WorldWideScience

Sample records for long-term safety evaluation

  1. Evaluating long term forecasts

    Energy Technology Data Exchange (ETDEWEB)

    Lady, George M. [Department of Economics, College of Liberal Arts, Temple University, Philadelphia, PA 19122 (United States)

    2010-03-15

    The U.S. Department of Energy's Energy Information Administration (EIA), and its predecessor organizations, has published projections of U.S. energy production, consumption, distribution and prices annually for over 30 years. A natural issue to raise in evaluating the projections is an assessment of their accuracy compared to eventual outcomes. A related issue is the determination of the sources of 'error' in the projections that are due to differences between the actual versus realized values of the associated assumptions. One way to do this would be to run the computer-based model from which the projections are derived at the time the projected values are realized, using actual rather than assumed values for model assumptions; and, compare these results to the original projections. For long term forecasts, this approach would require that the model's software and hardware configuration be archived and available for many years, possibly decades, into the future. Such archival creates many practical problems; and, in general, it is not being done. This paper reports on an alternative approach for evaluating the projections. In the alternative approach, the model is run many times for cases in which important assumptions are changed individually and in combinations. A database is assembled from the solutions and a regression analysis is conducted for each important projected variable with the associated assumptions chosen as exogenous variables. When actual data are eventually available, the regression results are then used to estimate the sources of the differences in the projections of the endogenous variables compared to their eventual outcomes. The results presented here are for residential and commercial sector natural gas and electricity consumption. (author)

  2. Disposal of radioactive waste: can long-term safety be evaluated

    International Nuclear Information System (INIS)

    1991-01-01

    The long-term safety of any hazardous waste disposal system must be convincingly shown prior to its implementation. For radioactive wastes, safety assessments over timescales far beyond the normal horizon of social and technical planning have already been conducted in many countries. These assessments provide the principal means to investigate, quantify, and explain long-term safety of each selected disposal concept and site for the appropriate authorities and the public. Such assessments are based on four main elements: definition of the disposal system and its environment, identification of possible processes and events that may affect the integrity of the disposal system, quantification of the radiological impact by predictive modelling, and description of associated uncertainties. The NEA Radioactive Waste Management Committee and the IAEA International Radioactive Waste Management Advisory Committee have carefully examined the current scientific methods for safety assessments of radioactive waste disposal systems, as briefly summarized in this report. The Committees have also reviewed the experience now available from using safety assessment methods in many countries, for different disposal concepts and formations, and in the framework of both nationally and internationally conducted studies, as referenced in this report [fr

  3. Development of methodology for evaluation of long-term safety aspects of organic cement paste components

    International Nuclear Information System (INIS)

    Andersson, M.; Holgersson, S.; Ervanne, H.

    2008-12-01

    Long-term safety aspects of superplasticizers (SP) and other cement paste components were studied in this joint Nagra - NUMO - SKB - Posiva project with aim to develop a methodology for the evaluation of the long-term safety aspects of superplasticizers (SP) and other organic components of cement pastes. The study also evaluated the effects of SPs and other cement paste components that have already been used or that are most likely to be used in the construction of the high-level nuclear waste repositories in Sweden, Switzerland, Finland and Japan. The main long-term safety issue of concern is whether the superplasticizers and/or other organic components of cement pastes might affect the transport properties of radionuclides. A full evaluation of whether the superplasticizers can be used in a high-level nuclear waste repository cannot be answered based on the studies but a classification of the superplasticizers based on their impact on sorption of radionuclides has been done. The basic methodology for testing, leaching and analyzing of leachants and solid samples of different types was developed at CRIEPI. Two different methodologies for studying the impact of SPs on the sorption of Eu on crushed rock were tested and developed by Helsinki University (HU) and Chalmers University of Technology (CTH). Methods for analyzing organics leaching from grouts were successfully tested by CRIEPI and CTH (Chalmers University of Technology). At CRIEPI the total organic content (TOC) of the leachants was analyzed by Infrared absorption spectrometry (IR) followed by Gel Permeation Chromatography (GPC) for the identification of the organic compounds. At CTH several different analytical methods were tested (e.g. IR, UV spectroscopy, NMR, MALDI-TOF), but these methods still require improvement. In addition to SPs, organics are present in several components of cement pastes, for example in cement grinding aid (CGA) and micro silica slurry. The results suggests that the main high

  4. Criticality safety evaluation for long term storage of FFTF fuel in interim storage casks

    International Nuclear Information System (INIS)

    Richard, R.F.

