WorldWideScience

Sample records for agent safety evaluation

  1. [Evaluation of the safety of innovative drugs against viruses and infectious agents].

    Science.gov (United States)

    Kobayashi, Tetsu; Yusa, Keisuke; Kawasaki, Nana

    2013-01-01

    Recently, several novel cellular therapy products and biological drugs are being developed to treat various previously untreatable diseases. One of the most important issues regarding these innovations is how to ensure safety over infectious agents, including viruses and prions, in the earliest treatments with these products. The object of this study is a risk assessment of cases of human infectious with the agents and to present a sample risk management plan based on a collaboration among the National Institute of Health Sciences, universities, marketing authorization holders, and scientific societies. There are three subjects of study: (1) the viral safety of cellular therapy products, (2) the viral safety of biological drugs, and (3) the safety of prions. In this report, we describe the objects of the study, the project members, the study plan outline, and the ongoing plans. The results of the viral risk identification and the risk analysis of cellular therapy products will also be described, based on a review of the literature and case reports obtained during the first year of this project.

  2. NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank.

    Science.gov (United States)

    Reiffel, James A; Weitz, Jeffrey I; Reilly, Paul; Kaminskas, Edvardas; Sarich, Troy; Sager, Philip; Seltzer, Jonathan

    2016-07-01

    Four non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban, and edoxaban) have been approved in the United States for treatment of atrial fibrillation (AF) and venous thromboembolic disease. They have been as or more effective than the prior standards of care, with less fatal or intracranial bleeding, fewer drug and dietary interactions, and greater patient convenience. Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention. Accordingly, a Cardiac Research Safety Consortium "think tank" meeting was held in February 2015 to address these concerns. This manuscript reports on the discussions held and the conclusions reached at that meeting.

  3. Bioprotective agents in safety control

    Directory of Open Access Journals (Sweden)

    Dimitrijević-Branković Suzana I.

    2003-01-01

    Full Text Available Food poisoning is the one of the main health hazards even today. More than 200 known diseases are transmitted through food. The causes of foodborne illness include viruses, bacteria, parasites, toxins, metals, and prions and the symptoms of foodborne illness range from mild gastroenteritis to life-threatening neurological, hepatic and renal syndromes.The prevention of food poisonings represents very serious task for food manufacturers. Beside food control according to the concept "from the farm to the table" there is increased need for the development of new technology for longer shelf lifes of food. Food fermented by lactic acid bacteria (LAB and traditionally considered to be safe. There are many substances produced by LAB that affect the shelf life of fermented food, by active suppression of poisoning microorganisms growth. Because of that, the LAB is recently considered as bioprotective agents that have important role in food safety.

  4. New Safety rule for Chemical Agents

    CERN Multimedia

    Safety Commission

    2010-01-01

    The following Safety rule has been issued on 08-01-2010: Safety Regulation SR-C Chemical Agents This document applies to all persons under the Director General’s authority. It sets out the minimal requirements for the protection of persons from risks to their safety and health arising, or likely to arise, from the effects of hazardous chemical agents used in any CERN activity. All Safety rules are available on the web pages.

  5. Single-dose safety and pharmacokinetic evaluation of fluorocoxib A: pilot study of novel cyclooxygenase-2-targeted optical imaging agent in a canine model

    OpenAIRE

    Cekanova, Maria; Uddin, Md. Jashim; Legendre, Alfred M.; Galyon, Gina; Bartges, Joseph W.; Callens, Amanda; Martin-Jimenez, Tomas; Marnett, Lawrence J.

    2012-01-01

    We evaluated preclinical single-dose safety, pharmacokinetic properties, and specific uptake of the new optical imaging agent fluorocoxib A in dogs. Fluorocoxib A, N-[(5-carboxy-X-rhodaminyl)but-4-yl]-2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetamide, selectively binds and inhibits the cyclooxygenase-2 (COX-2) enzyme, which is overexpressed in many cancers. Safety pilot studies were performed in research dogs following intravenous (i.v.) administration of 0.1 and 1  mg/kg fluo...

  6. Chronic preclinical safety evaluation of EPO-018B, a pegylated peptidic erythropoiesis-stimulating agent in monkeys and rats.

    Science.gov (United States)

    Gong, Xue-Lian; Gu, Xiao-Lei; Chen, Yong-Chun; Zhu, Hai; Xia, Zhen-Na; Li, Jian-Zhong; Lu, Guo-Cai

    2016-09-15

    EPO-018B, a synthetic peptide-based erythropoiesis stimulating agent (ESA), is mainly designed for treatment of anemia caused by chronic renal failure and chemotherapy against cancer. It overcomes the deficiencies of currently approved ESA, including the frequent administration of temperature-sensitive recombinant protein and anti-EPO antibody-mediated pure red cell aplasia (PRCA). This study was designed to evaluate the potential chronic toxicity of EPO-018B. Subcutaneous administration doses were designed as 0, 0.2, 1 and 10mg/kg for six months for 160 rats (20/gender/group) and 0, 0.3, 3 and 20mg/kg for nine months for 32 monkeys (4/gender/group) once every three weeks. The vehicles received the same volume of physiological saline injection. All animals survived to the scheduled necropsies after six weeks (for rats) and fourteen weeks (for monkeys) recovery period, except for the two high-dose female rats and two high-dose male monkeys, which were considered related to the increased RBCs, chronic blood hyperviscosity and chronic cardiac injury. EPO-018B is supposed to be subcutaneously injected once every month and the intended human therapeutic dose is 0.025mg/kg. The study findings at 0.2mg/kg for rats and 0.3mg/kg for monkeys were considered to be the study NOAEL (the no observed adverse effect level), which were more than ten times the intended human therapeutic dose. Higher doses caused adverse effects related to the liver toxicity, cardiotoxicity, appearance of neutralizing antibodies of EPO-018B and the decrease of serum glucose and cholesterol. Most treatment-induced effects were reversible or revealed ongoing recovery upon the discontinuation of treatment. The sequelae occurred in rats and monkeys were considered secondary to exaggerated pharmacology and would less likely occur in the intended patient population. As to the differences between human beings and animals, the safety of EPO-018B need to be further confirmed in the future clinical studies.

  7. Single-dose safety and pharmacokinetic evaluation of fluorocoxib A: pilot study of novel cyclooxygenase-2-targeted optical imaging agent in a canine model

    Science.gov (United States)

    Cekanova, Maria; Uddin, Md. Jashim; Legendre, Alfred M.; Galyon, Gina; Bartges, Joseph W.; Callens, Amanda; Martin-Jimenez, Tomas; Marnett, Lawrence J.

    2012-11-01

    We evaluated preclinical single-dose safety, pharmacokinetic properties, and specific uptake of the new optical imaging agent fluorocoxib A in dogs. Fluorocoxib A, N-[(5-carboxy-X-rhodaminyl)but-4-yl]-2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetamide, selectively binds and inhibits the cyclooxygenase-2 (COX-2) enzyme, which is overexpressed in many cancers. Safety pilot studies were performed in research dogs following intravenous (i.v.) administration of 0.1 and 1 mg/kg fluorocoxib A. Blood and urine samples collected three days after administration of each dose of fluorocoxib A revealed no evidence of toxicity, and no clinically relevant adverse events were noted on physical examination of exposed dogs over that time period. Pharmacokinetic parameters were assessed in additional research dogs from plasma collected at several time points after i.v. administration of fluorocoxib A using high-performance liquid chromatography analysis. The pharmacokinetic studies using 1 mg/kg showed a peak of fluorocoxib A (92±28 ng/ml) in plasma collected at 0.5 h. Tumor specific uptake of fluorocoxib A was demonstrated using a dog diagnosed with colorectal cancer expressing COX-2. Our data support the safe single-dose administration and in vivo efficacy of fluorocoxib A, suggesting a high potential for successful translation to clinical use as an imaging agent for improved tumor detection in humans.

  8. Evaluation of the short-term efficacy and safety of biological agents in different rheumatic diseases: a multidisciplinary therapeutic hospital"s experience

    Directory of Open Access Journals (Sweden)

    N A Mukhin

    2013-01-01

    Full Text Available There has been a substantial expansion in the possibilities of current therapy for rheumatic diseases (RD primarily due to the use of genetically engineered biological agents (GEBA. Objective: to evaluate the short-term efficacy and safety of GEBA in patients with different RD. Subjects and methods. The trial included all RD patients receiving GEBA: rituximab (RTM, infliximab (INF, adalimumab, etanercept, tocilizumab, abatacept in 2009-2012. Therapeutic efficiency and safety were evaluated 6 months later. The effect of GEBA was determined as “remission”, “improvement”, and “no response”, by using the parameters peculiar to specific diseases (such as BVAS, DAS28, BASDAI. Results. The trial enrolled 107 patients (49 men and 58 women; mean age 41.5 years with rheumatoid arthritis (n=34, ANCA-associated vasculitis (n = 34, systemic lupus erythematosus (n=16, cryoglobulinemic vasculitis (n=11, ankylosing spondyloarthritis (n = 8, systemic vasculitis with large artery involvement (n=6, and other RD. All the cases showed severe systemic autoimmune disease refractory to standard immunosuppressive therapy. RTM (n=66 and INF (n = 31 were most frequently used. The high rate of RTM prescription was due to the fact that this drug was given to all patients with ANCA-associated vasculitis, systemic lupus erythematosus, and cryoglobulinemic vasculitis who totaled more than half of the patients included into the trial. The vast majority of them received GEBA for the first time. After the treatment, there was remission in 62 (57.9% and improvement in 42 (39.3% cases. Mild or moderate adverse reactions were observed in 22 (20.6% patients and severe ones were seen in 6 (5.6%. Conclusion. GEBA therapy ensures a significant improvement in a substantial proportion of patients with different RD refractory to standard immunosuppressive therapy.

  9. Which agents threaten blood safety in the future?

    Science.gov (United States)

    Kitchen, A D; Barbara, J A

    2000-12-01

    The safety of the blood supply is critical to many parts of modern medicine. In a time when prescriber's and the public's expectations are increasing, it is essential that transfusion services globally ensure the safety of the blood supply. There are, however, many threats to this safety, one being the appearance of new infectious agents. Such agents may be truly 'novel', or may be existing agents, known but not routinely screened for, posing a new or increased threat. However, before an agent is considered to be a true threat to blood safety it must be well characterized, and evidence must be presented that (i) transfusion transmission is a significant route of spread, and (ii) the agent causes significant clinical disease. If either of these criteria are not met, the question has to be asked as to whether the agent is truly a threat to blood safety.

  10. Antipsychotic agents: efficacy and safety in schizophrenia

    Directory of Open Access Journals (Sweden)

    de Araújo AN

    2012-11-01

    Full Text Available Arão Nogueira de Araújo,1 Eduardo Pondé de Sena,1,2 Irismar Reis de Oliveira,1,3 Mario F Juruena41Postgraduation Program in Interactive Processes of Organs and Systems, 2Department of Pharmacology, Institute of Health Sciences, 3Department of Neurosciences and Mental Health, School of Medicine, Federal University of Bahia, Salvador, Brazil; 4Stress and Affective Disorders Program, Department of Neuroscience and Behavior, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Sao Paulo, BrazilAbstract: Antipsychotics have provided a great improvement in the management of people with schizophrenia. The first generation antipsychotics could establish the possibility of managing many psychotic subjects in an outpatient setting. With the advent of the second (SGA and third generation antipsychotics (TGA, other psychiatric disorders such as bipolar depression, bipolar mania, autism, and major depressive disorder have now been approved for the use of these drugs for their treatment. Also, the administration of more specific assessment tools has allowed for better delineation of the repercussions of these drugs on symptoms and the quality of life of patients who use antipsychotic agents. In general, the SGA share similar mechanisms of action to achieve these results: dopamine-2 receptor antagonism plus serotonin-2A receptor antagonism. The TGA (eg, aripiprazole have partial agonist activity at the dopamine-2 receptor site, and are also called dopaminergic stabilizers. The pharmacological profile of SGA and TGA may provide better efficacy against negative symptoms, and are less likely to produce extrapyramidal symptoms; however, the SGA and TGA are associated with many other adverse events. The clinician has to balance the risks and benefits of these medications when choosing an antipsychotic for an individual patient.Keywords: antipsychotic agents, schizophrenia, pharmacology, safety

  11. Agent-Based Simulation and Assessment of NAS Security and Safety Project

    Data.gov (United States)

    National Aeronautics and Space Administration — The key innovation proposed here is the use of agent-based modeling and simulation to evaluate the safety of the National Airspace under crisis operations and...

  12. Subchronic safety evaluation of EPO-018B, a pegylated peptidic erythropoiesis stimulating agent, after 5-week subcutaneous injection in Cynomolgus monkeys and Sprague-Dawley rats.

    Science.gov (United States)

    Gong, Xue-Lian; Zhang, Xiao-Dong; Li, Juan; Zhang, Xiao-Fang; Zong, Ying; Lu, Guo-Cai; Yuan, Bo-Jun

    2013-10-01

    EPO-018B, a synthetic peptide-based erythropoiesis stimulating agent (ESA), is coupled to polyethylene glycol (PEG) and designed to specifically bind and activate the erythropoietin (EPO) receptor to result in production of red blood cells. This study was designed to evaluate the potential subchronic toxicity of EPO-018B for Cynomolgus monkeys and Sprague-Dawley rats both at 0, 0.5, 5 and 50 mg/kg every week for 5 weeks, followed by 6-week recovery for rats and 12-week recovery for monkeys. The No Observed Adverse Effect Level (NOAEL) for rats and monkeys were both considered to be at least 0.5 mg/kg/day, the minimum toxic dose to be 5.0 mg/kg/day and the severe toxic dose to be more than 50.0 mg/kg/day. The toxicological effects included the exaggerated pharmacology and secondary sequelae that resulted from an erythropoiesis-stimulating agent treatment to healthy animals. Most treatment induced effects were reversible or showed ongoing recovery upon discontinuation of treatment. The anticipated patient population for EPO-018B treatment is targeted to be the anemia patients caused by chronic renal failure or chemotherapy against to cancer and is expected to have an ideal clinical application prospect.

  13. LNG Safety Assessment Evaluation Methods

    Energy Technology Data Exchange (ETDEWEB)

    Muna, Alice Baca [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); LaFleur, Angela Christine [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-05-01

    Sandia National Laboratories evaluated published safety assessment methods across a variety of industries including Liquefied Natural Gas (LNG), hydrogen, land and marine transportation, as well as the US Department of Defense (DOD). All the methods were evaluated for their potential applicability for use in the LNG railroad application. After reviewing the documents included in this report, as well as others not included because of repetition, the Department of Energy (DOE) Hydrogen Safety Plan Checklist is most suitable to be adapted to the LNG railroad application. This report was developed to survey industries related to rail transportation for methodologies and tools that can be used by the FRA to review and evaluate safety assessments submitted by the railroad industry as a part of their implementation plans for liquefied or compressed natural gas storage ( on-board or tender) and engine fueling delivery systems. The main sections of this report provide an overview of various methods found during this survey. In most cases, the reference document is quoted directly. The final section provides discussion and a recommendation for the most appropriate methodology that will allow efficient and consistent evaluations to be made. The DOE Hydrogen Safety Plan Checklist was then revised to adapt it as a methodology for the Federal Railroad Administration’s use in evaluating safety plans submitted by the railroad industry.

  14. Kansei Evaluation in Agent Rearing Game

    OpenAIRE

    野路, 浩一朗; 西野, 順二; 小高, 知宏; 小倉, 久和; NOJI, Koichiro; NISHINO, Junji; ODAKA, Tomohiro; OGURA, Hisakazu

    1999-01-01

    In this paper, We have studied the Kansei evaluation of the agent rearing game. The agent rearing game is a game by which the characters who are the agents are brouht up. The Kansei evaluation is an evaluation by Kansei engineering like the sensibility and feelings, etc. to treat technological1y. In this research, We produced the agent rearing game. We propose the method of the interesting the game using the technique of Kansei engineering for the evaluation.

  15. Safety Evaluation of New Hemostatic Agents, Smectite Granules, and Kaolin-Coated Gauze in a Vascular Injury Wound Model in Swine

    Science.gov (United States)

    2010-02-01

    histologic slides were done by a board-certified veterinarian pathologist (J.S.E.) who was initially blinded to the treatment of the samples. The blood...significant. RESULTS The baseline hemodynamic and hematological param- eters measured before vascular injuries were within normal ranges and not different...agents (Table 4). The total compression time to achieve hemostasis with each TABLE 1. Baseline Physiological and Hematological Measurements of the

  16. Agent Based Processing of Global Evaluation Function

    CERN Document Server

    Hossain, M Shahriar; Joarder, Md Mahbubul Alam

    2011-01-01

    Load balancing across a networked environment is a monotonous job. Moreover, if the job to be distributed is a constraint satisfying one, the distribution of load demands core intelligence. This paper proposes parallel processing through Global Evaluation Function by means of randomly initialized agents for solving Constraint Satisfaction Problems. A potential issue about the number of agents in a machine under the invocation of distribution is discussed here for securing the maximum benefit from Global Evaluation and parallel processing. The proposed system is compared with typical solution that shows an exclusive outcome supporting the nobility of parallel implementation of Global Evaluation Function with certain number of agents in each invoked machine.

  17. Preclinical Evaluation Of Photosensitizing Agents

    Science.gov (United States)

    Kessel, David

    1989-06-01

    Methods for the pre-clinical evaluation of new photosensitizing dyes are described. The resulting information can provide useful leads concerning likely modes and sites of localization. But correlations between results obtained in cell culture and in animal tumor models are sufficiently weak to indicate the need for caution in extrapolation of any in vitro result.

  18. Understanding the relationship between safety investment and safety performance of construction projects through agent-based modeling.

    Science.gov (United States)

    Lu, Miaojia; Cheung, Clara Man; Li, Heng; Hsu, Shu-Chien

    2016-09-01

    The construction industry in Hong Kong increased its safety investment by 300% in the past two decades; however, its accident rate has plateaued to around 50% for one decade. Against this backdrop, researchers have found inconclusive results on the causal relationship between safety investment and safety performance. Using agent-based modeling, this study takes an unconventional bottom-up approach to study safety performance on a construction site as an outcome of a complex system defined by interactions among a worksite, individual construction workers, and different safety investments. Instead of focusing on finding the absolute relationship between safety investment and safety performance, this study contributes to providing a practical framework to investigate how different safety investments interacting with different parameters such as human and environmental factors could affect safety performance. As a result, we could identify cost-effective safety investments under different construction scenarios for delivering optimal safety performance.

  19. Propagation Modeling of Food Safety Crisis Information Update Based on the Multi-agent System

    Directory of Open Access Journals (Sweden)

    Meihong Wu

    2015-08-01

    Full Text Available This study propose a new multi-agent system frame based on epistemic default complex adaptive theory and use the agent based simulation and modeling the information updating process to study food safety crisis information dissemination. Then, we explore interaction effect between each agent in food safety crisis information dissemination at the current environment and mostly reveals how the government agent, food company agent and network media agent influence users confidence in food safety. The information updating process give a description on how to guide a normal spread of food safety crisis in public opinion in the current environment and how to enhance the confidence of food quality and safety of the average users.

  20. Plutonium Finishing Plant safety evaluation report

    Energy Technology Data Exchange (ETDEWEB)

    1995-01-01

    The Plutonium Finishing Plant (PFP) previously known as the Plutonium Process and Storage Facility, or Z-Plant, was built and put into operation in 1949. Since 1949 PFP has been used for various processing missions, including plutonium purification, oxide production, metal production, parts fabrication, plutonium recovery, and the recovery of americium (Am-241). The PFP has also been used for receipt and large scale storage of plutonium scrap and product materials. The PFP Final Safety Analysis Report (FSAR) was prepared by WHC to document the hazards associated with the facility, present safety analyses of potential accident scenarios, and demonstrate the adequacy of safety class structures, systems, and components (SSCs) and operational safety requirements (OSRs) necessary to eliminate, control, or mitigate the identified hazards. Documented in this Safety Evaluation Report (SER) is DOE`s independent review and evaluation of the PFP FSAR and the basis for approval of the PFP FSAR. The evaluation is presented in a format that parallels the format of the PFP FSAR. As an aid to the reactor, a list of acronyms has been included at the beginning of this report. The DOE review concluded that the risks associated with conducting plutonium handling, processing, and storage operations within PFP facilities, as described in the PFP FSAR, are acceptable, since the accident safety analyses associated with these activities meet the WHC risk acceptance guidelines and DOE safety goals in SEN-35-91.

  1. Clinical evaluation of clotrimazole. A broad-spectrum antifungal agent.

    Science.gov (United States)

    Spiekermann, P H; Young, M D

    1976-03-01

    The efficacy and safety of the broad-spectrum, topically applied antifungal agent clotrimazole were evaluated in two double-blind, multicentric trials. Ten investigators reported on a total of 1,361 cases in which a 1% solution or a 1% cream formulation was compared with its respective vehicle. Clotrimazole was therapeutically effective, as confirmed by mycological cure (negative microscopy and culture) and clinical improvement, in tinea pedis, tinea cruris, tinea corporis, pityriasis versicolor, and cutaneous candidasis. Furthermore, species identification established the efficacy of clotrimazole against Trichophyton rubrum, T mentagrophytes, Epidermophyton floccosum, Microsporum canis, Malassezia furfur (Pityrosporum orbiculare), and Candida albicans. Safety was demonstrated by the low incidence of possibly drug-related adverse experiences, namely, 19 (2.7%) of 699 patients who were treated with clotrimazole, of whom four (0.6%) discontinued treatment.

  2. Safety evaluation of synthetic β-carotene

    NARCIS (Netherlands)

    Woutersen, R.A.; Wolterbeek, A.P.M.; Appel, M.J.; Berg, H. van den; Goldbohm, R.A.; Feron, V.J.

    1999-01-01

    The safety of β-carotene was reassessed by evaluating the relevant literature on the beneficial and adverse effects of β-carotene on cancer and, in particular, by evaluating the results of toxicity studies. β- Carotene appeared neither genotoxic nor reprotoxic or teratogenic, and no signs of organ t

  3. Safety Pharmacology Evaluation of Biopharmaceuticals.

    Science.gov (United States)

    Amouzadeh, Hamid R; Engwall, Michael J; Vargas, Hugo M

    2015-01-01

    Biotechnology-derived pharmaceuticals or biopharmaceuticals (BPs) are molecules such as monoclonal antibodies, soluble/decoy receptors, hormones, enzymes, cytokines, and growth factors that are produced in various biological expression systems and are used to diagnose, treat, or prevent various diseases. Safety pharmacology (SP) assessment of BPs has evolved since the approval of the first BP (recombinant human insulin) in 1982. This evolution is ongoing and is informed by various international harmonization guidelines. Based on these guidelines, the potential undesirable effect of every drug candidate (small molecule or BP) on the cardiovascular, central nervous, and respiratory systems, referred to as the "core battery," should be assessed prior to first-in-human administration. However, SP assessment of BPs poses unique challenges such as choice of test species and integration of SP parameters into repeat-dose toxicity studies. This chapter reviews the evolution of SP assessment of BPs using the approval packages of marketed BPs and discusses the past, current, and new and upcoming approach and methods that can be used to generate high-quality data for the assessment of SP of BPs.

  4. Research on the effect estimation of seismic safety evaluation

    Institute of Scientific and Technical Information of China (English)

    邹其嘉; 陶裕禄

    2004-01-01

    Seismic safety evaluation is a basic work for determining the seismic resistance requirements of major construction projects. The effect, especially the economic effect of the seismic safety evaluation has been generally concerned. The paper gives a model for estimating the effect of seismic safety evaluation and calculates roughly the economic effect of seismic safety evaluation with some examples.

  5. Safety evaluation of natural flavour complexes

    NARCIS (Netherlands)

    Smith, R.L.; Adams, T.B.; Cohen, S.M.; Doull, J.; Feron, V.J.; Goodman, J.I.; Hall, R.L.; Marnett, L.J.; Portoghese, P.S.; Waddell, W.J.; Wagner, B.M.

    2004-01-01

    Natural flavour complexes (NFCs) are chemical mixtures obtained by applying physical separation methods to botanical sources. Many NFCs are derived from foods. In the present paper, a 12-step procedure for the safety evaluation of NFCs, 'the naturals paradigm', is discussed. This procedure, which is

  6. Safety evaluation of superabsorbent baby diapers.

    Science.gov (United States)

    Kosemund, Kirstin; Schlatter, Harald; Ochsenhirt, Jennifer L; Krause, Edburga L; Marsman, Daniel S; Erasala, Geetha N

    2009-03-01

    Superabsorbent disposable baby diapers are sophisticated, well-engineered products that provide many benefits including convenience, comfort, exceptional leakage protection, improved hygiene and skin care benefits compared with cloth diapers. Safety assurance is an integral part of the diaper development process at Procter & Gamble, with the goal of ensuring safety for both caregivers and babies. A systematic, stepwise approach to safety assessment starts with a thorough evaluation of new design features and materials, using the principles of general risk assessment including, as appropriate, controlled trials to assess clinical endpoints or independent scientific review of safety data. The majority of the diaper materials are polymers that are safe and do not have inherent toxicity issues. Trace amounts of non-polymeric materials, such as colorants, are assessed based on their skin contact potential. New materials or design features are introduced in marketed products only if they have been shown to be safe under the conditions of recommended or foreseeable use. The product safety continues to be confirmed after launch by means of in-market monitoring. This article provides a broad overview of human safety exposure-based risk assessment used at Procter & Gamble for absorbent hygiene products.

  7. THE STUDY THE EFFICACY AND SAFETY OF ANTIMICROBIAL AGENTS

    Directory of Open Access Journals (Sweden)

    V. V. Bagaeva

    2015-01-01

    Full Text Available Abstract:Effective treatment of patients with infectious and inflammatory diseases of the skin and mucous membranes often involves the use of antimicrobial agents.The purpose of the study was an in vitro estimation of cytotoxicity and the efficiency of national resources for local use: gel with bacteriophages («Otofag», «Fagogin», «Fagoderm», «Fagodent» and antiseptic — «Сhlorhexidine» and «Miramistin».Materials and Methods. To study the effectiveness of antimicrobial agents they used to provide crop strains of Staphylococcus aureus and Streptococcus pyogenes as one of the most common representatives of pathogens. The study of cell viability and cytotoxicity antimicrobials performed on cell lines KB — epidermoid carcinoma of the oral cavity of a human. For this purpose we use mikrotetrazoly test, which is widely used in the assessment of the effects on the cells of toxins, pharmaceuticals, adverse environmental factors, allowing to evaluate the toxicity of investigational drugs in vitro.The results showed that the efficacy against pathogens Staphylococcus aureus and Streptococcus pyogenes, has even a 10‑fold dilution of «Сhlorhexidine» 0.05% and gels with bacteriophages. Antiseptic «Miramistin» is effective only on the initial concentration. The study of cytotoxicity showed that the processing of epidermoid carcinoma cells with «Chlorhexidine» and «Мiramistin» invokes the irreversible reactions, while the composition processing of gels based on bacteriophages not further affect cell viability.Conclusions The results of the experiment confirmed the significant toxicity of tools such as «Сhlorhexidine» and «Miramistin» in proposed concentrations in the pharmacy network. Despite the high efficiency of these vehicles with regard to the studied pathogens, their long-term use in treatment of inflammatory diseases of the skin and mucous membranes can cause a slowing of repair processes. Gel means with bacteriophages

  8. Safety, pharmacokinetic and dosimetry evaluation of the proposed thrombus imaging agent {sup 99m}Tc-DI-DD-3B6/22-80B3 Fab'

    Energy Technology Data Exchange (ETDEWEB)

    Macfarlane, David J. [Royal Brisbane and Women' s Hospital, Department of Nuclear Medicine, Brisbane (Australia); Smart, Richard C. [St George Hospital, Department of Nuclear Medicine, Sydney (Australia); Tsui, Wendy W. [St George Hospital, Department of Nuclear Medicine, Sydney (Australia); University of New South Wales, School of Medicine, Sydney (Australia); Gerometta, Michael [AGEN Biomedical Limited, Research and Development, Brisbane (Australia); Eisenberg, Paul R. [Eli Lilly Company, Lilly Research Laboratories, Indianapolis (United States); Scott, Andrew M. [Austin Health, Centre for PET, Melbourne (Australia); Ludwig Institute for Cancer Research, Melbourne (Australia)

    2006-06-15

    {sup 99m}Tc-DI-DD-3B6/22-80B3 (Thromboview, hereafter abbreviated to {sup 99m}Tc-DI-80B3 Fab') is a humanised, radiolabelled monoclonal antibody Fab' fragment with high affinity and specificity for the D-dimer domain of cross-linked fibrin. The purpose of this study was to evaluate the safety, pharmacokinetics and dosimetry of four increasing doses of {sup 99m}Tc-DI-80B3 Fab' in healthy volunteers. Thirty-two healthy volunteers (18-70 years; 16 male, 16 female) received a single intravenous injection of 0.5, 1.0, 2.0 or 4.0 mg of {sup 99m}Tc-DI-80B3 Fab'. Safety outcomes (vital signs, electrocardiography, haematology, biochemistry, adverse events and development of human anti-human antibodies) were assessed up to 30 days post injection. Blood and urine samples were collected up to 48 h post injection. Gamma camera images were acquired at 0.5, 1, 2, 4, 6 and 24 h post injection. Dosimetry was performed using standard MIRD methodology. No adverse events considered to be drug related were observed. Human anti-human antibody was not detectable in any subject during the follow-up period. {sup 99m}Tc-DI-80B3 Fab' had a rapid initial plasma clearance (t{sub 1/2}{alpha}=1 h). The pharmacokinetic profile of the Fab' fragment was generally linear across the four dose cohorts. By 24 h, 30-35% of the administered radioactivity appeared in the urine. There was marked renal accumulation with time, but no specific uptake was identified within other normal tissues. The effective dose was 9 mSv/750 MBq. (orig.)

  9. Safety assured financial evaluation of maintenance

    Science.gov (United States)

    Erguina, Vera

    Management decisions in complex industrial facilities usually consider both the economic and environmental aspects of the plant's performance. For nuclear power plants (NPPs), safety is also a very substantial issue. The objectives of this dissertation are to develop and demonstrate a novel useful conceptual model that could be used to allocate maintenance funds for a nuclear power plant in such a way as to meet all specified safety requirements and objectives, while achieving a high degree of economic performance. The model is based on the general theory that the reliability of a plant at any time is a function of its initial reliability and the maintenance history of the individual plant components (Smith, 1997). Such a model can assist in evaluating strategic management decisions regarding allocation of funds for nuclear power plant maintenance. It could be used as a simulation tool; various scenarios could be studied to answer "what if" questions. Simulations of this type will allow a better understanding of the relationship between maintenance, economic performance, and safety, and consequently will lead to better decision making. The novelty of this model is tied to the intimate relationship that it develops between maintenance activities at a nuclear plant, and their relationship to prescribed safety requirements and to the economic performance of that plant.

  10. Organizational Compliance: An agent-based model for designing and evaluating organizational interactions

    NARCIS (Netherlands)

    Jiang, J.

    2015-01-01

    The motivation of this research comes from the need of devising and evaluating solutions to achieving organizational compliance, which is an important factor in ensuring the success of business operations and the safety of business environments. Using normative multi-agent systems as the basis of co

  11. A probabilistic bridge safety evaluation against floods.

    Science.gov (United States)

    Liao, Kuo-Wei; Muto, Yasunori; Chen, Wei-Lun; Wu, Bang-Ho

    2016-01-01

    To further capture the influences of uncertain factors on river bridge safety evaluation, a probabilistic approach is adopted. Because this is a systematic and nonlinear problem, MPP-based reliability analyses are not suitable. A sampling approach such as a Monte Carlo simulation (MCS) or importance sampling is often adopted. To enhance the efficiency of the sampling approach, this study utilizes Bayesian least squares support vector machines to construct a response surface followed by an MCS, providing a more precise safety index. Although there are several factors impacting the flood-resistant reliability of a bridge, previous experiences and studies show that the reliability of the bridge itself plays a key role. Thus, the goal of this study is to analyze the system reliability of a selected bridge that includes five limit states. The random variables considered here include the water surface elevation, water velocity, local scour depth, soil property and wind load. Because the first three variables are deeply affected by river hydraulics, a probabilistic HEC-RAS-based simulation is performed to capture the uncertainties in those random variables. The accuracy and variation of our solutions are confirmed by a direct MCS to ensure the applicability of the proposed approach. The results of a numerical example indicate that the proposed approach can efficiently provide an accurate bridge safety evaluation and maintain satisfactory variation.

  12. Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

    Science.gov (United States)

    Bresler, B.; And Others

    This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

  13. Evaluation and Improvement of Food Safety Satisfaction Based on QFD

    Directory of Open Access Journals (Sweden)

    Pu Jin

    2015-05-01

    Full Text Available In view of the social phenomenon of people's generally low satisfaction with food safety, we introduced the QFD method to make evaluation and guidance for improvement. Based on scientific and reasonable evaluation index system of food safety satisfaction and the “quality house” of QFD core tool, a food safety satisfaction evaluation model was constructed. On the basis of the evaluation results, we analyzed the public food safety requirements and constructed the quality house between the public food safety requirements and the food safety satisfaction improvement measures, so as to determine the priority of configuration sequence of improvement measures.

  14. Safety evaluation for packaging (onsite) SERF cask

    Energy Technology Data Exchange (ETDEWEB)

    Edwards, W.S.

    1997-10-24

    This safety evaluation for packaging (SEP) documents the ability of the Special Environmental Radiometallurgy Facility (SERF) Cask to meet the requirements of WHC-CM-2-14, Hazardous Material Packaging and Shipping, for transfer of Type B quantities (up to highway route controlled quantities) of radioactive material within the 300 Area of the Hanford Site. This document shall be used to ensure that loading, tie down, transport, and unloading of the SERF Cask are performed in accordance with WHC-CM-2-14. This SEP is valid until October 1, 1999. After this date, an update or upgrade to this document is required.

  15. Note on evaluating safety performance of road infrastructure to motivate safety competition.

    Science.gov (United States)

    Han, Sangjin

    2016-01-01

    Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

  16. Efficacy and safety of biological agents for systemic juvenile idiopathic arthritis

    DEFF Research Database (Denmark)

    Tarp, Simon; Amarilyo, Gil; Foeldvari, Ivan;

    2016-01-01

    % improvement according to the modified American College of Rheumatology Paediatric 30 response criteria (JIA ACR30). The primary safety outcome was defined as serious adverse events (SAEs). Outcomes were analysed by pairwise and network meta-analyses. The quality of evidence between biologic agents...

  17. [Example of safety measures for antineoplastic agents immediately after market launch--a case of TS-1 capsule all example use result investigation that executes safety monitoring--].

    Science.gov (United States)

    Ito, Kunio

    2006-01-01

    As a measure to ensure safe use of TS-1 during the early marketing period, a drug use investigation was conducted on an all-case basis. Extra safety monitoring,rarely included in the use investigation,was also planned for patients who began therapy with this agent. Of the 4,177 subjects registered during the year beginning in March 1999, 3,882 started TS-1 therapy. Aside from 74 dropouts, 3,808 cases were evaluable for safety. The overall incidence of adverse reactions, with high frequencies of myelosuppression and gastrointestinal disorders, was 74.3%: a result similar to an incidence of 77.5% (100/129) found in the early phase II trial with gastric cancer patients. Safety monitoring made it possible to check if a given patients was eligible for proper use before treatment is begun. During TS-1 administration,collaboration was formed between physicians and medical representatives to ensure regular laboratory testing and to check the test findings. Measures were considered necessary to secure the safe use of drugs with manifest risk of serious adverse reactions, such as antineoplastic agents, during the initial period of market introduction. Our present approach proved effective as one of such measures.

  18. Subjective performance evaluations and reciprocity in principal-agent relations

    DEFF Research Database (Denmark)

    Sebald, Alexander Christopher; Walzl, Markus

    2014-01-01

    . In contrast to existing models of reciprocity, we find that agents tend to sanction whenever the feedback of principals is below their subjective self-evaluations even if agents' pay-offs are independent of it. In turn, principals provide more positive feedback (relative to their actual performance assessment...

  19. A distributed, collaborative intelligent agent system approach for proactive postmarketing drug safety surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Farber, Margo S; Yen, John; Dews, Peter; Miller, Richard E; Massanari, R Michael

    2010-05-01

    Discovering unknown adverse drug reactions (ADRs) in postmarketing surveillance as early as possible is of great importance. The current approach to postmarketing surveillance primarily relies on spontaneous reporting. It is a passive surveillance system and limited by gross underreporting (computers located in different places, are capable of continuously and autonomously collaborating with each other and assisting the human users (e.g., the food and drug administration (FDA), drug safety professionals, and physicians). The agents should enhance current systems and accelerate early ADR identification. To evaluate the performance of the ADRMonitor with respect to the current spontaneous reporting approach, we conducted simulation experiments on identification of ADR signal pairs (i.e., potential links between drugs and apparent adverse reactions) under various conditions. The experiments involved over 275,000 simulated patients created on the basis of more than 1000 real patients treated by the drug cisapride that was on the market for seven years until its withdrawal by the FDA in 2000 due to serious ADRs. Healthcare professionals utilizing the spontaneous reporting approach and the ADRMonitor were separately simulated by decision-making models derived from a general cognitive decision model called fuzzy recognition-primed decision (RPD) model that we recently developed. The quantitative simulation results show that 1) the number of true ADR signal pairs detected by the ADRMonitor is 6.6 times higher than that by the spontaneous reporting strategy; 2) the ADR detection rate of the ADRMonitor agents with even moderate decision-making skills is five times higher than that of spontaneous reporting; and 3) as the number of patient cases increases, ADRs could be detected significantly earlier by the ADRMonitor.

  20. Safety evaluation of Eugenia jambolana seed extract

    Institute of Scientific and Technical Information of China (English)

    Jayanta M Sankhari; Ravirajsinh N Jadeja; Menaka C Thounaojam; Ranjitsinh V Devkar; Ramachandran AV

    2010-01-01

    Objective: To evaluate the safety of ethanolic seed extract of Eugenia jambolana (EJSE) using acute and sub-chronic toxicity assays in Swiss albino mice as per Organisation for Economic Co-operation and Development (OECD) guidelines. Methods: Possible behavioral changes and lethality were observed in mice administered a single dose [1 000, 2 000, 3 000, 4 000 or 5 000mg/kg body weight (BW)] of EJSE. Plasma levels of metabolic, hepatic, cardiac and renal function markers, electrolytes, blood count and histopathology of major organs were monitored in mice chronically treated with EJSE (1 000, 2 000 or 3 000 mg/kg BW) for 28 days. Results: Since no mortality was recorded in the acute toxicity evaluation up to a dose of 5 000 mg/kg bodyweight of EJSE, 50%lethal dose (LD50) was assumed to be >5 000 mg/kg BW. In the sub-chronic toxicity evaluation, no adverse observations were recorded in mice administered with 2 000 mg/kg BW of EJSE;however at 3 000 mg/kg BW dose, moderately significant increase in the plasma levels of urea and creatinine was observed. Hence, the lowest observable adverse effect level (LOAEL) for EJSE was found to be 3 000 mg/kg BW and the no observable adverse effect level (NOAEL) was adjudged as 2 000 mg/kg BW. Conclusions: It can be concluded from this study that, orally administered EJSE is safe up to a10 fold higher dose than its reported therapeutic dose.

  1. MODEL-BASED PERFORMANCE EVALUATION APPROACH FOR MOBILE AGENT SYSTEMS

    Institute of Scientific and Technical Information of China (English)

    Li Xin; Mi Zhengkun; Meng Xudong

    2004-01-01

    Claimed as the next generation programming paradigm, mobile agent technology has attracted extensive interests in recent years. However, up to now, limited research efforts have been devoted to the performance study of mobile agent system and most of these researches focus on agent behavior analysis resulting in that models are hard to apply to mobile agent systems. To bridge the gap, a new performance evaluation model derived from operation mechanisms of mobile agent platforms is proposed. Details are discussed for the design of companion simulation software, which can provide the system performance such as response time of platform to mobile agent. Further investigation is followed on the determination of model parameters. Finally comparison is made between the model-based simulation results and measurement-based real performance of mobile agent systems. The results show that the proposed model and designed software are effective in evaluating performance characteristics of mobile agent systems. The proposed approach can also be considered as the basis of performance analysis for large systems composed of multiple mobile agent platforms.

  2. Biological safety evaluation of the modified urinary catheter

    Energy Technology Data Exchange (ETDEWEB)

    Kowalczuk, Dorota, E-mail: dorota.kowalczuk@umlub.pl [Department of Medicinal Chemistry, Medical University of Lublin, Jaczewskiego 4, 20-090 Lublin (Poland); Przekora, Agata; Ginalska, Grazyna [Department of Biochemistry and Biotechnology, Medical University of Lublin, Chodzki 1, 20-093 Lublin (Poland)

    2015-04-01

    The purpose of this study was to evaluate in vitro safety of the novel tosufloxacin (TOS)-treated catheters with the prolonged antimicrobial activity. The test samples of silicone latex catheter were prepared by the immobilization of TOS on chitosan (CHIT)-coated catheter by means of covalent bonds and non-covalent interactions. Each step of the modification process of catheter surface was observed using ATR–Fourier transform infrared spectroscopy. In vitro cytotoxicity of the modified and unmodified catheters was assessed by direct and indirect tests in accordance with ISO standards using green monkey kidney (GMK) cell line. The MTT, lactate dehydrogenase activity (LDH), WST-8, Sulforhodamine B (SRB) test results and microscopic observation clearly indicated that unmodified silicone latex catheters decrease cell metabolic activity, act as a cytotoxic agent causing cell lysis and induce cell death through necrotic or apoptotic process. We suggest that chitosan coat with TOS immobilized limits leaching of harmful agents from silicone latex material, which significantly enhances survivability of GMK cells and therefore is quite a good protection against the cytotoxic effect of this material. - Highlights: • Characterization of the novel antimicrobial urinary catheters • Monitoring of the catheter modification by FTIR analysis • Confirmation of high cytotoxicity of latex-based catheter used in urological practice • Chitosan-coated and tosufloxacin-treated catheter is less toxic than the untreated one. • The proposed surface modification protects cells against latex-induced death.

  3. Providing Nuclear Criticality Safety Analysis Education through Benchmark Experiment Evaluation

    Energy Technology Data Exchange (ETDEWEB)

    John D. Bess; J. Blair Briggs; David W. Nigg

    2009-11-01

    One of the challenges that today's new workforce of nuclear criticality safety engineers face is the opportunity to provide assessment of nuclear systems and establish safety guidelines without having received significant experience or hands-on training prior to graduation. Participation in the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and/or the International Reactor Physics Experiment Evaluation Project (IRPhEP) provides students and young professionals the opportunity to gain experience and enhance critical engineering skills.

  4. Simulation environment for algorithms and agents evaluation.

    Directory of Open Access Journals (Sweden)

    Pablo CHAMOSO

    2016-06-01

    Full Text Available This article presents an adaptive platform that can simulate the centralized control of different smart city areas. For example, public lighting and intelligent management, public zones of buildings, energy distribution, etc. It can operate the hardware infrastructure and perform optimization both in energy consumption and economic control from a modular architecture which is fully adaptable to most cities. Machine-to-machine (M2M permits connecting all the sensors of the city so that they provide the platform with a perfect perspective of the global city status. To carry out this optimization, the platform offers the developers a software that operates on the hardware infrastructure and merges various techniques of artificial intelligence (AI and statistics, such as artificial neural networks (ANN, multi-agent systems (MAS or a Service Oriented Approach (SOA, forming an Internet of Services (IoS. Different case studies were tested by using the presented platform, and further development is still underway with additional case studies.

  5. Simulation Approach for Safety Evaluation of Smart Transmitters in NPPs

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Yeong Jin; Jeong, Sang Yong; Kim, Hyung Tae; Choo, Jaeyul; Park, Hyun Shin; Jeong, Choong Heui [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of); Lee, Jea Heung [Hanbat National University, Daejeon (Korea, Republic of)

    2015-10-15

    Smart transmitters which are microprocessor-based device including software have been used for various industry. The necessity of preparing the regulatory guide or safety review plan for the smart transmitter is increased before using the smart transmitter for safety function. So the two year simulated approach study plan to extract some generic characteristics not limited typical smart transmitter was setup in Dec. 2014 to safety evaluation of safety grade smart transmitter. This paper addresses the considerations on safety evaluation and simulated approach for smart transmitter of the first year and middle of the second year study. This paper showed the first year and the middle of the second year activity for the smart transmitter safety evaluation and simulated approach. The PC-smart transmitter test bed was setup and the test case for confirming the characteristics of the smart transmitter has been established.

  6. [Analytic evaluation of potential nootropic agents].

    Science.gov (United States)

    Opatrilová, R; Sokolová, P

    2004-01-01

    The paper deals with analytical evaluation of newly prepared substances, derivatives of N-(4-alkoxy-phenyl)-2-(2-oxo-azepan-1-yl)-acetamide. The substances are a homological series (methyl- to hexyl-). The purity of the substances was verified by thin-layer adsorption chromatography, and the principal physical characteristics--melting point and solubility--were determined. Experimental determination of the partition coefficient, extraction of the substances between two liquids miscible to a limited degree (n-octanol--water), determination of RM values by means of TLC partition chromatography (glass plates DC-Fertigplatten RP-8 F254S), determination of the capacity factor by means of HPLC (column C18 Plaris), and calculation by means of computer programmes were employed to determine the lipophilicity of this series of substances. The antiradical activity of the substances was evaluated by the method of extinguishing the stable radical 2,2-diphenyl-1-picryl-hydrazyl. Ascorbic acid, in which an antiradical effect had been demonstrated, was used for the sake of comparison. The substances show a certain activity, but they do not reach the antioxidative effect of ascorbic acid.

  7. Formulation and evaluation of ciprofloxacin suspension using natural suspending agent

    Directory of Open Access Journals (Sweden)

    Sameer J. Nadaf

    2014-03-01

    Full Text Available The aim of the present study is to formulate and evaluate ciprofloxacin suspension using natural suspending agent. Trigonella foenum graecum Mucilage was used as natural suspending agent. Total 9 batches (C1-C9 were prepared by varying concentration of suspending agent from 0.5-2% and propylene glycol. Prepared suspension were evaluated by studying different parameters like pH, sedimentation volume, redispersibility, Flow rate (F, viscosity, degree of flocculation, effect of temperature etc. batches C6, C7 and C8 were found to be stable throughout the study. As the concentration of suspending agent increased viscosity also get increased which reduces the sedimentation and contributes to the stability of suspension. Increase in viscosity avoids the particle aggregation so particles remain in a flocculated state.

  8. Evaluation of safety management in an Appliances manufacturing company

    Directory of Open Access Journals (Sweden)

    F. Golbabaei

    2015-01-01

    Full Text Available Introduction: Prevention of accidents and work related diseases, are not allowed regardless of the safety of employees, customers, contractors and other persons. Assessment of individual safety management activities could reduce many losses. Present study aimed to evaluate the safety management of a household appliance manufacturing company.  .Material and Method: This study has done in a household appliance manufacturing company in Damavand city. Two questionnaires were firstly designed based on the weighted scores. The questionnaire 1 consisted of 4 indicators: Safety of machinery, Electrical safety, Risk assessment and Fire safety. Questionnaire 2 consisted of 11 sub indicators. Both questionnaires were completed by 30 HSE experts and supervisors. Reliability of questionnaires was based on cronbachs alpha coefficient. the safety status of each unit was determined and scored using information acquired by the questionnaires. Lastly, the safety of the entire company was determined.  .Result: Results showed that in safety management: the pressing and store house were in a good range of 66.66 and 60.12 points. Powder painting, enameling, laboratory were in a average range of 56.25, 55.92 and 54.15 points. Assembling and door storage were in a week range of 46.06 points.  .Conclusion: The findings showed that the safety status in the studied appliances company is in average range with 55.45 points. Therefore, it is recommended that the safety indicators should be improved for the betterment of the safety management in the company.

  9. Evaluating the STORE Reputation System in Multi-Agent Simulations

    Science.gov (United States)

    Andrulis, Jonas; Haller, Jochen; Weinhardt, Christof; Karabulut, Yuecel

    In recent global business environments, collaborations among organisations raise an increased demand for swift establishment. Such collaborations are formed between organisations entering Virtual Organizations (VOs), crossing geographic borders and frequently without prior experience of the other partner’s previous performance. In VOs, every participant risks engaging with partners who may exhibit unexpected fraudulent or otherwise untrusted behaviour. In order to cope with this risk, the STochastic REputation system (STORE) was designed to provide swift, automated decision support for selecting partner organisations in the early stages of the VO’s formation. The contribution of this paper first consists of a multi-agent simulation framework design and implementation to evaluate the STORE reputation system. This framework is able to simulate dynamic agent behaviour, agents hereby representing organisations, and to capture the business context of different VO application scenarios. A configuration of agent classes is a powerful tool to obtain not only well or badly performing agents for simulation scenarios, but also agents which are specialized in particular VO application domains or even malicious agents, attacking the VO community. The second contribution comprises of STORE’s evaluation in two simulation scenarios, set in the VO application domains of Collaborative Engineering and Ad-hoc Service provisioning. Besides the ability to clearly distinguish between agents of different classes according to their reputation, the results prove STORE’s ability to take an agent’s dynamic behaviour into account. The simulation results show, that STORE solves the difficult task of selecting the most trustworthy partner for a particular VO application domain from a set of honest agents that are specialized in a wide spread of VO application domains.

  10. Criticality safety benchmark evaluation project: Recovering the past

    Energy Technology Data Exchange (ETDEWEB)

    Trumble, E.F.

    1997-06-01

    A very brief summary of the Criticality Safety Benchmark Evaluation Project of the Westinghouse Savannah River Company is provided in this paper. The purpose of the project is to provide a source of evaluated criticality safety experiments in an easily usable format. Another project goal is to search for any experiments that may have been lost or contain discrepancies, and to determine if they can be used. Results of evaluated experiments are being published as US DOE handbooks.

  11. Evaluation of hydroxyapatite-putty as a hemostatic agent

    Energy Technology Data Exchange (ETDEWEB)

    Momota, Y.; Miyamoto, Y.; Takechi, M.; Yuasa, T.; Toh, T.; Nagayama, M. [Tokushima Univ. (Japan). First Dept. of Oral and Maxillofacial Surgery; Ishikawa, K.; Suzuki, K. [Okayama Univ. Dental School (Japan). Dept. of Biomaterials

    2001-07-01

    Although bone wax is often used as a hemostatic agent for bone in surgery, some problems in biocompatibility have been pointed out. Therefore, we have evaluated hydroxyapatite-putty (HAP-putty) as a hemostatic agent for bone. Adhesive strength of HAP-putty to bone increased with the amount of sodium alginate, reaching maximum value in case of containing 8% sodium alginate. An actual hemostatic ability of HAP-putty was evaluated using rabbits. Bleeding from bone was arrested within 3 minutes. Thus, HAP-putty showed excellent hemostatic ability. Soft tissue response to HAP-putty was evaluated in rabbit subcutaneous tissue. Histological observation revealed slight inflammatory response around HAP-putty. HAP-putty partially transformed to HAP 24 hours after the implantation. In conclusion, HAP-putty could be a useful hemostatic agent for bone due to its good hemostatic ability and excellent biocompatibility. (orig.)

  12. TA-55 Final Safety Analysis Report Comparison Document and DOE Safety Evaluation Report Requirements

    Energy Technology Data Exchange (ETDEWEB)

    Alan Bond

    2001-04-01

    This document provides an overview of changes to the currently approved TA-55 Final Safety Analysis Report (FSAR) that are included in the upgraded FSAR. The DOE Safety Evaluation Report (SER) requirements that are incorporated into the upgraded FSAR are briefly discussed to provide the starting point in the FSAR with respect to the SER requirements.

  13. Update on the safety and efficacy of commercial ultrasound contrast agents in cardiac applications.

    Science.gov (United States)

    Appis, Andrew W; Tracy, Melissa J; Feinstein, Steven B

    2015-06-01

    Ultrasound contrast agents (UCAs) are currently used throughout the world in both clinical and research settings. The concept of contrast-enhanced ultrasound imaging originated in the late 1960s, and the first commercially available agents were initially developed in the 1980s. Today's microbubbles are designed for greater utility and are used for both approved and off-label indications. In October 2007, the US Food and Drug Administration (FDA) imposed additional product label warnings that included serious cardiopulmonary reactions, several new disease-state contraindications, and a mandated 30 min post-procedure monitoring period for the agents Optison and Definity. These additional warnings were prompted by reports of cardiopulmonary reactions that were temporally related but were not clearly attributable to these UCAs. Subsequent published reports over the following months established not only the safety but also the improved efficacy of clinical ultrasound applications with UCAs. The FDA consequently updated the product labeling in June 2008 and reduced contraindications, although it continued to monitor select patients. In addition, a post-marketing program was proposed to the sponsors for a series of safety studies to further assess the risk of UCAs. Then in October 2011, the FDA leadership further downgraded the warnings after hearing the results of the post-marketing data, which revealed continued safety and improved efficacy. The present review focuses on the use of UCAs in today's clinical practice, including the approved indications, a variety of off-label uses, and the most recent data, which affirms the safety and efficacy of UCAs.

  14. Evaluating Water Demand Using Agent-Based Modeling

    Science.gov (United States)

    Lowry, T. S.

    2004-12-01

    The supply and demand of water resources are functions of complex, inter-related systems including hydrology, climate, demographics, economics, and policy. To assess the safety and sustainability of water resources, planners often rely on complex numerical models that relate some or all of these systems using mathematical abstractions. The accuracy of these models relies on how well the abstractions capture the true nature of the systems interactions. Typically, these abstractions are based on analyses of observations and/or experiments that account only for the statistical mean behavior of each system. This limits the approach in two important ways: 1) It cannot capture cross-system disruptive events, such as major drought, significant policy change, or terrorist attack, and 2) it cannot resolve sub-system level responses. To overcome these limitations, we are developing an agent-based water resources model that includes the systems of hydrology, climate, demographics, economics, and policy, to examine water demand during normal and extraordinary conditions. Agent-based modeling (ABM) develops functional relationships between systems by modeling the interaction between individuals (agents), who behave according to a probabilistic set of rules. ABM is a "bottom-up" modeling approach in that it defines macro-system behavior by modeling the micro-behavior of individual agents. While each agent's behavior is often simple and predictable, the aggregate behavior of all agents in each system can be complex, unpredictable, and different than behaviors observed in mean-behavior models. Furthermore, the ABM approach creates a virtual laboratory where the effects of policy changes and/or extraordinary events can be simulated. Our model, which is based on the demographics and hydrology of the Middle Rio Grande Basin in the state of New Mexico, includes agent groups of residential, agricultural, and industrial users. Each agent within each group determines its water usage

  15. Analytic choices in road safety evaluation

    DEFF Research Database (Denmark)

    Elvik, Rune

    2012-01-01

    Conducting rigorous before-and-after studies is essential for improving knowledge regarding the effects of road safety measures. However, state-of-the-art approaches like the empirical Bayes or fully Bayesian techniques cannot always be applied, as the data required by these approaches may....... The choice of comparison group when there is more than one candidate. It is found that the choices made with respect to these points can greatly influence the estimates of safety effects in before-and-after studies. Two second-best techniques (i.e. techniques other than the empirical Bayes approach...

  16. Research on the Evaluation System for Rural Public Safety Planning

    Institute of Scientific and Technical Information of China (English)

    Ming; SUN; Jianxin; YAN

    2014-01-01

    The indicator evaluation system is introduced to the study of rural public safety planning in this article.By researching the current rural public safety planning and environmental carrying capacity,we select some carrying capacity indicators influencing the rural public safety,such as land,population,ecological environment,water resources,infrastructure,economy and society,to establish the environmental carrying capacity indicator system.We standardize the indicators,use gray correlation analysis method to determine the weight of indicators,and make DEA evaluation of the indicator system,to obtain the evaluation results as the basis for decision making in rural safety planning,and provide scientific and quantified technical support for rural public safety planning.

  17. Evaluation on safety concerns of integral reactor: development of safety analysis technology for integral reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, W. S.; Kim, W. K.; Yun, Y. G.; Ahn, H. J.; Lee, J. S.; Lee, S. G.; Sin, A. D. [Korea Atomic Energy Research Institute, Taejeon (Korea)

    2000-03-01

    The Nuclear Desalination Plant (NDP) is being developed to produce electricity and fresh water, and is expected to locate near population zone. In the aspect of safety, it is required to protect the public and environment from the possible releases of fission products and to prevent the fresh water from the contamination of radioactivity. Thus, in a present study, the safety characteristics of the integral reactor adopting passive and inherent safety features significantly different from existing nuclear power plants were investigated. Also, safety requirements applicable to the NDP were analyzed based on the regulatory requirements for current light water reactor and advanced reactor designs, and user requirements for small-medium size reactors. Based on these analyses, some safety concerns to be considered in the design stage have been identified and discussed. They includes the use of proven technology for new safety features, systematic event classification and selection, strengthening containment function, and the safety impacts on desalination-related systems. These efforts to identify and technically resolve the safety concerns in the design stage will provide the early confidence of SMART safety and the technical basis to evaluate the safety to designers and reviewers in the future. 62 refs., 3 figs., 21 tabs. (Author)

  18. Expert system for evaluating the safety of pressure vessels

    Institute of Scientific and Technical Information of China (English)

    Dong Zhibo; Lu Yafeng; Wei Yanhong; Yang Yongfu; Ma Rui; Guo Ping

    2009-01-01

    With more application of welding technology in important structures more attention was paid to the evaluation of the safety of welded structures, the life prediction and decision to repair the welded structures. Based on material fiacture mechanism and Chinese standard of safety evaluations of pressure vessels, an expert system was developed to evaluate the safety of welded pressure vessels. The system can analyze the weld defects in a pressure vessel, convert different kinds of defects into equivalent cracks and obtain their equivalent sizes. Furthermore, the system can calculate the stress and strain in the positions of weld defects and make decision on whether the defects are tolerable or not according to the code. When it is tolerable, the system will calculate the safety margin. The fatigue life can be predicted if the defects undergo fatigue load too. Moreover, data bases are built for storing mechanical properties of material and evaluated results.

  19. HTGR Safety Evaluation Division. Quarterly report, July--September 1976

    Energy Technology Data Exchange (ETDEWEB)

    Schweitzer, D.G.

    1977-02-01

    Progress is reported in the following areas: fission product release and transport, primary coolant impurities, rapid graphite oxidation, structural evaluation, materials, safety instrumentation and control systems, and phenomena modeling and system analysis.

  20. A tool for safety evaluations of road improvements.

    Science.gov (United States)

    Peltola, Harri; Rajamäki, Riikka; Luoma, Juha

    2013-11-01

    Road safety impact assessments are requested in general, and the directive on road infrastructure safety management makes them compulsory for Member States of the European Union. However, there is no widely used, science-based safety evaluation tool available. We demonstrate a safety evaluation tool called TARVA. It uses EB safety predictions as the basis for selecting locations for implementing road-safety improvements and provides estimates of safety benefits of selected improvements. Comparing different road accident prediction methods, we demonstrate that the most accurate estimates are produced by EB models, followed by simple accident prediction models, the same average number of accidents for every entity and accident record only. Consequently, advanced model-based estimates should be used. Furthermore, we demonstrate regional comparisons that benefit substantially from such tools. Comparisons between districts have revealed significant differences. However, comparisons like these produce useful improvement ideas only after taking into account the differences in road characteristics between areas. Estimates on crash modification factors can be transferred from other countries but their benefit is greatly limited if the number of target accidents is not properly predicted. Our experience suggests that making predictions and evaluations using the same principle and tools will remarkably improve the quality and comparability of safety estimations.

  1. Comparative Evaluation for Pedestrian Safety Systems

    Directory of Open Access Journals (Sweden)

    Mukesh Chaudhari

    2013-12-01

    Full Text Available Pedestrian injuries, fatalities, and accessibility continue to be a serious concern in India and also across the world. There are major two systems used to protect the pedestrian from injury or death. Collisions between pedestrians and road vehicles present a major challenge for public health and traffic safety professionals. Pedestrian safety is a complicated problem due to the many variables that comprise the built environment and the complexity of understanding behavioral decisionmaking and outcomes. This literature review explores recent research on the roles of human factors and environmental factors in vehicle-pedestrian crashes, including a brief summary of recent sources that address countermeasures to improve the safety of the physical environment for pedestrians. Adult skull and face injuries in car pedestrian accidents is account for 60 percent of all pedestrian serious injuries, whereas 18 percent of skull injuries were due to the structure of bonnet. The above values show the essential to think more carefully the role of the bonnet in pedestrian skull safety. In 2010, 4,280 pedestrians were killed and an estimated 70,000 were injured in traffic crashes in the United States. On average, a pedestrian was killed every two hours and injured every eight minutes in traffic crashes. Pedestrians are the main fatality of fatal accidents. Nearly 90 percent of the total fatalities in our country occur on rural roads while only 10 percent occur on urban roads. Conventional planning is greatly biased to the motorized modes of transport, even though every road users is a pedestrian at some stage of journey. The problem is realized but efforts are negligent; therefore, authors suggest the need to address it within an integrated system of roads, road users and vehicles. As automobile transportation continues to increase around the world, bicyclists, pedestrians, and motorcyclists, also known as Vulnerable Road Users (VRU, will become more

  2. Efficacy, safety, and cost of thrombolytic agents for the management of dysfunctional hemodialysis catheters: a systematic review.

    Science.gov (United States)

    Hilleman, Daniel; Campbell, Jennifer

    2011-10-01

    Approximately 100,000 patients begin hemodialysis each year in the United States. Although an arteriovenous fistula or graft is the preferred method for long-term vascular access during hemodialysis, as these types of vascular access are the most reliable, approximately 30% of patients require the use of catheters to continue hemodialysis. Tunneled, cuffed hemodialysis catheters are discouraged for permanent vascular access because of their high rates of infection, morbidity and mortality, and thrombotic and technical complications. These catheters have a short functional life span and require medical intervention, often thrombolytic therapy, to treat the catheter malfunction. No thrombolytic agent is specifically indicated for the management of occluded hemodialysis catheters. Thus, we performed a systematic review to critically evaluate all available studies that examined the efficacy, safety, and cost of thrombolytic therapy for the management of dysfunctional hemodialysis catheters. Studies were included if they reported efficacy in a specific proportion of affected dysfunctional hemodialysis catheters; reported the proportion of patients experiencing an adverse outcome (especially bleeding); and described the type of catheter used, dose of thrombolytic agent, administration protocol, dwell time, definition of treatment success, time to follow-up for study end points, and sample size. Eighteen studies met the inclusion criteria. The mean ± SD success rate in clearing dysfunctional hemodialysis catheters was greatest with reteplase at 88 ± 4%, followed by alteplase at 81 ± 37% and tenecteplase at 41 ± 5%. Adverse effects associated with the use of these thrombolytic agents administered at low doses were extremely rare. No serious adverse bleeding events attributed to thrombolytic therapy were reported in any of the trials. Aliquotted reteplase from vials for intravenous use was the least costly thrombolytic agent. Thus, at centers that use high volumes of

  3. Evaluating safety-critical organizations - emphasis on the nuclear industry

    Energy Technology Data Exchange (ETDEWEB)

    Reiman, Teemu; Oedewald, Pia (VTT, Technical Research Centre of Finland (Finland))

    2009-04-15

    An organizational evaluation plays a key role in the monitoring, as well as controlling and steering, of the organizational safety culture. If left unattended, organizations have a tendency to gradually drift into a condition where they have trouble identifying their vulnerabilities and mechanisms or practices that create or maintain these vulnerabilities. The aim of an organizational evaluation should be to promote increased understanding of the sociotechnical system and its changing vulnerabilities. Evaluation contributes to organizational development and management. Evaluations are used in various situations, but when the aim is to learn about possible new vulnerabilities, identify organizational reasons for problems, or prepare for future challenges, the organization is most open to genuine surprises and new findings. It is recommended that organizational evaluations should be conducted when - there are changes in the organizational structures - new tools are implemented - when the people report increased workplace stress or a decreased working climate - when incidents and near-misses increase - when work starts to become routine - when weak signals (such as employees voicing safety concerns or other worries, the organization 'feels' different, organizational climate has changed) are perceived. In organizations that already have a high safety level, safety managers work for their successors. This means that they seldom see the results of their successful efforts to improve safety. This is due to the fact that it takes time for the improvement to become noticeable in terms of increased measurable safety levels. The most challenging issue in an organizational evaluation is the definition of criteria for safety. We have adopted a system safety perspective and we state that an organization has a high potential for safety when - safety is genuinely valued and the members of the organization are motivated to put effort on achieving high levels of safety

  4. Development of safety analysis technology for integral reactor; evaluation on safety concerns of integral reactor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hee Chul; Kim, Woong Sik; Lee, J. H. [Korea Institute of Nuclear Safety, Taejeon (Korea)

    2002-03-01

    The Nuclear Desalination Plant (NDP) is being developed to produce electricity and fresh water, and is expected to locate near population zone. In the aspect of safety, it is required to protect the public and environment from the possible releases of fission products and to prevent the fresh water from the contamination of radioactivity. Thus, in this study, the safety characteristics of the integral reactor adopting passive and inherent safety features significantly different from existing nuclear power plants were investigated. Also, safety requirements applicable to the NDP were analyzed based on the regulatory requirements for current light water reactor and advanced reactor designs, and user requirements for small-medium size reactors. Based on these analyses, some safety concerns to be considered in the design stage have been identified and discussed. They include the use of proven technology for new safety features, systematic event classification and selection, strengthening containment function, and the safety impacts on desalination-related systems. The study presents the general safety requirements applicable to licensing of an integral reactor and suggests additional regulatory requirements, which need to be developed, based on the direction to resolution of the safety concerns. The efforts to identify and technically resolve the safety concerns in the design stage will provide the early confidence of SMART safety and the technical basis to evaluate the safety to designers and reviewers in the future. Suggestion on the development of additional regulatory requirements will contribute for the regulator to taking actions for licensing of an integral reactor. 66 refs., 5 figs., 24 tabs. (Author)

  5. Synthesis and Performance Evaluation of a Synthetic Based Foaming Agent

    Institute of Scientific and Technical Information of China (English)

    Barugahare J avilla; SHUI Zhong-he; CHEN Wei

    2015-01-01

    The aim of this study was to create a foaming agent and then evaluate its performance.This foaming agent is made up of Sodium lauryl sulfate,Ethanol,Lauryl alcohol and Water.On aeration,the diluted foaming solution produces a stable foam whose properties,density,capacity and drainage were studied.The compressive strength,water absorption and density of foamed concrete were also studied.Test results show that the initial foam density is 104 kg/m3 at an optimum dilu-tion ratio of 1:40.Foamed concrete’s density can vary from 450 kg/m3 to 1 950 bkg/m3 and its compressive strength is in 0.5~23 MPa.Compressive strength test results of this foaming agent are higher than those produced with EABASSOC foa-ming agent.According to ASTM 869-91,this chemical composition qualifies to be used as a foaming agent.

