts developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just to identify the frequency of an event potentially leading to a system failure, but the proximity (or lack thereof) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. peak pressure in a pipe) is exceeded under certain conditions. Most of the capabilities, implemented having RELAP-7 as a principal focus, are easily deployable to other system codes. For this reason, several side activates have been employed (e.g. RELAP5-3D, any MOOSE-based App, etc.) or are currently ongoing for coupling RAVEN with several different software. The aim of this document is to provide a set of commented examples that can help the user to become familiar with the RAVEN code usage.« less

Guidance for the safety assessment of botanicals and botanical preparations for use in food and food supplements.

PubMed

Schilter, B; Andersson, C; Anton, R; Constable, A; Kleiner, J; O'Brien, J; Renwick, A G; Korver, O; Smit, F; Walker, R

2003-12-01

There is a growing interest by both consumers and industry for the development of food products with 'functional' properties, or health benefits. These products may take the form of dietary supplements or of foods. The health benefits are given by particular ingredients, and in many cases these are derived from botanicals. The variety of plants providing these functions is large, ranging from staple food sources such as cereals, fruits and vegetables, to herbals as used in traditional medicine. The food or ingredient conferring health properties may consist of the plants themselves, extracts thereof, or more purified components. The scientific literature is abundant with articles not only on the beneficial properties, but also on possible adverse health effects of plants and their components. The present report discusses the data required to determine the safe use of these types of ingredients, and provides advice on the development of risk assessment strategies consistent with due diligence under existing food regulations. Product specifications, composition and characterisation of standardised and authentic materials, documented history of use and comparison to existing products (taking into account the effect of industrial processing), description of the intended use and consequent exposure are highlighted as key background information on which to base a risk evaluation. The extent of experimental investigation required, such as in vitro, animal, and/or human studies, depends on the adequacy of this information. A decision tree is presented as an aid to determine the extent of data requirements based on product comparison. The ultimate safety in use depends on the establishment of an adequate safety margin between expected exposure and identified potential hazards. Health hazards may arise from inherent toxicities or contaminants of the plant materials, including the mechanism of the intended beneficial effect. A lower safety margin may therefore be expected than for food ingredients or additives where no physiological effects are intended. In rare cases, post launch monitoring programmes may be envisaged to confirm expected exposures and adequacy of the safety margin. This guidance document was elaborated by an expert group of the Natural Toxin Task Force of the European Branch of the International Life Sciences Institute--ILSI Europe and discussed with a wider audience of scientists at a workshop held on 13-15 May 2002 in Marseille, France.

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

PubMed

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.

Intra-fraction motion of larynx radiotherapy

NASA Astrophysics Data System (ADS)

Durmus, Ismail Faruk; Tas, Bora

2018-02-01

In early stage laryngeal radiotherapy, movement is an important factor. Thyroid cartilage can move from swallowing, breathing, sound and reflexes. The effects of this motion on the target volume (PTV) during treatment were examined. In our study, the target volume movement during the treatment for this purpose was examined. Thus, setup margins are re-evaluated and patient-based PTV margins are determined. Intrafraction CBCT was scanned in 246 fractions for 14 patients. During the treatment, the amount of deviation which could be lateral, vertical and longitudinal axis was determined. ≤ ± 0.1cm deviation; 237 fractions in the lateral direction, 202 fractions in the longitudinal direction, 185 fractions in the vertical direction. The maximum deviation values were found in the longitudinal direction. Intrafraction guide in laryngeal radiotherapy; we are sure of the correctness of the treatment, the target volume is to adjust the margin and dose more precisely, we control the maximum deviation of the target volume for each fraction. Although the image quality of intrafraction-CBCT scans was lower than the image quality of planning CT, they showed sufficient contrast for this work.

High Stability Engine Control (HISTEC): Flight Demonstration Results

NASA Technical Reports Server (NTRS)

Delaat, John C.; Southwick, Robert D.; Gallops, George W.; Orme, John S.

1998-01-01

Future aircraft turbine engines, both commercial and military, must be able to accommodate expected increased levels of steady-state and dynamic engine-face distortion. The current approach of incorporating sufficient design stall margin to tolerate these increased levels of distortion would significantly reduce performance. The High Stability Engine Control (HISTEC) program has developed technologies for an advanced, integrated engine control system that uses measurement- based estimates of distortion to enhance engine stability. The resulting distortion tolerant control reduces the required design stall margin, with a corresponding increase in performance and/or decrease in fuel burn. The HISTEC concept was successfully flight demonstrated on the F-15 ACTIVE aircraft during the summer of 1997. The flight demonstration was planned and carried out in two parts, the first to show distortion estimation, and the second to show distortion accommodation. Post-flight analysis shows that the HISTEC technologies are able to successfully estimate and accommodate distortion, transiently setting the stall margin requirement on-line and in real-time. Flight demonstration of the HISTEC technologies has significantly reduced the risk of transitioning the technology to tactical and commercial engines.

Middle to late Holocene fluctuations of the Vindue glacier, an outlet glacier of the Greenland Ice Sheet, central East Greenland.

NASA Astrophysics Data System (ADS)

Levy, L.; Hammer, S. K.; Kelly, M. A.; Lowell, T. V.; Hall, B. L.; Howley, J. A.; Wilcox, P.; Medford, A.

2014-12-01

The margins of the Greenland Ice Sheet are currently responding to present-day climate changes. Determining how the ice sheet margins have responded to past climate changes provides a means to understand how they may respond in the future. Here we present a multi-proxy record used to reconstruct the Holocene fluctuations of the Vindue glacier, an ice sheet outlet glacier in eastern Greenland. Lake sediment cores from Qiviut lake (informal name), located ~0.75 km from the present-day Vindue glacier margin contain a sharp transition from medium sand/coarse silt to laminated gyttja just prior to 6,340±130 cal yr BP. We interpret this transition to indicate a time when the Vindue glacier retreated sufficiently to cease glacial sedimentation into the lake basin. Above this contact the core contains laminated gyttja with prominent, ~0.5 cm thick, silt layers. 10Be ages of boulders on bedrock located between Qiviut lake and the present-day ice margin date to 6.81 ± 0.67 ka (n = 3), indicating the time of deglaciation. These ages also agree well with the radiocarbon age of the silt-gyttja transition in Qiviut lake cores. 10Be ages on boulders on bedrock located more proximal to the ice margin (~0.5 km) yield ages of 2.67 ± 0.18 ka (n = 2). These ages indicate either the continued recession of the ice margin during the late Holocene or an advance at this time. Boulders on the historical moraines show that ice retreated from the moraine by AD 1620 ± 20 yrs (n = 2). These results are in contrast with some areas of the western margin of the ice sheet where 10Be ages indicate that the ice sheet was behind its Historical limit from the middle Holocene (~6-7 ka) to Historical time. This may indicate that the eastern margin may have responded to late Holocene cooling more sensitively or that the advance associated with the Historical moraines overran any evidence of late Holocene fluctuations along the western margin of the ice sheet.

Principles of Safety Pharmacology

PubMed Central

Pugsley, M K; Authier, S; Curtis, M J

2008-01-01

Safety Pharmacology is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events. This gives Safety Pharmacology its unique character. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. This article sets out to explain the drivers for Safety Pharmacology so that the wider pharmacology community is better placed to understand the discipline. It concludes with a summary of principles that may help inform future resolution of unmet needs (especially establishing model validation for accurate risk assessment). Subsequent articles in this issue of the journal address specific aspects of Safety Pharmacology to explore the issues of model choice, the burden of proof and to highlight areas of intensive activity (such as testing for drug-induced rare event liability, and the challenge of testing the safety of so-called biologics (antibodies, gene therapy and so on.). PMID:18604233

Marginalized zero-inflated negative binomial regression with application to dental caries

PubMed Central

Preisser, John S.; Das, Kalyan; Long, D. Leann; Divaris, Kimon

2015-01-01

The zero-inflated negative binomial regression model (ZINB) is often employed in diverse fields such as dentistry, health care utilization, highway safety, and medicine to examine relationships between exposures of interest and overdispersed count outcomes exhibiting many zeros. The regression coefficients of ZINB have latent class interpretations for a susceptible subpopulation at risk for the disease/condition under study with counts generated from a negative binomial distribution and for a non-susceptible subpopulation that provides only zero counts. The ZINB parameters, however, are not well-suited for estimating overall exposure effects, specifically, in quantifying the effect of an explanatory variable in the overall mixture population. In this paper, a marginalized zero-inflated negative binomial regression (MZINB) model for independent responses is proposed to model the population marginal mean count directly, providing straightforward inference for overall exposure effects based on maximum likelihood estimation. Through simulation studies, the finite sample performance of MZINB is compared to marginalized zero-inflated Poisson, Poisson, and negative binomial regression. The MZINB model is applied in the evaluation of a school-based fluoride mouthrinse program on dental caries in 677 children. PMID:26568034

Optimal Investment in HIV Prevention Programs: More Is Not Always Better

PubMed Central

Brandeau, Margaret L.; Zaric, Gregory S.

2008-01-01

This paper develops a mathematical/economic framework to address the following question: Given a particular population, a specific HIV prevention program, and a fixed amount of funds that could be invested in the program, how much money should be invested? We consider the impact of investment in a prevention program on the HIV sufficient contact rate (defined via production functions that describe the change in the sufficient contact rate as a function of expenditure on a prevention program), and the impact of changes in the sufficient contact rate on the spread of HIV (via an epidemic model). In general, the cost per HIV infection averted is not constant as the level of investment changes, so the fact that some investment in a program is cost effective does not mean that more investment in the program is cost effective. Our framework provides a formal means for determining how the cost per infection averted changes with the level of expenditure. We can use this information as follows: When the program has decreasing marginal cost per infection averted (which occurs, for example, with a growing epidemic and a prevention program with increasing returns to scale), it is optimal either to spend nothing on the program or to spend the entire budget. When the program has increasing marginal cost per infection averted (which occurs, for example, with a shrinking epidemic and a prevention program with decreasing returns to scale), it may be optimal to spend some but not all of the budget. The amount that should be spent depends on both the rate of disease spread and the production function for the prevention program. We illustrate our ideas with two examples: that of a needle exchange program, and that of a methadone maintenance program. PMID:19938440

75 FR 81126 - Revisions to Lead Ambient Air Monitoring Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... Council (NRDC), the Missouri Coalition for the Environment Foundation, Physicians for Social... estimates from the 2002 and 2005 NEI (Table 2) and estimated design values (i.e., 3-month rolling average Pb... year of lead to protect public health with an adequate margin of safety. The available evidence...

77 FR 54402 - Dichlorvos (DDVP); Order Denying NRDC's Objections on Remand

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

... may be calculated separately for different age-based population groups (e.g., non-nursing infants) or... in conjunction with experimental toxicity data in assessing risk to humans from exposure to chemical substances. (Ref. 4). These numerical factors are designed to provide an additional margin of safety so that...

Meteorological Satellites (METSAT) and Earth Observing System (EOS) Advanced Microwave Sounding Unit-A (AMSU-A) Stress Analysis Report

NASA Technical Reports Server (NTRS)

Heffner, Robert

1996-01-01

Stress analysis of the primary structure of the Meteorological Satellites Project (METSAT) Advanced Microwave Sounding Units-A, A1 Module using static loads is presented. The structural margins of safety and natural frequency predictions for the METSAT design are reported.

Pilot Convective Weather Decision Making in En Route Airspace

NASA Technical Reports Server (NTRS)

Wu, Shu-Chieh; Gooding, Cary L.; Shelley, Alexandra E.; Duong, Constance G.; Johnson, Walter W.

2012-01-01

The present research investigates characteristics exhibited in pilot convective weather decision making in en route airspace. In a part-task study, pilots performed weather avoidance under various encounter scenarios. Results showed that the margins of safety that pilots maintain from storms are as fluid as deviation decisions themselves.

14 CFR 33.62 - Stress analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Stress analysis. 33.62 Section 33.62... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.62 Stress analysis. A stress analysis must be performed on each turbine engine showing the design safety margin of each turbine...

14 CFR 33.62 - Stress analysis.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Stress analysis. 33.62 Section 33.62... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.62 Stress analysis. A stress analysis must be performed on each turbine engine showing the design safety margin of each turbine...

14 CFR 33.62 - Stress analysis.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Stress analysis. 33.62 Section 33.62... STANDARDS: AIRCRAFT ENGINES Design and Construction; Turbine Aircraft Engines § 33.62 Stress analysis. A stress analysis must be performed on each turbine engine showing the design safety margin of each turbine...

77 FR 21594 - Duke Energy Carolinas, LLC; Environmental Assessment and Finding of No Significant Impact, Oconee...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-10

... of light-water nuclear power reactors provide adequate margins of safety during any condition of... toughness requirements for protection against pressurized thermal shock (PTS) events. The proposed action... for Protection Against Pressurized Thermal Shock Events,'' and 10 CFR part 50 Appendix G, ``Fracture...

Earth Observing System (EOS)/Advanced Microwave Sounding Unit-A (AMSU-A) Stress Analysis Report, A1 Module. Addendum 1

NASA Technical Reports Server (NTRS)

Ely, W.

1996-01-01

This addendum reports the structural margins of safety and natural frequency predictions for the design following the EOS AMSU-A1 Mechanical/Structural Subsystem Critical Design Review (CDR), based on a new and more refined finite element model.

Acute Effects of an Alternative Electronic-Control-Device Waveform in Swine

DTIC Science & Technology

2009-03-01

sequences in a normal individual. Bozeman [32] suggested that lethality due to ECD impact could be due to hyperkalemia related to muscle contraction...and our previous investigations [1, 2], there may be a wide margin of safety, relative to hyperkalemia , for most ECD applications. The increase in

40 CFR 264.90 - Applicability.

Code of Federal Regulations, 2011 CFR

2011-07-01

... care period; or (4) The Regional Administrator finds that there is no potential for migration of liquid... margin of safety in the prediction of potential migration of liquid, the owner or operator must base any predictions made under this paragraph on assumptions that maximize the rate of liquid migration. (5) He...

40 CFR 264.90 - Applicability.

Code of Federal Regulations, 2010 CFR

2010-07-01

... care period; or (4) The Regional Administrator finds that there is no potential for migration of liquid... margin of safety in the prediction of potential migration of liquid, the owner or operator must base any predictions made under this paragraph on assumptions that maximize the rate of liquid migration. (5) He...

Opinion of the Scientific Committee on Consumer Safety (SCCS) - Final version of the opinion on Phenoxyethanol in cosmetic products.

PubMed

Lilienblum, Werner

2016-12-01

The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided. The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults. This Opinion does not take into account exposure from sources other than cosmetics. Copyright © 2016 Elsevier Inc. All rights reserved.

Genuine worker participation-an indispensable key to effective global OHS.

PubMed

Brown, Garrett

2009-01-01

Working conditions, including workplace safety, in global supply chains of products sold by transnational corporations have only marginally improved over the last 15 years despite the development of hundreds of corporate "codes of conduct," code monitoring systems, and an elaborate new "corporate social responsibility" industry. The two underlying reasons for the lack of significant change are: 1) a schizophrenic business model which fatally undermines "socially responsible" sourcing programs with unyielding dictates for the lowest possible production costs; and 2) the lack of any meaningful participation by shop-floor workers in plant safety programs. Only when trained, empowered, and active workers are an integral part of workplace safety programs will conditions improve over the long term.

Safety of needle electromyography of the diaphragm: Anterior lung margins in quietly breathing healthy subjects.

PubMed

Podnar, Simon; Doorduin, Jonne

2016-06-01

Controversy persists as to whether the lung interposes on the needle electrode insertion path during diaphragm electromyography (EMG). Using high-resolution ultrasonography, we measured the distances between the medial recess of the intercostal spaces (ICSs) around the mid-clavicular line (MCL) and the lung margin. We performed measurements bilaterally during quiet breathing in the seated and supine positions. We studied 10 young healthy men and found that, in the first ICS with the medial recess clearly (i.e., several cm) lateral to MCL (usually the eighth ICS), the distance between the recommended insertion site and the lung margin varied from 7.5 to 17 cm. The distance was slightly larger on the right side and in the supine position. This study confirms that properly conducted "trans-intercostal" needle EMG of the diaphragm is generally safe in healthy subjects. Muscle Nerve 54: 54-57, 2016. © 2015 Wiley Periodicals, Inc.

Estimation of the full marginal costs of port related truck traffic.

PubMed

Berechman, Joseph

2009-11-01

NY region is expected to grow by additional 1 million people by 2020, which translates into roughly 70 million more tons of goods to be delivered annually. Due to lack of rail capacity, mainly trucks will haul this volume of freight, challenging an already much constrained highway network. What are the total costs associated with this additional traffic, in particular, congestion, safety and emission? Since a major source of this expected flow is the Port of New York-New Jersey, this paper focuses on the estimation of the full marginal costs of truck traffic resulting from the further expansion of the port's activities.

Multispectral visualization of surgical safety-margins using fluorescent marker seeds

PubMed Central

Chin, Patrick TK; Beekman, Chantal AC; Buckle, Tessa; Josephson, Lee; van Leeuwen, Fijs WB

2012-01-01

Optical guidance provided by luminescent marker seeds may be suitable for intraoperative determination of appropriate resection margins. In phantom studies we compared the tissue penetration of several organic dyes and inorganic particles (quantum dots; QDs) after incorporation in experimental marker seeds. The tissue penetration of (near infra-) red organic dyes was much better than the penetration of dyes and QDs with an emission in the visible range. By combining 3 dyes in a single marker seed we were able to distinguish four depth ranges. The difference in tissue penetration between the dyes and QDS enabled depth estimation via a ‘traffic light’ approach. PMID:23133810

Insight of Dogs' Inner Mandible Anatomy using Mathematical Models.

PubMed

Santos, M; Carreira, L M

2016-12-01

This study was performed in a sample of 20 dogs (n = 20) and aimed to: (1) characterize the mandible height (Mh), mandibular canal height (MCh) and distance between the inter-dental alveolar margin and the mandibular canal (dIAM-MC) dimensions, and (2) to develop mathematical models that express the insight's mandible anatomy of those important mandible structural elements allowing the prediction of their dimensions using physical parameters such as patient body weight (Wg) and the canine tooth width at the free gingival margin level-(wCGM). Lateral-view X-rays of both sides of the skull were taken for all the individuals. Three mathematical prediction models were developed to calculate Mh, MCh and dIAM-MC. Achieved proportions of the mandible considered parameters regarding its height were of 36.45% for MCh, 50.90% for dMAI-MC and 12.65% for vMC. Statistically significant differences were registered between the Wg and wCGM (P = 0.00), Mh (P = 0.00), MCh (P = 0.00) and dIAM-MC (P = 0.00). Only the Wg presented a strong correlation with the wCGM (R = 0.58), Mh (R = 0.70), dIAM-MC (R = 0.60) and MCh (R = 0.68). These models will allow a clinician to estimate the size of the mandible structures by only using data obtained during the physiological examination, with a sufficiently high prediction capacity and a very low standard error. The study points out the relationships of physiological parameters such as Wg and wCGM with mandible anatomical structural elements considered as important in oral surgery. The results of this study give the surgeon a new additional tool providing more information on the mandible anatomical structures and its relationships. This reduces the risk of iatrogenic lesions during the oral surgical procedures and improves patient safety. © 2016 Blackwell Verlag GmbH.

Improvements and applications of COBRA-TF for stand-alone and coupled LWR safety analyses

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

Avramova, M.; Cuervo, D.; Ivanov, K.

2006-07-01

The advanced thermal-hydraulic subchannel code COBRA-TF has been recently improved and applied for stand-alone and coupled LWR core calculations at the Pennsylvania State Univ. in cooperation with AREVA NP GmbH (Germany)) and the Technical Univ. of Madrid. To enable COBRA-TF for academic and industrial applications including safety margins evaluations and LWR core design analyses, the code programming, numerics, and basic models were revised and substantially improved. The code has undergone through an extensive validation, verification, and qualification program. (authors)

Computing Maximum Likelihood Estimates of Loglinear Models from Marginal Sums with Special Attention to Loglinear Item Response Theory. [Project Psychometric Aspects of Item Banking No. 53.] Research Report 91-1.