    1995-01-01

    It has been postulated that a degradation phenomenon, referred to as ''hot cell rot'', may affect irradiated FFTF mixed plutonium-uranium oxide (MOX) fuel during dry interim storage. ''Hot cell rot'' refers to a variety of phenomena that degrade fuel pin cladding during exposure to air and inert gas environments. It is thought to be a form of caustic stress corrosion cracking or environmentally assisted cracking. Here, a criticality safety analysis was performed to address the effect of the ''hot cell rot'' phenomenon on the long term storage of irradiated FFTF fuel in core component containers. The results show that seven FFTF fuel assemblies or six Ident-69 pin containers stored in core component containers within interim storage casks will remain safely subcritical

  5. A double-blind study evaluating the long-term safety of varenicline for smoking cessation.

    Science.gov (United States)

    Williams, Kathryn E; Reeves, Karen R; Billing, Clare B; Pennington, Ann M; Gong, Jason

    2007-04-01

    We assessed the safety of long-term varenicline administration for smoking cessation. In this randomized, double-blind, multicenter trial, eligible adult smokers (18-75 years) who smoked an average of > or =10 cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then every 4 weeks until week 52, with a follow-up visit at week 53. The target quit date was the morning of the week 1 clinic visit. Brief counseling was provided at each visit, and vital signs, adverse events (AEs), and smoking status were documented. Other laboratory measures were collected at specified visits. A total of 251 subjects were randomized to varenicline and 126 to placebo. Approximately half of the subjects in each arm completed the study (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% of varenicline- and 82.5% of placebo-treated subjects during the study. Common varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs leading to discontinuation of varenicline treatment included nausea (7.6%), insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo). Varenicline 1 mg BID can be safely administered for up to 1 year. Varenicline was also a more effective smoking cessation aid than placebo throughout the study, supporting both its short- (12-week) and long-term (52-week) efficacy.

  6. Evaluation of safety of excessive intake and efficacy of long-term intake of beverages containing apple polyphenols.

    Science.gov (United States)

    Akazome, Yoko; Kametani, Norihiro; Kanda, Tomomasa; Shimasaki, Hiroyuki; Kobayashi, Shuhei

    2010-01-01

    In the present study, a randomized, double-blind, placebo-controlled study was performed to evaluate the safety of an excessive intake and the efficacy of a long-term intake of polyphenols derived from apples for moderately underweight to moderately obese subjects (long-term intake: 94 subjects; excessive intake: 30 subjects). For each trial, the subjects were divided into the following two groups: a group that drank beverages with apple polyphenols (600 mg) (hereinafter referred to as the apple group) and a group that drank beverages without apple polyphenols (hereinafter referred to as the placebo group). For the long-term intake trial, the subjects were given a regular amount of the beverage (340 g) each day for 12 weeks. For the excessive intake trial, the subjects were given three times the regular amount of the beverage each day for 4 weeks. It is noteworthy that the visceral fat area (VFA) of subjects in the apple group for the long-term intake trial had decreased significantly by the 8- and 12-week marks (week 8: p or = 100 cm(2)) had decreased significantly by the 8- and 12-week marks compared to the baseline (week 8: p safety of the beverage with apple polyphenols.

  7. Evaluating the Long-Term Safety of a Repository at Yucca Mountain

    International Nuclear Information System (INIS)

    Luik, Abe Van

    2002-01-01

    Regulations require that the repository be evaluated for its health and safety effects for 10,000 years for the Site Recommendation process. Regulations also require potential impacts to be evaluated for up to a million years in an Environmental Impact Statement. The Yucca Mountain Project is in the midst of the Site Recommendation process. The Total System Performance Assessment (TSPA) that supports the Site Recommendation evaluated safety for these required periods of time. Results showed it likely that a repository at this site could meet the licensing requirements promulgated by the Nuclear Regulatory Commission. The TSPA is the tool that integrates the results of many years of scientific investigations with design information to allow evaluations of potential far-future impacts of building a Yucca Mountain repository. Knowledge created in several branches of physics is part of the scientific basis of the TSPA that supports the Site Recommendation process.

  8. Consideration of environmental change in the safety evaluation: Long-term climate scenarios in the Iberian Peninsula

    International Nuclear Information System (INIS)

    Recreo Jimenez, F.; Ruiz Rivas, C.

    1997-01-01

    The main objective of this report is twofold. On the one hand, to define the most likely sequences of climate states in the Iberian Peninsula for a period of 125 Ka into the future, to the next interglacial stage, 125 Ka AP; on the other hand, to establish potential climate scenarios during such a period of time determining also the variability ranges of primary climate and climate-related variables of interest to the post-closure performance assessment and underground repository safety evaluations. The report reviews the potential effects of environmental changes on the performance of underground radioactive waste repositories, emphasizing the consideration given to long-term climatic changes in radioactive waste disposal system safety evaluations. (Author)

  9. Performance assessment studies for the long-term safety evaluation of radioactive waste disposal facility

    International Nuclear Information System (INIS)

    Bujoreanu, D.; Olteanu, M.; Bujoreanu, L.