  6. Evaluation Indicator System for China’s Agricultural Industrial Safety

    Institute of Scientific and Technical Information of China (English)

    Qingpeng; GAO; Bin; CHEN; Qinyang; LI

    2013-01-01

    On the basis of new characteristics and trend of China’s agricultural development in the post-WTO period,combining analysis of factors influencing agricultural industrial safety,this paper builds an evaluation indicator system for China’s agricultural industrial safety by scientific indicator system design method.This indicator system includes risk factor indicators(showing risk degree)and capacity factor indicators(showing guaranteeing ability),and consists of 7 subsystems:consumption safety,production safety,industrial controlling capacity,industrial development capacity,industrial development environment,government functions and industrial foundation condition.Risk factor is divided into 5 levels:higher risk,high risk,medium risk,low risk and lower risk;guarantee risk is also divided into five levels:strong,healthy,normal,weak and disabled.According to the overall evaluation score obtained from weighting sum,the agricultural industrial safety includes 5 types:very safe,safe,basically safe,not safe and hazardous.This evaluation indicator system is expected to providing theoretical reference for evaluating China’s agricultural industrial safety.

  7. Safety evaluation of a hydrogen fueled transit bus

    Energy Technology Data Exchange (ETDEWEB)

    Coutts, D.A.; Thomas, J.K.; Hovis, G.L.; Wu, T.T. [Westinghouse Savannah River Co., Aiken, SC (United States)

    1997-12-31

    Hydrogen fueled vehicle demonstration projects must satisfy management and regulator safety expectations. This is often accomplished using hazard and safety analyses. Such an analysis has been completed to evaluate the safety of the H2Fuel bus to be operated in Augusta, Georgia. The evaluation methods and criteria used reflect the Department of Energy`s graded approach for qualifying and documenting nuclear and chemical facility safety. The work focused on the storage and distribution of hydrogen as the bus motor fuel with emphases on the technical and operational aspects of using metal hydride beds to store hydrogen. The safety evaluation demonstrated that the operation of the H2Fuel bus represents a moderate risk. This is the same risk level determined for operation of conventionally powered transit buses in the United States. By the same criteria, private passenger automobile travel in the United States is considered a high risk. The evaluation also identified several design and operational modifications that resulted in improved safety, operability, and reliability. The hazard assessment methodology used in this project has widespread applicability to other innovative operations and systems, and the techniques can serve as a template for other similar projects.

  8. Efficacy and safety of lanthanoids as X-ray contrast agents

    Energy Technology Data Exchange (ETDEWEB)

    Pietsch, Hubertus, E-mail: Hubertus.Pietsch@bayerhealthcare.com [Contrast Media Research, Bayer Schering Pharma AG, 13353 Berlin (Germany); Jost, Gregor, E-mail: Gregor.Jost@bayerhealthcare.com [Contrast Media Research, Bayer Schering Pharma AG, 13353 Berlin (Germany); Frenzel, Thomas, E-mail: Thomas.Frenzel@bayerhealthcare.com [Contrast Media Research, Bayer Schering Pharma AG, 13353 Berlin (Germany); Raschke, Marian, E-mail: Marian.Raschke@bayerhealthcare.com [Nonclinical Drug Safety, Bayer Schering Pharma AG, Berlin (Germany); Walter, Jakob, E-mail: Jakob.Walter@bayerhealthcare.com [Nonclinical Drug Safety, Bayer Schering Pharma AG, Berlin (Germany); Schirmer, Heiko, E-mail: Heiko.Schirmer@bayerhealthcare.com [Medical Chemistry VI, Bayer Schering Pharma AG, Berlin (Germany); Huetter, Joachim, E-mail: Joachim.Hutter@bayerhealthcare.com [Contrast Media Research, Bayer Schering Pharma AG, 13353 Berlin (Germany); Sieber, Martin A., E-mail: martin.sieber@bayerhealthcare.com [Contrast Media Research, Bayer Schering Pharma AG, 13353 Berlin (Germany)

    2011-11-15

    suited for higher X-ray tube voltages, particularly CT examinations. However, Ln-specific induction of NSF-like skin lesions and rapid elevation of pro-fibrotic serum cytokines levels were observed in rats following multiple administrations of high doses of Ln-DTPA-BMA complexes. The results of this animal study suggest that the stability of lanthanoid complexes may be an important consideration in evaluating the potential for in vivo safety. Furthermore the results suggest a potential of the entire class of lanthanoids to have the potential to trigger NSF-like skin lesions in rats rather than only some of the specific elements of this series.

  9. Safety performance evaluation using proactive indicators in a selected industry

    Directory of Open Access Journals (Sweden)

    Abolfazl Barkhordari

    2015-03-01

    Full Text Available Background & Objectives: Quality and effectiveness of safety systems are critical factors in achieving their goals. This study was aimed to represent a method for performance evaluation of safety systems by proactive indicators using different updated models in the field of safety which will be tested in a selected industry. Methods: This study is a cross-sectional study. Proactive indicators used in this study were: Unsafe acts rate, Safety Climate, Accident Proneness, and Near-miss incident rate. The number of in 1473 safety climate questionnaires and 543 Accident Proneness questionnaires was completed. Results: The minimum and maximum safety climate score were 56.88 and 58.2, respectively, and the minimum and maximum scores of Accident Proneness were 98.2 and 140.7, respectively. The maximum number of Near-miss incident rate were 408 and the minimum of that was 196. The maximum number of unsafe acts rate was 43.8 percent and the minimum of that was 27.2 percent. In nine dimensions of Safety climate the eighth dimension (personal perception of risk with the score of 4.07 has the lowest score and the fourth (laws and safety regulations dimension with 8.05 has the highest score. According to expert opinions, the most important indicator in the assessment of safety performance was unsafe acts rate, while near-miss incident rate was the least important one. Conclusion: The results of this survey reveal that using proactive (Prospective indicators could be an appropriate method in organizations safety performance evaluation.

  10. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents

    Directory of Open Access Journals (Sweden)

    J.B. Calixto

    2000-02-01

    Full Text Available This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs. Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

  11. An Evaluation Tool for Agricultural Health and Safety Mobile Applications.

    Science.gov (United States)

    Reyes, Iris; Ellis, Tammy; Yoder, Aaron; Keifer, Matthew C

    2016-01-01

    As the use of mobile devices and their software applications, or apps, becomes ubiquitous, use amongst agricultural working populations is expanding as well. The smart device paired with a well-designed app has potential for improving workplace health and safety in the hands of those who can act upon the information provided. Many apps designed to assess workplace hazards and implementation of worker protections already exist. However, the abundance and diversity of such applications also presents challenges regarding evaluation practices and assignation of value. This is particularly true in the agricultural workspace, as there is currently little information on the value of these apps for agricultural safety and health. This project proposes a framework for developing and evaluating apps that have potential usefulness in agricultural health and safety. The evaluation framework is easily transferable, with little modification for evaluation of apps in several agriculture-specific areas.

  12. Study on categorization of the safety design evaluation event

    Energy Technology Data Exchange (ETDEWEB)

    Kurisaka, Kenichi; Kani, Yoshio [Power Reactor and Nuclear Fuel Development Corp., Oarai, Ibaraki (Japan). Oarai Engineering Center

    1997-05-01

    In order to make a FBR practicable, it is important to make rational categorization of a safety design evaluation event. In this study, for the purpose of providing useful information into the event categorization, we developed the occurrence frequency data of various abnormal events, presented a proposal of the event categorization primarily based on the occurrence frequency and examined efficiency of the proposal. We researched and analyzed abnormal event instances of foreign and domestic FBR plants and of domestic light water reactor power plants. On the basis of the analysis, the failure occurrence frequency of the protection system (PS) in the FBR model plants with electric power production of 600MW and 1,000MW was quantified. Making use of results of probabilistic safety assessment study, loss-of-function probability of the mitigation system (MS) was quantified. Some of combinations of PS failure and loss of MS function were selected and their occurrence frequencies were quantified. We examined problems in the current categorization of the safety design evaluation event and presented a new proposal of the event categorization. Merits of the new proposal are to have divided the current category of `accident` into `small accident` and `rare accident`, explicitly to treat a multiple failure event not as a collateral analysis condition of supposing `a single failure` but as an event to be evaluated, and to have added a category for the event which is beyond design base, but should be supposed to evaluate depth of the safety design in terms of defense-in-depth. Some candidates of the safety design evaluation event were identified and applied to the new proposal. In comparison with the current categorization, we obtained perspective that it was possible to evaluate the safety design more in detail and effectively, especially depth of the safety design such as backup reactor shutdown system, decay heat removal function in a natural circulation mode etc. (J.P.N.)

  13. [Comics for traffic education: evaluation of a traffic safety campaign].

    Science.gov (United States)

    Bonfadelli, H

    1989-01-01

    Traffic safety campaigns often are ineffective to change driving behavior because they don't reach the target group or are recognized only by people who are already interested or concerned. The evaluation of a traffic safety campaign called "Leo Lässig", addressed to young new drivers, shows that recognition and acceptance by the target group were stimulated by the age-conform means of comic-strips.

  14. Safety evaluation for packaging (onsite) disposable solid waste cask

    Energy Technology Data Exchange (ETDEWEB)

    Flanagan, B.D., Westinghouse Hanford

    1996-12-20

    This safety evaluation for packaging (SEP) evaluates and documents the ability of the Disposable Solid Waste Cask (DSWC) to meet the packaging requirements of HNF-CM-2-14, Hazardous Material Packaging and Shipping, for the onsite transfer of special form, highway route controlled quantity, Type B fissile radioactive material. This SEP evaluates five shipments of DSWCs used for the transport and storage of Fast Flux Test Facility unirradiated fuel to the Plutonium Finishing Plant Protected Area.

  15. AGENTS FOR ECONOMIC ENTERPRISE AS THE BASIS TO DETERMINE THE STATE OF ITS FINANCIAL L SAFETY

    OpenAIRE

    Lavrova, J.

    2014-01-01

    Based on the analysis of existing approaches to understanding the nature of financial security, its objectives, methods of evaluation are proposed tools to determine the state of financial security. Instrument detection satisfaction of economic agents' financial interests of the company has developed. The degree of harmonization in space and time of interest by financial security company proposed to determine by building a "map positioning financial security interests of business enterprises....

  16. Strategies to evaluate the safety of bioengineered foods.

    Science.gov (United States)

    Delaney, Bryan

    2007-01-01

    A number of genetically modified (GM) crops bioengineered to express agronomic traits including herbicide resistance and insect tolerance have been commercialized. Safety studies conducted for the whole grains and food and feed fractions obtained from GM crops (i.e., bioengineered foods) bear similarities to and distinctive differences from those applied to substances intentionally added to foods (e.g., food ingredients). Similarities are apparent in common animal models, route of exposure, duration, and response variables typically assessed in toxicology studies. However, because of differences in the nutritional and physical properties of food ingredients and bioengineered foods and in the fundamental goals of the overall safety assessment strategies for these different classes of substances, there are recognizable differences in the individual components of the safety assessment process. The fundamental strategic difference is that the process for food ingredients is structured toward quantitative risk assessment whereas that for bioengineered foods is structured for the purpose of qualitative risk assessment. The strategy for safety assessment of bioengineered foods focuses on evaluating the safety of the transgenic proteins used to impart the desired trait or traits and to demonstrate compositional similarity between the grains of GM and non-GM comparator crops using analytical chemistry and, in some cases, feeding studies. Despite these differences, the similarities in the design of safety studies conducted with bioengineered foods should be recognized by toxicologists. The current paper reviews the basic principles of safety assessment for bioengineered foods and compares them with the testing strategies applied to typical food ingredients. From this comparison it can be seen that the strategies used to assess the safety of bioengineered foods are at least as robust as that used to assess the safety of typical food ingredients.

  17. Evaluating an Entertainment–Education Telenovela to Promote Workplace Safety

    Directory of Open Access Journals (Sweden)

    Diego E. Castaneda

    2013-08-01

    Full Text Available Occupational safety and health professionals worked with health communication experts to collaborate with a major Spanish language television network to develop and implement a construction workplace safety media intervention targeting Latino/Hispanic audiences. An Entertainment–Education (EE health communication strategy was used to create a worksite safety storyline weaved into the main plot of a nationally televised Telenovela (Spanish language soap opera. A secondary analysis of audience survey data in a pre/posttest cross-sectional equivalent group design was performed to evaluate the effectiveness of this EE media intervention to change knowledge, attitudes, and intention outcomes related to the prevention of fatal falls at construction worksites. Results indicate that using culturally relevant mediums can be an effective way of reaching and educating audiences about specific fall prevention information. This is aligned with recommendations by the Institute of Medicine (IOM to increase interventions and evaluations of culturally relevant and competent health communication.

  18. Development of neuroleptic agents: pharmacogenetics and current safety issues of regulatory concern.

    Science.gov (United States)

    Shah, Rashmi

    2002-12-01

    The development of safe and effective new drug treatments for schizophrenia poses a challenging task. This class of drugs is known to be associated with a wide range of serious and troublesome safety problems that include neurological, cardiac, endocrine, and metabolic side effects. Many of these drugs have a narrow therapeutic index and generate metabolites that often have their own unique pharmacological profile different from the parent compound. These features make it imperative that the optimal dose schedules for neuroleptic drugs are carefully characterized. Many of these drugs are metabolized by cytochrome P450 enzymes, which show genetic polymorphism and a bi modal distribution within the population, A significant subset of the population cannot eliminate these drugs as effectively as the majority. This brings an added dimension of complexity in characterizing the dose and individualizing therapy. Many neuroleptic agents are proarrhythmic with an adverse effect on cardiac repolarization. They are prone to prolonging the QT interval and inducing torsade de pointes. Given the potentially fatal outcome of this ventricular tachyarrhythmia, drug development programs need to ensure that the proarrhythmic potential of any new neuroleptic agent is thoroughly explored and its proarrhythmic risk characterized. The clinical use of many of these drugs is further troubled by their high potential for drug-drug interactions. These too need to be adequately investigated during development The approval and the labeling of a new neuroleptic agent require a careful regulatory assessment of its risk/benefit ratio in comparison with the available alternatives. Their safe and effective use in routine clinical practice depends on careful attention to prescribing information, especially the contraindications, precautions, and patient-monitoring requirements.

  19. Synthesis and Biological Evaluation of Hydrazone Derivatives as Antifungal Agents

    Directory of Open Access Journals (Sweden)

    Bruna B. Casanova

    2015-05-01

    Full Text Available Emerging yeasts are among the most prevalent causes of systemic infections with high mortality rates and there is an urgent need to develop specific, effective and non-toxic antifungal agents to respond to this issue. In this study 35 aldehydes, hydrazones and hydrazines were obtained and their antifungal activity was evaluated against Candida species (C. parapsilosis, C. tropicalis, C. krusei, C. albicans, C. glabrata and C. lusitaneae and Trichosporon asahii, in an in vitro screening. The minimum inhibitory concentrations (MICs of the active compounds in the screening was determined against 10 clinical isolates of C. parapsilosis and 10 of T. asahii. The compounds 4-pyridin-2-ylbenzaldehyde] (13a and tert-butyl-(2Z-2-(3,4,5-trihydroxybenzylidinehydrazine carboxylate (7b showed the most promising MIC values in the range of 16–32 μg/mL and 8–16 μg/mL, respectively. The compounds’ action on the stability of the cell membrane and cell wall was evaluated, which suggested the action of the compounds on the fungal cell membrane. Cell viability of leukocytes and an alkaline comet assay were performed to evaluate the cytotoxicity. Compound 13a was not cytotoxic at the active concentrations. These results support the discovery of promising candidates for the development of new antifungal agents.

  20. Aluminum Data Measurements and Evaluation for Criticality Safety Applications

    Science.gov (United States)

    Leal, L. C.; Guber, K. H.; Spencer, R. R.; Derrien, H.; Wright, R. Q.

    2002-12-01

    The Defense Nuclear Facility Safety Board (DNFSB) Recommendation 93-2 motivated the US Department of Energy (DOE) to develop a comprehensive criticality safety program to maintain and to predict the criticality of systems throughout the DOE complex. To implement the response to the DNFSB Recommendation 93-2, a Nuclear Criticality Safety Program (NCSP) was created including the following tasks: Critical Experiments, Criticality Benchmarks, Training, Analytical Methods, and Nuclear Data. The Nuclear Data portion of the NCSP consists of a variety of differential measurements performed at the Oak Ridge Electron Linear Accelerator (ORELA) at the Oak Ridge National Laboratory (ORNL), data analysis and evaluation using the generalized least-squares fitting code SAMMY in the resolved, unresolved, and high energy ranges, and the development and benchmark testing of complete evaluations for a nuclide for inclusion into the Evaluated Nuclear Data File (ENDF/B). This paper outlines the work performed at ORNL to measure, evaluate, and test the nuclear data for aluminum for applications in criticality safety problems.

  1. Synthesis and Evaluation of Some Coumarin Containing Potential Antimicrobial Agents

    Directory of Open Access Journals (Sweden)

    Sayali D. Kudale

    2012-01-01

    Full Text Available A series of the Schiff’s bases incorporating coumarin and chalcone moeities, 3-(4-(4-(substituted phenylprop-1-ene-3-one phenylimino methyl-4-chloro-2h-chromen-2-one 4(a-g were synthesized as potential antimicrobial agents. These compounds were characterized on the basis of their spectral (IR, 1H NMR data and evaluated for antimicrobial activity in vitro against gram positive and gram negative bacteria and fungi. Compound 4b was found to be most active with an MIC of 20 µg/mL against all the tested organisms.

  2. Safety Evaluation for Packaging (onsite) T Plant Canyon Items

    Energy Technology Data Exchange (ETDEWEB)

    OBRIEN, J.H.

    2000-07-14

    This safety evaluation for packaging (SEP) evaluates and documents the ability to safely ship mostly unique inventories of miscellaneous T Plant canyon waste items (T-P Items) encountered during the canyon deck clean off campaign. In addition, this SEP addresses contaminated items and material that may be shipped in a strong tight package (STP). The shipments meet the criteria for onsite shipments as specified by Fluor Hanford in HNF-PRO-154, Responsibilities and Procedures for all Hazardous Material Shipments.

  3. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Meng Wang

    Full Text Available Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA and epsilon aminocaproic acid (EACA, traditionally known as Amicar in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs, retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data. Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57-621.94 ml, 250.30 ml postoperatively (95% CI, 35.31-465.30, and 601.40 ml overall (95% CI, 306.64-896.16 ml. The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30-754.67 ml. The transfusion rate was 44.6% (108/242 in the patients with antifibrinolytic agents and 68.3% (142/208 in the patients with placebo. (OR 0.38; 95% CI; 0.25-0.58; P<0.00001, I2 = 9%. All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group.The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements

  4. 29 CFR 1960.80 - Secretary's evaluations of agency occupational safety and health programs.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Secretary's evaluations of agency occupational safety and... EMPLOYEE OCCUPATIONAL SAFETY AND HEALTH PROGRAMS AND RELATED MATTERS Evaluation of Federal Occupational Safety and Health Programs § 1960.80 Secretary's evaluations of agency occupational safety and...

  5. Children's Agricultural Safety Network: Evaluating Organizational Effectiveness and Impacts.

    Science.gov (United States)

    Cramer, Mary E; Wendl, Mary J

    2015-01-01

    Coalitions that are effectively organized and led are more likely to achieve their intended program outcomes and impacts, as well as achieve sustainability. External evaluation of the coalition's governance and leadership can help identify strengths and areas for improvement. This article describes the evaluation of the Children's Agricultural Safety Network (CASN)-a national coalition, or network of 45 organizational members. The conceptual framework, Internal Coalition Outcomes Hierarchy, guided the evaluation. We used a mixed-methods approach to answer study's primary objectives from the perspective of CASN members and leaders for (a) organizational effectiveness, (b) network impact, and (c) member benefits. We collected quantitative data using a survey and the Internal Coalition Effectiveness (ICE) instrument. Focused interviews were conducted by phone to gather rich data on examples. Combined findings showed that both members and leaders rated the CASN effective in all construct areas that define successful coalitions. Members feel as invested in CASN success as do leaders. The major impact of CASN has been as a national leader and clearinghouse for childhood safety issues, and the most frequently cited example of impact was the national tractor safety campaign. Members identified the benefits of CASN membership as networking, resource sharing, and opportunities to enhance their knowledge, skills, and practices in the area. Members also valued the national attention that CASN was able to bring to the important issues in childhood agricultural safety. Suggestions for improvement were to focus on more research to improve best practices and strengthen dissemination and implementation science.

  6. Intercostal nerve blockade for evaluation of local anaesthetic agents.

    Science.gov (United States)

    Bridenbaugh, P O

    1975-02-01

    Bilateral intercostal nerve block provides the opportunity to subject as many as 16 separate peripheral nerves in a single subject to known or unknown local anaesthetic agents in a variety of concentrations, volumes, and additives. It permits the observation of local (e.g., neuritis), clinical (e.g., onset and duration), and systemic (e.g., toxicity and blood concentration) effects of these variables. In double-blind studies, bilateral intercostal nerve block allows the use of each side of the trunk for comparison of two experimental drugs, a new drug against a standard, or two new drugs. Subtle differences in clinical properties as well as simultaneous blood concentrations may be detected in these studies. The advantages of this technique in evaluating local anaesthetic agents are primarily the use of a single subject as his own control while studying may separate peripheral nerves. This aids appreciably in limiting the variable of age, temperature, and perfusion, as well as techniques of administration and evaluation. The constancy of the anatomy of the intercostal nerve provides a highly reliable and reproducible block technique.

  7. Recommendations for safety pharmacology evaluations of oligonucleotide-based therapeutics.

    Science.gov (United States)

    Berman, Cindy L; Cannon, Keri; Cui, Yi; Kornbrust, Douglas J; Lagrutta, Armando; Sun, Sunny Z; Tepper, Jeff; Waldron, Gareth; Younis, Husam S

    2014-08-01

    This document was prepared by the Safety Pharmacology Subcommittee of the Oligonucleotide Safety Working Group (OSWG), a group of industry and regulatory scientists involved in the development and regulation of therapeutic oligonucleotides. The mission of the Subcommittee was to develop scientific recommendations for the industry regarding the appropriate scope and strategies for safety pharmacology evaluations of oligonucleotides (ONs). These recommendations are the consensus opinion of the Subcommittee and do not necessarily reflect the current expectations of regulatory authorities. 1) Safety pharmacology testing, as described in the International Conference on Harmonisation (ICH) S7 guidance, is as applicable to ONs as it is to small molecule drugs and biotherapeutics. 2) Study design considerations for ONs are similar to those for other classes of drugs. In general, as with other therapeutics, studies should evaluate the drug product administered via the clinical route. Species selection should ideally consider relevance of the model with regard to the endpoints of interest, pharmacological responsiveness, and continuity with the nonclinical development program. 3) Evaluation of potential effects in the core battery (cardiovascular, central nervous, and respiratory systems) is recommended. In general: a. In vitro human ether-a-go-go-related gene (hERG) testing does not provide any specific value and is not warranted. b. Emphasis should be placed on in vivo evaluation of cardiovascular function, typically in nonhuman primates (NHPs). c. Due to the low level of concern, neurologic and respiratory function can be assessed concurrently with cardiovascular safety pharmacology evaluation in NHPs, within repeat-dose toxicity studies, or as stand-alone studies. In the latter case, rodents are most commonly used. 4) Other dedicated safety pharmacology studies, beyond the core battery, may have limited value for ONs. Although ONs can accumulate in the kidney and liver

  8. Abrasive blasting agents: designing studies to evaluate relative risk.

    Science.gov (United States)

    Hubbs, Ann; Greskevitch, Mark; Kuempel, Eileen; Suarez, Fernando; Toraason, Mark

    Workers exposed to respirable crystalline silica used in abrasive blasting are at increased risk of developing a debilitating and often fatal fibrotic lung disease called silicosis. The National Institute for Occupational Safety and Health (NIOSH) recommends that silica sand be prohibited as abrasive blasting material and that less hazardous materials be used in blasting operations. However, data are needed on the relative risks associated with exposure to abrasive blasting materials other than silica. NIOSH has completed acute studies in rats (Hubbs et al., 2001; Porter et al., 2002). To provide dose-response data applicable to making recommendation for occupational exposure limits, NIOSH has collaborated with the National Toxicology Program (NTP) to design longer term studies with silica substitutes. For risk assessment purposes, selected doses will include concentrations that are relevant to human exposures. Rat lung burdens achieved should be comparable to those estimated in humans with working lifetime exposures, even if this results in "overloading" doses in rats. To quantify both dose and response, retained particle burdens in the lungs and lung-associated lymph nodes will be measured, as well as biochemical and pathological indices of pulmonary response. This design will facilitate assessment of the pulmonary fibrogenic potential of inhaled abrasive blasting agents at occupationally relevant concentrations.

  9. Do you get it? User-evaluated explainable BDI agents

    NARCIS (Netherlands)

    Broekens, J.; Harbers, M.; Hindriks, K.; Bosch, K. van den; Jonker, C.; Meyer, J.J.C.

    2010-01-01

    In this paper we focus on explaining to humans the behavior of autonomous agents, i.e., explainable agents. Explainable agents are useful for many reasons including scenario-based training (e.g. disaster training), tutor and pedagogical systems, agent development and debugging, gaming, and interacti

  10. Road network safety evaluation using Bayesian hierarchical joint model.

    Science.gov (United States)

    Wang, Jie; Huang, Helai

    2016-05-01

    Safety and efficiency are commonly regarded as two significant performance indicators of transportation systems. In practice, road network planning has focused on road capacity and transport efficiency whereas the safety level of a road network has received little attention in the planning stage. This study develops a Bayesian hierarchical joint model for road network safety evaluation to help planners take traffic safety into account when planning a road network. The proposed model establishes relationships between road network risk and micro-level variables related to road entities and traffic volume, as well as socioeconomic, trip generation and network density variables at macro level which are generally used for long term transportation plans. In addition, network spatial correlation between intersections and their connected road segments is also considered in the model. A road network is elaborately selected in order to compare the proposed hierarchical joint model with a previous joint model and a negative binomial model. According to the results of the model comparison, the hierarchical joint model outperforms the joint model and negative binomial model in terms of the goodness-of-fit and predictive performance, which indicates the reasonableness of considering the hierarchical data structure in crash prediction and analysis. Moreover, both random effects at the TAZ level and the spatial correlation between intersections and their adjacent segments are found to be significant, supporting the employment of the hierarchical joint model as an alternative in road-network-level safety modeling as well.

  11. Safety and Efficacy of Misoprostol and Dinoprostone as Cervical Ripening Agents

    Directory of Open Access Journals (Sweden)

    R Shakya

    2010-03-01

    Full Text Available INTRODUCTION: The study compares safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. METHODS: Patients with term, vertex, singleton pregnancy and Bishop score of 4 or less were randomly assigned to receive misoprostol pessary (n=35, 50 microg intravaginally or dinoprostone gel (n=31, 0.5 mg intracervically at 6 hourly intervals. If there were no progress in cervical dilatation or effective uterine contraction even after maximum dose, patients were taken for cesarean section. Patients who achieved Bishop's score more than 7 but the delivery was not progressing, were augmented with oxytocin drip. RESULTS: No uterine hyperstimulation was observed in both groups. However, abnormal fetal heart rate was observed in 3(8.6% cases inmisoprostol group and 2 (6.5% in dinoprostone group. There was no statistically significant difference in meconium passage in two groups. Apgar score less than 7 at 1 minute was seen in 6 (19.4% and 11 (31.4% neonates in dinoprostone and misoprostol group respectively. However Apgar score less than 7 at 5 minutes was found in only one neonate of dinoprostone treated patient. Both drugs were found to be equally effective in improving Bishops score with no significant difference in mean induction to delivery time. Cesarean section was done among 32.3% and 28.6% respectively in dinoprostone and misoprostol groups. There was significant reduction in the need for oxytocin augmentation in misoprostol (37.1% group than in dinoprostone (67.7% group. CONCLUSIONS: Vaginal misoprostol is an effective, safer and cheaper alternative to dinoprostone as a cervical ripening agent in underdeveloped countries. Keywords: Apgar score, Bishops score, cervical ripening, Dinoprostone, induction, Misoprostol

  12. Evaluating the effectiveness of active vehicle safety systems.

    Science.gov (United States)

    Jeong, Eunbi; Oh, Cheol

    2017-03-01

    Advanced vehicle safety systems have been widely introduced in transportation systems and are expected to enhance traffic safety. However, these technologies mainly focus on assisting individual vehicles that are equipped with them, and less effort has been made to identify the effect of vehicular technologies on the traffic stream. This study proposed a methodology to assess the effectiveness of active vehicle safety systems (AVSSs), which represent a promising technology to prevent traffic crashes and mitigate injury severity. The proposed AVSS consists of longitudinal and lateral vehicle control systems, which corresponds to the Level 2 vehicle automation presented by the National Highway Safety Administration (NHTSA). The effectiveness evaluation for the proposed technology was conducted in terms of crash potential reduction and congestion mitigation. A microscopic traffic simulator, VISSIM, was used to simulate freeway traffic stream and collect vehicle-maneuvering data. In addition, an external application program interface, VISSIM's COM-interface, was used to implement the AVSS. A surrogate safety assessment model (SSAM) was used to derive indirect safety measures to evaluate the effectiveness of the AVSS. A 16.7-km freeway stretch between the Nakdong and Seonsan interchanges on Korean freeway 45 was selected for the simulation experiments to evaluate the effectiveness of AVSS. A total of five simulation runs for each evaluation scenario were conducted. For the non-incident conditions, the rear-end and lane-change conflicts were reduced by 78.8% and 17.3%, respectively, under the level of service (LOS) D traffic conditions. In addition, the average delay was reduced by 55.5%. However, the system's effectiveness was weakened in the LOS A-C categories. Under incident traffic conditions, the number of rear-end conflicts was reduced by approximately 9.7%. Vehicle delays were reduced by approximately 43.9% with 100% of market penetration rate (MPR). These results

  13. Packaging Evaluation Approach to Improve Cosmetic Product Safety

    Directory of Open Access Journals (Sweden)

    Benedetta Briasco

    2016-09-01

    Full Text Available In the Regulation 1223/2009, evaluation of packaging has become mandatory to assure cosmetic product safety. In fact, the safety assessment of a cosmetic product can be successfully carried out only if the hazard deriving from the use of the designed packaging for the specific product is correctly evaluated. Despite the law requirement, there is too little information about the chemical-physical characteristics of finished packaging and the possible interactions between formulation and packaging; furthermore, different from food packaging, the cosmetic packaging is not regulated and, to date, appropriate guidelines are still missing. The aim of this work was to propose a practical approach to investigate commercial polymeric containers used in cosmetic field, especially through mechanical properties’ evaluation, from a safety point of view. First of all, it is essential to obtain complete information about raw materials. Subsequently, using an appropriate full factorial experimental design, it is possible to investigate the variables, like polymeric density, treatment, or type of formulation involved in changes to packaging properties or in formulation-packaging interaction. The variation of these properties can greatly affect cosmetic safety. In particular, mechanical properties can be used as an indicator of pack performances and safety. As an example, containers made of two types of polyethylene with different density, low-density polyethylene (LDPE and high-density polyethylene (HDPE, are investigated. Regarding the substances potentially extractable from the packaging, in this work the headspace solid-phase microextraction method (HSSPME was used because this technique was reported in the literature as suitable to detect extractables from the polymeric material here employed.

  14. Subjective Performance Evaluations, Self-esteem, and Ego-threats in Principal-agent Relations

    DEFF Research Database (Denmark)

    Sebald, Alexander Christopher; Walzl, Markus

    We conduct a laboratory experiment with agents working on and principals benefiting from a real effort task in which the agents' effort/performance can only be evaluated subjectively. Principals give subjective performance feedback to agents and agents have an opportunity to sanction principals. ...

  15. Development of a Novel Nuclear Safety Culture Evaluation Method for an Operating Team Using Probabilistic Safety Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Han, Sangmin; Lee, Seung Min; Seong, Poong Hyun [KAIST, Daejeon (Korea, Republic of)

    2015-05-15

    IAEA defined safety culture as follows: 'Safety Culture is that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance'. Also, celebrated behavioral scientist, Cooper, defined safety culture as,'safety culture is that observable degree of effort by which all organizational members direct their attention and actions toward improving safety on a daily basis' with his internal psychological, situational, and behavioral context model. With these various definitions and criteria of safety culture, several safety culture assessment methods have been developed to improve and manage safety culture. To develop a new quantitative safety culture evaluation method for an operating team, we unified and redefined safety culture assessment items. Then we modeled a new safety culture evaluation by adopting level 1 PSA concept. Finally, we suggested the criteria to obtain nominal success probabilities of assessment items by using 'operational definition'. To validate the suggested evaluation method, we analyzed the collected audio-visual recording data collected from a full scope main control room simulator of a NPP in Korea.

  16. Evaluation of SERS substrates for chemical agent detection

    Science.gov (United States)

    Huang, Hermes; Shende, Chetan; Sengupta, Atanu; Inscore, Frank; Farquharson, Stuart

    2012-06-01

    US Military forces are dependent on indigenous water supplies, which are considered prime targets to effect a chemical or biological attack. Consequently, there is a clear need for a portable analyzer capable of evaluating water supplies prior to use. To this end we have been investigating the use of a portable Raman analyzer with surface-enhanced Raman spectroscopy (SERS) sampling systems. The superior selectivity and exceptional sensitivity of SERS has been demonstrated by the detection of single molecules. However, the extreme sensitivity provided by SERS is attributed to "hot spot" structures, such as particle junctions that can provide as much as 10 orders of magnitude enhancement. Unfortunately, hotspots are not evenly distributed across substrates, which results in enhancements that cannot be quantitatively reproduced. Here we present analysis of uniformity for a newly developed substrate and commercial sample vials using benzenethiol and bispyridylethylene, two chemicals often used to characterize SERS substrates, and methyl phosphonic acid, a major hydrolysis product of the nerve agents.

  17. Technical evaluation of seismic qualification of safety-related equipment

    Energy Technology Data Exchange (ETDEWEB)

    Cho, Yang Hui; Park, Heong Gee; Park, Yeong Seok [Univ. of Incheon, Incheon (Korea, Republic of)] (and others)

    1994-04-15

    This study is purposed to evaluate the technical acceptability of the procedures and techniques of seismic qualifications which were performed for the YGN 3 and 4 safety-related equipment.This study is also targeted to suggest a systematized technical procedure guide for the effective performance and review of the seismic qualification, which reflects the most up-to-date licensing requirements and state-of the-art.

  18. Safety evaluation for packaging (onsite) depleted uranium waste boxes

    Energy Technology Data Exchange (ETDEWEB)

    McCormick, W.A.

    1997-08-27

    This safety evaluation for packaging (SEP) allows the one-time shipment of ten metal boxes and one wooden box containing depleted uranium material from the Fast Flux Test Facility to the burial grounds in the 200 West Area for disposal. This SEP provides the analyses and operational controls necessary to demonstrate that the shipment will be safe for the onsite worker and the public.

  19. Evaluation of natural anthracene-derived compounds as antimitotic agents.

    Science.gov (United States)

    Badria, Farid A; Ibrahim, Ahmed S

    2013-04-01

    Plants that contain anthracene-derived compounds such as anthraquinones have been reported to act as anticancer besides their use for millennia to treat constipation, but the mechanism of action is still unfolding. Therefore we pursue this study to explore a new horizon in the anticancer property of these agents with relevance to mitotic arrest. To achieve this goal, the antimitotic activity of a series of naturally occurring anthracene-derived anthraquinones including anthrone, alizarin (1,2-dihydroxyanthraquinone), quinizarin (1,4-dihydroxyanthraquinone), rhein (4,5-dihydroxyanthraquinone-2-carboxylic acid), emodin (1,6,8-trihydroxy-3-methylanthraquinone), and aloe emodin (1,8-dihydroxy-3-hydroxymethylanthraquinone) were evaluated using Allium cepa root tips. Initial results revealed that the mitosis was inhibited after 3, 6, and 24 h, respectively, of incubation with 500, 250, and 125 ppm of each compound in a dose-dependent manner. Furthermore, alizarin at 500 ppm was proved to be the most active compound to arrest the mitosis after 24 h followed by emodin, aloe emodin, rhein, and finally quinizarin. Interestingly, this inhibition of mitosis was irreversible in root tips incubated with each compound at concentration of 500 ppm but not with 250 ppm or 125 ppm, where the roots regained their normal mitotic activity after 96 h post-incubation in water. This re-evaluation of an old remedy suggests that several bioactive anthraquinones possess promising anti-mitotic activity that may have the potential to be lead compounds for the development of a new class of multifaceted natural anticancer/antimitotic agents.

  20. Subjective Performance Evaluations, Self-esteem, and Ego-threats in Principal-agent Relations

    DEFF Research Database (Denmark)

    Sebald, Alexander Christopher; Walzl, Markus

    find that agents sanction whenever the feedback of principals is below their subjective self-evaluations even if the agents' payoff is independent of the principals' feedback. Based on our experimental analysis we propose a principal-agent model with subjective performance evaluations that accommodates...

  1. Safety evaluation of rebaudioside A produced by fermentation.

    Science.gov (United States)

    Rumelhard, Mélina; Hosako, Hiromi; Eurlings, Irene M J; Westerink, Walter M A; Staska, Lauren M; van de Wiel, Jeanine A G; La Marta, James

    2016-03-01

    The safety of rebaudioside A, produced fermentatively by Yarrowia lipolytica encoding the Stevia rebaudiana metabolic pathway (fermentative Reb A), is based on several elements: first, the safety of steviol glycosides has been extensively evaluated and an acceptable daily intake has been defined; second, the use of Y. lipolytica, an avirulent yeast naturally found in foods and used for multiple applications; and third the high purity of fermentative Reb A and its compliance with internationally defined specifications. A bacterial reverse mutation assay and an in vitro micronucleus test conducted with fermentative Reb A provide evidence for its absence of mutagenicity, clastogenicity and aneugenicity. The oral administration of fermentative Reb A to Sprague-Dawley rats for at least 91 days did not lead to any adverse effects at consumption levels up to 2057 mg/kg bw/day for males and 2023 mg/kg bw/day for females, which were concluded to be the No Observed Adverse Effect Levels. The results were consistent with outcomes of previous studies conducted with plant-derived rebaudioside A, suggesting similar safety profiles for fermentative and plant-derived rebaudioside A. The results of the toxicity studies reported here support the safety of rebaudioside A produced fermentatively from Y. lipolytica, as a general purpose sweetener.

  2. Effectiveness and safety evaluation in the dyslipidemia treatment with statins

    Directory of Open Access Journals (Sweden)

    André Santos Silva

    2016-07-01

    Full Text Available Statins are used to reduce morbidity and mortality in patients with a high risk of cardiovascular disease. However, the use of statins does not ensure effectiveness and pharmacotherapeutic safety. In this context, the present study aimed to evaluate the effectiveness and safety of the therapy with statins in patients with dyslipidemia and high cardiovascular risk. To evaluate these parameters, this study selected 113 dyslipidemic patients with regular statins use of at least seven months. It was an observational cross-sectional study, based on data analysis collected from biochemical tests of patients with dyslipidemia in the public health system in the state of Pernambuco, Brazil. Isolated hypercholesterolemia was the most prevalent dyslipidemia type and the most used statin was atorvastatin (84%, followed by simvastatin (16%. The study observed no effectiveness in 58.4% of the patients; 28% had no safety in the treatment, and 48.3% were using doses above the standard dosage. Comparing effectiveness and safety between the same drugs, at standard dosage with higher dosages, there was not any statistical difference in biochemical test results. Therapeutic goals for LDL-C ≤ 70 mg/dL were found in 28% of cases. However, the useof doses above the standard dosage intended to reach very low LDL-C levels should be reevaluated, since there was no statistical difference in reducing the lipid profile, suggesting that the same results can be obtained with a lower standardized dose. This study provides  data relevant to the discussion of statins use and to the necessity of strengthening pharmacotherapeutic monitoring in dyslipidemia treatment.Keywords: Dyslipidemias. Drug Monitoring. Evaluation of Results of Therapeutic Interventions. Hydroxymethylglutaryl-CoA Reductase Inhibitors.  

  3. Agitator tank device and drag reduction agent evaluation

    Institute of Scientific and Technical Information of China (English)

    张帆; 肖博元; 汤养浩; 罗旗荣

    2008-01-01

    The device that consists of tank and disk agitator for evaluation drag reduction agents(DRA) was established.The effect of DRA was defined by testing the changes of agitator torque that drives the disk rotation.The HG-DRA for oil pipeline from Linyi to Puyang was studied by agitator tank device.The relationships between the drag reduction rate and Reynolds number,concentration,balance time were studied.The best concentration and the highest Renords number for the best drag reduction rate were confirmed.The results show that the drag reduction rate tested in agitator tank is close to that in pipeline.The maximum error of drag reduction rate between pipeline and agitator tank is 18.3%,which indicates that the agitator tank device is available to evaluate the effect of DRA for pipeline and it also has the advantages of simple,easy to be operated and using small volume of oil.Those are very helpful for operaters to know the properties of DRA and operate pipeline well.

  4. Squale: evaluation criteria of functioning safety; Squale: criteres d`evaluation de la surete de fonctionnement

    Energy Technology Data Exchange (ETDEWEB)

    Deswarte, Y.; Kaaniche, M. [Centre National de la Recherche Scientifique (CNRS), 31 - Toulouse (France). Laboratoire d`Analyse et d`Architecture des Systemes; Corneillie, P. [CE2A-DI, 92 - Courbevoie (France); Benoit, P. [Matra Transport International, 92 - Montrouge (France)

    1998-05-01

    The SQUALE (security, safety and quality evaluation for dependable systems) project is part of the ACTS (advanced communications, technologies and services) European program. Its aim is to develop confidence evaluation criteria to test the functioning safety of systems. All industrial sectors that use critical applications (nuclear, railway, aerospace..) are concerned. SQUALE evaluation criteria differ from the classical evaluation methods: they are independent of the application domains and industrial sectors, they take into account the overall functioning safety attributes, and they can progressively change according to the level of severity required. In order to validate the approach and to refine the criteria, a first experiment is in progress with the METEOR automatic underground railway and another will be carried out on a telecommunication system developed by Bouygues company. (J.S.) 15 refs.

  5. A Methodology to Evaluate Agent Oriented Software Engineering Techniques

    Energy Technology Data Exchange (ETDEWEB)

    Lin, Chia-En [University of North Texas; Kavi, Krishna M. [University of North Texas; Sheldon, Frederick T [ORNL; Daley, Kristopher M [ORNL; Abercrombie, Robert K [ORNL

    2007-01-01

    Systems using software agents (or multi-agent systems, MAS) are becoming more popular within the development mainstream because, as the name suggests, an agent aims to handle tasks autonomously with intelligence. To benefit from autonomous control and reduced running costs, system functions are performed automatically. Agent-oriented considerations are being steadily accepted into the various software design paradigms. Agents may work alone, but most commonly, they cooperate toward achieving some application goal(s). MAS's are components in systems that are viewed as many individuals living in a society working together. From a SE perspective, solving a problem should encompass problem realization, requirements analysis, architecture design and implementation. These steps should be implemented within a life-cycle process including testing, verification, and reengineering to proving the built system is sound. In this paper, we explore the various applications of agent-based systems categorized into different application domains. A baseline is developed herein to help us focus on the core of agent concepts throughout the comparative study and to investigate both the object-oriented and agent-oriented techniques that are available for constructing agent-based systems. In each respect, we address the conceptual background associated with these methodologies and how available tools can be applied within specific domains.

  6. Review on the Evaluation System of Public Safety Carrying Capacity about Small Town Community

    Institute of Scientific and Technical Information of China (English)

    Ming; SUN; Tianyu; ZHU

    2014-01-01

    Recently,small town community public safety problem has been increasingly highlighted,but its research is short on public safety carrying capacity. Through the investigation and study of community public safety carrying capacity,this paper analyzes the problem of community public safety in our country,to construct index evaluation system of public safety carrying capacity in small town community. DEA method is used to evaluate public safety carrying capacity in small town community,to provide scientific basis for the design of support and standardization theory about small town community in public safety planning.

  7. The Evaluation of Immune Response to Parasitic Agents in Sheep

    Directory of Open Access Journals (Sweden)

    Daniela Moţ

    2010-10-01

    Full Text Available The study was been performed to emphasizing the dynamics of immunological parameters in healthy and parasitically infested youth sheep from different private herds from Timiş district. The researches were been made on20 youth sheep 10-11 months aged from Ţurcana breed divided in two groups: first group (M comprised 10 healthy sheep periodic treated with antiparasitic drugs and the second group (E contained 10 sheep who never received any antiparasitic drugs. All animals are clinical healthy, but those of E group are more skinny and have long and bristled fleece. From both groups were been taken blood samples in the view of evaluation the dynamics of unspecific immune response, represented by some parameters, like seric properdine, seric lysozime, phagocytic index and leucogramme. The obtained results confirm that immune system in infected animals always tried to counteract the noxious action of parasitic agents through increased values of studied parameters. A coproscopic examination of both studied groups identified first instar larvae of Dictyocaulus filaria and Trichostrongylus spp. in E group.

  8. Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

    Energy Technology Data Exchange (ETDEWEB)

    Sygitowicz, L S

    2008-03-20

    A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiation Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a site

  9. Evaluation of new antiemetic agents and definition of antineoplastic agent emetogenicity--state of the art.

    Science.gov (United States)

    Grunberg, Steven M; Warr, David; Gralla, Richard J; Rapoport, Bernardo L; Hesketh, Paul J; Jordan, Karin; Espersen, Birgitte T

    2011-03-01

    Antiemetic drug development can follow the same logical path as antineoplastic drug development from appropriate preclinical models through Phase I, Phase II, and Phase III testing. However, due to the marked success of antiemetic therapy over the last 25 years, placebo antiemetic treatment against highly or moderately emetogenic chemotherapy is not acceptable. Promising antiemetic agents therefore rapidly reach Phase III testing, where they are substituted into or added to effective and accepted regimens. One challenge of antiemetic drug development is determining whether substitution is indeed acceptable or whether prior regimens must be maintained intact as a basis for further antiemetic drug development. An additional challenge is the classification of emetogenic level of new antineoplastic agents. Accurate reporting of emetogenicity of such antineoplastic agents in the absence of preventive antiemetic treatment may not be available. However, at the 2009 Multinational Association of Supportive Care in Cancer (MASCC)/European Society of Medical Oncology (ESMO) Consensus Conference, an expert panel used best available data to establish rankings of emetogenicity. Oral chemotherapeutic agents are ranked separately from intravenous agents, recognizing intrinsic differences in emetogenicity as well as differing schedules of administration. Since oral chemotherapeutic agents are often administered in extended regimens, the distinction between acute and delayed emesis is less clear, and cumulative emesis must be considered. As control of vomiting has improved, attention has shifted to control of nausea, a related but distinct and equally important problem. Additional efforts will be necessary to understand mechanisms of nausea and to identify optimal remedies.

  10. [In vitro safety evaluation study of Angong Niuhuang Wan].

    Science.gov (United States)

    Wang, Xin-mei; Zhang, Su; Wang, Mei-bo; Xia, Jing; Li, Li-min; Wang, Ke; Ji, Shen

    2015-01-01

    To study a vitro extraction method to determine soluble mercury and mercury species in Angong Niuhuang Wan and investigate a vitro safety evaluation method, the best extraction scheme was determined after a great deal of conditioning experiments focusing on how the solvent, purification, duration of extraction and purification etc impact on mercury extraction. Soluble mercury was determined by inductively coupled plasma mass spectrometry and mercury species were determined by high performance liquid chromatography/inductively coupled plasma mass spectrometry. Result show that the best extraction method of soluble mercury and its species was ultrasonic extraction in artificial intestinal juice at 37 °C for 2 hours, letting it stand for 20 hours and taking the supermatant. The method was reproducible, which could simulate the human body environment to maximum extent. Methyl mercury, ethyl mercury and Hg2+ were not found in the extracts of Angong Niuhuang, although the content of soluble mercury was high. It Was concluded that the method could be applied to the vitro extraction and determination of soluble mercury and mercury species in Chinese traditional medicines containing cinnabar. Methyl mercury, ethyl mercury and Hg2+ could be taken as the targets of in vitro safety evaluation of Angong Niuhuang.

  11. Alternatives to animal testing in the safety evaluation of products.

    Science.gov (United States)

    Knight, Derek J; Breheny, Damien

    2002-01-01

    The conventional method for assessing the safety of products, ranging from pharmaceuticals to agrochemicals, biocides and industrial and household chemicals - including cosmetics - involves determining their toxicological properties by using experimental animals. The aim is to identify any possible adverse effects in humans by using these animal models. Providing safe products is undoubtedly of the utmost importance but, over the last decade or so, this aim has come into conflict with strong public opinion, especially in Europe, against animal testing. Industry, academia and the regulators have worked in partnership to find other ways of evaluating the safety of products, by non-animal testing, or at least by reducing the numbers of animals required and the severity of the tests in which they are used. There is a long way to go before products can be evaluated without any animal studies, and it may be that this laudable aim is an impossible dream. Nevertheless, considerable progress has been made by using a combination of in vitro tests and the prediction of properties based on chemical structure. The aim of this review is to describe these important and worthwhile developments in various areas of toxicological testing, with a focus on the European regulatory framework for general industrial and household chemicals.

  12. Criticality safety evaluation report for the multi-canister overpack

    Energy Technology Data Exchange (ETDEWEB)

    KESSLER, S.F.

    1999-05-21

    This criticality evaluation is for Spent N Reactor fuel unloaded from the existing canisters in both KE and KW Basins, and loaded into multiple canister overpack (MCO) containers with specially built baskets containing a maximum of either 54 Mark 1V or 48 Mark IA fuel assemblies. The criticality evaluations include loading baskets into the cask-MCO, operations at the Cold Vacuum Drying Facility, and storage in the Canister Storage Building. Many conservatisms have been built into this analysis, the primary one being the selection of the k{sub eff} = 0.95 criticality safety limit. Additional analyses in this revision include partial fuel basket loadings, loading 26.1 inch Mark IA fuel assemblies into Mark IV fuel baskets, and the revised fuel and scrap basket designs. The MCO MCNP model was revised to include the shield plug assembly.

  13. A BDI Dialogue Agent for Social Support: Specification and Evaluation Method

    OpenAIRE

    Van der Zwaan, J.M.; Dignum, V; Jonker, C.M.

    2012-01-01

    An important task for empathic agents is to provide social support, that is, to help people increase their well-being and decrease the perceived burden of their problems. The contributions of this paper are 1) the specifcation of speech acts for a social support dialogue agent, and 2) an evaluation method for this agent. The dialogue agent provides emotional support and practical advice to victims of cyberbullying. The conversation is structured according to the 5-phase model, a methodology f...

  14. Evaluation of carbamate insecticides as chemotherapeutic agents for cancer

    Directory of Open Access Journals (Sweden)

    Mohd. Amanullah

    2011-01-01

    Full Text Available Background: Cancer chemotherapy has already been in practice by the use of toxins and some of the specific poisonous compounds of cyanide derivatives. Carbamate insecticides inhibit cellular metabolism including energy, protein, and nucleic acid metabolism, thereby, causing cell regression and death. Aim: Preliminary evaluation of three carbamate insecticides, namely, baygon, carbaryl, and carbofuran as chemotherapeutic agents for cancer is undertaken in the present study. Materials and Methods: The toxicity of carbamates on squamous cell carcinoma was assessed in-vitro using dye binding tests. Cells were grown in microtitration ELISA plates, as adherent cultures, for six hours, and then exposed to the drugs for 2, 4, 8, and 12 hours, and finally stained with neutral red, to assess the viable cell number, and with methylene blue for the determination of protein in the monolayer. Optical density was read in an ELISA reader. Statistical Analysis: The data obtained during the experiment was subjected to statistical analysis by using the student ′t′ test. Results: The results indicated that the percentage of the viable cell number reduced with an increase in the time of exposure of the drugs. Exposure of the tumor cells to the drugs for 12 hours detached them completely from the wells, and hence, all the cells were washed out. Exposure of the drugs prior to the establishment of the culture in-vitro resulted in the non-formation of the monolayer in the wells. Conclusions: Among the three drugs studied, the survival percent was least with carbaryl treatment followed by baygon, and with carbofuran treatment it was almost near to control group.

  15. Experimental evaluation of antifungal and antiseptic agents against Rhodotorula spp.

    Science.gov (United States)

    Preney, L; Théraud, M; Guiguen, C; Gangneux, J P

    2003-12-01

    We studied the susceptibility of 21 strains of Rhodotorula rubra and nine strains of R. glutinis to eight antifungals and tested eight antiseptic agents on one strain of R. rubra. The tested strains were susceptible to ketoconazole, 5-fluorocytosine, amphotericin B, and nystatin, intermediate to econazole and resistant to fluconazole, itraconazole and miconazole. After 5-min contact, six of the eight antiseptic agents tested showed a fungicidal activity on the tested R. rubra strain.

  16. SRTC criticality safety technical review: Nuclear Criticality Safety Evaluation 93-04 enriched uranium receipt

    Energy Technology Data Exchange (ETDEWEB)

    Rathbun, R.

    1993-10-13

    Review of NMP-NCS-930087, {open_quotes}Nuclear Criticality Safety Evaluation 93-04 Enriched Uranium Receipt (U), July 30, 1993, {close_quotes} was requested of SRTC (Savannah River Technology Center) Applied Physics Group. The NCSE is a criticality assessment to determine the mass limit for Engineered Low Level Trench (ELLT) waste uranium burial. The intent is to bury uranium in pits that would be separated by a specified amount of undisturbed soil. The scope of the technical review, documented in this report, consisted of (1) an independent check of the methods and models employed, (2) independent HRXN/KENO-V.a calculations of alternate configurations, (3) application of ANSI/ANS 8.1, and (4) verification of WSRC Nuclear Criticality Safety Manual procedures. The NCSE under review concludes that a 500 gram limit per burial position is acceptable to ensure the burial site remains in a critically safe configuration for all normal and single credible abnormal conditions. This reviewer agrees with that conclusion.

  17. Evaluating the safety of St. John's Wort in human pregnancy.

    Science.gov (United States)

    Moretti, Myla E; Maxson, Ashley; Hanna, Fionna; Koren, Gideon

    2009-07-01

    St. John's Wort is a herbal therapy, shown to be effective in treating mild to moderate depression; a disease common in women in their childbearing years. With a significant proportion of unplanned pregnancies, exposure to St. John's Wort into pregnancy is expected to occur. The purpose of this study was to determine whether exposure to this agent in pregnancy is associated with major malformations. We prospectively collected and followed subjects taking St. John's Wort and compared them to a matched group of pregnant women taking other pharmacologic therapy for depression and a third group of healthy women, not exposed to any known teratogens. We obtained follow-up information on 54 St. John's Wort exposed pregnancies and 108 pregnancies in the two comparator groups. Our results indicated that the rates of major malformations were similar across the three groups, with 5%, 4% and 0% in the St. John's Wort, disease comparator, and health group, respectively (p=0.26), This was not different that the 3-5% risk expected in the general population. The live birth and prematurity rates were also not different among the three groups. Though further large scale studies are still needed, this first study on the effects of St. John's Wort in human pregnancy does provide some evidence of fetal safety.

  18. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study

    DEFF Research Database (Denmark)

    Sorgenfrei, Iben F; Norrild, Kathrine; Larsen, Per Bo;

    2006-01-01

    Sugammadex (Org 25969) forms a complex with steroidal neuromuscular blocking agents, thereby reversing neuromuscular block. This study investigated the dose-response relation, safety, and pharmacokinetics of sugammadex to reverse rocuronium-induced block....

  19. Safety assessment for a KBS-3H spent nuclear fuel repository at Olkiluoto. Complementary evaluations of safety

    Energy Technology Data Exchange (ETDEWEB)

    Neall, Fiona; Pastina, Barbara; Snellman, Margit; Smith, Paul; Gribi, P.; Johnson, Lawrence

    2008-12-15

    The KBS-3H design is a variant of the more general KBS-3 method for the geological disposal of spent nuclear fuel in Finland and Sweden. In the KBS-3H design, multiple assemblies containing spent fuel are emplaced horizontally in parallel, approximately 300 m long, slightly inclined deposition drifts. The copper canisters, each with a surrounding layer of bentonite clay, are placed in perforated steel shells prior to deposition in the drifts; the assembly is called the 'supercontainer'. The other KBS-3 variant is the KBS-3V design, in which the copper canisters are emplaced vertically in individual deposition holes surrounded by bentonite clay but without steel supercontainer shells. SKB and Posiva have conducted a Research, Development and Demonstration programme over the period 2002-2007 with the overall aim of establishing whether KBS-3H represents a feasible alternative to KBS-3V. As part of this programme, the long-term safety of a KBS-3H repository has been assessed in the KBS-3H safety studies. In order to focus the safety studies, the Olkiluoto site in the municipality of Eurajoki, which is the proposed site for a spent fuel repository in Finland, was used as a hypothetical site for a KBS-3H repository. The present report is part of a portfolio of reports discussing the long-term safety of the KBS-3H repository. The overall outcome of the KBS-3H safety studies is documented in the summary report, 'Safety assessment for a KBS-3H repository for spent nuclear fuel at Olkiluoto'. The purpose and scope of the KBS-3H complementary evaluations of safety report is provided in Posiva's Safety Case Plan, which is based on Regulatory Guide YVL 8.4 and on international guidelines on complementary lines of argument to long-term safety that are considered an important element of a post-closure safety case for geological repositories. Complementary evaluations of safety require the use of evaluations, evidence and qualitative supporting arguments

  20. Numerical Analysis for Structural Safety Evaluation of Butterfly Valves

    Science.gov (United States)

    Shin, Myung-Seob; Yoon, Joon-Yong; Park, Han-Yung

    2010-06-01

    Butterfly valves are widely used in current industry to control the fluid flow. They are used for both on-off and throttling applications involving large flows at relatively low operating pressure especially in large size pipelines. For the industrial application of butterfly valves, it must be ensured that the valve could be used safety under the fatigue life and the deformations produced by the pressure of the fluid. In this study, we carried out the structure analysis of the body and the valve disc of the butterfly valve and the numerical simulation was performed by using ANSYS v11.0. The reliability of valve is evaluated under the investigation of the deformation, the leak test and the durability of the valve.

  1. Preliminary safety evaluation for the plutonium stabilization and packaging system

    Energy Technology Data Exchange (ETDEWEB)

    Shapley, J.E., Fluor Daniel Hanford

    1997-03-14

    This Preliminary Safety Evaluation (PSE) describes and analyzes the installation and operation of the Plutonium Stabilization and Packaging System (SPS) at the Plutonium Finishing Plant (PFP). The SPS is a combination of components required to expedite the safe and timely storage of Plutonium (Pu) oxide. The SPS program will receive site Pu packages, process the Pu for storage, package the Pu into metallic containers, and safely store the containers in a specially modified storage vault. The location of the SPS will be in the 2736- ZB building and the storage vaults will be in the 2736-Z building of the PFP, as shown in Figure 1-1. The SPS will produce storage canisters that are larger than those currently used for Pu storage at the PFP. Therefore, the existing storage areas within the PFP secure vaults will require modification. Other modifications will be performed on the 2736-ZB building complex to facilitate the installation and operation of the SPS.

  2. Food safety evaluation of broccoli and radish sprouts.

    Science.gov (United States)

    Martínez-Villaluenga, Cristina; Frías, Juana; Gulewicz, Piotr; Gulewicz, Krzysztof; Vidal-Valverde, Concepción

    2008-05-01

    Three cultivars of broccoli seeds (Brassica oleracea var. italica), cv. Tiburon, cv. Belstar and cv. Lucky, and two cultivars of radish seeds (Raphanus sativus), cv. Rebel and cv. Bolide, were germinated for three and five days and safety aspects such as microbiological counts and biogenic amines were investigated. Cytotoxicity evaluation was also carried out. Broccoli and radish sprouts contained numbers of mesophilic, psychrotrophic, total and faecal coliform bacteria which are the usual counts for minimally processed germinated seeds. Putrescine, cadaverine, histamine, tyramine, spermidine and spermine increased during sprout production although these levels were below those permitted by legislation (5 mg/100 g of edible food). Broccoli and radish sprouts demonstrated no toxic effects on proliferation and viability of HL-60 cells and should be included in our diets as healthy and safe fresh foods.

  3. [Safety evaluation of micronomicin. III. Teratogenicity studies in rats].

    Science.gov (United States)

    Hara, T; Nishikawa, S; Miyazaki, H; Ohguro, Y

    1983-01-01

    Micronomicin (MCR) is a new aminoglycoside antibiotic produced by Micromonospora sagamiensis var. nonreducans which was isolated from soil collected at Sagamihara by Nara et al. The purified antibiotic showed a close similarity to gentamicin C complex in physical and chemical properties. The antibacterial activity of MCR is broad-spectrum and almost equal to that of gentamicin C complex. MCR exhibits particularly high activity against Pseudomonas, Proteus, Klebsiella pneumoniae, Serratia, etc. and high activity against some Pseudomonas aeruginosa strains resistant to gentamicin C1a. Teratogenicity studies of MCR in rats were carried out by intravenous injection for safety evaluation (Dose; 25, 50 mg/kg and 75 mg/kg). The results of studies are as follows. 1. Fetal malformation attributable to MCR was not observed at any dose. 2. Suppression of maternal weight gain was observed at the dose levels of 50 mg/kg and over. 3. There was no adverse effect on new borns at any dose.

  4. Update on the safety and efficacy of commercial ultrasound contrast agents in cardiac applications

    OpenAIRE

    Appis, Andrew W; Tracy, Melissa J; Feinstein, Steven B.

    2015-01-01

    Ultrasound contrast agents (UCAs) are currently used throughout the world in both clinical and research settings. The concept of contrast-enhanced ultrasound imaging originated in the late 1960s, and the first commercially available agents were initially developed in the 1980s. Today's microbubbles are designed for greater utility and are used for both approved and off-label indications. In October 2007, the US Food and Drug Administration (FDA) imposed additional product label warnings that ...

  5. Evaluation of efficacy and safety of orlistat in obese patients

    Directory of Open Access Journals (Sweden)

    Suyog S Jain

    2011-01-01

    Full Text Available Context: Rapidly rising prevalence of obesity is alarming. Obesity predisposes to co-morbidities like hypertension, type 2 diabetes mellitus, dyslipidemias, thus substantially rising healthcare expenditure. Lifestyle modifications alone have very limited success, necessitating the addition of pharmacotherapy to it. Objective: Present study was carried out to evaluate the efficacy and safety of orlistat in obese patients. Materials and Methods: Eighty obese (BMI>30 patients according to inclusion and exclusion criteria were randomized into either of the two groups. Group 1 received orlistat 120 mg three times a day and group 2 received placebo three times a day. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL, LDL were measured at baseline and then at 8 th , 16 th and 24 th week. ADR reported by patients were recorded. For safety evaluation various hematological and biochemical parameters were assessed. Z test was used for analysis of data. Results: Compared to placebo, orlistat caused significant reduction (P<0.05 in weight (4.65 kg vs 2.5 kg; orlistat vs placebo, respectively, BMI (1.91 kg/m 2 vs 0.64 kg/m 2 and waist circumference (4.84 cm vs 2 cm, cholesterol (10.68 mg vs 6.18 mg and LDL level (5.87 mg vs 2.33 mg. In the orlistat group, the GI side effects like loose stools, oily stools/spotting, abdominal pain and fecal urgency were observed. Conclusion: Orlistat is an effective and well-tolerated antiobesity drug, which can be employed as an adjunct to therapeutic lifestyle changes to achieve and maintain optimal weight.

  6. Persuasion Model and Its Evaluation Based on Positive Change Degree of Agent Emotion

    Science.gov (United States)

    Jinghua, Wu; Wenguang, Lu; Hailiang, Meng

    For it can meet needs of negotiation among organizations take place in different time and place, and for it can make its course more rationality and result more ideal, persuasion based on agent can improve cooperation among organizations well. Integrated emotion change in agent persuasion can further bring agent advantage of artificial intelligence into play. Emotion of agent persuasion is classified, and the concept of positive change degree is given. Based on this, persuasion model based on positive change degree of agent emotion is constructed, which is explained clearly through an example. Finally, the method of relative evaluation is given, which is also verified through a calculation example.

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

    NARCIS (Netherlands)

    Hernandez-Moreno, J.; Soffers, A.E.M.F.; Wiratno,; Falke, H.E.; Rietjens, I.; Murk, A.J.

    2013-01-01

    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 euge

  8. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  9. PGSFR Core Thermal Design Procedure to Evaluate the Safety Margin

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Sun Rock; Kim, Sang-Ji [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2014-10-15

    The Korea Atomic Energy Research Institute (KAERI) has performed a SFR design with the final goal of constructing a prototype plant by 2028. The main objective of the SFR prototype plant is to verify the TRU metal fuel performance, reactor operation, and transmutation ability of high-level wastes. The core thermal design is to ensure the safe fuel performance during the whole plant operation. Compared to the critical heat flux in typical light water reactors, nuclear fuel damage in SFR subassemblies arises from a creep induced failure. The creep limit is evaluated based on the maximum cladding temperature, power, neutron flux, and uncertainties in the design parameters, as shown in Fig. 1. In this work, the core thermal design procedures are compared to verify the present PGSFR methodology based on the nuclear plant design criteria/guidelines and previous SFR thermal design methods. The PGSFR core thermal design procedure is verified based on the nuclear plant design criteria/guidelines and previous methods in LWRs and SFRs. The present method aims to directly evaluate the fuel cladding failure and to assure more safety margin. The 2 uncertainty is similar to 95% one-side tolerance limit of 1.96 in LWRs. The HCFs, ITDP, and MCM reveal similar uncertainty propagation for cladding midwall temperature for typical SFR conditions. The present HCFs are mainly employed from the CRBR except the fuel-related uncertainty such as an incorrect fuel distribution. Preliminary PGSFR specific HCFs will be developed by the end of 2015.

  10. Safety pharmacology and genotoxicity evaluation of AVI-4658.

    Science.gov (United States)

    Sazani, Peter; Weller, Doreen L; Shrewsbury, Stephen B

    2010-01-01

    Duchenne muscular dystrophy (DMD) is caused by dystrophin gene mutations. Restoration of dystrophin by exon skipping was demonstrated with the phosphorodiamidate morpholino oligomers (PMO) class of splice-switching oligomers, in both mouse and dog disease models. The authors report the results of Good Laboratory Practice-compliant safety pharmacology and genotoxicity evaluations of AVI-4658, a PMO under clinical evaluation for DMD. In cynomolgus monkeys, no test article-related effects were seen on cardiovascular, respiratory, global neurological, renal, or liver parameters at the maximum feasible dose (320 mg/kg). Genotoxicity battery showed that AVI-4658 has no genotoxic potential at up to 5000 microg/mL in an in vitro mammalian chromosome aberration test and a bacterial reverse mutation assay. In the mouse bone marrow erythrocyte micronucleus test, a single intravenous injection up to 2000 mg/kg was generally well tolerated and resulted in no mutagenic potential. These results allowed initiation of systemic clinical trials in DMD patients in the United Kingdom.