ERIC Educational Resources Information Center

Kelderman, Henk

In this paper, algorithms are described for obtaining the maximum likelihood estimates of the parameters in log-linear models. Modified versions of the iterative proportional fitting and Newton-Raphson algorithms are described that work on the minimal sufficient statistics rather than on the usual counts in the full contingency table. This is…

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

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

Ryan, Patricia C., E-mail: ryanp@medimmune.com; Sleeman, Matthew A.; Rebelatto, Marlon

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters othermore » than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. • Lung changes observed reflect role of GM-CSF in alveolar macrophage function. • High safety margins support continued clinical development of mavrilimumab.« less

49 CFR Appendix A to Part 209 - Statement of Agency Policy Concerning Enforcement of the Federal Railroad Safety Laws

Code of Federal Regulations, 2013 CFR

2013-10-01

... exercise of jurisdiction. In this context, the presence of intrusion detection devices to alert one or both... about sufficient intrusion detection and related safety measures designed to avoid a collision between...). By “general railroad system of transportation,” FRA refers to the network of standard gage track over...

49 CFR Appendix A to Part 209 - Statement of Agency Policy Concerning Enforcement of the Federal Railroad Safety Laws

Code of Federal Regulations, 2014 CFR

2014-10-01

... exercise of jurisdiction. In this context, the presence of intrusion detection devices to alert one or both... about sufficient intrusion detection and related safety measures designed to avoid a collision between...). By “general railroad system of transportation,” FRA refers to the network of standard gage track over...

49 CFR Appendix A to Part 209 - Statement of Agency Policy Concerning Enforcement of the Federal Railroad Safety Laws

Code of Federal Regulations, 2012 CFR

2012-10-01

... exercise of jurisdiction. In this context, the presence of intrusion detection devices to alert one or both... about sufficient intrusion detection and related safety measures designed to avoid a collision between...). By “general railroad system of transportation,” FRA refers to the network of standard gage track over...

Ultrasound-ultrasound image overlay fusion improves real-time control of radiofrequency ablation margin in the treatment of hepatocellular carcinoma.

PubMed

Minami, Yasunori; Minami, Tomohiro; Hagiwara, Satoru; Ida, Hiroshi; Ueshima, Kazuomi; Nishida, Naoshi; Murakami, Takamichi; Kudo, Masatoshi

2018-05-01

To assess the clinical feasibility of US-US image overlay fusion with evaluation of the ablative margin in radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC). Fifty-three patients with 68 HCCs measuring 0.9-4.0 cm who underwent RFA guided by US-US overlay image fusion were included in this retrospective study. By an overlay of pre-/postoperative US, the tumor image could be projected onto the ablative hyperechoic zone. Therefore, the ablative margin three-dimensionally could be shown during the RFA procedure. US-US image overlay was compared to dynamic CT a few days after RFA for assessment of early treatment response. Accuracy of graded response was calculated, and the performance of US-US image overlay fusion was compared with that of CT using a Kappa agreement test. Technically effective ablation was achieved in a single session, and 59 HCCs (86.8 %) succeeded in obtaining a 5-mm margin on CT. The response with US-US image overlay correctly predicted early CT evaluation with an accuracy of 92.6 % (63/68) (k = 0.67; 95 % CI: 0.39-0.95). US-US image overlay fusion can be proposed as a feasible guidance in RFA with a safety margin and predicts early response of treatment assessment with high accuracy. • US-US image overlay fusion visualizes the ablative margin during RFA procedure. • Visualizing the margin during the procedure can prompt immediate complementary treatment. • US image fusion correlates with the results of early evaluation CT.

Role of Adjuvant Treatment in Esophageal Cancer With Incidental Pathologic Node Positivity.

PubMed

Gao, Sarah J; Park, Henry S; Corso, Christopher D; Rutter, Charles E; Kim, Anthony W; Johung, Kimberly L

2017-07-01

The optimal adjuvant treatment for cT1-2 N0 esophageal cancer patients found to have pathologic nodal involvement after an upfront operation is unclear. This study investigated the effects of postoperative chemotherapy and chemoradiation therapy on overall survival in cT1-2 N0 patients with incidental pN + disease stratified by margin status. We identified cT1-2 N0 M0 esophageal carcinoma patients from 2004 to 2012 from the National Cancer Data Base. Patients were categorized as having received surgical resection alone, surgical resection followed by chemotherapy (S+CT), and surgical resection followed by concurrent chemoradiation therapy (S+CRT). Subset analyses were conducted on margin-negative and margin-positive patients. Overall survival was compared by Kaplan-Meier estimation, the log-rank test, and multivariable Cox regression analysis. Among 443 patients, 52.6% received surgical resection alone, 18.7% received S+CT, and 28.6% received S+CRT. Significantly more adenocarcinoma patients received adjuvant treatment (50.8%) than squamous cell carcinoma patients (27.7%, p = 0.001). On multivariable analysis, S+CT (hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; p = 0.014) and S+CRT (hazard ratio, 0.73; 95% confidence interval,. 0.55 to 0.98; p = 0.038) both were associated with significantly increased overall survival. These findings persisted among margin-negative patients. However, in margin-positive patients, S+CRT (hazard ratio, 0.29; p = 0.002) was the only treatment arm that was associated with significantly improved survival compared with surgical resection alone. Among cT1-2 N0 pN + esophageal cancer patients, adjuvant chemotherapy may be sufficient for margin-negative patients, whereas adjuvant chemoradiation therapy appears necessary for margin-positive patients. Further prospective studies are needed to confirm the results. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

U. S. refining margins languishing: Ominous undercurrent

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

Not Available

1991-12-17

In recent weeks, most petroleum product prices have plunged on both the US Gulf and West Coasts. Even though most crude oil prices have weakened as well, the refining sector ends 1991 on a powerless note. The problem: from 1992 forward, continued cast infusions will scarcely afford sufficient processing and capacity changes in preparation for dramatic Clean Air Act requirements, while reluctant demand will scarcely accommodate cost increase pass throughs. This issue updates prices and margins for several important crudes processed in the US and tracks recent product price trends. The issue also presents the following: (1) the ED Refiningmore » Netback Data Series for the US Gulf and West Coasts, Rotterdam, and Singapore as of Dec. 6, 1991; and (2) the ED Fuel Price/Tax Series for countries of the Western Hemisphere, December 1991 edition.« less

Ammonia Release on ISS

NASA Technical Reports Server (NTRS)

Macatangay, Ariel

2009-01-01

Crew: Approximately 53% metabolic load Product of protein metabolism Limit production of ammonia by external regulation NOT possbile Payloads Potential source Scientific experiments Thorough safety review ensures sufficient levels of containment

A study for safety and health management problem of semiconductor industry in Taiwan.

PubMed

Chao, Chin-Jung; Wang, Hui-Ming; Feng, Wen-Yang; Tseng, Feng-Yi

2008-12-01

The main purpose of this study is to discuss and explore the safety and health management in semiconductor industry. The researcher practically investigates and interviews the input, process and output of the safety and health management of semiconductor industry by using the questionnaires and the interview method which is developed according to the framework of the OHSAS 18001. The result shows that there are six important factors for the safety and health management in Taiwan semiconductor industry. 1. The company should make employee clearly understand the safety and health laws and standards. 2. The company should make the safety and health management policy known to the public. 3. The company should put emphasis on the pursuance of the safety and health management laws. 4. The company should prevent the accidents. 5. The safety and health message should be communicated sufficiently. 6. The company should consider safety and health norm completely.

The fee-for-service shift to bundled payments: financial considerations for hospitals.

PubMed

Scamperle, Keely

2013-01-01

Skyrocketing health care costs are forcing payers to demand delivery efficiencies that preserve and promote quality care while reducing costs. Hospitals are challenged to meet the pressure from payers to deliver value and outcome-based health care while preserving sufficient financial margins. The fee-for-service (FFS) model with its perverse incentives to incur high-volume services is no longer, if ever, sufficient to ensure quality, cost-efficient health care. In response, payers have sought to force the issue through accelerated efforts to bundle payments to providers. It is theorized that by tying together providers throughout the continuum or episode of care for a patient, efficiencies in delivery inclusive of cost reductions will be obtained. This article examines the bundled payment models and the financial considerations for hospital facility providers.

Assessing the Financial Condition of Provider-Sponsored Health Plans.

PubMed

McCue, Michael J

2015-06-01

The aim of this study was to assess the performance of health plans sponsored by provider organizations, with respect to plans generating strong positive cash flow relative to plans generating weaker cash flow. A secondary aim was to assess their capital adequacy. The study identified 24 provider-sponsored health plans (PSHPs) with an average positive cash flow margin from 2011 through 2013 at or above the top 75th percentile, defined as "strong cash flow PSHPs:" This group was compared with 72 PSHPs below the 75th percentile, defined as "weak cash flow PSHPs:" Atlantic Information Services Directory of Health Plans was used to identify the PSHPs. Financial ratios were computed from 2013 National Association of Insurance Commissioners Financial Filings. The study conducted a t test mean comparison between strong and weak cash flow PSHPs across an array of financial performance and capital adequacy measures. In 2013, the strong cash flow PSHPs averaged a cash-flow margin ratio of 6.6%. Weak cash flow PSHPs averaged a cash-flow margin of -0.4%. The net worth capital position of both groups was more than 4.5 times authorized capital. The operational analysis shows that strong cash-flow margin PSHPs are managing their medical costs to achieve this position. Although their medical loss ratio increased by almost 300 basis points from 2011 to 2013, it was still statistically significantly lower than the weaker cash flow PSHP group (P<.001). In terms of capital adequacy, both strong and weak cash-flow margin PSHP groups possessed sufficient capital to ensure the viability of these plans.

21 CFR 250.105 - Gelsemium-containing preparations regarded as prescription drugs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Gelsemium-containing preparations regarded as prescription drugs. 250.105 Section 250.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... prescription drugs. It is the consensus of informed medical opinion that the margin of safety between the...

78 FR 11754 - Approval and Promulgation of Implementation Plans; Tennessee: Knox County Supplement Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-20

... December 18, 2012, (77 FR 74820), EPA proposed to approve through parallel processing Tennessee's October... well as changes to future vehicle mix assumptions, that influence the emission estimations. TDEC has... 2014. \\2\\ A safety margin is the difference between the attainment level of emissions from all source...

Fire Detector

NASA Technical Reports Server (NTRS)

1978-01-01

An early warning fire detection sensor developed for NASA's Space Shuttle Orbiter is being evaluated as a possible hazard prevention system for mining operations. The incipient Fire Detector represents an advancement over commercially available smoke detectors in that it senses and signals the presence of a fire condition before the appearance of flame and smoke, offering an extra margin of safety.

Protect Children Instead of Guns, 2001.

ERIC Educational Resources Information Center

Children's Defense Fund, Washington, DC.

Noting that firearms outnumber children by a margin of almost three to one in the United States, this report advocates gun safety policies to protect children. The report provides information on trends in youth firearm deaths and finds the statistics alarming, despite recent decline. The first of three tables in the report delineates 1979-1999…

Nurturing Care for Young Children under Conditions of Fragility and Conflict

ERIC Educational Resources Information Center

Richter, Linda M.; Lye, Stephen J.; Proulx, Kerrie

2018-01-01

Forced displacement worldwide is at its highest in decades and millions of young children are living in conflict zones, in transitional or enduring refugee contexts, and in demographically diverse marginalized and informal settlements. There is a huge unmet need for delivering early childhood development interventions to ensure the safety and…

78 FR 42809 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Order Approving Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-17

... remain subject to all of the GSD's normal risk management procedures, which include marking member portfolios to the market on an intraday basis and charging variation margins accordingly.\\19\\ These risk management procedures should help ensure the safety of the securities and funds handled by the GSD in...

77 FR 67679 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-13

... diesel generator surveillance requirements. Margin of safety is related to the ability of the fission... surveillance tests, allowing testing in any MODE of operation. The Division 3 AC sources, including the diesel generator (DG) and its associated emergency loads are accident mitigating features, not accident initiators...

Some bivariate distributions for modeling the strength properties of lumber

Treesearch

Richard A. Johnson; James W. Evans; David W. Green

Accurate modeling of the joint stochastic nature of the strength properties of dimension lumber is essential to the determination of reliability-based design safety factors. This report reviews the major techniques for obtaining bivariate distributions and then discusses bivariate distributions whose marginal distributions suggest they might be useful for modeling the...

Diatoms and stratigraphically significant silicoflagellates from the Atlantic Margin Coring Project and other Atlantic margin sites

USGS Publications Warehouse

Abbott, W.H.

1980-01-01

In 1976, 19 sites were cored along the U.S. Atlantic Continental Shelf and Slope by the Oceanographic Branch of the U.S. Geological Survey aboard the Glomar Conception. Only 6 sites contained siliceous microfossil assemblages of sufficient quantity and quality for biostratigraphic study. Two of the sites, AMCOR (Atlantic Margin Coring Project) 6002 and AMCOR 6011, contained good Miocene assemblages: a small Pleistocene assemblage occurred at the top of AMCOR 6002. A Late Miocene to Early Pliocene assemblage was encountered in AMCOR 6007B. AMCOR 6013, 6019, and 6021 contained Pleistocene assemblages. In addition to the AMCOR cores, 3 additional Atlantic Margin cores were studied. These were the JOIDES 1 (Caldrill) core, and Atlantic Slope Project (ASP) cores 10 and 22. JOIDES 1 contains a Middle Miocene assemblage similar to AMCOR 6002. ASP 10 contains a Lower Pliocene assemblage and ASP 22 contains a Middle to Late Oligocene and a Pleistocene assemblage. Siliceous assemblages at all sites consisted mainly of shallow shelf species, including brackish and marine benthics and occasionally freshwater forms. Although planktonic forms were present, they were few and most were extant cosmopolitan species. This makes it difficult to correlate the biostratigraphy of the sediments with siliceous microfossil zonations from other oceans. The only biostratigraphic zonations for Atlantic Shelf diatom assemblages are for the Miocene.

Drosophila Lyra mutations are gain-of-function mutations of senseless

NASA Technical Reports Server (NTRS)

Nolo, R.; Abbott, L. A.; Bellen, H. J.

2001-01-01

The Lyra mutation was first described by Jerry Coyne in 1935. Lyra causes recessive pupal lethality and adult heterozygous Lyra mutants exhibit a dominant loss of the anterior and posterior wing margins. Unlike many mutations that cause loss of wing tissue (e.g., scalloped, Beadex, cut, and apterous-Xasta), Lyra wing discs do not exhibit increased necrotic or apoptotic cell death, nor do they show altered BrdU incorporation. However, during wing disc eversion, loss of the anterior and posterior wing margins is apparent. We have previously shown that senseless, a gene that is necessary and sufficient for peripheral nervous system (PNS) development, is allelic to Lyra. Here we show by several genetic criteria that Lyra alleles are neomorphic alleles of senseless that cause ectopic expression of SENSELESS in the wing pouch. Similarly, overexpression of SENSELESS in the wing disc causes loss of wing margin tissue, thereby mimicking the Lyra phenotype. Lyra mutants display aberrant expression of DELTA, VESTIGIAL, WINGLESS, and CUT. As in Lyra mutants, overexpression of SENSELESS in some areas of the wing pouch also leads to loss of WINGLESS and CUT. In summary, our data indicate that overexpression of SENSELESS causes a severe reduction in NOTCH signaling that in turn may lead to decreased transcription of several key genes required for wing development, leading to a failure in cell proliferation and loss of wing margin tissue.

Biofuel development, food security and the use of marginal land in China.

PubMed

Qiu, Huanguang; Huang, Jikun; Keyzer, Michiel; van Veen, Wim; Rozelle, Scott; Fisher, Guenther; Ermolieva, Tatiana

2011-01-01

With concerns of energy shortages, China, like the United States, European Union, and other countries, is promoting the development of biofuels. However, China also faces high future demand for food and feed, and so its bioenergy program must try to strike a balance between food and fuel. The goals of this paper are to provide an overview of China's current bioethanol program, identify the potential for using marginal lands for feedstock production, and measure the likely impacts of China's bioethanol development on the nation's future food self-sufficiency. Our results indicate that the potential to use marginal land for bioethanol feedstock production is limited. Applying a modeling approach based on highly disaggregated data by region, our analysis shows that the target of 10 million t of bioethanol by 2020 seems to be a prudent target, causing no major disturbances in China's food security. But the expansion of bioethanol may increase environmental pressures due to the higher levels of fertilizer use. This study shows also that if China were able to cultivate 45% of its required bioethanol feedstock on new marginal land, it would further limit negative effects of the bioethanol program on the domestic and international economy, but at the expense of having to apply another 750 thousand t of fertilizer. Copyright © by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America, Inc.

Food security status among grade 5 students in Nova Scotia, Canada and its association with health outcomes.

PubMed

Kirk, Sara F L; Kuhle, Stefan; McIsaac, Jessie-Lee D; Williams, Patty L; Rossiter, Melissa; Ohinmaa, Arto; Veugelers, Paul J

2015-11-01

Food security (FS) exists when all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their needs. The present research sought to determine whether students from households experiencing moderate or severe food insecurity (FI) had poorer diet quality, higher body weights and poorer psychosocial outcomes than students from households classed as having high FS or marginal FI status. Population-based survey conducted in schools. Multiple regression analysis was used to explore associations between FS status (high FS; marginal, moderate, severe FI), dietary behaviours and intake, and health-related outcomes (body weight, quality of life, mood, peer relationships, externalizing problems). Nova Scotia, Canada. Grade 5 students (n 5853), aged 10-11 years, with complete information on FS status and student outcomes. In this sample, rates of household FS were 73·5% (high FS), 8·3% (marginal FI) 10·2% (moderate FI) and 7·1% (severe FI status). Students living in households experiencing moderate or severe FI had poorer diet quality, higher BMI and poorer psychosocial outcomes than students classed as having high FS or marginal FI. These findings provide important evidence for policy makers on the prevalence of FI among families in Nova Scotia with grade 5 children and its relationship with childhood nutrition, psychosocial and quality of life factors, and weight status.

Patient engagement at the margins: Health care providers' assessments of engagement and the structural determinants of health in the safety-net.

PubMed

Fleming, Mark D; Shim, Janet K; Yen, Irene H; Thompson-Lastad, Ariana; Rubin, Sara; Van Natta, Meredith; Burke, Nancy J

2017-06-01

Increasing "patient engagement" has become a priority for health care organizations and policy-makers seeking to reduce cost and improve the quality of care. While concepts of patient engagement have proliferated rapidly across health care settings, little is known about how health care providers make use of these concepts in clinical practice. This paper uses 20 months of ethnographic and interview research carried out from 2015 to 2016 to explore how health care providers working at two public, urban, safety-net hospitals in the United States define, discuss, and assess patient engagement. We investigate how health care providers describe engagement for high cost patients-the "super-utilizers" of the health care system-who often face complex challenges related to socioeconomic marginalization including poverty, housing insecurity, exposure to violence and trauma, cognitive and mental health issues, and substance use. The health care providers in our study faced institutional pressure to assess patient engagement and to direct care towards engaged patients. However, providers considered such assessments to be highly challenging and oftentimes inaccurate, particularly because they understood low patient engagement to be the result of difficult socioeconomic conditions. Providers tried to navigate the demand to assess patient engagement in care by looking for explicit positive and negative indicators of engagement, while also being sensitive to more subtle and intuitive signs of engagement for marginalized patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

Patient Engagement at the Margins: Health Care Providers’ Assessments of Engagement and the Structural Determinants of Health in the Safety-net

PubMed Central

Fleming, Mark D.; Shim, Janet K.; Yen, Irene; Thompson-Lastad, Ariana; Rubin, Sara; Van Natta, Meredith; Burke, Nancy J.

2017-01-01

Increasing “patient engagement” has become a priority for health care organizations and policy-makers seeking to reduce cost and improve the quality of care. While concepts of patient engagement have proliferated rapidly across health care settings, little is known about how health care providers make use of these concepts in clinical practice. This paper uses 20 months of ethnographic and interview research carried out from 2015 to 2016 to explore how health care providers working at two public, urban, safety-net hospitals in the United States define, discuss, and assess patient engagement. We investigate how health care providers describe engagement for high cost patients—the “super-utilizers” of the health care system—who often face complex challenges related to socioeconomic marginalization including poverty, housing insecurity, exposure to violence and trauma, cognitive and mental health issues, and substance use. The health care providers in our study faced institutional pressure to assess patient engagement and to direct care towards engaged patients. However, providers considered such assessments to be highly challenging and oftentimes inaccurate, particularly because they understood low patient engagement to be the result of difficult socioeconomic conditions. Providers tried to navigate the demand to assess patient engagement in care by looking for explicit positive and negative indicators of engagement, while also being sensitive to more subtle and intuitive signs of engagement for marginalized patients. PMID:28445806

Collapse of passive margins by lithospheric damage and plunging grain size

NASA Astrophysics Data System (ADS)

Mulyukova, Elvira; Bercovici, David

2018-02-01

The collapse of passive margins has been proposed as a possible mechanism for the spontaneous initiation of subduction. In order for a new trench to form at the junction between oceanic and continental plates, the cold and stiff oceanic lithosphere must be weakened sufficiently to deform at tectonic rates. Such rates are especially hard to attain in the cold ductile portion of the lithosphere, at which the mantle lithosphere reaches peak strength. The amount of weakening required for the lithosphere to deform in this tectonic setting is dictated by the available stress. Stress in a cooling passive margin increases with time (e.g., due to ridge push), and is augmented by stresses present in the lithosphere at the onset of rifting (e.g., due to drag from underlying mantle flow). Increasing stress has the potential to weaken the ductile portion of the lithosphere by dislocation creep, or by decreasing grain size in conjunction with a grain-size sensitive rheology like diffusion creep. While the increasing stress acts to weaken the lithosphere, the decreasing temperature acts to stiffen it, and the dominance of one effect or the other determines whether the margin might weaken and collapse. Here, we present a model of the thermal and mechanical evolution of a passive margin, wherein we predict formation of a weak shear zone that spans a significant depth-range of the ductile portion of the lithosphere. Stiffening due to cooling is offset by weakening due to grain size reduction, driven by the combination of imposed stresses and grain damage. Weakening via grain damage is modest when ridge push is the only source of stress in the lithosphere, making the collapse of a passive margin unlikely in this scenario. However, adding even a small stress-contribution from mantle drag results in damage and weakening of a significantly larger portion of the lithosphere. We posit that rapid grain size reduction in the ductile portion of the lithosphere can enable, or at least significantly facilitate, the collapse of a passive margin and initiate a new subduction zone. We use this model to estimate the conditions for passive margin collapse for modern and ancient Earth, as well as for Venus.

Child allowances, fertility, and chaotic dynamics.

PubMed

Chen, Hung-Ju; Li, Ming-Chia

2013-06-01

This paper analyzes the dynamics in an overlapping generations model with the provision of child allowances. Fertility is an increasing function of child allowances and there exists a threshold effect of the marginal effect of child allowances on fertility. We show that if the effectiveness of child allowances is sufficiently high, an intermediate-sized tax rate will be enough to generate chaotic dynamics. Besides, a decrease in the inter-temporal elasticity of substitution will prevent the occurrence of irregular cycles.

Product plots.

PubMed

Wickham, Hadley; Hofmann, Heike

2011-12-01

We propose a new framework for visualising tables of counts, proportions and probabilities. We call our framework product plots, alluding to the computation of area as a product of height and width, and the statistical concept of generating a joint distribution from the product of conditional and marginal distributions. The framework, with extensions, is sufficient to encompass over 20 visualisations previously described in fields of statistical graphics and infovis, including bar charts, mosaic plots, treemaps, equal area plots and fluctuation diagrams. © 2011 IEEE

Reviving the carbohydrate economy via multi-product lignocellulose biorefineries.

PubMed

Zhang, Y-H Percival

2008-05-01

Before the industrial revolution, the global economy was largely based on living carbon from plants. Now the economy is mainly dependent on fossil fuels (dead carbon). Biomass is the only sustainable bioresource that can provide sufficient transportation fuels and renewable materials at the same time. Cellulosic ethanol production from less costly and most abundant lignocellulose is confronted with three main obstacles: (1) high processing costs (dollars /gallon of ethanol), (2) huge capital investment (dollars approximately 4-10/gallon of annual ethanol production capacity), and (3) a narrow margin between feedstock and product prices. Both lignocellulose fractionation technology and effective co-utilization of acetic acid, lignin and hemicellulose will be vital to the realization of profitable lignocellulose biorefineries, since co-product revenues would increase the margin up to 6.2-fold, where all purified lignocellulose co-components have higher selling prices (> approximately 1.0/kg) than ethanol ( approximately 0.5/kg of ethanol). Isolation of large amounts of lignocellulose components through lignocellulose fractionation would stimulate R&D in lignin and hemicellulose applications, as well as promote new markets for lignin- and hemicellulose-derivative products. Lignocellulose resource would be sufficient to replace significant fractionations (e.g., 30%) of transportation fuels through liquid biofuels, internal combustion engines in the short term, and would provide 100% transportation fuels by sugar-hydrogen-fuel cell systems in the long term.

Correlation between safety climate and contractor safety assessment programs in construction

PubMed Central

Sparer, EH1; Murphy, LA; Taylor, KM; Dennerlein, Jt

2015-01-01

Background Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Methods 401 construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. Results There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers’ safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. Conclusions A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. PMID:24038403

Medicare Payment Penalties and Safety Net Hospital Profitability: Minimal Impact on These Vulnerable Hospitals.

PubMed

Bazzoli, Gloria J; Thompson, Michael P; Waters, Teresa M

2018-02-08

To examine relationships between penalties assessed by Medicare's Hospital Readmission Reduction Program and Value-Based Purchasing Program and hospital financial condition. Centers for Medicare and Medicaid Services, American Hospital Association, and Area Health Resource File data for 4,824 hospital-year observations. Bivariate and multivariate analysis of pooled cross-sectional data. Safety net hospitals have significantly higher HRRP/VBP penalties, but, unlike nonsafety net hospitals, increases in their penalty rate did not significantly affect their total margins. Safety net hospitals appear to rely on nonpatient care revenues to offset higher penalties for the years studied. While reassuring, these funding streams are volatile and may not be able to compensate for cumulative losses over time. © Health Research and Educational Trust.

The STAT7 Code for Statistical Propagation of Uncertainties In Steady-State Thermal Hydraulics Analysis of Plate-Fueled Reactors

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

Dunn, Floyd E.; Hu, Lin-wen; Wilson, Erik

The STAT code was written to automate many of the steady-state thermal hydraulic safety calculations for the MIT research reactor, both for conversion of the reactor from high enrichment uranium fuel to low enrichment uranium fuel and for future fuel re-loads after the conversion. A Monte-Carlo statistical propagation approach is used to treat uncertainties in important parameters in the analysis. These safety calculations are ultimately intended to protect against high fuel plate temperatures due to critical heat flux or departure from nucleate boiling or onset of flow instability; but additional margin is obtained by basing the limiting safety settings onmore » avoiding onset of nucleate boiling. STAT7 can simultaneously analyze all of the axial nodes of all of the fuel plates and all of the coolant channels for one stripe of a fuel element. The stripes run the length of the fuel, from the bottom to the top. Power splits are calculated for each axial node of each plate to determine how much of the power goes out each face of the plate. By running STAT7 multiple times, full core analysis has been performed by analyzing the margin to ONB for each axial node of each stripe of each plate of each element in the core.« less

A test of the hydraulic vulnerability segmentation hypothesis in angiosperm and conifer tree species

DOE PAGES

Johnson, Daniel M.; Wortemann, Remi; McCulloh, Katherine A.; ...

2016-05-04

Water transport from soils to the atmosphere is critical for plant growth and survival. However, we have a limited understanding about many portions of the whole-tree hydraulic pathway, because the vast majority of published information is on terminal branches. Our understanding of mature tree trunk hydraulic physiology, in particular, is limited. The hydraulic vulnerability segmentation hypothesis (HVSH) stipulates that distal portions of the plant (leaves, branches and roots) should be more vulnerable to embolism than trunks, which are non-redundant organs that require a massive carbon investment. In the current study, we compared vulnerability to loss of hydraulic function, leaf andmore » xylem water potentials and the resulting hydraulic safety margins (in relation to the water potential causing 50% loss of hydraulic conductivity) in leaves, branches, trunks and roots of four angiosperms and four conifer tree species. Across all species, our results supported strongly the HVSH as leaves and roots were less resistant to embolism than branches or trunks. However, branches were consistently more resistant to embolism than any other portion of the plant, including trunks. Also, calculated whole-tree vulnerability to hydraulic dysfunction was much greater than vulnerability in branches. This was due to hydraulic dysfunction in roots and leaves at less negative water potentials than those causing branch or trunk dysfunction. Leaves and roots had narrow or negative hydraulic safety margins, but trunks and branches maintained positive safety margins. By using branch-based hydraulic information as a proxy for entire plants, much research has potentially overestimated embolism resistance, and possibly drought tolerance, for many species. This study highlights the necessity to reconsider past conclusions made about plant resistance to drought based on branch xylem only. As a result, this study also highlights the necessity for more research of whole-plant hydraulic physiology to better understand strategies of plant drought tolerance and the critical control points within the hydraulic pathway.« less

A test of the hydraulic vulnerability segmentation hypothesis in angiosperm and conifer tree species

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

Johnson, Daniel M.; Wortemann, Remi; McCulloh, Katherine A.

Water transport from soils to the atmosphere is critical for plant growth and survival. However, we have a limited understanding about many portions of the whole-tree hydraulic pathway, because the vast majority of published information is on terminal branches. Our understanding of mature tree trunk hydraulic physiology, in particular, is limited. The hydraulic vulnerability segmentation hypothesis (HVSH) stipulates that distal portions of the plant (leaves, branches and roots) should be more vulnerable to embolism than trunks, which are non-redundant organs that require a massive carbon investment. In the current study, we compared vulnerability to loss of hydraulic function, leaf andmore » xylem water potentials and the resulting hydraulic safety margins (in relation to the water potential causing 50% loss of hydraulic conductivity) in leaves, branches, trunks and roots of four angiosperms and four conifer tree species. Across all species, our results supported strongly the HVSH as leaves and roots were less resistant to embolism than branches or trunks. However, branches were consistently more resistant to embolism than any other portion of the plant, including trunks. Also, calculated whole-tree vulnerability to hydraulic dysfunction was much greater than vulnerability in branches. This was due to hydraulic dysfunction in roots and leaves at less negative water potentials than those causing branch or trunk dysfunction. Leaves and roots had narrow or negative hydraulic safety margins, but trunks and branches maintained positive safety margins. By using branch-based hydraulic information as a proxy for entire plants, much research has potentially overestimated embolism resistance, and possibly drought tolerance, for many species. This study highlights the necessity to reconsider past conclusions made about plant resistance to drought based on branch xylem only. As a result, this study also highlights the necessity for more research of whole-plant hydraulic physiology to better understand strategies of plant drought tolerance and the critical control points within the hydraulic pathway.« less

NASA's Spaceliner Investment Area Technology Activities

NASA Technical Reports Server (NTRS)

Hueter, Uwe; Lyles, Garry M. (Technical Monitor)

2001-01-01

NASA's has established long term goals for access-to-space. The third generation launch systems are to be fully reusable and operational around 2025. The goals for the third generation launch system are to significantly reduce cost and improve safety over current conditions. The Advanced Space Transportation Program Office (ASTP) at the NASA's Marshall Space Flight Center in Huntsville, AL has the agency lead to develop space transportation technologies. Within ASTP, under the Spaceliner Investment Area, third generation technologies are being pursued in the areas of propulsion, airframes, integrated vehicle health management (IVHM), avionics, power, operations, and range. The ASTP program will mature these technologies through both ground and flight system testing. The Spaceliner Investment Area plans to mature vehicle technologies to reduce the implementation risks for future commercially developed reusable launch vehicles (RLV). The plan is to substantially increase the design and operating margins of the third generation RLV (the Space Shuttle is the first generation) by incorporating advanced technologies in propulsion, materials, structures, thermal protection systems, avionics, and power. Advancements in design tools and better characterization of the operational environment will allow improvements in design margins. Improvements in operational efficiencies will be provided through use of advanced integrated health management, operations, and range technologies. The increase in margins will allow components to operate well below their design points resulting in improved component operating life, reliability, and safety which in turn reduces both maintenance and refurbishment costs. These technologies have the potential of enabling horizontal takeoff by reducing the takeoff weight and achieving the goal of airline-like operation. These factors in conjunction with increased flight rates from an expanding market will result in significant improvements in safety and reductions in operational costs of future vehicles. The paper describes current status, future plans and technologies that are being matured by the Spaceliner Investment Area under the Advanced Space Transportation Program Office.

Financial Stability of Level I Trauma Centers Within Safety-Net Hospitals.

PubMed

Knowlton, Lisa M; Morris, Arden M; Tennakoon, Lakshika; Spain, David A; Staudenmayer, Kristan L

2018-04-20

Level I trauma centers often exist within safety-net hospitals (SNHs), facilities servicing high proportions of low-income and uninsured patients. Given the current health care funding environment, trauma centers within SNHs may be at particular risk. Using California as a model, we hypothesized that SNHs with trauma centers vary in terms of financial stability. We performed a retrospective cohort study using data from publicly available financial disclosure reports from California's Office of Statewide Health Planning and Development. Safety-net hospitals were identified from the California Association of Public Hospitals and Health Systems. The primary outcomes metric for financial performance was operating margin. California hospitals with Level I trauma centers were analyzed (11 SNH sites, 2 non SNH). The SNHs did not behave uniformly, and were clustered into county-owned SNHs (36%, n = 4) and nonprofit-owned SNHs (64%, n = 7). Mean operating margins for county SNHs, nonprofit SNHs, and non SNHs were -16.5%, 8.4%, and 9.5%, respectively (p < 0.001). From 2010 to 2015, operating margins improved for all hospitals, partly due to increases in the percent of insured patients and changes in payer mix. Nonprofit SNHs had a payer mix similar to that of non SNHs; county SNHs had the highest proportions of MediCal (California Medicaid) (45% vs 36% vs 12%, respectively, p < 0.001) and uninsured patients (17% vs 5% vs 0%, respectively, p < 0.001) compared with nonprofit SNHs and non SNHs, respectively. The majority (85%) of Level I trauma centers are within SNHs, whose financial stability is highly variable. A group of SNHs rely on infusions of government funds and are therefore susceptible to changes in policy. These findings suggest deliberate funding efforts are critical to protect the health of the US academic trauma system. Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Adaptive Flight Control for Aircraft Safety Enhancements

NASA Technical Reports Server (NTRS)

Nguyen, Nhan T.; Gregory, Irene M.; Joshi, Suresh M.

2008-01-01

This poster presents the current adaptive control research being conducted at NASA ARC and LaRC in support of the Integrated Resilient Aircraft Control (IRAC) project. The technique "Approximate Stability Margin Analysis of Hybrid Direct-Indirect Adaptive Control" has been developed at NASA ARC to address the needs for stability margin metrics for adaptive control that potentially enables future V&V of adaptive systems. The technique "Direct Adaptive Control With Unknown Actuator Failures" is developed at NASA LaRC to deal with unknown actuator failures. The technique "Adaptive Control with Adaptive Pilot Element" is being researched at NASA LaRC to investigate the effects of pilot interactions with adaptive flight control that can have implications of stability and performance.

46 CFR 77.35-5 - General.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and Health Administration (MSHA) and the National Institute for Occupational Safety and Health (NIOSH... responsibility of the master and chief engineer to ascertain that a sufficient number of the crew are familiar...

Sense and avoid technology for Global Hawk and Predator UAVs

NASA Astrophysics Data System (ADS)

McCalmont, John F.; Utt, James; Deschenes, Michael; Taylor, Michael J.

2005-05-01

The Sensors Directorate at the Air Force Research Laboratory (AFRL) along with Defense Research Associates, Inc. (DRA) conducted a flight demonstration of technology that could potentially satisfy the Federal Aviation Administration's (FAA) requirement for Unmanned Aerial Vehicles (UAVs) to sense and avoid local air traffic sufficient to provide an "...equivalent level of safety, comparable to see-and-avoid requirements for manned aircraft". This FAA requirement must be satisfied for autonomous UAV operation within the national airspace. The real-time on-board system passively detects approaching aircraft, both cooperative and non-cooperative, using imaging sensors operating in the visible/near infrared band and a passive moving target indicator algorithm. Detection range requirements for RQ-4 and MQ-9 UAVs were determined based on analysis of flight geometries, avoidance maneuver timelines, system latencies and human pilot performance. Flight data and UAV operating parameters were provided by the system program offices, prime contractors, and flight-test personnel. Flight demonstrations were conducted using a surrogate UAV (Aero Commander) and an intruder aircraft (Beech Bonanza). The system demonstrated target detection ranges out to 3 nautical miles in nose-to-nose scenarios and marginal visual meteorological conditions. (VMC) This paper will describe the sense and avoid requirements definition process and the system concept (sensors, algorithms, processor, and flight rest results) that has demonstrated the potential to satisfy the FAA sense and avoid requirements.

Post-surgical management of non-functioning pituitary adenoma.

PubMed

Cortet-Rudelli, Christine; Bonneville, Jean-François; Borson-Chazot, Françoise; Clavier, Lorraine; Coche Dequéant, Bernard; Desailloud, Rachel; Maiter, Dominique; Rohmer, Vincent; Sadoul, Jean Louis; Sonnet, Emmanuel; Toussaint, Patrick; Chanson, Philippe

2015-07-01

Post-surgical surveillance of non-functioning pituitary adenoma (NFPA) is based on magnetic resonance imaging (MRI) at 3 or 6 months then 1 year. When there is no adenomatous residue, annual surveillance is recommended for 5 years and then at 7, 10 and 15 years. In case of residue or doubtful MRI, prolonged annual surveillance monitors any progression. Reintervention is indicated if complete residue resection is feasible, or for symptomatic optic pathway compression, to create a safety margin between the tumor and the optic pathways ahead of complementary radiation therapy (RT), or in case of post-RT progression. In case of residue, unless the tumor displays elevated growth potential, it is usually recommended to postpone RT until progression is manifest, as efficacy is comparable whether treatment is immediate or postponed. The efficacy of the various RT techniques in terms of tumor volume control is likewise comparable. RT-induced hypopituitarism is frequent, whatever the technique. The choice thus depends basically on residue characteristics: size, delineation, and proximity to neighboring radiation-sensitive structures. Reduced rates of vascular complications and secondary brain tumor can be hoped for with one-dose or hypofractionated stereotactic RT, but there has been insufficient follow-up to provide evidence. Somatostatin analogs and dopaminergic agonists have yet to demonstrate sufficient efficacy. Temozolomide is an option in aggressive NFPA resistant to surgery and RT. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Genetically engineered oncolytic Newcastle disease virus mediates cytolysis of prostate cancer stem like cells.

PubMed

Raghunath, Shobana; Pudupakam, Raghavendra Sumanth; Allen, Adria; Biswas, Moanaro; Sriranganathan, Nammalwar

2017-10-20

Oncolytic virotherapy is a promising novel approach that overcomes the limitations posed by radiation and chemotherapy. In this study, the oncolytic efficacy of a recombinant Newcastle disease virus (rNDV) BC-KLQL-GFP, against prostate cancer stem-like/tumor initiating cells was evaluated. Xenograft derived prostaspheres (XPS) induced tumor more efficiently than monolayer cell derived prostaspheres (MCPS) in nude mice. Primary and secondary XPS show enhanced self-renewal and clonogenic potential compared to MCPS. XPS also expressed embryonic stem cell markers, such as Nanog, CD44 and Nestin. Further, prostate specific antigen (PSA) activated recombinant Newcastle Disease Virus (rNDV) was selectively cytotoxic to tumor derived DU145 prostaspheres. An effective concentration (EC 50 ) of 0.11-0.14 multiplicity of infection was sufficient to cause prostasphere cell death in serum free culture. DU145 tumor xenograft derived prostaspheres were used as tumor surrogates as they were enriched for a putative tumor initiating cell population. PSA activated rNDV was efficient in inducing cell death of cells and prostaspheres derived from primary xenografts ex-vivo, thus signifying a potential in vivo efficacy. The EC 50 (∼0.1 MOI) for cytolysis of tumor initiating cells was slightly higher than that was required for the parental cell line, but within the therapeutic margin for safety and efficacy. Copyright © 2017 Elsevier B.V. All rights reserved.

A minimally invasive micro sampler for quantitative sampling with an ultrahigh-aspect-ratio microneedle and a PDMS actuator.

PubMed

Liu, Long; Wang, Yan; Yao, Jinyuan; Yang, Cuijun; Ding, Guifu

2016-08-01

This study describes a novel micro sampler consisting of an ultrahigh-aspect-ratio microneedle and a PDMS actuator. The microneedle was fabricated by a new method which introduced reshaped photoresist technology to form a flow channel inside. The microneedle includes two parts: shaft and pedestal. In this study, the shaft length is 1500 μm with a 45° taper angle on the tip and pedestal is 1000 μm. Besides, the shaft and pedestal are connected by an arc connection structure with a length of 600 μm. The microneedles have sufficient mechanical strength to insert into skin with a wide safety margin which was proved by mechanics tests. Moreover, a PDMS actuator with a chamber inside was designed and fabricated in this study. The chamber, acting as a reservoir in sampling process as well as providing power, was optimized by finite element analysis (FEA) to decrease dead volume and improve sampling precision. The micro sampler just needs finger press to activate the sampling process as well as used for quantitative micro injection to some extent. And a volume of 31.5 ± 0.8 μl blood was successfully sampled from the ear artery of a rabbit. This micro sampler is suitable for micro sampling for diagnose or therapy in biomedical field.