  11. Development and application of an integrated evaluation framework for preventive safety applications

    NARCIS (Netherlands)

    Scholliers, J.; Joshi, S.; Gemou, M.; Hendriks, F.; Ljung Aust, M.; Luoma, J.; Netto, M.; Engstrom, J.; Leanderson Olsson, S.; Kutzner, R.; Tango, F.; Amditis, A.J.; Blosseville, J.M.; Bekiaris, E.

    2011-01-01

    Preventive safety functions help drivers avoid or mitigate accidents. No quantitative methods have been available to evaluate the safety impact of these systems. This paper describes a framework for the assessment of preventive and active safety functions, which integrates procedures for technical p

  12. 49 CFR Appendix A to Part 385 - Explanation of Safety Audit Evaluation Criteria

    Science.gov (United States)

    2010-10-01

    ... Evaluation Criteria I. General (a) Section 210 of the Motor Carrier Safety Improvement Act (49 U.S.C. 31144.... Using “safety audit” avoids any possible confusion with the safety reviews previously conducted by the... Appropriations Act; and 3. In the event that a carrier is found not to be in compliance with applicable...

  13. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution

    Directory of Open Access Journals (Sweden)

    Jui-Wen Ma

    2017-03-01

    Full Text Available In this study, a chlorine dioxide solution (UC-1 composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50 of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl-2,5-diphenyltetrazolium bromide (MTT test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO2 concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports.

  14. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution

    Science.gov (United States)

    Ma, Jui-Wen; Huang, Bin-Syuan; Hsu, Chu-Wei; Peng, Chun-Wei; Cheng, Ming-Long; Kao, Jung-Yie; Way, Tzong-Der; Yin, Hao-Chang; Wang, Shan-Shue

    2017-01-01

    In this study, a chlorine dioxide solution (UC-1) composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50) of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO2 concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports. PMID:28327506

  15. Managing trafic safety : an approach to the evaluation of new vehicle safety systems

    OpenAIRE

    2012-01-01

    Road traffic crashes are killing more than one million road users per year, worldwide. Preventive measures to decrease this number are warranted. Relevant measures can be to introduce systematic road traffic safety management and to improve the safety pro- perties of components in the road transport system. The so called Vision Zero, a holistic system to improve road safety, is built around the general idea to build a ‘‘safe system” based on knowledge regarding human capacity and where no pre...

  16. Applying a realistic evaluation model to occupational safety interventions

    DEFF Research Database (Denmark)

    Pedersen, Louise Møller

    2017-01-01

    Background: Recent literature characterizes occupational safety interventions as complex social activities, applied in complex and dynamic social systems. Hence, the actual outcomes of an intervention will vary, depending on the intervention, the implementation process, context, personal...... and qualitative methods. This revised model has, however, not been applied in a real life context. Method: The model is applied in a controlled, four-component, integrated behaviour-based and safety culture-based safety intervention study (2008-2010) in a medium-sized wood manufacturing company. The interventions...... involve the company’s safety committee, safety manager, safety groups and 130 workers. Results: The model provides a framework for more valid evidence of what works within injury prevention. Affective commitment and role behaviour among key actors are identified as crucial for the implementation...

  17. Synthesis and Biological Evaluation of Liguzinediol Mono- and Dual Ester Prodrugs as Promising Inotropic Agents

    Directory of Open Access Journals (Sweden)

    Jing Zhang

    2014-11-01

    Full Text Available The potent positive inotropic effect, together with the relatively low safety risk of liguzinediol (LZDO, relative to currently available inotropic drugs, has prompted us to intensively research and develop LZDO as a potent positive inotropic agent. In this study, to obtain LZDO alternatives for oral chronic administration, a series of long-chain fatty carboxylic mono- and dual-esters of LZDO were synthesized, and preliminarily evaluated for physicochemical properties and bioconversion. Enhanced lipophilic properties and decreased solubility of the prodrugs were observed as the side chain length increased. All esters showed conspicuous chemical stability in phosphate buffer (pH 7.4. Moreover, the enzymatic hydrolysis of esters in human plasma and human liver microsomes confirmed that the majority of esters were converted to LZDO, with release profiles that varied due to the size and structure of the side chain. In vivo pharmacokinetic studies following oral administration of monopivaloyl (M5, monodecyl (M10 and monododecyl (M12 esters demonstrated the evidently extended half-lives relative to LZDO dosed alone. In particular the monopivaloyl ester M5 exhibited an optimal pharmacokinetic profile with appropriate physiochemical characteristics.

  18. A BDI Dialogue Agent for Social Support: Specification and Evaluation Method

    NARCIS (Netherlands)

    Van der Zwaan, J.M.; Dignum, V.; Jonker, C.M.

    2012-01-01

    An important task for empathic agents is to provide social support, that is, to help people increase their well-being and decrease the perceived burden of their problems. The contributions of this paper are 1) the specifcation of speech acts for a social support dialogue agent, and 2) an evaluation

  19. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  20. Evaluation of the efficiency and safety in cosmetic products.

    Science.gov (United States)

    Uckaya, Meryem; Uckaya, Fatih; Demir, Nazan; Demir, Yasar

    2016-02-29

    Chemicals used in cosmetics have to interact with enzymes for beneficial or destroy purpose after they enter in our body. Active sections of enzymes that catalyze reactions have three dimensions and they are active optically. When these limitations of catalytic sections are considered, it may be considered that defining geometric specifications of chemical materials and functional groups they contain may contribute on safety evaluations of cosmetic products. In this study, defining similarities and differences of geometric structures of chemicals that are prohibited to be used in cosmetic products and chemical that are allowed to be used by using group theory and analyze of functional groups that are often encountered in these chemicals are aimed. Molecule formulas related to chemical material of, 276 pieces chemicals that are prohibited to be used in cosmetic products and 65 pieces chemicals that are allowed, are used as the material. Two and three-dimension structures of these formulas are drawn and types and quantity of functional groups they contain are defined. And as a method, freeware (Free Trial) version of "Chem-BioOffice Ultra 13.0 Suite" chemical drawing program to draw two and three-dimension of formulas, "Campus-Licensed" version that are provided for use by our university of "Autodesk 3DS Max" for three-dimension drawings are used. In order to analyze geometric specifications of drawn molecules according to Group Theory and define type and quantity of available functional groups, Excel applications developed by Prof. Dr. Yaşar Demir are used.

  1. Safety evaluation of monophosphoryl lipid A (MPL): an immunostimulatory adjuvant.

    Science.gov (United States)

    Baldrick, Paul; Richardson, Derek; Elliott, Gary; Wheeler, Alan W

    2002-06-01

    Animal models have shown the potential use of monophosphoryl lipid A (MPL), a detoxified bacterial lipopolysaccharide, as a vaccine adjuvant. Immunostimulatory activity with diverse effects on the cellular elements of the immune system has been demonstrated and a range of vaccines incorporating MPL, including allergy vaccines, are currently under clinical evaluation. A series of preclinical safety investigations was performed to support clinical use of MPL as used in allergy vaccines and comprised cardiovascular/respiratory assessment in dog (up to 100 microg/kg/day); repeat-dose toxicity in rat, rabbit, and dog (up to 2500 and 1200 microg/kg/day in the rat and dog, respectively); reproduction toxicity in rat and rabbit (up to 100 microg/kg/day); and genotoxicity studies. Overall, repeat-dose toxicity studies in the rat and dog showed expected immunostimulatory effects and/or signs of toxicity associated with overstimulation of the immune system (notably increased spleen weight and white blood cell values). Studies in the rabbit with weekly doses of MPL produced no effects. MPL was shown to have no adverse effects on cardiovascular/respiratory function, reproduction, and genotoxicity.

  2. Safety Evaluation of a Hybrid Substructure for Offshore Wind Turbine

    Directory of Open Access Journals (Sweden)

    Min-Su Park

    2016-01-01

    Full Text Available Towers and rotor-nacelles are being enlarged to respond to the need for higher gross generation of the wind turbines. However, the accompanying enlargement of the substructure supporting these larger offshore wind turbines makes it strongly influenced by the effect of wave forces. In the present study, the hybrid substructure is suggested to reduce the wave forces by composing a multicylinder having different radii near free surface and a gravity substructure at the bottom of the multicylinder. In addition, the reaction forces acting on the substructure due to the very large dead load of the offshore wind turbine require very firm foundations. This implies that the dynamic pile-soil interaction has to be fully considered. Therefore, ENSOFT Group V7.0 is used to calculate the stiffness matrices on the pile-soil interaction conditions. These matrices are then used together with the loads at TP (Transition Piece obtained from GH-Bladed for the structural analysis of the hybrid substructure by ANSYS ASAS. The structural strength and deformation are evaluated to derive an ultimate structural safety of the hybrid substructure for various soil conditions and show that the first few natural frequencies of the substructure are heavily influenced by the wind turbine. Therefore, modal analysis is carried out through GH-Bladed to examine the resonance between the wind turbine and the hybrid substructure.

  3. Safety evaluation of saffron (Crocus sativus) tablets in healthy volunteers.

    Science.gov (United States)

    Modaghegh, Mohammad-Hadi; Shahabian, Masoud; Esmaeili, Habib-Allah; Rajbai, Omid; Hosseinzadeh, Hossein

    2008-12-01

    Saffron (Crocus sativus) stigma tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. The study was a double-blind, placebo-controlled design consisting of a 1 week treatment of saffron tablets. Volunteers were divided into 3 groups of 10 each (5 males and 5 females). Group I received placebo; groups 2 and 3 received 200 and 400mg saffron tablets, respectively, for 7 days. General measures of health were recorded during the study such as hematological, biochemical and electrocardiographic parameters done in pre- and post-treatment periods. Clinical examination showed no gross changes in all volunteers after intervention. Saffron with higher dose (400mg) decreased standing systolic blood pressure and mean arterial pressures significantly. Saffron decreased slightly some hematological parameters such as red blood cells, hemoglobin, hematocrit and platelets. Saffron increased sodium, blood urea nitrogen and creatinine. This study showed that saffron tablets may change some hematological and biochemical parameters. However, these alterations were in normal ranges and they were not important clinically.

  4. Dynamic probability evaluation of safety levels of earth-rockfill dams using Bayesian approach

    Directory of Open Access Journals (Sweden)

    Zi-wu FAN

    2009-06-01

    Full Text Available In order to accurately predict and control the aging process of dams, new information should be collected continuously to renew the quantitative evaluation of dam safety levels. Owing to the complex structural characteristics of dams, it is quite difficult to predict the time-varying factors affecting their safety levels. It is not feasible to employ dynamic reliability indices to evaluate the actual safety levels of dams. Based on the relevant regulations for dam safety classification in China, a dynamic probability description of dam safety levels was developed. Using the Bayesian approach and effective information mining, as well as real-time information, this study achieved more rational evaluation and prediction of dam safety levels. With the Bayesian expression of discrete stochastic variables, the a priori probabilities of the dam safety levels determined by experts were combined with the likelihood probability of the real-time check information, and the probability information for the evaluation of dam safety levels was renewed. The probability index was then applied to dam rehabilitation decision-making. This method helps reduce the difficulty and uncertainty of the evaluation of dam safety levels and complies with the current safe decision-making regulations for dams in China. It also enhances the application of current risk analysis methods for dam safety levels

  5. Dynamic probability evaluation of safety levels of earth-rockfill dams using Bayesian approach

    Institute of Scientific and Technical Information of China (English)

    Zi-wu FAN; Shu-hai JIANG; Ming ZHANG

    2009-01-01

    In order to accurately predict and control the aging process of dams, new information should be collected continuously to renew the quantitative evaluation of dam safety levels. Owing to the complex structural characteristics of dams, it is quite difficult to predict the time-varying factors affecting their safety levels. It is not feasible to employ dynamic reliability indices to evaluate the actual safety levels of dams. Based on the relevant regulations for dam safety classification in China, a dynamic probability description of dam safety levels was developed. Using the Bayesian approach and effective information mining, as well as real-time information, this study achieved more rational evaluation and prediction of dam safety levels. With the Bayesian expression of discrete stochastic variables, the a priori probabilities of the dam safety levels determined by experts were combined with the likelihood probability of the real-time check information, and the probability information for the evaluation of dam safety levels was renewed. The probability index was then applied to dam rehabilitation decision-making. This method helps reduce the difficulty and uncertainty of the evaluation of dam safety levels and complies with the current safe decision-making regulations for dams in China. It also enhances the application of current risk analysis methods for dam safety levels.

  6. Preclinical safety evaluation of inhaled cyclosporine in propylene glycol.

    Science.gov (United States)

    Wang, Tao; Noonberg, Sarah; Steigerwalt, Ronald; Lynch, Maryellen; Kovelesky, Rosemary A; Rodríguez, Carlos A; Sprugel, Katherine; Turner, Nancy

    2007-01-01

    Cyclosporine inhalation solution has the potential to improve outcomes following lung transplantation by delivering high concentrations of an immunosuppressant directly to the allograft while minimizing systemic drug exposure and associated toxicity. The objective of these studies was to evaluate the potential toxicity of aerosolized cyclosporine formulated in propylene glycol when given by inhalation route to rats and dogs for 28 days. Sprague-Dawley rats received total inhaled doses of 0 (air), 0 (vehicle, propylene glycol), 7.4, 24.3, and 53.9 mg cyclosporine/kg/day. In a separate study, beagle dogs were exposed to 0, 4.4, 7.7, and 9.7 mg cyclosporine/kg/day. Endpoints used to evaluate potential toxicity of inhaled cyclosporine were clinical observations, body weight, food consumption, respiratory functions, toxicokinetics, and clinical/anatomic pathology. Daily administration of aerosolized cyclosporine did not result in observable accumulation of cyclosporine in blood or lung tissue. Toxicokinetic analysis from the rat study showed that the exposure of cyclosporine was approximately 18 times higher in the lung tissue compared to the blood. Systemic effects were consistent with those known for cyclosporine. There was no unexpected systemic toxicity or clinically limiting local respiratory toxicity associated with inhalation exposure to cyclosporine inhalation solution at exposures up to 2.7 times the maximum human exposure in either rats or dogs. There were no respiratory or systemic effects of high doses of propylene glycol relative to air controls. These preclinical studies demonstrate the safety of aerosolized cyclosporine in propylene glycol and support its continued clinical investigation in patients undergoing allogeneic lung transplantation.

  7. Considerations on Safety Evaluation of Safety grade Smart Transmitter in Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyung Tae; Jeong, Choong heui [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-05-15

    Non-safety grade smart transmitters have been used for I and C systems of NPPs(Nuclear Power Plants). Smart transmitter is a microprocessor-based device including software and provides capability for digital signals to be communicated on top of the 4-20 mA analog signals. Recently, smart transmitters have been used for safety grade I and C systems as well as non-safety grade I and C system for SKN 3 and 4. Due to potential benefits of smart transmitter, it is anticipated smart transmitters will be widely used safety-related applications at NPPs. For those reasons, smart transmitter's technology and characteristics need to be investigated. Smart transmitters have been used for safety grade as well as non-safety grade I and C system since SKN 3 and 4. Due to potential benefits of smart transmitter, it is anticipated smart transmitters will be widely used safety-related applications at NPPs. For those reasons, smart transmitter's technology and characteristics need to be investigated. To get useful information about that, we surveyed EPRI qualification report, NRC event report, and SKN 3 and 4's review.

  8. Affect-as-Information Approach to a Sentiment Analysis Based Evaluation of Conversational Agents

    OpenAIRE

    Ptaszynski, Michal; Dybala, Pawel; Higuchi, Shinsuke; Rzepka, Rafal; Araki, Kenji

    2017-01-01

    In this paper we propose a novel method forautomatic evaluation of conversational agents. Themethod is based on analyzing the user’s affectconveyed in utterances. From analyzing: the user’sgeneral emotional engagement in the conversation andthe emotion types conveyed by the user in theconversation, a simple psychological reasoning isderived about the user’s sentiment about the agent’sperformance. The evaluation experiment on twoJapanese-speaking conversational agents showed thesame tendencies...

  9. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines

    NARCIS (Netherlands)

    Pane, J. (Josep); P.M. Coloma (Preciosa); K.M.C. Verhamme (Katia); M.C.J.M. Sturkenboom (Miriam); Rebollo, I. (Irene)

    2017-01-01

    textabstractRecent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our obje

  10. 77 FR 15399 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

    Science.gov (United States)

    2012-03-15

    ... COMMISSION Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force... Regulatory Commission (NRC) is announcing the availability of the model safety evaluation (SE) for plant..., Revision 1, is available in ADAMS under Accession No. ML111650552; the model application is available...

  11. 77 FR 58421 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

    Science.gov (United States)

    2012-09-20

    ... COMMISSION Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...-415- 4737, or by email to pdr.resource@nrc.gov . TSTF-522, Revision 0, includes a model application and is available in ADAMS under Accession No. ML100890316. The model safety evaluation (SE) of...

  12. 77 FR 27814 - Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force...

    Science.gov (United States)

    2012-05-11

    ... COMMISSION Model Safety Evaluation for Plant-Specific Adoption of Technical Specifications Task Force... availability. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is announcing the availability of the model safety evaluation (SE) for plant-specific adoption of Technical Specifications (TSs) Task Force...

  13. 77 FR 72435 - Pipeline Safety: Using Meaningful Metrics in Conducting Integrity Management Program Evaluations

    Science.gov (United States)

    2012-12-05

    ... self-assessments were ``superficial and resulted in no improvements to the integrity management program... Conducting Integrity Management Program Evaluations AGENCY: Pipeline and Hazardous Materials Safety... responsibilities, under Federal integrity management regulations, to perform evaluations of their...

  14. Youth and Evaluation: Empowered Social-Change Agents.

    Science.gov (United States)

    Fetterman, David

    2003-01-01

    Summarizes the chapters of this theme issue on youth participatory evaluation. The overarching theme from this collection is the shift from a focus on youth as defective to a view of youth as assets in community development. (SLD)

  15. Safety of Nicergoline as an Agent for Management of Cognitive Function Disorders

    Directory of Open Access Journals (Sweden)

    Bernd Saletu

    2014-01-01

    Full Text Available Nicergoline is a semisynthetic ergot derivative and has a selective alpha-1A adrenergic receptor blocking property and also other additional mechanisms of actions, both in the brain and in the periphery. It is in clinical use for over three decades in over fifty countries for conditions such as cerebral infarction, acute and chronic peripheral circulation disorders, vascular dementia, and Alzheimer’s disease and has been found to be beneficial in a variety of other conditions. However, concerns about its safety have been raised, especially after the European medicines agency’s (EMEA’s restriction in the use of all ergot derivatives including nicergoline. But, most of the available literature and data suggest that the adverse events with nicergoline are mild and transient. Further, none of the available treatment options for cognitive disorders afford definitive resolution of symptoms. In this backdrop, we discuss the pharmacology of nicergoline with special emphasis on the safety of this compound, especially when used in patients suffering from cognitive function disorders.

  16. Evaluation of Safety, Quality and Productivity in Construction

    Science.gov (United States)

    Usmen, M. A.; Vilnitis, M.

    2015-11-01

    This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

  17. Evaluation model for safety capacity of chemical industrial park based on acceptable regional risk

    Institute of Scientific and Technical Information of China (English)

    Guohua Chen; Shukun Wang; Xiaoqun Tan

    2015-01-01

    The paper defines the Safety Capacity of Chemical Industrial Park (SCCIP) from the perspective of acceptable regional risk. For the purpose of exploring the evaluation model for the SCCIP, a method based on quantitative risk assessment was adopted for evaluating transport risk and to confirm reasonable safety transport capacity of chemical industrial park, and then by combining with the safety storage capacity, a SCCIP evaluation model was put forward. The SCCIP was decided by the smaller one between the largest safety storage capacity and the maximum safety transport capacity, or else, the regional risk of the park will exceed the acceptable level. The developed method was applied to a chemical industrial park in Guangdong province to obtain the maximum safety transport capacity and the SCCIP. The results can be realized in the regional risk control of the park effectively.

  18. Guidelines for retrospective safety analysis. Prepared for DRIVE II Project V2002 Horizontal Project for the Evaluation of Safety HOPES.

    NARCIS (Netherlands)

    Oppe, S. (ed.)

    1994-01-01

    This report contains the following contributions: Concepts and definitions (Oppe, S); Traffic in its social context (Chaloupka, C and Risser, R); The checklist as a retrospective safety tool (Chaloupka, C and Risser, R); Experimental design (Kulmala, R); Evaluation of the traffic process and its saf

  19. PREPARATION AND EVALUATION OF MUCOADHESIVE NANOPARTICLE OF AN ANTIHYPERTENSIVE AGENT

    Directory of Open Access Journals (Sweden)

    Vaibhav Shukla

    2012-02-01

    Full Text Available Diltiazem HCl (DTZ is an antihypertensive agent that antagonizes the action of beta-1 receptor. DTZ when given orally is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect. DTZ undergoes extensive metabolism in which only 2% to 4% of the unchanged drug appears in the urine. Drugs which induce or inhibit hepatic microsomal enzymes may alter DTZ disposition. It has been reported that the absolute bioavailability of DTZ when given orally is 30-40%. The biological half-life of DTZ is 4-6 hour and the main site of absorption is proximal small intestine.The reduced bioavailability of DTZ may be because of transportation of dosage form from the region of absorption window to site where it is less absorbed. Therefore there was a need to increase gastroretention time of dosage form so that drug would be available at the site of absorption and results in improved bioavailability. A mucoadhesive nanoparticle delivery system was envisioned for DTZ as such a system when administered would adhere on the gastric mucosa for a prolong period of time and the drug would be available at the main site of absorption i.e. proximal small intestine resulting in enhanced bioavailability.

  20. Canagliflozin: Efficacy and Safety in Combination with Metformin Alone or with Other Antihyperglycemic Agents in Type 2 Diabetes.

    Science.gov (United States)

    Qiu, Rong; Balis, Dainius; Capuano, George; Xie, John; Meininger, Gary

    2016-12-01

    Metformin is typically the first pharmacologic treatment recommended for type 2 diabetes mellitus (T2DM), but many patients do not achieve glycemic control with metformin alone and eventually require combination therapy with other agents. Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, was assessed in a comprehensive Phase 3 clinical development program consisting of ~10,000 participants, of which ~80% were on background therapy that consisted of metformin alone or in combination with other antihyperglycemic agents (AHAs; e.g., pioglitazone, sulfonylurea, and insulin). In addition, the efficacy and safety of canagliflozin and metformin as the initial combination therapy and canagliflozin monotherapy were assessed versus metformin in treatment-naïve patients with T2DM. Across studies in patients with T2DM who were on metformin alone or in combination with other AHAs, canagliflozin 100 and 300 mg provided improvements in glycated hemoglobin for up to 104 weeks. Canagliflozin was also associated with reductions in body weight and systolic blood pressure when added to background therapy consisting of metformin alone or with other AHAs. Canagliflozin was generally well tolerated, with increased incidence of adverse events (AEs) related to the mechanism of SGLT2 inhibition (i.e., genital mycotic infections, urinary tract infections, and osmotic diuresis-related AEs). Consistent with its insulin-independent mechanism of action, canagliflozin was associated with low rates of hypoglycemia when background therapy did not include sulfonylurea or insulin. Due to its favorable efficacy and safety profile, these results suggest that adding canagliflozin to a background regimen consisting of metformin or implementing treatment with a fixed-dose regimen of canagliflozin and metformin would provide an effective and safe treatment regimen for T2DM management.

  1. Comparative Efficacy and Safety of Antihypertensive Agents for Adult Diabetic Patients with Microalbuminuric Kidney Disease: A Network Meta-Analysis

    Science.gov (United States)

    Huang, Rongzhong; Feng, Yuxing; Wang, Ying; Qin, Xiaoxia; Melgiri, Narayan Dhruvaraj; Sun, Yang; Li, Xingsheng

    2017-01-01

    Background Antihypertensive treatment mitigates the progression of chronic kidney disease. Here, we comparatively assessed the effects of antihypertensive agents in normotensive and hypertensive diabetic patients with microalbuminuric kidney disease. Methods MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were systematically searched for randomized controlled trials (RCTs) comparing oral antihypertensive agents in adult diabetic patients with microalbuminuria. The primary efficacy outcome was reduction in albuminuria, and the primary safety outcomes were dry cough, presyncope, and edema. Random-effects pairwise and Bayesian network meta-analyses were performed to produce outcome estimates for all RCTs, only hypertensive RCTs, or only normotensive RCTs. Surface under the cumulative ranking (SUCRA) probability rankings were calculated for all outcomes. Sensitivity analyses on type 2 diabetes status, age, or follow-up duration were also performed. Results A total of 38 RCTs were included in the meta-analyses. The angiotensin-converting enzyme inhibitor-calcium channel blocker (ACEI-CCB) combination therapy of captopril+diltiazem was most efficacious in reducing albuminuria irrespective of blood pressure status. However, the ACEI-angiotensin receptor blocker (ACEI-ARB) combination therapy of trandolapril+candesartan was the most efficacious in reducing albuminuria for normotensive patients, while the ACEI-CCB combination therapy of fosinopril+amlodipine was the most efficacious in reducing albuminuria for hypertensive patients. The foregoing combination therapies displayed inferior safety profiles relative to ACEI monotherapy with respect to dry cough, presyncope, and edema. With respect to type 2 diabetic patients with microalbuminuria, the Chinese herbal medicine Tangshen formula followed by the ACEI ramipril were the most efficacious in reducing albuminuria. Conclusions Trandolapril+candesartan appears to be the most efficacious intervention

  2. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review.

    Science.gov (United States)

    Hibbard, John S

    2005-01-01

    This article reviews the results and conclusions from four pivotal and two comparative clinical trials. The six randomized, controlled, single-blinded, parallel-group clinical trials were conducted to determine which antiseptic is best for use as a patient preoperative skin preparation. The objective of these studies was to compare the immediate, persistent (residual), and cumulative antimicrobial efficacy and safety of 2% chlorhexidine gluconate (CHG) combined with 70% isopropyl alcohol (IPA) (ChloraPrep); another combination CHG and IPA antiseptic (CHG+IPA) and 2% aqueous CHG alone; 4% CHG (Hibiclens) alone; 70% isopropyl alcohol (IPA) alone; and an iodine-containing solution, 10% povidone-iodine (Betadine) alone as preoperative skin topical antiseptics for potential prevention of nosocomial infections.

  3. FOREST GUARD: A complete safety for Wildlife using Mobile Agents and Sensor Clouds in WSN

    Directory of Open Access Journals (Sweden)

    Sumit Kumar Tetarave

    2012-11-01

    Full Text Available With growing human population and search for new habitus and unsustainable use of natural resources, over exploitation of forests and wildlife is taking place world over. This is resulting in drastic decline in the number of essential flora and fauna. We propose a complete safe guard model named Forest Guard, for saving wildlife from human as well as their own collisions. This model will not guard them directly; rather it will help in collecting vital information about their real-time condition and will alert the institutional mechanisms to take corrective initiatives. The paper mentions this indirect support in the form of wireless sensor networks (WSN. In WSN, our proposed model uses mobile agents (MAs for handling huge area communication and injecting them for different guarding issues of different species of wildlife. A novel concept of Virtual Sensor Cloud (VSC is being discussed to trace different group of endangered wild animals such as Tigers, Lions, Elephants, etc.

  4. Food safety involving ingestion of foods and beverages prepared with phthalate-plasticizer-containing clouding agents.

    Science.gov (United States)

    Yen, Tzung-Hai; Lin-Tan, Dan-Tzu; Lin, Ja-Liang

    2011-11-01

    In May 2011, the illegal use of the phthalate plasticizer di(2-ethylhexyl) phthalate in clouding agents for use in foods and beverages was reported in Taiwan. This food scandal has caused shock and panic among the majority of Taiwanese people and has attracted international attention. Phthalate exposure is assessed by ambient monitoring or human biomonitoring. Ambient monitoring relies on measuring chemicals in environmental media, foodstuff and consumer products. Human biomonitoring determines body burden by measuring the chemicals, their metabolites or specific reaction products in human specimens. In mammalian development, the fetus is set to develop into a female. Because the female phenotype is the default, impairment of testosterone production or action before the late phase may lead to feminizing characteristics. Phthalates disrupt the development of androgen-dependent structures by inhibiting fetal testicular testosterone biosynthesis. The spectrum of effects obtained following perinatal exposure of male rats to phthalates has remarkable similarities with the human testicular dysgenesis syndrome. Epidemiological studies have suggested associations between phthalate exposure and shorter gestational age, shorter anogenital distance, shorter penis, incomplete testicular descent, sex hormone alteration, precocious puberty, pubertal gynecomastia, premature thelarche, rhinitis, eczema, asthma, low birth weight, attention deficit hyperactivity disorder, low intelligence quotient, thyroid hormone alteration, and hypospadias in infants and children. Furthermore, many studies have suggested associations between phthalate exposure and increased sperm DNA damage, decreased proportion of sperm with normal morphology, decreased sperm concentration, decreased sperm morphology, sex hormone alteration, decreased pulmonary function, endometriosis, uterine leiomyomas, breast cancer, obesity, hyperprolactinemia, and thyroid hormone alteration in adults. Finally, the number of

  5. Safety design maps: an early evaluation of safety to support reactor design

    Energy Technology Data Exchange (ETDEWEB)

    Zanocco, P. E-mail: zanoccop@cab.cnea.gov.ar; Gimenez, M.; Delmastro, D

    2003-11-01

    A new tendency in nuclear reactor conceptual design is to include safety criteria through accident analysis to address the selection of the engineering solutions and the value of the main design parameters. In this work, the concept of design map is used to correlate reactor safety performance with the design parameters. The effect of different design parameters on characteristic safety variables, referred to as 'observable variables', extracted from reactor evolution during accidents, is analyzed, and the concept of 'safety design maps' is introduced. The sensitivity of these 'observables variables' regarding changes in design parameters is visualized. Several safety design maps are built from the performance of an integral type reactor during loss of heat sink (LOHS) and main steam line break sequences without SCRAM to show the technique potentiality. Maximum reactor pressure vessel (RPV) pressure and minimum departure from nucleate boiling ratio are chosen as 'observable variables' and their sensitivity to geometry-related parameters and reactivity coefficient is studied. Multiple-parameter single design maps and combined design maps for both accidental sequences are built as examples. The results show the usefulness of this technique to balance and optimize reactor design through an early engineering step. A computer code (HUARPE) has been developed in order to simulate these transients. The cooling circuit, the steam dome, the pressure vessel structures and core models are considered.

  6. Evaluation of an educational intervention using the enhanced food safety cost-of-illness model.

    Science.gov (United States)

    Scharff, Robert L; McDowell, Joyce; Medeiros, Lydia

    2009-01-01

    In recent years, a number of federally sponsored state-based food safety education programs have conducted economic evaluations aimed at demonstrating the efficacy of their approaches. These evaluations have typically been based on the "Virginia method," a comprehensive, but overly simplistic means of estimating benefit-cost ratios for food safety and nutrition education programs. In this article, we use the enhanced food safety cost-of-illness model, coupled with a more complete food safety education intervention model to evaluate the efficacy of the Ohio Family Nutrition Program. We find that, under most reasonable assumptions, the derived benefit-cost ratios imply that this program is socially beneficial. The model presented here is of particular use because it can be replicated to evaluate other broad-based food safety programs.

  7. Application of Mixed Group Decision Making to Safety Evaluation of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    In view of the gravity of issues concerning safety of agricultural products and urgency of resolving these issues,after analyzing the problems existing in safety of agricultural products,this article offers a method for evaluating safety of agricultural products on the basis of mixed group decision making.First of all,it introduces the factors influencing safety evaluation of agricultural products;subsequently,given that the judgment matrices offered by the group of experts contain both reciprocal and complementary judgment matrices in the process of jointly participating in evaluation arising from personal preference,it proposes to assemble expert information in order to obtain indicator weight using the OWA operator;finally,the process of evaluating safety of agricultural products is given.

  8. Evaluation of antiseptic antiviral activity of chemical agents.

    Science.gov (United States)

    Geller, Chloé; Finance, Chantal; Duval, Raphaël Emmanuel

    2011-06-01

    Antiviral antisepsis and disinfection are crucial for preventing the environmental spread of viral infections. Emerging viruses and associated diseases, as well as nosocomial viral infections, have become a real issue in medical fields, and there are very few efficient and specific treatments available to fight most of these infections. Another issue is the potential environmental resistance and spread of viral particles. Therefore, it is essential to properly evaluate the efficacy of antiseptics-disinfectants (ATS-D) on viruses. ATS-D antiviral activity is evaluated by (1) combining viruses and test product for an appropriately defined and precise contact time, (2) neutralizing product activity, and (3) estimating the loss of viral infectivity. A germicide can be considered to have an efficient ATS-D antiviral activity if it induces a >3 or >4 log(10) reduction (American and European regulatory agency requirements, respectively) in viral titers in a defined contact time. This unit describes a global methodology for evaluating chemical ATS-D antiviral activity.

  9. Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients

    NARCIS (Netherlands)

    Kroes, R.; Renwick, A.G.; Feron, V.; Galli, C.L.; Gibney, M.; Greim, H.; Guy, R.H.; Lhuguenot, J.C.; Sandt, J.J.M. van de

    2007-01-01

    The threshold of toxicological concern (TTC) has been used for the safety assessment of packaging migrants and flavouring agents that occur in food. The approach compares the estimated oral intake with a TTC value derived from chronic oral toxicity data for structurally-related compounds. Applicatio

  10. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis

    OpenAIRE

    Meng Wang; Xin-Feng Zheng; Lei-Sheng Jiang

    2015-01-01

    Background Routine use of antifibrinolytic agents in spine surgery is still an issue of debate. Objective To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery. Methods We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrosp...

  11. Occupational health and safety: Designing and building with MACBETH a value risk-matrix for evaluating health and safety risks

    Science.gov (United States)

    Lopes, D. F.; Oliveira, M. D.; Costa, C. A. Bana e.

    2015-05-01

    Risk matrices (RMs) are commonly used to evaluate health and safety risks. Nonetheless, they violate some theoretical principles that compromise their feasibility and use. This study describes how multiple criteria decision analysis methods have been used to improve the design and the deployment of RMs to evaluate health and safety risks at the Occupational Health and Safety Unit (OHSU) of the Regional Health Administration of Lisbon and Tagus Valley. ‘Value risk-matrices’ (VRMs) are built with the MACBETH approach in four modelling steps: a) structuring risk impacts, involving the construction of descriptors of impact that link risk events with health impacts and are informed by scientific evidence; b) generating a value measurement scale of risk impacts, by applying the MACBETH-Choquet procedure; c) building a system for eliciting subjective probabilities that makes use of a numerical probability scale that was constructed with MACBETH qualitative judgments on likelihood; d) and defining a classification colouring scheme for the VRM. A VRM built with OHSU members was implemented in a decision support system which will be used by OHSU members to evaluate health and safety risks and to identify risk mitigation actions.

  12. Scale development of safety management system evaluation for the airline industry.

    Science.gov (United States)

    Chen, Ching-Fu; Chen, Shu-Chuan

    2012-07-01

    The airline industry relies on the implementation of Safety Management System (SMS) to integrate safety policies and augment safety performance at both organizational and individual levels. Although there are various degrees of SMS implementation in practice, a comprehensive scale measuring the essential dimensions of SMS is still lacking. This paper thus aims to develop an SMS measurement scale from the perspective of aviation experts and airline managers to evaluate the performance of company's safety management system, by adopting Schwab's (1980) three-stage scale development procedure. The results reveal a five-factor structure consisting of 23 items. The five factors include documentation and commands, safety promotion and training, executive management commitment, emergency preparedness and response plan and safety management policy. The implications of this SMS evaluation scale for practitioners and future research are discussed.

  13. An approach using multi-factor combination to evaluate high rocky slope safety

    Science.gov (United States)

    Su, Huaizhi; Yang, Meng; Wen, Zhiping

    2016-06-01

    A high rocky slope is an open complex giant system for which there is contradiction among different influencing factors and coexistence of qualitative and quantitative information. This study presents a comprehensive intelligent evaluation method of high rocky slope safety through an integrated analytic hierarchy process, extension matter element model and entropy weight to assess the safety behavior of the high rocky slope. The proposed intelligent evaluation integrates subjective judgments derived from the analytic hierarchy process with the extension matter model and entropy weight into a multiple indexes dynamic safety evaluation approach. A combined subjective and objective comprehensive evaluation process, a more objective study, through avoiding subjective effects on the weights, and a qualitative safety assessment and quantitative safety amount are presented in the proposed method. The detailed computational procedures were also provided to illustrate the integration process of the above methods. Safety analysis of one high rocky slope is conducted to illustrate that this approach can adequately handle the inherent imprecision and contradiction of the human decision-making process and provide the flexibility and robustness needed for the decision maker to better monitor the safety status of a high rocky slope. This study was the first application of the proposed integrated evaluation method in the safety assessment of a high rocky slope. The study also indicated that it can also be applied to other similar problems.

  14. Evaluation procedure of software safety plan for digital I and C of KNGR

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jang Soo; Park, Jong Kyun; Lee, Ki Young; Kwon, Ki Choon; Kim, Jang Yeol; Cheon, Se Woo

    2000-05-01

    The development, use, and regulation of computer systems in nuclear reactor instrumentation and control (I and C) systems to enhance reliability and safety is a complex issue. This report is one of a series of reports from the Korean next generation reactor (KNGR) software safety verification and validation (SSVV) task, Korea Atomic Energy Research Institute, which investigates different aspects of computer software in reactor I and C systems, and describes the engineering procedures for developing such a software. The purpose of this guideline is to give the software safety evaluator the trail map between the code and standards layer and the design methodology and documents layer for the software important to safety in nuclear power plants. Recently, the safety planning for safety-critical software systems is being recognized as the most important phase in the software life cycle, and being developed new regulatory positions and standards by the regulatory and the standardization organizations. The requirements for software important to safety of nuclear reactor are described in such positions and standards, for example, the new standard review plan (SRP), IEC 880 supplements, IEEE standard 1228-1994, IEEE standard 7-4.3.2-1993, and IAEA safety series No. 50-SG-D3 and D8. We presented the guidance for evaluating the safety plan of the software in the KNGR protection systems. The guideline consists of the regulatory requirements for software safety in chapter 2, the evaluation checklist of software safety plan in chapter3, and the evaluation results of KNGR software safety plan in chapter 4.

  15. The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS)

    OpenAIRE

    Vinardell Martínez-Hidalgo, Ma. Pilar

    2014-01-01

    In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g. colorants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, present...

  16. Evaluation of food safety management systems in Serbian dairy industry

    Directory of Open Access Journals (Sweden)

    Igor Tomašević

    2016-01-01

    Full Text Available This paper reports incentives, costs, difficulties and benefits of food safety management systems implementation in the Serbian dairy industry. The survey involved 27 food business operators with the national milk and dairy market share of 65 %. Almost two thirds of the assessed dairy producers (70.4 % claimed that they had a fully operational and certified HACCP system in place, while 29.6 % implemented HACCP, but had no third party certification. ISO 22000 was implemented and certified in 29.6 % of the companies, while only 11.1 % had implemented and certified IFS standard. The most important incentive for implementing food safety management systems for Serbian dairy producers was to increase and improve safety and quality of dairy products. The cost of product investigation/analysis and hiring external consultants were related to the initial set-up of food safety management system with the greatest importance. Serbian dairy industry was not greatly concerned by the financial side of implementing food safety management systems due to the fact that majority of prerequisite programmes were in place and regularly used by almost 100 % of the producers surveyed. The presence of competency gap between the generic knowledge for manufacturing food products and the knowledge necessary to develop and implement food safety management systems was confirmed, despite the fact that 58.8 % of Serbian dairy managers had university level of education. Our study brings about the innovation emphasizing the attitudes and the motivation of the food production staff as the most important barrier for the development and implementation of HACCP. The most important identified benefit was increased safety of dairy products with the mean rank scores of 6.85. The increased customer confidence and working discipline of staff employed in food processing were also found as important benefits of implementing/operating HACCP. The study shows that the level of HACCP

  17. An Automatic Evaluation Method for Conversational Agents Based on Affect-as-Information Theory

    OpenAIRE

    Ptaszynski, Michal; Dybala, Pawel; Rzepka, Rafal; Araki, Kenji

    2010-01-01

    This paper presents a method for automatic evaluation of conversational agents. The method consists of several steps. First, an affect analysis system is used to detect users' general emotional engagement in the conversation and classify their specific emotional states. Next, we interpret this data with the use of reasoning based on Affect-as-Information Theory to obtain information about users' general attitudes to the conversational agent and its performance. The affect analysis system was ...

  18. Integration of Occupational Safety to Contractors` or Subcontractors` Performance Evaluation in Construction Projects

    Science.gov (United States)

    Kozlovská, Mária; Struková, Zuzana

    2013-06-01

    Several factors should be considered by the owner and general contractor in the process of contractors` and subcontractors` selection and evaluation. The paper reviews the recent models addressed to guide general contractors in subcontractors' selection process and in evaluation of different contractors during the execution of the project. Moreover the paper suggests the impact of different contractors' performance to the overall level of occupational health and safety culture at the sites. It deals with the factors influencing the safety performance of contractors during construction and analyses the methods for assessing the safety performance of construction contractors. The results of contractors' safety performance evaluation could be a useful tool in motivating contractors to achieve better safety outcomes or could have effect on owners` or general contractors' decision making about contractors suitability for future contracting works.

  19. Effectiveness evaluation methodology for safety processes to enhance organisational culture in hazardous installations.

    Science.gov (United States)

    Mengolini, A; Debarberis, L

    2008-06-30

    Safety performance indicators are widely collected and used in hazardous installations. The IAEA, OECD and other international organisations have developed approaches that strongly promote deployment of safety performance indicators. These indicators focus mainly on operational performance, but some of them also address organisational and safety culture aspects. However, operators of hazardous installations, in particular those with limited resources and time constraints, often find it difficult to collect the large number of different safety performance indicators. Moreover, they also have difficulties with giving a meaning to the numbers and trends recorded, especially to those that should reflect a positive safety culture. In this light, the aim of this article is to address the need to monitor and assess progress on implementation of a programme to enhance safety and organisational culture. It proposes a specific process-view approach to effectiveness evaluation of organisational and safety culture indicators by means of a multi-level system in which safety processes and staff involvement in defining improvement activities are central. In this way safety becomes fully embedded in staff activities. Key members of personnel become directly involved in identifying and supplying leading indicators relating to their own daily activity and become responsible and accountable for keeping the measurement system alive. Besides use of lagging indicators, particular emphasis is placed on the importance of identifying and selecting leading indicators which can be used to drive safety performance for organisational and safety culture aspects as well.

  20. Evaluation of Aconitum diterpenoid alkaloids as antiproliferative agents.

    Science.gov (United States)

    Wada, Koji; Ohkoshi, Emika; Zhao, Yu; Goto, Masuo; Morris-Natschke, Susan L; Lee, Kuo-Hsiung

    2015-04-01

    Little information has been reported on the antitumor effects of the diterpenoid alkaloid constituents of Aconitum plants, used in the herbal drug 'bushi'. This study was aimed at determining the antitumor activities of Aconitum C19-and C20-diterpenoid alkaloids and synthetic derivatives against lung (A549), prostate (DU145), nasopharyngeal (KB), and vincristine-resistant nasopharyngeal (KB-VIN) cancer cell lines. Newly synthesized C20-diterpenoid alkaloid derivatives showed substantial suppressive effects against all human tumor cell lines tested. In contrast, natural and derivatized C19-diterpenoid alkaloids showed only a slight or no effect. Most of the active compounds were hetisine-type C20-diterpenoid alkaloids, specifically kobusine and pseudokobusine analogs with two different substitution patterns, C-11 and C-11,15. Notably, several C20-diterpenoid alkaloids were more potent against multidrug-resistant KB subline KB-VIN cells. Pseudokobusine 11-3'-trifluoromethylbenzoate (94) is a possible promising new lead meriting additional evaluation against multidrug-resistant tumors.

  1. 21 CFR 570.20 - General principles for evaluating the safety of food additives.

    Science.gov (United States)

    2010-04-01

    ... food additives. 570.20 Section 570.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVES Food Additive Safety § 570.20 General principles for evaluating the safety of food additives. (a) In reaching...

  2. 29 CFR 1960.11 - Evaluation of occupational safety and health performance.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Evaluation of occupational safety and health performance. 1960.11 Section 1960.11 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL...

  3. Occupational Safety and Health Professionals' Training in Italy: Qualitative Evaluation Using T-LAB

    Science.gov (United States)

    Papaleo, Bruno; Cangiano, Giovanna; Calicchia, Sara

    2013-01-01

    Purpose: The purpose of this paper is to describe the evaluation of a training course on chemicals for occupational safety and health (OSH) professionals. The study aims were to assess the effectiveness of the course; to find out what type of training met these workers' needs best, as their role is vital in the management of safety at work; and to…

  4. 29 CFR 1960.79 - Self-evaluations of occupational safety and health programs.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Self-evaluations of occupational safety and health programs. 1960.79 Section 1960.79 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) BASIC PROGRAM ELEMENTS FOR FEDERAL EMPLOYEE OCCUPATIONAL...

  5. Short-term and area-wide evaluation of safety measures.

    NARCIS (Netherlands)

    Oppe, S. & Wegman, F.C.M.

    1982-01-01

    A background paper for the seminar on short-term and area-wide evaluation of safety measures is presented. The seminar is restricted to safety measures, thus only countermeasures that are intended to reduce accidents are regarded. The measures should be furthermore for the short-term and area-wide.

  6. 21 CFR 170.20 - General principles for evaluating the safety of food additives.

    Science.gov (United States)

    2010-04-01

    ... food additives. 170.20 Section 170.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.20 General principles for evaluating the safety of food additives. (a) In reaching...

  7. Development of an Evaluation Tool for Online Food Safety Training Programs

    Science.gov (United States)

    Neal, Jack A., Jr.; Murphy, Cheryl A.; Crandall, Philip G.; O'Bryan, Corliss A.; Keifer, Elizabeth; Ricke, Steven C.

    2011-01-01

    The objective of this study was to provide the person in charge and food safety instructors an assessment tool to help characterize, identify strengths and weaknesses, determine the completeness of the knowledge gained by the employee, and evaluate the level of content presentation and usability of current retail food safety training platforms. An…

  8. Safety evaluation of an α-cyclodextrin glycosyltranferase preparation

    NARCIS (Netherlands)

    Bär, A.; Krul, C.A.M.; Jonker, D.; Vogel, N. de

    2004-01-01

    Alpha-cyclodextrin glucosyltransferase (α-CGTase, EC 2.4.1.19) is an amylolytic enzyme used for the production of α-cyclodextrin (α-CD), a novel, soluble dietary fiber, from food-grade starch. The safety of an α-CGTase preparation obtained by batch fermentation from a recombinant strain of Escherich

  9. An Energy-Based Safety Evaluation Index of Blast Vibration

    Directory of Open Access Journals (Sweden)

    Mingsheng Zhao

    2015-01-01

    Full Text Available The combined peak particle velocity (PPV and frequency safety criterion for blast vibration is widely used in blasting engineering. However, some field investigations are inconsistent with this criterion. On the basis of field investigations, it is found that there are two failure modes of structures subjected to blasting seismic waves, that is, first-excursion failure and cumulative plastic damage failure. Moreover, the nature of structural responses under blast vibrations is a process of energy input, transformation, and dissipation. Therefore, an energy-based dual safety standard is proposed in this work to more comprehensively explain all failure modes of structures under blast vibrations. To this end, structures are simplified into elastic-plastic single degree of freedom (SDOF systems with bilinear restoring force models, and energy responses of SDOF systems are then determined using the Newmark-β method. From the energy responses, the maximum instantaneous input energy and hysteretic energy are selected as the basis of the dual safety criterion, because they can reflect first-excursion failure and cumulative plastic damage failure, respectively. Finally, field investigations in a blasting site in Zunyi, Guizhou province, China, are used to prove that compared to the PPV-frequency criterion the proposed energy-based dual safety criterion is more capable of assessing the damage potential of blast vibrations.

  10. Economic evaluation of safety measures for transport companies

    NARCIS (Netherlands)

    Rietveld, Piet; Rienstra, Sytze A.

    1998-01-01

    Measures to reduce material damage within companies may both increase the business economic performance of the company and traffic safety in general. In this paper the notion of whether such measures are economically feasible is investigated. Results are presented of a series of interviews amongtran

  11. Discovery and Evaluation of Thiazinoquinones as Anti-Protozoal Agents

    Directory of Open Access Journals (Sweden)

    Marcel Kaiser

    2013-09-01

    Full Text Available Pure compound screening has identified the dioxothiazino-quinoline-quinone ascidian metabolite ascidiathiazone A (2 to be a moderate growth inhibitor of Trypanosoma brucei rhodesiense (IC50 3.1 μM and Plasmodium falciparum (K1 dual drug resistant strain (IC50 3.3 μM while exhibiting low levels of cytotoxicity (L6, IC50 167 μM. A series of C-7 amide and Δ2(3 analogues were prepared that explored the influence of lipophilicity and oxidation state on observed anti-protozoal activity and selectivity. Little variation in anti-malarial potency was observed (IC50 0.62–6.5 μM, and no correlation was apparent between anti-malarial and anti-T. brucei activity. Phenethylamide 7e and Δ2(3-glycine analogue 8k exhibited similar anti-Pf activity to 2 but with slightly enhanced selectivity (SI 72 and 93, respectively, while Δ2(3-phenethylamide 8e (IC50 0.67 μM, SI 78 exhibited improved potency and selectivity towards T. brucei rhodesiense compared to the natural product hit. A second series of analogues were prepared that replaced the quinoline ring of 2 with benzofuran or benzothiophene moieties. While esters 10a/10b and 15 were once again found to exhibit cytotoxicity, carboxylic acid analogues exhibited potent anti-Pf activity (IC50 0.34–0.035 μM combined with excellent selectivity (SI 560–4000. In vivo evaluation of a furan carboxylic acid analogue against P. berghei was undertaken, demonstrating 85.7% and 47% reductions in parasitaemia with ip or oral dosing respectively.

  12. Analysis on evaluation ability of nonlinear safety assessment model of coal mines based on artificial neural network

    Institute of Scientific and Technical Information of China (English)

    SHI Shi-liang; LIU Hai-bo; LIU Ai-hua

    2004-01-01

    Based on the integration analysis of goods and shortcomings of various methods used in safety assessment of coal mines, combining nonlinear feature of mine safety sub-system, this paper establishes the neural network assessment model of mine safety, analyzes the ability of artificial neural network to evaluate mine safety state, and lays the theoretical foundation of artificial neural network using in the systematic optimization of mine safety assessment and getting reasonable accurate safety assessment result.

  13. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: a contemporary evaluation

    Directory of Open Access Journals (Sweden)

    Mary E. Westerman

    Full Text Available ABSTRACT Introduction: Hemorrhagic cystitis (HC represents a challenging clinical entity. While various intravesical agents have been utilized in this setting, limited data exist regarding safety or efficacy. Herein, then, we evaluated the effectiveness and complications associated with intravesical alum instillation for HC in a contemporary cohort. Materials and Methods: We identified 40 patients treated with intravesical alum for HC between 1997-2014. All patients had failed previous continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation. Results: Median patient age was 76.5 years (IQR 69, 83. Pelvic radiation was the most common etiology for HC (n=38, 95%. Alum use decreased patient's transfusion requirement, with 82% (32/39 receiving a transfusion within 30 days before alum instillation (median 4 units versus 59% (23/39 within 30 days after completing alum (median 3 units (p=0.05. In total, 24 patients (60% required no additional therapy prior to hospital discharge. Moreover, at a median follow-up of 17 months (IQR 5, 38.5, 13 patients (32.5% remained without additional treatment for HC. Adverse effects were reported in 15 patients (38%, with bladder spasms representing the most common event (14/40; 35%. No clinical evidence of clinically significant systemic absorption was detected. Conclusion: Intravesical alum therapy is well-tolerated, with resolution of HC in approximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC.

  14. Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

    Science.gov (United States)

    Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

    2017-01-01

    Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

  15. [Safety evaluation of food from transgenic fish and the molecular biological mechanism].

    Science.gov (United States)

    Zhang, Xichun; Yang, Xiaoguang

    2004-03-01

    More progresses have been made in the studying of transgenic fish in China, but the studying work of safety evaluation of food from transgenic fish are started up just now. Compared to plants and animals on the land, it is more difficult to control the mobility of fish and fish can give birth to a large number of offsprings, so the ecological risk or hazard about transgenic fish is more critical than others. Another safety problem is the chimerism which is initiated by the gene transfer methods used in the transgenic fish. Getting sterile triploid transgenic fish and fixed point integration are efficient to solve the two problems above respectively. The solution of the two problems are also the basis of safety evaluation and detection of food from transgenic fish. Up to now, there are little reports on the safety evaluation of transgenic fish including nutritional evaluation and allergic reaction, and there are no basic research on the detection of transgenic fish for the aim of food safety. In brief, it is very urgent to start up the research on the safety evaluation and detection of transgenic fish for the control of food safety.

  16. Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?

    NARCIS (Netherlands)

    Kooijman, M.; Meer, P.J.K. van; Moors, E.H.M.; Schellekens, H.

    2012-01-01

    Introduction: The first biopharmaceuticals were developed 30 years ago. Biopharmaceuticals differ significantly from small molecule therapeutics (SMTs). Because of such differences, it was expected that classical preclinical safety evaluation procedures applied to SMTs would not predict the adverse

  17. Evaluation of safety margins during dry storage of CANDU fuel in MACSTOR/KN-400 module

    Energy Technology Data Exchange (ETDEWEB)

    Beaudoin, R.; Shill, R. [Atomic Energy Of Canada Limited, Montreal, Quebec (Canada); Lee, K.-H.; Chung, S.-H.; Yoon, J.-H.; Choi, B.-I.; Lee, H.-Y.; Song, M.-J. [KHNP, Nuclear Environment Technology Inst., Taejon (Korea, Republic of)

    2005-03-15

    This paper covers an evaluation of the available safety margin against fuel bundle degradation during dry storage of CANDU spent fuel bundles in a MACSTOR/KN-400 module, considering normal, off-normal and postulated accidental conditions. (author)

  18. Active Tectonic Research for Seismic Safety Evaluation of Long-Line Engineering Sites in China

    Institute of Scientific and Technical Information of China (English)

    Ran Yongkang; Chen Lichun

    2005-01-01

    Long-line engineering sites usually have to pass through active tectonics, so the research of active tectonics is of great importance to seismic safety evaluation of this sort of site. In the paper, basing on the summarization and analysis of the requirements for seismic safety evaluation of long-line engineering site and the status quo of active tectonics research, we propose the focal points of active tectonics research for seismic safety evaluation of long-line engineering sites, including the research contents, technical targets and routes, and the submission of the achievements, etc. Finally, we make a preliminary analysis and discussion about the problems existing in the present-day active tectonics research for seismic safety evaluation of long-line engineering sites.

  19. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Science.gov (United States)

    2012-05-31

    ... possess and use source material for a fluorine extraction and depleted uranium deconversion facility. The... COMMISSION Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction Process and Depleted Uranium Deconversion Plan, Lea County, NM AGENCY: Nuclear Regulatory...

  20. Evaluation of the immunogenicity and safety of Brucella melitensis B115 vaccination in pregnant sheep.

    Science.gov (United States)

    Pérez-Sancho, Marta; Adone, Rosanna; García-Seco, Teresa; Tarantino, Michaela; Diez-Guerrier, Alberto; Drumo, Rosanna; Francia, Massimiliano; Domínguez, Lucas; Pasquali, Paolo; Álvarez, Julio

    2014-04-01

    In spite of its limitations, Rev.1 is currently recognized as the most suitable vaccine against Brucella melitensis (the causative agent of ovine and caprine brucellosis). However, its use is limited to young animals when test-and-slaughter programs are in place because of the occurrence of false positive-reactions due to Rev.1 vaccination. The B. melitensis B115 rough strain has demonstrated its efficacy against B. melitensis virulent strains in the mouse model, but there is a lack of information regarding its potential use in small ruminants for brucellosis control. Here, the safety and immune response elicited by B115 strain inoculation were evaluated in pregnant ewes vaccinated at their midpregnancy. Vaccinated (n=8) and non-vaccinated (n=3) sheep were periodically sampled and analyzed for the 108 days following inoculations using tests designed for the detection of the response elicited by the B115 strain and routine serological tests for brucellosis [Rose Bengal Test (RBT), Complement Fixation Test (CFT) and blocking ELISA (ELISAb)]. Five out of the 8 vaccinated animals aborted, indicating a significant abortifacient effect of B115 inoculation at midpregnancy. In addition, a smooth strain was recovered from one vaccinated animal, suggesting the occurrence of an in vivo reversion phenomenon. Only one animal was positive in both RBT and CFT simultaneously (91 days after vaccination) confirming the lack of induction of cross-reacting antibody responses interfering with routine brucellosis diagnostic tests in most B115-vaccinated animals.

  1. Safety evaluation of Phytovagex, a pessary formulation of Nigella sativa, on pregnant rats

    Directory of Open Access Journals (Sweden)

    Reza Salarinia

    2016-01-01

    Full Text Available Objective: The possible toxicity of drugs in pregnancy should be tested before their use in pregnant patients. In the present study, we aimed to evaluate the safety of phytovagex, a pessary formulation of Nigella sativa (N. sativa, which is already in clinical use for vaginal fungal infection. Materials and Methods: The pregnant rats were treated intravaginal with physiological saline (vehicle or phytovagex pessary in the first half of their pregnancy (days 1 to 10 of gestation. Duration of pregnancy and health parameters of the newborns were recorded after parturition. Also, cytotoxicity of N. sativa hydroalcoholic extract was tested against ovary Cho cells.  Results: The phytovagex had no significant effect on the duration of pregnancy, number of newborns, weight of neonates, and percent of stillbirth. No deformity or general behavioral abnormality was observed in neonates monitored for 30 days after birth. N. sativa extract had no significant effect on the viability of ovary cells at the concentrations of 12.5-200 µg/mL. Conclusion: Results of this animal study showed that phytovagex has no overall effect on the duration of pregnancy and health parameters of the newborns. Also, its active agent, N. sativa, does not induce any cytotoxic effect on ovary cells.

  2. PERFORMANCE EVALUATION FOR DAMPING CONTROLLERS OF POWER SYSTEMS BASED ON MULTI-AGENT MODELS

    Institute of Scientific and Technical Information of China (English)

    Ancheng XUE; Yiguang HONG

    2009-01-01

    This paper proposes a multi-layer multi-agent model for the performance evaluation of power systems, which is different from the existing multi-agent ones. To describe the impact of the structure of the networked power system, .the proposed model consists of three kinds of agents that form three layers: control agents such as the generators and associated controllers, information agents to exchange the information based on the wide area measurement system (WAMS) or transmit control signals to the power system stabilizers (PSSs), and network-node agents such as the generation nodes and load nodes connected with transmission lines. An optimal index is presented to evaluate the performance of damping controllers to the system's inter-area oscillation with respect to the information-layer topology.Then, the authors show that the inter-area information exchange is more powerful than the exchange within a given area to control the inter-area low frequency oscillation based on simulation analysis.

  3. Passive Safety Features Evaluation of KIPT Neutron Source Facility

    Energy Technology Data Exchange (ETDEWEB)

    Zhong, Zhaopeng [Argonne National Lab. (ANL), Argonne, IL (United States); Gohar, Yousry [Argonne National Lab. (ANL), Argonne, IL (United States)

    2016-06-01

    Argonne National Laboratory (ANL) of the United States and Kharkov Institute of Physics and Technology (KIPT) of Ukraine have cooperated on the development, design, and construction of a neutron source facility. The facility was constructed at Kharkov, Ukraine and its commissioning process is underway. It will be used to conduct basic and applied nuclear research, produce medical isotopes, and train young nuclear specialists. The facility has an electron accelerator-driven subcritical assembly. The electron beam power is 100 kW using 100 MeV electrons. Tungsten or natural uranium is the target material for generating neutrons driving the subcritical assembly. The subcritical assembly is composed of WWR-M2 - Russian fuel assemblies with U-235 enrichment of 19.7 wt%, surrounded by beryllium reflector assembles and graphite blocks. The subcritical assembly is seated in a water tank, which is a part of the primary cooling loop. During normal operation, the water coolant operates at room temperature and the total facility power is ~300 KW. The passive safety features of the facility are discussed in in this study. Monte Carlo computer code MCNPX was utilized in the analyses with ENDF/B-VII.0 nuclear data libraries. Negative reactivity temperature feedback was consistently observed, which is important for the facility safety performance. Due to the design of WWR-M2 fuel assemblies, slight water temperature increase and the corresponding water density decrease produce large reactivity drop, which offset the reactivity gain by mistakenly loading an additional fuel assembly. The increase of fuel temperature also causes sufficiently large reactivity decrease. This enhances the facility safety performance because fuel temperature increase provides prompt negative reactivity feedback. The reactivity variation due to an empty fuel position filled by water during the fuel loading process is examined. Also, the loading mistakes of removing beryllium reflector assemblies and

  4. Evaluation of food safety management systems in Serbian dairy industry

    OpenAIRE

    Igor Tomašević; Nada Šmigić; Ilija Đekić; Vlade Zarić; Nikola Tomić; Jelena Miocinovic; Andreja Rajković

    2016-01-01

    This paper reports incentives, costs, difficulties and benefits of food safety management systems implementation in the Serbian dairy industry. The survey involved 27 food business operators with the national milk and dairy market share of 65 %. Almost two thirds of the assessed dairy producers (70.4 %) claimed that they had a fully operational and certified HACCP system in place, while 29.6 % implemented HACCP, but had no third party certification. ISO 22000 was implemented and certified in ...

  5. Modification of JRR-4 based on safety evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Izumo, Hironobu; Nakajima, Teruo; Funayama, Yoshiro [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-10-01

    Since the first criticality was achieved on January 28, 1965, JRR-4 has been operated safely until on January 12, 1996. The modification of JRR-4 was planned according to the framework of reduced enrichment on research reactor program. The modification was designed based on the several national safety guides. JRR-4 has some modifications of facilities to satisfy the guides and guides criteria. (author)

  6. Metals in cosmetics: an a posteriori safety evaluation.

    Science.gov (United States)

    Marinovich, Marina; Boraso, Maria Serena; Testai, Emanuela; Galli, Corrado L

    2014-08-01

    According to EU Regulation No. 1223/2009/CE cosmetic products for daily use can contain 'technically unavoidable traces' of metals. This definition is too vague. Authorities should set well-defined limits, considering the risks associated with metal contamination of personal care products (PCPs). This paper characterizes the risk arising from a number of metals (antimony, arsenic, cadmium, cobalt, chromium, mercury, nickel, lead) that may occur in 'unavoidable traces" in raw materials and, consequently, in PCPs. A 'worst case scenario' was adopted, based on the following assumptions: (i) the individual ingredients contained the maximum amount in traces allowed for each metal; (ii) the hypothetical PCP was produced exclusively with that single ingredient; (iii) when absorption through the skin was not known, data related to oral absorption were used. Risk characterization was performed calculating the Systemic Exposure Dosage (SED) and the Margin of Safety (MoS=NOAEL or BMDL10/SED). Exposure to the allegedly 'technically unavoidable' maximum amounts of metals in cosmetic ingredients resulted in MoSs exceeding 100 (safety threshold) with one exception. This suggests that the availability of experimental dermal absorption rates could enable significant improvement in MoS, thus increasing safety levels. Although results are reassuring, the authors recommend minimization of contamination, according to the state of the art of manufacturing methods.

  7. Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?

    OpenAIRE

    Kooijman, M.; van Meer, P.J.K.; E. H. M. MOORS; Schellekens, H.

    2012-01-01

    Introduction: The first biopharmaceuticals were developed 30 years ago. Biopharmaceuticals differ significantly from small molecule therapeutics (SMTs). Because of such differences, it was expected that classical preclinical safety evaluation procedures applied to SMTs would not predict the adverse effects of biopharmaceuticals. Therefore, until sufficient experience was gained, the preclinical safety evaluation of biopharmaceuticals was carried out on a case-by-case basis. 30 years of experi...

  8. Criticality Safety Evaluation of Hanford Site High Level Waste Storage Tanks

    Energy Technology Data Exchange (ETDEWEB)

    ROGERS, C.A.

    2000-02-17

    This criticality safety evaluation covers operations for waste in underground storage tanks at the high-level waste tank farms on the Hanford site. This evaluation provides the bases for criticality safety limits and controls to govern receipt, transfer, and long-term storage of tank waste. Justification is provided that a nuclear criticality accident cannot occur for tank farms operations, based on current fissile material and operating conditions.

  9. A New Method for the Evaluation of Vaccine Safety Based on Comprehensive Gene Expression Analysis

    Directory of Open Access Journals (Sweden)

    Haruka Momose

    2010-01-01

    Full Text Available For the past 50 years, quality control and safety tests have been used to evaluate vaccine safety. However, conventional animal safety tests need to be improved in several aspects. For example, the number of test animals used needs to be reduced and the test period shortened. It is, therefore, necessary to develop a new vaccine evaluation system. In this review, we show that gene expression patterns are well correlated to biological responses in vaccinated rats. Our findings and methods using experimental biology and genome science provide an important means of assessment for vaccine toxicity.

  10. Evaluation Model for Capability of Enterprise Agent Coalition Based on Information Fusion and Attribute Reduction

    Institute of Scientific and Technical Information of China (English)

    Dongjun Liu; Li Li; and Jiayang Wang

    2016-01-01

    For the issue of evaluation of capability of enterprise agent coalition, an evaluation model based on information fusion and entropy weighting method is presented. The attribute reduction method is utilized to reduce indicators of the capability according to the theory of rough set. The new indicator system can be determined. Attribute reduction can also reduce the workload and remove the redundant information, when there are too many indicators or the indicators have strong correlation. The research complexity can be reduced and the efficiency can be improved. Entropy weighting method is used to determine the weights of the remaining indicators, and the importance of indicators is analyzed. The information fusion model based on nearest neighbor method is developed and utilized to evaluate the capability of multiple agent coalitions, compared to cloud evaluation model and D-S evidence method. Simulation results are reasonable and with obvious distinction. Thus they verify the effectiveness and feasibility of the model. The information fusion model can provide more scientific, rational decision support for choosing the best agent coalition, and provide innovative steps for the evaluation process of capability of agent coalitions.