Hydraulic limits preceding mortality in a piñon-juniper woodland under experimental drought.

PubMed

Plaut, Jennifer A; Yepez, Enrico A; Hill, Judson; Pangle, Robert; Sperry, John S; Pockman, William T; McDowell, Nate G

2012-09-01

Drought-related tree mortality occurs globally and may increase in the future, but we lack sufficient mechanistic understanding to accurately predict it. Here we present the first field assessment of the physiological mechanisms leading to mortality in an ecosystem-scale rainfall manipulation of a piñon-juniper (Pinus edulis-Juniperus monosperma) woodland. We measured transpiration (E) and modelled the transpiration rate initiating hydraulic failure (E(crit) ). We predicted that isohydric piñon would experience mortality after prolonged periods of severely limited gas exchange as required to avoid hydraulic failure; anisohydric juniper would also avoid hydraulic failure, but sustain gas exchange due to its greater cavitation resistance. After 1 year of treatment, 67% of droughted mature piñon died with concomitant infestation by bark beetles (Ips confusus) and bluestain fungus (Ophiostoma spp.); no mortality occurred in juniper or in control piñon. As predicted, both species avoided hydraulic failure, but safety margins from E(crit) were much smaller in piñon, especially droughted piñon, which also experienced chronically low hydraulic conductance. The defining characteristic of trees that died was a 7 month period of near-zero gas exchange, versus 2 months for surviving piñon. Hydraulic limits to gas exchange, not hydraulic failure per se, promoted drought-related mortality in piñon pine. © 2012 Blackwell Publishing Ltd.

The Parable of the Boiled Safety Professional

NASA Technical Reports Server (NTRS)

Shivers, Charles H.

2011-01-01

Common and unique issues contribute to system failures. This paper touches on the concept of drift to failure as a cautionary message. Managers and leaders, design team members, fabricators and assemblers, analysis and assurance personnel, and others associated with operating and maintaining systems, need to pay attention to identify the manifestation of individual and collective behaviors that might indicate slips in rigor or focus or decisions that might eat away at safety margins as our system drifts to failure. Corrections to drift made during design and development phases may efficiently prevent or mitigate drift problems occurring in the operational phase.

The architecture of safety: hospital design.

PubMed

Joseph, Anjali; Rashid, Mahbub

2007-12-01

This paper reviews recent research literature reporting the effects of hospital design on patient safety. Features of hospital design that are linked to patient safety in the literature include noise, air quality, lighting conditions, patient room design, unit layout, and several other interior design features. Some of these features act as latent conditions for adverse events, and impact safety outcomes directly and indirectly by impacting staff working conditions. Others act as barriers to adverse events by providing hospital staff with opportunities for preventing accidents before they occur. Although the evidence linking hospital design to patient safety is growing, much is left to be done in this area of research. Nevertheless, the evidence reported in the literature may already be sufficient to have a positive impact on hospital design.

A review and assessment of non-governmental organization-based STD/AIDS education and prevention projects for marginalized groups.

PubMed

Crane, S F; Carswell, J W

1992-06-01

A review of projects run by non-governmental organizations (NGOs) in primarily developing countries, which have aimed to provide STD/AIDS education and prevention skills to various marginalized groups, reveals that past quantitative and formative research has failed to identify key programmatic factors which lead to more successful project implementation and sustainability. In observations, interviews with field staff, visits to program sites and information drawn from the literature, a variety of methods to reach a wide range of groups such as men who have sex with men, prostitutes, clients of prostitutes, prisoners, street children, migrant workers and refugees are explored. Factors found to facilitate project success include the following: at least one full-time committed staff member; respectful treatment and appropriate motivation of the target group; suitable and sufficient equipment and supplies (particularly condoms); planning ahead for the participation of HIV-positive individuals and ways to meet their needs; focusing on qualitative rather than quantitative evaluation; planning in advance beyond a 9 or 12 month 'model'. Despite some evidence that marginalized groups can be successfully motivated to practise safer sex through prevention education, long-term behaviour change still presents major challenges--even when specific conditions are met.

Buried Mesozoic rift basins of Moroccan Atlantic continental margin

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

Mohamed, N.; Jabour, H.; El Mostaine, M.

1995-08-01

The Atlantic continental margin is the largest frontier area for oil and gas exploration in Morocco. Most of the activity has been concentrated where Upper Jurassic carbonate rocks have been the drilling objectives, with only one significant but non commercial oil discovery. Recent exploration activities have focused on early Mesozoic Rift basins buried beneath the post-rift sediments of the Middle Atlantic coastal plain. Many of these basins are of interest because they contain fine-grained lacustrine rocks that have sufficient organic richness to be classified as efficient oil prone source rock. Location of inferred rift basins beneath the Atlantic coastal plainmore » were determined by analysis of drilled-hole data in combination with gravity anomaly and aeromagnetic maps. These rift basins are characterized by several half graben filled by synrift sediments of Triassic age probably deposited in lacustrine environment. Coeval rift basins are known to be present in the U.S. Atlantic continental margin. Basin modeling suggested that many of the less deeply bored rift basins beneath the coastal plain are still within the oil window and present the most attractive exploration targets in the area.« less

Half forehead reconstruction with a single rotational scalp flap for dermatofibrosarcoma protuberans treatment.

PubMed

Mori, Stefano; Di Monta, Gianluca; Marone, Ugo; Chiofalo, Maria Grazia; Caracò, Corrado

2012-05-06

Dermatofibrosarcoma protuberans (DFSP) is a soft tissue neoplasm of intermediate to low-grade malignancy. Although metastasis rarely occurs, DFSP has a locally aggressive behavior with a high recurrence rate. In the head and neck area, resection involving a wide margin of healthy tissue can be difficult because of functional and cosmetic considerations. We describe a novel reconstructive method for half forehead defects with an innovative single local wide scalp flap following excision of DFSP with a 3 cm margin of healthy tissue. Two patients underwent wide resection of forehead DFSP and reconstruction with a single rotational scalp flap. The scalp flap blood supply was provided from three main vessels: the superficial temporal artery, occipital artery and posterior auricular artery. No early or late complications were observed in either patient with no local recurrence after 18 months of follow-up. The donor area could be closed primarily in both cases and the flaps survived completely. This innovative technique allowed a radical excision of forehead DFSP with sufficient healthy margins, thus potentially decreasing tumor recurrence rate. Reconstruction was achieved avoiding microsurgery, skin expanders and large skin grafts. Moreover, all main reconstructive criteria, such as functional and cosmetic tissue characteristics, were completely fulfilled.

Costs and financial feasibility of malaria elimination

PubMed Central

Sabot, Oliver; Cohen, Justin M; Hsiang, Michelle S; Kahn, James G; Basu, Suprotik; Tang, Linhua; Zheng, Bin; Gao, Qi; Zou, Linda; Tatarsky, Allison; Aboobakar, Shahina; Usas, Jennifer; Barrett, Scott; Cohen, Jessica L; Jamison, Dean T; Feachem, Richard GA

2010-01-01

Summary The marginal costs and benefits of converting malaria programmes from a control to an elimination goal are central to strategic decisions, but empirical evidence is scarce. We present a conceptual framework to assess the economics of elimination and analyse a central component of that framework—potential short-term to medium-term financial savings. After a review that showed a dearth of existing evidence, the net present value of elimination in five sites was calculated and compared with effective control. The probability that elimination would be cost-saving over 50 years ranged from 0% to 42%, with only one site achieving cost-savings in the base case. These findings show that financial savings should not be a primary rationale for elimination, but that elimination might still be a worthy investment if total benefits are sufficient to outweigh marginal costs. Robust research into these elimination benefits is urgently needed. PMID:21035839

Modeling and Analysis of Wholesale Electricity Market Design. Understanding the Missing Money Problem. December 2013 - January 2015

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

Papalexopoulos, A.; Hansen, C.; Perrino, D.

This project examined the impact of renewable energy sources, which have zero incremental energy costs, on the sustainability of conventional generation. This “missing money” problem refers to market outcomes in which infra-marginal energy revenues in excess of operations and maintenance (O&M) costs are systematically lower than the amortized costs of new entry for a marginal generator. The problem is caused by two related factors: (1) conventional generation is dispatched less, and (2) the price that conventional generation receives for its energy is lower. This lower revenue stream may not be sufficient to cover both the variable and fixed costs ofmore » conventional generation. In fact, this study showed that higher wind penetrations in the Electric Reliability Council of Texas (ERCOT) system could cause many conventional generators to become uneconomic.« less

Deformations of superconformal theories

DOE PAGES

Córdova, Clay; Dumitrescu, Thomas T.; Intriligator, Kenneth

2016-11-22

Here, we classify possible supersymmetry-preserving relevant, marginal, and irrelevant deformations of unitary superconformal theories in d ≥ 3 dimensions. Our method only relies on symmetries and unitarity. Hence, the results are model independent and do not require a Lagrangian description. Two unifying themes emerge: first, many theories admit deformations that reside in multiplets together with conserved currents. Such deformations can lead to modifications of the supersymmetry algebra by central and noncentral charges. Second, many theories with a sufficient amount of supersymmetry do not admit relevant or marginal deformations, and some admit neither. The classification is complicated by the fact thatmore » short superconformal multiplets display a rich variety of sporadic phenomena, including supersymmetric deformations that reside in the middle of a multiplet. We illustrate our results with examples in diverse dimensions. In particular, we explain how the classification of irrelevant supersymmetric deformations can be used to derive known and new constraints on moduli-space effective actions.« less

New research opportunities for roadside safety barriers improvement

NASA Astrophysics Data System (ADS)

Cantisani, Giuseppe; Di Mascio, Paola; Polidori, Carlo

2017-09-01

Among the major topics regarding the protection of roads, restraint systems still represent a big opportunity in order to increase safety performances. When accidents happen, in fact, the infrastructure can substantially contribute to the reduction of consequences if its marginal spaces are well designed and/or effective restraint systems are installed there. Nevertheless, basic concepts and technology of road safety barriers have not significantly changed for the last two decades. The paper proposes a new approach to the study aimed to define possible enhancements of restraint safety systems performances, by using new materials and defining innovative design principles. In particular, roadside systems can be developed with regard to vehicle-barrier interaction, vehicle-oriented design (included low-mass and extremely low-mass vehicles), traffic suitability, user protection, working width reduction. In addition, thanks to sensors embedded into the barriers, it is also expected to deal with new challenges related to the guidance of automatic vehicles and I2V communication.

Comparisons of Wilks’ and Monte Carlo Methods in Response to the 10CFR50.46(c) Proposed Rulemaking

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

Zhang, Hongbin; Szilard, Ronaldo; Zou, Ling

The Nuclear Regulatory Commission (NRC) is proposing a new rulemaking on emergency core system/loss-of-coolant accident (LOCA) performance analysis. In the proposed rulemaking, designated as 10CFR50.46(c), the US NRC put forward an equivalent cladding oxidation criterion as a function of cladding pre-transient hydrogen content. The proposed rulemaking imposes more restrictive and burnup-dependent cladding embrittlement criteria; consequently nearly all the fuel rods in a reactor core need to be analyzed under LOCA conditions to demonstrate compliance to the safety limits. New analysis methods are required to provide a thorough characterization of the reactor core in order to identify the locations of themore » limiting rods as well as to quantify the safety margins under LOCA conditions. With the new analysis method presented in this work, the limiting transient case and the limiting rods can be easily identified to quantify the safety margins in response to the proposed new rulemaking. In this work, the best-estimate plus uncertainty (BEPU) analysis capability for large break LOCA with the new cladding embrittlement criteria using the RELAP5-3D code is established and demonstrated with a reduced set of uncertainty parameters. Both the direct Monte Carlo method and the Wilks’ nonparametric statistical method can be used to perform uncertainty quantification. Wilks’ method has become the de-facto industry standard to perform uncertainty quantification in BEPU LOCA analyses. Despite its widespread adoption by the industry, the use of small sample sizes to infer statement of compliance to the existing 10CFR50.46 rule, has been a major cause of unrealized operational margin in today’s BEPU methods. Moreover the debate on the proper interpretation of the Wilks’ theorem in the context of safety analyses is not fully resolved yet, even more than two decades after its introduction in the frame of safety analyses in the nuclear industry. This represents both a regulatory and application risk in rolling out new methods. With the 10CFR50.46(c) proposed rulemaking, the deficiencies of the Wilks’ approach are further exacerbated. The direct Monte Carlo approach offers a robust alternative to perform uncertainty quantification within the context of BEPU analyses. In this work, the Monte Carlo method is compared with the Wilks’ method in response to the NRC 10CFR50.46(c) proposed rulemaking.« less

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2015-10-01

RAVEN is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncertainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters that need tomore » be perturbed are accessible by inputs files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused toward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN has started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assessment capability to RELAP-7, currently under development at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activaties are currently ongoing for coupling RAVEN with software such as RELAP5-3D, etc. The aim of this document is the explanation of the input requirements, focalizing on the input structure.« less

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2016-02-01

RAVEN is a generic software framework to perform parametric and probabilistic analysis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncertainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters that need tomore » be perturbed are accessible by input files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused toward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is interested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assessment capability to RELAP-7, currently under development at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activates are currently ongoing for coupling RAVEN with software such as RELAP5-3D, etc. The aim of this document is the explanation of the input requirements, focusing on the input structure.« less

RAVEN User Manual

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

Mandelli, Diego; Rabiti, Cristian; Cogliati, Joshua Joseph

2017-03-01

RAVEN is a generic software framework to perform parametric and probabilistic analy- sis based on the response of complex system codes. The initial development was aimed to provide dynamic risk analysis capabilities to the Thermo-Hydraulic code RELAP-7, currently under development at the Idaho National Laboratory (INL). Although the initial goal has been fully accomplished, RAVEN is now a multi-purpose probabilistic and uncer- tainty quantification platform, capable to agnostically communicate with any system code. This agnosticism includes providing Application Programming Interfaces (APIs). These APIs are used to allow RAVEN to interact with any code as long as all the parameters thatmore » need to be perturbed are accessible by inputs files or via python interfaces. RAVEN is capable of investigating the system response, and investigating the input space using Monte Carlo, Grid, or Latin Hyper Cube sampling schemes, but its strength is focused to- ward system feature discovery, such as limit surfaces, separating regions of the input space leading to system failure, using dynamic supervised learning techniques. The development of RAVEN has started in 2012, when, within the Nuclear Energy Advanced Modeling and Simulation (NEAMS) program, the need to provide a modern risk evaluation framework became stronger. RAVEN principal assignment is to provide the necessary software and algorithms in order to employ the concept developed by the Risk Informed Safety Margin Characterization (RISMC) program. RISMC is one of the pathways defined within the Light Water Reactor Sustainability (LWRS) program. In the RISMC approach, the goal is not just the individuation of the frequency of an event potentially leading to a system failure, but the closeness (or not) to key safety-related events. Hence, the approach is in- terested in identifying and increasing the safety margins related to those events. A safety margin is a numerical value quantifying the probability that a safety metric (e.g. for an important process such as peak pressure in a pipe) is exceeded under certain conditions. The initial development of RAVEN has been focused on providing dynamic risk assess- ment capability to RELAP-7, currently under develop-ment at the INL and, likely, future replacement of the RELAP5-3D code. Most the capabilities that have been implemented having RELAP-7 as principal focus are easily deployable for other system codes. For this reason, several side activates are currently ongoing for coupling RAVEN with soft- ware such as RELAP5-3D, etc. The aim of this document is the explaination of the input requirements, focalizing on the input structure.« less

Flooding Capability for River-based Scenarios

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

Smith, Curtis L.; Prescott, Steven; Ryan, Emerald

2015-10-01

This report describes the initial investigation into modeling and simulation tools for application of riverine flooding representation as part of the Risk-Informed Safety Margin Characterization (RISMC) Pathway external hazards evaluations. The report provides examples of different flooding conditions and scenarios that could impact river and watershed systems. Both 2D and 3D modeling approaches are described.

The Violence Continuum: Creating a Safe School Climate

ERIC Educational Resources Information Center

Manvell, Elizabeth C.

2012-01-01

We expect schools to be a safe haven, but after more than a decade of targeted school violence prevention laws and safety plans, students are still marginalized and bullied to the point of despondence, retaliation, and even suicide. This thoughtful exploration of what makes a school a safe place is based on the understanding that violence is a…

Moving from the Margins: Culturally Safe Teacher Education in Remote Northwestern British Columbia

ERIC Educational Resources Information Center

Harrison, Edward B.; Lautensach, Alexander K.; McDonald, Verna Lynn

2012-01-01

In 2007 the University of Northern British Columbia initiated a two-year elementary teacher education program at the Northwest Campus in Terrace, British Columbia. The program was designed to meet specific community needs in the North that arise from inequities in the cultural safety of Indigenous teachers and students. The authors share three…

Planning, evaluation and analytical studies in planetary quarantine and spacecraft sterilization

NASA Technical Reports Server (NTRS)

1972-01-01

The technical and analytical support used to aid in developing requirements for planetary quarantine are presented. The investigation was divided into 8 work tasks which are presented in tabular form. Data include methods of sterilization, safety margins for quarantine, revision of contamination logs for Mars and Venus, and estimates of encapsulated and 'free' microbial burden.

Stress analysis of 27% scale model of AH-64 main rotor hub

NASA Technical Reports Server (NTRS)

Hodges, R. V.

1985-01-01

Stress analysis of an AH-64 27% scale model rotor hub was performed. Component loads and stresses were calculated based upon blade root loads and motions. The static and fatigue analysis indicates positive margins of safety in all components checked. Using the format developed here, the hub can be stress checked for future application.

The challenging scales of the bird: Shuttle tile structural integrity

NASA Technical Reports Server (NTRS)

Schneider, W. C.; Miller, G. J.

1985-01-01

The principal design issues, tests, and analyses required to solve the tile integrity problem on the space shuttle orbiters are addressed. Proof testing of installed tiles is discussed along with an airflow test of special tiles. Orbiter windshield tiles are considered in terms of changes necessary to ensure acceptable margins of safety for flight.

Protect Children Instead of Guns, 2000.

ERIC Educational Resources Information Center

Children's Defense Fund, Washington, DC.

Noting that firearms outnumber children by a margin of almost three to one in the United States, this report advocates gun safety policies to protect children. The report provides information on trends in youth firearm deaths from 1994 and 1999 and comparisons of U.S. data to those of other industrialized countries. A table delineates 1996-1998…

Toxicology: Bee P450s Take the Sting out of Cyanoamidine Neonicotinoids.

PubMed

Feyereisen, René

2018-05-07

The neonicotinoid insecticides have raised concerns regarding the health of bee pollinators. New research has identified a P450 enzyme that protects honey bees and bumble bees from the toxicity of two neonicotinoids, thiacloprid and acetamiprid. This P450 enzyme provides a margin of safety to bees. Copyright © 2018 Elsevier Ltd. All rights reserved.

Aviation Weather for Pilots and Flight Operations Personnel.

ERIC Educational Resources Information Center

National Oceanic and Atmospheric Administration (DOC), Rockville, MD. National Weather Service.

The revised Aviation Weather book discusses each aspect of weather as it relates to aircraft operations and flight safety. The book is not an aircraft operating manual and omits all reference to specific weather services. Much of the book has been devoted to marginal, hazardous, and violent weather. It teaches pilots to learn to appreciate good…

Am I Safe Here? LGBTQ Teens and Bullying in Schools

ERIC Educational Resources Information Center

Short, Donn

2017-01-01

"Am I safe here?" LGBTQ students ask this question every day within the school system. This book shines a light on the marginalization and bullying faced by LGBTQ youth, offering a new conceptualization of school safety. Donn Short treats students as the experts on what happens in their schools, giving them a chance to speak for…

Xylem hydraulic safety margins in woody plants: coordination of stomatal control of xylem tension with hydraulic capacitance

Treesearch

Frederick C. Meinzer; Daniel M. Johnson; Barbara Lachenbruch; Katherine A. McCulloh; David R. Woodruff

2009-01-01

The xylem pressure inducing 50% loss of hydraulic conductivity due to embolism (P50) is widely used for comparisons of xylem vulnerability among species and across aridity gradients. However, despite its utility as an index of resistance to catastrophic xylem failure under extreme drought, P50 may have no special...

Ergonomics and dentistry.

PubMed

Murphy, D C

1997-01-01

Since 1992 the Occupational Safety and Health Administration (OSHA) has been preparing Federal legislation concerned with ergonomic hazards in at-risk workplaces. Although multifactorial in nature, there is sufficient evidence in the scientific literature to document an association between the practice of dentistry and a variety of musculoskeletal disorders. There are preventive strategies already known and available to us. Should dentistry be considered an at-risk profession and be required to comply with the forthcoming standard, or is self-monitoring sufficient?

An Investigation Into Low Fuel Pressure Warnings on a Macchi-Viper Aircraft

DTIC Science & Technology

1988-05-01

was sufficient To activate the low pressure warning light. The pressure switch is normally set to a differential of between 2.5 - 3 psi. Partial...only a 2.1 psig margin for light illumination, if the pressure switch is set at 3 psig, and gives little scope for extra pipe or filter losses when... pressure switch is set between 2.5 - 3 psig. Any untoward pressure resistance in the fuel delivery line and filtering system would soon erode this

Palladium-chromium static strain gage for high temperature propulsion systems

NASA Technical Reports Server (NTRS)

Lei, Jih-Fen

1991-01-01

The present electrical strain gage for high temperature static strain measurements is in its fine-wire and thin-film forms designed to be temperature-compensated on any substrate material. The gage element is of Pd-Cr alloy, while the compensator is of Pt. Because the thermally-induced apparent strain of this compensated wire strain gage is sufficiently small, with good reproducibility between thermal cycles to 800 C, output figures can be corrected within a reasonable margin of error.

Erosional dynamics, flexural isostasy, and long-lived escarpments: A numerical modeling study

NASA Technical Reports Server (NTRS)

Tucker, Gregory E.; Slingerland, Rudy L.

1994-01-01

Erosional escarpments common features of high-elevation rifted continets. Fission track data suffest that these escarpments form by base level lowering and/or marginal uplift during rifting, followed by lateral retreat of an erosion front across tens to hundreds of kioometers. Previous modeling studies have shown that this characteristic pattern of denudation can have a profound impact upon marginal isostatic uplift and the evolution of offshore sedimentary basins. Yet at present there is only a rudimentary understanding of the geomorphic mechanisms capable of driving such prolonged escarpment retreat. In this study we present a nonlinear, two-dimensional landscape evolution model tha tis used to asses the necessary and sufficient conditions for long-term retreat of a rift-generated escarpment. The model represents topography as a grid of cells, with drainage networkds evolving as water flows across the grid in the direction of steepest descent. The model accounts for sediment production by weathering, fluvial sediment transport, bedrock channel erosion, and hillslope sediment transport by diffusive mechanisms and by mass failure. Numerical experiments presented explore the effects of different combinations of erosion processes and of dynamic coupling between denudation and flexural isostatic uplift. Model results suggest that the necessary and sufficient conditions for long-term escarpment retreat are (1) incising bedrock channels in which the erosion rate increases with increasing drainage area, so that the channels steepen and propagate headward; (2) a low rate of sediment production relative to sediment transport efficiency, which promotes relief-generating processes over diffusive ones; (3) high continental elevation, which allows greater freedom for fluvial dissection; and (4) any process, including flexural isostatic uplift, that helps to maintain a drainage divide near an escarpment crest. Flexural isostatic uplift also facilitates escarpment, thereby increasing channel gradients and accelerating erosion which in turn generates additional isostatic uplift. Of all the above conditions, high continental elevation is common ot most rift margin escarpments and may ultimately be the most important factor.

Acceptance Testing of a Satellite SCADA Photovoltaic-Diesel Hybrid System

NASA Technical Reports Server (NTRS)

Kalu, A.; Emrich, C.; Ventre, G.; Wilson, W.; Acosta, Roberto (Technical Monitor)

2000-01-01

Satellite Supervisory Control and Data Acquisition (SCADA) of a Photovoltaic (PV)/diesel hybrid system was tested using NASA's Advanced Communication Technology Satellite (ACTS) and Ultra Small Aperture Terminal (USAT) ground stations. The setup consisted of a custom-designed PV/diesel hybrid system, located at the Florida Solar Energy Center (FSEC), which was controlled and monitored at a "remote" hub via Ka-band satellite link connecting two 1/4 Watt USATs in a SCADA arrangement. The robustness of the communications link was tested for remote monitoring of the health and performance of a PV/diesel hybrid system, and for investigating load control and battery charging strategies to maximize battery capacity and lifetime, and minimize loss of critical load probability. Baseline hardware performance test results demonstrated that continuous two-second data transfers can be accomplished under clear sky conditions with an error rate of less than 1%. The delay introduced by the satellite (1/4 sec) was transparent to synchronization of satellite modem as well as to the PV/diesel-hybrid computer. End-to-end communications link recovery times were less than 36 seconds for loss of power and less than one second for loss of link. The system recovered by resuming operation without any manual intervention, which is important since the 4 dB margin is not sufficient to prevent loss of the satellite link during moderate to heavy rain. Hybrid operations during loss of communications link continued seamlessly but real-time monitoring was interrupted. For this sub-tropical region, the estimated amount of time that the signal fade will exceed the 4 dB margin is about 10%. These results suggest that data rates of 4800 bps and a link margin of 4 dB with a 1/4 Watt transmitter are sufficient for end-to-end operation in this SCADA application.

Safety Challenges and Improvement Strategies of Ethnic Minority Construction Workers: A Case Study in Hong Kong.

PubMed

Wu, Chunlin; Luo, Xiaowei; Wang, Tao; Wang, Yue; Sapkota, Bibek

2018-04-18

Due to cultural differences, ethnic minority construction workers are more difficult to manage and more vulnerable to accidents. This study aims to identify the major barriers faced by ethnic minority workers from their own perspectives and determine potential strategies to enhance safety climate of construction projects, thus ultimately improve their safety performance. A survey with modified Nordic safety climate questionnaire was conducted in a certain sub-contractor in Hong Kong. In-depth interviews, status quo description, major challenge investigation and safety knowledge tests were carried as well. The top three most important safety challenges identified are improper stereotypes from the whole industry, lack of opportunities for job assignment, and language barriers. To improve the safety performance, employers should allocate sufficient personal protective equipment and governments should organize unannounced site visits more frequently. Besides, the higher-level management should avoid giving contradictory instructions to foremen against to the standards of supervisors.

Safety-I, Safety-II and Resilience Engineering.

PubMed

Patterson, Mary; Deutsch, Ellen S

2015-12-01

In the quest to continually improve the health care delivered to patients, it is important to understand "what went wrong," also known as Safety-I, when there are undesired outcomes, but it is also important to understand, and optimize "what went right," also known as Safety-II. The difference between Safety-I and Safety-II are philosophical as well as pragmatic. Improving health care delivery involves understanding that health care delivery is a complex adaptive system; components of that system impact, and are impacted by, the actions of other components of the system. Challenges to optimal care include regular, irregular and unexampled threats. This article addresses the dangers of brittleness and miscalibration, as well as the value of adaptive capacity and margin. These qualities can, respectively, detract from or contribute to the emergence of organizational resilience. Resilience is characterized by the ability to monitor, react, anticipate, and learn. Finally, this article celebrates the importance of humans, who make use of system capabilities and proactively mitigate the effects of system limitations to contribute to successful outcomes. Copyright © 2015 Mosby, Inc. All rights reserved.

Does the width of the surgical margin of safety or premalignant dermatoses at the negative surgical margin affect outcome in surgically treated penile cancer?

PubMed

Gunia, Sven; Koch, Stefan; Jain, Anjun; May, Matthias

2014-03-01

To evaluate the prognostic impact of the width of negative surgical margins (NSM) and associated and preinvasive lesions at the NSM in patients with penile squamous cell cancer (PSC). Enrolling 87 patients with NSM who underwent surgery for PSC, the archived margin slides and entirely wax-embedded surgical margins were retrieved from the pathology files. After step sections were cut, margins were stained with antibodies against CK5/6, p16, p53 and Ki-67 and subjected to in situ hybridisation for high-risk human papillomavirus (HPV). All NSM were histologically examined for squamous hyperplasia (SH), lichen sclerosus (LS) and subtypes of penile intraepithelial neoplasia (PeIN). Then, histological findings were correlated with cancer-specific mortality (CSM, median follow-up 34 months; IQR 6-70). All NSM were negative for high-risk HPV and exhibited SH (p16 and p53 negative, Ki-67 variably positive), LS (p16 negative, variable p53 and Ki-67 positivity) and differentiated PeIN (dPeIN; p16 negative, Ki-67 positive, variable p53 positivity) in 28 (32%), 30 (34%) and 22 (25%) cases, respectively, whereas PeIN subtypes other then dPeIN did not occur. Pathological tumour stage was the only independent predictive parameter with respect to CSM in the multivariable analysis (p=0.001). SH, LS and dPeIN are frequent histological findings at the NSM of surgically treated PSC. However, neither the width of the NSM nor dPeIN, LS or SH at the NSM influences prognostic outcome.

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations

PubMed Central

Hariharan, Prasanna; D’Souza, Gavin A.; Horner, Marc; Morrison, Tina M.; Malinauskas, Richard A.; Myers, Matthew R.

2017-01-01

A “credible” computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing “model credibility” is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a “threshold-based” validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results (“S”) of velocity and viscous shear stress were compared with inter-laboratory experimental measurements (“D”). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student’s t-test. However, following the threshold-based approach, a Student’s t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be considered sufficiently validated for the COU. However, for Re = 6500, at certain locations where the shear stress is close the hemolysis threshold, the CFD model could not be considered sufficiently validated for the COU. Our analysis showed that the model could be sufficiently validated either by reducing the uncertainties in experiments, simulations, and the threshold or by increasing the sample size for the experiments and simulations. The threshold approach can be applied to all types of computational models and provides an objective way of determining model credibility and for evaluating medical devices. PMID:28594889

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations.

PubMed

Hariharan, Prasanna; D'Souza, Gavin A; Horner, Marc; Morrison, Tina M; Malinauskas, Richard A; Myers, Matthew R

2017-01-01

A "credible" computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing "model credibility" is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a "threshold-based" validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results ("S") of velocity and viscous shear stress were compared with inter-laboratory experimental measurements ("D"). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student's t-test. However, following the threshold-based approach, a Student's t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be considered sufficiently validated for the COU. However, for Re = 6500, at certain locations where the shear stress is close the hemolysis threshold, the CFD model could not be considered sufficiently validated for the COU. Our analysis showed that the model could be sufficiently validated either by reducing the uncertainties in experiments, simulations, and the threshold or by increasing the sample size for the experiments and simulations. The threshold approach can be applied to all types of computational models and provides an objective way of determining model credibility and for evaluating medical devices.

HSE's safety assessment principles for criticality safety.

PubMed

Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

2008-06-01

The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf).

Correlation between safety climate and contractor safety assessment programs in construction.

PubMed

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

WE-AB-209-08: Novel Beam-Specific Adaptive Margins for Reducing Organ-At-Risk Doses

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

Tsang, H; Kamerling, CP; Ziegenhein, P

2016-06-15

Purpose: Current practice of using 3D margins in radiotherapy with high-energy photon beams provides larger-than-required target coverage. According to the photon depth-dose curve, target displacements in beam direction result in minute changes in dose delivered. We exploit this behavior by generating margins on a per-beam basis which simultaneously account for the relative distance of the target and adjacent organs-at-risk (OARs). Methods: For each beam, we consider only geometrical uncertainties of the target location perpendicular to beam direction. By weighting voxels based on its proximity to an OAR, we generate adaptive margins that yield similar overall target coverage probability and reducedmore » OAR dose-burden, at the expense of increased target volume. Three IMRT plans, using 3D margins and 2D per-beam margins with and without adaptation, were generated for five prostate patients with a prescription dose Dpres of 78Gy in 2Gy fractions using identical optimisation constraints. Systematic uncertainties of 1.1, 1.1, 1.5mm in the LR, SI, and AP directions, respectively, and 0.9, 1.1, 1.0mm for the random uncertainties, were assumed. A verification tool was employed to simulate the effects of systematic and random errors using a population size of 50,000. The fraction of the population that satisfies or violates a given DVH constraint was used for comparison. Results: We observe similar target coverage across all plans, with at least 97.5% of the population meeting the D98%>95%Dpres constraint. When looking at the probability of the population receiving D5<70Gy for the rectum, we observed median absolute increases of 23.61% (range, 2.15%–27.85%) and 6.97% (range, 0.65%–17.76%) using per-beam margins with and without adaptation, respectively, relative to using 3D margins. Conclusion: We observed sufficient and similar target coverage using per-beam margins. By adapting each per-beam margin away from an OAR, we can further reduce OAR dose without significantly lowering target coverage probability by irradiating more less-important tissues. This work is supported by Cancer Research UK under Programme C33589/A19908. Research at ICR is also supported by Cancer Research UK under Programme C33589/A19727 and NHS funding to the NIHR Biomedical Research Centre at RMH and ICR.« less

Fragility Analysis of Concrete Gravity Dams

NASA Astrophysics Data System (ADS)

Tekie, Paulos B.; Ellingwood, Bruce R.

2002-09-01

Concrete gravity dams are an important part ofthe nation's infrastructure. Many dams have been in service for over 50 years, during which time important advances in the methodologies for evaluation of natural phenomena hazards have caused the design-basis events to be revised upwards, in some cases significantly. Many existing dams fail to meet these revised safety criteria and structural rehabilitation to meet newly revised criteria may be costly and difficult. A probabilistic safety analysis (PSA) provides a rational safety assessment and decision-making tool managing the various sources of uncertainty that may impact dam performance. Fragility analysis, which depicts fl%e uncertainty in the safety margin above specified hazard levels, is a fundamental tool in a PSA. This study presents a methodology for developing fragilities of concrete gravity dams to assess their performance against hydrologic and seismic hazards. Models of varying degree of complexity and sophistication were considered and compared. The methodology is illustrated using the Bluestone Dam on the New River in West Virginia, which was designed in the late 1930's. The hydrologic fragilities showed that the Eluestone Dam is unlikely to become unstable at the revised probable maximum flood (PMF), but it is likely that there will be significant cracking at the heel ofthe dam. On the other hand, the seismic fragility analysis indicated that sliding is likely, if the dam were to be subjected to a maximum credible earthquake (MCE). Moreover, there will likely be tensile cracking at the neck of the dam at this level of seismic excitation. Probabilities of relatively severe limit states appear to be only marginally affected by extremely rare events (e.g. the PMF and MCE). Moreover, the risks posed by the extreme floods and earthquakes were not balanced for the Bluestone Dam, with seismic hazard posing a relatively higher risk.

Commercial truck crash injury severity analysis using gradient boosting data mining model.

PubMed

Zheng, Zijian; Lu, Pan; Lantz, Brenda

2018-06-01

Truck crashes contribute to a large number of injuries and fatalities. This study seeks to identify the contributing factors affecting truck crash severity using 2010 to 2016 North Dakota and Colorado crash data provided by the Federal Motor Carrier Safety Administration. To fulfill a gap of previous studies, broad considerations of company and driver characteristics, such as company size and driver's license class, along with vehicle types and crash characteristics are researched. Gradient boosting, a data mining technique, is applied to comprehensively analyze the relationship between crash severities and a set of heterogeneous risk factors. Twenty five variables were tested and 22 of them are identified as significant variables contributing to injury severities, however, top 11 variables account for more than 80% of injury forecasting. The relative variable importance analysis is conducted and furthermore marginal effects of all contributing factors are also illustrated in this research. Several factors such as trucking company attributes (e.g., company size), safety inspection values, trucking company commerce status (e.g., interstate or intrastate), time of day, driver's age, first harmful events, and registration condition are found to be significantly associated with crash injury severity. Even though most of the identified contributing factors are significant for all four levels of crash severity, their relative importance and marginal effect are all different. For the first time, trucking company and driver characteristics are proved to have significant impact on truck crash injury severity. Some of the results in this study reinforce previous studies' conclusions. Findings in this study can be helpful for transportation agencies to reduce injury severity, and develop efficient strategies to improve safety. Copyright © 2018 National Safety Council and Elsevier Ltd. All rights reserved.

Safety Concerns of Startup Airlines

DOT National Transportation Integrated Search

1997-01-01

Startup airlines that do not have sufficient capital are forced to acquire older aircraft and contract out maintenance, crew training, and operation management. These factors can contribute to the poorly supervised practices as illustrated in this ca...

Assuring Ground-Based Detect and Avoid for UAS Operations

NASA Technical Reports Server (NTRS)

Denney, Ewen W.; Pai, Ganeshmadhav Jagadeesh; Berthold, Randall; Fladeland, Matthew; Storms, Bruce; Sumich, Mark

2014-01-01

One of the goals of the Marginal Ice Zones Observations and Processes Experiment (MIZOPEX) NASA Earth science mission was to show the operational capabilities of Unmanned Aircraft Systems (UAS) when deployed on challenging missions, in difficult environments. Given the extreme conditions of the Arctic environment where MIZOPEX measurements were required, the mission opted to use a radar to provide a ground-based detect-and-avoid (GBDAA) capability as an alternate means of compliance (AMOC) with the see-and-avoid federal aviation regulation. This paper describes how GBDAA safety assurance was provided by interpreting and applying the guidelines in the national policy for UAS operational approval. In particular, we describe how we formulated the appropriate safety goals, defined the processes and procedures for system safety, identified and assembled the relevant safety verification evidence, and created an operational safety case in compliance with Federal Aviation Administration (FAA) requirements. To the best of our knowledge, the safety case, which was ultimately approved by the FAA, is the first successful example of non-military UAS operations using GBDAA in the U.S. National Airspace System (NAS), and, therefore, the first nonmilitary application of the safety case concept in this context.

On the formation of the tunnel valleys of the southern Laurentide ice sheet

USGS Publications Warehouse

Hooke, R. LeB; Jennings, C.E.

2006-01-01

Catastrophic releases of meltwater, produced by basal melting and stored for decades in subglacial reservoirs at high pressure, may have been responsible for eroding the broad, deep tunnel valleys that are common along the margins of some lobes of the southern Laurentide ice sheet. We surmise that these releases began when the high water pressure was transmitted to the margin through the substrate. The water pressure in the substrate at the margin would then have been significantly above the overburden pressure, leading to sapping failure. Headward erosion of a conduit in the substrate (piping) could then tap the stored water, resulting in the outburst. In some situations, development of a siphon may have lowered the reservoir below its overflow level, thus tapping additional water. Following the flood, the seal could have reformed and the reservoir refilled, setting up conditions for another outburst. Order of magnitude calculations suggest that once emptied, a subglacial reservoir could refill in a matter of decades. The amount of water released during several outbursts appears to be sufficient to erode a tunnel valley. We think that tunnel valleys are most likely to have formed in this way where and when the glacier margin was frozen to the bed and permafrost extended from the glacier forefield several kilometers back under the glacier, as reservoirs would then have been larger and more common, and the seal more robust and more likely to reform after an outburst. ?? 2006 Elsevier Ltd. All rights reserved.

Russian roulette

NASA Astrophysics Data System (ADS)

Showstack, Randy

Following a recent collision, fire, series of computer and power failures, and other mishaps on the Russian space station, Mir, the U.S. Congress held a hearing on September 18 to question the safety of American astronauts staying aboard the aging spacecraft.“There has been sufficient evidence put before this hearing to raise doubts about the safety of continued American long-term presence on the Mir,” said House Science Committee Chairman Rep. James Sensenbrenner (R-Wisc.) at the hearing.

A novel mechanism for electrical currents inducing ventricular fibrillation: The three-fold way to fibrillation.

PubMed

Kroll, Mark W; Panescu, Dorin; Hinz, Andrew F; Lakkireddy, Dhanunjaya

2010-01-01

It has been long recognized that there are 2 methods for inducing VF (ventricular fibrillation) with electrical currents‥ These are: (1) delivering a high-charge shock into the cardiac T-wave, and (2) delivering lower level currents for 1-5 seconds. Present electrical safety standards are based on this understanding. We present new data showing a 3(rd) mechanism of inducing VF which involves the steps of delivering sufficient current to cause high-rate cardiac capture, causing cardiac output collapse, leading to ischemia, for sufficiently long duration, which then lowers the VFT (VF threshold) to the level of the current, which finally results in VF. This requires about 40% of the normal VF-induction current but requires a duration of minutes instead of seconds for the VF to be induced. Anesthetized and ventilated swine (n=6) had current delivered from a probe tip 10 mm from the epicardium sufficient to cause hypotensive capture but not directly induce VF within 5 s. After a median time of 90 s, VF was induced. This 3(rd) mechanism of VF induction should be studied further and considered for electrical safety standards and is relevant to long-duration TASER Electronic Control Device applications.

[The new Blood Law and new principles of transfusion therapy].