  11. A Web-based Alternative Non-animal Method Database for Safety Cosmetic Evaluations.

    Science.gov (United States)

    Kim, Seung Won; Kim, Bae-Hwan

    2016-07-01

    Animal testing was used traditionally in the cosmetics industry to confirm product safety, but has begun to be banned; alternative methods to replace animal experiments are either in development, or are being validated, worldwide. Research data related to test substances are critical for developing novel alternative tests. Moreover, safety information on cosmetic materials has neither been collected in a database nor shared among researchers. Therefore, it is imperative to build and share a database of safety information on toxicological mechanisms and pathways collected through in vivo, in vitro, and in silico methods. We developed the CAMSEC database (named after the research team; the Consortium of Alternative Methods for Safety Evaluation of Cosmetics) to fulfill this purpose. On the same website, our aim is to provide updates on current alternative research methods in Korea. The database will not be used directly to conduct safety evaluations, but researchers or regulatory individuals can use it to facilitate their work in formulating safety evaluations for cosmetic materials. We hope this database will help establish new alternative research methods to conduct efficient safety evaluations of cosmetic materials.

  12. Pooling, meta-analysis, and the evaluation of drug safety

    Directory of Open Access Journals (Sweden)

    Leizorovicz Alain

    2002-03-01

    Full Text Available Abstract Background The "integrated safety report" of the drug registration files submitted to health authorities usually summarizes the rates of adverse events observed for a new drug, placebo or active control drugs by pooling the safety data across the trials. Pooling consists of adding the numbers of events observed in a given treatment group across the trials and dividing the results by the total number of patients included in this group. Because it considers treatment groups rather than studies, pooling ignores validity of the comparisons and is subject to a particular kind of bias, termed "Simpson's paradox." In contrast, meta-analysis and other stratified analyses are less susceptible to bias. Methods We use a hypothetical, but not atypical, application to demonstrate that the results of a meta-analysis can differ greatly from those obtained by pooling the same data. In our hypothetical model, a new drug is compared to 1 a placebo in 4 relatively small trials in patients at high risk for a certain adverse event and 2 an active reference drug in 2 larger trials of patients at low risk for this event. Results Using meta-analysis, the relative risk of experiencing the adverse event with the new drug was 1.78 (95% confidence interval [1.02; 3.12] compared to placebo and 2.20 [0.76; 6.32] compared to active control. By pooling the data, the results were, respectively, 1.00 [0.59; 1.70] and 5.20 [2.07; 13.08]. Conclusions Because these findings could mislead health authorities and doctors, regulatory agencies should require meta-analyses or stratified analyses of safety data in drug registration files.

  13. High speed railway environment safety evaluation based on measurement attribute recognition model.

    Science.gov (United States)

    Hu, Qizhou; Gao, Ningbo; Zhang, Bing

    2014-01-01

    In order to rationally evaluate the high speed railway operation safety level, the environmental safety evaluation index system of high speed railway should be well established by means of analyzing the impact mechanism of severe weather such as raining, thundering, lightning, earthquake, winding, and snowing. In addition to that, the attribute recognition will be identified to determine the similarity between samples and their corresponding attribute classes on the multidimensional space, which is on the basis of the Mahalanobis distance measurement function in terms of Mahalanobis distance with the characteristics of noncorrelation and nondimensionless influence. On top of the assumption, the high speed railway of China environment safety situation will be well elaborated by the suggested methods. The results from the detailed analysis show that the evaluation is basically matched up with the actual situation and could lay a scientific foundation for the high speed railway operation safety.

  14. Study on development of education model and its evaluation system for radiation safety

    CERN Document Server

    Seo, K W; Nam, Y M

    2002-01-01

    As one of the detailed action strategy of multi object preparedness for strengthening of radiation safety management by MOST, this project was performed, in order to promote the safety culture for user and radiation worker through effective education program. For the prevention of radiological accident and effective implementation of radiation safety education and training, this project has been carried out the development of education model and its evaluation system on radiation safety. In the development of new education model, education course was classified; new and old radiation worker, temporary worker, lecturer and manager. The education model includes the contents of expanding the education opportunity and workplace training. In the development of evaluation system, the recognition criteria for commission-education institute and inside-education institute which should establish by law were suggested for evaluation program. The recognition criteria contains classification, student, method, facilities, ...

  15. Food Safety Evaluation Based on Near Infrared Spectroscopy and Imaging: A Review.

    Science.gov (United States)

    Fu, Xiaping; Ying, Yibin

    2016-08-17

    In recent years, due to the increasing consciousness of food safety and human health, much progress has been made in developing rapid and nondestructive techniques for the evaluation of food hazards, food authentication, and traceability. Near infrared (NIR) spectroscopy and imaging techniques have gained wide acceptance in many fields because of their advantages over other analytical techniques. Following a brief introduction of NIR spectroscopy and imaging basics, this review mainly focuses on recent NIR spectroscopy and imaging applications for food safety evaluation, including (1) chemical hazards detection; (2) microbiological hazards detection; (3) physical hazards detection; (4) new technology-induced food safety concerns; and (5) food traceability. The review shows NIR spectroscopy and imaging to be effective tools that will play indispensable roles for food safety evaluation. In addition, on-line/real-time applications of these techniques promise to be a huge growth field in the near future.

  16. High Speed Railway Environment Safety Evaluation Based on Measurement Attribute Recognition Model

    Directory of Open Access Journals (Sweden)

    Qizhou Hu

    2014-01-01

    Full Text Available In order to rationally evaluate the high speed railway operation safety level, the environmental safety evaluation index system of high speed railway should be well established by means of analyzing the impact mechanism of severe weather such as raining, thundering, lightning, earthquake, winding, and snowing. In addition to that, the attribute recognition will be identified to determine the similarity between samples and their corresponding attribute classes on the multidimensional space, which is on the basis of the Mahalanobis distance measurement function in terms of Mahalanobis distance with the characteristics of noncorrelation and nondimensionless influence. On top of the assumption, the high speed railway of China environment safety situation will be well elaborated by the suggested methods. The results from the detailed analysis show that the evaluation is basically matched up with the actual situation and could lay a scientific foundation for the high speed railway operation safety.

  17. Synthesis and biological evaluation of andrographolide derivatives as potent anti-HIV agents

    Institute of Scientific and Technical Information of China (English)

    Bin Wang; Jing Li; Wen Long Huang; Hui Bin Zhang; Hai Qian; Yong Tang Zheng

    2011-01-01

    A series of Andro derivatives were described and evaluated for their anti-HIV activity in vitro. Compound 10 and 16b, of which TI were >10, had some anti-HTV-1 activity in vitro. Therein, compound 10 which was the best potent compound, could serve as a new lead for further development of anti-AIDS agents.

  18. A Teachable-Agent-Based Game Affording Collaboration and Competition: Evaluating Math Comprehension and Motivation

    Science.gov (United States)

    Pareto, Lena; Haake, Magnus; Lindstrom, Paulina; Sjoden, Bjorn; Gulz, Agneta

    2012-01-01

    This paper presents an educational game in mathematics based on an apprenticeship model using a teachable agent, as well as an evaluative study of how the game affects (1) conceptual understanding and (2) attitudes towards mathematics. In addition, we discuss how collaborative and competitive affordances of the game may affect understanding and…

  19. Synthesis and preliminary cytotoxic evaluation of substituted indoles as potential anticancer agents

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    A variety of indole derivatives were designed, synthesized and preliminarily evaluated for their in vitro cytotoxic activity in the A431 and H460 cell lines. All the compounds examined conferred unusual potency in a tumor cell cytotoxicity assay. The findings showed the indole derivatives would be a promising candidate for the development of new anticancer agents.

  20. A Qualitative Evaluation of Social Support by an Empathic Agent (abstract)

    NARCIS (Netherlands)

    Van der Zwaan, J.M.; Dignum, M.V.; Jonker, C.M.

    2013-01-01

    This paper presents a qualitative study of the supportive behavior of an Embodied Conversational Agent (ECA) that provides social support to cyberbullying victims. The results indicate that social support is conveyed. In addition, we demonstrate a method that can be utilized to evaluate embodied age

  1. Exposure Factor considerations for safety evaluation of modern disposable diapers.

    Science.gov (United States)

    Dey, Swatee; Purdon, Mike; Kirsch, Taryn; Helbich, HansMartin; Kerr, Kenny; Li, Lijuan; Zhou, Shaoying

    2016-11-01

    Modern disposable diapers are complex products and ubiquitous globally. A robust safety assessment for disposable diapers include two important exposure parameters, i) frequency of diaper use & ii) constituent transfer from diaper to skin from direct and indirect skin contact materials. This article uses published information and original studies to quantify the exposure parameters for diapers. Using growth tables for the first three years of diapered life, an average body weight of 10-11 kg can be calculated, with a 10th percentile for females (8.5-8.8 kg). Data from surveys and diary studies were conducted to determine the frequency of use of diapers. The overall mean in the US is 4.7 diapers per day with a 75th, 90th, and 95th percentile of 5.0, 6.0, and 7.0 respectively. Using diaper topsheet-lotion transfer as a model, direct transfer to skin from the topsheet was 3.0-4.3% of the starting amount of lotion. Indirect transfer of diaper core materials as a measure of re-wetting of the skin via urine resurfacing back to the topsheet under pressure was estimated at a range of 0.32-0.66% averaging 0.46%. As described, a thorough data-based understanding of exposure is critical for a robust exposure based safety assessment of disposable diapers.

  2. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  3. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  4. Evaluation of patient safety culture among Malaysian retail pharmacists: results of a self-reported survey

    Directory of Open Access Journals (Sweden)

    Sivanandy P

    2016-07-01

    Full Text Available Palanisamy Sivanandy,1 Mari Kannan Maharajan,1 Kingston Rajiah,1 Tan Tyng Wei,2 Tan Wee Loon,2 Lim Chong Yee2 1Department of Pharmacy Practice, School of Pharmacy, 2School of Pharmacy, International Medical University, Wilayah Persekutuan Kuala Lumpur, Malaysia Background: Patient safety is a major public health issue, and the knowledge, skills, and experience of health professionals are very much essential for improving patient safety. Patient safety and medication error are very much associated. Pharmacists play a significant role in patient safety. The function of pharmacists in the medication use process is very different from medical and nursing colleagues. Medication dispensing accuracy is a vital element to ensure the safety and quality of medication use.Objective: To evaluate the attitude and perception of the pharmacist toward patient safety in retail pharmacies setup in Malaysia.Methods: A Pharmacy Survey on Patient Safety Culture questionnaire was used to assess patient safety culture, developed by the Agency for Healthcare Research and Quality, and the convenience sampling method was adopted.Results: The overall positive response rate ranged from 31.20% to 87.43%, and the average positive response rate was found to be 67%. Among all the eleven domains pertaining to patient safety culture, the scores of “staff training and skills” were less. Communication openness, and patient counseling are common, but not practiced regularly in the Malaysian retail pharmacy setup compared with those in USA. The overall perception of patient safety of an acceptable level in the current retail pharmacy setup.Conclusion: The study revealed that staff training, skills, communication in patient counseling, and communication across shifts and about mistakes are less in current retail pharmacy setup. The overall perception of patient safety should be improved by educating the pharmacists about the significance and essential of patient safety. Keywords

  5. Comparative evaluation of microleakage of newer generation dentin bonding agents: An in vitro study

    Directory of Open Access Journals (Sweden)

    Rani Somani

    2016-01-01

    Full Text Available Context: Adhesive dentistry has been progressing with rapid pace over the past decade. Composite resin is the most esthetic restorative material currently available for restoring teeth. In spite of it being in use since a decade, still failure cases are seen which are mainly due to polymerization shrinkage and subsequent inadequate adhesion to cavity walls, leading to microleakage. Various generations of dentin bonding agents have been introduced to overcome the shortcoming of composite resin. Aims: To determine the microleakage of the 6 th , 7 th , and 8 th generation dentin bonding agents. Materials and Methods: Forty-five extracted human premolars were taken for the study. Standardized Class V cavities were prepared on all the teeth. The samples were divided into three groups according to the generation of bonding agent used. Group I was bonded with the 6 th generation, Group II with the 7 th generation, and Group III with the 8 th generation dentin bonding agent. All the Class V preparations were restored with a nano-ceramic composite restorative (Ceram X. The samples were then thermocycled between 5 and 55 ± 2°C for 100 cycles and immersed in 2% methylene blue for 48 h for evaluation of microleakage under a stereomicroscope. Statistical Analysis Used: The data was statistically analyzed using Kruskal-Wallis nonparametric analysis, and Mann-Whitney U-test was applied to compare the various groups. Results: The microleakage value was the highest in Group II (7 th generation bonding agent followed by Group I (6 th generation bonding agent and least in Group III (8 th generation bonding agent. Conclusions: The 8 th generation dentin bonding showed statistically significant results in terms of lesser microleakage as compared to the 6 th and 7 th generation dentin bonding agents.

  6. Assessment of the global trigger tool to measure, monitor and evaluate pateint safety in cancer patients

    DEFF Research Database (Denmark)

    Otto Mattsson, Thea; Lehmann-Knudsen, Janne; Lauritsen, Jens M

    2013-01-01

    BACKGROUND: Countries around the world are currently aiming to improve patient safety by means of the Institute for Healthcare Improvement global trigger tool (GTT), which is considered a valid tool for evaluating and measuring patient safety within organisations. So far, only few data....... RESULTS: Only 31% of adverse events (AE) were identified by both teams, and further differences in categorisation of identical events was found. Moderate interrater agreement (κ=0.45) between teams gave rise to different conclusions on the patient safety process when monitoring using SPC charts. The Bland......-Altman plot suggests little systematic error but large random error. CONCLUSIONS: Review teams may identify different AE and reach different conclusions on the safety process when using the GTT on identical charts. Tracking true change in the safety level is difficult due to measurement error of the GTT...

  7. Safety evaluation of a xylanase expressed in Bacillus subtilis.

    Science.gov (United States)

    Harbak, L; Thygesen, H V

    2002-01-01

    A programme of studies was conducted to establish the safety of a xylanase expressed in a self-cloned strain of Bacillus subtilis to be used as a processing aid in the baking industry. To assess acute and subchronic oral toxicity, rat feeding studies were conducted. In addition, the potential of the enzyme to cause mutagenicity and chromosomal aberrations was assessed in microbial and tissue culture in vitro studies. Acute and subchronic oral toxicity was not detected at the highest dose recommended by OECD guidelines. There was no evidence of mutagenic potential or chromosomal aberrations. Furthermore, the organism used for production of the xylanase is already accepted as safe by several major national regulatory agencies.

  8. Evaluation of motorcycle safety strategies using the severity of injuries.

    Science.gov (United States)

    Jung, Soyoung; Xiao, Qin; Yoon, Yoonjin

    2013-10-01

    The growth of motorcycle fatalities in California has been especially prominent, specifically with regard to the 24 and under age group and those aged 45-54. This research quantitatively examined factors associated with motorcyclist fatalities and assessed strategies that could improve motorcyclist safety, specifically focusing on the two age groups mentioned above. Severity of injury was estimated separately for both age groups with multinomial logit models and pseudo-elasticity using motorcycle-related collision data that was collected between 2005 and 2009. The results were compared with motorcyclists aged 35-44, a group that shows a consistent trend of fatalities. This research found that lack or improper use of helmets, victim ejection, alcohol/drug effects, collisions (head-on, broadside, hit-object), and truck involvement were more likely to result in fatal injuries regardless of age group. Weekend and non-peak hour activity was found to have a strong effect in both the younger and older age groups. Two factors, movement of running off the road preceding a collision and multi-vehicle involvement, were found to be statistically significant factors in increasing older motorcyclist fatalities. Use of street lights in the dark was found to decrease the probability of severe injury for older motorcyclists. Driver type of victim, at-fault driver, local road, and speed violation were significant factors in increasing the fatalities of younger motorcyclists. Road conditions and collision location factors were not found to be statistically significant to motorcyclist fatalities. Based on the statistically significant factors identified in this research, the following safety strategies appear to be effective methods of reducing motorcyclist fatalities: public education of alcohol use, promoting helmet use, enforcing heavy vehicle and speed violations, improving roadway facilities, clearer roadway guidance and street lighting systems, and motorcyclist training.

  9. Evaluation of three percent Aqueous Film Forming Foam (AFFF) concentrates as fire fighting agents

    Science.gov (United States)

    Jablonski, E. J.

    1981-04-01

    A large-scale fire test program involving 20,000-square foot JP-4 fuel fires was conducted to evaluate the fire suppression effectiveness and compatibility of 3 percent Aqueous Film Forming Foam (AFFF) agents in Air Force fire fighting vehicles. Three commercially available 3 percent AFFF concentrates were tested in accordance with military specification MIL-F-24385B. Test results are summarized in Appendix A. As a result of these tests, an updated Revision C to this MIL SPEC has been accomplished with new requirements for both 3 percent and 6 percent AFFF extinguishing agents.

  10. Efficacy and safety of second-line agents for treatment of metastatic castration-resistant prostate cancer progressing after docetaxel. A systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Gianpaolo Perletti

    2015-07-01

    Full Text Available Objective: We performed a systematic review of the literature to assess the efficacy and the safety of second-line agents targeting metastatic castration-resistant prostate cancer (mCRPC that has progressed after docetaxel. Pooled-analysis was also performed, to assess the effectiveness of agents targeting the androgen axis via identical mechanisms of action (abiraterone acetate, orteronel. Materials and Methods: We included phase III randomized controlled trials that enrolled patients with mCRPC progressing during or after first-line docetaxel treatment. Trials were identified by electronic database searching. The primary outcome of the review was overall survival. Secondary outcomes were radiographic progression-free survival (rPFS and severe adverse effects (grade 3 or higher. Results: Ten articles met the inclusion criteria for the review. These articles reported the results of five clinical trials, enrolling in total 5047 patients. The experimental interventions tested in these studies were enzalutamide, ipilimumab, abiraterone acetate, orteronel and cabazitaxel. Compared to control cohorts (active drug-treated or placebotreated, the significant overall survival advantages achieved were 4.8 months for enzalutamide (hazard ratio for death vs. placebo: 0.63; 95% CI 0.53 to 0.75, P < 0.0001, 4.6 months for abiraterone (hazard ratio for death vs. placebo: 0.66, 95% CI 0.58 to 0.75, P < 0.0001 and 2.4 months for cabazitaxel (hazard ratio for death vs. mitoxantrone-prednisone: 0.70, 95% CI 0.59 to 0.83, p < 0.0001. Pooled analysis of androgen synthesis inhibitors orteronel and abiraterone resulted in significantly increased overall and progression-free survival for anti-androgen agents, compared to placebo (hazard ratio for death: 0.76, 95% CI 0.67 to 0.87, P < 0.0001; hazard ratio for radiographic progression: 0.7, 95% CI 0.63 to 0.77, P < 0.00001. Androgen synthesis inhibitors induced significant increases in risk ratios for adverse effects

  11. Performance Evaluation of Bidding-Based Multi-Agent Scheduling Algorithms for Manufacturing Systems

    Directory of Open Access Journals (Sweden)

    Antonio Gordillo

    2014-10-01

    Full Text Available Artificial Intelligence techniques have being applied to many problems in manufacturing systems in recent years. In the specific field of manufacturing scheduling many studies have been published trying to cope with the complexity of the manufacturing environment. One of the most utilized approaches is (multi agent-based scheduling. Nevertheless, despite the large list of studies reported in this field, there is no resource or scientific study on the performance measure of this type of approach under very common and critical execution situations. This paper focuses on multi-agent systems (MAS based algorithms for task allocation, particularly in manufacturing applications. The goal is to provide a mechanism to measure the performance of agent-based scheduling approaches for manufacturing systems under key critical situations such as: dynamic environment, rescheduling, and priority change. With this mechanism it will be possible to simulate critical situations and to stress the system in order to measure the performance of a given agent-based scheduling method. The proposed mechanism is a pioneering approach for performance evaluation of bidding-based MAS approaches for manufacturing scheduling. The proposed method and evaluation methodology can be used to run tests in different manufacturing floors since it is independent of the workshop configuration. Moreover, the evaluation results presented in this paper show the key factors and scenarios that most affect the market-like MAS approaches for manufacturing scheduling.

  12. EDGE study in Russian Federation: efficacy and safety of vildagliptine in comparison with other oral antidiabetic agents in patients with type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    G R Galstyan

    2013-06-01

    Full Text Available According to international consensus, metformin is acknowledged as a first-line therapeutic agent for type 2 diabetes mellitus (T2DM. However, in most cases this treatment eventually requires intensification by supplementation with other hypoglycemic medications. The aim of the EDGE study (Effective Diabetes control with vildaGliptin and vildagliptin/mEtformin was to assess the efficacy and safety of vildagliptin in comparison with other oral agents in routine management of patients with T2DM that has been poorly controlled by metformin monotherapy.

  13. Research on anti-dandruff agents and their safety%常用去屑剂的安全研究进展

    Institute of Scientific and Technical Information of China (English)

    宋杰; 赵文忠; 洪盛杰; 胡卫华; 赵华; 孟宏

    2012-01-01

    通过综述分析常用去屑剂在洗发香波中的应用现状,对常用去屑剂的功效性和安全性进行了探讨,展望了去屑剂的应用前景。%In this paper, several anti-dandruff agents commonly used in shampoo were illustrated, and their efficacies and safeties were studied, Moreover, the application and prospect of anti-dandruff agents in shampoo were reviewed.

  14. Risk assessment of medical devices: Evaluation of microbiological and toxicological safety

    Science.gov (United States)

    Dorpema, J. W.

    1995-02-01

    Safety assessment of medical devices includes sterilization and biological evaluation or biocompatibility testing. Sterilization by ETO gas is critised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program.

  15. An evaluation of an airline cabin safety education program for elementary school children.

    Science.gov (United States)

    Liao, Meng-Yuan

    2014-04-01

    The knowledge, attitude, and behavior intentions of elementary school students about airline cabin safety before and after they took a specially designed safety education course were examined. A safety education program was designed for school-age children based on the cabin safety briefings airlines given to their passengers, as well as on lessons learned from emergency evacuations. The course is presented in three modes: a lecture, a demonstration, and then a film. A two-step survey was used for this empirical study: an illustrated multiple-choice questionnaire before the program, and, upon completion, the same questionnaire to assess its effectiveness. Before the program, there were significant differences in knowledge and attitude based on school locations and the frequency that students had traveled by air. After the course, students showed significant improvement in safety knowledge, attitude, and their behavior intention toward safety. Demographic factors, such as gender and grade, also affected the effectiveness of safety education. The study also showed that having the instructor directly interact with students by lecturing is far more effective than presenting the information using only video media. A long-term evaluation, the effectiveness of the program, using TV or video accessible on the Internet to deliver a cabin safety program, and a control group to eliminate potential extraneous factors are suggested for future studies.

  16. Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

    Science.gov (United States)

    Pauwels, Marleen; Rogiers, Vera

    2004-06-15

    Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

  17. Safety evaluation in the development of medical devices and combination products

    CERN Document Server

    Gad, Shayne C

    2008-01-01

    Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

  18. [Evaluation of safety and efficacy of tebipenem pivoxil granules for pediatric in pneumonia, otitis media and sinusitis].

    Science.gov (United States)

    Kataoka, Hiroshi; Kasahara, Hiroshi; Sasagawa, Yuji; Matsumoto, Masato; Shimada, Seiya

    2016-02-01

    We conducted a postmarketing surveillance of tebipenem pivoxil granules (Orapenem® fine granules 10% for pediatric), an oral carbapenem antibacterial agent, between April 2010 and March 2013 to evaluate the safety and efficacy in patients with pneumonia or otitis media, or sinusitis Of 3,547 patients enrolled, 3,540 from whom survey forms were collected were analyzed. Of these 3,540 patients, there were a total of 3,331 patients included in the safety analysis, 2,844 in the efficacy analysis, 2,769 in the clinical efficacy analysis, and 461 in the bacteriological efficacy analysis. The incidence of adverse drug reactions (ADRs) was 9.97% (332/3,331 patients), and the major ADRs were gastrointestinal disorders including diarrhoea in 317 patients (9.52%). Diarrhoea was reported in 313 patients (316 events), which were not clinically significant and 94.9% (297/313 patients) were recovery and/or remission. The overall clinical efficacy rate was 94.0% (2,604/2,769 patients). The clinical efficacy rate by the type of infection was 95.6% (415/434 patients) for pneumonia, 93.7% (1,389/1,482 patients) for otitis media and 93.6% (659/704 patients) for sinusitis. The eradication rate of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis which are major causative organisms in pediatric infection of pneumonia, otitis media and sinusitis were 94.4% (134/142 strains), 92.2% (130/141 strains) and 97.8% (45/46 strains), respectively. The compliance was good in 83.1% of the patients (2,767/3,331 patients). Overall, Orapenem® fine granules 10% for pediatric showed good safety, efficacy, and compliance. These results indicate that Orapenem® fine granules 10% for pediatric is a useful agent in pediatrics with pneumonia or otitis media, or sinusitis.

  19. Safety Evaluation for Packaging 101-SY Hydrogen Mitigation Mixer Pump package

    Energy Technology Data Exchange (ETDEWEB)

    Carlstrom, R.F.

    1994-10-05

    This Safety Evaluation for Packaging (SEP) provides analysis and considered necessary to approve a one-time transfer of the 101-SY Hydrogen Mitigation Mixer Pump (HMMP). This SEP will demonstrate that the transfer of the HMMP in a new shipping container will provide an equivalent degree of safety as would be provided by packages meeting US Department of Transportation (DOT)/US Nuclear Regulatory Commission (NRC) requirements. This fulfills onsite, transportation requirements implemented by WHC-CM-2-14.

  20. 3D GIS BASED EVALUATION OF THE AVAILABLE SIGHT DISTANCE TO ASSESS SAFETY OF URBAN ROADS

    OpenAIRE

    Bassani, M.; Grasso, N.; Piras, M.

    2015-01-01

    The available sight distance (ASD) in front of the driver to detect possible conflicts with unexpected obstacles is fundamental for traffic safety. In the last 20 years, road design software (RDS) has been continuously updated with dedicated modules to estimate ASD, thus assessing the quality of project from a safety point of view. Unfortunately, the evaluation of ASD still represents an issue in the case of existing road, and the object of discussion in the research community. To avoid probl...

  1. Evaluation of halothane as stressor agent in poultry / Avaliação do halotano como agente estressor em frangos

    Directory of Open Access Journals (Sweden)

    Massami Shimokomaki

    2010-07-01

    Full Text Available Studies have been demonstrating in poultry, the existence of at least two causes for the formation of PSE meat: genetic through the sensibility towards halothane and the environmental factor in particular the temperature as the main factor. Thus the objective of this work was to evaluate halothane as stressor agent for broiler concomitantly to evaluating the PSE incidence by submitting these birds to thermal stress. In this experiment, 24 broilers of commercial lineage were divided in 6 animals for 4 treatments: HHH, broilers submitted to halothane test and slaughtered 1h after this test; HET broilers submitted to halothane at 35°C/1h after 48h of halothane test followed by the birds slaughtering; EET, broilers submitted to thermal stress and slaughtered immediately after this treatment, and finally the control treatment (CCC where broilers were not submitted to halothane test nor to thermal stress as control. The initial pH of Pectoralis major m, was evaluated 30 min post mortem and the pH final, color, (L*, a*, b* water holding capacity (WHC, and R value analysis were carried out after 24h of storage of fillet samples at 40C. The pH24h was higher (p ? 0.05 for CCC samples in comparison to other treatments and R value was higher for birds under HET and EET treatments in comparison to CCC (p ? 0.05 suggesting that the rigor mortis was more rapid in samples from birds submitted to thermal stress. The HHH, HET, and EET treatments presented 4 birds each with PSE meat and 2 broilers from CCC treatment originated PSE meat showing the influence not only halothane but also the thermal stress over broilers welfare. Finally, results demonstrated that halothane is a stressor agent as well as the thermal stress and both promoted dramatic biochemical changes bringing about the formation of broiler PSE meat. Resultados vêm mostrando uma direta relação entre a sensibilidade ao halotano e a ocorrência de filés PSE em aves, que pode ser originado pela

  2. Non-clinical safety evaluation of intranasal iota-carrageenan.

    Directory of Open Access Journals (Sweden)

    Alexandra Hebar

    Full Text Available Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug's action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application.

  3. Safety evaluation of a lipase expressed in Aspergillus oryzae.

    Science.gov (United States)

    Greenough, R J; Perry, C J; Stavnsbjerg, M

    1996-02-01

    A programme of studies was conducted to establish the safety of a lipase artificially expressed in Aspergillus oryzae to be used in the detergent industry and as a processing aid in the baking industry. Laboratory animal studies were used to assess general and inhalation toxicity, skin sensitization, and skin and eye irritation. Its potential to cause mutagenicity and chromosomal aberrations was assessed in microbial and tissue culture in vitro studies. The pathogenicity of A. oryzae, the organism used to produce the lipase, was also assessed in laboratory animals. Basic ecotoxicity in a variety of test species was studied. General and inhalation toxicity was low. There was evidence of mild skin irritation. There was no evidence of eye irritation, skin sensitization, mutagenic potential, chromosomal aberrations, exotoxicity or notable pathogenicity. Comparison of these results with human exposure levels and previously published data indicates that the lipase appears safe for consumers in the given applications, requires no special occupational health precautions in manufacture and is of low environmental impact. Furthermore, the organism used in production of the lipase hs no notable pathogenicity.

  4. Safety evaluation of nuclease P1 from Penicillium citrinum.

    Science.gov (United States)

    Okado, Nobuo; Hasegawa, Kazushige; Mizuhashi, Fukutaro; Lynch, Barry S; Vo, Trung D; Roberts, Ashley S

    2016-02-01

    Nuclease P1 has been widely used in the food industry to enhance or create flavor. One commercial source of this enzyme is Penicillium citrinum, an anamorphic mesophilic fungus with a long history of safe use in Europe and Asia as a fermentation organism used in the production of ribonucleases. Given the intended use in food for human consumption, and noting its potential presence at trace levels in finished products, a series of safety studies including an in vitro Ames and chromosome aberration assay, an in vivo rat erythrocyte micronucleus assay and a 90-day oral toxicity study in rats were conducted. No mutagenic activity was observed in the Ames assay. Equivocal activity in the chromosome aberration assay was not replicated in the micronucleus assay at doses of up to 1007 mg total organic solids (TOS)/kg body weight (bw)/day. Following oral administration of nuclease P1 at dosages of 10.1, 101 or 1007 mg TOS/kg bw/day to Sprague-Dawley rats, no adverse effects on any study parameter were observed. The no-observed-adverse-effect level was considered to be 1007 mg TOS/kg bw/day. The results of the genotoxicity studies and subchronic rat study support the safe use in food production of nuclease P1 produced from P. citrinum.

  5. I Feel You: The Design and Evaluation of a Domotic Affect-Sensitive Spoken Conversational Agent

    Directory of Open Access Journals (Sweden)

    Juan Manuel Montero

    2013-08-01

    Full Text Available We describe the work on infusion of emotion into a limited-task autonomous spoken conversational agent situated in the domestic environment, using a need-inspired task-independent emotion model (NEMO. In order to demonstrate the generation of affect through the use of the model, we describe the work of integrating it with a natural-language mixed-initiative HiFi-control spoken conversational agent (SCA. NEMO and the host system communicate externally, removing the need for the Dialog Manager to be modified, as is done in most existing dialog systems, in order to be adaptive. The first part of the paper concerns the integration between NEMO and the host agent. The second part summarizes the work on automatic affect prediction, namely, frustration and contentment, from dialog features, a non-conventional source, in the attempt of moving towards a more user-centric approach. The final part reports the evaluation results obtained from a user study, in which both versions of the agent (non-adaptive and emotionally-adaptive were compared. The results provide substantial evidences with respect to the benefits of adding emotion in a spoken conversational agent, especially in mitigating users’ frustrations and, ultimately, improving their satisfaction.

  6. I feel you: the design and evaluation of a domotic affect-sensitive spoken conversational agent.

    Science.gov (United States)

    Lutfi, Syaheerah Lebai; Fernández-Martínez, Fernando; Lorenzo-Trueba, Jaime; Barra-Chicote, Roberto; Montero, Juan Manuel

    2013-08-13

    We describe the work on infusion of emotion into a limited-task autonomous spoken conversational agent situated in the domestic environment, using a need-inspired task-independent emotion model (NEMO). In order to demonstrate the generation of affect through the use of the model, we describe the work of integrating it with a natural-language mixed-initiative HiFi-control spoken conversational agent (SCA). NEMO and the host system communicate externally, removing the need for the Dialog Manager to be modified, as is done in most existing dialog systems, in order to be adaptive. The first part of the paper concerns the integration between NEMO and the host agent. The second part summarizes the work on automatic affect prediction, namely, frustration and contentment, from dialog features, a non-conventional source, in the attempt of moving towards a more user-centric approach. The final part reports the evaluation results obtained from a user study, in which both versions of the agent (non-adaptive and emotionally-adaptive) were compared. The results provide substantial evidences with respect to the benefits of adding emotion in a spoken conversational agent, especially in mitigating users' frustrations and, ultimately, improving their satisfaction.

  7. Idaho Chemical Processing Plant safety document ICPP hazardous chemical evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Harwood, B.J.

    1993-01-01

    This report presents the results of a hazardous chemical evaluation performed for the Idaho Chemical Processing Plant (ICPP). ICPP tracks chemicals on a computerized database, Haz Track, that contains roughly 2000 individual chemicals. The database contains information about each chemical, such as its form (solid, liquid, or gas); quantity, either in weight or volume; and its location. The Haz Track database was used as the primary starting point for the chemical evaluation presented in this report. The chemical data and results presented here are not intended to provide limits, but to provide a starting point for nonradiological hazards analysis.

  8. Safety Comprehensive Evaluation of Spacecraft Assembly Process Based on Grey-Fuzzy Method

    Directory of Open Access Journals (Sweden)

    Jin Tian

    2014-04-01

    Full Text Available Multilevel evaluation indicator system for spacecraft assembly safety was built, considering six aspects: operators, process equipment, operating environment, operation types, objects to be operated, and emergency measures. Based on that, a grey-fuzzy comprehensive evaluation approach was proposed to support the spacecraft assembly safety evaluation. In the approach, analytic hierarchy process and grey degree were applied to construct weight matrix, and the principle with which the appropriate memberships could be determined was taken as a basis for creation of grey-fuzzy comprehensive evaluation matrix. The docking assembly, a typical stage in spacecraft assembly process, was taken as the case study to evaluate its safety level by the proposed grey-fuzzy comprehensive evaluation method, and it was confirmed that the result is coherent with the reality of the accident statistics. The evaluation results can be utilized as a technical basis for developing safety and protective measures, perfecting risk management, and furthermore lowering the risk to minimize economic loss and behind-schedule of project.

  9. Safety evaluation of vitamin A in growing dogs.

    Science.gov (United States)

    Morris, Penelope J; Salt, Carina; Raila, Jens; Brenten, Thomas; Kohn, Barbara; Schweigert, Florian J; Zentek, Jürgen

    2012-11-28

    The safe upper limit for inclusion of vitamin A in complete diets for growing dogs is uncertain, with the result that current recommendations range from 5.24 to 104.80 μmol retinol (5000 to 100 000 IU vitamin A)/4184 kJ (1000 kcal) metabolisable energy (ME). The aim of the present study was to determine the effect of feeding four concentrations of vitamin A to puppies from weaning until 1 year of age. A total of forty-nine puppies, of two breeds, Labrador Retriever and Miniature Schnauzer, were randomly assigned to one of four treatment groups. Following weaning at 8 weeks of age, puppies were fed a complete food supplemented with retinyl acetate diluted in vegetable oil and fed at 1 ml oil/100 g diet to achieve an intake of 5·24, 13·10, 78·60 and 104·80 μmol retinol (5000, 12 500, 75 000 and 100 000 IU vitamin A)/4184 kJ (1000 kcal) ME. Fasted blood and urine samples were collected at 8, 10, 12, 14, 16, 20, 26, 36 and 52 weeks of age and analysed for markers of vitamin A metabolism and markers of safety including haematological and biochemical variables, bone-specific alkaline phosphatase, cross-linked carboxyterminal telopeptides of type I collagen and dual-energy X-ray absorptiometry. Clinical examinations were conducted every 4 weeks. Data were analysed by means of a mixed model analysis with Bonferroni corrections for multiple endpoints. There was no effect of vitamin A concentration on any of the parameters, with the exception of total serum retinyl esters, and no effect of dose on the number, type and duration of adverse events. We therefore propose that 104·80 μmol retinol (100 000 IU vitamin A)/4184 kJ (1000 kcal) is a suitable safe upper limit for use in the formulation of diets designed for puppy growth.

  10. GA-SVC model and application of comprehensive evaluation of coal mine essential safety management

    Institute of Scientific and Technical Information of China (English)

    Zhi-Jun WANG; Rui-Lin ZHANG; Wen-Ting SONG

    2013-01-01

    In order to evaluate the level of the coal mine essential safety management,the comprehensive index system was designed base on the connotation principle of the mine essential safety management.Due to the disadvantage of index weight setting by subjective idea in the former method,support vector classification algorithm was used to assess the level of coal mine essential safety management.According to the advantages of the global search capability of the genetic algorithm,support vector classification parameters optimization method was proposed based on genetic algorithm,and genetic algorithm-support vector classification model of coal mine essential safety management assessment was established.Learning samples were constructed on the basis of former data of mine essential safety management evaluation.The test results show that the genetic algorithm-support vector classification model has higher evaluation accuracy and good generalization ability,and the advantage of no need for artificial setting of index weight and absence of the subjective factors influence to evaluation results.

  11. Implementing, monitoring, evaluating, and updating a road safety programme : contribution to the Best in Europe 2003 Conference of the European Transport Safety Council: Targeted Road Safety Programmes in the EU, Brussels, June 10, 2003.

    NARCIS (Netherlands)

    Wegman, F.C.M.

    2004-01-01

    In all EU countries, attempts are being made to promote road safety, and each country has its own approach. This contribution examines the implementation of road safety programmes, their monitoring and evaluation, and their updating. For analyzing policy implementation, monitoring and evaluation, a

  12. Comparative assessment of nanomaterial definitions and safety evaluation considerations.

    Science.gov (United States)

    Boverhof, Darrell R; Bramante, Christina M; Butala, John H; Clancy, Shaun F; Lafranconi, Mark; West, Jay; Gordon, Steve C

    2015-10-01

    Nanomaterials continue to bring promising advances to science and technology. In concert have come calls for increased regulatory oversight to ensure their appropriate identification and evaluation, which has led to extensive discussions about nanomaterial definitions. Numerous nanomaterial definitions have been proposed by government, industry, and standards organizations. We conducted a comprehensive comparative assessment of existing nanomaterial definitions put forward by governments to highlight their similarities and differences. We found that the size limits used in different definitions were inconsistent, as were considerations of other elements, including agglomerates and aggregates, distributional thresholds, novel properties, and solubility. Other important differences included consideration of number size distributions versus weight distributions and natural versus intentionally-manufactured materials. Overall, the definitions we compared were not in alignment, which may lead to inconsistent identification and evaluation of nanomaterials and could have adverse impacts on commerce and public perceptions of nanotechnology. We recommend a set of considerations that future discussions of nanomaterial definitions should consider for describing materials and assessing their potential for health and environmental impacts using risk-based approaches within existing assessment frameworks. Our intent is to initiate a dialogue aimed at achieving greater clarity in identifying those nanomaterials that may require additional evaluation, not to propose a formal definition.

  13. A Comparative Evaluation of Hydroxyapatite Crystals and Glutaraldehyde as Agents for Pulpotomy in Deciduous Molars

    OpenAIRE

    2009-01-01

    Purpose: To evaluate and compare clinically and radiographically use of hydroxyapatite crystals and 2% glutaraldehyde as a pulpotomy agent. Method: Thirty deciduous molars were treated with pulpotomy using hydroxyapatite crystals and 2% glutaraldehyde. Results: Clinical and radiographic findings were observed at three months and six months. The success rate was found to be 100% clinically and 80.33% radiographically in the hydroxyapatite crystals group and 100% clinically and radiographically...

  14. Safety evaluation of disposable baby diapers using principles of quantitative risk assessment.

    Science.gov (United States)

    Rai, Prashant; Lee, Byung-Mu; Liu, Tsung-Yun; Yuhui, Qin; Krause, Edburga; Marsman, Daniel S; Felter, Susan

    2009-01-01

    Baby diapers are complex products consisting of multiple layers of materials, most of which are not in direct contact with the skin. The safety profile of a diaper is determined by the biological properties of individual components and the extent to which the baby is exposed to each component during use. Rigorous evaluation of the toxicological profile and realistic exposure conditions of each material is important to ensure the overall safety of the diaper under normal and foreseeable use conditions. Quantitative risk assessment (QRA) principles may be applied to the safety assessment of diapers and similar products. Exposure to component materials is determined by (1) considering the conditions of product use, (2) the degree to which individual layers of the product are in contact with the skin during use, and (3) the extent to which some components may be extracted by urine and delivered to skin. This assessment of potential exposure is then combined with data from standard safety assessments of components to determine the margin of safety (MOS). This study examined the application of QRA to the safety evaluation of baby diapers, including risk assessments for some diaper ingredient chemicals for which establishment of acceptable and safe exposure levels were demonstrated.

  15. An Evaluation Methodology Development and Application Process for Severe Accident Safety Issue Resolution

    Directory of Open Access Journals (Sweden)

    Robert P. Martin

    2012-01-01

    Full Text Available A general evaluation methodology development and application process (EMDAP paradigm is described for the resolution of severe accident safety issues. For the broader objective of complete and comprehensive design validation, severe accident safety issues are resolved by demonstrating comprehensive severe-accident-related engineering through applicable testing programs, process studies demonstrating certain deterministic elements, probabilistic risk assessment, and severe accident management guidelines. The basic framework described in this paper extends the top-down, bottom-up strategy described in the U.S Nuclear Regulatory Commission Regulatory Guide 1.203 to severe accident evaluations addressing U.S. NRC expectation for plant design certification applications.

  16. Evaluation of a Radiation Worker Safety Training Program at a nuclear facility

    Energy Technology Data Exchange (ETDEWEB)

    Lindsey, J.E.

    1993-05-01

    A radiation safety course was evaluated using the Kirkpatrick criteria of training evaluation as a guide. Thirty-nine employees were given the two-day training course and were compared with 15 employees in a control group who did not receive the training. Cognitive results show an immediate gain in knowledge, and substantial retention at 6 months. Implications of the results are discussed in terms of applications to current radiation safety training was well as follow-on training research and development requirements.

  17. Study on mechanical characteristics and safety evaluation method of steel frame structure after fire

    Directory of Open Access Journals (Sweden)

    Qiang Sun

    2014-01-01

    Full Text Available Mechanical characterization of steel frame structure after fire are analyzed based on fire dynamics, heat transfer theory, structural mechanics, and finite element theory. We study the temperature characteristics and mechanical properties of steel frame structure under different fire locations and propose a safety evaluation method. We also analyze damage level of main frame components, maximum temperature of fire, thermal characteristics of frame components, firing duration, etc. to provide useful information for fire resistance design of the steel frame structure and post-disaster safety evaluation.

  18. Synthesis and evaluation of new protecting agents against ionizing radiations; Synthese et evaluation de nouveaux agents de protection contre les rayonnements ionisants

    Energy Technology Data Exchange (ETDEWEB)

    Nadal, B.

    2009-10-15

    This thesis is devoted to the synthesis of new pulvinic acid derivatives and the evaluation of their antioxidant and radioprotective properties. This study has been conducted with the aim to develop new protecting agents against ionizing radiations. A new access to pulvinic acid derivatives was developed starting from L-dimethyl tartrate. It is based on a Dieckmann cyclization a dehydration and a Suzuki-Miyaura coupling. It allows a short effective preparation of various pulvinic acid derivatives: tetronic acid derivatives, mono-substituted pulvinic acid derivatives and methyl pulvinates. A modified method has been used to prepare pulvinones. This strategy gave access in four steps to the desired pulvinones. The rapidity of this method is provided by a tandem process, carried out in the final step, involving a Dieckmann cyclization and a {beta}-elimination. A synthesis of 3-aryltetramic acids has also been developed in order to prepare nitrogen derivatives of pulvinic acid. The antioxidant activity of the prepared compounds was then evaluated using various tests: DPPH, ABTS, protection of thymidine and DNA study of lipid peroxidation. These evaluations allowed to define interesting structure-activity relationships of pulvinic derivatives. They have shown that several derivatives have very good antioxidant activities. Finally, radioprotective tests on TK6 cells and mice have have been performed on selected compounds. (author)

  19. Raman spectroscopic evaluation of efficacy of current paraffin wax section dewaxing agents.

    Science.gov (United States)

    Faoláin, Eoghan O; Hunter, Mary B; Byrne, Joe M; Kelehan, Peter; Lambkin, Helen A; Byrne, Hugh J; Lyng, Fiona M

    2005-01-01

    During a spectroscopic study to identify biochemical changes in cervical tissue with the onset of carcinogenesis, residual paraffin wax contributions were observed on almost all dewaxed formalin-fixed paraffin-processed (FFPP) tissue sections examined. Subsequently, the present study was formulated to evaluate the efficacy of current dewaxing agents using Raman spectroscopy. Three cervical FFPP sections were subjected to each of the protocols. Sections were dewaxed using four common dewaxing protocols, namely, xylene, Histoclear, heat-mediated antigen retrieval (HMAR) using xylene and citrate buffer, and Trilogy (combined deparaffinization and unmasking of antigens). The potential for hexane as a dewaxing agent was also evaluated. Sections were dewaxed in multiple dewaxing cycles using xylene, Histoclear, and hexane. Residual paraffin wax contributions remained at 1062 cm(-1), 1296 cm(-1), and 1441 cm(-1). HMAR using xylene and citrate buffer, and HMAR using Trilogy, showed a similar efficacy, resulting in incomplete removal of wax. Hexane was shown to be the most effective dewaxing agent, resulting in almost complete removal of wax. Immunohistochemistry was carried out on dewaxed slides, and those dewaxed with hexane displayed a stronger positivity (approximately 28%). Implications for histopathology and immunohistochemistry are considered, as well as problems that residual wax poses for spectroscopic evaluation of dewaxed FFPP sections with a view to disease diagnosis.

  20. Efficacy and Safety of HER2-Targeted Agents for Breast Cancer with HER2-Overexpression: A Network Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Qiuyan Yu

    Full Text Available Clinical trials of human epidermal growth factor receptor 2 (HER2-targeted agents added to standard treatment have been efficacious for HER2-positive (HER2+ advanced breast cancer. To our knowledge, no meta-analysis has evaluated HER2-targeted therapy including trastuzumab emtansine (T-DM1 and pertuzumab for HER2-positive breast caner and ranked the targeted treatments. We performed a network meta-analysis of both direct and indirect comparisons to evaluate the effect of adding HER2-targeted agents to standard treatment and examined side effects.We performed a Bayesian-framework network meta-analysis of randomized controlled trials to compare 6 HER2-targeted treatment regimens and 1 naïve standard treatment (NST, without any-targeted drugs in targeted treatment of HER2+ breast cancer in adults. These treatment regimens were T-DM1, LC (lapatinib, HC (trastuzumab, PEC (pertuzumab, LHC (lapatinib and trastuzumab, and PEHC (pertuzumab and trastuzumab. The main outcomes were overall survival and response rates. We also examined side effects of rash, LVEF (left ventricular ejection fraction, fatigue, and gastrointestinal disorders, and performed subgroup analysis for the different treatment regimens in metastatic or advanced breast cancer.We identified 25 articles of 21 trials, with data for 11,276 participants. T-DM1 and PEHC were more efficient drug regimens with regard to overall survival as compared with LHC, LC, HC and PEC. The incidence of treatment-related rash occurs more frequently in the patients who received LC treatment regimen than PEHC and T-DM1 and HC. In subgroup analysis, T-DM1 was associated with increased overall survival as compared with LC and HC. PEHC was associated with increased overall response as compared with LC, HC, and NST.Overall, the regimen of T-DM1 as well as pertuzumab in combination with trastuzumab and docetaxel is efficacious with fewer side effects as compared with other regimens, especially for advanced HER2

  1. An evaluation of a new instrument to measure organisational safety culture values and practices.

    Science.gov (United States)

    Díaz-Cabrera, D; Hernández-Fernaud, E; Isla-Díaz, R

    2007-11-01

    The main aim of this research is to evaluate a safety culture measuring instrument centred upon relevant organisational values and practices related to the safety management system. Seven dimensions that reflect underlying safety meanings are proposed. A second objective is to explore the four cultural orientations in the field of safety arising from the competing values framework. The study sample consisted of 299 participants from five companies in different sectors. The results show six dimensions of organisational values and practices and different company profiles in the organisations studied. The four cultural orientations proposed by the competing values framework are not confirmed. Nevertheless, a coexistence of diverse cultural orientations or paradoxes in the companies is observed.

  2. Preliminary safety evaluation for 241-C-106 waste retrieval, project W-320

    Energy Technology Data Exchange (ETDEWEB)

    Conner, J.C.

    1994-10-18

    This document presents the Preliminary Safety Evaluation for Project W-320, Tank 241-C-106 Waste Retrieval Sluicing System (WRSS). The US DOE has been mandated to develop plans for response to safety issues associated with the waste storage tanks at the Hanford Site, and to report the progress of implementing those plans to Congress. The objectives of Project W-230 are to design, fabricate, develop, test, and operate a new retrieval system capable of removing a minimum of about 75% of the high-heat waste contained in C-106. It is anticipated that sluicing operations can remove enough waste to reduce the remaining radiogenic heat load to levels low enough to resolve the high-heat safety issue as well as allow closure of the tank safety issue.

  3. Safety evaluation of some wild plants in the New Nordic Diet

    DEFF Research Database (Denmark)

    Mithril, Charlotte; Dragsted, Lars Ove

    2012-01-01

    One of the dietary components in the New Nordic Diet, is plants from the wild countryside. However, these may have a high content of bioactive components, some of which could be toxic in larger quantities. The objective of this paper is to outline a strategy for safety evaluation of wild plants...... not covered in current food compositional databases and to apply the method for selected plants used in the New Nordic Diet recipes. Four examples of typical wild edible plants were evaluated (stinging nettle, sorrel, chickweed and common lambsquarters), and based on substantial equivalence with known food....... It is concluded that a substance-by-substance evaluation of intake by equivalence to common foods is a useful and efficient strategy to evaluate the safety of newly introduced wild edible plants. Further evaluation and better compositional analyses are warranted before a daily consumption of significant amounts...

  4. Stage Right operational safety analysis and evaluation of Pantex personnel operations

    Energy Technology Data Exchange (ETDEWEB)

    Rountree, S.L.K.; Whitehurst, H.O.; Tomlin, E.H.; Restrepo, L.F. [Sandia National Labs., Albuquerque, NM (United States); White, J. [Sandia National Labs., Albuquerque, NM (United States)]|[Intera, Albuquerque, NM (United States)

    1995-01-01

    This report documents a study (Stage Right Operational Safety Analysis) that was performed to evaluate the effects of new Stage Right operations on the safety of Pantex personnel who perform the operations and maintain the equipment. The primary concern of the evaluation was for personnel safety during Stage Right operations, but operations equipment damage and degradation also were taken into account. This analysis evaluates safety of the work process in the staging of dismantled nuclear weapon pits within the modified Richmond magazines only. This Stage Right Process and Operational Safety Analysis includes the following processes: moving the pelletized drums from the pallet trailer to the pallet turner, staging of pallets and removal of pallets from the magazine, recovery from an incident in a magazine, setting up, opening, and closing a Zone 4 magazine, inventory of pelletized drums in the magazines, transporting pelletized drums from Zone 12 to Zone 4, and maintenance on the shielded lift truck that involves removal of the cab shielding. The analysis includes the following undesirable consequences: injury to personnel, breach of an AL-R8 container, drop of a loaded pallet, damage to equipment, and equipment unreliability.

  5. Review of Overall Safety Manual for space nuclear systems. An evaluation of a nuclear safety analysis methodology for plutonium-fueled space nuclear systems

    Energy Technology Data Exchange (ETDEWEB)

    Coleman, J.; Inhaber, H.

    1984-02-01

    As part of its duties in connection with space missions involving nuclear power sources, the Office of Nuclear Safety (ONS) of the Office of Assistant Secretary for Environmental Protection, Safety, and Emergency Preparedness has been assigned the task of reviewing the Overall Safety Manual (OSM) (memo from B.J. Rock to J.R. Maher, December 1, 1982). The OSM, dated July 1981 and in four volumes, was prepared by NUS Corporation, Rockville, Maryland, for the US Department of Energy. The OSM provides many of the technical models and much of the data which are used by (1) space launch contractors in safety analysis reports and (2) the broader Interagency Nuclear Safety Review Panel (INSRP) safety evaluation reports. If fhs interaction between the OSM, contractors, and INSRP is to work effectively, the OSM must be accurate, comprehensive, understandable, and usable.

  6. Evaluation of the Finnish nuclear safety research program 'SAFIR2010'

    Energy Technology Data Exchange (ETDEWEB)

    2010-07-01

    A panel of three members has been asked by the Ministry of Employment and the Economy (MEE) to evaluate SAFIR2010, the Finnish research program on nuclear power plant safety. The program was established for the period 2007-2010 to help maintain expertise in nuclear safety, to integrate young people into the research in order to help assure the future availability of expertise, and to support international collaborations. The program is directed by a Steering Group, appointed by MEE, with representatives from all organizations involved with nuclear safety in Finland. SAFIR2010 has consisted of approximately 30 projects from year to year that fall into eight subject areas: 1. Organization and human factors 2. Automation and control room 3. Fuel and reactor physics 4. Thermal hydraulics 5. Severe accidents 6. Structural safety of reactor circuit 7. Construction safety 8. Probabilistic safety analysis (PSA) For each of these areas there are Reference Groups that provide oversight of the projects within their jurisdiction. The panel carried out its evaluation by reviewing copies of relevant documents and, during a one-week period 17-22 January 2010, meeting with key individuals. The results of the panel are provided as general conclusions, responses to questions posed by MEE, challenges and recommendations and comments on specific projects in each subject area. The general conclusions reflect the panel's view that SAFIR2010 is meeting its objectives and carrying out quality research. The questions addressed are: (a.) Are the achieved results in balance with the funding? Are the results exploited efficiently in practice? (b.) How well does the expertise cover the field? Is the entire SAFIR2010 programme balanced to all different fields in nuclear safety? Does it raise efficiently new experts? (c.) Have the 2006 evaluation results been implemented successfully into SAFIR2010 program? (d.) Challenges and recommendations. In general the panel was very positive about

  7. HACCP and water safety plans in Icelandic water supply: preliminary evaluation of experience.

    Science.gov (United States)

    Gunnarsdóttir, María J; Gissurarson, Loftur R

    2008-09-01

    Icelandic waterworks first began implementing hazard analysis and critical control points (HACCP) as a preventive approach for water safety management in 1997. Since then implementation has been ongoing and currently about 68% of the Icelandic population enjoy drinking water from waterworks with a water safety plan based on HACCP. Preliminary evaluation of the success of HACCP implementation was undertaken in association with some of the waterworks that had implemented HACCP. The evaluation revealed that compliance with drinking water quality standards improved considerably following the implementation of HACCP. In response to their findings, waterworks implemented a large number of corrective actions to improve water safety. The study revealed some limitations for some, but not all, waterworks in relation to inadequate external and internal auditing and a lack of oversight by health authorities. Future studies should entail a more comprehensive study of the experience with the use of HACCP with the purpose of developing tools to promote continuing success.

  8. Nanoparticles skin absorption: New aspects for a safety profile evaluation.

    Science.gov (United States)

    Larese Filon, Francesca; Mauro, Marcella; Adami, Gianpiero; Bovenzi, Massimo; Crosera, Matteo

    2015-07-01

    Nanoparticles (NPs) skin absorption is a wide issue, which needs to be better understood. The attempt of this review is to summarize the scientific evidence concerning open questions, i.e.: the role of NPs intrinsic characteristics (size, shape, charge, surface properties), the penetration of NPs through the intact or impaired skin barrier, the penetration pathways which should be considered and the role of NPs interaction in physiological media. The outcomes suggest that one main difference should be made between metal and non-metal NPs. Both kinds have a secondary NPs size which is given after interaction in physiological media, and allows a size-dependent skin penetration: NPs⩽4nm can penetrate and permeate intact skin, NPs size between 4 and 20nm can potentially permeate intact and damaged skin, NPs size between 21 and 45nm can penetrate and permeate only damaged skin, NPs size>45nm cannot penetrate nor permeate the skin. Other aspects play an important role, mostly for metal NPs, i.e., dissolution in physiological media, which can cause local and systemic effects, the sensitizing or toxic potential and the tendency to create aggregates. This paper suggests a decision tree to evaluate the potential risk for consumers and workers exposed to NPs.

  9. The use of non-animal alternatives in the safety evaluations of cosmetics ingredients by the Scientific Committee on Consumer Safety (SCCS).

    Science.gov (United States)

    Vinardell, M P

    2015-03-01

    In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g., colourants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers submitted to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition.

  10. Research on safety evaluation model for in-vehicle secondary task driving.

    Science.gov (United States)

    Jin, Lisheng; Xian, Huacai; Niu, Qingning; Bie, Jing

    2015-08-01

    This paper presents a new method for evaluating in-vehicle secondary task driving safety. There are five in-vehicle distracter tasks: tuning the radio to a local station, touching the touch-screen telephone menu to a certain song, talking with laboratory assistant, answering a telephone via Bluetooth headset, and finding the navigation system from Ipad4 computer. Forty young drivers completed the driving experiment on a driving simulator. Measures of fixations, saccades, and blinks are collected and analyzed. Based on the measures of driver eye movements which have significant difference between the baseline and secondary task driving conditions, the evaluation index system is built. The Analytic Network Process (ANP) theory is applied for determining the importance weight of the evaluation index in a fuzzy environment. On the basis of the importance weight of the evaluation index, Fuzzy Comprehensive Evaluation (FCE) method is utilized to evaluate the secondary task driving safety. Results show that driving with secondary tasks greatly distracts the driver's attention from road and the evaluation model built in this study could estimate driving safety effectively under different driving conditions.

  11. Evaluation of biological control agents for mosquitoes control in artificial breeding places

    Institute of Scientific and Technical Information of China (English)

    Salim Abadi Yaser; Vatandoost Hassan; Rassi Yavar; Abai Mohammad Reza; Sanei Dehkordi Ali Reza; Paksa Azim

    2010-01-01

    Objective:To evaluate the entomological impact of chlorpyrifos-methyl,Bacillus thuringiensis, andGambusia affinis on mosquitoes control in artificial breeding places.Methods:A Latin square design with 4 replicates was performed in order to evaluate the efficacy of chlorpyrifos-methyl,Bacillus thuringiensis, andGambusia affinis on larva. The larvicide was applied at the dosage of 100 mg a.h/ha,Bacillus thuringiensis at the recommended dosage and 10 fishes per m2 were applied at 1í1 m2 artificial breeding sites. The larval densities for both anopheline and culicine were counted according to larvae /10 dippers prior and 24 h after application.Results:All three control agents are effective for mosquito density reduction, and the difference between the three agents and the control is significant (P<0.05). There is also significant difference among chlorpyrifos-methyl,Bacillus thuringiensis andGambusia affinis.Bacillus thuringiensisexhibited more reduction on mosquito larval density than fish and larvicide (P<0.05).Conclusions:Bacillus thuringiensis in comparison with two other agents is the appropriate method for larviciding in the breeding places. Although long term assessing for biological activities as well as monitoring and mapping of resistance is required.

  12. Pineapple juice as a negative oral contrast agent in magnetic resonance cholangiopancreatography: a preliminary evaluation.

    Science.gov (United States)

    Riordan, R D; Khonsari, M; Jeffries, J; Maskell, G F; Cook, P G

    2004-12-01

    The quality of magnetic resonance cholangiopancreatography (MRCP) images is frequently degraded by high signal from the gastrointestinal tract. The aim of this study is to evaluate pineapple juice (PJ) as an oral negative contrast agent in MRCP. Preliminary in vitro evaluation demonstrated that PJ shortened T(2) relaxation time and hence decreased T(2) signal intensity on a standard MRCP sequence to a similar degree to a commercially available negative contrast agent (ferumoxsil). Electrothermal atomic absorption spectrometry assay demonstrated a high manganese concentration in PJ of 2.76 mg dl(-1), which is likely to be responsible for its T(2) imaging properties. MRCP was subsequently performed in 10 healthy volunteers, before and at 15 min and 30 min following ingestion of 400 ml of PJ. Images were assessed blindly by two Consultant Radiologists using a standard grading technique based on contrast effect (degree of suppression of bowel signal), and image effect (diagnostic quality). There were statistically significant improvements in contrast and image effect between pre and post PJ images. There was particularly significant improvement in visualization of the pancreatic duct, but no significant difference between 15 min and 30 min post PJ images. Visualization of the ampulla, common bile duct, common hepatic and central intrahepatic ducts were also significantly improved at 15 min following PJ. Our results demonstrate that PJ, may be used as an alternative to commercially available negative oral contrast agent in MRCP.

  13. Evaluating Social Media Networks in Medicines Safety Surveillance: Two Case Studies

    NARCIS (Netherlands)

    P.M. Coloma (Preciosa); B. Becker (Benedikt); M.C.J.M. Sturkenboom (Miriam); E.M. Van Mulligen (Erik M.); J.A. Kors (Jan)

    2015-01-01

    textabstractIntroduction: There is growing interest in whether social media can capture patient-generated information relevant for medicines safety surveillance that cannot be found in traditional sources. Objective: The aim of this study was to evaluate the potential contribution of mining social m

  14. Safety Measures with Communicable Diseases. Courseware Evaluation for Vocational and Technical Education.

    Science.gov (United States)

    Yarbrough, Stephen

    This courseware evaluation rates the "Safety Measures with Communicable Diseases" program developed by Lane Community College in Eugene, Oregon. (This program--not contained in this document--is designed to teach means of preventing the spread of communicable respiratory diseases and ways of protecting oneself.) Part A describes the program in…

  15. 75 FR 62895 - Notice of Availability of Safety Evaluation Report; AREVA Enrichment Services LLC, Eagle Rock...

    Science.gov (United States)

    2010-10-13

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Notice of Availability of Safety Evaluation Report; AREVA Enrichment Services LLC, Eagle Rock... special nuclear material. This proposed facility is known as the Eagle Rock Enrichment Facility (EREF)...

  16. Road Safety Education in a Science Course: Evaluation of "Science and the Road."

    Science.gov (United States)

    Gardner, Paul L.

    1989-01-01

    A traffic safety instructional package--"Science and the Road"--was assessed. It was designed by the Road Traffic Authority of Victoria (Australia) for use in tenth-grade science courses. Evaluation findings resulted in revision of the unit and implementation of more inservice courses for teachers lacking relevant biology and physics…

  17. Post-stroke depression treated with acupuncture and moxibustion: an evaluation of therapeutic effect and safety

    Institute of Scientific and Technical Information of China (English)

    聂容荣

    2013-01-01

    Objective To evaluate the efficacy and safety of acupuncture and moxibustion in the treatment of post-stroke depression (PSD) by regulating the liver and strengthening the root prescription.Methods In light of the random controlled trial principle,123 cases were

  18. Safety evaluation for packaging transport of LSA-II liquids in MC-312 cargo tanks

    Energy Technology Data Exchange (ETDEWEB)

    Carlstrom, R.F.

    1996-09-11

    This safety evaluation for packaging authorizes the onsite transfer of bulk LSA-II radioactive liquids in the 222-S Laboratory Cargo Tank and Liquid Effluent Treatment Facility Cargo Tanks (which are U.S. Department of Transportation MC-312 specification cargo tanks) from their operating facilities to tank farm facilities.

  19. Evaluation of safety, performance and emissions of synthetic fuel blends in a Cessna Citation II

    NARCIS (Netherlands)

    Snijders, T.A.; Melkert, J.A.

    2011-01-01

    Prior to being used in aviation, alternative fuels have to be tested thoroughly to ensure safe operation. At Delft University of Technology, a test programme was performed to evaluate the safety, performance and emissions of synthetic fuel blends. During test preparations, compatibility of the synth

  20. Evaluation of On-Farm Food Safety Programming in Pennsylvania: Implications for Extension

    Science.gov (United States)

    Nayak, Roshan; Tobin, Daniel; Thomson, Joan; Radhakrishna, Rama; LaBorde, Luke

    2015-01-01

    Penn State Extension conducted on-farm food safety workshops statewide to train fruit and vegetable growers on Good Agricultural Practices (GAPs). These workshops were evaluated using pre- and post-tests to assess the impact of the training on participating growers. Results indicate overall increases in produce growers' knowledge, attitudes,…

  1. Advancing the Science of Developmental Neurotoxicity (DNT) Testing for Better Safety Evaluation

    DEFF Research Database (Denmark)

    Bal-Price, Anna; Coecke, Sandra; Costa, Lucio;

    2012-01-01

    Bal-Price AK, Coecke S, Costa L, Crofton KM, Fritsche E, Goldberg A, Grandjean P, Lein PJ, Li A, Lucchini R, Mundy WR, Padilla S, Persico A, Seiler AEM, Kreysa J. Conference Report: Advancing the Science of Developmental Neurotoxicity (DNT) Testing for Better Safety Evaluation. Altex 2012: 29: 20...

  2. Evaluation of aviation-based safety team training in a hospital in The Netherlands

    NARCIS (Netherlands)

    D.F. de Korne (Dirk); J.D.H. van Wijngaarden (Jeroen); C. van Dyck (Cathy); U.F. Hiddema (Frans); N.S. Klazinga (Niek)

    2014-01-01

    textabstractPurpose – The purpose of this paper is to evaluate the implementation of a broad-scale team resource management (TRM) program on safety culture in a Dutch eye hospital, detailing the program’s content and procedures. Aviation-based TRM training is recognized as a useful approach to incre

  3. An Evaluation of Computerized Behavioral Skills Training to Teach Safety Skills to Young Children

    Science.gov (United States)

    Vanselow, Nicholas R.; Hanley, Gregory P.

    2014-01-01

    Previous research has demonstrated the efficacy of behavioral skills training (BST) and in situ training (IST) for teaching children to protect themselves. However, BST may be resource intensive and difficult to implement on a large scale. We evaluated a computerized version of BST (CBST) to teach safety skills and determined the extent to which…

  4. Design, synthesis, and biological evaluation of anti-EV71 agents.

    Science.gov (United States)

    Li, Peng; Yang, Bailing; Hao, Fei; Wang, Ping; He, Haiying; Huang, Lei; Zhang, Xuan; Zhang, Shengbin; Peng, Xuanjia; Yin, Ke; Hu, Jiao; Chen, Xinsheng; Gu, Zhengxian; Wang, Li; Shen, Liang; Hu, Guoping; Li, Ning; Li, Jian; Chen, Shuhui; Xiao, Wei; Wang, Zhenzhong; Guo, Qingming; Chang, Xiujuan; Zhang, Lanjun; Cai, Qixu; Lin, Tianwei

    2016-07-15

    Enterovirus 71 (EV71) is a major causative agent of hand, foot and mouth disease (HFMD), which can spread its infections to the central nervous and other systems with severe consequences. In this article, design, chemical synthesis, and biological evaluation of various anti-EV71 agents which incorporate Michael acceptors are described. Further SAR study demonstrated that lactone type of Michael acceptor provided a new lead of anti-EV71 drug candidates with high anti-EV71 activity in cell-based assay and enhanced mouse plasma stability. One of the most potent compounds (2K, cell-based anti-EV71 EC50=0.028μM), showed acceptable stability profile towards mouse plasma, which resulted into promising pharmacokinetics in mouse via IP administration.