PubMed

Takahashi, Koki

2005-01-01

The new Blood Law for Self-sufficiency, Stable Supply of Safe Blood Products and Other Transfusion-related Rules was enacted in July 2003. In terms of the safety of blood products, improvement of screening tests and the introduction of the viral nucleic acid amplification test to shorten the so-called window period have markedly reduced the incidence of blood-borne virus transmission, although they cannot completely protect against transfusion-associated adverse reactions. Even with increasing blood safety, there remains an iatrogenic risk of ABO-mismatched transfusions without proper management systems and standard operation procedures. Fresh frozen plasma and plasma derivatives have been and continue to be used much more in Japan compared with the international standard. As a result, the shortage of domestic blood products remains an obstacle to achieving self-sufficiency. The goal of the new law is to provide safe transfusion therapy and achieve self-sufficiency in all blood products including plasma derivatives such as albumin solutions. To reach this goal medical professionals should recognize the necessity for safe and appropriate transfusions and establish new principles for improved transfusion therapy, including standard indications, safe operation procedure guidelines, and a 24-hour management system in each hospital.

Is self-sufficiency financially viable and ethically justifiable?--a commercial viewpoint.

PubMed

Christie, R B

1994-12-01

Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.

Observations at convergent margins concerning sediment subduction, subduction erosion, and the growth of continental crust

USGS Publications Warehouse

von Huene, Roland E.; Scholl, D. W.

1991-01-01

At ocean margins where two plates converge, the oceanic plate sinks or is subducted beneath an upper one topped by a layer of terrestrial crust. This crust is constructed of continental or island arc material. The subduction process either builds juvenile masses of terrestrial crust through arc volcanism or new areas of crust through the piling up of accretionary masses (prisms) of sedimentary deposits and fragments of thicker crustal bodies scraped off the subducting lower plate. At convergent margins, terrestrial material can also bypass the accretionary prism as a result of sediment subduction, and terrestrial matter can be removed from the upper plate by processes of subduction erosion. Sediment subduction occurs where sediment remains attached to the subducting oceanic plate and underthrusts the seaward position of the upper plate's resistive buttress (backstop) of consolidated sediment and rock. Sediment subduction occurs at two types of convergent margins: type 1 margins where accretionary prisms form and type 2 margins where little net accretion takes place. At type 2 margins (???19,000 km in global length), effectively all incoming sediment is subducted beneath the massif of basement or framework rocks forming the landward trench slope. At accreting or type 1 margins, sediment subduction begins at the seaward position of an active buttress of consolidated accretionary material that accumulated in front of a starting or core buttress of framework rocks. Where small-to-mediumsized prisms have formed (???16,300 km), approximately 20% of the incoming sediment is skimmed off a detachment surface or decollement and frontally accreted to the active buttress. The remaining 80% subducts beneath the buttress and may either underplate older parts of the frontal body or bypass the prism entirely and underthrust the leading edge of the margin's rock framework. At margins bordered by large prisms (???8,200 km), roughly 70% of the incoming trench floor section is subducted beneath the frontal accretionary body and its active buttress. In rounded figures the contemporary rate of solid-volume sediment subduction at convergent ocean margins (???43,500 km) is calculated to be 1.5 km3/yr. Correcting type 1 margins for high rates of terrigenous seafloor sedimentation during the past 30 m.y. or so sets the long-term rate of sediment subduction at 1.0 km3/yr. The bulk of the subducted material is derived directly or indirectly from continental denudation. Interstitial water currently expulsed from accreted and deeply subducted sediment and recycled to the ocean basins is estimated at 0.9 km3/yr. The thinning and truncation caused by subduction erosion of the margin's framework rock and overlying sedimentary deposits have been demonstrated at many convergent margins but only off northern Japan, central Peru, and northern Chile has sufficient information been collected to determine average or long-term rates, which range from 25 to 50 km3/m.y. per kilometer of margin. A conservative long-term rate applicable to many sectors of convergent margins is 30 km3/km/m.y. If applied to the length of type 2 margins, subduction erosion removes and transports approximately 0.6 km3/yr of upper plate material to greater depths. At various places, subduction erosion also affects sectors of type 1 margins bordered by small- to medium-sized accretionary prisms (for example, Japan and Peru), thus increasing the global rate by possibly 0.5 km3/yr to a total of 1.1 km3/yr. Little information is available to assess subduction erosion at margins bordered by large accretionary prisms. Mass balance calculations allow assessments to be made of the amount of subducted sediment that bypasses the prism and underthrusts the margin's rock framework. This subcrustally subducted sediment is estimated at 0.7 km3/yr. Combined with the range of terrestrial matter removed from the margin's rock framework by subduction erosion, the global volume of subcrustally subducted materia

Integrated Advanced Microwave Sounding Unit-A (AMSU-A) METOP Stress Analysis Report (Qual Level Random Vibration) A1 Module

NASA Technical Reports Server (NTRS)

Mehitretter, R.

1996-01-01

Stress analysis of the primary structure of the Meteorological Satellites Project (METSAT) Advanced Microwave Sounding Units-A, A1 Module performed using the Meteorological Operational (METOP) Qualification Level 9.66 grms Random Vibration PSD Spectrum is presented. The random vibration structural margins of safety and natural frequency predictions are summarized.

Airworthiness criteria development for powered-lift aircraft: A program summary

NASA Technical Reports Server (NTRS)

Heffley, R. K.; Stapleford, R. L.; Rumold, R. C.

1977-01-01

A four-year simulation program to develop airworthiness criteria for powered-lift aircraft is summarized. All flight phases affected by use of powered lift (approach, landing, takeoff) are treated with regard to airworthiness problem areas (limiting flight conditions and safety margins: stability, control, and performance; and systems failure). The general features of powered-lift aircraft are compared to conventional aircraft.

Hydraulic patterns and safety margins, from stem to stomata, in three eastern US tree species

Treesearch

D.M. Johnson; K.A. McCulloh; F.C. Meinzer; D.R. Woodruff; D.M. Eissenstat

2011-01-01

Adequate water transport is necessary to prevent stomatal closure and allow for photosynthesis. Dysfunction in the water transport pathway can result in stomatal closure, and can be deleterious to overall plant health and survival. Although much is known about small branch hydraulics, little is known about the coordination of leaf and stem hydraulic function....

A Conceptual Aerospace Vehicle Structural System Modeling, Analysis and Design Process

NASA Technical Reports Server (NTRS)

Mukhopadhyay, Vivek

2007-01-01

A process for aerospace structural concept analysis and design is presented, with examples of a blended-wing-body fuselage, a multi-bubble fuselage concept, a notional crew exploration vehicle, and a high altitude long endurance aircraft. Aerospace vehicle structures must withstand all anticipated mission loads, yet must be designed to have optimal structural weight with the required safety margins. For a viable systems study of advanced concepts, these conflicting requirements must be imposed and analyzed early in the conceptual design cycle, preferably with a high degree of fidelity. In this design process, integrated multidisciplinary analysis tools are used in a collaborative engineering environment. First, parametric solid and surface models including the internal structural layout are developed for detailed finite element analyses. Multiple design scenarios are generated for analyzing several structural configurations and material alternatives. The structural stress, deflection, strain, and margins of safety distributions are visualized and the design is improved. Over several design cycles, the refined vehicle parts and assembly models are generated. The accumulated design data is used for the structural mass comparison and concept ranking. The present application focus on the blended-wing-body vehicle structure and advanced composite material are also discussed.

Element Load Data Processor (ELDAP) Users Manual

NASA Technical Reports Server (NTRS)

Ramsey, John K., Jr.; Ramsey, John K., Sr.

2015-01-01

Often, the shear and tensile forces and moments are extracted from finite element analyses to be used in off-line calculations for evaluating the integrity of structural connections involving bolts, rivets, and welds. Usually the maximum forces and moments are desired for use in the calculations. In situations where there are numerous structural connections of interest for numerous load cases, the effort in finding the true maximum force and/or moment combinations among all fasteners and welds and load cases becomes difficult. The Element Load Data Processor (ELDAP) software described herein makes this effort manageable. This software eliminates the possibility of overlooking the worst-case forces and moments that could result in erroneous positive margins of safety and/or selecting inconsistent combinations of forces and moments resulting in false negative margins of safety. In addition to forces and moments, any scalar quantity output in a PATRAN report file may be evaluated with this software. This software was originally written to fill an urgent need during the structural analysis of the Ares I-X Interstage segment. As such, this software was coded in a straightforward manner with no effort made to optimize or minimize code or to develop a graphical user interface.

Evaluation of the breakdown behaviour of ATLAS silicon pixel sensors after partial guard-ring removal

NASA Astrophysics Data System (ADS)

Goessling, C.; Klingenberg, R.; Muenstermann, D.; Wittig, T.

2010-12-01

To avoid geometrical inefficiencies in the ATLAS pixel detector, the concept of shingling is used up to now in the barrel section. For the upgrades of ATLAS, it is desired to avoid this as it increases the volume and material budget of the pixel layers and complicates the cooling. A direct planar edge-to-edge arrangement of pixel modules has not been possible in the past due to about 1100 μm of inactive edge composed of approximately 600 μm of guard rings and 500 μm of safety margin. In this work, the safety margin and guard rings of ATLAS SingleChip sensors were cut at different positions using a standard diamond dicing saw and irradiated afterwards to explore the breakdown behaviour and the leakage current development. It is found that the inactive edge can be reduced to about 400 μm of guard rings with almost no reduction in pre-irradiation testability and leakage current performance. This is in particular important for the insertable b-layer upgrade of ATLAS (IBL) where inactive edges of less than 450 μm width are required.

Grip force regulation during pinch grip lifts under somatosensory guidance: comparison between people with stroke and healthy controls.

PubMed

Blennerhassett, Jannette M; Carey, Leeanne M; Matyas, Thomas A

2006-03-01

To compare the timing and grip force application in a pinch grip task performed under somatosensory guidance in stroke and matched controls and to identify characteristics of impaired grip force regulation after stroke. Matched-pairs control group. University research laboratory. Forty-five people with stroke who could pick up a pen lid using a pinch grip and actively participated in rehabilitation and 45 adults without neurologic conditions or musculoskeletal or skin impairments affecting the hand, matched for age, sex, and hand dominance. Not applicable. Timing and magnitude of grip forces applied during pinch grip lift and hold. Prolonged time to grip and lift objects, and excessive grip force prior to commencing the lift occurred in approximately half of the contralesional (involved) hands of people with stroke. Fluctuating irregular forces and reduced adaptation of the grip safety margin were also observed. Excessive safety margins were not predominant after stroke. Extreme slowing and disorganized sequencing of the grip and lifting forces and difficulty maintaining a stable grip characterized severe dysfunction. Delayed grip formulation and variable grip force application are key characteristics of grip dysfunction after stroke.

Handheld fetal Doppler device for assessing heart rate in neonatal resuscitation.

PubMed

Shimabukuro, Rinshu; Takase, Kozo; Ohde, Sachiko; Kusakawa, Isao

2017-10-01

The use of neonatal three-lead electrocardiograms (Neo-ECG) is suggested for the assessment of heart rate (HR) in neonatal resuscitation, but primary childbirth facilities (i.e. maternity clinics or maternity homes) are not sufficiently equipped for this. The aim of this study was to therefore to confirm the potential of a handheld fetal Doppler device (FDD), widely used to assess HR in labor room resuscitation, and to compare its equivalency to Neo-ECG. In low-risk full-term infants, HR was measured five times per minute in minutes 1-5 after delivery using the FDD and Neo-ECG, and their equivalence compared. The equivalence margin was set at a HR difference of <±5 beats/min and <±5%. Moreover, the times at which HR was displayed were measured for both methods. FDD and Neo-ECG HR correlated strongly (r = 0.977) in 155 measurements in 33 cases. The mean HR difference was -0.123 beats/min (95%CI: -0.594 to +0.345), and the logarithmic transformation of the HR ratio was -0.0003 (95%CI: -0.0020 to +0.0015). The mean HR difference and HR ratio were within the equivalence margin. For HR assessment using the FDD, 155 of 165 measurements (93.9%) could be obtained in <10 s. In HR assessment, FDD is a valid substitute for Neo-ECG in primary childbirth facilities that are not sufficiently equipped for Neo-ECG. © 2017 Japan Pediatric Society.

Behavior of squamous cell carcinoma of the floor of the mouth. Is supraomohyoid neck dissection sufficiently safe to manage clinically N0 patients?

PubMed

Cariati, Paolo; Cabello Serrano, Almudena; Roman Ramos, Maria; Sanchez Lopez, Dario; Fernandez Solis, Jose; Martinez Lara, Ildefonso

2018-05-11

The main aim of the present report is to study the behavior of SCC of the floor of the mouth. A retrospective analysis was conducted using the records of patients diagnosed with squamous cell carcinoma of the floor of the mouth between 2000 and 2012 in the HUVN. Ninety-three patients with squamous cell carcinoma of the floor of the mouth treated with tumourectomy and selective neck dissection were included in the study. The pattern of distribution of cervical metastases and numerous histological features such as T-stage, N stage, surgical margins, tumor thickness, ECS (extracapsular spread) and vascular invasion were analyzed. Level I was the most affected level, followed by Level II. T stage, tumor thickness, and surgical margins showed a strong relationship with the risk of developing a local or cervical failure at follow-up. Overall survival was 52.7%. T stage, tumor thickness, N stage, recurrence, extracapsular spread, and vascular invasion were also associated with a poor prognosis. SCC of the floor of the mouth is an aggressive disease even at early stages. Due to the low rate of positive nodes observed at level IV and V in clinically N0 patients, supraomohyoid neck dissection might be considered sufficiently safe in this group. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

Radiologic safety assessment for low level waste storage on TRU pads

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

Ryan, J.P.

1986-03-17

The reference document (TA 2-1118) proposes to store Low Level Radioactive Solid Waste in B-25 boxes on concrete pads at the 643-G burial ground site, pending resolution of policy concernig its ultimate disposal. This analysis verifies that the reference proposal is safe, as long as it is applied to a limited material quantity of low specific activity, as described in the reference document. The predominant concern in the safety analysis is the emission of airborne activity as a result of tornados and fires. However, containment provided by B-25 boxes is sufficient to mitigate the consequences of these events sufficiently. Nevertheless,more » it is strongly recommended that any above-ground storage procedures include provisions for covering the waste containment boxes to prevent exposure to rainwater and subsequent corrosion if the storage period is to extend beyond one year.« less

Cybercrimes vs. Cyberliberties

NASA Astrophysics Data System (ADS)

Strossen, Nadine

This new Introduction explains how all of the themes and conclusions of the original chapter remain valid despite intervening developments, including the 2001 terrorist attacks. It shows that the major points that the 1999 chapter made about one particular medium, at one particular historical point, concerning particular safety and security issues that were then at the forefront of public concern, apply more universally to other media, during other historical periods, and regarding other safety and security concerns. The Introduction supports this generalization by analyzing two sets of subsequent developments. First, it shows that post-911 surveillance measures that target communications, including Internet communications, violate freedom of speech and privacy without sufficient countervailing security benefits. Second, it shows that the government’s continuing efforts to suppress online sexual expression, in order to protect children from seeing it, continue appropriately to be struck down by the courts as violating free speech rights without sufficient countervailing benefits.

Measuring food and nutrition security: tools and considerations for use among people living with HIV.

PubMed

Fielden, Sarah J; Anema, Aranka; Fergusson, Pamela; Muldoon, Katherine; Grede, Nils; de Pee, Saskia

2014-10-01

As an increasing number of countries implement integrated food and nutrition security (FNS) and HIV programs, global stakeholders need clarity on how to best measure FNS at the individual and household level. This paper reviews prominent FNS measurement tools, and describes considerations for interpretation in the context of HIV. There exist a range of FNS measurement tools and many have been adapted for use in HIV-endemic settings. Considerations in selecting appropriate tools include sub-types (food sufficiency, dietary diversity and food safety); scope/level of application; and available resources. Tools need to reflect both the needs of PLHIV and affected households and FNS program objectives. Generalized food sufficiency and dietary diversity tools may provide adequate measures of FNS in PLHIV for programmatic applications. Food consumption measurement tools provide further data for clinical or research applications. Measurement of food safety is an important, but underdeveloped aspect of assessment, especially for PLHIV.

Problems and pitfalls in cardiac drug therapy.

PubMed

Stone, S M; Rai, N; Nei, J

2001-01-01

Medical errors in the care of patients may account for 44,000 to 98,000 deaths per year, and 7,000 deaths per year are attributed to medication errors alone. Increasing awareness among health care providers of potential errors is a critical step toward improving the safety of medical care. Because today's medications are increasingly complex, approved at an accelerated rate, and often have a narrow therapeutic window with only a small margin of safety, patient and provider education is critical in assuring optimal therapeutic outcomes. Providers can use electronic resources such as Web sites to keep informed on drug-drug, drug-food, and drug-nutritional supplements interactions.

Food safety considerations for innovative nutrition solutions.

PubMed

Byrd-Bredbenner, Carol; Cohn, Marjorie Nolan; Farber, Jeffrey M; Harris, Linda J; Roberts, Tanya; Salin, Victoria; Singh, Manpreet; Jaferi, Azra; Sperber, William H

2015-07-01

Failure to secure safe and affordable food to the growing global population leads far too often to disastrous consequences. Among specialists and other individuals, food scientists have a key responsibility to improve and use science-based tools to address risk and advise food handlers and manufacturers with best-practice recommendations. With collaboration from production agriculture, food processors, state and federal agencies, and consumers, it is critical to implement science-based strategies that address food safety and that have been evaluated for effectiveness in controlling and/or eliminating hazards. It is an open question whether future food safety concerns will shift in priority given the imperatives to supply sufficient food. This report brings together leading food safety experts to address these issues with a focus on three areas: economic, social, and policy aspects of food safety; production and postharvest technology for safe food; and innovative public communication for food safety and nutrition. © 2015 New York Academy of Sciences.

Toward a New U.S. Chemicals Policy: Rebuilding the Foundation to Advance New Science, Green Chemistry, and Environmental Health

PubMed Central

Wilson, Michael P.; Schwarzman, Megan R.

2009-01-01

Objective We describe fundamental weaknesses in U.S. chemicals policy, present principles of chemicals policy reform, and articulate interdisciplinary research questions that should be addressed. With global chemical production projected to double over the next 24 years, federal policies that shape the priorities of the U.S. chemical enterprise will be a cornerstone of sustainability. To date, these policies have largely failed to adequately protect public health or the environment or motivate investment in or scientific exploration of cleaner chemical technologies, known collectively as green chemistry. On this trajectory, the United States will face growing health, environmental, and economic problems related to chemical exposures and pollution. Conclusions Existing policies have produced a U.S. chemicals market in which the safety of chemicals for human health and the environment is undervalued relative to chemical function, price, and performance. This market barrier to green chemistry is primarily a consequence of weaknesses in the Toxic Substances Control Act. These weaknesses have produced a chemical data gap, because producers are not required to investigate and disclose sufficient information on chemicals’ hazard traits to government, businesses that use chemicals, or the public; a safety gap, because government lacks the legal tools it needs to efficiently identify, prioritize, and take action to mitigate the potential health and environmental effects of hazardous chemicals; and a technology gap, because industry and government have invested only marginally in green chemistry research, development, and education. Policy reforms that close the three gaps—creating transparency and accountability in the market—are crucial for improving public and environmental health and reducing the barriers to green chemistry. The European Union’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation has opened an opportunity for the United States to take this step; doing so will present the nation with new research questions in science, policy, law, and technology. PMID:19672398

Toward a new U.S. chemicals policy: rebuilding the foundation to advance new science, green chemistry, and environmental health.

PubMed

Wilson, Michael P; Schwarzman, Megan R

2009-08-01

We describe fundamental weaknesses in U.S. chemicals policy, present principles of chemicals policy reform, and articulate interdisciplinary research questions that should be addressed. With global chemical production projected to double over the next 24 years, federal policies that shape the priorities of the U.S. chemical enterprise will be a cornerstone of sustainability. To date, these policies have largely failed to adequately protect public health or the environment or motivate investment in or scientific exploration of cleaner chemical technologies, known collectively as green chemistry. On this trajectory, the United States will face growing health, environmental, and economic problems related to chemical exposures and pollution. Existing policies have produced a U.S. chemicals market in which the safety of chemicals for human health and the environment is undervalued relative to chemical function, price, and performance. This market barrier to green chemistry is primarily a consequence of weaknesses in the Toxic Substances Control Act. These weaknesses have produced a chemical data gap, because producers are not required to investigate and disclose sufficient information on chemicals' hazard traits to government, businesses that use chemicals, or the public; a safety gap, because government lacks the legal tools it needs to efficiently identify, prioritize, and take action to mitigate the potential health and environmental effects of hazardous chemicals; and a technology gap, because industry and government have invested only marginally in green chemistry research, development, and education. Policy reforms that close the three gaps-creating transparency and accountability in the market-are crucial for improving public and environmental health and reducing the barriers to green chemistry. The European Union's REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation has opened an opportunity for the United States to take this step; doing so will present the nation with new research questions in science, policy, law, and technology.

Topical 5% 5-fluorouracil in the treatment of multifocal basal cell carcinoma of the face: A novel chemotherapeutic approach.

PubMed

Naik, Mayuresh P; Mehta, Anuj; Abrol, Sangeeta; Kumar, Sandeep; Gupta, Vishnu S

2016-12-01

To determine the safety and efficacy of topical 5-fluorouracil (5-FU) 5% ointment in treatment of non-syndromic multifocal basal cell carcinoma. A 55-year-old male patient, with 8 hours of daily sun exposure, having histologically proven and radiologically non-syndromic, multifocal basal cell carcinoma with involvement of 6 sites on the face, was treated with topical 5-FU 5% ointment twice daily over all sites except the site involving lid margin to prevent corneal toxicity. Left lid lesion underwent wide surgical excision with 5-mm clear margins and reconstruction with nasal septal mucoperichondrium and local skin mobilization. Pharmacologic effects first appeared at 4 weeks and by 8 weeks, the lesions had scabbed and had fallen off with no induration but residual mild perilesional erythema. Patient had post-op histopathological clear margins and recovered uneventfully. No recurrence in 6 months. A topical 5-FU 5% ointment represents a paradigm shift in the treatment of BCC from invasive and disfiguring options (surgery and chemoradiotherapy) to cheap, convenient, effective, non-invasive, non-disfiguring topical chemotherapy. Topical 5% 5-FU is a safe and effective modality of treatment of superficial spreading multifocal basal carcinoma, especially lesions larger than 10 mm, where margins cannot be identified clearly and recurrent lesions.

LQR-Based Optimal Distributed Cooperative Design for Linear Discrete-Time Multiagent Systems.

PubMed

Zhang, Huaguang; Feng, Tao; Liang, Hongjing; Luo, Yanhong

2017-03-01

In this paper, a novel linear quadratic regulator (LQR)-based optimal distributed cooperative design method is developed for synchronization control of general linear discrete-time multiagent systems on a fixed, directed graph. Sufficient conditions are derived for synchronization, which restrict the graph eigenvalues into a bounded circular region in the complex plane. The synchronizing speed issue is also considered, and it turns out that the synchronizing region reduces as the synchronizing speed becomes faster. To obtain more desirable synchronizing capacity, the weighting matrices are selected by sufficiently utilizing the guaranteed gain margin of the optimal regulators. Based on the developed LQR-based cooperative design framework, an approximate dynamic programming technique is successfully introduced to overcome the (partially or completely) model-free cooperative design for linear multiagent systems. Finally, two numerical examples are given to illustrate the effectiveness of the proposed design methods.

Review Guidelines for Software Languages for use in Nuclear Power Plant Safety Systems

DTIC Science & Technology

1997-10-01

desirable to segregate base classes from derived classes. Review is facilitated and safety is enhanced if project-specific guidance is provided on the... Segregate base from derived classes. In C++, it is desirable to segregate base classes from derived classes. 4.4.1.8 Minimizing Use of Literals...memory utilization. At the lowest level are base attributes, i.e., attributes xv NUREG/CR-6463 Rev. 1 sufficiently specific to define guidelines. An

77 FR 41442 - Notice of Availability of the Draft Order of the Secretary on Oil and Gas and Potash Development...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... protection of other mineral resources, other natural resources, environmental quality, life, health, safety... sufficient thickness and quality to be mineable), the Development Areas would generally be larger...

Fluor Daniel Hanford contract standards/requirements identification document

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

Bennett, G.L.

1997-04-24

This document, the Standards/Requirements Identification Document (S/RID) for the Fluor Daniel Hanford Contract, represents the necessary and sufficient requirements to provide an adequate level of protection of the worker, public health and safety, and the environment.

Long-term safety concerns with proton pump inhibitors.

PubMed

Ali, Tauseef; Roberts, David Neil; Tierney, William M

2009-10-01

Proton pump inhibitors (PPIs) are among the most widely prescribed medications worldwide. Their use has resulted in dramatic improvements in treatment of peptic ulcer disease and gastroesophageal reflux disease. Despite an acceptable safety profile, mounting data demonstrate concerns about the long-term use of PPIs. To provide a comprehensive review regarding the concerns of long-term PPI use, a literature search was performed to identify pertinent original and review articles. Despite study shortcomings, the collective body of information overwhelmingly suggests an increased risk of infectious complications and nutritional deficiencies. Data regarding any increased risk in gastric or colon malignancy are less convincing. PPIs have revolutionized the management and complications of acid-related disorders with a high margin of safety; however, with the data available, efforts to reduce the dosing of or discontinue the use of PPIs must be reassessed frequently.

Reducing Conservatism in Aircraft Engine Response Using Conditionally Active Min-Max Limit Regulators

NASA Technical Reports Server (NTRS)

May, Ryan D.; Garg, Sanjay

2012-01-01

Current aircraft engine control logic uses a Min-Max control selection structure to prevent the engine from exceeding any safety or operational limits during transients due to throttle commands. This structure is inherently conservative and produces transient responses that are slower than necessary. In order to utilize the existing safety margins more effectively, a modification to this architecture is proposed, referred to as a Conditionally Active (CA) limit regulator. This concept uses the existing Min-Max architecture with the modification that limit regulators are active only when the operating point is close to a particular limit. This paper explores the use of CA limit regulators using a publicly available commercial aircraft engine simulation. The improvement in thrust response while maintaining all necessary safety limits is demonstrated in a number of cases.

A human factors engineering paradigm for patient safety: designing to support the performance of the healthcare professional

PubMed Central

Karsh, B‐T; Holden, R J; Alper, S J; Or, C K L

2006-01-01

The goal of improving patient safety has led to a number of paradigms for directing improvement efforts. The main paradigms to date have focused on reducing injuries, reducing errors, or improving evidence based practice. In this paper a human factors engineering paradigm is proposed that focuses on designing systems to improve the performance of healthcare professionals and to reduce hazards. Both goals are necessary, but neither is sufficient to improve safety. We suggest that the road to patient and employee safety runs through the healthcare professional who delivers care. To that end, several arguments are provided to show that designing healthcare delivery systems to support healthcare professional performance and hazard reduction should yield significant patient safety benefits. The concepts of human performance and hazard reduction are explained. PMID:17142611

NASA's aviation safety research and technology program

NASA Technical Reports Server (NTRS)

Fichtl, G. H.

1977-01-01

Aviation safety is challenged by the practical necessity of compromising inherent factors of design, environment, and operation. If accidents are to be avoided these factors must be controlled to a degree not often required by other transport modes. The operational problems which challenge safety seem to occur most often in the interfaces within and between the design, the environment, and operations where mismatches occur due to ignorance or lack of sufficient understanding of these interactions. Under this report the following topics are summarized: (1) The nature of operating problems, (2) NASA aviation safety research, (3) clear air turbulence characterization and prediction, (4) CAT detection, (5) Measurement of Atmospheric Turbulence (MAT) Program, (6) Lightning, (7) Thunderstorm gust fronts, (8) Aircraft ground operating problems, (9) Aircraft fire technology, (10) Crashworthiness research, (11) Aircraft wake vortex hazard research, and (12) Aviation safety reporting system.

Nanodrugs: pharmacokinetics and safety

PubMed Central

Onoue, Satomi; Yamada, Shizuo; Chan, Hak-Kim

2014-01-01

To date, various nanodrug systems have been developed for different routes of administration, which include dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles. Nanodrug systems have been employed to improve the efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profile of pharmaceutical substances. In particular, functionalized nanodrug systems can offer enhanced bioavailability of orally taken drugs, prolonged half-life of injected drugs (by reducing immunogenicity), and targeted delivery to specific tissues. Thus, nanodrug systems might lower the frequency of administration while providing maximized pharmacological effects and minimized systemic side effects, possibly leading to better therapeutic compliance and clinical outcomes. In spite of these attractive pharmacokinetic advantages, recent attention has been drawn to the toxic potential of nanodrugs since they often exhibit in vitro and in vivo cytotoxicity, oxidative stress, inflammation, and genotoxicity. A better understanding of the pharmacokinetic and safety characteristics of nanodrugs and the limitations of each delivery option is necessary for the further development of efficacious nanodrugs with high therapeutic potential and a wide safety margin. This review highlights the recent progress in nanodrug system development, with a focus on the pharmacokinetic advantages and safety challenges. PMID:24591825

Oral antioxidant therapy for marginal dry eye.

PubMed

Blades, K J; Patel, S; Aidoo, K E

2001-07-01

To assess the efficacy of an orally administered antioxidant dietary supplement for managing marginal dry eye. A prospective, randomised, placebo controlled trial with cross-over. Eye Clinic, Department of Vision Sciences, Glasgow Caledonian University. Forty marginal dry eye sufferers composed of 30 females and 10 males (median age 53 y; range 38-69 y). Baseline assessments were made of tear volume sufficiency (thread test), tear quality (stability), ocular surface status (conjunctival impression cytology) and dry eye symptoms (questionnaire). Each subject was administered courses of active treatment, placebo and no treatment, in random order for 1 month each and results compared to baseline. Tear stability and ocular surface status were significantly improved following active treatment (P<0.05). No changes from baseline were detected following administration of placebo and no treatment (P>0.05). Absolute increase in tear stability correlated with absolute change in goblet cell population density. Tear volume was not improved following any treatment period and dry eye symptom responses were subject to placebo effect. Oral antioxidants improved both tear stability and conjunctival health, although it is not yet understood whether increased ocular surface health mediates increased tear stability or vice versa. This study was supported by a PhD scholarship funded by the Department of Vision Sciences, Glasgow Caledonian University, Scotland. Antioxidant supplements and placebos were kindly donated by Vitabiotics.

From marginal to marginalised: The inclusion of men who have sex with men in global and national AIDS programmes and policy.

PubMed

McKay, Tara

2016-01-01

In the last decade, gay men and other men who have sex with men (msm) have come to the fore of global policy debates about AIDS prevention. In stark contrast to programmes and policy during the first two decades of the epidemic, which largely excluded msm outside of the Western countries, the Joint United Nations Programme on HIV/AIDS now identifies gay men and other msm as 'marginalized but not marginal' to the global response. Drawing on archival data and five waves of United Nations Country Progress Reports on HIV/AIDS (2001-2012), this paper examines the productive power of international organisations in the development and diffusion of the msm category, and considers how international organisations have shaped the interpretation of msm in national policies and programmes. These data show that the increasing separation of sexual identity and sexual behaviour at the global level helped to construct notions of risk and disease that were sufficiently broad to accommodate the diverse interests of global policy-makers, activists, and governments. However, as various international and national actors have attempted to develop prevention programmes for msm, the failure of the msm category to map onto lived experience is increasingly apparent.

Half forehead reconstruction with a single rotational scalp flap for dermatofibrosarcoma protuberans treatment

PubMed Central

2012-01-01

Background Dermatofibrosarcoma protuberans (DFSP) is a soft tissue neoplasm of intermediate to low-grade malignancy. Although metastasis rarely occurs, DFSP has a locally aggressive behavior with a high recurrence rate. In the head and neck area, resection involving a wide margin of healthy tissue can be difficult because of functional and cosmetic considerations. We describe a novel reconstructive method for half forehead defects with an innovative single local wide scalp flap following excision of DFSP with a 3 cm margin of healthy tissue. Methods Two patients underwent wide resection of forehead DFSP and reconstruction with a single rotational scalp flap. The scalp flap blood supply was provided from three main vessels: the superficial temporal artery, occipital artery and posterior auricular artery. Results No early or late complications were observed in either patient with no local recurrence after 18 months of follow-up. The donor area could be closed primarily in both cases and the flaps survived completely. Conclusion This innovative technique allowed a radical excision of forehead DFSP with sufficient healthy margins, thus potentially decreasing tumor recurrence rate. Reconstruction was achieved avoiding microsurgery, skin expanders and large skin grafts. Moreover, all main reconstructive criteria, such as functional and cosmetic tissue characteristics, were completely fulfilled. PMID:22559860

Coral forests diversity in the outer shelf of the south Sardinian continental margin

NASA Astrophysics Data System (ADS)

Cau, Alessandro; Moccia, Davide; Follesa, Maria Cristina; Alvito, Andrea; Canese, Simonepietro; Angiolillo, Michela; Cuccu, Danila; Bo, Marzia; Cannas, Rita

2017-04-01

Ecological theory predicts that heterogeneous habitats allow more species to co-exist in a given area, but to date, knowledge on relationships between habitat heterogeneity and biodiversity of coral forests in the outer shelf and upper slope along continental margins is rather limited. We investigated biodiversity of coral forests from 8 sites spread over two different geomorphological settings (namely, pinnacles vs. canyons) in the outer shelf along Sardinian continental margin. Using a combination of multivariate statistical analyses, we show here that differences in the composition of coral assemblages among contrasting geomorphological settings were not statistically significant, whereas significant differences emerged among sites within similar geomorphologies (i.e. among pinnacles and among canyons). Our results reveal that environmental and bathymetric factors such as sediment coverage, slope of the substrate, terrain ruggedness, bathymetric positioning index and aspect were important drivers of the observed patterns of coral biodiversity, in both settings. Spatial variability of coral forests' biodiversity is affected by environmental factors that act at the scale of each geomorphological setting (i.e. within each pinnacle and canyon) rather than by the contrasting geomorphological settings themselves. This result allows us to suggest that simple categorization of benthic communities according topographically defined habitat is unlikely to be sufficient for addressing conservation purposes.

The Use of a Lidar Forward-Looking Turbulence Sensor for Mixed-Compression Inlet Unstart Avoidance and Gross Weight Reduction on a High Speed Civil Transport

NASA Technical Reports Server (NTRS)

Soreide, David; Bogue, Rodney K.; Ehernberger, L. J.; Seidel, Jonathan

1997-01-01

Inlet unstart causes a disturbance akin to severe turbulence for a supersonic commercial airplane. Consequently, the current goal for the frequency of unstarts is a few times per fleet lifetime. For a mixed-compression inlet, there is a tradeoff between propulsion system efficiency and unstart margin. As the unstart margin decreases, propulsion system efficiency increases, but so does the unstart rate. This paper intends to first, quantify that tradeoff for the High Speed Civil Transport (HSCT) and second, to examine the benefits of using a sensor to detect turbulence ahead of the airplane. When the presence of turbulence is known with sufficient lead time to allow the propulsion system to adjust the unstart margin, then inlet un,starts can be minimized while overall efficiency is maximized. The NASA Airborne Coherent Lidar for Advanced In-Flight Measurements program is developing a lidar system to serve as a prototype of the forward-looking sensor. This paper reports on the progress of this development program and its application to the prevention of inlet unstart in a mixed-compression supersonic inlet. Quantified benefits include significantly reduced takeoff gross weight (TOGW), which could increase payload, reduce direct operating costs, or increase range for the HSCT.

Experimental Evidence for LENR in a Polarized Pd/D Lattice

NASA Astrophysics Data System (ADS)

Szpak, S.

2005-03-01

Experimental evidence in support of claims that excess enthalpy production in a polarized Pd/D lattice is of a nuclear origin is questioned on various grounds, eg marginal intensity and difficulty in reproducing. Here, evidence is presented that is 100% reproducible and of sufficient intensity to be well outside of experimental errors. In addition to the thermal behavior, the nuclear manifestations include: X-ray emission; tritium production; and, when an operating cell is placed in an external electric field, fusion to create heavier metals such as Ca, Al, Mg, and Zn.

Initial Results from the 2002 Gulf of California Conjugate Margin Seismic Experiment

NASA Astrophysics Data System (ADS)

Holbrook, S.; Lizarralde, D.; Kent, G.; Harding, A.; Fletcher, J.; Gonzalez-Fernandez, A.; Umhoefer, P.; Axen, G.

2003-04-01

The Gulf of California, which marks the ongoing separation of Baja California from mainland Mexico, is one of the few locales where active continental breakup can be studied along unambiguous flow lines that join clear conjugate margin pairs. In Fall 2002, we conducted an onshore-offshore seismic experiment across the conjugate rifted margins of the Gulf of California in several rift segments. The joint U.S.-Mexico project, sponsored principally by the MARGINS program of the U.S. National Science Foundation, aimed to image crustal structure across conjugate margins of four major basins to determine the modes of extension and the influence of sedimentation and magmatism on breakup. Here we present an overview of the experiment, which was substantially altered at sea due to concerns for marine-mammal safety, and present some preliminary findings. Three flow-line transects were acquired, in the Alarcon Basin, the Guaymas Basin, and between Cabo and Tres Marias Islands. In addition, a fourth transect across the Baja Peninsula was acquired. Data acquired included (1) multichannel seismic reflection data using the R/V Ewing’s 20-gun array and 480-channel, 6-km-long streamer, (2) wide-angle reflection/refraction data recorded on ocean-bottom seismometers, from 206 deployments conducted by the R/V New Horizon, and (3) onshore-offshore data recorded on portable seismometers deployed up to 100 km inland on all transects. Initial results from the experiment include (1) clear evidence for asymmetric basement structure on the conjugate rifted margins and across the active mid-ocean spreading center, of the Guaymas Basin, (2) the suggestion of substantial magmatism in an early failed rift of the Alarcon Basin, and (3) active subduction beneath the margin at the Tres Marias islands. In addition, we will discuss new procedures for mitigating effects on marine mammals that may have a significant impact on future U.S.-sponsored seismic reflection activities.

75 FR 66007 - Mark Edward Leyse; Mark Edward Leyse and Raymond Shadis, on Behalf of the New England Coalition...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-27

... cladding temperature in order to provide a necessary margin of safety in the event of a loss-of-coolant... confirming that we have received your comments, contact us directly at 301-415-1677. Hand-deliver comments to...-conservative in their peak cladding temperature limit of 2200 [deg]F, and that the Baker-Just and Cathcart...

Development Program for Field-Repairable/Expendable Main Rotor Blades

DTIC Science & Technology

1976-09-01

honeycomb aft 2, and it represents the most cost- core, and extruded aluminum alloy effective approach to a repairable trailing-edge spline (Reference...materials lend themselves to relatively inexpensive fabrication techniques, the questionable torsional stiffness of composite spars eliminated them...values of the fatigue strength of aluminum , the spline and aft doublers are predicted to have a negative margin of safety for infinite life. The

The application of measurement techniques to track flutter testing

NASA Technical Reports Server (NTRS)

Roglin, H. R.

1975-01-01

The application is discussed of measurement techniques to captive flight flutter tests at the Supersonic Naval Ordnance Research Track (SNORT), U. S. Naval Ordnance Test Station, China Lake, California. The high-speed track, by its ability to prove the validity of design and to accurately determine the actual margin of safety, offers a unique method of flutter testing for the aircraft design engineer.

Retention of stored water enables tropical tree saplings to survive extreme drought conditions.