  5. Synthesis and Evaluation of Ciprofloxacin-Nitroxide Conjugates as Anti-Biofilm Agents

    Directory of Open Access Journals (Sweden)

    Anthony D. Verderosa

    2016-06-01

    Full Text Available As bacterial biofilms are often refractory to conventional antimicrobials, the need for alternative and/or novel strategies for the treatment of biofilm related infections has become of paramount importance. Herein, we report the synthesis of novel hybrid molecules comprised of two different hindered nitroxides linked to the piperazinyl secondary amine of ciprofloxacin via a tertiary amine linker achieved utilising reductive amination. The corresponding methoxyamine derivatives were prepared alongside their radical-containing counterparts as controls. Subsequent biological evaluation of the hybrid compounds on preformed P. aeruginosa flow cell biofilms divulged significant dispersal and eradication abilities for ciprofloxacin-nitroxide hybrid compound 10 (up to 95% eradication of mature biofilms at 40 μM. Importantly, these hybrids represent the first dual-action antimicrobial-nitroxide agents, which harness the dispersal properties of the nitroxide moiety to circumvent the well-known resistance of biofilms to treatment with antimicrobial agents.

  6. Isolation and Evaluation of Mucilage of Adansonia digitata Linn as a Suspending Agent.

    Science.gov (United States)

    Deshmukh, S S; Katare, Y S; Shyale, S S; Bhujbal, S S; Kadam, S D; Landge, D A; Shah, D V; Pawar, J B

    2013-01-01

    Natural excipients can serve as alternative to synthetic products because of local accessibility, biodegradability, eco-friendly nature and cost effectiveness as compared to synthetic products. Therefore, it is a current need to explore natural excipients that can be used as an effective alternative excipient for the formulation of pharmaceutical dosage forms. Adansonia digitata (Malvaceae) has been traditionally used as febrifuge, antiasthmatic and also in the treatment of dysentery, smallpox, and measles. Reports have indicated that mucilage of the leaves of the plant is edible and nontoxic; hence, the present study is an attempt of isolation and evaluation of mucilage obtained from leaves of Adansonia digitata as suspending agent. Various physicochemical as well as suspending agent properties of mucilage were studied. Mucilage obtained from leaves has shown comparable results with sodium carboxy methyl cellulose.

  7. Isolation and Evaluation of Mucilage of Adansonia digitata Linn as a Suspending Agent

    Directory of Open Access Journals (Sweden)

    S. S. Deshmukh

    2013-01-01

    Full Text Available Natural excipients can serve as alternative to synthetic products because of local accessibility, biodegradability, eco-friendly nature and cost effectiveness as compared to synthetic products. Therefore, it is a current need to explore natural excipients that can be used as an effective alternative excipient for the formulation of pharmaceutical dosage forms. Adansonia digitata (Malvaceae has been traditionally used as febrifuge, antiasthmatic and also in the treatment of dysentery, smallpox, and measles. Reports have indicated that mucilage of the leaves of the plant is edible and nontoxic; hence, the present study is an attempt of isolation and evaluation of mucilage obtained from leaves of Adansonia digitata as suspending agent. Various physicochemical as well as suspending agent properties of mucilage were studied. Mucilage obtained from leaves has shown comparable results with sodium carboxy methyl cellulose.

  8. Integrated indicator to evaluate vehicle performance across: Safety, fuel efficiency and green domains.

    Science.gov (United States)

    Torrao, G; Fontes, T; Coelho, M; Rouphail, N

    2016-07-01

    In general, car manufacturers face trade-offs between safety, efficiency and environmental performance when choosing between mass, length, engine power, and fuel efficiency. Moreover, the information available to the consumers makes difficult to assess all these components at once, especially when aiming to compare vehicles across different categories and/or to compare vehicles in the same category but across different model years. The main objective of this research was to develop an integrated tool able to assess vehicle's performance simultaneously for safety and environmental domains, leading to the research output of a Safety, Fuel Efficiency and Green Emissions (SEG) indicator able to evaluate and rank vehicle's performance across those three domains. For this purpose, crash data was gathered in Porto (Portugal) for the period 2006-2010 (N=1374). The crash database was analyzed and crash severity prediction models were developed using advanced logistic regression models. Following, the methodology for the SEG indicator was established combining the vehicle's safety and the environmental evaluation into an integrated analysis. The obtained results for the SEG indicator do not show any trade-off between vehicle's safety, fuel consumption and emissions. The best performance was achieved for newer gasoline passenger vehicles (engine size (fuel economy and/or in green performance. On the other hand, for larger engine size vehicles (>2000cm(3)) the combined score for safety user profile was in average more satisfactory than for vehicles in the smaller engine size group (fuel efficiency and green emissions). Furthermore, SEG indicator allows the comparison of vehicles across different categories and vehicle model years. Hence, this research is intended to support the decision-making process for transportation policy, safety and sustainable mobility, providing insights not only to policy makers, but also for general public guidance.

  9. Evaluation of Efficacy and Safety of Drugs Penetrated into Skin Using Their Physicochemical Parameters

    OpenAIRE

    押坂, 勇志; 藤堂, 浩明; 杉林, 堅次

    2012-01-01

    Skin has been paid attention as a site of application of prescription drugs, over-the-counter drugs (non-prescription drugs) and cosmetics. Skin permeation and skin concentration of the compounds should be considered after topical administration, as well as their blood concentration to evaluate efficacy and safety. Since the evaluation of the amount of drugs permeated through skin is important for topically applied drugs, studies on the skin permeation has been greatly advanced. In addition, ...

  10. A Rodent Model of Chikungunya Virus Infection in RAG1 -/- Mice, with Features of Persistence, for Vaccine Safety Evaluation.

    Directory of Open Access Journals (Sweden)

    Robert L Seymour

    Full Text Available Chikungunya virus (CHIKV is a positive sense, single stranded RNA virus in the genus Alphavirus, and the etiologic agent of epidemics of severe arthralgia in Africa, Asia, Europe and, most recently, the Americas. CHIKV causes chikungunya fever (CHIK, a syndrome characterized by rash, fever, and debilitating, often chronic arthritis. In recent outbreaks, CHIKV has been recognized to manifest more neurologic signs of illness in the elderly and those with co-morbidities. The syndrome caused by CHIKV is often self-limited; however, many patients develop persistent arthralgia that can last for months or years. These characteristics make CHIKV not only important from a human health standpoint, but also from an economic standpoint. Despite its importance as a reemerging disease, there is no licensed vaccine or specific treatment to prevent CHIK. Many studies have begun to elucidate the pathogenesis of CHIKF and the mechanism of persistent arthralgia, including the role of the adaptive immune response, which is still poorly understood. In addition, the lack of an animal model for chronic infection has limited studies of CHIKV pathogenesis as well as the ability to assess the safety of vaccine candidates currently under development. To address this deficiency, we used recombination activating gene 1 (RAG1-/- knockout mice, which are deficient in both T and B lymphocytes, to develop a chronic CHIKV infection model. Here, we describe this model as well as its use in evaluating the safety of a live-attenuated vaccine candidate.

  11. A Rodent Model of Chikungunya Virus Infection in RAG1 -/- Mice, with Features of Persistence, for Vaccine Safety Evaluation.

    Science.gov (United States)

    Seymour, Robert L; Adams, A Paige; Leal, Grace; Alcorn, Maria D H; Weaver, Scott C

    2015-01-01

    Chikungunya virus (CHIKV) is a positive sense, single stranded RNA virus in the genus Alphavirus, and the etiologic agent of epidemics of severe arthralgia in Africa, Asia, Europe and, most recently, the Americas. CHIKV causes chikungunya fever (CHIK), a syndrome characterized by rash, fever, and debilitating, often chronic arthritis. In recent outbreaks, CHIKV has been recognized to manifest more neurologic signs of illness in the elderly and those with co-morbidities. The syndrome caused by CHIKV is often self-limited; however, many patients develop persistent arthralgia that can last for months or years. These characteristics make CHIKV not only important from a human health standpoint, but also from an economic standpoint. Despite its importance as a reemerging disease, there is no licensed vaccine or specific treatment to prevent CHIK. Many studies have begun to elucidate the pathogenesis of CHIKF and the mechanism of persistent arthralgia, including the role of the adaptive immune response, which is still poorly understood. In addition, the lack of an animal model for chronic infection has limited studies of CHIKV pathogenesis as well as the ability to assess the safety of vaccine candidates currently under development. To address this deficiency, we used recombination activating gene 1 (RAG1-/-) knockout mice, which are deficient in both T and B lymphocytes, to develop a chronic CHIKV infection model. Here, we describe this model as well as its use in evaluating the safety of a live-attenuated vaccine candidate.

  12. Preparation and evaluation of a radiogallium complex-conjugated bisphosphonate as a bone scintigraphy agent

    Energy Technology Data Exchange (ETDEWEB)

    Ogawa, Kazuma, E-mail: kogawa@p.kanazawa-u.ac.jp [Graduate School of Natural Science and Technology, Kanazawa University, Kanazawa 920-1192 (Japan); Takai, Kenichiro; Kanbara, Hiroya; Kiwada, Tatsuto [Graduate School of Natural Science and Technology, Kanazawa University, Kanazawa 920-1192 (Japan); Kitamura, Yoji; Shiba, Kazuhiro [Advanced Science Research Center, Kanazawa University, Kanazawa 920-8640 (Japan); Odani, Akira [Graduate School of Natural Science and Technology, Kanazawa University, Kanazawa 920-1192 (Japan)

    2011-07-15

    Introduction: {sup 68}Ga is a radionuclide of great interest as a positron emitter for positron emission tomography (PET). To develop a new bone-imaging agent with radiogallium, 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA) was chosen as a chelating site and Ga-DOTA complex-conjugated bisphosphonate, which has a high affinity for bone, was prepared and evaluated. Although we are interested in developing {sup 68}Ga-labeled bone imaging agents for PET, in these initial studies {sup 67}Ga was used because of its longer half-life. Methods: DOTA-conjugated bisphosphonate (DOTA-Bn-SCN-HBP) was synthesized by conjugation of 2-(4-isothiocyanatebenzyl)-1,4,7,10-tetraazacyclododecane-1,4,7, 10-tetraacetic acid to 4-amino-1-hydroxybutylidene-1,1-bisphosphonate (alendronate). {sup 67}Ga-DOTA-Bn-SCN-HBP was prepared by coordination with {sup 67}Ga, and its in vitro and in vivo evaluations were performed. Results: {sup 67}Ga-DOTA-Bn-SCN-HBP was prepared with a radiochemical purity of over 95% without purification. {sup 67}Ga-DOTA-Bn-SCN-HBP had great affinity for hydroxyapatite in binding assay. In biodistribution experiments, {sup 67}Ga-DOTA-Bn-SCN-HBP accumulated in bone rapidly but was hardly observed in tissues other than bone. Pretreatment of an excess amount of alendronate inhibited the bone accumulation of {sup 67}Ga-DOTA-Bn-SCN-HBP. Conclusions: {sup 67}Ga-DOTA-Bn-SCN-HBP showed ideal biodistribution characteristics as a bone-imaging agent. These findings should provide useful information on the drug design of bone imaging agents for PET with {sup 68}Ga.

  13. COMPARATIVE EVALUATION OF TAPIOCA SAGO AND POTATO STARCHES AS DISINTEGRATING AGENTS IN TABLET FORMULATION

    Directory of Open Access Journals (Sweden)

    Gulam Rabbani

    2011-02-01

    Full Text Available In the present study Tapioca sago starch was employed as a disintegrating agent in Chloroquine based tablets at concentration of 5–15% w/w. Properties of the starch were evaluated for angle of repose, bulk density, tapped density, carr’s compressibility index, hausner’s ratio, hydration capacity and swelling capacity. The granules were evaluated for moisture content, angle of repose, bulk density and tapped density, carr’s compressibility index and hausner’s ratio. The tablets were evaluated for thickness, weight variation, crushing strength, friability, disintegration time and dissolution profiles. Batches of tablets containing equivalent concentration of potato starch were employed as standard. Results obtained indicate that as a disintegrant Tapioca sago starch showed comparable results in Chloroquine phosphate tablets with the standard.

  14. Technology Development, Evaluation, and Application (TDEA) FY 2001 Progress Report Environment, Safety, and Health (ESH) Division

    Energy Technology Data Exchange (ETDEWEB)

    L.G. Hoffman; K. Alvar; T. Buhl; E. Foltyn; W. Hansen; B. Erdal; P. Fresquez; D. Lee; B. Reinert

    2002-05-01

    This progress report presents the results of 11 projects funded ($500K) in FY01 by the Technology Development, Evaluation, and Application (TDEA) Committee of the Environment, Safety, and Health Division (ESH). Five projects fit into the Health Physics discipline, 5 projects are environmental science and one is industrial hygiene/safety. As a result of their TDEA-funded projects, investigators have published sixteen papers in professional journals, proceedings, or Los Alamos reports and presented their work at professional meetings. Supplement funds and in-kind contributions, such as staff time, instrument use, and workspace, were also provided to TDEA-funded projects by organizations external to ESH Divisions.

  15. Seismic stability safety evaluation of gravity dam with shear strength reduction method

    Institute of Scientific and Technical Information of China (English)

    Da-sheng WANG; Liao-jun ZHANG; Jian-jun XU; Ming-jie HE; Wei-di ZHANG

    2009-01-01

    A new method of numerical seismic stability safety evaluation for a rock slope is proposed based on the analysis of a gravity dam foundation subjected to earthquake loading. The shear strengths of the weak discontinuities are divided by different shear strength reduction ratios (K) and numerical seismic analysis is carried out after the static analysis is completed. With different K values, the curves of the permanent horizontal displacement of key points of the dam foundation (K-displacement curves) are studied. According to the curve change, the distribution of plastic zones in the foundation, and the slow convergence of the finite element method (FEM), the seismic stability safety factor is defined as K when the gravity dam is in the limit equilibrium state subjected to earthquake loading. These concepts were applied to the evaluation of seismic stability safety of a gravity dam for a hydropower project. The analysis of the example shows that the proposed method is feasible and is an effective method of seismic stability safety evaluation.

  16. Seismic stability safety evaluation of gravity dam with shear strength reduction method

    Directory of Open Access Journals (Sweden)

    Da-sheng WANG

    2009-06-01

    Full Text Available A new method of numerical seismic stability safety evaluation for a rock slope is proposed based on the analysis of a gravity dam foundation subjected to earthquake loading. The shear strengths of the weak discontinuities are divided by different shear strength reduction ratios (K and numerical seismic analysis is carried out after the static analysis is completed. With different K values, the curves of the permanent horizontal displacement of key points of the dam foundation (K-displacement curves are studied. According to the curve change, the distribution of plastic zones in the foundation, and the slow convergence of the finite element method (FEM, the seismic stability safety factor is defined as K when the gravity dam is in the limit equilibrium state subjected to earthquake loading. These concepts were applied to the evaluation of seismic stability safety of a gravity dam for a hydropower project. The analysis of the example shows that the proposed method is feasible and is an effective method of seismic stability safety evaluation.

  17. Evaluation Standard for Safety Coefficient of Roller Compacted Concrete Dam Based on Finite Element Method

    Directory of Open Access Journals (Sweden)

    Bo Li

    2014-01-01

    Full Text Available The lack of evaluation standard for safety coefficient based on finite element method (FEM limits the wide application of FEM in roller compacted concrete dam (RCCD. In this paper, the strength reserve factor (SRF method is adopted to simulate gradual failure and possible unstable modes of RCCD system. The entropy theory and catastrophe theory are used to obtain the ultimate bearing resistance and failure criterion of the RCCD. The most dangerous sliding plane for RCCD failure is found using the Latin hypercube sampling (LHS and auxiliary analysis of partial least squares regression (PLSR. Finally a method for determining the evaluation standard of RCCD safety coefficient based on FEM is put forward using least squares support vector machines (LSSVM and particle swarm optimization (PSO. The proposed method is applied to safety coefficient analysis of the Longtan RCCD in China. The calculation shows that RCCD failure is closely related to RCCD interface strength, and the Longtan RCCD is safe in the design condition. Considering RCCD failure characteristic and combining the advantages of several excellent algorithms, the proposed method determines the evaluation standard for safety coefficient of RCCD based on FEM for the first time and can be popularized to any RCCD.

  18. In vitro and ex vivo evaluation of silica-coated super paramagnetic iron oxide nanoparticles (SPION) as biomedical photoacoustic contrast agent

    Science.gov (United States)

    Alwi, Rudolf; Telenkov, Sergey A.; Mandelis, Andreas; Leshuk, Timothy; Gu, Frank; Oladepo, Sulayman; Michaelian, Kirk; Dickie, Kristopher

    2013-03-01

    The employment of contrast agents in photoacoustic imaging has gained significant attention within the past few years for their biomedical applications. In this study, the use of silica-coated superparamagnetic iron oxide (Fe3O4) nanoparticles (SPION) was investigated as a contrast agent in biomedical photoacoustic imaging. SPIONs have been widely used as Food-and-Drug-Administration (FDA)-approved contrast agents for magnetic resonance imaging (MRI) and are known to have an excellent safety profile. Using our frequency-domain photoacoustic correlation technique ("the photoacoustic radar") with modulated laser excitation, we examined the effects of nanoparticle size, concentration and biological medium (e.g. serum, sheep blood) on its photoacoustic response in turbid media (intralipid solution). Maximum detection depth and minimum measurable SPION concentration were determined experimentally. The detection was performed using a single element transducer. The nanoparticle-induced optical contrast ex vivo in dense muscular tissues (avian pectus) was evaluated using a phased array photoacoustic probe and the strong potential of silicacoated SPION as a possible photoacoustic contrast agent was demonstrated. This study opens the way for future clinical applications of nanoparticle-enhanced photoacoustic imaging in cancer therapy.

  19. Synthesis and evaluation of pyrazolines bearing benzothiazole as anti-inflammatory agents.

    Science.gov (United States)

    Kharbanda, Chetna; Alam, Mohammad Sarwar; Hamid, Hinna; Javed, Kalim; Bano, Sameena; Dhulap, Abhijeet; Ali, Yakub; Nazreen, Syed; Haider, Saqlain

    2014-11-01

    The present study aims at the synthesis of pyrazolines bearing benzothiazole and their evaluation as anti-inflammatory agents. The synthesized compounds were evaluated for their anti-inflammatory potential using carrageenan induced paw edema model. Two compounds 5a and 5d alleviated inflammation more than the standard drug celecoxib. Eight compounds 5 b, 5 c, 5 e, 5 g, 5 h, 6 b, 6 e and 6 f showed anti-inflammatory activity comparable to celecoxib. To understand the mode of action, COX-2 enzyme assay and TNF-α assay were carried out. All the active compounds were assessed for their cytotoxicity. The ulcerogenic risk evaluation was performed on the active compounds that were not found to be cytotoxic. Out of ten active compounds, two compounds (5 d and 6 f) were finally found to be the most potent anti-inflammatory agents attributing to the suppression of the COX-2 enzyme activity and TNF-α production without being either cytotoxic or ulcerogenic.

  20. Evaluation of a targeted nanobubble ultrasound contrast agent for potential tumor imaging

    Science.gov (United States)

    Li, Chunfang; Shen, Chunxu; Liu, Haijuan; Wu, Kaizhi; Zhou, Qibing; Ding, Mingyue

    2015-03-01

    Targeted nanobubbles have been reported to improve the contrast effect of ultrasound imaging due to the enhanced permeation and retention effects at tumor vascular leaks. In this work, the contrast enhancement abilities and the tumor targeting potential of a self-made VEGFR2-targeted nanobubble ultrasound contrast agent was evaluated in-vitro and in-vivo. Size distribution and zeta potential were assessed. Then the contrast-enhanced ultrasound imaging of the VEGFR2 targeted nanobubbles were evaluated with a custom-made experimental apparatus and in normal Wistar rats. Finally, the in-vivo tumor-targeting ability was evaluated on nude mice with subcutaneous tumor. The results showed that the target nanobubbles had uniform distribution with the average diameter of 208.1 nm, polydispersity index (PDI) of 0.411, and zeta potential of -13.21 mV. Significant contrast enhancement was observed in both in-vitro and in-vivo ultrasound imaging, demonstrating that the self-made target nanobubbles can enhance the contrast effect of ultrasound imaging efficiently. Targeted tumor imaging showed less promising result, due to the fact that the targeted nanobubbles arriving and permeating through tumor vessels were not many enough to produce significant enhancement. Future work will focus on exploring new imaging algorithm which is sensitive to targeted nanobubbles, so as to correctly detect the contrast agent, particularly at a low bubble concentration.

  1. GROWTH OF THE INTERNATIONAL CRITICALITY SAFETY AND REACTOR PHYSICS EXPERIMENT EVALUATION PROJECTS

    Energy Technology Data Exchange (ETDEWEB)

    J. Blair Briggs; John D. Bess; Jim Gulliford

    2011-09-01

    Since the International Conference on Nuclear Criticality Safety (ICNC) 2007, the International Criticality Safety Benchmark Evaluation Project (ICSBEP) and the International Reactor Physics Experiment Evaluation Project (IRPhEP) have continued to expand their efforts and broaden their scope. Eighteen countries participated on the ICSBEP in 2007. Now, there are 20, with recent contributions from Sweden and Argentina. The IRPhEP has also expanded from eight contributing countries in 2007 to 16 in 2011. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Criticality Safety Benchmark Experiments1' have increased from 442 evaluations (38000 pages), containing benchmark specifications for 3955 critical or subcritical configurations to 516 evaluations (nearly 55000 pages), containing benchmark specifications for 4405 critical or subcritical configurations in the 2010 Edition of the ICSBEP Handbook. The contents of the Handbook have also increased from 21 to 24 criticality-alarm-placement/shielding configurations with multiple dose points for each, and from 20 to 200 configurations categorized as fundamental physics measurements relevant to criticality safety applications. Approximately 25 new evaluations and 150 additional configurations are expected to be added to the 2011 edition of the Handbook. Since ICNC 2007, the contents of the 'International Handbook of Evaluated Reactor Physics Benchmark Experiments2' have increased from 16 different experimental series that were performed at 12 different reactor facilities to 53 experimental series that were performed at 30 different reactor facilities in the 2011 edition of the Handbook. Considerable effort has also been made to improve the functionality of the searchable database, DICE (Database for the International Criticality Benchmark Evaluation Project) and verify the accuracy of the data contained therein. DICE will be discussed in separate papers at ICNC 2011. The status of the

  2. Evaluation of experimental methods for assessing safety for ultrasound radiation force elastography.

    Science.gov (United States)

    Skurczynski, M J; Duck, F A; Shipley, J A; Bamber, J C; Melodelima, D

    2009-08-01

    Standard test tools have been evaluated for the assessment of safety associated with a prototype transducer intended for a novel radiation force elastographic imaging system. In particular, safety has been evaluated by direct measurement of temperature rise, using a standard thermal test object, and detection of inertial cavitation from acoustic emission. These direct measurements have been compared with values of the thermal index and mechanical index, calculated from acoustic measurements in water using standard formulae. It is concluded that measurements using a thermal test object can be an effective alternative to the calculation of thermal index for evaluating thermal hazard. Measurement of the threshold for cavitation was subject to considerable variability, and it is concluded that the mechanical index still remains the preferred standard means for assessing cavitation hazard.

  3. Restart of K-Reactor, Savannah River Site: Safety evaluation report

    Energy Technology Data Exchange (ETDEWEB)

    1991-04-01

    This Safety Evaluation Report (SER) focuses on those issues required to support the restart of the K-Reactor at the Savannah River Plant. This SER provides the safety criteria for restart and documents the results of the staff reviews of the DOE and operating contractor activities to meet these criteria. To develop the restart criteria for the issues discussed in this SER, the Savannah River Restart Office and Savannah River Special Projects Office staffs relied, when possible, on commercial industry codes and standards and on NRC requirements and guidelines for the commercial nuclear industry. However, because of the age and uniqueness of the Savannah River reactors, criteria for the commercial plants were not always applicable. In these cases, alternate criteria were developed. The restart criteria applicable to each of the issues are identified in the safety evaluations for each issue. The restart criteria identified in this report are intended to apply only to restart of the Savannah River reactors. Following the development of the acceptance criteria, the DOE staff and their support contractors evaluated the results of the DOE and operating contractor (WSRC) activities to meet these criteria. The results of those evaluations are documented in this report. Deviations or failures to meet the requirements are either justified in the report or carried as open or confirmatory items to be completed and evaluated in supplements to this report before restart. 62 refs., 1 fig.

  4. 76 FR 65734 - Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption...

    Science.gov (United States)

    2011-10-24

    ...-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Guidance for Industry: Evaluating the Safety of Flood-Affected Food Crops for Human Consumption... information on how to evaluate the safety of flood-affected food crops for human consumption. DATES:...

  5. Ecological Safety of Textile Pre-treatment Agent (Ⅰ)%纺织品前处理剂的生态安全概况(上)

    Institute of Scientific and Technical Information of China (English)

    白濛

    2012-01-01

      本文系统论述了纺织印染前处理剂生态评估存在的相关问题以及前处理中主要表面活性剂和螯合分散剂的生态安全问题。重点从毒理学角度讨论烷基苯环酸钠、烷基酚聚氧乙烯醚和EDTA的生态安全性。%  This article discussed the ecological assessment of the pretreatment agent and related issues in textile dyeing and printing, as well as the ecological safety of major surfactants and chelating dispersants. The ecological safety of alkyl benzene ring sodium, alkyphenol ethoxylates and EDTA was mainly discussed on toxicological aspect.

  6. Synthesis and pharmacological evaluation of pyrazolopyrimidopyrimidine derivatives: anti-inflammatory agents with gastroprotective effect in rats

    OpenAIRE

    2013-01-01

    We report the synthesis of new anti-inflammatory 1,7-dihydropyrazolo[3′,4′:4,5]pyrimido[1,6-a]pyrimidine 5 from aminocyanopyrazole. All compounds were characterized by physical, chemical and spectral studies. Preliminary pharmacological evaluation of the resulting products showed that compounds 5a, b, f (50–100 mg/kg, i.p) are active anti-inflammatory agents in carrageenan-induced rat paw oedema assay, and their effects are comparable to that of acetylsalicylic–lysine (300 mg/kg, i.p.), used ...

  7. Quantitative Evaluation of Contamination on Dental Zirconia Ceramic by Silicone Disclosing Agents after Different Cleaning Procedures

    Directory of Open Access Journals (Sweden)

    Sebastian Wille

    2015-05-01

    Full Text Available The aim of this study was to evaluate the effectiveness of cleaning procedures for air-abraded zirconia after contamination with two silicone disclosing agents. Air-abraded zirconia ceramic specimens (IPS e.max ZirCAD were contaminated with either GC Fit Checker white or GC Fit Checker II. Untreated zirconia specimens were used as control. Afterwards the surfaces were cleaned either with waterspray or ultrasonically in 99% isopropanol or using a newly developed cleaning paste (Ivoclean. After cleaning X-ray photoelectron spectroscopy (XPS was performed and the relative peak intensities of Zr, C and Si were used for a qualitative comparison of the residuals. There was no significant difference between the two different silicone disclosing agents. An additional cleaning step with isopropanol led to a significantly lower amount of residuals on the surface, but an additional cleaning process with Ivoclean did not reduce the amount of carbon residuals in comparison to the isopropanol cleaning. Just the silicone amount on the surface was reduced. None of the investigated cleaning processes removed all residuals from the contaminated surface. Standard cleaning processes do not remove all residuals of the silicone disclosing agent from the surface. This may lead to a failure of the resin-ceramic bonding.

  8. Development of dental resin luting agents based on Bis-EMA4: bond strength evaluation

    Directory of Open Access Journals (Sweden)

    2008-02-01

    Full Text Available The aim of this study was to investigate the influence of incorporating Bis-EMA4 monomer into experimental Bis-GMA/TEGDMA-based resin luting agents on the bond strength to dentin. Seven mixtures were prepared with the following ratios (wt% of Bis-GMA/TEGDMA/Bis-EMA4: 50/50/0, 50/30/20, 50/10/40, 50/0/50, 30/10/60, 10/10/80 and 0/0/100. Camphorquinone (0.4 wt%, N,N-dimethyl-p-toluidine (0.8 wt% and hydroquinone (0.2 wt% were dissolved in each mixture, which was loaded with silanated strontium glass fillers to a constant content of 60 wt%. Bond strength was evaluated by microshear testing (n = 10 on bovine dentin. Data were submitted to Analysis of Variance (p<0.05. Modes of failure were classified under magnification (200×. Bond strength means (MPa, respective to each agent, were: 19.4, 19.8, 20.0, 19.1, 16.8, 18.7 and 17.8. No significant differences were detected among groups. Mixed failures were generally predominant for all materials. In conclusion, the addition of Bis-EMA4 presented no significant influence on the bond strength of the experimental resin luting agents to dentin.

  9. Biocompatibility and Effectiveness Evaluation of a New Hemostatic Embolization Agent: Thrombin Loaded Alginate Calcium Microsphere

    Directory of Open Access Journals (Sweden)

    Fengqi Xuan

    2017-01-01

    Full Text Available Background. Until now, there has been no ideal embolization agent for hemorrhage in interventional treatment. In this study, the thrombin was encapsulated in alginate calcium microsphere using electrostatic droplet technique to produce new embolization agent: thrombin loaded alginate calcium microspheres (TACMs. Objectives. The present work was to evaluate the biocompatibility and hemostatic efficiency of TACMs. Methods. Cell cytotoxicity, hemolysis, and superselective embolization of dog liver arteries were performed to investigate the biocompatibility of TACMs. To clarify the embolic effect of TACMs mixed thrombus in vivo, hepatic artery injury animal model of 6 beagles was established and transcatheter artery embolization for bleeding was performed. Results. Coculture with VECs revealed the noncytotoxicity of TACMs, and the hemolysis experiment was negligible. Moreover, the histological study of TACMs in liver blood vessel showed signs of a slight inflammatory reaction. The results of transcatheter application of TACMs mixed thrombus for bleeding showed that the blood flow was shut down completely after the TACMs mixed thrombus was delivered and the postprocedural survival rate of animal models at 12 weeks was 100%. Conclusions. With their good biocompatibility and superior hemostatic efficiency, TACMs might be a promising new hemostatic agent with a wide range of potential applications.

  10. Biocompatibility and Effectiveness Evaluation of a New Hemostatic Embolization Agent: Thrombin Loaded Alginate Calcium Microsphere

    Science.gov (United States)

    Xuan, Fengqi; Rong, Jingjing; Liang, Ming; Zhang, Xuwen; Sun, Jingyang; Zhao, Lijun; Li, Yang; Liu, Dan; Li, Fei; Wang, Xiaozeng

    2017-01-01

    Background. Until now, there has been no ideal embolization agent for hemorrhage in interventional treatment. In this study, the thrombin was encapsulated in alginate calcium microsphere using electrostatic droplet technique to produce new embolization agent: thrombin loaded alginate calcium microspheres (TACMs). Objectives. The present work was to evaluate the biocompatibility and hemostatic efficiency of TACMs. Methods. Cell cytotoxicity, hemolysis, and superselective embolization of dog liver arteries were performed to investigate the biocompatibility of TACMs. To clarify the embolic effect of TACMs mixed thrombus in vivo, hepatic artery injury animal model of 6 beagles was established and transcatheter artery embolization for bleeding was performed. Results. Coculture with VECs revealed the noncytotoxicity of TACMs, and the hemolysis experiment was negligible. Moreover, the histological study of TACMs in liver blood vessel showed signs of a slight inflammatory reaction. The results of transcatheter application of TACMs mixed thrombus for bleeding showed that the blood flow was shut down completely after the TACMs mixed thrombus was delivered and the postprocedural survival rate of animal models at 12 weeks was 100%. Conclusions. With their good biocompatibility and superior hemostatic efficiency, TACMs might be a promising new hemostatic agent with a wide range of potential applications. PMID:28303245

  11. Ecological Safety Evaluation of Land Use in Ji’an City Based on the Principal Component Analysis

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    According to the ecological safety evaluation index data of land-use change in Ji’an City from 1999 to 2008,positive treatment on selected reverse indices is conducted by Reciprocal Method.Meanwhile,Index Method is used to standardize the selected indices,and Principal Component Analysis is applied by using year as a unit.FB is obtained,which is related with the ecological safety of land-use change from 1999 to 2008.According to the scientific,integrative,hierarchical,practical and dynamic principles,ecological safety evaluation index system of land-use change in Ji’an City is established.Principal Component Analysis and evaluation model are used to calculate four parameters,including the natural resources safety index of land use,the socio-economic safety indicators of land use,the eco-environmental safety index of land use,and the ecological safety degree of land use in Ji’an City.Result indicates that the ecological safety degree of land use in Ji’an City shows a slow upward trend as a whole.At the same time,ecological safety degree of land-use change is relatively low in Ji’an City with the safety value of 0.645,which is at a weak safety zone and needs further monitoring and maintenance.

  12. STANDARDIZATION AND TOXICOLOGICAL EVALUATION FOR EFFICACY AND SAFETY OF PIMPINELLA ANISUM L.

    Directory of Open Access Journals (Sweden)

    Kalam N

    2012-07-01

    Full Text Available The demand of herbal medicine is increasing day by day due to their efficacy, safety (rare chances of side effects in the treatment and good faith of society on herbal medicine and also their products. Therefore standardization and toxicological study of herbal medicine is quite necessary to check quality, Purity, strength and safety of the drugs. The present work is an attempt to evaluate toxicological parameters for safety of an herbal drug Pimpinella anisum L. such as microbial contamination, aflatoxins, pesticide residues and heavy metals. Additional standardization parameters like, physical constants, ash content, solvent residues, and microscopical analysis were also carried out and reported. The results obtained may be helpful to the regulatory authorities, scientific organizations and manufacturers for developing standards and maintaining the quality of drugs.

  13. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  14. Efficacy and safety of combining intra-articular methylprednisolone and anti-TNF agent to achieve prolonged remission in patients with recurrent inflammatory monoarthritis.

    LENUS (Irish Health Repository)

    Haroon, Muhammad

    2012-02-01

    OBJECTIVE: To control local inflammation, the role of intra-articular corticosteroid is well established; similarly, with time there are more reports on the experience of intra-articular anti-TNF agent for localized joint inflammation. The aim of this study was to assess the safety, local tolerability and clinical response after combining intra-articular administration of corticosteroids and anti-TNF agents for recurrent inflammatory monoarthritis. METHODS: Patients with recurrent monoarthritis of the knee were recruited from our inflammatory arthritis clinics. These patients required intra-articular corticosteroids every 8-12 weeks, with good short-term results. Five such consecutive patients were invited to partake in this study. Patients were maintained on their baseline immunosuppressive therapy. After aspiration of knee joint, the involved joint was injected with 80mg of methylprednisolone mixed with 5ml of lignocaine 1%; this was followed by the injection of an anti-TNF agent. RESULTS: In majority of our patients (three out of five), combining anti-TNF agent and methylprednisolone led to prolonged anti-inflammatory response, and these patients remain in remission to date (mean follow-up of 12 months). These responders were noted to be naive to anti-TNF therapy. Conversely, the remaining two patients were found to be on baseline systemic anti-TNF therapy, and both of them failed to respond either partly or completely. CONCLUSION: Combining intra-articular corticosteroid and anti-TNF agent has proved to be safe in our cohort of patients. We conclude that in particular subset of patients who suffer from recurrent inflammatory monoarthritis or oligoarthritis, combination therapy of intra-articular corticosteroids and anti-TNF agents appears attractive and promising.

  15. Evaluation of pedestrian safety at intersections: A theoretical framework based on pedestrian-vehicle interaction patterns.

    Science.gov (United States)

    Ni, Ying; Wang, Menglong; Sun, Jian; Li, Keping

    2016-11-01

    Pedestrians are the most vulnerable road users, and pedestrian safety has become a major research focus in recent years. Regarding the quality and quantity issues with collision data, conflict analysis using surrogate safety measures has become a useful method to study pedestrian safety. However, given the inequality between pedestrians and vehicles in encounters and the multiple interactions between pedestrians and vehicles, it is insufficient to simply use the same indicator(s) or the same way to aggregate indicators for all conditions. In addition, behavioral factors cannot be neglected. To better use information extracted from trajectories for safety evaluation and pay more attention on effects of behavioral factors, this paper develops a more sophisticated framework for pedestrian conflict analysis that takes pedestrian-vehicle interactions into consideration. A concept of three interaction patterns has been proposed for the first time, namely "hard interaction," "no interaction," and "soft-interaction." Interactions have been categorized under one of these patterns by analyzing profiles of speed and conflict indicators during the whole interactive processes. In this paper, a support vector machine (SVM) approach has been adopted to classify severity levels for a dataset including 1144 events extracted from three intersections in Shanghai, China, followed by an analysis of variable importance. The results revealed that different conflict indicators have different contributions to indicating the severity level under various interaction patterns. Therefore, it is recommended either to use specific conflict indicators or to use weighted indicator aggregation for each interaction pattern when evaluating pedestrian safety. The implementation has been carried out at the fourth crosswalk, and the results indicate that the proposed method can achieve a higher accuracy and better robustness than conventional methods. Furthermore, the method is helpful for better

  16. Efficacy and Safety Assessment of the Addition of Bevacizumab to Adjuvant Therapy Agents in Cancer Patients : A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Ahmadizar, Fariba; Onland-Moret, N Charlotte; de Boer, Anthonius; Liu, Geoffrey; Maitland-van der Zee, Anke H

    2015-01-01

    AIM: To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. METHODS & DESIGN/ RESULTS: PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials compari

  17. Efficacy and safety assessment of the addition of bevacizumab to adjuvant therapy agents in cancer patients: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Ahmadizar, Fariba; Onland-Moret, N. Charlotte; De Boer, Anthonius; Liu, Geoffrey; Maitland-Van Der Zee, Anke H.

    2015-01-01

    Aim: To evaluate the efficacy and safety of bevacizumab in the adjuvant cancer therapy setting within different subset of patients. Methods & Design/Results: PubMed, EMBASE, Cochrane and Clinical trials.gov databases were searched for English language studies of randomized controlled trials comparin

  18. The safety and effectiveness of once daily detemir in patients with type 2 diabetes previously failing oral agents:the Chinese cohort from SOL-VETM observational study

    Institute of Scientific and Technical Information of China (English)

    潘长玉

    2013-01-01

    Objective To evaluate the safety and effectiveness of initiating once-daily insulin detemir(Levemir) as add-on therapy in patients with type 2 diabetes mellitus(T2DM) who failed treatment of oral anti-diabetic drugs(OAD).Methods The present study was derived from the data of

  19. Evaluating the safety risk of roadside features for rural two-lane roads using reliability analysis.

    Science.gov (United States)

    Jalayer, Mohammad; Zhou, Huaguo

    2016-08-01

    The severity of roadway departure crashes mainly depends on the roadside features, including the sideslope, fixed-object density, offset from fixed objects, and shoulder width. Common engineering countermeasures to improve roadside safety include: cross section improvements, hazard removal or modification, and delineation. It is not always feasible to maintain an object-free and smooth roadside clear zone as recommended in design guidelines. Currently, clear zone width and sideslope are used to determine roadside hazard ratings (RHRs) to quantify the roadside safety of rural two-lane roadways on a seven-point pictorial scale. Since these two variables are continuous and can be treated as random, probabilistic analysis can be applied as an alternative method to address existing uncertainties. Specifically, using reliability analysis, it is possible to quantify roadside safety levels by treating the clear zone width and sideslope as two continuous, rather than discrete, variables. The objective of this manuscript is to present a new approach for defining the reliability index for measuring roadside safety on rural two-lane roads. To evaluate the proposed approach, we gathered five years (2009-2013) of Illinois run-off-road (ROR) crash data and identified the roadside features (i.e., clear zone widths and sideslopes) of 4500 300ft roadway segments. Based on the obtained results, we confirm that reliability indices can serve as indicators to gauge safety levels, such that the greater the reliability index value, the lower the ROR crash rate.

  20. Evaluation of Patient Safety Culture and Organizational Culture as a Step in Patient Safety Improvement in a Hospital in Jakarta, Indonesia

    Directory of Open Access Journals (Sweden)

    Afrisya Iriviranty

    2016-07-01

    Full Text Available Introduction: Establishment of patient safety culture is the first step in the improvement of patient safety. As such, assessment of patient safety culture in hospitals is of paramount importance. Patient safety culture is an inherent component of organizational culture, so that the study of organizational culture is required in developing patient safety. This study aimed to evaluate patient safety culture among the clinical staff of a hospital in Jakarta, Indonesia and identify organizational culture profile. Materials and Methods: This cross-sectional, descriptive, qualitative study was conducted in a hospital in Jakarta, Indonesia in 2014. Sample population consisted of nurses, midwives, physicians, pediatricians, obstetrics and gynecology specialists, laboratory personnel, and pharmacy staff (n=152. Data were collected using the Hospital Survey on Patient Safety Culture developed by the Agency for Healthcare Research and Quality (AHRQ and Organizational Culture Assessment Instrument (OCAI. Results: Teamwork within units” was the strongest dimension of patient safety culture (91.7%, while “staffing” and “non-punitive response to error” were the weakest dimensions (22.7%. Moreover, clan culture was the most dominant type of organizational culture in the studied hospital. This culture serves as a guide for the changes in the healthcare organization, especially in the development of patient safety culture. Conclusion: According to the results of this study, healthcare providers were positively inclined toward the patient safety culture within the organization. As such, the action plan was designed through consensus decision-making and deemed effective in articulating patient safety in the vision and mission of the organization.

  1. Human health safety evaluation of cosmetics in the EU: a legally imposed challenge to science.

    Science.gov (United States)

    Pauwels, M; Rogiers, V

    2010-03-01

    As stated in the European legislation, cosmetic products present on the European market must be safe for the consumer. Safety evaluation of the products is carried out by a qualified safety assessor who needs to consider potential exposure scenarios next to the physicochemical and toxicological profiles of all composing ingredients. Whereas, until recently, the tools to determine the toxicological profile of cosmetic ingredients mainly consisted of animal experiments, they have now been narrowed down substantially by the legally imposed animal testing ban on cosmetic ingredients, taken up in the Cosmetic Products Directive (76/768/EEC). This Directive, however, is not a stand-alone piece of European legislation, since as well directly as indirectly it is influenced by a complex web of related legislations. Vertical legislations deal with different categories of chemicals, including dangerous substances, biocides, plant protection products, food additives, medicinal products, and of course also cosmetics. Horizontal legislative texts, on the contrary, cover more general fields such as protection of experimental animals, consumer product safety, misleading of consumers, specific provisions for aerosols, and others. Experience has learnt that having a general overview of these related legislations is necessary to understand their impact on the cosmetic world in general terms and on cosmetic safety evaluation in particular. This goes for a variety of concerned parties, including national and European regulators/agencies, contract laboratories, raw material suppliers, cosmetic companies, research and educational centers. They all deal with a number of aspects important for the quality and toxicity of cosmetics and their ingredients. This review summarises the most relevant points of the legislative texts of different types of product categories and emphasises their impact on the safety evaluation of cosmetics.

  2. Evaluating the Effectiveness of an Educational Intervention to Improve the Patient Safety Attitudes of Intern Pharmacists

    Science.gov (United States)

    Fois, Romano A.; McLachlan, Andrew J.; Chen, Timothy F.

    2017-01-01

    Objective. To evaluate the effectiveness of a face-to-face educational intervention in improving the patient safety attitudes of intern pharmacists. Methods. A patient safety education program was delivered to intern pharmacists undertaking The University of Sydney Intern Training Program in 2014. Their patient safety attitudes were evaluated immediately prior to, immediately after, and three-months post-intervention. Underlying attitudinal factors were identified using exploratory factor analysis. Changes in factor scores were examined using analysis of variance. Results. Of the 120 interns enrolled, 95 (78.7%) completed all three surveys. Four underlying attitudinal factors were identified: attitudes towards addressing errors, questioning behaviors, blaming individuals, and reporting errors. Improvements in all attitudinal factors were evident immediately after the intervention. However, only improvements in attitudes towards blaming individuals involved in errors were sustained at three months post-intervention. Conclusion. The educational intervention was associated with short-term improvements in pharmacist interns’ patient safety attitudes. However, other factors likely influenced their attitudes in the longer term. PMID:28289295

  3. Safety Evaluation Report for the Claiborne Enrichment Center, Homer, Louisiana (Docket No. 70-3070)

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    This report documents the US Nuclear Regulatory Commission (NRC) staff review and safety evaluation of the Louisiana Energy Services, L.P. (LES, the applicant) application for a license to possess and use byproduct, source, and special nuclear material and to enrich natural uranium to a maximum of 5 percent U-235 by the gas centrifuge process. The plant, to be known as the Claiborne Enrichment Center (CEC), would be constructed near the town of Homer in Claiborne Parish, Louisiana. At full production in a given year, the plant will receive approximately 4,700 tonnes of feed UF{sub 6} and produce 870 tonnes of low-enriched UF{sub 6}, and 3,830 tonnes of depleted UF{sub 6} tails. Facility construction, operation, and decommissioning are expected to last 5, 30, and 7 years, respectively. The objective of the review is to evaluate the potential adverse impacts of operation of the facility on worker and public health and safety under both normal operating and accident conditions. The review also considers the management organization, administrative programs, and financial qualifications provided to assure safe design and operation of the facility. The NRC staff concludes that the applicant`s descriptions, specifications, and analyses provide an adequate basis for safety review of facility operations and that construction and operation of the facility does not pose an undue risk to public health and safety.

  4. Evaluation of an experimental rat model for comparative studies of bleaching agents

    Science.gov (United States)

    CINTRA, Luciano Tavares Angelo; BENETTI, Francine; FERREIRA, Luciana Louzada; RAHAL, Vanessa; ERVOLINO, Edilson; JACINTO, Rogério de Castilho; GOMES, João Eduardo; BRISO, André Luiz Fraga

    2016-01-01

    ABSTRACT Dental materials in general are tested in different animal models prior to the clinical use in humans, except for bleaching agents. Objectives To evaluate an experimental rat model for comparative studies of bleaching agents, by investigating the influence of different concentrations and application times of H2O2 gel in the pulp tissue during in-office bleaching of rats’ vital teeth. Material and Methods The right and left maxillary molars of 50 Wistar rats were bleached with 20% and 35% H2O2 gels, respectively, for 5, 10, 15, 30, or 45 min (n=10 rats/group). Ten animals were untreated (control). The rats were killed after 2 or 30 days, and the maxillae were examined by light microscopy. Inflammation was evaluated through histomorphometric analysis with inflammatory cell count in the coronal and radicular thirds of the pulp. Fibroblasts were also counted. Scores were attributed to odontoblastic layer and vascular changes. Tertiary dentin area and pulp chamber central area were measured histomorphometrically. Data were compared by analysis of variance and Kruskal-Wallis test (p<0.05). Results After 2 days, the amount of inflammatory cells increased in the coronal pulp occlusal third up to the 15-min application groups of each bleaching gel. In the groups exposed to each concentration for 30 and 45 min, the number of inflammatory cells decreased along with the appearance of necrotic areas. After 30 days, reduction on the pulp chamber central area and enlargement of the tertiary dentin area were observed, without the detection of inflammation areas. Conclusion The rat model of extracoronal bleaching showed to be adequate for studies of bleaching protocols, as it was possible to observe alterations in the pulp tissues and tooth structure caused by different concentrations and application periods of bleaching agents. PMID:27119766

  5. Evaluation of an experimental rat model for comparative studies of bleaching agents

    Directory of Open Access Journals (Sweden)

    Luciano Tavares Angelo Cintra

    2016-02-01

    Full Text Available ABSTRACT Dental materials, in general, are tested in different animal models prior to their clinical use in humans, except for bleaching agents. Objectives To evaluate an experimental rat model for comparative studies of bleaching agents by investigating the influence of different concentrations and application times of H2O2 gel in the pulp tissue during in-office bleaching of rats’ vital teeth. Material and methods The right and left maxillary molars of 50 Wistar rats were bleached with 20% and 35% H2O2 gels, respectively, for 5, 10, 15, 30, or 45 min (n=10 rats/group. Ten animals (control were untreated. The rats were killed after 2 or 30 days, and the maxillae were examined by light microscopy. Inflammation was evaluated by histomorphometric analysis with inflammatory cell counting in the coronal and radicular thirds of the pulp. The counting of fibroblasts was also performed. Scores were attributed to the odontoblastic layer and to vascular changes. The tertiary dentin area and the pulp chamber central area were histomorphometrically measured. Data were compared by the analysis of variance and the Kruskal-Wallis test (p<0.05. Results After 2 days, the amount of inflammatory cells increased in the occlusal third of the coronal pulp until the time of 15 min for both concentrations of bleaching gels. In 30 and 45 min groups of each concentration, the number of inflammatory cells decreased along with the appearance of necrotic areas. After 30 days, a reduction in the pulp chamber central area and an enlargement of tertiary dentin area were observed without the detection of inflammation areas. Conclusion The rat model of extra coronal bleaching showed to be adequate for bleaching protocols studies, as it was possible to observe alterations in the pulp tissues and in the tooth structure caused by different concentrations and periods of application of bleaching agents.

  6. Evaluation of biosurfactant obtained from Lactobacillus pentosus as foaming agent in froth flotation.

    Science.gov (United States)

    Vecino, X; Devesa-Rey, R; Cruz, J M; Moldes, A B

    2013-10-15

    This study analyzes the kinetics of sediment sorption on two chemical surfactants (Tween 20 and SDS) and a biotechnologically produced surfactant (obtained from Lactobacillus pentosus). Biosurfactants were produced by fermentation of hemicellulosic sugars from vineyard pruning waste supplied as a substrate to L. pentosus. Results obtained showed that almost no SDS was adsorbed onto the sediments, whereas Tween 20 and biosurfactants from L. pentosus were absorbed after a few minutes. Kinetic models revealed that adsorption of surfactant onto riverbed sediments is governed not only by an intra-particle diffusion model (evaluated by the Weber and Morris model), but also by surface reaction models (evaluated by first, second, third order equations and Elovich equation), showing the best fit when employing the Elovich model. The adsorption properties showed by biosurfactant from L. pentosus onto sediments present it as a potential foaming agent in froth flotation.

  7. [Pertinence of animal and human models in the evaluation of ventricular anti-arrhythmia agents].

    Science.gov (United States)

    Funck-Brentano, C; Le Heuzey, J Y

    1991-02-01

    The development of antiarrhythmic agents for the treatment of ventricular arrhythmias depends to a large extent on their effects in different animal and human models. The clinical relevance of the data so obtained is debatable. Firstly, in vitro animal models of arrhythmias are not very predictive of the multiple clinical forms of ventricular arrhythmias. Secondly, the intermediary criteria of evaluation of the effects of antiarrhythmic drugs in humans are generally not valid in terms of criteria of substitution for the evaluation of therapeutic effects. Nevertheless, cellular and hemodynamic studies of the electrophysiological properties of drugs are essential for correct clinical usage of antiarrhythmics. They help predict the principal clinical electrocardiographic changes and their modulation with respect to parameters such as ischemia or heart rate, their hemodynamic tolerance and certain undesirable, especially proarrhythmic, effects. However, the clinical pertinence of these studies remains limited for a number of reasons. In particular, most antiarrhythmic agents have multiple electrophysiological effects, the resultant of which is difficult to predict in the clinical situation. In addition, many of these drugs have active metabolites, the formation of which varies from person to person, which also reduces the clinical relevance of studies of the parent molecule alone. Clinical trials in appropriate patient populations should therefore be preferred to the multiplication of studies on experimental models of uncertain relevance.

  8. Synthesis and Evaluation of New Benzodioxole- Based Thiosemicarbazone Derivatives as Potential Antitumor Agents

    Directory of Open Access Journals (Sweden)

    Mehlika Dilek Altıntop

    2016-11-01

    Full Text Available New benzodioxole-based thiosemicarbazone derivatives were synthesized and evaluated for their cytotoxic effects on A549 human lung adenocarcinoma, C6 rat glioma and NIH/3T3 mouse embryonic fibroblast cells. In order to examine the correlation between anticancer activity and cholinesterases, the compounds were evaluated for their inhibitory effects on AChE and BuChE. The most effective anticancer agents were investigated for their effects on DNA synthesis, apoptosis and mitochondrial membrane potential. 4-(1,3-Benzodioxol-5-yl-1-([1,1′-biphenyl]-4-ylmethylenethiosemicarbazide (5 was identified as the most promising anticancer agent against C6 and A549 cell lines due to its inhibitory effects on C6 and A549 cells and low toxicity to NIH/3T3 cells. Compound 5 increased early and late apoptosis in A549 and C6 cells. Compound 5 also caused disturbance on mitochondrial membrane potential and showed DNA synthesis inhibitory activity in A549 and C6 cells. Compound 5 was investigated for SIRT1 inhibitory activity to provide mechanistic insight and for that purpose docking studies were also performed for this compound on SIRT1. On the other hand, compound 5 did not show any inhibitory activity against AChE and BuChE. This outcome pointed out that there is no relationship between anticancer activity of compound 5 and cholinesterases.

  9. Road safety risk evaluation and target setting using data envelopment analysis and its extensions.

    Science.gov (United States)

    Shen, Yongjun; Hermans, Elke; Brijs, Tom; Wets, Geert; Vanhoof, Koen

    2012-09-01

    Currently, comparison between countries in terms of their road safety performance is widely conducted in order to better understand one's own safety situation and to learn from those best-performing countries by indicating practical targets and formulating action programmes. In this respect, crash data such as the number of road fatalities and casualties are mostly investigated. However, the absolute numbers are not directly comparable between countries. Therefore, the concept of risk, which is defined as the ratio of road safety outcomes and some measure of exposure (e.g., the population size, the number of registered vehicles, or distance travelled), is often used in the context of benchmarking. Nevertheless, these risk indicators are not consistent in most cases. In other words, countries may have different evaluation results or ranking positions using different exposure information. In this study, data envelopment analysis (DEA) as a performance measurement technique is investigated to provide an overall perspective on a country's road safety situation, and further assess whether the road safety outcomes registered in a country correspond to the numbers that can be expected based on the level of exposure. In doing so, three model extensions are considered, which are the DEA based road safety model (DEA-RS), the cross-efficiency method, and the categorical DEA model. Using the measures of exposure to risk as the model's input and the number of road fatalities as output, an overall road safety efficiency score is computed for the 27 European Union (EU) countries based on the DEA-RS model, and the ranking of countries in accordance with their cross-efficiency scores is evaluated. Furthermore, after applying clustering analysis to group countries with inherent similarity in their practices, the categorical DEA-RS model is adopted to identify best-performing and underperforming countries in each cluster, as well as the reference sets or benchmarks for those

  10. Road safety effects of porous asphalt: a systematic review of evaluation studies

    DEFF Research Database (Denmark)

    Elvik, R.; Greibe, Poul

    2005-01-01

    This paper presents a systematic review of studies that have evaluated the effects on road safety of porous asphalt. Porous asphalt is widely used on motorways in Europe, mainly in order to reduce traffic noise and increase road capacity. A meta-analysis was made of six studies, containing a total...... of eighteen estimates of the effect of porous asphalt on accident rates. No clear effect on road safety of porous asphalt was found. All summary estimates of effect indicated very small changes in accident rates and very few were statistically significant at conventional levels. Studies that have evaluated...... the effects of porous asphalt on nine different risk factors associated with accident occurrence were also reviewed. It was found that four of the risk factors were favourably influenced by porous asphalt, three were adversely influenced, and two were not influenced by porous asphalt. The net impact...

  11. Safety evaluation for packaging (onsite) plutonium recycle test reactor graphite cask

    Energy Technology Data Exchange (ETDEWEB)

    Romano, T.

    1997-09-29

    This safety evaluation for packaging (SEP) provides the evaluation necessary to demonstrate that the Plutonium Recycle Test Reactor (PRTR) Graphite Cask meets the requirements of WHC-CM-2-14, Hazardous Material Packaging and Shipping, for transfer of Type B, fissile, non-highway route controlled quantities of radioactive material within the 300 Area of the Hanford Site. The scope of this SEP includes risk, shieldling, criticality, and.tiedown analyses to demonstrate that onsite transportation safety requirements are satisfied. This SEP also establishes operational and maintenance guidelines to ensure that transport of the PRTR Graphite Cask is performed safely in accordance with WHC-CM-2-14. This SEP is valid until October 1, 1999. After this date, an update or upgrade to this document is required.

  12. Safety Evaluation Report Restart of K-Reactor Savannah River Site

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-01

    In April 1991, the Department of Energy (DOE) issued DOE/DP-0084T, Safety Evaluation Report Restart of K-Reactor Savannah River Site.'' The Safety Evaluation Report (SER) documents the results of DOE reviews and evaluations of the programmatic aspects of a large number of issues necessary to be satisfactorily addressed before restart. The issues were evaluated for compliance with the restart criteria included in the SER. The results of those evaluations determined that the restart criteria had been satisfied for some of the issues. However, for most of the issues at least part of the applicable restart criteria had not been found to be satisfied at the time the evaluations were prepared. For those issues, open or confirmatory items were identified that required resolution. In August 1991, DOE issued DOE/DP-0090T, Safety Evaluation Report Restart of K-Reactor Savannah River Site Supplement 1.'' That document was the first Supplement to the April 1991 SER, and documented the resolution of 62 of the open items identified in the SER. This document is the second Supplement to the April 1991 SER. This second SER Supplement documents the resolution of additional open times identified in the SER, and includes a complete list of all remaining SER open items. The resolution of those remaining open items will be documented in future SER Supplements. Resolution of all open items for an issue indicates that its associated restart criteria have been satisfied, and that DOE concludes that the programmatic aspects of the issue have been satisfactorily addressed.

  13. Evaluation of home-based programs for teaching personal safety skills to children

    OpenAIRE

    Miltenberger, Raymond G; Thiesse-Duffy, Ellyn

    1988-01-01

    We evaluated the efficacy of a commercially available program, the Red Flag, Green Flag Prevention Book, used by parents to teach their children personal safety skills. Children's knowledge and skills regarding the prevention of sexual abuse and abduction were assessed prior to, during, and after training. In one group, training consisted of parents using the prevention book to train their children. Parents of children in the second group used the prevention book with added instructions. Chil...

  14. Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers

    OpenAIRE

    Raut, Ashwinikumar A.; Rege, Nirmala N.; Tadvi, Firoz M.; Solanki, Punita V.; Kene, Kirti R.; Shirolkar, Sudatta G.; Shefali N Pandey; Vaidya, Rama A.; Ashok B Vaidya

    2012-01-01

    Ashwagandha (Withania somnifera) (WS), a “rasayana” drug, is recommended for balavardhan and mamsavardhan. The study was intended to evaluate dose-related tolerability, safety, and activity of WS formulation in normal individuals. The design was prospective, open-labeled, variable doses in volunteers. Eighteen apparently healthy volunteers (12M:6F, age:18-30 years, and BMI: 19-30) were enrolled. After baseline investigations, they received WS capsules (Rx) (aqueous extract, 8:1) daily in two ...

  15. Evaluation of safety and tolerability of antiretroviral therapy in pregnant and non-pregnant women

    OpenAIRE

    Kamini Tyagi; Veena Gupta

    2015-01-01

    Background: The study was conducted to evaluate safety and tolerability of different components of combined antiretroviral therapy (CART) in pregnant and non-pregnant women and to find out substitute of the drug causing intolerance. Methods: An observational study on 75 pregnant and 125 non pregnant, HIV infected women receiving CART, over a period of 1 year (Jan 2013-Jan 20140 in SRN Hospital affiliated to MLN Medical college, Allahabad. All women were examined clinically and investigated...

  16. Safety evaluation for packaging for onsite transfer of B Plant organic waste

    Energy Technology Data Exchange (ETDEWEB)

    Mercado, M.S.

    1996-10-07

    This safety evaluation for packaging authorizes the use of a 17,500-L (4,623-gal) tank manufactured by Brenner Tank, Incorporated, to transport up to 16,221 L (4,285 gal) of radioactive organic liquid waste. The waste will be transported from the organic loading pad to a storage pad. Both pads are within the B Plant complex, but approximately 4 mi apart.

  17. Seismic stability safety evaluation of gravity dam with shear strength reduction method

    OpenAIRE

    Wang, Da-Sheng; Liao-jun ZHANG; Xu, Jian-Jun; Ming-jie HE; Wei-di ZHANG

    2009-01-01

    A new method of numerical seismic stability safety evaluation for a rock slope is proposed based on the analysis of a gravity dam foundation subjected to earthquake loading. The shear strengths of the weak discontinuities are divided by different shear strength reduction ratios (K) and numerical seismic analysis is carried out after the static analysis is completed. With different K values, the curves of the permanent horizontal displacement of key points of the dam foundation (K-displacement...

  18. Criticality safety evaluation of disposing of K Basin sludge in double-shell tank AW-105

    Energy Technology Data Exchange (ETDEWEB)

    ROGERS, C.A.

    1999-06-04

    A criticality safety evaluation is made of the disposal of K Basin sludge in double-shell tank (DST) AW-105 located in the 200 east area of Hanford Site. The technical basis is provided for limits and controls to be used in the development of a criticality prevention specification (CPS). A model of K Basin sludge is developed to account for fuel burnup. The iron/uranium mass ration required to ensure an acceptable magrin of subcriticality is determined.

  19. Development and evaluation of a university campus-based food safety media campaign for young adults.

    Science.gov (United States)

    Abbot, Jaclyn Maurer; Policastro, Peggy; Bruhn, Christine; Schaffner, Donald W; Byrd-Bredbenner, Carol

    2012-06-01

    Food safety information campaigns are more likely to be most effective if the messages are tailored to the needs of a specific audience. Designing effective campaigns involves careful study of the target population and working with them using a community-based participatory research model. Thus, the development of the campaign materials for a university campus-based food safety media campaign for young adults followed intense efforts of working with the target audience to gather the baseline data needed to characterize this audience, to identify the most salient messages for college students, and to create materials and events that would resonate with them. This campaign was implemented and evaluated on eight university campuses in the United States. The results indicate that the campaign significantly increased self-ratings of food safety knowledge and skill, actual food safety knowledge, food safety self-efficacy, stage of change for safe food handling, and reported hand washing behaviors of a geographically and racially diverse group of college students. The positive study outcomes support the value of engaging in these research and development efforts and reflect the usefulness of the audience-specific materials and activities developed for the campaign. The findings also demonstrate the versatility and utility of the materials on different campuses. Developing health media campaigns specifically for unique populations is key to ensuring health messages reach the target audience and, even more importantly, appeal to them. The detailed overview of the development of a food safety media campaign aimed at young adults presented in this article illustrates how health professionals can work with their target population to develop a focused, effective health promotion campaign.

  20. Evaluating North Carolina Food Pantry Food Safety-Related Operating Procedures.

    Science.gov (United States)

    Chaifetz, Ashley; Chapman, Benjamin

    2015-11-01

    Almost one in seven American households were food insecure in 2012, experiencing difficulty in providing enough food for all family members due to a lack of resources. Food pantries assist a food-insecure population through emergency food provision, but there is a paucity of information on the food safety-related operating procedures used in the pantries. Food pantries operate in a variable regulatory landscape; in some jurisdictions, they are treated equivalent to restaurants, while in others, they operate outside of inspection regimes. By using a mixed methods approach to catalog the standard operating procedures related to food in 105 food pantries from 12 North Carolina counties, we evaluated their potential impact on food safety. Data collected through interviews with pantry managers were supplemented with observed food safety practices scored against a modified version of the North Carolina Food Establishment Inspection Report. Pantries partnered with organized food bank networks were compared with those that operated independently. In this exploratory research, additional comparisons were examined for pantries in metropolitan areas versus nonmetropolitan areas and pantries with managers who had received food safety training versus managers who had not. The results provide a snapshot of how North Carolina food pantries operate and document risk mitigation strategies for foodborne illness for the vulnerable populations they serve. Data analysis reveals gaps in food safety knowledge and practice, indicating that pantries would benefit from more effective food safety training, especially focusing on formalizing risk management strategies. In addition, new tools, procedures, or policy interventions might improve information actualization by food pantry personnel.

  1. Evaluation of natural phenomena hazards as part of safety assessments for nuclear facilities

    Energy Technology Data Exchange (ETDEWEB)

    Kot, C.A.; Hsieh, B.J.; Srinivasan, M.G.; Shin, Y.W.

    1995-02-01

    The continued operation of existing US Department of Energy (DOE) nuclear facilities and laboratories requires a safety reassessment based on current criteria and guidelines. This also includes evaluations for the effects of Natural Phenomena Hazards (NPH), for which these facilities may not have been designed. The NPH evaluations follow the requirements of DOE Order 5480.28, Natural Phenomena Hazards Mitigation (1993) which establishes NPH Performance Categories (PCs) for DOE facilities and associated target probabilistic performance goals. These goals are expressed as the mean annual probability of exceedance of acceptable behavior for structures, systems and components (SSCs) subjected to NPH effects. The assignment of an NPH Performance Category is based on the overall hazard categorization (low, moderate, high) of a facility and on the function of an SSC under evaluation (DOE-STD-1021, 1992). Detailed guidance for the NPH analysis and evaluation criteria are also provided (DOE-STD-1020, 1994). These analyses can be very resource intensive, and may not be necessary for the evaluation of all SSCs in existing facilities, in particular for low hazard category facilities. An approach relying heavily on screening inspections, engineering judgment and use of NPH experience data (S. J. Eder et al., 1993), can minimize the analytical effort, give reasonable estimates of the NPH susceptibilities, and yield adequate information for an overall safety evaluation of the facility. In the following sections this approach is described in more detail and is illustrated by an application to a nuclear laboratory complex.

  2. Comprehensive Evaluation of Entropy-hierarchical Grey Correlation Analysis for Highway Safety Life Protection Engineering

    Directory of Open Access Journals (Sweden)

    Jin Shuxins

    2016-01-01

    Full Text Available Different highway safety life protection engineering decision-making have important meaning. The achieving goals and optimal highway safety life protection engineering scheme can not only improve the function of the highway facilities and service level, still can reduce the traffic accident, which caused by the imperfect highway facilities. Different highway safety life protection engineering decision-making is a multiple targets, multi-layers and multi-schemes system evaluation problem. With regard to lack of concrete data on multiple targets, multi-layers and multi-schemes system evaluation problem, make analytical hierarchy process combined with the entropy value analysis into the grey relational comprehensive evaluation method, and then get entropy-hierarchical grey correlation analysis method. This method is a qualitative and quantitative decision method, which combine comparison principle of analytic hierarchy process (AHP and the entropy principle of entropy value analysis method to determine the relative weight of various indexes between factors layer-by-layer. Then using grey relational analysis by low-layer to high-layer step by step in the possible scheme and referenced scheme. Finally, calculating the comprehensive correlation degree between the possible scheme and referenced scheme, the best plan which has maximum grey correlation degree can be selected.