PubMed

Wolfe, Brett T

2017-04-01

Trees generally maintain a small safety margin between the stem water potential (Ψstem) reached during seasonal droughts and the Ψstem associated with their mortality. This pattern may indicate that species face similar mortality risk during extreme droughts. However, if tree species vary in their ability to regulate Ψstem, then safety margins would poorly predict drought mortality. To explore variation among species in Ψstem regulation, I subjected potted saplings of six tropical tree species to extreme drought and compared their responses with well-watered plants and pretreatment reference plants. In the drought treatment, soil water potential reached <-10 MPa, yet three species, Bursera simaruba (L.) Sarg., Cavanillesia platanifolia (Bonpl.) Kunth and Cedrela odorata L. had 100% survival and maintained Ψstem near -1 MPa (i.e., desiccation-avoiding species). Three other species, Cojoba rufescens (Benth.) Britton and Rose, Genipa americana L. and Hymenaea courbaril L. had 50%, 0% and 25% survival, respectively, and survivors had Ψstem <-6 MPa (i.e., desiccation-susceptible species). The desiccation-avoiding species had lower relative water content (RWC) in all organs and tissues (root, stem, bark and xylem) in the drought treatment than in the reference plants (means 72.0-90.4% vs 86.9-97.9%), but the survivors of the desiccation-susceptible C. rufescens had much lower RWC in the drought treatment (44.5-72.1%). Among the reference plants, the desiccation-avoiding species had lower tissue density, leaf-mass fraction and lateral-root surface area (LRA) than the desiccation-susceptible species. Additionally, C. platanifolia and C. odorata had reduced LRA in the drought treatment, which may slow water loss into dry soil. Together, these results suggest that the ability to regulate Ψstem during extreme drought is associated with functional traits that favor retention of stored water and that safety margins during seasonal drought poorly predict survival during extreme drought. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

R&D Plan for RISMC Industry Application #1: ECCS/LOCA Cladding Acceptance Criteria

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

Szilard, Ronaldo Henriques; Zhang, Hongbin; Epiney, Aaron Simon

The Nuclear Regulatory Commission (NRC) is finalizing a rulemaking change that would revise the requirements in 10 CFR 50.46. In the proposed new rulemaking, designated as 10 CFR 50.46c, the NRC proposes a fuel performance-based equivalent cladding reacted (ECR) criterion as a function of cladding hydrogen content before the accident (pre-transient) in order to include the effects of higher burnup on cladding performance as well as to address other technical issues. A loss of operational margin may result due to the more restrictive cladding embrittlement criteria. Initial and future compliance with the rule may significantly increase vendor workload and licenseemore » costs as a spectrum of fuel rod initial burnup states may need to be analyzed to demonstrate compliance. The Idaho National Laboratory (INL) has initiated a project, as part of the DOE Light Water Reactor Sustainability Program (LWRS), to develop analytical capabilities to support the industry in the transition to the new rule. This project is called the Industry Application 1 (IA1) within the Risk-Informed Safety Margin Characterization (RISMC) Pathway of LWRS. The general idea behind the initiative is the development of an Integrated Evaluation Model (IEM). The motivation is to develop a multiphysics framework to analyze how uncertainties are propagated across the stream of physical disciplines and data involved, as well as how risks are evaluated in a LOCA safety analysis as regulated under 10 CFR 50.46c. This IEM is called LOTUS which stands for LOCA Toolkit for US, and it represents the LWRS Program’s response to the proposed new rule making. The focus of this report is to complete an R&D plan to describe the demonstration of the LOCA/ECCS RISMC Industry Application # 1 using the advanced RISMC Toolkit and methodologies. This report includes the description and development plan for a RISMC LOCA tool that fully couples advanced MOOSE tools already in development in order to characterize and optimize plant safety and operational margins. Advanced MOOSE tools that are needed to complete this integrated evaluation model are: RAVEN, RELAP-7, BISON, and MAMMOTH.« less

Presurgical mapping of basal cell carcinoma or squamous cell carcinoma by confocal laser endomicroscopy compared to traditional micrographic surgery: a single-centre prospective feasibility study.

PubMed

Schulz, Alexandra; Daali, Samira; Javed, Mehreen; Fuchs, Paul Christian; Brockmann, Michael; Igressa, Alhadi; Charalampaki, Patra

2016-12-01

At present, no ideal diagnostic tools exist in the market to excise cancer tissue with the required safety margins and to achieve optimal aesthetic results using tissue-conserving techniques. In this prospective study, confocal laser endomicroscopy (CLE) and the traditional gold standard of magnifying glasses (MG) were compared regarding the boundaries of in vivo basal cell carcinoma and squamous cell carcinoma. Tumour diameters defined by both methods were measured and compared with those determined by histopathological examination. Nineteen patients were included in the study. The CLE technique was found to be superior to excisional margins based on MG only. Re-excision was required in 68% of the cases following excision based on MG evaluation, but only in 27% of the cases for whom excision margins were based on CLE. Our results are promising regarding the distinction between tumour and healthy surrounding tissue, and indicate that presurgical mapping of basal cell carcinoma and squamous cell carcinoma is possible. The tool itself should be developed further with special attention to early detection of skin cancer.

Metal Construction

NASA Technical Reports Server (NTRS)

Verduzio, Rodolfo

1922-01-01

The future development of aerial navigation is closely connected with the condition of obtaining airplanes of great stability and sufficient strength. Different construction materials such as wood, aluminum, iron, and alloys are examined to determine which materials or combination of materials provides a greater coefficient of safety.

Use of Barriers in Rural Open Road Conditions--A Synthesis Study : [Technical Summary

DOT National Transportation Integrated Search

2012-01-01

Although sufficiently wide medians and clear zones improve : roadside safety, the AASHTO Design Policy allows : for the use of barriers under restricted conditions. Recent : experience with Indianas I-69 corridor challenges : the current design pr...

Evidence for the hERG Liability of Antihistamines, Antipsychotics, and Anti-Infective Agents: A Systematic Literature Review From the ARITMO Project.

PubMed

Hazell, Lorna; Raschi, Emanuel; De Ponti, Fabrizio; Thomas, Simon H L; Salvo, Francesco; Ahlberg Helgee, Ernst; Boyer, Scott; Sturkenboom, Miriam; Shakir, Saad

2017-05-01

A systematic review was performed to categorize the hERG (human ether-a-go-go-related gene) liability of antihistamines, antipsychotics, and anti-infectives and to compare it with current clinical risk of torsade de pointes (TdP). Eligible studies were hERG assays reporting half-minimal inhibitory concentrations (IC50). A "hERG safety margin" was calculated from the IC50 divided by the peak human plasma concentration (free C max ). A margin below 30 defined hERG liability. Each drug was assigned an "uncertainty score" based on volume, consistency, precision, and internal and external validity of evidence. The hERG liability was compared to existing knowledge on TdP risk (www.credibledrugs.org). Of 1828 studies, 82 were eligible, allowing calculation of safety margins for 61 drugs. Thirty-one drugs (51%) had evidence of hERG liability including 6 with no previous mention of TdP risk (eg, desloratadine, lopinavir). Conversely, 16 drugs (26%) had no evidence of hERG liability including 6 with known, or at least conditional or possible, TdP risk (eg, chlorpromazine, sulpiride). The main sources of uncertainty were the validity of the experimental conditions used (antihistamines and antipsychotics) and nonuse of reference compounds (anti-infectives). In summary, hERG liability was categorized for 3 widely used drug classes, incorporating a qualitative assessment of the strength of available evidence. Some concordance with TdP risk was observed, although several drugs had hERG liability without evidence of clinical risk and vice versa. This may be due to gaps in clinical evidence, limitations of hERG/C max data, or other patient/drug-specific factors that contribute to real-life TdP risk. © 2016, The American College of Clinical Pharmacology.

Accuracy and Consistency of Respiratory Gating in Abdominal Cancer Patients

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

Ge, Jiajia; Santanam, Lakshmi; Yang, Deshan

2013-03-01

Purpose: To evaluate respiratory gating accuracy and intrafractional consistency for abdominal cancer patients treated with respiratory gated treatment on a regular linear accelerator system. Methods and Materials: Twelve abdominal patients implanted with fiducials were treated with amplitude-based respiratory-gated radiation therapy. On the basis of daily orthogonal fluoroscopy, the operator readjusted the couch position and gating window such that the fiducial was within a setup margin (fiducial-planning target volume [f-PTV]) when RPM indicated “beam-ON.” Fifty-five pre- and post-treatment fluoroscopic movie pairs with synchronized respiratory gating signal were recorded. Fiducial motion traces were extracted from the fluoroscopic movies using a template matchingmore » algorithm and correlated with f-PTV by registering the digitally reconstructed radiographs with the fluoroscopic movies. Treatment was determined to be “accurate” if 50% of the fiducial area stayed within f-PTV while beam-ON. For movie pairs that lost gating accuracy, a MATLAB program was used to assess whether the gating window was optimized, the external-internal correlation (EIC) changed, or the patient moved between movies. A series of safety margins from 0.5 mm to 3 mm was added to f-PTV for reassessing gating accuracy. Results: A decrease in gating accuracy was observed in 44% of movie pairs from daily fluoroscopic movies of 12 abdominal patients. Three main causes for inaccurate gating were identified as change of global EIC over time (∼43%), suboptimal gating setup (∼37%), and imperfect EIC within movie (∼13%). Conclusions: Inconsistent respiratory gating accuracy may occur within 1 treatment session even with a daily adjusted gating window. To improve or maintain gating accuracy during treatment, we suggest using at least a 2.5-mm safety margin to account for gating and setup uncertainties.« less

No impact of DvSnf7 RNA on honey bee (Apis mellifera L.) adults and larvae in dietary feeding tests.

PubMed

Tan, Jianguo; Levine, Steven L; Bachman, Pamela M; Jensen, Peter D; Mueller, Geoffrey M; Uffman, Joshua P; Meng, Chen; Song, Zihong; Richards, Kathy B; Beevers, Michael H

2016-02-01

The honey bee (Apis mellifera L.) is the most important managed pollinator species worldwide and plays a critical role in the pollination of a diverse range of economically important crops. This species is important to agriculture and historically has been used as a surrogate species for pollinators to evaluate the potential adverse effects for conventional, biological, and microbial pesticides, as well as for genetically engineered plants that produce pesticidal products. As part of the ecological risk assessment of MON 87411 maize, which expresses a double-stranded RNA targeting the Snf7 ortholog (DvSnf7) in western corn rootworm (Diabrotica virgifera virgifera), dietary feeding studies with honey bee larvae and adults were conducted. Based on the mode of action of the DvSnf7 RNA in western corn rootworm, the present studies were designed to be of sufficient duration to evaluate the potential for adverse effects on larval survival and development through emergence and adult survival to a significant portion of the adult stage. Testing was conducted at concentrations of DvSnf7 RNA that greatly exceeded environmentally relevant exposure levels based on expression levels in maize pollen. No adverse effects were observed in either larval or adult honey bees at these high exposure levels, providing a large margin of safety between environmental exposure levels and no-observed-adverse-effect levels. © 2015 The Authors. Environmental Toxicology and Chemistry Published by Wiley Periodicals, Inc. on behalf of SETAC.

Safety assessment of plant food supplements (PFS).

PubMed

van den Berg, Suzanne J P L; Serra-Majem, Lluis; Coppens, Patrick; Rietjens, Ivonne M C M

2011-12-01

Botanicals and botanical preparations, including plant food supplements (PFS), are widely used in Western diets. The growing use of PFS is accompanied by an increasing concern because the safety of these PFS is not generally assessed before they enter the market. Regulatory bodies have become more aware of this and are increasing their efforts to ensure the safety of PFS. The present review describes an overview of the general framework for the safety assessment of PFS, focusing on the different approaches currently in use to assess the safety of botanicals and/or botanical compounds, including their history of safe use, the tiered approach proposed by the European Food Safety Authority (EFSA), the Threshold of Toxicological Concern (TTC) and the Margin of Exposure (MOE) concept. Moreover, some examples of botanical compounds in PFS that may be of concern are discussed. Altogether, it is clear that "natural" does not equal "safe" and that PFS may contain compounds of concern at levels far above those found in the regular diet. In addition, the traditional use of a PFS compound as a herb or tea does not guarantee its safety when used as a supplement. This points at a need for stricter regulation and control of botanical containing products, especially given their expanding market volume.

Addendum to NuMI shielding assessment

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

Vaziri, Kamran; /Fermilab

2007-10-01

The original safety assessment and the Safety Envelope for the NuMI beam line corresponds to 400 kW of beam power. The Main Injector is currently capable of and approved for producing 500 kW of beam power2. However, operation of the NuMI beam line at 400 kW of power brings up the possibility of an occasional excursion above 400 kW due to better than usual tuning in one of the machines upstream of the NuMI beam line. An excursion above the DOE approved Safety Envelope will constitute a safety violation. The purpose of this addendum is to evaluate the radiological issuesmore » and modifications required to operate the NuMI beam line at 500 kW. This upgrade will allow 400 kW operations with a reasonable safety margin. Configuration of the NuMI beam line, boundaries, safety system and the methodologies used for the calculations are as described in the original NuMI SAD. While most of the calculations presented in the original shielding assessment were based on Monte Carlo simulations, which were based on the design geometries, most of the results presented in this addendum are based on the measurements conducted by the AD ES&H radiation safety group.« less

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.

Safety Assessment and Biological Effects of a New Cold Processed SilEmulsion for Dermatological Purpose

PubMed Central

Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C.; Urbano, Manuela; Ribeiro, Helena M.

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids. PMID:24294598

Safety assessment and biological effects of a new cold processed SilEmulsion for dermatological purpose.

PubMed

Raposo, Sara; Salgado, Ana; Gonçalves, Lídia; Pinto, Pedro C; Urbano, Manuela; Ribeiro, Helena M

2013-01-01

It is of crucial importance to evaluate the safety profile of the ingredients used in dermatological emulsions. A suitable equilibrium between safety and efficacy is a pivotal concern before the marketing of a dermatological product. The aim was to assess the safety and biological effects of a new cold processed silicone-based emulsion (SilEmulsion). The hazard, exposure, and dose-response assessment were used to characterize the risk for each ingredient. EpiSkin assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the SilEmulsion was studied using biophysical measurements in human volunteers during 21 days. According to the safety assessment of the ingredients, 1,5-pentanediol was an ingredient of special concern since its margin of safety was below the threshold of 100 (36.53). EpiSkin assay showed that the tissue viability after the application of the SilEmulsion was 92 ± 6% and, thus considered nonirritant to the skin. The human studies confirmed that the SilEmulsion was not a skin irritant and did not induce any sensitization on the volunteers, being safe for human use. Moreover, biological effects demonstrated that the SilEmulsion increased both the skin hydration and skin surface lipids.

Can the pattern of vertebral marrow oedema differentiate intervertebral disc infection from degenerative changes?

PubMed

Shrot, S; Sayah, A; Berkowitz, F

2017-07-01

To evaluate whether various patterns of bone marrow oedema could be used to discriminate between infection and degenerative change. Seventy patients with imaging features suspicious for discitis and available clinical follow-up were blindly reviewed for vertebral marrow oedema on sagittal short-tau inversion recovery (STIR) images according to the following patterns: I, vertebra oedema is adjacent to the intervertebral space and sharply-marginated; II, vertebral oedema is adjacent to the intervertebral space but not sharply marginated from normal marrow or involves the entire vertebral body; and III, vertebral oedema is distant from the endplate with intervening hypointense marrow signal. Of 45 patients with a clinical diagnosis of discitis, pattern II was the most common oedema pattern (64%). Approximately 20% and 9% of discitis patients showed patterns I and III, respectively. In patients with degenerative changes, 44% patients showed pattern I, 32% showed pattern II, and 24% showed pattern III. Pattern II had a sensitivity, specificity, and positive predictive value of 0.64, 0.68, and 0.78 for diagnosing spine infection, respectively. Although bone marrow oedema in infective discitis most often extends from the disc space and has indistinct margins, the oedema may also have sharp margins or be remote from the involved intervertebral space. Bone marrow oedema patterns of infective discitis overlap with those of degenerative disease and are not sufficiently reliable to exclude infection in cases with magnetic resonance imaging findings suggestive of discitis. Copyright © 2017 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Casting made simple using modified sprue design: an in vitro study.

PubMed

Baskaran, B Eswaran; Geetha Prabhu, K R; Prabhu, R; Krishna, G Phani; Eswaran, M A; Gajapathi, B

2014-01-01

Success in dental casting restorations for fixed partial dentures (FPDs) depends on the castability. Castability is described as the ability of an alloy to faithfully reproduce sharp detail and fine margins of a wax pattern. The goal of a prosthodontist is to provide the patient with restorations that fit precisely. Regardless of the alloy used for casting, the casting technique should yield a casted alloy, which should possess sufficient mass, surface hardness and minimal porosity after casting. Twenty patterns for casting were made from three-dimensional printed resin pattern simulating a 3 unit FPD and casted using modified sprue technique. Later test samples were cemented sequentially on stainless steel model using pressure indicating paste and evaluated for vertical marginal gap in eight predetermined reference areas. Marginal gap were measured in microns using Video Measuring System (VMS2010F-CIP Corporation, Korea). A portion of the axial wall of the cast abutments depicting premolar and molar were sectioned and embedded in acrylic resin and tested for micro hardness using Reichert Polyvar 2 Met Microhardness tester (Reichert, Austria) and porosity using Quantimet Image Analyzer (Quantimet Corporation London, England). The results obtained for marginal gap, micro hardness, and porosity of all test samples were tabulated, descriptive statistics were calculated and the values were found to be within the clinically acceptable range. The new sprue technique can be an alternative and convenient method for casting which would minimize metal wasting and less time consuming. However, further studies with same technique on various parameters are to be conducted for its broad acceptance.

Integrated skin flash planning technique for intensity-modulated radiation therapy for vulvar cancer prevents marginal misses and improves superficial dose coverage.

PubMed

Dyer, Brandon A; Jenshus, Abriel; Mayadev, Jyoti S

2018-02-28

Radiation therapy (RT) plays a definitive role in locally advanced vulvar cancer, and in the adjuvant setting with high risk postoperative features after wide local excision. There is significant morbidity associated with traditional, large RT fields using 2D or 3D techniques, and the use of intensity-modulated radiation therapy (IMRT) in vulvar cancer is increasing. However, there remains a paucity of technical information regarding the prevention of a marginal miss during the treatment planning process. The use of an integrated skin flash (ISF) during RT planning can be used to account for anatomic variation, and intra- and interfraction motion seen during treatment. Herein we present the case of a patient with a T1aN0M0, Stage IA vulva cancer to illustrate the progressive vulvar swelling and lymph edema seen during treatment and retrospectively evaluate the dosimetric effects of using an ISF RT plan vs standard RT planning techniques. Standard planning techniques to treat vulvar cancer patients with IMRT do not sufficiently account for the change in patient anatomy and can lead to a marginal miss. ISF is an RT planning technique that can decrease the risk of a marginal miss and the technique is easily implemented during the planning stages of RT treatment. Furthermore, use of an ISF technique can improve vulvar clinical target volume coverage and plan homogeneity. Based on our experience, and this study, a 2-cm ISF is suggested to account for variations in daily clinical setup and changes in patient anatomy during treatment. Published by Elsevier Inc.

Comparative assessment of endocrine modulators with oestrogenic activity: I. Definition of a hygiene-based margin of safety (HBMOS) for xeno-oestrogens against the background of European developments.

PubMed

Bolt, H M; Janning, P; Michna, H; Degen, G H

2001-01-01

A novel concept - the hygiene-based margin of safety (HBMOS) - is suggested for the assessment of the impact of potential endocrine modulators. It integrates exposure scenarios and potency data for industrial chemicals and naturally occurring dietary compounds with oestrogenic activity. An HBMOS is defined as a quotient of estimated daily intakes weighted by the relative in vivo potencies of these compounds. The Existing Chemicals Programme of the European Union provides Human and Environmental Risk Assessments of Existing Chemicals which include human exposure scenarios. Such exposure scenarios, along with potency estimates for endocrine activities, may provide a basis for a quantitative comparison of the potential endocrine-modulating effects of industrial chemicals with endocrine modulators as natural constituents of human diet. Natural phyto-oestrogens exhibit oestrogenic activity in vitro and in vivo. Important phyto-oestrogens for humans are isoflavones (daidzein, genistein) and lignans, with the highest quantities found in soybeans and flaxseed, respectively. Daily isoflavone exposures calculated for infants on soy-based formulae were in the ranges of 4.5-8 mg/kg body wt.; estimates for adults range up to 1 mg/kg body wt. The Senate Commission on the Evaluation of Food Safety (SKLM) of the Deutsche Forschungsgemeinschaft has also indicated a wide range of dietary exposures. For matters of risk assessment, the SKLM has based recommendations on dietary exposure scenarios, implying a daily intake of phyto-oestrogens in the order of 1 mg/kg body wt. On the basis of information compiled within the Existing Chemicals Programme of the EU, it appears that a daily human exposure to nonylphenol of 2 microg/kg body wt. may be a worst-case assumption, but which is based on valid scenarios. The intake of octylphenol is much lower, due to a different use pattern and applications, and may be neglected. Data from migration studies led to estimations of the daily human uptake of bisphenol A of maximally 1 microg/kg body wt. On the basis of comparative data from uterotrophic assays in rats, with three consecutive days of oral applications involved, and taking the natural phyto-oestrogen daidzein as reference (= 1), relative uterotrophic activities in DA/Han rats follow the sequence: daidzein = 1; bisphenol A = 1; p-tertoctylphenol = 2; o, p'-DDT = 4; ethinyl oestradiol = 40,000. The derived values from exposure scenarios, as well as these relative potency values and bridging assumptions, led to calculations of HBMOS as a quantitative comparison of potential endocrine-modulating effects of industrial chemicals with those of natural constituents of human diet. HBMOS estimates for nonylphenol ranged between 250 and 500, dependent on bridging assumptions, and around 1000 for bisphenol A. The derivations of HBMOS were in full support of the conclusions reached by the SKLM of the Deutsche Forschungsgemeinschaft. The estimated HBMOS values for the industrial chemicals (nonylphenol, bisphenol A) appear sufficiently high to ensure the absence of a practical risk to human health under the present exposure conditions.