  3. Development of Non-safety System Architecture and Evaluation of Components/Systems

    Energy Technology Data Exchange (ETDEWEB)

    Oh, I. S.; Lee, C. K.; Kim, D. H.; Lee, J. W.; Lee, D. Y.; Park, W. M.; Hwang, I. K.; Hur, S.; Kim, J. T.; Park, J. C.; Lee, J. W

    2007-10-15

    We describe in this report the works performed for a technical evaluation of the non-safety digital control system of the KNICS, the non-safety process control system of the KNICS, a communication load analysis for the MMIS (including both the non-safety and the safety systems) of the KNICS, the development of MMI and an implementation of the logic for the CVCS, and the works performed to support writing a proposal needed for bidding an I and C system based on the KNICS. The technical evaluation results were aimed to be used by the designers to detect parts needed to be corrected or to be newly inserted, and also by the developers during the development phase. The requirement specifications and the data requirement characteristics have been identified for each subsystem of the determined KNICS structure. For each communication node, the specifications related to the data transfer including the data capacity for interfaces, delay time for the data transfer, and the marginal availability of its performance capabilities have been analyzed to identify the amount of data transfer and hence to verify that both of the designed structures for the safety related communications network and for the digital communications network are appropriate. The results of the supporting work performed for writing the technical specifications related to each subsystem of the KNICS structure, are expected to be useful in writing a proposal for the expected Uljin new units 1 and 2, and in the I and C upgrade for any of the existing nuclear power plants under operation. Also included in this report are the descriptions on a design of the chemical volume control system (CVCS), on the supporting work performed to draw the logic diagrams for CVCS using the tool ISaGRAF, and on the generation of a set of system displays to be used as references.

  4. Food Quality Safety Evaluation Model in College Canteens Based on the Improved AHP-taking Bengbu College as an Example

    Directory of Open Access Journals (Sweden)

    Huaxi Chen

    2013-04-01

    Full Text Available Based on the results of investigation and the suggestion from the experts, the factors influencing the college canteen food quality and safety are found and assessment system for university cafeteria food quality and safety is constructed. With the improved Analytic Hierarchy Process (AHP to the various indexes for the empowerment and the fuzzy comprehensive evaluation method, the university canteen food quality and safety evaluation method is created. Then based on the example from Bengbu College, the solution of the model is provided, thus it is concluded that the process management factors, food factors and environmental factors, make the biggest influence on the canteen food quality and safety. Meanwhile, the extent of the influence of the second level factor on the canteen food quality and safety is identified and further it should be paid a greater attention to the several factors in order to improve the status of the food quality and safety condition.

  5. Safety evaluation of cation-exchange resins. [For use in separating and processing radionuclides

    Energy Technology Data Exchange (ETDEWEB)

    Kalkwarf, D.R.

    1977-08-01

    Results are presented of a study to evaluate whether sufficient information is available to establish conservative limits for the safe use of cation-exchange resins in separating radionuclides and, if not, to recommend what new data should be acquired. The study was also an attempt to identify in-line analytical techniques for the evaluation of resin degradation during radionuclide processing. The report is based upon a review of the published literature and upon discussions with many people engaged in the use of these resins. It was concluded that the chief hazard in the use of cation-exchange resins for separating radionuclides is a thermal explosion if nitric acid or other strong oxidants are present in the process solution. Thermal explosions can be avoided by limiting process parameters so that the rates of heat and gas generation in the system do not exceed the rates for their transfer to the surroundings. Such parameters include temperature, oxidant concentration, the amounts of possible catalysts, the radiation dose absorbed by the resin and the diameter of the resin column. Current information is not sufficient to define safe upper limits for these parameters. They can be evaluated, however, from equations derived from the Frank-Kamenetskii theory of thermal explosions provided the heat capacities, thermal conductivities and rates of heat evolution in the relevant resin-oxidant mixtures are known. It is recommended that such measurements be made and the appropriate limits be evaluated. A list of additional safety precautions are also presented to aid in the application of these limits and to provide additional margins of safety. In-line evaluation of resin degradation to assess its safety hazard is considered impractical. Rather, it is recommended that the resin be removed from use before it has received the limiting radiation dose, evaluated as described above.

  6. Evaluation of a liquid embolization agent (Onyx) for transcatheter embolization for renal vascular lesions

    Energy Technology Data Exchange (ETDEWEB)

    Rennert, Janine; Herold, T.; Schreyer, A.G.; Jung, E.M.; Mueller-Wille, R.; Zorger, N. [Inst. fuer Roentgendiagnostik, Klinikum der Univ. Regensburg (Germany); Banas, B.; Feuerbach, S. [Medizinische Klinik, Nephrologie, Univ. Regensburg (Germany); Lenhart, M. [Klinik fuer Diagnostische und Interventionelle Radiologie, Sozialstiftung Bamberg (Germany)

    2009-10-15

    Purpose: to evaluate the therapeutic outcome after endovascular treatment of renal vascular lesions using the liquid embolization agent, Onyx. Materials and methods: between 2004 and 2008 nine patients with renal vascular lesions were treated with transcatheter arterial embolization using Onyx. The renal vascular lesions consisted of 4 AV-fistulas, a pseudoaneurysm, bleeding from a single subsegmental artery, diffuse parenchymal bleeding after trauma, septic embolizations and multiple aneurysms in endocarditis. All patients underwent selective angiography of the renal artery. A dimethyl sulfoxide (DMSO)-compatible microcatheter was used and Onyx was injected. The technical and clinical success rate, examination time and procedure-related complications were documented. Results: the overall technical and clinical success rate was 100%. One patient had to be treated twice due to recurrent bleeding after an accidental puncture with a drainage catheter. No loss of viable renal tissue occurred in 4 cases. In 4 patients mild to moderate parenchyma loss was noted. In one patient having diffuse renal bleeding, occlusion of the main renal artery was performed. No procedure-related complications were noted. The mean examination time was 16.17 min when treating with Onyx alone and 60 min when using a combination of Onyx and coils. Within an average follow-up period of 21 months, no recurrent renal bleeding or recurrent AV-fistulas occurred. Conclusion: Onyx is an effective embolization agent for the treatment of renal vascular lesions. It allows controlled and quick application with low complication rates and a short examination time as a standalone agent or in combination with coils. (orig.)

  7. Statistical evaluation of the New Zealand food safety authority sampling protocol for imported food.

    Science.gov (United States)

    Govindaraju, Kondaswamy; Bebbington, Mark; Wrathall, Thewaporn

    2010-05-01

    The New Zealand Food Safety Authority sampling protocol for compliance inspection of imported food products is evaluated for its ability to provide consumer protection. The sampling protocol involves both partial testing of imported consignments and complete skipping inspection of consignments based on the quality history. The risk posed by the strategies of partial testing and skipping inspection of imports is evaluated using the average outgoing quality limit and other performance measures. The cost dimension of sampling inspection is also considered. Suggestions for improvement, which include tightening the skipping inspection parameters, are made.

  8. An evaluation of safety-critical Java on a Java processor

    DEFF Research Database (Denmark)

    Rios Rivas, Juan Ricardo; Schoeberl, Martin

    2014-01-01

    The safety-critical Java (SCJ) specification provides a restricted set of the Java language intended for applications that require certification. In order to test the specification, implementations are emerging and the need to evaluate those implementations in a systematic way is becoming important....... In this paper we evaluate our SCJ implementation which is based on the Java Optimized Processor JOP and we measure different performance and timeliness criteria relevant to hard real-time systems. Our implementation targets Level 0 and Level1 of the specification and to test it we use a series of micro...

  9. Safety evaluation for packaging (onsite) for cesium chloride capsules with type W overpacks

    Energy Technology Data Exchange (ETDEWEB)

    McCoy, J.C.

    1997-09-15

    This Safety Evaluation for Packaging (SEP) documents the evaluation of a new basket design and overpacked cesium chloride capsule payload for the Beneficial Uses Shipping System (BUSS) Cask in accordance with the onsite transportation requirements of the Hazardous Material Packaging and Shipping manual, WHC-CM-2-14. This design supports the one-time onsite shipment of 16 cesium chloride capsules with Type W overpacks from the 324 Building to the 224T Building at the Waste Encapsulation and Storage Facility (WESF). The SEP is valid for a one-time onsite shipment or until August 1, 1998, whichever occurs first.

  10. EVALUATION OF BRACHYTHERAPY FACILITY SHIELDING STATUS IN KOREA OBTAINED FROM RADIATION SAFETY REPORTS

    Directory of Open Access Journals (Sweden)

    MI HYUN KEUM

    2013-10-01

    Full Text Available Thirty-eight radiation safety reports for brachytherapy equipment were evaluated to determine the current status of brachytherapy units in Korea and to assess how radiation oncology departments in Korea complete radiation safety reports. The following data was collected: radiation safety report publication year, brachytherapy unit manufacturer, type and activity of the source that was used, affiliation of the drafter, exposure rate constant, the treatment time used to calculate workload and the HVL values used to calculate shielding design goal values. A significant number of the reports (47.4% included the personal information of the drafter. The treatment time estimates varied widely from 12 to 2,400 min/week. There was acceptable variation in the exposure rate constant values (ranging between 0.469 and 0.592 (R-m2/Ci·hr, as well as in the HVLs of concrete, steel and lead for Iridium-192 sources that were used to calculate shielding design goal values. There is a need for standard guidelines for completing radiation safety reports that realistically reflect the current clinical situation of radiation oncology departments in Korea. The present study may be useful for formulating these guidelines.

  11. Safe Eats: an evaluation of the use of social media for food safety education.

    Science.gov (United States)

    Bramlett Mayer, Ashley; Harrison, Judy A

    2012-08-01

    Many undergraduate students are cooking for the first time, and they need to learn safe food practices to reduce their risk of foodborne illness. Social media tools are being utilized to disseminate public health messages, but limited research has been conducted to examine the effectiveness of these tools for food safety education. The purpose of this study was to develop and evaluate a social media-based intervention for young adults to improve food safety attitudes, practices, and knowledge. Preliminary surveys were conducted and online focus groups were convened to guide design of this social media intervention. College students (710) were included in treatment and control groups. Results from pretests and posttests indicate that participation in the "Safe Eats" Facebook intervention leads to improvements in food safety attitudes, practices, and knowledge. Although students reported that they learned more from the intervention than from a traditional lecture, the combination of lecture and Facebook resulted in higher knowledge scores than those resulting from the intervention alone. Participants who spent more time on the Facebook page had greater improvements in food safety attitudes and practices.

  12. Synthesis and evaluation of novel fluorinated pyrazolo-1,2,3-triazole hybrids as antimycobacterial agents.

    Science.gov (United States)

    Emmadi, Narender Reddy; Bingi, Chiranjeevi; Kotapalli, Sudha Sravanti; Ummanni, Ramesh; Nanubolu, Jagadeesh Babu; Atmakur, Krishnaiah

    2015-08-01

    A library of novel 3-trifluoromethyl pyrazolo-1,2,3-triazole hybrids (5-7) were accomplished starting from 5-phenyl-3-(trifluoromethyl)-1H-pyrazol-4-amine (1) via key intermediate 2-azido-N-(5-phenyl-3-(trifluoromethyl)-1H-pyrazol-4-yl)acetamide (3) through click chemistry approach. Thus obtained compounds in 5-7 series were evaluated for in vitro antimycobacterial activity against Mycobacterium smegmatis (MC(2) 155) and also verified the cytotoxicity. These studies engendered promising lead compounds 5q, 7b and 7c with MIC (μg/mL) values 15.34, 16.18 and 16.60, respectively. Amongst these three compounds, 2-(4-(4-methoxybenzoyl)-1H-1,2,3-triazol-1-yl)-N-(5-phenyl-3-(trifluoromethyl)-1H-pyrazol-4-yl) acetamide (5q) emerged as the most promising antitubercular agent with lowest cytotoxicity against the A549 cancer cell line. This is the first report to demonstrate the pyrazolo triazole hybrids as potential antimycobacterial agents.

  13. Design, synthesis and pharmacological evaluation of omeprazole-like agents with anti-inflammatory activity.

    Science.gov (United States)

    El-Nezhawy, Ahmed O H; Biuomy, Ayman R; Hassan, Fatma S; Ismaiel, Ayman K; Omar, Hany A

    2013-04-01

    A new series of novel benzimidazole derivatives containing substituted pyrid-2-yl moiety and polyhydroxy sugar conjugated to the N-benzimidazole moiety has been synthesized and evaluated as orally bioavailable anti-inflammatory agents with anti-ulcerogenic activity. The anti-inflammatory and anti-ulcerogenic activities of these compounds were compared to diclofenac and omeprazole, respectively. In carrageenan-induced paw oedema assay, 2-methyl-N-((3,4-dimethoxypyridin-2-yl)methyl)-1H-benzimidazol-5-amine (12d) and 1-(1,2,3,5-tetrahydroxy-α-D-mannofuranose)-5-(((3,4-dimethoxypyridin-2yl)methyl)amino)-2-methyl-1H-benzimidazole (15d) displayed dose-dependent anti-inflammatory activities by decreasing the inflammation by 62% and 72%, respectively which is comparable to that of diclofenac (73%). In contrast to diclofenac, the anti-inflammatory activity of these compounds was not only free from any side effects on the gastric mucosa but also showed significant anti-ulcerogenic activity in rat pyloric ligation and ethanol-induced gastric ulcer models similar to that of omeprazole. Together, these findings suggest that 12d and 15d are potent anti-inflammatory agents with concurrent anti-ulcerogenic activity and support its clinical promise as a component of therapeutic strategies for inflammation, for which the gastric side effects are always a major limitation.

  14. An overview of the current methodologies used for evaluation of aphrodisiac agents

    Institute of Scientific and Technical Information of China (English)

    Ramandeep Singh; Ashraf Ali; G Jeyabalan; Alok Semwal; Jaikishan

    2013-01-01

    Discoveries in the past two decades have continued to improve our understanding of the pathophysiology of erectile dysfunction disease and animal models have played a significant role to define the basic mechanisms of erectile dysfunction treatment.Bothin vitroandin vivomodels have been developed in the past years to study the aphrodisiac agents.Methods that are used in aphrodisiac study can be categorized into physical methods including male sexual behavior (mount frequency, mount latency, intromission frequency, intromission latency, ejaculation frequency, post-ejaculatory interval, couplatory rate, index of libido, computed male sexual behavior parameter), pendiculation study, orientation behavior, determination of hesitation time & attraction towards female, test of potency, test for libido, penile microcirculation study, Intracavernous pressure study and biochemical methods, histopathology, sperm count,Fructose content in seminal vesicles, sperm preservation, organ weight, hormonal determination, assay of nitric oxide synthase, In vitro nitric oxide release & androgen receptor protein.This review aims to highlight some of the new and currently used experimental models that are used for the evaluation of aphrodisiac agents.

  15. Evaluation of antibacterial activity of N-phosphonium chitosan as a novel polymeric antibacterial agent.

    Science.gov (United States)

    Guo, Aijie; Wang, Feihu; Lin, Wentao; Xu, Xiaofen; Tang, Tingting; Shen, Yuanyuan; Guo, Shengrong

    2014-06-01

    N-phosphonium chitosans (NPCSs) with different degrees of substitution (3%, 13% and 21%) were synthesized and evaluated as novel polymeric antibacterial agents. Their antibacterial activities compared with hydroxypropyltrimethyl ammonium chloride chitosan (HACC), parent chitosan and (5-carboxypentyl) triphenylphosphonium bromide (CTPB) were tested against Escherichia coli and two strains of drug-resistance Staphylococcus aureus by minimal inhibitory concentration (MIC), minimum bactericidal concentration (MBC) and biofilm prevention assays. The results show that the NPCS with 3% or 13% substitution has lower MIC and MBC values and stronger ability to inhibit biofilm formation of all the three bacteria than HACC, chitosan and CTPB. In addition, the antibacterial activity of NPCSs increases with their substitution decreasing from 21% to 3%. Overall, the antibacterial activity of NPCS with 3% or 13% substitution is better than that of NPCS with 21% substitution, HACC with 22% substitution, chitosan and CTPB. It can be considered that NPCS with appropriate degree of substitution has favorable antibacterial activity and is a potential polymeric antibacterial agent.

  16. Evaluation of the Safety Detective Program: A Classroom-Based Intervention to Increase Kindergarten Children's Understanding of Home Safety Hazards and Injury-Risk Behaviors to Avoid.

    Science.gov (United States)

    Morrongiello, Barbara A; Bell, Melissa; Park, Katey; Pogrebtsova, Katya

    2016-01-01

    Home injuries are a leading cause of mortality and morbidity for young children. Most programs that aim to improve their knowledge of home safety have been narrowly focused on one injury type and/or required specialized personnel for delivery. The purpose of the current study was to evaluate the effectiveness of a new Safety Detective Program that was designed to teach young children (4-6 years) about several types of home safety hazards and unsafe behaviors, with the program delivered in a classroom setting by non-experts based on manualized training. The current study used a randomized group, pre-post design to evaluate the effectiveness of the program to increase children's knowledge and understanding of home safety hazards and injury-risk behaviors to avoid. Children participated in six structured sessions, covering burns, falls, drowning, and poisoning. Each session involved play-based activities (storybook, song, and game or craft) to teach main messages about hazards and injury-risk behaviors, a take home activity, and a parent information sheet about the injury type covered that day. An individually administered photo-sort task with follow-up interview was used to measure intervention and control group participants' knowledge and understanding of injury-risk behaviors before and after program delivery. Children in the intervention, but not the control, group exhibited significant gains in their knowledge and understanding of home safety hazards and injury-risk behaviors to avoid, establishing the effectiveness of the program. This evaluation indicates that the Safety Detective Program can be delivered in classrooms without requiring specialized personnel or extensive training and with positive changes obtained. The program holds much promise as a means of improving kindergarten children's understanding of a broad range of home hazards and injury-risk behaviors that are relevant to their safety.

  17. Detoxification of organophosphorus pesticides and nerve agents through RSDL: efficacy evaluation by (31)P NMR spectroscopy.

    Science.gov (United States)

    Elsinghorst, Paul W; Worek, Franz; Koller, Marianne

    2015-03-04

    Intoxication by organophosphorus compounds, especially by pesticides, poses a considerable risk to the affected individual. Countermeasures involve both medical intervention by means of antidotes as well as external decontamination to reduce the risk of dermal absorption. One of the few decontamination options available is Reactive Skin Decontamination Lotion (RSDL), which was originally developed for military use. Here, we present a (31)P NMR spectroscopy based methodology to evaluate the detoxification efficacy of RSDL with respect to a series of organophosphorus pesticides and nerve agents. Kinetic analysis of the obtained NMR data provided degradation half-lives proving that RSDL is also reasonably effective against organophosphorus pesticides. Unexpected observations of different RSDL degradation patterns are presented in view of its reported oximate-catalyzed mechanism of action.

  18. Evaluation of surfactants as solubilizing agents in microsomal metabolism reactions with lipophilic substrates.

    Science.gov (United States)

    Randall, Kathleen; Cheng, Shun Wen; Kotchevar, Anne Therese

    2011-10-01

    Solubilizing agents are routinely added when investigating the biotransformation of lipophilic substrates using hepatic microsomes. For highly lipophilic compounds, the concentration of solvent or surfactant necessary for dissolution can be detrimental to enzyme activity. This study evaluates the effect of 12 surfactants on microsomal metabolism and the ability of the same surfactants to improve the aqueous solubility of the pentabrominated diphenyl ether BDE-100, a lipophilic environmental contaminant previously found to be recalcitrant to in vitro metabolism. Of the surfactants investigated, Cremophor EL and Tween 80 displayed the best combination of increased BDE-100 solubility and minimal inhibition of microsomal metabolism. However, a comparison of the in vitro metabolism products of BDE-100 in the presence of the two surfactants revealed varying amounts of metabolites depending on the surfactant used.

  19. Preparation and in vitro evaluation of benzylsulfanyl benzoxazole derivatives as potential antituberculosis agents.

    Science.gov (United States)

    Klimesová, Vera; Kocí, Jan; Waisser, Karel; Kaustová, Jarmila; Möllmann, Ute

    2009-05-01

    A set of 2-benzylsulfanyl derivatives of benzoxazole was synthesized and evaluated for their in vitro antimycobacterial activity against Mycobacterium tuberculosis, non-tuberculous mycobacteria and multidrug-resistant M. tuberculosis. The activities were expressed as the minimum inhibitory concentration (MIC) in mmol/L. The substances showed similar activity against all tested strains. The lead compounds in the set, dinitro derivatives exhibited significant activity against both sensitive and resistant strains of M. tuberculosis and also against non-tuberculous mycobacteria. To facilitate drug design of benzoxazole as potential antituberculosis agent, we have explored the quantitative structure-activity relationship (QSAR). We demonstrated that lower lipophilicity has significant contribution to activity. Dinitrobenzylsulfanyl derivative of benzoxazole represents the promising small-molecule synthetic antimycobacterials.

  20. Evaluation and testing of sequestering agents for the removal of actinides from waste streams

    Energy Technology Data Exchange (ETDEWEB)

    Hoffman, D.C.; Romanovski, V.V.; Veeck, A.C. [Lawrence Livermore National Lab., CA (United States)] [and others

    1997-10-01

    The purpose of this project is to evaluate and test the complexing ability of a variety of promising new complexing agents synthesized by Professor Kenneth Raymond`s group at the University of California, Berkeley (ESP-CP TTP Number SF16C311). Some of these derivatives have already shown the potential for selectivity binding Pu(IV) in a wide range of solutions in the presence of other metals. Professor Raymond`s group uses molecular modeling to design and synthesize ligands based on modification of natural siderophores, or their analogs, for chelation of actinides. The ligands are then modified for use as liquid/liquid and solid/liquid extractants. The authors` group at the Glenn T. Seaborg Institute for Transactinium Science (ITS) at Lawrence Livermore National Laboratory determines the complex formation constants between the ligands and actinide ions, the capacity and time dependence for uptake on the resins, and the effect of other metal ions and pH.

  1. Design, synthesis and biological evaluation of new rhodacyanine analogues as potential antitumor agents

    Institute of Scientific and Technical Information of China (English)

    Yang Xiong Li; Xin Zhai; Wei Ke Liao; Wu Fu Zhu; Ying He; Ping Gong

    2012-01-01

    In an attempt to develop potent antitumor agents,new rhodacyanine analogues containing the pyridinium ring (5a-5h),the isoquinolinium ring (6a-6c) and the quinolinium ring (7a-7e) linked to the rhodanine ring via N-N covalent bond were designed,synthesized and evaluated for antitumor activity against human lung cancer cell line (H460) by MTT assay in vitro.Most of the tested compounds showed enhanced antitumor activity with IC50 values ranging from 0.006 to 9.2 μmol/L as compared to the lead compound MKT-077.Among them,the most promising compound 7d (IC50 =0.006 μmol/L) was 216.7 times more active than MKT-077 (IC50 =1.3 μmol/L).The preliminary structure-activity relationship of the target compounds was discussed.

  2. Evaluation of wholesale electric power market rules and financial risk management by agent-based simulations

    Science.gov (United States)

    Yu, Nanpeng

    As U.S. regional electricity markets continue to refine their market structures, designs and rules of operation in various ways, two critical issues are emerging. First, although much experience has been gained and costly and valuable lessons have been learned, there is still a lack of a systematic platform for evaluation of the impact of a new market design from both engineering and economic points of view. Second, the transition from a monopoly paradigm characterized by a guaranteed rate of return to a competitive market created various unfamiliar financial risks for various market participants, especially for the Investor Owned Utilities (IOUs) and Independent Power Producers (IPPs). This dissertation uses agent-based simulation methods to tackle the market rules evaluation and financial risk management problems. The California energy crisis in 2000-01 showed what could happen to an electricity market if it did not go through a comprehensive and rigorous testing before its implementation. Due to the complexity of the market structure, strategic interaction between the participants, and the underlying physics, it is difficult to fully evaluate the implications of potential changes to market rules. This dissertation presents a flexible and integrative method to assess market designs through agent-based simulations. Realistic simulation scenarios on a 225-bus system are constructed for evaluation of the proposed PJM-like market power mitigation rules of the California electricity market. Simulation results show that in the absence of market power mitigation, generation company (GenCo) agents facilitated by Q-learning are able to exploit the market flaws and make significantly higher profits relative to the competitive benchmark. The incorporation of PJM-like local market power mitigation rules is shown to be effective in suppressing the exercise of market power. The importance of financial risk management is exemplified by the recent financial crisis. In this

  3. Recent European Food Safety Authority toxicological evaluations of major phthalates used in food contact materials.

    Science.gov (United States)

    Lhuguenot, Jean-Claude

    2009-08-01

    During the 1980s and 1990s, and at the EU level, the Scientific Committee for Food evaluated a number of phthalates that were being used, or were requested for use, as additives in plastics. At this time, peroxisome proliferation was considered as the pivotal effect on which toxicological evaluation of these chemicals was based. At the end of 1990s, a general consensus has been agreed that rodents are highly sensitive to the phenomenon of peroxisome proliferation and that this particular effect should not be used for human risk assessment. Consequently in 2004, it was requested from the newly created European Food Safety Authority to perform a new evaluation of the mainly used phthalates on the basis of existing data. This paper summarizes evaluations of butylbenzylphthalate, dibutylphthalate, diethylhexylphthalate.

  4. Minimum Safety Factor for Evaluation of Critical Buckling Pressure of Zirconium Alloy Tube

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyung Kyu; Kim, Jae Yong; Yoon, Kyung Ho; Lee, Young Ho; Lee, Kang Hee; Kang, Heung Seok [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2011-03-15

    We consider the uncertainty in the elastic buckling formula for a thin tube. We take into account the measurement uncertainty of Young's modulus and Poisson's ratio and the tolerance of the tube thickness and diameter. Elastic buckling must be prohibited for a thin tube such as a nuclear fuel rod that must satisfy a self-stand criterion. Since the predicted critical buckling pressure overestimated that found in the experiment, the determination of the minimum safety factor is crucial. The uncertainty in each parameter (i.e., Young's modulus, Poisson's ratio, thickness, and diameter) is mutually independent, so the safety factor is evaluated as the sum of the inverse of each uncertainty. We found that the thickness variation greatly affects the uncertainty. The minimum safety factor of a thin tube of Zirconium alloy is evaluated as 1.547 for a thickness of 0.87 mm and 3.487 for a thickness of 0.254 mm.

  5. 3D GIS BASED EVALUATION OF THE AVAILABLE SIGHT DISTANCE TO ASSESS SAFETY OF URBAN ROADS

    Directory of Open Access Journals (Sweden)

    M. Bassani

    2015-08-01

    Full Text Available The available sight distance (ASD in front of the driver to detect possible conflicts with unexpected obstacles is fundamental for traffic safety. In the last 20 years, road design software (RDS has been continuously updated with dedicated modules to estimate ASD, thus assessing the quality of project from a safety point of view. Unfortunately, the evaluation of ASD still represents an issue in the case of existing road, and the object of discussion in the research community. To avoid problems related to the limitation associated with the use of digital terrain models typically employed in RDS, the Geographic Information Systems (GIS software can use digital surface models (DSM which are more flexible in the modelling of sight obstruction due to vegetation, street furniture, and vertical surfaces largely diffused in urbanized areas. The paper deals with the evaluation of GIS in the estimation of ASD in a typical urban road where the density of sight obstruction along the roadside is relatively high. The work explores the case study of a collector road in the city of Turin (Italy. Results confirm the potentiality of GIS software in capturing the complex morphology of the urban environment, thus confirming that GIS could become an important analysis tool for road engineers in the field of road safety. The investigation here described is part of the Pro-VISION Project (funded in 2014 by the Regione Piemonte, Italy.

  6. Safety evaluation of saffron stigma (Crocus sativus L. aqueous extract and crocin in patients with schizophrenia

    Directory of Open Access Journals (Sweden)

    Bentolhoda Mousavi

    2015-08-01

    Full Text Available Objectives: Saffron is the stigma of Crocus sativus L., which has the potentials to play a role in the treatment of many diseases. Although many researches are now going on this precious spice, there are few data on saffron safety in human, especially in patients with chronic mental illnesses. This study aimed to evaluate the short-term safety and tolerability of both saffron and crocin (its major constituent in adult patients with schizophrenia. Materials and Methods: The capsules of saffron aqueous extract (SAE and crocin were used to evaluate short-term safety and tolerability in patients with schizophrenia. A double-blind, placebo-controlled study was performed on patients with schizophrenia. The patients were all male and were divided into three 22-patient groups. While receiving their normal treatment, they also received a 12 week treatment with SAE (15 mg twice daily, crocin (15 mg twice daily or placebo. Results: A total of 61 patients completed the trial; none of them reported a serious side effect. WBC count increased significantly in patients receiving saffron aqua extract (SAE, but it was within the normal range and had no clinical significance. Other hematologic components, markers of thyroid, liver and kidney or inflammation markers had no statistically significant difference among the groups. Conclusions: This study showed that SAE and crocin in doses of 15 mg twice daily were safely tolerated in patients with schizophrenia.

  7. In vitro and in vivo evaluation of efficacy and safety of photoprotective formulations containing antioxidant extracts

    Directory of Open Access Journals (Sweden)

    Maria Cristina P.P. Reis Mansur

    2016-04-01

    Full Text Available ABSTRACT Chronic exposure to solar radiation could contribute to premature skin aging and skin cancer. Skin presents its own antioxidant defense, however when defenses are out of balance, reactive oxygen species could damage biological structures. In the present work, an oil-in-water photoprotective emulsion was developed and Bauhinia microstachya var. massambabensis Vaz, Fabaceae, extracts at 1% (obtained by extraction with different solvents were added to this emulsion. In vitro and in vivo efficacy and safety of the formulations were evaluated. Spectrophotometric methods and in vivo Colipa test were performed to evaluated efficacy of the formulations, through sun protection factor (SPF determination and UVA protection factor assessment. To the in vitro safety assessment HET-CAM, CAM-TBS and Red Blood Cell tests were performed. Results showed that both extracts contributed to a higher in vivo photoprotection (SPF 18 when compared to the formulation without extract (SPF 13, this result could be attributed to the antioxidant activity of the plant extracts that act by capturing reactive oxygen species. Concerning safety, all formulations were considered non-irritant according to in vitro tests. Formulations containing extracts could be considered efficient and safe for cosmetic use since they presented higher sun protection factor and passed the toxicity tests.

  8. Simulation and evaluation of urban rail transit network based on multi-agent approach

    Directory of Open Access Journals (Sweden)

    Xiangming Yao

    2013-03-01

    Full Text Available Purpose: Urban rail transit is a complex and dynamic system, which is difficult to be described in a global mathematical model for its scale and interaction. In order to analyze the spatial and temporal characteristics of passenger flow distribution and evaluate the effectiveness of transportation strategies, a new and comprehensive method depicted such dynamic system should be given. This study therefore aims at using simulation approach to solve this problem for subway network. Design/methodology/approach: In this thesis a simulation model based on multi-agent approach has been proposed, which is a well suited method to design complex systems. The model includes the specificities of passengers’ travelling behaviors and takes into account of interactions between travelers and trains. Findings: Research limitations/implications: We developed an urban rail transit simulation tool for verification of the validity and accuracy of this model, using real passenger flow data of Beijing subway network to take a case study, results show that our simulation tool can be used to analyze the characteristic of passenger flow distribution and evaluate operation strategies well. Practical implications: The main implications of this work are to provide decision support for traffic management, making train operation plan and dispatching measures in emergency. Originality/value: A new and comprehensive method to analyze and evaluate subway network is presented, accuracy and computational efficiency of the model has been confirmed and meet with the actual needs for large-scale network.

  9. Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

    Energy Technology Data Exchange (ETDEWEB)

    Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.; Buczek, Jeffrey A.; Lietzow, J.; McCoy, F.; Beranek, F.; Gupta, M.

    2013-11-07

    A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25 recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.

  10. The Development of a Food Safety Brochure for Families: The Use of Formative Evaluation and Plain Language Strategies

    Science.gov (United States)

    Perry, Christina; Albrecht, Julie; Litchfield, Ruth; Meysenburg, Rebecca L.; Er, Ida NgYin; Lum, Adeline; Beattie, Sam; Larvick, Carol; Schwarz, Carol; Temple, Jan; Meimann, Elizabeth

    2012-01-01

    Printed materials have been used extensively as an educational tool to increase food safety awareness. Few educational materials have been designed to target families with young children for food safety education. This article reports the use of the formative evaluation process to develop a brochure designed to enhance awareness about food safety…

  11. Evaluation of Chemical Warfare Agent Percutaneous Vapor Toxicity: Derivation of Toxicity Guidelines for Assessing Chemical Protective Ensembles.

    Energy Technology Data Exchange (ETDEWEB)

    Watson, A.P.

    2003-07-24

    Percutaneous vapor toxicity guidelines are provided for assessment and selection of chemical protective ensembles (CPEs) to be used by civilian and military first responders operating in a chemical warfare agent vapor environment. The agents evaluated include the G-series and VX nerve agents, the vesicant sulfur mustard (agent HD) and, to a lesser extent, the vesicant Lewisite (agent L). The focus of this evaluation is percutaneous vapor permeation of CPEs and the resulting skin absorption, as inhalation and ocular exposures are assumed to be largely eliminated through use of SCBA and full-face protective masks. Selection of appropriately protective CPE designs and materials incorporates a variety of test parameters to ensure operability, practicality, and adequacy. One aspect of adequacy assessment should be based on systems tests, which focus on effective protection of the most vulnerable body regions (e.g., the groin area), as identified in this analysis. The toxicity range of agent-specific cumulative exposures (Cts) derived in this analysis can be used as decision guidelines for CPE acceptance, in conjunction with weighting consideration towards more susceptible body regions. This toxicity range is bounded by the percutaneous vapor estimated minimal effect (EME{sub pv}) Ct (as the lower end) and the 1% population threshold effect (ECt{sub 01}) estimate. Assumptions of exposure duration used in CPE certification should consider that each agent-specific percutaneous vapor cumulative exposure Ct for a given endpoint is a constant for exposure durations between 30 min and 2 hours.

  12. In vitro evaluation of alternative oral contrast agents for MRI of the gastrointestinal tract

    Energy Technology Data Exchange (ETDEWEB)

    Babos, Magor [University of Szeged, Faculty of Science (Hungary); Euromedic Diagnostics Szeged, 6720 Szeged, Semmelweiss u. 6 (Hungary)], E-mail: babosmagor@yahoo.com; Schwarcz, Attila [University of Pecs, Department of Neurosurgery, Pecs Diagnostic Institute, 7624 Pecs, Retu. 2 (Hungary)], E-mail: attila.schwarcz@aok.pte.hu; Randhawa, Manjit Singh [University of Szeged, Faculty of Medicine, Department of Radiology, 6720 Szeged, Semmelweiss u. 6 (Hungary)], E-mail: majyaal@hotmail.com; Marton, Balazs [University of Szeged, Faculty of Medicine, Department of Radiology, 6720 Szeged, Semmelweiss u. 6 (Hungary)], E-mail: balazsmarton@freemail.hu; Kardos, Lilla [Euromedic Diagnostics Szeged, 6720 Szeged, Semmelweiss u. 6 (Hungary)], E-mail: medlis@tiszanet.hu; Palko, Andras [Euromedic Diagnostics Szeged, 6720 Szeged, Semmelweiss u. 6 (Hungary); University of Szeged, Faculty of Medicine, Department of Radiology, 6720 Szeged, Semmelweiss u. 6 (Hungary)], E-mail: palko@radio.szote.u-szeged.hu

    2008-01-15

    Purpose: In vitro evaluation of different materials as potential alternative oral contrast agents for small bowel MRI. Materials and methods: The T1 and T2 relaxation times of rose hip syrup, black currant extract, cocoa, iron-deferoxamine solution and a commonly used oral contrast material (1 mM Gd-DTPA) were determined in vitro at different concentrations on a 1.0 T clinical MR scanner. T1 values were obtained with an inversion prepared spoiled gradient echo sequence. T2 values were obtained using multiple echo sequences. Finally the materials were visualized on T1-, T2- and T2*-weighted MR images. Results: The relaxation times of the undiluted rose hip syrup (T1 = 110 {+-} 5 ms, T2 = 86 {+-} 3 ms), black currant extract (T1 = 55 {+-} 3 ms, T2 = 39 {+-} 2 ms) and 5 mM iron-deferoxamine solution (T1 = 104 {+-} 4 ms, T2 = 87 {+-} 2 ms) were much shorter than for a 1 mM Gd-DTPA solution (T1 = 180 {+-} 8 ms, T2 = 168 {+-} 5 ms). Dilution of black currant extract to 30% or a 3 mM iron-deferoxamine solution conducted to T1 relaxation times which are quite comparable to a 1 mM Gd-DTPA solution. Despite its much lower metal content an aqueous cocoa suspension (100 g/L) produced T2 relaxation times (T1 = 360 {+-} 21 ms, T2 = 81 {+-} 3 ms) more or less in the same range like the 5 mM iron-deferoxamine solution. Imaging of our in vitro model using clinical sequences allowed to anticipate the T1-, T2- and T2*-depiction of all used substances. Cocoa differed from all other materials with its low to moderate signal intensity on T1- and T2-weighted sequences. While all substances presented a linear 1/T1 and 1/T2 relationship towards concentration, rose hip syrup broke ranks with a disproportionately high increase of relaxation at higher concentrations. Conclusions: Rose hip syrup, black currant extract and iron-deferoxamine solution due to their positive T1 enhancement characteristics and drinkability appear to be valuable oral contrast agents for T1-weighted small bowel MRI

  13. The problem in the evaluation of the efficacy and safety of nonsteroidal anti-inflammatory drugs

    Directory of Open Access Journals (Sweden)

    N. V. Chichasova

    2016-01-01

    Full Text Available The review gives data on the safety of nimesulide used for the treatment of chronic joint diseases. The first-line treatment at its any stage for joint diseases is nonsteroidal anti-inflammatory drugs (NSAIDs. Questions have recently arisen of the safety of nimesulide; however, epidemiological findings and clinical experience confirm a positive benefit/risk profile of nimesulide in the treatment of acute pain. The International Consensus Meeting (Vienna, 2014 noted that the risk of severe adverse hepatic NSAID reactions was low and the rate of liver damage associated with nimesulide was completely similar to that observed with other NSAIDs. There are data available in the literature on the rate of serious adverse liver reactions to different NSAIDs and paracetamol. The rate of such reactions to all NSAIDs per million patientyears was 1.55 and that to nimesulide was 1.88. The members of the International Consensus Group concluded that nimesulide, if properly used, remained a valuable and safe drug for the treatment of various conditions, characterized by the presence of acute inflammatory pain, by virtue of the rapid onset of analgesic action and an evidence-based positive benefit/risk profile. The long successful experience with nimesulide in our country suggests that the agent may be successfully used to treat chronic and acute pain (including dysmenorrhea in a daily dose of 200 mg/day. The safety profile of the drug is quite satisfactorily for all adverse reactions typical of NSAIDs, including its negative effect on the liver.

  14. Reactor Safety Gap Evaluation of Accident Tolerant Components and Severe Accident Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Farmer, Mitchell T. [Argonne National Lab. (ANL), Argonne, IL (United States); Bunt, R. [Southern Nuclear, Atlanta, GA (United States); Corradini, M. [Univ. of Wisconsin, Madison, WI (United States); Ellison, Paul B. [GE Power and Water, Duluth, GA (United States); Francis, M. [Argonne National Lab. (ANL), Argonne, IL (United States); Gabor, John D. [Erin Engineering, Walnut Creek, CA (United States); Gauntt, R. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Henry, C. [Fauske and Associates, Burr Ridge, IL (United States); Linthicum, R. [Exelon Corp., Chicago, IL (United States); Luangdilok, W. [Fauske and Associates, Burr Ridge, IL (United States); Lutz, R. [PWR Owners Group (PWROG); Paik, C. [Fauske and Associates, Burr Ridge, IL (United States); Plys, M. [Fauske and Associates, Burr Ridge, IL (United States); Rabiti, Cristian [Idaho National Lab. (INL), Idaho Falls, ID (United States); Rempe, J. [Rempe and Associates LLC, Idaho Falls, ID (United States); Robb, K. [Argonne National Lab. (ANL), Argonne, IL (United States); Wachowiak, R. [Electric Power Research Inst. (EPRI), Knovville, TN (United States)

    2015-01-31

    The overall objective of this study was to conduct a technology gap evaluation on accident tolerant components and severe accident analysis methodologies with the goal of identifying any data and/or knowledge gaps that may exist, given the current state of light water reactor (LWR) severe accident research, and additionally augmented by insights obtained from the Fukushima accident. The ultimate benefit of this activity is that the results can be used to refine the Department of Energy’s (DOE) Reactor Safety Technology (RST) research and development (R&D) program plan to address key knowledge gaps in severe accident phenomena and analyses that affect reactor safety and that are not currently being addressed by the industry or the Nuclear Regulatory Commission (NRC).

  15. Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety

    Science.gov (United States)

    Culpepper, Larry; Wingertzahn, Mark A.

    2015-01-01

    Objective: To investigate the level of evidence supporting the use of common over-the-counter (OTC) agents (diphenhydramine, doxylamine, melatonin, and valerian) for occasional disturbed sleep or insomnia. Data sources: A systematic review of the literature was conducted on July 31, 2014, using MEDLINE (PubMed) and the search terms (insomnia OR sleep) AND (over*the*counter OR OTC OR non*prescription OR antihistamine OR doxylamine OR diphenhydramine OR melatonin OR valerian) with the filters English, human, and clinical trials. Study selection: Identified publications (from 2003 to July 31, 2014, following previous published literature reviews) that met the inclusion criteria were selected. The criteria included randomized placebo-controlled clinical studies that utilized overnight objective (polysomnography) or next-day participant-reported sleep-related endpoints and that were conducted in healthy participants with or without occasional disturbed sleep or diagnosed insomnia. Results: Measures of efficacy and tolerability were summarized for each study individually and grouped according to OTC agent: H1 antagonists or antihistamines (3 studies, diphenhydramine), melatonin (8), and valerian or valerian/hops (7). Of the 3 sleep agents, studies conducted with melatonin, especially prolonged-release formulations in older individuals with diagnosed insomnia, demonstrated the most consistent beneficial effects (vs placebo) on sleep measures, specifically sleep onset and sleep quality, with favorable tolerability. In contrast, the clinical trial data for diphenhydramine, immediate-release melatonin, and valerian suggested limited beneficial effects. Conclusions: A review of randomized controlled studies over the past 12 years suggests commonly used OTC sleep-aid agents, especially diphenhydamine and valerian, lack robust clinical evidence supporting efficacy and safety. PMID:27057416

  16. Criticality safety evaluation for the Advanced Test Reactor enhanced low enriched uranium fuel elements

    Energy Technology Data Exchange (ETDEWEB)

    Montierth, Leland M. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-07-19

    The Global Threat Reduction Initiative (GTRI) convert program is developing a high uranium density fuel based on a low enriched uranium (LEU) uranium-molybdenum alloy. Testing of prototypic GTRI fuel elements is necessary to demonstrate integrated fuel performance behavior and scale-up of fabrication techniques. GTRI Enhanced LEU Fuel (ELF) elements based on the ATR-Standard Size elements (all plates fueled) are to be fabricated for testing in the Advanced Test Reactor (ATR). While a specific ELF element design will eventually be provided for detailed analyses and in-core testing, this criticality safety evaluation (CSE) is intended to evaluate a hypothetical ELF element design for criticality safety purposes. Existing criticality analyses have analyzed Standard (HEU) ATR elements from which controls have been derived. This CSE documents analysis that determines the reactivity of the hypothetical ELF fuel elements relative to HEU ATR elements and whether the existing HEU ATR element controls bound the ELF element. The initial calculations presented in this CSE analyzed the original ELF design, now referred to as Mod 0.1. In addition as part of a fuel meat thickness optimization effort for reactor performance other designs have been evaluated. As of early 2014 the most current conceptual designs are Mk1A and Mk1B that were previously referred to as conceptual designs Mod 0.10 and Mod 0.11, respectively. Revision 1 evaluates the reactivity of the ATR HEU Mark IV elements for a comparison with the Mark VII elements.

  17. Criticality safety evaluation for the Advanced Test Reactor enhanced low enriched uranium fuel elements

    Energy Technology Data Exchange (ETDEWEB)

    Montierth, Leland M. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-07-19

    The Global Threat Reduction Initiative (GTRI) convert program is developing a high uranium density fuel based on a low enriched uranium (LEU) uranium-molybdenum alloy. Testing of prototypic GTRI fuel elements is necessary to demonstrate integrated fuel performance behavior and scale-up of fabrication techniques. GTRI Enhanced LEU Fuel (ELF) elements based on the ATR-Standard Size elements (all plates fueled) are to be fabricated for testing in the Advanced Test Reactor (ATR). While a specific ELF element design will eventually be provided for detailed analyses and in-core testing, this criticality safety evaluation (CSE) is intended to evaluate a hypothetical ELF element design for criticality safety purposes. Existing criticality analyses have analyzed Standard (HEU) ATR elements from which controls have been derived. This CSE documents analysis that determines the reactivity of the hypothetical ELF fuel elements relative to HEU ATR elements and whether the existing HEU ATR element controls bound the ELF element. The initial calculations presented in this CSE analyzed the original ELF design, now referred to as Mod 0.1. In addition, as part of a fuel meat thickness optimization effort for reactor performance, other designs have been evaluated. As of early 2014 the most current conceptual designs are Mk1A and Mk1B, that were previously referred to as conceptual designs Mod 0.10 and Mod 0.11, respectively. Revision 1 evaluates the reactivity of the ATR HEU Mark IV elements for a comparison with the Mark VII elements.

  18. A lattice-based Monte Carlo evaluation of Canada Deuterium Uranium-6 safety parameters

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Yong Hee; Hartanto, Donny; Kim, Woo Song [Dept. of Nuclear and Quantum Engineering, Korea Advanced Institute of Science and Technology (KAIST), Daejeon (Korea, Republic of)

    2016-06-15

    Important safety parameters such as the fuel temperature coefficient (FTC) and the power coefficient of reactivity (PCR) of the CANada Deuterium Uranium (CANDU-6) reactor have been evaluated using the Monte Carlo method. For accurate analysis of the parameters, the Doppler broadening rejection correction scheme was implemented in the MCNPX code to account for the thermal motion of the heavy uranium-238 nucleus in the neutron-U scattering reactions. In this work, a standard fuel lattice has been modeled and the fuel is depleted using MCNPX. The FTC value is evaluated for several burnup points including the mid-burnup representing a near-equilibrium core. The Doppler effect has been evaluated using several cross-section libraries such as ENDF/B-VI.8, ENDF/B-VII.0, JEFF-3.1.1, and JENDL-4.0. The PCR value is also evaluated at mid-burnup conditions to characterize the safety features of an equilibrium CANDU-6 reactor. To improve the reliability of the Monte Carlo calculations, we considered a huge number of neutron histories in this work and the standard deviation of the k-infinity values is only 0.5-1 pcm.

  19. INTEGRAL BENCHMARKS AVAILABLE THROUGH THE INTERNATIONAL REACTOR PHYSICS EXPERIMENT EVALUATION PROJECT AND THE INTERNATIONAL CRITICALITY SAFETY BENCHMARK EVALUATION PROJECT

    Energy Technology Data Exchange (ETDEWEB)

    J. Blair Briggs; Lori Scott; Enrico Sartori; Yolanda Rugama

    2008-09-01

    Interest in high-quality integral benchmark data is increasing as efforts to quantify and reduce calculational uncertainties accelerate to meet the demands of next generation reactor and advanced fuel cycle concepts. The International Reactor Physics Experiment Evaluation Project (IRPhEP) and the International Criticality Safety Benchmark Evaluation Project (ICSBEP) continue to expand their efforts and broaden their scope to identify, evaluate, and provide integral benchmark data for method and data validation. Benchmark model specifications provided by these two projects are used heavily by the international reactor physics, nuclear data, and criticality safety communities. Thus far, 14 countries have contributed to the IRPhEP, and 20 have contributed to the ICSBEP. The status of the IRPhEP and ICSBEP is discussed in this paper, and the future of the two projects is outlined and discussed. Selected benchmarks that have been added to the IRPhEP and ICSBEP handbooks since PHYSOR’06 are highlighted, and the future of the two projects is discussed.

  20. 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.

    Directory of Open Access Journals (Sweden)

    Dipen A Patel

    Full Text Available BACKGROUND: A network meta-analysis can provide estimates of relative efficacy for treatments not directly studied in head-to-head randomized controlled trials. We estimated the relative efficacy and safety of dolutegravir (DTG versus third agents currently recommended by guidelines, including ritonavir-boosted atazanavir (ATV/r, ritonavir-boosted darunavir (DRV/r, efavirenz (EFV, cobicistat-boosted elvitegravir (EVG/c, ritonavir-boosted lopinavir (LPV/r, raltegravir (RAL, and rilpivirine (RPV, in treatment-naive HIV-1-infected patients. METHODS: A systematic review of published literature was conducted to identify phase 3/4 randomized controlled clinical trials (up to August 2013 including at least one third agent of interest in combination with a backbone nucleoside reverse transcriptase inhibitor (NRTI regimen. Bayesian fixed-effect network meta-analysis models adjusting for the type of nucleoside reverse transcriptase inhibitor backbone (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC] or abacavir/lamivudine [ABC/3TC] were used to evaluate week 48 efficacy (HIV-RNA suppression to <50 copies/mL and change in CD4+ cells/µL and safety (lipid changes, adverse events, and discontinuations due to adverse events of DTG relative to all other treatments. Sensitivity analyses assessing the impact of NRTI treatment adjustment and random-effects models were performed. RESULTS: Thirty-one studies including 17,000 patients were combined in the analysis. Adjusting for the effect of NRTI backbone, treatment with DTG resulted in significantly higher odds of virologic suppression (HIV RNA<50 copies/mL and increase in CD4+ cells/µL versus ATV/r, DRV/r, EFV, LPV/r, and RPV. Dolutegravir had better or equivalent changes in total cholesterol, LDL, triglycerides, and lower odds of adverse events and discontinuation due to adverse events compared to all treatments. Random-effects and unadjusted models resulted in similar conclusions. CONCLUSION: Three

  1. Utilization Evaluation of Antimicrobial Agents in Neutropenic Cancer Patients in a Teaching hospital: Urgent of Drug Utilization Evaluation Studies

    Directory of Open Access Journals (Sweden)

    Hadi Hamishehkar

    2015-10-01

    Full Text Available Background: More than 80% of patients with hematologic malignancies will develop fever during more than one chemotherapy cycle combined with neutropenia. We aim to evaluate empiric antibiotic strategies in Febrile Neutropenic (FN cancer patients.Methods: This is a concurrent study performed in the “Shahid Ghazi” teaching hospital, hematology-oncology center of Tabriz, Iran during the period of December 2011 to September2012. During this period, patients with FN were evaluated in view of antibiotics utilization based on Infectious Disease Society of America (IDSA and National Comprehensive Cancer Network (NCCN instructions.Results: Seventy patients had a total of 91 episodes of FN in the duration of this study. Among them 63 (90% patients were the cases of acute leukemia. For 88 (96.7 % patients, imipenem was used as the initial empirical antibiotic regimen. It was changed to piperacillin/tazobactam in 8 (8.8% of them without indication. Cultures didn’t obtain before the initiation of empirical therapy in 19 (20.9% episodes. Empiric vancomycin didn’t discontinue after 3 days even if it was not warranted in 23 episodes. In 16 cases vancomycin was switched to teicoplanin. The fluconazole dosages generally given to patients were all suboptimal. Adjusting the dosages of vancomycin or imipenem was not done correctly in 13 (14.29% episodes.Conclusion: The results of this study showed that choosing antimicrobial agents and their dosing for prophylaxis and treatment of FN patients and discharge antimicrobial planning of FN patients do not follow the evaluated guidelines. Drug Usage Evaluation studies need to be done regularly in such a center.

  2. [Economic evaluation of prevention programmes for occupational health and safety: the pertinence of cost-benefit analysis].

    Science.gov (United States)

    Antonopoulou, Lila; Targoutzidis, Antonis

    2010-01-01

    This article provides a critical examination of economic evaluation methods for health programmes and of techniques in the specific area of occupational health and safety. The study focuses on the evaluation methods that can be applied at two levels - the business level and the societal level. With respect to evaluation at the level of society, the importance of the social conception of risk as an influential factor that affects economic evaluation is emphasized. This study points to the need to formulate measures that will incorporate such social parameters in the evaluation of prevention programmes for health and safety in the workplace.

  3. Evaluation of Chitosan/Fructose Model as an Antioxidant and Antimicrobial Agent for Shelf Life Extension of Beef Meat During Freezing

    Directory of Open Access Journals (Sweden)

    Shaheen Mohmed S.

    2016-12-01

    Full Text Available In the present study the effect of chitosan/fructose Maillard reaction products (CF-MRPs as antioxidant and antimicrobial agents was evaluated and applied on minced beef meat during frozen storage. Antioxidant and antimicrobial properties of chitosan-fructose complexes were tested. Anti-oxidant properties were measured by the DPPH, β-carotene and ABTS methods. These three methods showed the same profile of antioxidant activity. Chitosan with 4% fructose autoclaved for 45 min (CF9 showed to have the most effective antioxidant activity. It was demonstrated that the browning product exhibited antioxidant activity. For antimicrobial activity, most chitosan-fructose complexes were less effective than chitosan. Thus, MRPs derived from chitosan-sugar model system can be promoted as a novel antioxidant to prevent lipid oxidation in minced beef. Chitosan-sugar complex could be a potential alternative natural product for synthetic food additive replacement that would additionally meet consumer safety requirement.

  4. Occupational safety and health as an element of a complex compensation system evaluation within an organization.

    Science.gov (United States)

    Beck-Krala, Ewa; Klimkiewicz, Katarzyna

    2016-12-01

    Occupational safety and health (OSH) plays a significant role in today's organizations, because it helps in attracting and retaining employees as well as molding their attitudes and behaviors at work. This is why the issue of OSH is stressed in a comprehensive approach to employee rewards: the total reward concept. This article explains how OSH may be included in a complex evaluation process of the compensation system. Although the literature on the effectiveness of employee compensation refers mainly to financial and non-financial components, there is a need for inclusion of working conditions in such analyses. An evaluation of the compensation system that incorporates OSH can drive many benefits for both the organization and employees. Obtaining such benefits, however, requires systematic evaluation of the reward system, including OSH. Incorporation of OSH issue within the comprehensive analysis of compensation systems promotes responsible behavior of all stakeholders.

  5. Tools and Techniques for Evaluating the Effects of Maintenance Resource Management (MRM) in Air Safety

    Science.gov (United States)

    Taylor, James C.

    2002-01-01

    This research project was designed as part of a larger effort to help Human Factors (HF) implementers, and others in the aviation maintenance community, understand, evaluate, and validate the impact of Maintenance Resource Management (MRM) training programs, and other MRM interventions; on participant attitudes, opinions, behaviors, and ultimately on enhanced safety performance. It includes research and development of evaluation methodology as well as examination of psychological constructs and correlates of maintainer performance. In particular, during 2001, three issues were addressed. First a prototype process for measuring performance was developed and used. Second an automated calculator was developed to aid the HF implementer user in analyzing and evaluating local survey data. These results include being automatically compared with the experience from all MRM programs studied since 1991. Third the core survey (the Maintenance Resource Management Technical Operations Questionnaire, or 'MRM/TOQ') was further developed and tested to include topics of added relevance to the industry.

  6. Synthesis and Biological Evaluation of Novel 2-Methoxypyridylamino-Substituted Riminophenazine Derivatives as Antituberculosis Agents

    Directory of Open Access Journals (Sweden)

    Dongfeng Zhang

    2014-04-01

    Full Text Available Clofazimine, a member of the riminophenazine class, is one of the few antibiotics that are still active against multidrug-resistant Mycobacterium tuberculosis (M. tuberculosis. However, the clinical utility of this agent is limited by its undesirable physicochemical properties and skin pigmentation potential. With the goal of maintaining potent antituberculosis activity while improving physicochemical properties and lowering skin pigmentation potential, a series of novel riminophenazine derivatives containing a 2-methoxypyridylamino substituent at the C-2 position of the phenazine nucleus were designed and synthesized. These compounds were evaluated for antituberculosis activity against M. tuberculosis H37Rv and screened for cytotoxicity. Riminophenazines bearing a 3-halogen- or 3,4-dihalogen-substituted phenyl group at the N-5 position exhibited potent antituberculosis activity, with MICs ranging from 0.25~0.01 μg/mL. The 3,4-dihalogen- substituted compounds displayed low cytotoxicity, with IC50 values greater than 64 μg/mL. Among these riminophenazines, compound 15 exhibited equivalent in vivo efficacy against M. tuberculosis infection and reduced skin discoloration potential in an experimental mouse infection model as compared to clofazimine. Compound 15, as compared to clofazimine, also demonstrated improved physicochemical properties and pharmacokinetic profiles with a short half-life and less drug tissue accumulation. This compound is being evaluated as a potential drug candidate for the treatment of multidrug resistant tuberculosis.

  7. Development and evaluation of a novel VEGFR2-targeted nanoscale ultrasound contrast agents

    Science.gov (United States)

    Yu, Houqiang; Li, Chunfang; He, Xiaoling; Zhou, Qibing; Ding, Mingyue

    2016-04-01

    Recent literatures have reported that the targeted nanoscale ultrasound contrast agents are becoming more and more important in medical application, like ultrasound imaging, detection of perfusion, drug delivery and molecular imaging and so on. In this study, we fabricated an uniform nanoscale bubbles (257 nm with the polydispersity index of 0.458) by incorporation of antibody targeted to vascular endothelial growth factor receptor 2 (VEGFR2) into the nanobubbles membrane by using avidin-biotin interaction. Some fundamental characterizations such as nanobubble suspension, surface morphology, particle size distribution and zeta potential were investigated. The concentration and time-intensity curves (TICs) were obtained with a self-made ultrasound experimental setup in vitro evaluation. In addition, in order to evaluate the contrast enhancement ability and the potential tumor-targeted ability in vivo, normal Wistar rats and nude female BALB/c mice were intravascular administration of the nanobubbles via tail vein injection, respectively. Significant contrast enhancement of ultrasound imaging within liver and tumor were visualized. These experiments demonstrated that the targeted nanobubbles is efficient in ultrasound molecular imaging by enhancement of the contrast effect and have potential capacity for targeted tumor diagnosis and therapy in the future.

  8. Environment, Safety and Health independent evaluation of Fernald Environmental Restoration Management Company`s (FERMCO) Comprehensive Environmental Occupational Safety and Health Program (CEOSHP)

    Energy Technology Data Exchange (ETDEWEB)

    1994-04-01

    The Office of Environmental Management (EM) requested the Office of Environment, Safety and Health (EH) to perform an independent evaluation of Fernald Environmental Restoration Management Corporation`s (FERMCO`s) Comprehensive Environmental occupational Safety and Health Program (CEOSHP) document. In 1992, FERMCO was awarded the Department of Energy`s (DOE) first Environmental Restoration Management Contract and developed the CEOSHP to respond to contract requirements. EH limited its review to the CEOSHP because this document constitutes FERMCO`s written environment, safety and health (ES&H) program document and thus provides the basis for FERMCO`s ES&H program. EH`s independent review identified several major areas of the CEOSHP that need to be revised if it is to function successfully as the program-level document for FERMCO`s environment, safety and health program. The problems identified occur throughout the document and apply across the three CEOSHP sections evaluated by EH: the Occupational Safety and Health program, the Environmental Protection program, and the Radiological Control program. Primary findings of the CEOSHP: (1) Does not fully reflect the occupational safety and health, environmental protection, and radiological control requirements of the Department; (2) Does not convey a strong sense of management leadership of the program or clearly delineate employee rights, responsibilities, and roles in FERMCO`s ES&H program; (3) Is not a program management-level document; (4) Does not describe a ``seamless`` ES&H program; and (5) Does not clearly convey how FERMCO`s ES&H program actually works. EH`s detailed evaluation of FERMCO`s CEOSHP, along with specific recommendations are presented in Sections 2, 3, and 4 of this report. EH believes that EM will find this review and analysis useful in its efforts to assist FERMCO in a comprehensive redrafting of the CEOSHP.

  9. Evaluation of microbubbles as contrast agents for ultrasonography and magnetic resonance imaging.

    Directory of Open Access Journals (Sweden)

    Ling Li

    Full Text Available BACKGROUND: Microbubbles (MBs can serve as an ultrasound contrast agent, and has the potential for magnetic resonance imaging (MRI. Due to the relatively low effect of MBs on MRI, it is necessary to develop new MBs that are more suitable for MRI. In this study, we evaluate the properties of SonoVue® and custom-made Fe(3O(4-nanoparticle-embedded microbubbles (Fe(3O(4-MBs in terms of contrast agents for ultrsonography (US and MRI. METHODOLOGY/PRINCIPAL FINDINGS: A total of 20 HepG2 subcutaneous-tumor-bearing nude mice were randomly assigned to 2 groups (i.e., n = 10 mice each group, one for US test and the other for MRI test. Within each group, two tests were performed for each mouse. The contrast agent for the first test is SonoVue®, and the second is Fe(3O(4-MBs. US was performed using a Technos(MPX US system (Esaote, Italy with a contrast-tuned imaging (CnTI™ mode. MRI was performed using a 7.0T Micro-MRI (PharmaScan, Bruker Biospin GmbH, Germany with an EPI-T(2* sequence. The data of signal-to-noise ratio (SNR from the region-of-interest of each US and MR image was calculated by ImageJ (National Institute of Health, USA. In group 1, enhancement of SonoVue® was significantly higher than Fe(3O(4-MBs on US (P0.05. The SNR analysis of the enhancement process reveals a strong negative correlation in both cases (i.e., SonoVue® r = -0.733, Fe(3O(4-MBs r = -0.903, with P<0.05. CONCLUSIONS: It might be important to change the Fe(3O(4-MBs' shell structure and/or the imagining strategy of US to improve the imaging quality of Fe(3O(4-MBs on US. As an intriguing prospect that can be detected by US and MRI, MBs are worthy of further study.

  10. Evaluation of Gd-DTPA-monophytanyl and phytantriol nanoassemblies as potential MRI contrast agents.

    Science.gov (United States)

    Gupta, Abhishek; de Campo, Liliana; Rehmanjan, Beenish; Willis, Scott A; Waddington, Lynne J; Stait-Gardner, Tim; Kirby, Nigel; Price, William S; Moghaddam, Minoo J

    2015-02-03

    Supramolecular self-assembling amphiphiles have been widely used in drug delivery and diagnostic imaging. In this report, we present the self-assembly of Gd (III) chelated DTPA-monophytanyl (Gd-DTPA-MP) amphiphiles incorporated within phytantriol (PT), an inverse bicontinuous cubic phase forming matrix at various compositions. The dispersed colloidal nanoassemblies were evaluated as potential MRI contrast agents at various magnetic field strengths. The homogeneous incorporation of Gd-DTPA-MP in PT was confirmed by polarized optical microscopy (POM) and synchrotron small-angle X-ray scattering (SAXS) of the bulk phases of the mixtures. The liquid crystalline nanostructures, morphology, and the size distribution of the nanoassemblies were studied by SAXS, cryogenic transmission electron microscopy (cryo-TEM), and dynamic light scattering (DLS). The dispersions with up to 2 mol % of Gd-DTPA-MP in PT retained inverse cubosomal nanoassemblies, whereas the rest of the dispersions transformed to liposomal nanoassemblies. In vitro relaxivity studies were performed on all the dispersions at 0.54, 9.40, and 11.74 T and compared to Magnevist, a commercially available contrast agent. All the dispersions showed much higher relaxivities compared to Magnevist at both low and high magnetic field strengths. Image contrast of the nanoassemblies was also found to be much better than Magnevist at the same Gd concentration at 11.74 T. Moreover, the Gd-DTPA-MP/PT dispersions showed improved relaxivities over the pure Gd-DTPA-MP dispersion at high magnetic fields. These stable colloidal nanoassemblies have high potential to be used as combined delivery matrices for diagnostics and therapeutics.

  11. Evaluation of Chlorella as a Decorporation Agent to Enhance the Elimination of Radioactive Strontium from Body

    Science.gov (United States)

    Ogawa, Kazuma; Fukuda, Tadahisa; Han, Jaegab; Kitamura, Yoji; Shiba, Kazuhiro; Odani, Akira

    2016-01-01

    Background Release of radionuclides, such as 137Cs and 90Sr, into the atmosphere and the ocean presents an important problem because internal exposure to 137Cs and 90Sr could be very harmful to humans. Chlorella has been reported to be effective in enhancing the excretion of heavy metals; thus, we hypothesized that Chlorella could also enhance the elimination of 137Cs or 90Sr from the body. We evaluated the potential of Chlorella as a decorporation agent in vitro and in vivo, using 85Sr instead of 90Sr. Methods In vitro experiments of adsorption of 137Cs and 85Sr to Chlorella were performed under wide pH conditions. The maximum sorption capacity of Chlorella to strontium was estimated using the Langmuir model. A 85Sr solution was orally administrated to mice pretreated with Chlorella. At 48 h after 85Sr administration, the biodistribution of radioactivity was determined. Results In the in vitro experiments, although 85Sr barely adsorbed to Chlorella at low pH, the 85Sr adsorption ratio to Chlorella increased with increasing pH. The maximum sorption capacity of Chlorella to strontium was 9.06 mg / g. 137Cs barely adsorbed to Chlorella under any pH conditions. In the biodistribution experiments, bone accumulation of radioactivity after 85Sr administration was significantly decreased in the Chlorella pretreatment group compared with the non-treatment control group. Conclusions In conclusion, these results indicated that Chlorella could inhibit the absorption of 90Sr into the blood and enhance the elimination of 90Sr from the body through adsorption in intestine. Further studies are required to elucidate the mechanism and the components of Chlorella needed for adsorption to strontium and could promote the development of more effective decorporation agents. PMID:26828430

  12. Evaluation of Chlorella as a Decorporation Agent to Enhance the Elimination of Radioactive Strontium from Body.

    Directory of Open Access Journals (Sweden)

    Kazuma Ogawa

    Full Text Available Release of radionuclides, such as 137Cs and 90Sr, into the atmosphere and the ocean presents an important problem because internal exposure to 137Cs and 90Sr could be very harmful to humans. Chlorella has been reported to be effective in enhancing the excretion of heavy metals; thus, we hypothesized that Chlorella could also enhance the elimination of 137Cs or 90Sr from the body. We evaluated the potential of Chlorella as a decorporation agent in vitro and in vivo, using 85Sr instead of 90Sr.In vitro experiments of adsorption of 137Cs and 85Sr to Chlorella were performed under wide pH conditions. The maximum sorption capacity of Chlorella to strontium was estimated using the Langmuir model. A 85Sr solution was orally administrated to mice pretreated with Chlorella. At 48 h after 85Sr administration, the biodistribution of radioactivity was determined.In the in vitro experiments, although 85Sr barely adsorbed to Chlorella at low pH, the 85Sr adsorption ratio to Chlorella increased with increasing pH. The maximum sorption capacity of Chlorella to strontium was 9.06 mg / g. 137Cs barely adsorbed to Chlorella under any pH conditions. In the biodistribution experiments, bone accumulation of radioactivity after 85Sr administration was significantly decreased in the Chlorella pretreatment group compared with the non-treatment control group.In conclusion, these results indicated that Chlorella could inhibit the absorption of 90Sr into the blood and enhance the elimination of 90Sr from the body through adsorption in intestine. Further studies are required to elucidate the mechanism and the components of Chlorella needed for adsorption to strontium and could promote the development of more effective decorporation agents.

  13. An in vitro Comparative Evaluation of Three Remineralizing Agents using Confocal Microscopy

    Science.gov (United States)

    Chokshi, Achala; Konde, Sapna; Shetty, Sunil Raj; Chandra, Kumar Narayan; Jana, Sinjana; Mhambrey, Sanjana; Thakur, Sneha

    2016-01-01

    Introduction The caries process has been thought to be irreversible, resulting in the permanent loss of tooth substance and eventually the development of a cavity. Recent approaches focused on application of remineralizing agents to incipient carious lesions, aim at controlling demineralization and promoting remineralization. Remineralizing agents create a supersaturated environment around the lesion; thus, preventing mineral loss and forces calcium and phosphate ions in the vacant areas. Aim To compare and evaluate the remineralization potential of Fluoride Varnish, CPP-ACP Paste (Casein Phosphopeptide-Amorphous Calcium Phosphate) and fTCP Paste (functionalized Tricalcium Phosphate) using confocal microscope. Materials and Methods Two windows of 3X3mm were created on the labial cervical and incisal thirds in 60 permanent maxillary central incisors. The teeth were demineralized to create artificial caries and divided into three groups of 20 each. Group I specimens were coated with Fluoride Varnish once whereas those in CPP-ACP paste group and fTCP group were brushed for 2 minutes, twice daily for 20 and 40 days. The specimens were stored in artificial saliva during the study period and were later sectioned and observed under confocal microscope. Data obtained was statistically analyzed using Fischer’s exact test, ANOVA and post-hoc Bonferroni’s test. Results Fluoride Varnish, CPP-ACP Paste and fTCP Paste showed remineralization of artificial carious lesions at both the time intervals. Fluoride varnish showed the highest remineralization followed by CPP-ACP Paste and fTCP Paste. A statistically significant increase in remineralization potential of CPP-ACP Paste and fTCP Paste was observed at the end of 40 days as compared to 20 days. Conclusion Fluoride varnish showed the greatest remineralization potential of artificial carious lesions followed by CPP-ACP Paste and fTCP Paste respectively. PMID:27504408

  14. EVALUATION OF EFFICACY AND SAFETY OF DIACEREIN IN KNEE OSTEOARTHRITIS IN CHINESE PATIENTS

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    Objective To evaluate the efficacy and safety of diacerein in patients with knee osteoarthritis (OA).Methods A total of 223 patients satisfying the American College of Rheumatology criteria for knee OA were chosen for this 17-week, randomized, double-dummy, diclofenac sodium-controlled trial, with diacerein dosage of 100mg/d and diclofenac sodium of 75mg/d. Efficacy and safety of both drugs were evaluated.Results Totally 106 patients in the diacerein group and 107 patients in the diclofenac group were considered qualified for the evaluation. After 12 weeks of treatment, the total effective rates of patients/physicians' overall assessment in diacerein and diclofenac groups were 65.4%/61.6% and 61.2%/61.2%, respectively (P>0.05). The primary efficacy parameter [visual analog scale (VAS) assessment of pain on 20 metres walking] and the secondary efficacy parameters [tenderness on palpation, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and 36-item Short-Form (SF-36) Health Survey] significantly improved compared with baseline in both groups ( P<0.05). In the follow-up period, there were no obvious changes in above parameters in diacerein group. However, in diclofenac group,pain on 20 metres walking, tenderness on palpation, and WOMAC became aggravated after withdrawing the drug for 4weeks (P<0.05). Moreover, the consumption of paracetamol was significantly lower in diacerein group than in diclofenac group during follow-up (P<0.001). The incidences of related adverse events were 35.7% in diacerein and 45.1%in diclofenac group, respectively. Mild-to-moderate gastrointestinal disorders were the most frequent adverse events.Conclusions Diacerein is as effective as diclofenac sodium in treating patients with knee OA. Furthermore, it has better extended effect and a good safety profile. It is generally well tolerated and has no severe adverse effect.

  15. An evaluation of the appropriateness and safety of nurse and midwife prescribing in Ireland.

    LENUS (Irish Health Repository)

    Naughton, Corina

    2012-09-19

    AIM: To evaluate the clinical appropriateness and safety of nurse and midwife prescribing practice. BACKGROUND: The number of countries introducing nurse and midwife prescribing is increasing; however, concerns over patient safety remain. DESIGN: A multi-site documentation evaluation was conducted using purposeful and random sampling. The sample included 142 patients\\' records and 208 medications prescribed by 25 Registered Nurse Prescribers. METHODS: Data were extracted from patient and prescription records between March-May 2009. Two expert reviewers applied the modified Medication Appropriate Index tool (8 criteria) to each drug. The percentage of appropriate or inappropriate responses for each criterion was reported. Reviewer concordance was measured using the Cohen\\'s kappa statistic (inter-rater reliability). RESULTS: Nurse or midwife prescribers from eight hospitals working in seventeen different areas of practice were included. The reviewers judged that 95-96% of medicines prescribed were indicated and effective for the diagnosed condition. Criteria relating to dosage, directions, drug-drugs or disease-condition interaction, and duplication of therapy were judged appropriate in 87-92% of prescriptions. Duration of therapy received the lowest value at 76%. Overall, reviewers indicated that between 69 (reviewer 2)-80% (reviewer 1) of prescribing decisions met all eight criteria. CONCLUSION: The majority of nurse and midwife prescribing decisions were deemed safe and clinically appropriate. However, risk of inappropriate prescribing with the potential for drug errors was detected. Continuing education and evaluation of prescribing practice, especially related to drug and condition interactions, is required to maximize appropriate and safe prescribing.

  16. Safety of short-term valacyclovir as an anti-sickling agent in sickle-cell anemia.

    Science.gov (United States)

    Ender, Katherine L; DeBellis, Robert H; Erlanger, Bernard F; Billote, Genia B; Brittenham, Gary M

    2011-05-01

    To assess safety and tolerability, we administered valacyclovir, an oral anti-viral medication that inhibits erythrocyte sickling in vitro, to 14 subjects with sickle-cell anemia for 1 week at a standard dose of 1,000 mg every 8 hr. No clinically significant adverse effects occurred. In 11 subjects in steady state, the mean hemoglobin concentration was almost constant while the absolute reticulocyte count decreased in eight (P = 0.1) and the overall mean fell slightly although not significantly (10%, P = 0.2). These results suggest that valacyclovir is safe and well tolerated in patients with sickle-cell anemia and that a longer duration of therapy merits investigation.

  17. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results

    Science.gov (United States)

    Blum, Kristie A.; Martin, Peter; Goy, Andre; Auer, Rebecca; Kahl, Brad S.; Jurczak, Wojciech; Advani, Ranjana H.; Romaguera, Jorge E.; Williams, Michael E.; Barrientos, Jacqueline C.; Chmielowska, Ewa; Radford, John; Stilgenbauer, Stephan; Dreyling, Martin; Jedrzejczak, Wieslaw Wiktor; Johnson, Peter; Spurgeon, Stephen E.; Zhang, Liang; Baher, Linda; Cheng, Mei; Lee, Dana; Beaupre, Darrin M.; Rule, Simon

    2015-01-01

    Ibrutinib, an oral inhibitor of Bruton tyrosine kinase, is approved for patients with mantle cell lymphoma (MCL) who have received one prior therapy. We report the updated safety and efficacy results from the multicenter, open-label phase 2 registration trial of ibrutinib (median 26.7-month follow-up). Patients (N = 111) received oral ibrutinib 560 mg once daily, and those with stable disease or better could enter a long-term extension study. The primary end point was overall response rate (ORR). The median patient age was 68 years (range, 40-84), with a median of 3 prior therapies (range, 1-5). The median treatment duration was 8.3 months; 46% of patients were treated for >12 months, and 22% were treated for ≥2 years. The ORR was 67% (23% complete response), with a median duration of response of 17.5 months. The 24-month progression-free survival and overall survival rates were 31% (95% confidence interval [CI], 22.3-40.4) and 47% (95% CI, 37.1-56.9), respectively. The most common adverse events (AEs) in >30% of patients included diarrhea (54%), fatigue (50%), nausea (33%), and dyspnea (32%). The most frequent grade ≥3 infections included pneumonia (8%), urinary tract infection (4%), and cellulitis (3%). Grade ≥3 bleeding events in ≥2% of patients were hematuria (2%) and subdural hematoma (2%). Common all-grade hematologic AEs were thrombocytopenia (22%), neutropenia (19%), and anemia (18%). The prevalence of infection, diarrhea, and bleeding was highest for the first 6 months of therapy and less thereafter. With longer follow-up, ibrutinib continues to demonstrate durable responses and favorable safety in relapsed/refractory MCL. The trial is registered to www.ClinicalTrials.gov as #NCT01236391. PMID:26059948

  18. Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

    Science.gov (United States)

    Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

    2015-08-01

    The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered.

  19. Key Performance Indicators in the Evaluation of the Quality of Radiation Safety Programs.

    Science.gov (United States)

    Schultz, Cheryl Culver; Shaffer, Sheila; Fink-Bennett, Darlene; Winokur, Kay

    2016-08-01

    Beaumont is a multiple hospital health care system with a centralized radiation safety department. The health system operates under a broad scope Nuclear Regulatory Commission license but also maintains several other limited use NRC licenses in off-site facilities and clinics. The hospital-based program is expansive including diagnostic radiology and nuclear medicine (molecular imaging), interventional radiology, a comprehensive cardiovascular program, multiple forms of radiation therapy (low dose rate brachytherapy, high dose rate brachytherapy, external beam radiotherapy, and gamma knife), and the Research Institute (including basic bench top, human and animal). Each year, in the annual report, data is analyzed and then tracked and trended. While any summary report will, by nature, include items such as the number of pieces of equipment, inspections performed, staff monitored and educated and other similar parameters, not all include an objective review of the quality and effectiveness of the program. Through objective numerical data Beaumont adopted seven key performance indicators. The assertion made is that key performance indicators can be used to establish benchmarks for evaluation and comparison of the effectiveness and quality of radiation safety programs. Based on over a decade of data collection, and adoption of key performance indicators, this paper demonstrates one way to establish objective benchmarking for radiation safety programs in the health care environment.

  20. An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects

    Science.gov (United States)

    Borchert, Mark; Bruce, Suzanne; Wirta, David; Yoelin, Steven G; Lee, Sungwook; Mao, Cheri; VanDenburgh, Amanda

    2016-01-01

    Purpose Evaluate the safety and effectiveness of bimatoprost 0.03% for treatment of eyelash hypotrichosis in a pediatric population. Patients and methods This multicenter, randomized, double-masked, parallel-group study was conducted at seven sites in the US and Brazil. Subjects with eyelash hypotrichosis caused by chemotherapy or alopecia areata (aged 5–17 years) or healthy adolescents aged 15–17 years were enrolled (N=71). Subjects applied bimatoprost 0.03% or vehicle to upper eyelid margins once nightly for 4 months and were followed for 1 month post-treatment. Eyelash prominence was assessed using the validated 4-grade Global Eyelash Assessment scale with photonumeric guide. Changes in eyelash length, thickness, and darkness were measured by digital image analysis. Safety was assessed by adverse events and ophthalmic observations. Results Eyelash prominence improved in a significantly greater proportion of subjects treated with bimatoprost compared with vehicle at month 4 (70.8% versus 26.1%; Pbimatoprost. Significant treatment benefits with bimatoprost versus vehicle were evident among the healthy adolescents but not in the postchemotherapy or alopecia areata subgroups. The safety profile of bimatoprost was consistent with previous studies in adults. Conclusion Bimatoprost was safe and well tolerated in pediatric subjects with eyelash hypotrichosis. In this study with limited sample size, subgroup analyses showed that treatment was effective in healthy adolescents with no concurrent contributing medical condition, but not in those with eyelash hypotrichosis due to chemotherapy or alopecia areata. PMID:27022239

  1. Evaluation of Primary Safety Belt Laws in California, Louisiana, and Georgia

    OpenAIRE

    1998-01-01

    This study evaluated three states that changed to primary enforcement of safety belt laws, collecting statewide seat belt observation data for several years and conducting monthly seat belt observations for 6 months after passage of the primary law in 6 California cities, 5 Louisiana cities, and 5 Georgia cities (average 1,000–6,000 vehicles a month); monthly motorist surveys at DMVs for 6 months in these sites (n=7,061); focus groups with law enforcement officers and supervisors in each site...

  2. Structural safety evaluation of the K Basin railcar and truck applications

    Energy Technology Data Exchange (ETDEWEB)

    Winkel, B.V. [ICF Kaiser Hanford Co., Richland, WA (United States)

    1995-08-01

    There are two rail spurs in the storage/transfer areas of both the K East and K West fuel storage basins. These rail spurs both end at the west edge of the basins. To avoid accidental entry of a railcar into a basin, administrative procedures and rail control hardware have been provided. Based upon a combination of historical documentation and existing adminstrative controls, a maximum credible impact accident was established. Using this design basis accident, the existing rail control hardware was evaluated for structural adequacy. The K Basin rail spurs are embedded in concrete, which permits truck/trailer entry into the same area. Safety issues for truck applications are also addressed.

  3. Safety evaluation for packaging for 1720-DR sodium-filled tank

    Energy Technology Data Exchange (ETDEWEB)

    Mercado, M.S.

    1996-03-09

    Preparations are under way to sell the sodium stored in the 1720-DR tank in the 1720-DR building. This will require that the tank, as well as the 1720-DR facility, be moved to the 300 Area, so that the sodium may be melted and transferred into a railroad tanker car. Because the sodium is a hazardous material and is being shipped in a nonspecification packaging, a safety evaluation for packaging (SEP) is required. This SEP approves the sodium-filled tank for a single shipment from the 105-DR area to the 300 Area.

  4. Technology Development, Evaluation, and Application (TDEA) FY 1999 Progress Report, Environment, Safety, and Health (ESH) Division

    Energy Technology Data Exchange (ETDEWEB)

    Larry G. Hoffman

    2000-12-01

    This progress report presents the results of 10 projects funded ($500K) in FY99 by the Technology Development, Evaluation, and Application (TDEA) Committee of the Environment, Safety, and Health Division. Five are new projects for this year; seven projects have been completed in their third and final TDEA-funded year. As a result of their TDEA-funded projects, investigators have published thirty-four papers in professional journals, proceedings, or Los Alamos reports and presented their work at professional meetings. Supplemental funds and in-kind contributions, such as staff time, instrument use, and work space, were also provided to TDEA-funded projects by organizations external to ESH Division.

  5. Envelope Functions of Time Histories in Seismic Safety Evaluation and Scenario Earthquakes

    Institute of Scientific and Technical Information of China (English)

    Shen Jianwen; Yu Zhan; Shi Shuzhong

    2008-01-01

    It has been a period of time since the concept of scenario earthquake was proposed, but this concept has rarely been used in seismic safety evaluation in China since then. Meanwhile, because of the uncertainties of magnitudes-distances pairs, there is large arbitrariness while determining the envelope function of time histories in seismic hazard analysis. In this paper, we describe a method to control the envelope functions of the time histories by introducing the most-likely combinations of magnitude and distance of the scenario earthquakes based on a probabilistic method, revise the software of the ellipse model for seismic hazard analysis, and give a computation example.

  6. Comparison of long-term drug survival and safety of biologic agents in patients with psoriasis vulgaris

    DEFF Research Database (Denmark)

    Gniadecki, R; Bang, B; Bryld, L E

    2015-01-01

    a significantly longer drug survival than the anti-TNF-α agents. Switching from one biologic to another is associated with an impairment of drug survival. Preventing loss of efficacy is a major area of medical need in the biologic therapy of psoriasis and the strategies that improve drug survival should......BACKGROUND: Drug survival (time to drug discontinuation) has recently emerged as an important parameter reflecting the long-term therapeutic performance in a real-life setting. Biologic drug survival in psoriasis is mainly limited by a gradual loss of efficacy over time. Previous studies have been...... limited by small patient population size and short observation times and yielded discrepant survival times for different biologics. OBJECTIVES: To calculate the long-term drug survival for adalimumab, etanercept, infliximab and ustekinumab in a large cohort of real-life patients with psoriasis vulgaris...

  7. Development, preclinical safety, formulation, and stability of clinical grade bevacizumab-800CW, a new near infrared fluorescent imaging agent for first in human use.

    Science.gov (United States)

    Ter Weele, Eva J; Terwisscha van Scheltinga, Anton G T; Linssen, Matthijs D; Nagengast, Wouter B; Lindner, Ingo; Jorritsma-Smit, Annelies; de Vries, Elisabeth G E; Kosterink, Jos G W; Lub-de Hooge, Marjolijn N

    2016-07-01

    There is a dire need for better visualization of cancer and analysis of specific targets in vivo. Molecular imaging with fluorescence is gaining more and more attention, as it allows detection of these targets and has advantages over radioactivity, such as no radiation dose, and lower costs. A key challenge in optical imaging however, is translation of the newly developed tracers from pre-clinical phase to clinical application. We describe the development and safety testing of clinical grade bevacizumab-800CW, an antibody-based targeted agent for non-invasive imaging of vascular endothelial growth factor A (VEGF-A). Development included implementing the manufacturing process and analytical methods according to current Good Manufacturing Practice (cGMP), formulation studies, extended characterization and stability testing. For safety pharmacology an extended single dose toxicity study in mice was performed. Bevacizumab-800CW was formulated in isotonic phosphate buffered sodium chloride solution at pH 7. The production was robust and showed a reproducible labeling efficiency, and no impurities. The binding affinity to VEGF-A remained intact. The optimized product meets all release specifications, is stable up to at least 3months and its characteristics did not significantly differ from the unlabeled bevacizumab. Toxicity testing in mice showed no remarkable findings. In conclusion, sterile bevacizumab-800CW (6mg=6ml) can be produced in stock according to current Good Manufacturing Practice. It is ready for first-in-human use.

  8. Evaluation of hygiene and safety criteria in the production of a traditional Piedmont cheese

    Directory of Open Access Journals (Sweden)

    Sara Astegiano

    2014-08-01

    Full Text Available Traditional products and related processes must be safe to protect consumers’ health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B. Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (Aw] were performed as well. Shiga-toxin Escherichia coli, aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae, E.coli and coagulase-positive staphylococci (CPS were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and Aw values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and Aw are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  9. Evaluation of Hygiene and Safety Criteria in the Production of a Traditional Piedmont Cheese

    Science.gov (United States)

    Bellio, Alberto; Adriano, Daniela; Bianchi, Daniela Manila; Gallina, Silvia; Gorlier, Alessandra; Gramaglia, Monica; Lombardi, Giampiero; Macori, Guerrino; Zuccon, Fabio; Decastelli, Lucia

    2014-01-01

    Traditional products and related processes must be safe to protect consumers’ health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B). Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (Aw)] were performed as well. Shiga-toxin Escherichia coli, aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae, E.coli and coagulase-positive staphylococci (CPS) were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and Aw values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and Aw are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  10. Preliminary safety evaluation for the Laxemar subarea. Based on data and site descriptions after the initial site investigation stage

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan [JA Streamflow AB, Aelvsjoe (Sweden)

    2006-03-15

    The main objectives of this Preliminary Safety Evaluation (PSE) of the Laxemar subarea have been to determine, with limited efforts, whether the feasibility study's judgement of the suitability of the candidate area with respect to long-term safety holds up in the light of the actual site investigation data; to provide feedback to continued site investigations and site-specific repository design and to identify site-specific scenarios and geoscientific issues for further analyses. The PSE focuses on comparing the attained knowledge of the sites with the suitability criteria as set out by SKB in 2000. These criteria both concern properties of the site judged to be necessary for safety and engineering (requirements) and properties judged to be beneficial (preferences). The findings are then evaluated in order to provide feedback to continued investigations and design work. The PSE does not aim at comparing sites and does not assess compliance with safety and radiation protection criteria. The latter is eventually done in coming Safety Assessments. This preliminary safety evaluation shows that, according to existing data, the Laxemar subarea meets all safety requirements. The evaluation also shows that the Laxemar subarea meets most of the safety preferences, but for some aspects of the site description further reduction of the uncertainties would enhance the safety case. Despite the stated concerns, there is no reason, from a safety point of view, not to continue the Site Investigations at the Laxemar subarea. There are uncertainties to resolve and the safety would eventually need to be verified through a proper safety assessment. Only some of the uncertainties noted in the Site Descriptive Model have safety implications and need further resolution for this reason. Furthermore, uncertainties may need resolving for other reasons, such as giving an adequate assurance of site understanding or assisting in optimising design. Notably, there are questions about the

  11. Genotoxic and Cytotoxic Safety Evaluation of Papain (Carica papaya L. Using In Vitro Assays

    Directory of Open Access Journals (Sweden)

    Claudia R. da Silva

    2010-01-01

    This work evaluated the toxic and mutagenic potential of papain and its potential antioxidant activity against induced-H2O2 oxidative stress in Escherichia coli strains. Cytotoxicity assay, Growth inhibition test, WP2-Mutoxitest and Plasmid-DNA treatment, and agarose gel electrophoresis were used to investigate if papain would present any toxic or mutagenic potential as well as if papain would display antioxidant properties. Papain exhibited negative results for all tests. This agent presented an activity protecting cells against H2O2-induced mutagenesis.

  12. An evaluation of pretreatment agents for the stimulation of secondary biogenic coalbed natural gas

    Science.gov (United States)

    Huang, Zaixing

    Coalbed methane is considered to be an underexploited source of clean energy and, with the realization of its biogenic nature, it has attracted increasing interest in recent decades. Most of the published studies on biogenic coal bed natural gas (CBNG) have focused either on biostimulation (the addition of nutrients to stimulate the native microbial populations) or bioaugmentation (the addition of both nutrients and non-native microbial consortia of microorganisms). Although these approaches have shown promise, they are predicated on the assumption that the coal seam is nutrient-limited or that the existing microbial communities are not optimized to convert coal to natural gas. The premise of this research is that the organic matter present within the coal matrix is, for the most part, environmentally inert and not readily available to the microorganisms living within the coal seam. The goal of this research has been to focus on treatments that will increase the solubility, and hence the bioavailability, of coal to the indigenous microbial community. Initially, treatment agents representing acids, bases and oxidants were selected to evaluate the potential for the in situ solubilization and depolymerization of subbituminous coal. The bioavailability of the coal-derived constituents was then evaluated aerobically using biometer assays and anaerobic bioassays. The experiments have shown that the acid (nitric acid) and base (sodium hydroxide) treatments are more efficient than the oxidants (potassium permanganate and catalyzed hydrogen peroxide) with respect to total organic carbon (TOC). The carbon contained in the solubilized/depolymerized product of nitric acid treatments accounted for approximately 14% of the carbon from the Powder River Basin (PRB) coal evaluated in the study; however, the biometer assays revealed that the bioavailability of the solubilized/depolymerized products was not directly correlated to the amount of dissolved organic carbon (TOC). The

  13. Preliminary safety evaluation of an aircraft impact on a near-surface radioactive waste repository

    Energy Technology Data Exchange (ETDEWEB)

    Lo Frano, R.; Forasassi, G.; Pugliese, G. [Department of Industrial and Civil Engineering (DICI), University of Pisa, Pisa (Italy)

    2013-07-01

    The aircraft impact accident has become very significant in the design of a nuclear facilities, particularly, after the tragic September 2001 event, that raised the public concern about the potential damaging effects that the impact of a large civilian airplane could bring in safety relevant structures. The aim of this study is therefore to preliminarily evaluate the global response and the structural effects induced by the impact of a military or commercial airplane (actually considered as a 'beyond design basis' event) into a near surface radioactive waste (RWs) disposal facility. The safety evaluation was carried out according to the International safety and design guidelines and in agreement with the stress tests requirements for the security track. To achieve the purpose, a lay out and a scheme of a possible near surface repository, like for example those of the El Cabril one, were taken into account. In order to preliminarily perform a reliable analysis of such a large-scale structure and to determine the structural effects induced by such a types of impulsive loads, a realistic, but still operable, numerical model with suitable materials characteristics was implemented by means of FEM codes. In the carried out structural analyses, the RWs repository was considered a 'robust' target, due to its thicker walls and main constitutive materials (steel and reinforced concrete). In addition to adequately represent the dynamic response of repository under crashing, relevant physical phenomena (i.e. penetration, spalling, etc.) were simulated and analysed. The preliminary assessment of the effects induced by the dynamic/impulsive loads allowed generally to verify the residual strength capability of the repository considered. The obtained preliminary results highlighted a remarkable potential to withstand the impact of military/large commercial aircraft, even in presence of ongoing concrete progressive failure (some penetration and spalling of the

  14. Teaching children about bicycle safety: an evaluation of the New Jersey Bike School program.

    Science.gov (United States)

    Lachapelle, Ugo; Noland, Robert B; Von Hagen, Leigh Ann

    2013-03-01

    There are multiple health and environmental benefits associated with increasing bicycling among children. However, the use of bicycles is also associated with severe injuries and fatalities. In order to reduce bicycle crashes, a bicycling education program was implemented in selected New Jersey schools and summer camps as part of the New Jersey Safe Routes to School Program. Using a convenience sample of participants to the program, an opportunistic study was designed to evaluate the effectiveness of two bicycle education programs, the first a more-structured program delivered in a school setting, with no on-road component, and the other a less structured program delivered in a summer camp setting that included an on-road component. Tests administered before and after training were designed to assess knowledge acquired during the training. Questions assessed children's existing knowledge of helmet use and other equipment, bicycle safety, as well as their ability to discriminate hazards and understand rules of the road. Participating children (n=699) also completed a travel survey that assessed their bicycling behavior and their perception of safety issues. Response to individual questions, overall pre- and post-training test scores, and changes in test scores were compared using comparison of proportion, t-tests, and ordinary least-squares (OLS) regression. Improvements between the pre-training and post-training test are apparent from the frequency distribution of test results and from t-tests. Both summer camps and school-based programs recorded similar improvements in test results. Children who bicycled with their parents scored higher on the pre-training test but did not improve as much on the post-training test. Without evaluating long-term changes in behavior, it is difficult to ascertain how successful the program is on eventual behavioral and safety outcomes.

  15. New geometric design consistency model based on operating speed profiles for road safety evaluation.

    Science.gov (United States)

    Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo

    2013-12-01

    To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment.

  16. Evaluation of the SEDline to improve the safety and efficiency of conscious sedation.

    Science.gov (United States)

    Caputo, Thomas D; Ramsay, Michael A E; Rossmann, Jeffrey A; Beach, M Miles; Griffiths, Garth R; Meyrat, Benjamin; Barnes, James B; Kerns, David G; Crump, Brad; Bookatz, Barnett; Ezzo, Paul

    2011-07-01

    Brain function monitors have improved safety and efficiency in general anesthesia; however, they have not been adequately tested for guiding conscious sedation for periodontal surgical procedures. This study evaluated the patient state index (PSI) obtained from the SEDline monitor (Sedline Inc., San Diego, CA) to determine its capacity to improve the safety and efficiency of intravenous conscious sedation during outpatient periodontal surgery. Twenty-one patients at the periodontics clinic of Baylor College of Dentistry were admitted to the study in 2009 and sedated to a moderate level using midazolam and fentanyl during periodontal surgery. The PSI monitoring was blinded from the clinician, and the following data were collected: vital signs, Ramsay sedation scale (RSS), medications administered, adverse events, PSI, electroencephalography, and the patients' perspective through visual analogue scales. The data were correlated to evaluate the PSI's ability to assess the level of sedation. Results showed that the RSS and PSI did not correlate (r = -0.25) unless high values associated with electromyographical (EMG) activity were corrected (r = -0.47). Oxygen desaturation did not correlate with the PSI (r = -0.08). Satisfaction (r = -0.57) and amnesia (r = -0.55) both increased as the average PSI decreased. In conclusion, within the limits of this study, PSI appears to correlate with amnesia, allowing a practitioner to titrate medications to that effect. It did not provide advance warning of adverse events and had inherent inaccuracies due to EMG activity during oral surgery. The PSI has the potential to increase safety and efficiency in conscious sedation but requires further development to eliminate EMG activity from confounding the score.

  17. Efficacy and safety of travoprost alone or in combination with other agents for glaucoma and ocular hypertension: patient considerations

    Directory of Open Access Journals (Sweden)

    Emilio Rintaro Suzuki Jr

    2010-10-01

    Full Text Available Emilio Rintaro Suzuki Jr, Cibele Lima Belico SuzukiInstituto de Olhos Pampulha, Belo, Horizonte, Minas Gerais, BrazilAbstract: Travoprost is a prostaglandin analog used in the management of glaucoma and ocular hypertension for reducing intraocular pressure (IOP. The IOP-lowering efficacy of travoprost has been shown to be similar to that of other prostaglandins, including latanoprost and bimatoprost. When compared with fixed combinations of timolol and either latanoprost or dorzolamide, travoprost alone can reduce mean IOP in a similar or superior manner. Concomitant therapy of travoprost and timolol can reach even greater IOP reductions than fixed combinations at some time points, but with no difference in the early morning, when IOP is usually higher. In addition, the long duration of action of travoprost can also provide better control of IOP fluctuation, probably due to its stronger prostaglandin F receptor mechanism. The side effects of travoprost do not represent a risk to the vision or health of the patient. The proven efficacy and safety combined with convenient once-daily dosing for travoprost increases patient compliance with treatment for glaucoma.Keywords: travoprost, prostaglandin, glaucoma

  18. Design, Synthesis and in Vivo Evaluation of Novel Glycosylated Sulfonylureas as Antihyperglycemic Agents.

    Science.gov (United States)

    Suaifan, Ghadeer A R Y; Shehadeh, Mayadah B; Darwish, Rula M; Al-Ijel, Hebah; Abbate, Vincenzo

    2015-11-06

    Sulphonylurea compounds have versatile activities such as antidiabetic, diuretic, herbicide, oncolytic, antimalarial, antifungal and anticancer. The present study describes the design, synthesis and in vivo testing of novel glycosylated aryl sulfonylurea compounds as antihyperglycaemic agents in streptozocine-induced diabetic mice. The rational for the introduction of the glucosamine moiety is to enhance selective drug uptake by pancreatic β-cells in order to decrease the cardiotoxic side effect commonly associated with sulfonylurea agents. 2-Deoxy-2-(4-chlorophenylsulfonylurea)-D-glucopyranose was found to be the most potent antihyperglycaemic agents among the synthesized compounds in diabetic mice. This investigation indicates the importance of this novel class as potential antihyperglycaemic agents.

  19. In vitro and in vivo safety evaluation of Dipteryx alata Vogel extract

    Directory of Open Access Journals (Sweden)

    Esteves-Pedro Natália

    2012-02-01

    Full Text Available Abstract Background Dipteryx alata Vogel popularly known as "baru" is an important commercial leguminous tree species from the Brazilian Cerrado, which possess medicinal properties, besides its fruits consumption by animals and humans. The use of the "naturally occurring plants" as herbal remedies and foods mainly from leaves, seeds, flowers and roots of plants or extracts require precautions before ensuring these are safe and efficacious. The objective of this study was to evaluate the safety of D. alata barks extract. Methods Vegetal drugs of D. alata barks were submitted to quality control assays and further to the safety assays under 1 in vitro parameter by Salmonella (Ames mutagenicity, and 2 in vivo parameter on the pregnancy of rats. Results The extract was non-mutagenic to any of the assessed strains TA97a, TA98, TA100 and TA102 even after metabolic activation (+S9. All in vivo parameters (reproductive ability evaluation, physical development of rat offsprings, and neurobehavioral development assays showed no changes related to control group. Conclusion D. alata barks extract is neither mutagenic by the Ames test nor toxic in the pregnancy of rats, with no physical-neurobehavioral consequences on the rat offsprings development.

  20. Safety Evaluation of Crocin (a constituent of saffron Tablets in Healthy Volunteers

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    Amir Houshang Mohamadpour

    2013-01-01

    Full Text Available Objective(s: Crocin is the chemical ingredient primarily responsible for the color of saffron. It has different pharmacological effects such as antioxidant, anticancer and memory improving activities. Crocin tablets were evaluated for short-term safety and tolerability in healthy adult volunteers. Materials and Methods: The study was a randomized, double-blind, placebo-controlled design consisting of one month treatment of crocin tablets. Volunteers who fulfilled inclusion and exclusion criteria were randomized into 2 groups of 22 each (males and females and received 20 mg crocin tablets or placebo. General measures of health were recorded during the study such as hematological, biochemical, hormonal and urinary parameters in pre and post-treatment periods. Results: No major adverse events were reported during the trial. Crocin tablets did not change the above parameters except that it decreased amylase, mixed white blood cells and PTT in healthy volunteers after one month. Conclusion: This clinical safety evaluation showed a relatively safe and normal profile for crocin in healthy volunteers at the given doses within the trial period.

  1. The Evaluation of the Safety and Efficacy of Transradial Coronary Procedures

    Institute of Scientific and Technical Information of China (English)

    Wu Jiansheng; Hu Xuesong; Zhang Donghui; Zhang Xinxia; Huang Jianping; Xu Xiangguang

    2006-01-01

    Objectives To evaluate the safety and efficacy of transradial coronary procedures (TRCP). Methods The data of 83 cases who accepted transradial coronary angiography (CAG) and transradial percutaneous coronary intervention (PCI)in our department were summarized. The success rates,proximal coronary complications, peripheral vascular complications, severe vagal reflex, mean operation time (MOT), mean recumbent time (MRT), mean hospital-staying time (MHT) were analyzed. The data were compared with that of 420 cases of transfemoral coronary procedures (TFCP) in the same period.Results Success rates and proximal coronary complications were similar in both groups. Severe vagal reflexes were less in TRCP group than in TFCP group.MOT was longer in TRCP group. MRT and MHT were shorter in TRCP group. 12(14.5%) radial artery spasm,3(3.6%) radial artery obstruction, 1 sudden respiratory arrest caused by jugular hematoma were observed in TRCP group. Conclusions The efficacy and safety of TRCP are definite. TRCP is more economical. For the purpose of properly evaluate the peripheral vascular complications of TRCP, it is necessary to pay special attention to radial artery occlusion, radial artery stenosis, and jugular hematoma.

  2. Modeling of dynamic vehicle-road interactions for safety-related road evaluation.

    Science.gov (United States)

    Orfila, O; Coiret, A; Do, M T; Mammar, S

    2010-11-01

    Usually, road safety is assessed by following adequate highway geometric design standards and can be controlled later by measurement and expertise. Nevertheless, interactions between vehicle dynamics and road characteristics cannot be simultaneously analyzed for these two means of safety evaluation. In this study, an analytical method based on road/vehicle physical interactions applied to road diagnosis is proposed. Vehicle "point" and "bicycle" models are used in this first approach. French highway geometric design standards and a statistical method are presented and evaluated on a real curve case. The proposed numerical criterion, for the "bicycle" model, is then compared to these two classical methods for the considered road section. Its advantages are that it takes into account several combined parameters, that road defects are precisely localized and that it provides hierarchically classified solutions to the road managers. After this comparison step, further improvements should be focused on the modeling of successive curves and on the improvement of the informations given to the road manager.

  3. Safety/relief valve quencher loads: evaluation for BWR Mark II and III containments

    Energy Technology Data Exchange (ETDEWEB)

    Su, T.M.

    1982-10-01

    Boiling water reactor (BWR) plants are equipped with safety/relief valves (SRVs) to protect the reactor from overpressurization. Plant operational transients, such as turbine trips, will actuate the SRV. Once the SRV opens, the air column within the partially submerged discharge line is compressed by the high-pressure steam released from the reactor. The compressed air discharged into the suppression pool produces high-pressure bubbles. Oscillatory expansion and contraction of these bubbles create hydrodynamic loads on the containment structures, piping, and equipment inside containment. This report presents the results of the staff's evaluation of SRV loads. The evaluation, however, is limited to the quencher devices used in Mark II and III containments. With respect to Mark I containments, the SRV acceptance criteria are presented in NUREG-0661 issued July 1980. The staff acceptance criteria for SRV loads for Mark II and III containments are presented in this report.

  4. Growth hormone and the adolescent athlete: What are the data for its safety and efficacy as an ergogenic agent?

    Science.gov (United States)

    Rogol, Alan D

    2009-08-01

    There is great interest among athletes and in the sports and general media for the subject of "doping" with human growth hormone (hGH). The hype about this substance goes far beyond the available data. The issue of administration of recombinant rhGH to adolescents, whether for athletic performance or for esthetic purposes adds another wrinkle because normal pubertal growth and the acquisition of adult body composition depends upon the GH/IGF-I and the hypothalamic-pituitary-gonadal axes. The range of normal is wide and it is more difficult to determine the natural evolution of pubertal development from that fueled by rhGH (or anabolic steroids). There are no compelling data based on clinical trials to indicate enhanced athletic performance (young adults); however, one cannot be sure how rhGH is used in combination with other agents, including anabolic steroids and anabolic "supplements". There are no studies in adolescent athletes. The detection of administration of rhGH to adolescents using the analytes of the GH/IGF-I and of collagen turnover (bone modeling and remodeling) is complicated by the physiologic increases in these parameters during normal puberty. It should be noted that many older adolescents are physiologically younger, especially in those aesthetic sports that demand the thin (linear) physique.

  5. The Dynamic Safety Evaluation Model of the Safety Control Theory and Its Application%安全控制论的动态安全评价模型及其应用

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    In this paper, on the principle of the modern control theory, the safety state equation of the safety systems was established and the dynamic model of the safety evaluation was put out. And finally, the example of its application in an iron and steel corporation was given.

  6. Synthesis, Molecular docking and Biological evaluation of 4-Cycloalkylidineamino 1, 2-Naphthoquinone Semicarbazones as Anticancer agents

    Institute of Scientific and Technical Information of China (English)

    Shubhanjali Shukla; Radhey Shyam Srivastava; Sushant Kumar Shrivastava; Ajit Sodhi; Pankaj Kumar

    2012-01-01

    Objective: In an effort to etablish new candidates with improved antineoplastic activity, 4-cycloalkylidineamino 1,2-naphthoquinone semicarbazones were synthesized, characterized and evaluated for anticancer activity. Method: The desired compounds were synthesized by condensation of 4- amino1, 2-naphthoquinone with cyclic ketones and further subsequent reaction of this product with semicarbazide hydrochloride. Compounds were characterized by FT-IR, 1H NMR, 13C NMR, elemental analysis and screened for antiproliferative activity against three human cancer cell lines (HepG2, MG-63 and MCF-7) by MTT assay using doxorubicin as standard. Docking was performed by using the Glide 5.7 integrated with Maestro 9.2 (Schrödinger, LLC, 2011) to understand the binding preference of synthesized compounds with target enzyme topoisomerase-II. Results: 4-(cyclohexylideneamino) [1, 2] naphthoquinone 2-semicarbazone was found to be most active cytotoxic agent against all cancer cell lines with IC50 values in the range of 5.58–6.31 µM. Results of molecular docking were also well correlated in vitro cytotoxicity assay. Insilico ADME studies revealed the drug likeliness of compounds. Conclusions: The synthesized compounds were found to have significant anticancer activity and able to enter in higher phases of the drug development process due to favorable pharmacokinetic properties.

  7. Synthesis and Evaluation of Aminothiazole-Paeonol Derivatives as Potential Anticancer Agents

    Directory of Open Access Journals (Sweden)

    Chia-Ying Tsai

    2016-01-01

    Full Text Available In this study, novel aminothiazole-paeonol derivatives were synthesized and characterized using 1H-NMR, 13C-NMR, IR, mass spectroscopy, and high performance liquid chromatography. All the new synthesized compounds were evaluated according to their anticancer effect on seven cancer cell lines. The experimental results indicated that these compounds possess high anticancer potential regarding human gastric adenocarcinoma (AGS cells and human colorectal adenocarcinoma (HT-29 cells. Among these compounds, N-[4-(2-hydroxy-4-methoxyphenylthiazol-2-yl]-4-methoxybenzenesulfonamide (13c had the most potent inhibitory activity, with IC50 values of 4.0 µM to AGS, 4.4 µM to HT-29 cells and 5.8 µM to HeLa cells. The 4-fluoro-N-[4-(2-hydroxy-4-methoxyphenylthiazol-2-yl]benzenesulfonamide (13d was the second potent compound, showing IC50 values of 7.2, 11.2 and 13.8 µM to AGS , HT-29 and HeLa cells, respectively. These compounds are superior to 5-fluorouracil (5-FU for relatively higher potency against AGS and HT-29 human cancer cell lines along with lower cytotoxicity to fibroblasts. Novel aminothiazole-paeonol derivatives in this work might be a series of promising lead compounds to develop anticancer agents for treating gastrointestinal adenocarcinoma.

  8. Discovery and biological evaluation of the novel naturally occurring diterpene pepluanone as antiinflammatory agent.

    Science.gov (United States)

    Corea, Gabriella; Fattorusso, Ernesto; Lanzotti, Virginia; Di Meglio, Paola; Maffia, Pasquale; Grassia, Gianluca; Ialenti, Armando; Ianaro, Angela

    2005-11-03

    From the whole plant of Euphorbia peplus L., a new diterpene based on a rare pepluane skeleton, named pepluanone (1), was isolated together with a known pepluane diterpene (2). The stereostructure of pepluanone was determined on the basis of an extensive NMR study, MS data, and chemical reaction. The ability of these compounds to act as antiinflammatory agents has been evaluated for the first time by in vivo tests on carrageenin-induced rat paw edema, an experimental model of acute inflammation. Comparison of the bioactivity of pepluanone and compound 2 in terms of chemical structure, evidenced the high efficiency of pepluanone and the absence of appreciable activity for compound 2, thus giving a first insight into the structure-activity relationship. Further in vitro experiments performed on pepluanone let us hypothesize that its activity could be explained in reducing the production of nitric oxide, prostaglandin E(2), and TNF-alpha by inhibiting the expression of inducible nitric oxide synthase, cyclooxygenase-2, and TNF-alpha mRNA through the down-regulation of NF-kappaB binding activity.

  9. Biological evaluation of Phellinus linteus-fermented broths as anti-inflammatory agents.

    Science.gov (United States)

    Lin, Chun-Jung; Lien, Hsiu-Man; Chang, Hsiao-Yun; Huang, Chao-Lu; Liu, Jau-Jin; Chang, Yun-Chieh; Chen, Chia-Chang; Lai, Chih-Ho

    2014-07-01

    Phellinus linteus and its constituent hispolon induce potent anti-inflammatory activity in macrophages. Efficient production of the effective constituent and the biological function of P. linteus in the regulation of innate sensing have rarely been investigated. The aim of this study was to efficiently manufacture P. linteus-fermented broth containing the effective constituent, hispolon, and evaluate its immunoregulatory functions in macrophages. Four distinct fermented broths (PL1-4) and the medium dialyzate (MD) were prepared to screen suitable culture conditions for the mycelial growth of P. linteus. The P. linteus-fermented broth exhibited a dose-responsive inhibition of lipopolysaccharide (LPS)-induced nitric oxide (NO) production by murine macrophages. In addition, the P. linteus-fermented broths suppressed macrophage LPS-mediated nuclear factor (NF)-κB activity and tumor necrosis factor (TNF)-α. Among the tested samples from P. linteus, PL4 contained vast amounts of hispolon and showed the greatest anti-inflammatory activity in both the RAW264.7 cells and murine primary peritoneal exudate macrophages (PEMs). This study demonstrates that the purification of the effective constituent from P. linteus-fermented broth may enable the production of a potent therapeutic agent for anti-inflammation in macrophages.

  10. Evaluation of glycerin as preserving agent of chicken serum for plate agglutination test

    Directory of Open Access Journals (Sweden)

    ES de Freitas

    2014-09-01

    Full Text Available Serum is widely used for the purpose of monitoring and diagnosis support for most of poultry diseases. In the case of the serum plate agglutination test (SPA, commonly used to detect antibodies for Salmonella Pullorum (SP, Mycoplasma gallisepticum (MG and Mycoplasma synoviae (MS, serum cannot be frozen because it may result in false positive. Without freezing, serum can last only for a few days. In this experiment, glycerin was evaluated as a serum preservering agent. About 50 samples for each disease and analyzed by SPA test previously were separated. Glycerin was added to serum from commercial chickens, with and without antibodies for SP, MG and MS, in the proportion of 1:1 (serum:glycerin and kept at refrigerated conditions (2 to 8 ºC. For four years they were tested by the SPA, initially weekly, afterward monthly and then annually. The results show that serum with glycerin give consistent and valid results according to the kind of antibodies present for the period tested. Sera that glycerin was not added to, the results were valid only for the first week. From the second week on, microbial growth affected the test results of the sera without glycerin. Our investigation shows that glycerin can be used to preserve chicken serum for SPA under refrigerated conditions. It is an easy, simple and cheap procedure that can extend serum shelf life, useful mainly for control sera.

  11. Evaluation of Se-75 BISTAES as a potential articular cartilage imaging agent

    Energy Technology Data Exchange (ETDEWEB)

    Yu, S.W.K.

    1987-01-01

    The potential of Se-75 bis (..beta..-N,N,N-trimethylamino)-ethyl) selenide diiodide (Se-75 BISTAES) as an articular cartilage imaging agent for the early diagnosis of osteoarthritis was evaluated. The compound was synthesized and the identity was established. The radiochemical purity and stability were determined initially and over a two-month period of storage at three temperatures. The biodistribution of Se-75 BISTAES in rabbits and guinea pigs was studied. A high concentration of radioactivity was found in the knee and shoulder cartilage. The radioactivity in the cartilage was the highest at 15 minutes to one hour post-injection. In rabbits, the highest ratio of radioactivity in the cartilage to the surrounding tissues was about 30. A minimal ratio of 10 is required for nuclear medicine imaging. Nuclear medicine imaging conducted on rabbits demonstrated increased radioactivity in the articular cartilage in the knee and shoulder. The impression from the nuclear medicine images and the findings of the biodistribution study indicated that the route of excretion of Se-75 BISTAES was the urine. The in vitro binding between Se-75 BISTAES and chondroitin sulfate was determined by an equilibrium dialysis technique.

  12. Application of Green Chemistry Principle in Synthesis of Phenytoin and Its Biogical Evaluation as Anticonvulsant Agents

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    Abhijit Kadam

    2011-01-01

    Full Text Available Phenytoin (5,5'-dipenylimidazolidine-2,4-dione is the prime example of anticonvulsant agent. According to reported procedure, it is synthesized by condensation of benzil and urea in presence of base (30% w/v NaOH using ethanol as solvent which itself acts as CNS stimulant. Removal of solvent after synthesis is most difficult and non-assured process. In case of phenytoin transformation in polymorphism plays an important role when solvent other than water is used. About 30% extra cost is calculated if solvent other than water is used. Therefore by application of green chemistry principle phenytoin was synthesized by condensation of benzil and urea in presence of base (30% NaOH and water as green solvent. This compound was characterized on the basis of its spectral (IR, 1H NMR data and evaluated for anticonvulsant activity using MES induced and PTZ induced seizure models in Swiss albino mice. Significant anticonvulsant activity was found by using 25 mg/kg and 50 mg/kg of phenytoin compared with standard phenytoin at 25 mg/kg dose.

  13. Evaluation of guar gum derivatives as gelling agents for microbial culture media.

    Science.gov (United States)

    Gangotri, Waikhom; Jain-Raina, Ruchi; Babbar, Shashi B

    2012-05-01

    Guar gum, a galactomannan, has been reported to be an inexpensive substitute of agar for microbial culture media. However, its use is restricted probably because of (1) its highly viscous nature even at high temperatures, making dispensing of the media to Petri plates difficult and (2) lesser clarity of the guar gum gelled media than agar media due to impurities present in guar gum. To overcome these problems, three guar gum derivatives, carboxymethyl guar, carboxymethyl hydroxypropyl guar and hydroxypropyl guar, were tested as gelling agents for microbial growth and differentiation. These were also evaluated for their suitability for other routine microbiological methods, such as, enumeration, use of selective and differential media, and antibiotic sensitivity test. For evaluation purpose, growth and differentiation of eight fungi and eight bacteria grown on the media gelled with agar (1.5%), guar gum (4%) or one of the guar gum derivatives (4%), were compared. All fungi and bacteria exhibited normal growth and differentiation on all these media. Generally, growth of most of the fungi was better on guar gum derivatives gelled medium than on agar medium. The enumeration carried out for Serratia sp. and Pseudomonas aeruginosa by serial dilution and pour plate method yielded similar counts in all the treatments. Likewise, the selective succinate medium, specific for P. aeruginosa, did not allow growth of co-inoculated Bacillus sp. even if gelled with guar gum derivatives. The differential medium, Congo red mannitol agar could not differentiate between Agrobacterium tumefaciens and Rhizobium meliloti on color basis, if gelled with guar gum or any of its derivatives However, for antibiotic sensitivity tests for both Gram-positive and -negative bacteria, guar gum and its derivatives were as effective as agar.

  14. Evaluation of effects of dentin bonding agents on microleakage in composite restorations

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    Pahlevan A.

    2002-08-01

    Full Text Available Dentin bonding agents create stronger bonding between dental composites and dentin. But, none of them can prevent the microleakage. The important factors of progressing microleakage are the stress of polymerization shrinkage of resin composite and removal of smear layer in total-etch technique. The aim of this study was the evaluation of the effect of experimental method (modifying smear layer and etching of enamel margin and comparison with the total-etch technique. In this experimental method, 60 extracted human molar teeth were disinfected. Then, class 5 cavities were prepared on the buccal surface and 1 mm above CEJ. The specimens were divided randomly to 6 groups with iO samples in each group. The specimens groups were:"n1- Scotchbond Muiti- Purpose Plus Adhesive System (S.B.M.P.P +Tetric composite"n2- S.B.M.P.P + Ariston composite"n3- Ariston liner + Ariston composite"n4- S.B.M.P.P without enamel and dentin etching + Tetric composite + rebonding with Flowable Tetric"n5- S.B.M.P.P without enamel and dentin etching + Ariston composite + rebonding with Flowable Tetric"n6- S.B.M.P.P without enamel and dentin etching + Tetric composite"nAfter finishing and polishing, the specimens were termocycled, stained with fushin, sectioned within the specimens and evaluated for dye penetration with stereomicroscope. Wilcoxon Sign and Kruskal Wallis tests were used for statistical analysis."nResults showed that group 3 had microleakage more than groups of 1, 2 and 5 (P<0.0 5 and this difference was significant. There was no significant difference among the other groups.

  15. The Idea Storming Cube: Evaluating the Effects of Using Game and Computer Agent to Support Divergent Thinking

    Science.gov (United States)

    Huang, Chun-Chieh; Yeh, Ting-Kuang; Li, Tsai-Yen; Chang, Chun-Yen

    2010-01-01

    The objective of this article is to evaluate the effectiveness of a collaborative and online brainstorming game, Idea Storming Cube (ISC), which provides users with a competitive game-based environment and a peer-like intelligent agent. The program seeks to promote students' divergent thinking to aid in the process of problem solving. The…

  16. Evaluation of anti-inflammatory effect of anti-platelet agent-clopidogrel in experimentally induced inflammatory bowel disease

    OpenAIRE

    2012-01-01

    Aim: To evaluate the anti-inflammatory effect of antiplatelet agent, clopidogrel, in experimentally induced inflammatory bowel disease (IBD). Materials and Methods: TNBS induced Crohn′s disease model and oxazolone induced ulcerative colitis model were used to evaluate the role of clopidogrel in IBD. Spargue Dawley female and Wistar male rats were used respectively. The colitis was induced by a single intra-colonic application of TNBS (0.25 ml, 120 mg/ml in 50% ethanol) and oxazolone (450 ...

  17. A phase I trial to evaluate the safety and pharmacokinetics of low-dose methotrexate as an anti-malarial drug in Kenyan adult healthy volunteers

    Directory of Open Access Journals (Sweden)

    Oyoo George O

    2011-03-01

    Full Text Available Abstract Background Previous investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. A phase I evaluation was conducted to assess the safety and pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers. Methods Twenty five healthy adult volunteers were recruited and admitted to receive a 5 mg dose of methotrexate/day/5 days. Pharmacokinetics blood sampling was carried out at 2, 4, 6, 12 and 24 hours following each dose. Nausea, vomiting, oral ulcers and other adverse events were solicited during follow up of 42 days. Results The mean age of participants was 23.9 ± 3.3 years. Adherence to protocol was 100%. No grade 3 solicited adverse events were observed. However, one case of transiently elevated liver enzymes, and one serious adverse event (not related to the product were reported. The maximum concentration (Cmax was 160-200 nM and after 6 hours, the effective concentration (Ceff was Conclusion Low-dose methotraxate had an acceptable safety profile. However, methotrexate blood levels did not reach the desirable Ceff of 250-400-nM required to clear malaria infection in vivo. Further dose finding and safety studies are necessary to confirm suitability of this drug as an anti-malarial agent.

  18. Evaluation of the benefit of the bispyridinium compound MB327 for the antidotal treatment of nerve agent-poisoned mice.

    Science.gov (United States)

    Kassa, Jiri; Pohanka, Miroslav; Timperley, Christopher M; Bird, Mike; Green, A Christopher; Tattersall, John E H

    2016-06-01

    The potency of the bispyridinium non-oxime compound MB327 [1,1'-(propane-1,3-diyl)bis(4-tert-butylpyridinium) diiodide] to increase the therapeutic efficacy of the standard antidotal treatment (atropine in combination with an oxime) of acute poisoning with organophosphorus nerve agents was studied in vivo. The therapeutic efficacy of atropine alone - or atropine in combination with an oxime, MB327, or both an oxime and MB237 - was evaluated by the determination of LD50 values of several nerve agents (tabun, sarin and soman) in mice with and without treatment. The addition of MB327 increased the therapeutic efficacy of atropine alone, and atropine in combination with an oxime, against all three nerve agents, although differences in the LD50 values only reached statistical significance for sarin. In conclusion, the addition of the compound MB327 to the standard antidotal treatment of acute poisonings with nerve agents was beneficial regardless of the chemical structure of the nerve agent, although at the dose employed, MB327 in combination with atropine, or atropine and an oxime, provided only a modest increase in protection ratio. These results from mice, and previous ones from guinea-pigs, provide consistent evidence for additional, albeit modest, efficacy resulting from the inclusion of the antinicotinic compound MB327 in standard antidotal therapy. Given the typically steep probit slope for the dose-lethality relationship for nerve agents, such modest increases in protection ratio could provide significant survival benefit.

  19. PERFORMANCE EVALUATION OF CLUSTERING IN WEB-LOG ANALYSIS BASED ON AGENT

    Directory of Open Access Journals (Sweden)

    Himani

    2012-06-01

    Full Text Available Web mining is the use of data mining Technique toautomatically discover & extract information from webdocuments. When user searches for goods the managementagent receives order from graphical user interface.Management agent receives information, update agentinformation store house and feedback the mining result touser. Intelligent agent can help making computer systemeasier to use, enable finding & filtering information. Themining agent is the analytical center of whole agentsystem.It mainly adopts two kind of analytical method:related rule mining and cluster analysis. Cluster of objectsare formed so that objects with in a cluster have highsimilarity. The aim of this paper is to analyze the web logdata .To achieve this clustering tool is used. It performs intwo phases. First it captures the web-log data. Then itanalyzes the data& discovers the hidden pattern. Agentrequires an agent communication language to describe &process agent request. The future internet will use PERL toencode information with meaningful structure & semantics.

  20. EFFICACY AND SAFETY OF DEFERASIROX WHEN COMPARED TO D EFERIPRONE AS ORAL IRON CHELATING AGENT : A RANDOMIZED CONTROL TRIAL

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    Sanjeeva

    2015-03-01

    Full Text Available BACKGROUND : Thalassemia is one of the most common inherited hemoglobinopathy seen in southern India. With regular blood transfusion, these children live longer but associated morbidity due to iron overload impairs the quality of life. We studied the efficacy and safety of new oral iron chelator, deferasirox, compared with deferiprone which was used for long time. MATERIAL AND METHODS : We cond ucted a prospective randomised control study, between January 2011 to June 2012 at thalassemia day care centre of Indira Gandhi I nstitute of C hild H ealth, Bengaluru. The children who were diagnosed as Thalassemia and receiving regular blood transfusion wit h serum ferritin levels more than 1000ng/ml and not receiving any chelation therapy were included in the study. These children were randomly divided into two groups as group 1 and group 2 by computer generated randomization. The children included in g roup 1 received Deferasirox and group 2 received Deferiprone as chelation therapy. The dosage of deferasirox was 20mg/kg/day once daily and that of deferiprone 75 mg/kg/day in three divided daily doses. The primary study outcome was to measure and compare the d ecrease in serum ferritin levels between the two study groups. The secondary outcome measures were to compare the side effect profiles among the two groups. RESULTS : We included 41 thalessemic children and 19 of them were included in group 1 (Deferasirox and 22 children in Group 2 (Deferiprone. At the end of study period of 18 months three children in group II discontinued therapy due to side effects, hence the remaining 19 were available for final analysis in group 2 whereas no drop outs in the group 1. During the study period, the serum ferritin decreased from 3261±2613ng/dl to 1586±766 ng/dl in group 1 as compared in group 2 from 4109±3153 ng/dl to 1743±1138 ng/dl (fig 2. This was also not statistically significant. In group 2, 68% of the children expe rienced adverse effect as compared

  1. Sunscreening Agents

    Science.gov (United States)

    Martis, Jacintha; Shobha, V; Sham Shinde, Rutuja; Bangera, Sudhakar; Krishnankutty, Binny; Bellary, Shantala; Varughese, Sunoj; Rao, Prabhakar; Naveen Kumar, B.R.

    2013-01-01

    The increasing incidence of skin cancers and photodamaging effects caused by ultraviolet radiation has increased the use of sunscreening agents, which have shown beneficial effects in reducing the symptoms and reoccurrence of these problems. Many sunscreen compounds are in use, but their safety and efficacy are still in question. Efficacy is measured through indices, such as sun protection factor, persistent pigment darkening protection factor, and COLIPA guidelines. The United States Food and Drug Administration and European Union have incorporated changes in their guidelines to help consumers select products based on their sun protection factor and protection against ultraviolet radiation, whereas the Indian regulatory agency has not yet issued any special guidance on sunscreening agents, as they are classified under cosmetics. In this article, the authors discuss the pharmacological actions of sunscreening agents as well as the available formulations, their benefits, possible health hazards, safety, challenges, and proper application technique. New technologies and scope for the development of sunscreening agents are also discussed as well as the role of the physician in patient education about the use of these agents. PMID:23320122

  2. Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

    Directory of Open Access Journals (Sweden)

    Schweizer A

    2011-02-01

    Full Text Available Anja Schweizer1, Sylvie Dejager2, James E Foley3, Wolfgang Kothny31Novartis Pharma AG, Basel, Switzerland; 2Novartis Pharma SAS, Rueil-Malmaison, France; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAAim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs, of vildagliptin based on a large pooled database of Phase II and III clinical trials.Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks' duration. AE profiles of vildagliptin (50 mg bid; N = 6116 were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210. Absolute incidence rates were calculated for all AEs, serious AEs (SAEs, discontinuations due to AEs, and deaths.Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively, whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators. The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas.Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies.Keywords: type 2 diabetes, dipeptidyl peptidase-4, edema, safety, vildagliptin

  3. Efficiency evaluation of a safety department in a construction company-A case study: A DEA approach

    Directory of Open Access Journals (Sweden)

    Solomon Odeyale

    2015-01-01

    Full Text Available Data Envelopment Analysis (DEA is a decision making tool based on linear programming for measuring the relative efficiency of a set of comparable units. DEA helps us identify the sources and level of inefficiency for each of the inputs and outputs. This approach has been used to evaluate the efficiency of the safety department in five construction companies. A three-input, safety workforce, safety training, and safety budget, and two-output, Perfect days and Uptime, constant returns-to-scale (CRS model was developed. The model indicated the necessary improvements required in the inefficient unit’s inputs and outputs to make it efficient, by identifying what factor is responsible for the low efficiency of performance, and also what factor should be improved in order to improve the efficiency of the safety department. The result shows that the safety department of firm A, B and D are efficient, but Firm C and Firm E can improve their efficiency by reducing inputs up to 3.34% and 6.05%, respectively. The inputs identified for reduction were; number of safety staffs and safety budget for Firm C and E respectively.

  4. Comparative pharmacokinetics and the evaluation of human food safety for veterinary drugs

    Institute of Scientific and Technical Information of China (English)

    CraiA

    2002-01-01

    The evaluation of human food safety for veterinary drugs used in food animals is required as part of the veterinary drug approval process in most countries.Two elements necessary to demonstrate human food safety are toxicology data concerning the acute and chronic toxicity of the parent drug and its metabolites,and data describing the pharmacokinetics of residues of the drug and metabolites in the species of animals in which the drug will be used.Interspecies differences in metabolism can be qualitative and quantitative.In most food animals,qualitative differences in metabolism of veterinary drugs is not seen.Differences are almost always in the amounts of individual metabolites and their distribution.Because residues are composed of the parent drug and metabolites,interspecies comparisons must involve consideration of comparative xenobiotic metabolism.Aspects of comparative food animal drug metabolism which can afect the composition of residues will be reviewed.Additionally,the residue studies which are required to establish human food safety,and interspecies differences and similarities in the pharmacokinetics of drugs which impact residues of drugs in animal derived foods will be studied.To illustrate the factors which can complicate and assist these comparisons,two drugs will be examined in detail;ivemectin and fenbendazole.The results of recent residue studies exploring comparative pharmacokinetics and metabolism in avian species will be presented.Lastly,the activities of two US programs,FARAD and The NRSP-7 Minor Use Animal Drug Program,which routinely address interspecies comparisons will be presented along with potential strategies which may be employed in the study of species diffecences.

  5. The Safety Evaluation of Salvianolic Acid B and Ginsenoside Rg1 Combination on Mice

    Directory of Open Access Journals (Sweden)

    Qun Zhao

    2015-12-01

    Full Text Available Our previous study indicated that the combination of salvianolic acid B (SalB and ginsenoside Rg1 (Rg1, the main components of Salvia miltiorrhizae and Panax notoginseng, improves myocardium structure and ventricular function in rats with ischemia/reperfusion injury. The present study aimed to determine the safety of the combined SalB and Rg1 (SalB-Rg1 in mice. The safety of SalB-Rg1 was evaluated through acute toxicity and repeated-dose toxicity. In the acute toxicity study, the up and down procedure was carried out firstly, and then, the Bliss method was applied. In the toxicity study for seven-day repeated treatment of SalB-Rg1, forty Kunming mice were randomly divided into four groups. The intravenous median lethal dose (LD50 of the SalB-Rg1 combination was 1747 mg/kg using the Bliss method. For both the acute toxicity study and the seven-day repeated toxicity study, SalB-Rg1 did not induce significant abnormality on brain, heart, kidney, liver and lung structure at any dose based on H&E stain. There were no significant changes related to the SalB-Rg1 toxicity detected on biochemical parameters for two kinds of toxicity studies. The LD50 in mice was 1747 mg/kg, which was more than one hundred times higher than the effective dose. Both studies of acute toxicity and seven-day repeated dose toxicity indicated the safety of the SalB-Rg1 combination.

  6. The Safety Evaluation of Salvianolic Acid B and Ginsenoside Rg1 Combination on Mice.

    Science.gov (United States)

    Zhao, Qun; Yang, Min; Deng, Yanping; Yu, Haitao; Wang, Linlin; Teng, Fukang; Cho, Kenka; Ma, Hongmei; Wu, Peng; Li, Xue; Wu, Wanying; Liu, Xuan; Xu, Feng; Jiang, Baohong; Guo, De-An

    2015-12-09

    Our previous study indicated that the combination of salvianolic acid B (SalB) and ginsenoside Rg1 (Rg1), the main components of Salvia miltiorrhizae and Panax notoginseng, improves myocardium structure and ventricular function in rats with ischemia/reperfusion injury. The present study aimed to determine the safety of the combined SalB and Rg1 (SalB-Rg1) in mice. The safety of SalB-Rg1 was evaluated through acute toxicity and repeated-dose toxicity. In the acute toxicity study, the up and down procedure was carried out firstly, and then, the Bliss method was applied. In the toxicity study for seven-day repeated treatment of SalB-Rg1, forty Kunming mice were randomly divided into four groups. The intravenous median lethal dose (LD50) of the SalB-Rg1 combination was 1747 mg/kg using the Bliss method. For both the acute toxicity study and the seven-day repeated toxicity study, SalB-Rg1 did not induce significant abnormality on brain, heart, kidney, liver and lung structure at any dose based on H&E stain. There were no significant changes related to the SalB-Rg1 toxicity detected on biochemical parameters for two kinds of toxicity studies. The LD50 in mice was 1747 mg/kg, which was more than one hundred times higher than the effective dose. Both studies of acute toxicity and seven-day repeated dose toxicity indicated the safety of the SalB-Rg1 combination.

  7. Safety Re-evaluation of Kyoto University Research Reactor by reflecting the Accident of Fukushima Daiichi Nuclear Power Plant

    Energy Technology Data Exchange (ETDEWEB)

    Nakajima, K.; Yamamoto, T. [Kyoto Univ., Kyoto (Japan)

    2013-07-01

    Kyoto University Research Reactor (KUR) is a light-water moderated tank-type reactor operated at rated thermal power of 5MW. After the accident of Fukushima Daiichi nuclear power plant, we have settled a 40-ton water tank near the reactor room, and prepared a mobile fire pump and a mobile power generator as additional safety measures for beyond design basis accidents (BDBAs). We also have conducted the safety re-evaluation of KUR, and confirmed that the integrity of KUR fuels could be kept against the BDBA with the use of the additional safety measures when the several restrictions were imposed on the reactor operation.

  8. Phase I trial evaluating the antiviral agent Cidofovir in combination with chemoradiation in cervical cancer patients

    Science.gov (United States)

    Deutsch, Eric; Haie-Meder, Christine; Bayar, Mohamed Amine; Mondini, Michele; Laporte, Mélanie; Mazeron, Renaud; Adam, Julien; Varga, Andrea; Vassal, Gilles; Magné, Nicolas; Chargari, Cyrus; Lanoy, Emilie; Pautier, Patricia; Levy, Antonin; Soria, Jean-Charles

    2016-01-01

    Purpose This phase I trial aimed to assess the safety and determine the recommended Phase II dose (RP2D) of Cidofovir combined with chemoradiotherapy in patients with stage IB2-IVA cervical cancer. Experimental design Incremental doses (1, 2.5, 5 and 6.5 mg/kg) of IV Cidofovir were administered weekly for two weeks, and then every 2 weeks from the start of chemoradiotherapy to the initiation of utero-vaginal brachytherapy. Biological expression of HPV was analyzed during treatment and tumor response was assessed according to RECIST v1.0 criteria. Results A total of 15 patients were treated with Cidofovir. Dose-limiting toxicities occurred in 2/6 patients at the 6.5 mg/kg dose level (G3 proteinuria, and G3 acute pyelonephritis with G3 febrile neutropenia). No toxicity occurred at the 5 mg/kg dose level, but only 3 patients received this dose due to trial interruption because of low accrual. The most frequent G3-4 adverse effects observed during the trial were: abdominal pain (n=3), infection (n=2), leuckoneutropenia (n=2), and others (n=6). No toxic death or major renal side effect occurred. The best response was that 8/9 evaluable patients achieved a complete response (89%). In the intention to treat population, the 2-year overall and progression-free survival rates were 93% and 76%, respectively. Biological monitoring of HPV-related markers (decreased p16 expression, and increased p53 and pRb levels) was possible on sequential tumor biopsy samples. The genomic alterations identified were PIK3CA (n=5; one also had a KRAS mutation), and HRAS (n=1) mutations. Conclusion Cidofovir at a dose of 5mg/kg combined with chemoradiotherapy appeared tolerable and yielded tumor regressions. Due to early trial interruption, the RP2D was not confirmed. PMID:27016411

  9. Evaluation on the efficacy and safety of domestic bivalirudin during percutaneous coronary intervention

    Institute of Scientific and Technical Information of China (English)

    XIANG Ding-cheng; GU Xiao-long; SONG Yao-ming; HUANG Wei-jian; TANG Liang-qiu; YIN Yao-hui; GENG Shao-hua

    2013-01-01

    Background Bivalirudin was widely used as an anticoagulant during coronary interventional procedure in western countries.However,it was not available in China before this clinical trial was designed.This randomized,single-blind and multicenter clinical trial aimed to evaluate the efficacy and the safety of domestic bivalirudin during percutaneous coronary intervention (PCI).Methods A randomized,single-blind,multicenter trial was designed.Elective PCI candidates in five centers were randomized into a bivalirudin group and a heparin group,which were treated with domestic bivalirudin and non-fractional heparin during the PCI procedure.The efficacy was evaluated by comparing the activated coagulation time (ACT),the procedural success rate (residual stenosis <20% in target lesions without any coronary artery related adverse events within 24 hours after PCI),and the survival rate without major adverse cardiac events at 30 days after PCI between the two groups.Safety was evaluated by the major/minor bleeding rate.Results A total of 218 elective PCI patients were randomized into a bivalirudin group (n=110) and heparin group (n=108).Except for two patients needing additional dosing in the heparin group,the ACT values of all other patients in both groups were longer than 225 seconds at 5 minutes after the first intravenous bolus.Procedural success rates were respectively 100.0% and 98.2% in the bivalirudin group and heparin group (P>0.05).Survival rates without major adverse cardiac events at 30 days after PCI were 100.0% in the bivalirudin group and 98.2% in the heparin group (P>0.05).Mild bleeding rates were 0.9% and 6.9% (P<0.05) at 24 hours,and 1.9% and 8.8% (P<0.05) at 30 days after PCI in the bivalirudin group and heparin group respectively.There was one severe gastrointestinal bleeding case in the heparin group.Conclusions Domestic bivalirudin is an effective and safe anticoagulant during elective PCI procedures.The efficacy is not inferior

  10. Safety evaluation and risk assessment of the herbicide Roundup and its active ingredient, glyphosate, for humans.

    Science.gov (United States)

    Williams, G M; Kroes, R; Munro, I C

    2000-04-01

    Reviews on the safety of glyphosate and Roundup herbicide that have been conducted by several regulatory agencies and scientific institutions worldwide have concluded that there is no indication of any human health concern. Nevertheless, questions regarding their safety are periodically raised. This review was undertaken to produce a current and comprehensive safety evaluation and risk assessment for humans. It includes assessments of glyphosate, its major breakdown product [aminomethylphosphonic acid (AMPA)], its Roundup formulations, and the predominant surfactant [polyethoxylated tallow amine (POEA)] used in Roundup formulations worldwide. The studies evaluated in this review included those performed for regulatory purposes as well as published research reports. The oral absorption of glyphosate and AMPA is low, and both materials are eliminated essentially unmetabolized. Dermal penetration studies with Roundup showed very low absorption. Experimental evidence has shown that neither glyphosate nor AMPA bioaccumulates in any animal tissue. No significant toxicity occurred in acute, subchronic, and chronic studies. Direct ocular exposure to the concentrated Roundup formulation can result in transient irritation, while normal spray dilutions cause, at most, only minimal effects. The genotoxicity data for glyphosate and Roundup were assessed using a weight-of-evidence approach and standard evaluation criteria. There was no convincing evidence for direct DNA damage in vitro or in vivo, and it was concluded that Roundup and its components do not pose a risk for the production of heritable/somatic mutations in humans. Multiple lifetime feeding studies have failed to demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that glyphosate is noncarcinogenic. Glyphosate, AMPA, and POEA were not teratogenic or developmentally toxic. There were no effects on fertility or reproductive parameters in two multigeneration reproduction studies with

  11. Safety Evaluation Method of power production%电力生产安全性评价方法研究

    Institute of Scientific and Technical Information of China (English)

    陈萍

    2015-01-01

    近年来,随着我国工农业用电量的持续增加,电力企业面临着非常严峻的问题,即如何确保电力生产的安全性.针对电力生产安全问题,本文主要在介绍安全性评价概念的基础上,对电力生产与运行中的安全性评价作了详细研究,并提出了电力生产安全评价的具体方法,从而确保电力系统的安全运行.%In recent years, with the continued increase in industrial and agricultural use of electricity, power companies facing a very serious problem, namely, how to ensure the safety of power production. For power production safety issue, this paper describes the safety evaluation on the basis of the concept, the production of electricity and the operation of the safety evaluation of detailed study and propose concrete methods of power production safety evaluation to ensure the safety of the power system run.

  12. Evaluation of Bogie Frame Safety of Shanghai Metro Line 1 by 3D FEM Analysis

    Science.gov (United States)

    Xiongyao, Xie; Guolong, Jin; Rulu, Wang

    2010-05-01

    The vehicle bogies of Shanghai metro line 1 began to crack just in the third year after the trains operated. More than 50 cracks occurred in the succeeding six year during the train operation. This paper evaluated the safety of the motorized bogies. First, the loading conditions imposed on the vehicle structure were calculated based on the measured data in service of the train, and compared with the original design load. Then, this paper calculated simulated the stress of the vehicle bogie by 3D FEM, and presented the distribution of every stress concentration point in Goodman fatigue diagram. The computational locations of the strength less than the safety are agreed with where cracks have happened. Finally, this paper calculated the fatigue life of the motor bracket of the bogie through S-N curve based on revised Miner theory. In conclusion, this paper think that the bogie cracks of Shanghai metro line 1 are contributed by the overburden fatigue load, and ignoring the lateral vibration load in the design of the vehicle bogie is the important cause that bogie cracks occurred far earlier than in the designed time.

  13. Functional and safety evaluation of transgenic pork rich in omega-3 fatty acids.

    Science.gov (United States)

    Tang, Maoxue; Qian, Lili; Jiang, Shengwang; Zhang, Jian; Song, Pengkun; Chen, Yaoxing; Cui, Wentao; Li, Kui

    2014-08-01

    Genetically modified animals rich in omega-3 unsaturated fatty acid offer a new strategy to improve the human health, but at the same time present a challenge in terms of food safety assessment. In this study, we evaluated the function and safety of sFat-1 transgenic pork rich in omega-3 fatty acids in mice by feeding basic diet and diets that contain wild type pork and sFat-1 transgenic pork. Blood biochemistry, haematology, peripheral T cell distributions, bacterial counts, gross necropsy, histopathology and organ weights were performed in mice fed with different doses of wild type and transgenic pork. Results indicated that both low and high dose of wild type and transgenic pork had no significant effect on blood biochemistry, T cell distribution, immunoglobulins and bacterial counts in intestine and feces. However, it was noted that both low and high dose of transgenic pork improved the liver immune system in mice, which is probably due to the beneficial contribution of high level of the "good" fatty acids in transgenic pork. There is no significant effect of transgenic pork on all other organs in mice. In summary, our study clearly demonstrated that feeding transgenic pork rich in omega-3 fatty acids did not cause any harm to mice, and in fact, improved the liver immune system.

  14. Application of metal magnetic memory test in failure analysis and safety evaluation of vessels

    Institute of Scientific and Technical Information of China (English)

    Yiliang ZHANG; Song YANG; Xuedong XU

    2009-01-01

    Metal magnetic memory test (MMMT), which is a new subject in the field of nondestructive examination, can determine regions of stress concentration by testing the distribution of the magnetic field of metal structures so as to effectively diagnose premature defects. MMMT and other test methods are applied in the study to put a propylene purifier of a temperature-jump accident and a leaked ammonia vessel through safety evaluation. Results are as follows: The margin of safety declines after the purifier is overburnt; several stress concentrations are observed within the overburnt area and the level of stress concentration rises after one-month operation; and overpressure operation of the purifier must be strictly avoided and carefully monitored during later operation. Cracks are observed on the ammonia vessel after one year's service. Extremely high residual stress is the primary cause of cracks. After four years in service, the residual stresses existing in the area of the base metal and weld zone are still greater than 0.5 ors, which results in numerous cracks due to stress corrosion. From the MMMT result of the ammonia vessel's defects, it can be seen that the derivative of magnetic density (dHp/dx) is an important reference variable. Within the 31 leakage points, the one whose values of dHp/dx are above 10 occupy 67.7%, and the ones above 8 share 96.8%.

  15. Safety Evaluation of the Grape Marc Spirit by GC-FID Analysis

    Directory of Open Access Journals (Sweden)

    Teodora Coldea

    2013-11-01

    Full Text Available There were investigated grape marc spirits regarding their safety on consumers. Major volatile compounds which present risk to human health (such as methanol, furfural, and acetaldehyde and ethyl alcohol content were compared to European Union Regulation and other values found in previous studies.  The aim of our study was to evaluate the safety of grape marc spirits considering their content in major volatile compounds by comparison with the requirements of European Union Regulation. We investigated the ethyl alcohol content by electronic densimetry and 10 major volatile compounds (acetaldehyde, ethyl acetate, methanol, 1-propanol, 1-butanol, 2-butanol, isobutyl alcohol, isoamyl alcohol, amyl active alcohol and furfural by Gas Chromatography coupled with Flame Ionization Detector. We used reference chemicals to identify these compounds and 3-pentanol as internal standard to quantify the volatiles. Results were compared with the requirements of European Union Regulation. All major volatile compounds registered values in accordance to EU Regulation and the grape pomace spirits samples do not present any kind of risk for consumption.

  16. Development of a real-time scour monitoring system for bridge safety evaluation

    Science.gov (United States)

    Lin, Tzu-Kang; Chang, Yu-Shian

    2017-01-01

    The fact that hydraulic problems are major factors in bridge collapse has made bridge scour monitoring an important research topic. In view of the complex nonlinear behavior of bridge structure/soil/water interactions, the fundamental frequency of the bridge may gradually change as the height of the bed drops during scour. With an insufficient embedded depth, the bridge may collapse or sink unexpectedly without warning. As experimental investigation in past research has shown that bridge failure may be governed by rigid body motion, a real-time bridge scour monitoring system to distinguish the influence of rigid body motion from the vibration frequency of the bridge is proposed. The signal measured from the superstructure of the bridge is decomposed into a structural vibration set controlling the fundamental frequency change and a rigid body motion set controlling the rigid body motion, and an instability index to examine the safety condition of the bridge is further proposed. Following a successful preliminary single-pile scour experiment, the method is applied to a series of full-bridge testing. According to analysis result, the instability index deviated considerably from its original range before the bridge piles began tilting significantly, allowing an early warning alert for bridge safety evaluation.

  17. Probabilistic safety evaluation: Development of procedures with applications on components used in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Dillstroem, P. [Det Norske Veritas AB, Stockholm (Sweden)

    2000-12-01

    A probabilistic procedure has been developed by SAQ Kontroll AB to calculate two different failure probabilities, P{sub F}: Probability of failure, defect size given by NDT/NDE. Probability of failure, defect not detected by NDT/NDE. Based on the procedure, SAQ Kontroll AB has developed a computer program PROPSE (PRObabilistic Program for Safety Evaluation). Within PROPSE, the following features are implemented: Two different algorithms to calculate the probability of failure are included: Simple Monte Carlo Simulation (MCS), with an error estimate on P{sub F}. First-Order Reliability Method (FORM), with sensitivity factors using the most probable point of failure in a standard normal space. Using these factors, it is possible to rank the parameters within an analysis. Estimation of partial safety factors, given an input target failure probability and characteristic values for fracture toughness, yield strength, tensile strength and defect depth. Extensive validation has been carried out, using the probabilistic computer program STAR6 from Nuclear Electric and the deterministic program SACC from SAQ Kontroll AB. The validation showed that the results from PROPSE were correct, and that the algorithms used in STAR6 were not intended to work for a general problem, when the standard deviation is either 'small' or 'large'. Distributions, to be used in a probabilistic analysis, are discussed. Examples on data to be used are also given.

  18. Preclinical evaluation of the metabolism and disposition of RRx-001, a novel investigative anticancer agent.

    Science.gov (United States)

    Scicinski, Jan; Oronsky, Bryan; Taylor, Michael; Luo, Gang; Musick, Timothy; Marini, Joseph; Adams, Christopher M; Fitch, William L

    2012-09-01

    RRx-001 has shown promise as a novel cancer therapeutic agent. The disposition of RRx-001 was evaluated in vitro and after intravenous administration to rats. At both 24 and 168 h after a single intravenous administration of ¹⁴C-RRx-001 (10 mg/kg), the majority of radiolabel was in the blood. The recovery of label in excreta was quite low, but the major route of radiolabel excretion was via the kidney, with approximately 26% in the urine by the first 8 h and decreasing amounts in all subsequent collections to a total of 36.3% by 168 h. The partitioning of total radioactivity in red blood cells (RBCs) and plasma was determined after in vitro addition to human, rat, dog, and monkey whole blood at 1 and 20 μM. In rat, at 30 min, approximately 75% of the radioactivity is associated with RBCs and 25% with plasma. In human, at 30 min, approximately 25% of the radioactivity is associated with RBCs and 75% with plasma. Analysis by liquid chromatography/radiodetection/mass spectrometry showed that ¹⁴C-RRx-001 reacted rapidly with whole blood to give four major soluble metabolites: the GSH and Cys adducts of RRx-001 (M1 and M2) and the corresponding mononitro GSH and Cys adducts (M3 and M4). Human Hb was incubated with cold RRx-001 in buffer, and a standard proteomics protocol was used to separate and identify the tryptic peptides. Standard peptide collision-induced fragment ions supported the structure of the peptide GTFATLSELHCDK with the alkylation on the Cys-93 locus of the Hb β chain.

  19. Whose mind matters more--the agent or the artist? An investigation of ethical and aesthetic evaluations.

    Directory of Open Access Journals (Sweden)

    Angelina Hawley-Dolan

    Full Text Available Theory of mind, the capacity for reasoning about mental states such as beliefs and intentions, represents a critical input to ethical and aesthetic evaluations. Did the agent cause harm on purpose? Were those brushstrokes intentional? The current study investigates theory of mind for moral and artistic judgments within the same paradigm. In particular, we target the role of intent for two kinds of judgments: "objective" judgments of quality and "subjective" judgments of preference or liking. First, we show that intent matters more for objective versus subjective judgments in the case of ethics and aesthetics. Second, we show that, overall, intent matters more for ethical versus aesthetic evaluations. These findings suggest that an "objective-subjective" dimension describes judgments across both domains, and that observers assign more weight to the mind of the moral agent than the mind of the artist when making the relevant evaluations.

  20. Evaluation of the Level of Food Safety Protection Provided by the U.S. Grade "A" Pasteurized Milk Ordinance and Its Associated Cooperative Grade "A" Milk Safety Program.

    Science.gov (United States)

    Ma, Yinqing; Klontz, Karl C; DiNovi, Michael J; Edwards, Alison J; Hennes, Robert F

    2015-08-01

    The present study was conducted to evaluate the level of food safety protection provided to consumers of Grade "A" milk and milk products in the United States by the National Conference on Interstate Milk Shipments (NCIMS) Grade "A" Milk Safety Program through its implementation and enforcement of the U.S. Grade "A" Pasteurized Milk Ordinance (PMO). The number of reported illnesses associated with Grade "A" milk and milk products in the United States was obtained from state and federal agencies and published articles. The consumption of Grade "A" milk and milk products in the United States was estimated from food consumption survey data for individuals. The level of food safety protection was measured quantitatively using the metric of annual illness attack rate. During a 15-year period (1999 through 2013), the estimated annual illness attack rate was 0.41 reported illnesses per 1 billion exposures (estimated using person-day intake data) or 0.52 reported illnesses per 1 billion lb (454 million kg) of Grade "A" milk and milk products consumed. Food safety protection provided to consumers of Grade "A" milk and milk products by the NCIMS through its implementation and enforcement of the PMO is important given the common consumption of Grade "A" milk and milk products in the United States.

  1. An evaluation of passive safety features of the Japanese prototype LMFBR Monju

    Energy Technology Data Exchange (ETDEWEB)

    Tomoko Ishizu; Hiroshi Endo; Yoshihisa Shindo; Kazuo Haga [Safety Analysis and Evaluation Div., Japan Nuclear Energy Safety Organization (JNES) Kamiya-cho MT bldg., 4-3-20, Toranomon, Minato-ku, Tokyo, 105-0001 (Japan)

    2005-07-01

    Japan Nuclear Energy Safety Organization, JNES, has developed a system dynamics analysis code NALAP-II, in order to apply in the safety regulation of liquid-metal-cooled fast breeder reactor (LMFBR). In this study, the heat removal by the coolant natural circulation (NC), which is one of passive safety features of LMFBR, was examined using the code. This paper presents the model verification of the decay heat removal system and the result of trial calculation to the Japanese prototype LMFBR MONJU. In the MONJU plant, the decay heat is removed normally by three loops of the secondary heat transport system (SHTS) coupled with the intermediate reactor auxiliary cooling system (IRACS) as shown in Fig.1. To enable the cooling by NC, the air cooler (AC) of MONJU is installed in a position where the heat-transfer center is higher than that of the intermediate heat exchanger (IHX). Verification analyses of the IRACS model of NALAP-II have been carried out, by using the data of a 'natural convection test' conducted as a part of MONJU's performance tests. This test was conducted adding the heat generated by the pump operation in the primary heat transport system (PHTS) instead of the reactor power. The test was started by tripping SHTS pony-motored pump and sodium began to flow by the natural convective force through the air cooling system (ACS) of the IRACS. Figure 2 presents the analytical results of the SHTS transient comparing with the test results. In this test, about 2% of the rated SHTS flow rate was kept by the NC resulting from the balance between the heat input at IHX and the heat removal at IRACS. The calculated results of SHTS flow rate and sodium temperature during NC showed a good agreement with the test results. Then, using the verified NALAP-II, an evaluation of heat removal by NC of MONJU IRACS after the trip at the rated power operation was performed. The result showed that even if only one loop operation of IRACS removes the decay heat

  2. Using lagging and leading indicators for the evaluation of occupational safety and health performance in industry.

    Science.gov (United States)

    Pawłowska, Zofia

    2015-01-01

    Improvement of occupational safety and health (OSH) management is closely related to the development of OSH performance measurement, which should include OSH outcomes (e.g., occupational accidents), OSH inputs (including working conditions) and OSH-related activities. The indicators used to measure the OSH outcomes are often called lagging indicators, and the indicators of inputs and OSH activities are leading indicators. A study was conducted in 60 companies in order to determine what kinds of indicators were used for OSH performance measurement by companies with different levels of OSH performance. The results reveal that the indicators most commonly used in all of the companies are those related to ensuring compliance with the statutory requirements. At the same time, the leading indicators are much more often adopted in companies with a higher performance level. These companies also much more often monitor on a regular basis the indicators adopted for the evaluation of their OSH performance.

  3. Digital System Reliability Test for the Evaluation of safety Critical Software of Digital Reactor Protection System

    Directory of Open Access Journals (Sweden)

    Hyun-Kook Shin

    2006-08-01

    Full Text Available A new Digital Reactor Protection System (DRPS based on VME bus Single Board Computer has been developed by KOPEC to prevent software Common Mode Failure(CMF inside digital system. The new DRPS has been proved to be an effective digital safety system to prevent CMF by Defense-in-Depth and Diversity (DID&D analysis. However, for practical use in Nuclear Power Plants, the performance test and the reliability test are essential for the digital system qualification. In this study, a single channel of DRPS prototype has been manufactured for the evaluation of DRPS capabilities. The integrated functional tests are performed and the system reliability is analyzed and tested. The results of reliability test show that the application software of DRPS has a very high reliability compared with the analog reactor protection systems.

  4. Safety Evaluation for Packaging for onsite Transfer of plutonium recycle test reactor ion exchange columns

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.J.

    1995-09-11

    The purpose of this Safety Evaluation for Packaging (SEP) is to authorize the use of three U.S. Department of Transportation (DOT) 7A, Type A metal boxes (Capital Industries Part No. S 0600-0600-1080- 0104) to package 12 Plutonium Recycle Test Reactor (PRTR) ion exchange columns as low-level waste (LLW). The packages will be transferred from the 309 Building in the 300 Area to low level waste burial in the 200 West Area. Revision 1 of WHC-SD-TP-SEP-035 (per ECN No. 621467) documents that the boxes containing ion exchange columns and grout will maintain the payload under normal conditions of transport if transferred without the box lids

  5. Evaluation of the safety of latrogenic lntestinal perforation during placement of percutaneous drainage catheter in rabbit

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Choon Hyeong; Oh, Joo Hyung; Park, Ga Young; Shin, Hong Sub; Kim, In Sub; Yoon, Yup; Lee, Dong Ho; Ko, Young Tae; Choi, Woo Suk; Lim, Joo Won [Kyunghee Univ. Hospital, Seoul (Korea, Republic of)

    1996-10-01

    To evaluate the safety of transgression of the bowel during intraperitoneal percutaneous catheter placement in an animal model. Eight 8-F straight catheters were percutaneously inserted into the small and large bowel of eight rabbits. In four animals, the catheters were left in place until autopsy, whereas in the remaining four, the catheters were withdrawn five days after insertion. Autopsy was performed in all animals ten days after catheter placement, and gross and microscopic examination was carried out. Transgressing the bowel during intraperitoneal percutaneous catheter placement did not contribute to any clinically significant complications. At autopsy, there was no bowel leakage, peritonitis, or abscess, although peritoneal adhesions were found around the catheter tract. Although further study is warranted, our study with an animal model indicated that transgression of the intestine during percutaneous placement of an intraabdominal catheter did not produce significant complications.

  6. Safety Evaluation for Packaging for the N Reactor/single pass reactor fuel characterization shipments

    Energy Technology Data Exchange (ETDEWEB)

    Stevens, P.F.

    1994-10-13

    The purpose of this Safety Evaluation for Packaging (SEP) is to authorize the ChemNuclear CNS 1-13G packaging to ship samples of irradiated fuel elements from the 100 K East and 100 K West basins to the Postirradiation Testing Laboratory (PTL) in support of the spent nuclear fuel characterization effort. It also authorizes the return of the fuel element samples to the 100 K East facility using the same packaging. The CNS 1-13G cask has been-chosen to transport the fuel because it has a Certificate of Compliance (CoC) issued by the US Nuclear Regulatory Commission (NRC) for transporting irradiated oxide and metal fuel in commerce. It is capable of being loaded and offloaded underwater and may be shipped with water in the payload compartment.

  7. Experimental Studies of quantitative evaluation using HPLC and safety of Bee Venom Acupuncture

    Directory of Open Access Journals (Sweden)

    Seong Bong Jang

    2006-02-01

    Full Text Available Objectives : This study was conducted to carry out quantitative evaluation and safety of Bee Venom Acupuncture. Methods : Content analysis was done using HPLC, measurement of , and histological observations were made on the skin and muscles. Results : 1. According to HPLC analysis, each BVA-1 contained approximately , and BVA-2 contained approximately . But the volume of coating was so minute, slight difference exists between each needle. 2. LD50 of mouse with BVA-1 was 16 counts and this is equivalent to 640 needles/kg, making Bee Venom Acupuncture safe treatment apparatus. 3. Regardless of the number of needles, there was no sign of blood stasis or inflammation detected on the skin and muscle tissues. Conclusion : Above results indicate that the Bee Venom Acupuncture can complement shortcomings of syringe usage as a part of Oriental medicine treatment, but extensive researches should be done for further verification.

  8. Evaluation of safety profile of black shilajit after 91 days repeated administration in rats

    Institute of Scientific and Technical Information of China (English)

    Velmurugan C; Vivek B; Wilson E; Bharathi T; Sundaram T

    2012-01-01

    Objective: To evaluate the safety of shilajit by 91 days repeated administration in different dose levels in rats. Methods: In this study the albino rats were divided into four groups. Group I received vehicle and group II, III and IV received 500, 2500 and 5000 mg/kg of shilajit, respectively. Finally animals were sacrificed and subjected to histopathology and iron was estimated by flame atomic absorption spectroscopy and graphite furnace. Results: The result showed that there were no significant changes in iron level of treated groups when compared with control except liver (5000 mg/kg) and histological slides of all organs revealed normal except negligible changes in liver and intestine with the highest dose of shilajit. The weight of all organs was normal when compared with control. Conclusions: The result suggests that black shilajit, an Ayurvedic formulation, is safe for long term use as a dietary supplement for a number of disorders like iron deficiency anaemia.

  9. [Safety evaluation of micronomicin VIII. Teratogenicity studies in rabbits after intravenous injection].

    Science.gov (United States)

    Hara, T; Fujita, T; Takahashi, H; Deguchi, T

    1983-11-01

    Micronomicin (MCR) is a new aminoglycoside antibiotic produced by Micromonospora sagamiensis var. nonreducans which was isolated from soil collected at Sagamihara City by Nara et al. This antibiotic shows a close similarity to gentamicin C components in physical and chemical properties. The antibacterial activity of MCR is broad-spectrum and almost equal to that of gentamicin C complex. MCR exhibits particularly high activity against Pseudomonas, Proteus, Klebsiella pneumoniae, Serratia, etc. as well as against some Pseudomonas aeruginosa strains resistant to gentamicin C1a. Teratogenicity studies of MCR in rabbits were carried out by intravenous injection for safety evaluation (Dose; 25, 50 mg/kg and 70 mg/kg). The results of studies are as follows. Fetal malformation attributable to MCR was not observed at any dose. There was no adverse effect on new borns at any dose.

  10. Technology Development, Evaluation, and Application (TDEA) FY 1998 Progress Report Environment, Safety, and Health (ESH) Division

    Energy Technology Data Exchange (ETDEWEB)

    Larry G. Hoffman; Kenneth Alvar; Thomas Buhl; Bruce Erdal; Philip Fresquez; Elizabeth Foltyn; Wayne Hansen; Bruce Reinert

    1999-06-01

    This progress report presents the results of 10 projects funded ($504K) in FY98 by the Technology Development, Evaluation, and Application (TDEA) Committee of the Environment, Safety, and Health Division. Nine projects are new for this year; two projects were completed in their third and final TDEA-funded year. As a result of their TDEA-funded projects, investigators have published 19 papers in professional journals, proceedings, or Los Alamos reports and presented their work at professional meetings. Supplemental funds and in-kind contributions, such as staff time, instrument use, and work space were also provided to the TDEA-funded projects by organizations external to ESH Division. Products generated from the projects funded in FY98 included a new extremity dosimeter that replaced the previously used finger-ring dosimeters, a light and easy-to-use detector to measure energy deposited by neutron interactions, and a device that will allow workers to determine the severity of a hazard.

  11. Evaluation of {sup 99m}Tc(CO){sub 5}I as a potential lung perfusion agent

    Energy Technology Data Exchange (ETDEWEB)

    Miroslavov, Alexander E.; Gorshkov, Nikolay I.; Lumpov, Alexander L. [Division of Radiochemical Research, Khlopin Radium Institute, 2nd Murinskii pr. 28, 194021, St Petersburg (Russian Federation); Yalfimov, Anatoly N. [Nuclear Medicine Department, Central Research Institute of Roentgenology and Radiology, Leningradskaya str. 70/4, 197000, St Petersburg (Russian Federation); Suglobov, Dmitrii N. [Division of Radiochemical Research, Khlopin Radium Institute, 2nd Murinskii pr. 28, 194021, St Petersburg (Russian Federation); Ellis, Beverley L. [Department of Nuclear Medicine, Manchester Royal Infirmary, M13 9WL Manchester (United Kingdom)], E-mail: bev.ellis@manchester.ac.uk; Braddock, Rattana; Smith, Anne-Marie [Imaging Science and Biomedical Engineering, School of Cancer and Imaging Science, Stopford Building, The University of Manchester, Oxford Road, Manchester M13 9PT (United Kingdom); Prescott, Mary C.; Lawson, Richard S. [Department of Nuclear Medicine, Manchester Royal Infirmary, M13 9WL Manchester (United Kingdom); Sharma, Harbans L. [Imaging Science and Biomedical Engineering, School of Cancer and Imaging Science, Stopford Building, The University of Manchester, Oxford Road, Manchester M13 9PT (United Kingdom)

    2009-01-15

    Introduction: The use of {sup 99m}Tc-macroggregated albumin for lung perfusion imaging is well established in nuclear medicine. However, there have been safety concerns over the use of blood-derived products because of potential contamination by infective agents, for example, Variant Creutzfeldt Jakob Disease. Preliminary work has indicated that Tc(CO){sub 5}I is primarily taken up in the lungs following intravenous administration. The aim of this study was to evaluate the biodistribution and pharmacokinetics of {sup 99m}Tc(CO){sub 5}I and its potential as a lung perfusion agent. Methods: {sup 99m}Tc(CO){sub 5}I was synthesized by carbonylation of {sup 99m}TcO{sub 4-} at 160 atm of CO at 170 deg. C in the presence of HI for 40 min. Radiochemical purity was determined by HPLC using {sup 99}Tc(CO){sub 5}I as a reference. {sup 99m}Tc(CO){sub 5}I was administered by ear-vein injection to three chinchilla rabbits, and dynamic images were acquired using a gamma camera (Siemens E-cam) over 20 min. Imaging studies were also performed with {sup 99m}Tc-labeled macroaggregated albumin ({sup 99m}Tc-MAA) and {sup 99m}TcO{sub 4-} for comparison. {sup 99m}Tc(CO){sub 5}I was administered intravenously to Sprague-Dawley rats, and tissue distribution studies were obtained at 15 min and 1 h postinjection. Comparative studies were performed using {sup 99m}Tc-MAA. Results: Radiochemical purity, assessed by HPLC, was 98%. The retention time was similar to that of {sup 99}Tc(CO){sub 5}I. The dynamic images showed that 70% of {sup 99m}Tc(CO){sub 5}I appeared promptly in the lungs and remained constant for at least 20 min. In contrast, {sup 99m}TcO{sub 4-} rapidly washed out of the lungs after administration. As expected {sup 99m}Tc-MAA showed 90% lung accumulation. The percentage of injected dose per gram of organ {+-}S.D. at 1 h for {sup 99m}Tc(CO){sub 5}I was as follows: blood, 0.22{+-}0.02; lung, 12.8{+-}2.87; liver, 0.8{+-}0.15; heart, 0.15{+-}0.01; kidney, 0.47{+-}0.08. The

  12. Development of thermal-hydraulic models for the safety evaluation of CANDU reactors

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jae Young; Hwang, Gi Suk; Jung, Yun Sik [Handong Univ., Pohang (Korea, Republic of); No, Hee Cheon; Moon, Young Min [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    2003-03-15

    The objective of the present research is to evaluate the safety analysis for CANDU and to improve the Horizontal Stratification Entrainment Model (HSEM) of RELAP5/MOD3.3. This report includes two items : the one is the development of experimental facility for the safety evaluation of CANDU, the other is the results of comparison with the existing correlations and data. The literature reviews are performed and the database for previous off-take experiments are built. By a survey of state-of-the-articles, the deficiencies of previous works and limitations of existing models are examined. The hydraulic behavior branching through the feeder pipes from the header pipe is analyzed and the test facility of off-take experiment is designed and manufactured as the prototype CANDU6, by a proper scaling methodologies. The test facility contains various branch pipes not only for three directions (top, side and bottom), but for arbitrary directions. The experiments about the onset of entrainment and branch quality only for three directions (top, side and bottom) are carried out by using air-water as working fluids. On the whole, the existing correlations predict the present experimental results well branch quality, entrainment, which validates the availability of experimental facility and methodology. Especially, for the branch quality with top and bottom branches, the different results are shown because of the unstable flow regimes in the horizontal pipe and the different branch diameters. The deficiencies of previous works and limitations of existing models are considered. The off-take experiment for arbitrary branch angles continues as the next year research.

  13. Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents

    Directory of Open Access Journals (Sweden)

    Naohide Yamashita

    2014-09-01

    Full Text Available Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA with sodium ferrous citrate (SFC in diabetic patients treated with one or more oral hypoglycemic agents (OHAs. Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population. Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively. The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG and hemoglobin A1c (HbA1c. Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent. Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs.

  14. A signal processing application for evaluating self-monitoring blood glucose strategies in a software agent model.

    Science.gov (United States)

    Wang, Zhanle; Paranjape, Raman

    2015-07-01

    We propose the signal processing technique of calculating a cross-correlation function and an average deviation between the continuous blood glucose and the interpolation of limited blood glucose samples to evaluate blood glucose monitoring frequency in a self-aware patient software agent model. The diabetic patient software agent model [1] is a 24-h circadian, self-aware, stochastic model of a diabetic patient's blood glucose levels in a software agent environment. The purpose of this work is to apply a signal processing technique to assist patients and physicians in understanding the extent of a patient's illness using a limited number of blood glucose samples. A second purpose of this work is to determine an appropriate blood glucose monitoring frequency in order to have a minimum number of samples taken that still provide a good understanding of the patient's blood glucose levels. For society in general, the monitoring cost of diabetes is an extremely important issue, and these costs can vary tremendously depending on monitoring approaches and monitoring frequencies. Due to the cost and discomfort associated with blood glucose monitoring, today, patients expect monitoring frequencies specific to their health profile. The proposed method quantitatively assesses various monitoring protocols (from 6 times per day to 1 time per week) in nine predefined categories of patient agents in terms of risk factors of health status and age. Simulation results show that sampling 6 times per day is excessive, and not necessary for understanding the dynamics of the continuous signal in the experiments. In addition, patient agents in certain conditions only need to sample their blood glucose 1 time per week to have a good understanding of the characteristics of their blood glucose. Finally, an evaluation scenario is developed to visualize this concept, in which appropriate monitoring frequencies are shown based on the particular conditions of patient agents. This base line can

  15. Evaluation of Efficacy and Safety of Propranolol for Pediatric Migraine Prophylaxis

    Directory of Open Access Journals (Sweden)

    M Ordooei

    2013-04-01

    Full Text Available Introduction: Migraine is the most frequent and most important headache in childhood. Therefore, prophylactic therapy should be exerted in children with frequent or disabling headaches. The purpose of this study was to evaluate efficacy and safety of propranolol for children’s migraine prophylaxis. Methods: In this quasi- experimental study, monthly frequency, severity and duration of headache, migraine disability and side effects of fifty migrainous children were evaluated who were treated with 1mg/kg/day of propranolol for three months and referred to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from April 2011. Results: Twenty seven (54% girls and 23(46% boys with mean age of 10.68± 2.35 years were evaluated. Monthly frequency, severity and duration of headache decreased with treatment, from 16.2±6.74 to 8.88±4.54 attacks, from 6. 1±1.54 to 4.18±1.61, and from 2.2±1.36 to 1.08±1.08 hours, respectively. Pediatric Migraine Disability Assessment score reduced with TPM from 33.08±8.98 to 23.64 ± 9.88. (p<0.05. Transient side effects were seen in 10%(N=5 of the patients including mild hypotension in three and drowsiness in two children. Conclusion: Propranolol is partially effective and safe for pediatric migraine prophylaxis.

  16. Application of the threshold of toxicological concern approach for the safety evaluation of calendula flower (Calendula officinalis) petals and extracts used in cosmetic and personal care products.

    Science.gov (United States)

    Re, T A; Mooney, D; Antignac, E; Dufour, E; Bark, I; Srinivasan, V; Nohynek, G

    2009-06-01

    Calendula flower (Calendula officinalis) (CF) has been used in herbal medicine because of its anti-inflammatory activity. CF and C. officinalis extracts (CFE) are used as skin conditioning agents in cosmetics. Although data on dermal irritation and sensitization of CF and CFE's are available, the risk of subchronic systemic toxicity following dermal application has not been evaluated. The threshold of toxicological concern (TTC) is a pragmatic, risk assessment based approach that has gained regulatory acceptance for food and has been recently adapted to address cosmetic ingredient safety. The purpose of this paper is to determine if the safe use of CF and CFE can be established based upon the TTC class for each of its known constituents. For each constituent, the concentration in the plant, the molecular weight, and the estimated skin penetration potential were used to calculate a maximal daily systemic exposure which was then compared to its corresponding TTC class value. Since the composition of plant extracts are variable, back calculation was used to determine the maximum acceptable concentration of a given constituent in an extract of CF. This paper demonstrates the utility and practical application of the TTC concept when used as a tool in the safety evaluation of botanical extracts.

  17. First preclinical evaluation of mono-[{sup 123}I]iodohypericin as a necrosis-avid tracer agent

    Energy Technology Data Exchange (ETDEWEB)

    Ni, Yicheng; Chen, Feng; Marchal, Guy [University Hospital Gasthuisberg, Department of Radiology, Leuven (Belgium); Huyghe, Dieter; Verbeke, Kristin; Verbruggen, Alfons M.; Bormans, Guy M. [University of Leuven, Laboratory of Radiopharmaceutical Chemistry, Faculty of Pharmaceutical Sciences, Leuven (Belgium); Witte, Peter A. de [University of Leuven, Laboratory of Pharmaceutical Biology and Phytopharmacology, Faculty of Pharmaceutical Sciences, Leuven (Belgium); Nuyts, Johan; Mortelmans, Luc [University Hospital Gasthuisberg, Department of Nuclear Medicine, Leuven (Belgium)

    2006-05-15

    We have labelled hypericin, a polyphenolic polycyclic quinone found in St. John's wort (Hypericum perforatum), with{sup 123}I and evaluated mono-[{sup 123}I]iodohypericin (MIH) as a potential necrosis-avid diagnostic tracer agent. MIH was prepared by an electrophilic radioiodination method. The new tracer agent was evaluated in animal models of liver infarction in the rat and heart infarction in the rabbit using single-photon emission computed tomography (SPECT), triphenyltetrazolium chloride (TTC) histochemical staining, serial sectional autoradiography and microscopy, and radioactivity counting techniques. Using in vivo SPECT imaging, hepatic and cardiac infarctions were persistently visualised as well-defined hot spots over 48 h. Preferential uptake of the tracer agent in necrotic tissue was confirmed by perfect match of images from post-mortem TTC staining, autoradiography (ARX) and histology. Radioactivity concentration in infarcted tissues was over 10 times (liver; 3.51% ID/g in necrotic tissue vs 0.38% ID/g in normal tissue at 60 h p.i.) and over 6 times (myocardium; 0.36% ID/g in necrotic tissue vs 0.054% ID/g in normal tissue; ratios up to 18 for selected parts on ARX images) higher than in normal tissues. The results suggest that hypericin derivatives may serve as powerful necrosis-avid diagnostic agents for assessment of tissue viability. (orig.)

  18. Evaluation of the low tube voltage in the computed tomography scan technique using a low concentration contrast agent

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Kang Kyo; Cho, Pyong Kon [Dept. of Radiological Science, Catholic University of DaeGu, Deagu (Korea, Republic of)

    2016-03-15

    The purpose of this study is computed tomography contrast agent at low concentrations and low tube voltage technique to evaluate the usefulness on the phantom image. By varying the degree of mixture by the contrast medium concentration it was inserted in phantom. It was taken by changing the tube voltage and tube current step by step, and to evaluate the dose and the CT value obtained from the phantom image. As a result, low-contrast, low tube voltage(300 mgI/ml, 100 kV) was reduced by an average 21%(CTDIvol; computed tomography dose indexvol) more standard condition(350 mgI/ml, 120 kV). SNR was increased at all depths of the phantom, respectively 1:10 and 1:20(by diluting a contrast agent and normal saline) 12.2(26%) 6.2(17%). CNR was increased at all depths of the phantom, respectively 1:10 and 1:20(by diluting a contrast agent and normal saline) 11.5(32%), 6.3(26%). Research work on the CT scan is necessary in a variety of studies on the low contrast concentration and low tube voltage techniques for dose reduction and reducing of side effects the contrast agent.

  19. An Agent-based Transportation Route Planning Method for Led Fabricating Line and Its Evaluation Using Lagrangian Relaxation

    Science.gov (United States)

    Nishi, Tatsushi; Sotobayashi, Ken; Ando, Masakazu; Konishi, Masami

    In most of Light Emitting Diode (LED) semiconductor fabricating line, AGVs (Automated Guided Vehicles) are used to transport the products between the facilities in order to ensure dust-free operation in the transportation systems. It has been demanded to realize the route planning system which speedily derives a feasible transportation route so that each AGV does not interfere with other AGVs. In this paper, we applied an agent-based optimization method for the route planning problems with multiple AGVs in LED fabricating bay in which the total transportation time is minimized. In the agent-based method, each AGV agent independently searches its candidate of route. The imitated pheromone is effectively used to generate the route which avoids the collision among AGVs. In order to evaluate the performance of the proposed method, the lower bound of the original problem is obtained by using the Lagrangian relaxation technique. The performances of the proposed method are evaluated by using the value of duality gap for a large scale problem. The effectiveness of the agent-based optimization method is demonstrated.

  20. Synthesis and biological evaluation of a novel series of chalcones incorporated pyrazole moiety as anticancer and antimicrobial agents.

    Science.gov (United States)

    Mohamed, Magda F; Mohamed, Mervat S; Shouman, Samia A; Fathi, Mohamed M; Abdelhamid, Ismail Abdelshafy

    2012-11-01

    A newly synthesized series of chalcone derivatives containing pyrazole rings were synthesized and evaluated for their cytotoxic activities in vitro against several human cancer cell lines. Most of the prepared compounds showed potential cytotoxicity against human breast cancer cell lines MCF-7, HEPG-2, and HCT-116. Also the compounds were evaluated as antimicrobial agents. The three compounds 3, 4, and 5 were proved to be better anticancer agents than the positive standard doxorubicin with IC50 values (4.7, 4.4, and 3.9 μg/ml) against the same human cancer cell lines, whereas compounds 5 and 6 showed the most active antimicrobial compounds in comparison to the other chalcones.

  1. Recommendations for the development and application of Evaluation Tools for road infrastructure safety management in the EU. Road Infrastructure Safety Management Evaluation Tools (RISMET), Deliverable No. 7.

    NARCIS (Netherlands)

    Schermers, G. Cardoso, J. Elvik, R. Weller, G. Dietze, M. Reurings, M. Azeredo, S. & Charman, S.

    2014-01-01

    “ERA-NET ROAD — Coordination and Implementation of Road Research in Europe” was a Coordination Action funded by the 6th Framework Programme of the EC. The partners in the 2009 ERA-NET ROAD (ENR) Safety at the heart of road design initiative were the United Kingdom, Finland, Netherlands, Sweden, Germ

  2. CHARACTERIZATION AND PERFORMANCE EVALUATION OF REUSED WABE AS FLOCCULANTS AGENT TO TREAT INDUSTRIAL PAPER MILL WASTEWATER

    Directory of Open Access Journals (Sweden)

    MUHAMMAD H. J. KHADIDI

    2016-05-01

    Full Text Available The present research mainly to explore the performance of customize flocculants agent made by reusable waste (WABE to treat actual wastewater from different industry. The effect of mixing rate (10, 20, 30, 150, 175 and 200 rpm, sedimentation time (5, 15 and 30 min, initial pH (5, 6, 7 and original pH of initial wastewater and flocculation dosage (2, 5 and 10% v/v were investigated based on turbidity removal. WABE characterized by Inductively Coupled Plasma Mass Spectrometry (ICP-MS and Fourier Transform Infrared Spectroscopy (FTIR. The result shows flocculants agents have high turbidity removal up to 90% at optimum condition. This study also provides strong evident WABE can be developed as flocculants agent at low cost and low maintenance.

  3. Safety evaluation for packaging transportation of equipment for tank 241-C-106 waste sluicing system

    Energy Technology Data Exchange (ETDEWEB)

    Calmus, D.B.

    1994-08-25

    A Waste Sluicing System (WSS) is scheduled for installation in nd waste storage tank 241-C-106 (106-C). The WSS will transfer high rating sludge from single shell tank 106-C to double shell waste tank 241-AY-102 (102-AY). Prior to installation of the WSS, a heel pump and a transfer pump will be removed from tank 106-C and an agitator pump will be removed from tank 102-AY. Special flexible receivers will be used to contain the pumps during removal from the tanks. After equipment removal, the flexible receivers will be placed in separate containers (packagings). The packaging and contents (packages) will be transferred from the Tank Farms to the Central Waste Complex (CWC) for interim storage and then to T Plant for evaluation and processing for final disposition. Two sizes of packagings will be provided for transferring the equipment from the Tank Farms to the interim storage facility. The packagings will be designated as the WSSP-1 and WSSP-2 packagings throughout the remainder of this Safety Evaluation for Packaging (SEP). The WSSP-1 packagings will transport the heel and transfer pumps from 106-C and the WSSP-2 packaging will transport the agitator pump from 102-AY. The WSSP-1 and WSSP-2 packagings are similar except for the length.

  4. A collision model for safety evaluation of autonomous intelligent cruise control.

    Science.gov (United States)

    Touran, A; Brackstone, M A; McDonald, M

    1999-09-01

    This paper describes a general framework for safety evaluation of autonomous intelligent cruise control in rear-end collisions. Using data and specifications from prototype devices, two collision models are developed. One model considers a train of four cars, one of which is equipped with autonomous intelligent cruise control. This model considers the car in front and two cars following the equipped car. In the second model, none of the cars is equipped with the device. Each model can predict the possibility of rear-end collision between cars under various conditions by calculating the remaining distance between cars after the front car brakes. Comparing the two collision models allows one to evaluate the effectiveness of autonomous intelligent cruise control in preventing collisions. The models are then subjected to Monte Carlo simulation to calculate the probability of collision. Based on crash probabilities, an expected value is calculated for the number of cars involved in any collision. It is found that given the model assumptions, while equipping a car with autonomous intelligent cruise control can significantly reduce the probability of the collision with the car ahead, it may adversely affect the situation for the following cars.

  5. Safety Evaluation of Osun River Water Containing Heavy Metals and Volatile Organic Compounds (VOCs) in Rats.

    Science.gov (United States)

    Azeez, L; Salau, A K; Adewuyi, S O; Osineye, S O; Tijani, K O; Balogun, R O

    2015-12-20

    This study evaluated the pH, heavy metals and volatile organic compounds (VOCs) in Osun river water. It also evaluated its safety in rats. Heavy metals were determined by atomic absorption spectrophotometry (AAS) while VOCs were determined by gas chromatography coupled with flame ionization detector (GC-FID). Male and female rats were exposed to Osun river water for three weeks and then sacrificed. The abundance of heavy metals in Osun river followed the trend Pb > Cd > Zn > Fe > Cr > Cu while VOCs followed the trend benzene < ethylbenzene < toluene < xylene. The concentrations of Pb, Cd and benzene were higher than the permissible limits of Standards Organization of Nigeria (SON) and World Health Organization (WHO) respectively. Rats exposed to Osun river water for three weeks had increased WBC, thiobarbituric acid reactive substances (TBARS), serum proteins and serum aminotransferases. There were also significant decreases in HCT, PLT, liver aminotransferases and liver glutathione compared to the control. These results show that the pollutants in Osun river water are capable of inducing hematological imbalance and liver cell injury. The toxicity induced in blood was sex-dependent affecting female rats more than male rats.

  6. Substituted 3-Benzylcoumarins as Allosteric MEK1 Inhibitors: Design, Synthesis and Biological Evaluation as Antiviral Agents

    Directory of Open Access Journals (Sweden)

    Ping Xu

    2013-05-01

    Full Text Available In order to find novel antiviral agents, a series of allosteric MEK1 inhibitors were designed and synthesized. Based on docking results, multiple optimizations were made on the coumarin scaffold. Some of the derivatives showed excellent MEK1 binding affinity in the appropriate enzymatic assays and displayed obvious inhibitory effects on the ERK pathway in a cellular assay. These compounds also significantly inhibited virus (EV71 replication in HEK293 and RD cells. Several compounds showed potential as agents for the treatment of viral infective diseases, with the most potent compound 18 showing an IC50 value of 54.57 nM in the MEK1 binding assay.

  7. An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects

    Directory of Open Access Journals (Sweden)

    Borchert M

    2016-03-01

    Full Text Available Mark Borchert,1 Suzanne Bruce,2 David Wirta,3 Steven G Yoelin,4 Sungwook Lee,5 Cheri Mao,5 Amanda VanDenburgh5 1Children’s Hospital Los Angeles, Los Angeles, CA, USA; 2Suzanne Bruce and Associates, PA, Houston, TX, USA; 3David Wirta and Associates, Newport Beach, CA, USA; 4Medical Associates Inc., Newport Beach, CA, USA; 5Allergan plc, Irvine, CA, USA Purpose: Evaluate the safety and effectiveness of bimatoprost 0.03% for treatment of eyelash hypotrichosis in a pediatric population. Patients and methods: This multicenter, randomized, double-masked, parallel-group study was conducted at seven sites in the US and Brazil. Subjects with eyelash hypotrichosis caused by chemotherapy or alopecia areata (aged 5–17 years or healthy adolescents aged 15–17 years were enrolled (N=71. Subjects applied bimatoprost 0.03% or vehicle to upper eyelid margins once nightly for 4 months and were followed for 1 month post-treatment. Eyelash prominence was assessed using the validated 4-grade Global Eyelash Assessment scale with photonumeric guide. Changes in eyelash length, thickness, and darkness were measured by digital image analysis. Safety was assessed by adverse events and ophthalmic observations. Results: Eyelash prominence improved in a significantly greater proportion of subjects treated with bimatoprost compared with vehicle at month 4 (70.8% versus 26.1%; P<0.001. This benefit was sustained at month 5 post-treatment assessment. Digital image analysis measures were significantly improved with bimatoprost. Significant treatment benefits with bimatoprost versus vehicle were evident among the healthy adolescents but not in the postchemotherapy or alopecia areata subgroups. The safety profile of bimatoprost was consistent with previous studies in adults. Conclusion: Bimatoprost was safe and well tolerated in pediatric subjects with eyelash hypotrichosis. In this study with limited sample size, subgroup analyses showed that treatment was effective in

  8. Evaluating the Cost, Safety, and Proliferation Risks of Small Floating Nuclear Reactors.

    Science.gov (United States)

    Ford, Michael J; Abdulla, Ahmed; Morgan, M Granger

    2017-01-17

    It is hard to see how our energy system can be decarbonized if the world abandons nuclear power, but equally hard to introduce the technology in nonnuclear energy states. This is especially true in countries with limited technical, institutional, and regulatory capabilities, where safety and proliferation concerns are acute. Given the need to achieve serious emissions mitigation by mid-century, and the multidecadal effort required to develop robust nuclear governance institutions, we must look to other models that might facilitate nuclear plant deployment while mitigating the technology's risks. One such deployment paradigm is the build-own-operate-return model. Because returning small land-based reactors containing spent fuel is infeasible, we evaluate the cost, safety, and proliferation risks of a system in which small modular reactors are manufactured in a factory, and then deployed to a customer nation on a floating platform. This floating small modular reactor would be owned and operated by a single entity and returned unopened to the developed state for refueling. We developed a decision model that allows for a comparison of floating and land-based alternatives considering key International Atomic Energy Agency plant-siting criteria. Abandoning onsite refueling is beneficial, and floating reactors built in a central facility can potentially reduce the risk of cost overruns and the consequences of accidents. However, if the floating platform must be built to military-grade specifications, then the cost would be much higher than a land-based system. The analysis tool presented is flexible, and can assist planners in determining the scope of risks and uncertainty associated with different deployment options.

  9. Evaluation of intestinal phosphate binding to improve the safety profile of oral sodium phosphate bowel cleansing.

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    Stef Robijn

    Full Text Available Prior to colonoscopy, bowel cleansing is performed for which frequently oral sodium phosphate (OSP is used. OSP results in significant hyperphosphatemia and cases of acute kidney injury (AKI referred to as acute phosphate nephropathy (APN; characterized by nephrocalcinosis are reported after OSP use, which led to a US-FDA warning. To improve the safety profile of OSP, it was evaluated whether the side-effects of OSP could be prevented with intestinal phosphate binders. Hereto a Wistar rat model of APN was developed. OSP administration (2 times 1.2 g phosphate by gavage with a 12h time interval induced bowel cleansing (severe diarrhea and significant hyperphosphatemia (21.79 ± 5.07 mg/dl 6h after the second OSP dose versus 8.44 ± 0.97 mg/dl at baseline. Concomitantly, serum PTH levels increased fivefold and FGF-23 levels showed a threefold increase, while serum calcium levels significantly decreased from 11.29 ± 0.53 mg/dl at baseline to 8.68 ± 0.79 mg/dl after OSP. OSP administration induced weaker NaPi-2a staining along the apical proximal tubular membrane. APN was induced: serum creatinine increased (1.5 times baseline and nephrocalcinosis developed (increased renal calcium and phosphate content and calcium phosphate deposits on Von Kossa stained kidney sections. Intestinal phosphate binding (lanthanum carbonate or aluminum hydroxide was not able to attenuate the OSP induced side-effects. In conclusion, a clinically relevant rat model of APN was developed. Animals showed increased serum phosphate levels similar to those reported in humans and developed APN. No evidence was found for an improved safety profile of OSP by using intestinal phosphate binders.

  10. Evaluation of outbreak response immunization in the control of pertussis using agent-based modeling

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    Alexander Doroshenko

    2016-08-01

    Full Text Available Background Pertussis control remains a challenge due to recently observed effects of waning immunity to acellular vaccine and suboptimal vaccine coverage. Multiple outbreaks have been reported in different ages worldwide. For certain outbreaks, public health authorities can launch an outbreak response immunization (ORI campaign to control pertussis spread. We investigated effects of an outbreak response immunization targeting young adolescents in averting pertussis cases. Methods We developed an agent-based model for pertussis transmission representing disease mechanism, waning immunity, vaccination schedule and pathogen transmission in a spatially-explicit 500,000-person contact network representing a typical Canadian Public Health district. Parameters were derived from literature and calibration. We used published cumulative incidence and dose-specific vaccine coverage to calibrate the model’s epidemiological curves. We endogenized outbreak response by defining thresholds to trigger simulated immunization campaigns in the 10–14 age group offering 80% coverage. We ran paired simulations with and without outbreak response immunization and included those resulting in a single ORI within a 10-year span. We calculated the number of cases averted attributable to outbreak immunization campaign in all ages, in the 10–14 age group and in infants. The count of cases averted were tested using Mann–Whitney U test to determine statistical significance. Numbers needed to vaccinate during immunization campaign to prevent a single case in respective age groups were derived from the model. We varied adult vaccine coverage, waning immunity parameters, immunization campaign eligibility and tested stronger vaccination boosting effect in sensitivity analyses. Results 189 qualified paired-runs were analyzed. On average, ORI was triggered every 26 years. On a per-run basis, there were an average of 124, 243 and 429 pertussis cases averted across all age

  11. A Preclinical Evaluation of Antimycin A as a Potential Antilung Cancer Stem Cell Agent

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    Chi-Tai Yeh

    2013-01-01

    Full Text Available Drug resistance and tumor recurrence are major obstacles in treating lung cancer patients. Accumulating evidence considers lung cancer stem cells (CSCs as the major contributor to these clinical challenges. Agents that can target lung CSCs could potentially provide a more effective treatment than traditional chemotherapy. Here, we utilized the side-population (SP method to isolate lung CSCs from A549 and PC-9 cell lines. Subsequently, a high throughput platform, connectivity maps (CMAPs, was used to identify potential anti-CSC agents. An antibiotic, antimycin A (AMA, was identified as a top candidate. SP A549 cells exhibited an elevated stemness profile, including Nanog, β-catenin, Sox2, and CD133, and increased self-renewal ability. AMA treatment was found to suppress β-catenin signaling components and tumor sphere formation. Furthermore, AMA treatment decreased the proliferation of gefitinib-resistant PC-9/GR cells and percentage of SP population. AMA demonstrated synergistic suppression of PC-9/GR cell viability when combined with gefitinib. Finally, AMA treatment suppressed tumorigenesis in mice inoculated with A549 SP cells. Collectively, we have identified AMA using CMAP as a novel antilung CSC agent, which acts to downregulate β-catenin signaling. The combination of AMA and targeted therapeutic agents could be considered for overcoming drug resistance and relapse in lung cancer patients.

  12. Evaluating Urban Parking Policies with Agent-Based Model of Driver Parking Behavior

    NARCIS (Netherlands)

    Martens, C.J.C.M.; Benenson, I.

    2008-01-01

    This paper presents an explicit agent-based model of parking search in a city. In the model, “drivers” drive toward their destination, search for parking, park, remain at the parking place, and leave. The city’s infrastructure is represented by a high-resolution geographic information system (GIS) o

  13. An agent-based hydroeconomic model to evaluate water policies in Jordan

    Science.gov (United States)

    Yoon, J.; Gorelick, S.

    2014-12-01

    Modern water systems can be characterized by a complex network of institutional and private actors that represent competing sectors and interests. Identifying solutions to enhance water security in such systems calls for analysis that can adequately account for this level of complexity and interaction. Our work focuses on the development of a hierarchical, multi-agent, hydroeconomic model that attempts to realistically represent complex interactions between hydrologic and multi-faceted human systems. The model is applied to Jordan, one of the most water-poor countries in the world. In recent years, the water crisis in Jordan has escalated due to an ongoing drought and influx of refugees from regional conflicts. We adopt a modular approach in which biophysical modules simulate natural and engineering phenomena, and human modules represent behavior at multiple scales of decision making. The human modules employ agent-based modeling, in which agents act as autonomous decision makers at the transboundary, state, organizational, and user levels. A systematic nomenclature and conceptual framework is used to characterize model agents and modules. Concepts from the Unified Modeling Language (UML) are adopted to promote clear conceptualization of model classes and process sequencing, establishing a foundation for full deployment of the integrated model in a scalable object-oriented programming environment. Although the framework is applied to the Jordanian water context, it is generalizable to other regional human-natural freshwater supply systems.

  14. Synthesis and biological evaluation of novel gigantol derivatives as potential agents in prevention of diabetic cataract

    Science.gov (United States)

    As a continuation of our efforts directed towards the development of natural anti-diabetic cataract agents, gigantol was isolated from Herba dendrobii and was found to inhibit both aldose reductase (AR) and inducible nitric oxide synthase (iNOS) activity, which play a significant role in the develop...

  15. Evaluation of FloSeal as a Potential Intracavitary Hemostatic Agent

    Science.gov (United States)

    2006-02-01

    into the closed body cavity to provide hemostasis via a combination of coagulative and tamponade effects. FloSeal is an agent containing collagen and...bovine thrombin. When exposed to blood, FloSeal gelatin granules expand by 20% to provide a certain amount of tamponade ,6,7 and thrombin converts

  16. 'Do you smell rotten eggs?' Evaluating interactions with mobile agents in crisis response situations

    NARCIS (Netherlands)

    A. Winterboer; H.S.M. Cramer; G. Pavlin; F.C.A. Groen; V. Evers

    2009-01-01

    In this paper, we present ongoing research concerning the interaction between users and autonomous mobile agents in the environmental monitoring domain. The overarching project, DIADEM, deals with developing a system that detects potentially hazardous situations in populated industrial areas using i

  17. An Evaluation of Antifungal Agents for the Treatment of Fungal Contamination in Indoor Air Environments

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    Senthaamarai Rogawansamy

    2015-06-01

    Full Text Available Fungal contamination in indoor environments has been associated with adverse health effects for the inhabitants. Remediation of fungal contamination requires removal of the fungi present and modifying the indoor environment to become less favourable to growth.  This may include treatment of indoor environments with an antifungal agent to prevent future growth. However there are limited published data or advice on chemical agents suitable for indoor fungal remediation. The aim of this study was to assess the relative efficacies of five commercially available cleaning agents with published or anecdotal use for indoor fungal remediation. The five agents included two common multi-purpose industrial disinfectants (Cavicide® and Virkon®, 70% ethanol, vinegar (4.0%-4.2% acetic acid, and a plant-derived compound (tea tree (Melaleuca alternifolia oil tested in both a liquid and vapour form. Tea tree oil has recently generated interest for its antimicrobial efficacy in clinical settings, but has not been widely employed for fungal remediation. Each antifungal agent was assessed for fungal growth inhibition using a disc diffusion method against a representative species from two common fungal genera, (Aspergillus fumigatus and Penicillium chrysogenum, which were isolated from air samples and are commonly found in indoor air. Tea tree oil demonstrated the greatest inhibitory effect on the growth of both fungi, applied in either a liquid or vapour form. Cavicide® and Virkon® demonstrated similar, although less, growth inhibition of both genera. Vinegar (4.0%–4.2% acetic acid was found to only inhibit the growth of P. chrysogenum, while 70% ethanol was found to have no inhibitory effect on the growth of either fungi. There was a notable inhibition in sporulation, distinct from growth inhibition after exposure to tea tree oil, Virkon®, Cavicide® and vinegar. Results demonstrate that common cleaning and antifungal agents differ in their capacity to

  18. Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

    Science.gov (United States)

    Cezar, Cristina; Tchartchian, Garri; Korell, Matthias; Ziegler, Nicole; Senshu, Kazuhisa; De Wilde, Maya Sophie; Herrmann, Anja; Larbig, Angelika; De Wilde, Rudy Leon

    2016-08-01

    We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment

  19. Evaluation of the efficacy and safety of vilazodone for treating major depressive disorder

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    Zhang XF

    2015-08-01

    Full Text Available Xiao-Fei Zhang, Lei Wu, Dong-Jun Wan, Ruo-Zhuo Liu, Zhao Dong, Min Chen, Sheng-Yuan Yu Department of Neurology, Chinese PLA General Hospital, Beijing, People’s Republic of China Purpose: Vilazodone is a novel serotonin (5-HT-reuptake inhibitor and 5-HT1A partial agonist that was recently developed for the treatment of major depressive disorder (MDD. We conducted a meta-analysis and systematic review to better evaluate the efficacy and safety of vilazodone. Materials and methods: We performed a thorough literature search to identify all randomized double-blind placebo-controlled trials that were designed to investigate the efficacy of vilazodone for the treatment of MDD, and that were published in electronic databases, including Medline, Embase, and the Cochrane Central Register of Controlled Trials. A manual search was also conducted to investigate the relevant references of the retrieved studies. Subsequently, we conducted a meta-analysis and systematic literature review. Results: A total of five randomized controlled trials were finally included, involving 1,200 patients with vilazodone and 1,193 patients with placebo. The primary efficacy end point of the Montgomery–Åsberg Depression Rating Scale (standardized mean difference -3.58, 95% confidence interval -4.59 to -2.56; P<0.00001, and the key secondary efficacy end points (Clinical Global Impression - Severity scale, Clinical Global Impression - Improvement scale, and Hamilton Anxiety Rating Scale indicated that vilazodone was more effective than placebo. Most common adverse events, including diarrhea and nausea, were evaluated, and safety assessments indicated that vilazodone was well tolerated (diarrhea odds ratio 3.54, 95% confidence interval 2.81–4.45; P<0.00001; nausea odds ratio 3.85, 95% confidence interval 3.00–4.96; P<0.00001; discontinuations due to adverse events odds ratio 2.71, 95% confidence interval 1.81–4.05; P<0.00001. Conclusion: Our findings indicate that the

  20. Safety and toxicological evaluation of a novel Citrus sudachi extract powder

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    Yasuhiro Shikishima

    2016-10-01

    Full Text Available Background: Citrus sudachi, an evergreen tree primarily found in the prefecture of Tokushima, Japan, is a widely used popular citrus fruit used in cooking and consumed as a juice. Citrus sudachi peels are rich in flavonoids including sudachitin (5,7,4’-trihydroxy- 6,8,3’- trimethoxyflavone, and exhibit potent antioxidant, antimicrobial and anti-diabetic properties; additionally, several limonoids and their glucosides are found in its seeds. We examined the broad spectrum safety of a novel light yellow to golden yellow Citrus sudachi Extract Powder (CSEP, organic, nutritive from the dried fruit rind (25:1 herbs to extract ratio containing no less than 1% sudachitin in various toxicology models in GLP-approved laboratories. Methods: The acute oral toxicity study was conducted in female Sprague-Dawley rats with an up and down procedure. The single dose acute dermal LD 50 of CSEP was assessed in both male and female rats. The primary skin irritation toxicity of CSEP was assessed in female New Zealand Albino rabbits in order to determine the potential for CSEP to produce irritation after a single topical application, while primary eye irritation index of CSEP was conducted in female New Zealand Albino rabbits. Ames’ bacterial reverse mutation assay was conducted to determine the ability of CSEP to induce reverse mutation at selected histidine loci in five tester strains of Salmonella typhimurium viz. TA1535, TA97a, TA98, TA100, and TA102 in the presence and absence of a metabolic activation system (S9 at the doses of 5000, 1500, 500, 150 and 50 mg/plate. The mutagenic potential of CSEP was also evaluated in an in vitro mammalian cell gene mutation test using the thymidine kinase gene of L5178 Tk+/- 3.7.2C mouse lymphoma cell line. Results: The acute oral LD 50 of CSEP was found to be greater than 5000 mg/kg body weight. The single dose acute dermal LD 50 of CSEP was found to be greater than 2000 mg/kg body weight in both male and female rats