    2008-01-01

    Especially during the last ten years, a part of Romanian research program 'Management of Radioactive Waste and Spent Fuel' was focused mainly on applicative research for the design of near-surface disposal facility, which intends to accommodate the low and intermediate radioactive waste generated from Cernavoda NPP. In this frame, our contribution was at the acquisition of technical data for the characterization of the future disposal facility. In the present, the project of the disposal facility, located on the Saligny site, near Cernavoda NPP, must be licensed. As regards to the safe disposal, the location of final disposal, the Saligny site, has been characterized through the five geological formations which contain potential routes for transport of radionuclide released from disposal facility, in the receiving zones(potential receiving zones), into liquid and gaseous phases. The technical characteristics of the disposal facility were adapted at the Romanian disposal concept using the reference data from IAEA technical report (IAEA,1999). Input parameters which characterized from physical and chemical point of view the disposal system, were partially taken from literature. The performance assessment studies, which follows the preliminary design development phases and the selection, describes how the source term is affected by the infiltration of water through the disposal facility, degradation process of engineering barriers (reflected in the distribution coefficient values) and solubility limit. The studies regard the evaluation of the source term, sensitivity and uncertainty analysis provide the information on 'how' and 'why' were evaluated, following: (i) radiological safety assessment of near-surface disposal facility on Saligny site; (ii) complexity standard assessment of the Engineering Barriers Systems (EBS); (iii) identification of the elements which must be elaborated for the increase of the disposal safety and the necessity for new technical data for

  10. Evaluation of uncertainty associated with parameters for long-term safety assessments of geological disposal

    International Nuclear Information System (INIS)

    Yamaguchi, Tetsuji; Minase, Naofumi; Iida, Yoshihisa; Tanaka, Tadao; Nakayama, Shinichi

    2005-01-01

    This paper describes the current status of our data acquisition on quantifying uncertainties associated with parameters for safety assessment on groundwater scenarios for geological disposal of radioactive wastes. First, sources of uncertainties and the resulting priority in data acquisition were briefed. Then, the current status of data acquisition for quantifying the uncertainties in assessing solubility, diffusivity in bentonite buffer and distribution coefficient on rocks is introduced. The uncertainty with the solubility estimation is quantified from that associated with thermodynamic data and that in estimating groundwater chemistry. The uncertainty associated with the diffusivity in bentonite buffer is composed of variations of relevant factors such as porosity of the bentonite buffer, montmorillonite content, chemical composition of pore water and temperature. The uncertainty of factors such as the specific surface area of the rock, pH, ionic strength, carbonate concentration in groundwater compose uncertainty of the distribution coefficient of radionuclides on rocks. Based on these investigations, problems to be solved in future studies are summarized. (author)

  11. French Approach for Long Term Storage Safety

    International Nuclear Information System (INIS)

    Marciano, Jacob; Carreton, Jean-Pierre; Lizot, Marie Therese; Lhomme, Veronique

    2014-01-01

    IRSN presents its statement regarding long-term storage facilities; in France, the regulatory documents do not define the long term duration. The storage facility lifetime can only be appreciated according to the needs and materials stored therein. However, the magnitude of the long-term can be estimated at a few hundred years compared to a few decades for current storage. Usually, in France, construction of storage facilities is driven from the necessity various necessities, linked to the management of radioactive material (eg spent fuel) and to the management of radioactive waste. Because of the variety of 'stored materials and objects' (fission product solutions, plutonium oxide powders, activated solids, drums containing technological waste, spent fuel...), a great number of storage facility design solutions have been developed (surface, subsurface areas, dry or wet conditions...) in the World. After describing the main functions of a storage facility, IRSN displays the safety principles and the associated design principles. The specific design principles applied to particular storage (dry or wet spent fuel storage, depleted uranium or reprocessed uranium storage, plutonium storage, waste containing tritium storage, HLW and ILLW storage...) are also presented. Finally, the concerns due to the long-term duration storage and related safety assessment are developed. After discussing these issues, IRSN displays its statement. The authorization procedures governing the facility lifetime are similar to those of any basic nuclear installation, the continuation of the facility operation remaining subject to periodic safety reviews (in France, every 10 years). The applicant safety cases have to show, that the safety requirements are always met; this requires, at minimum, to take into account at the design stage, comfortable design margins. (author)

  12. Safety of long-term PPI therapy

    DEFF Research Database (Denmark)

    Reimer, Christina

    2013-01-01

    Proton pump inhibitors have become the mainstay of medical treatment of acid-related disorders. Long-term use is becoming increasingly common, in some cases without a proper indication. A large number of mainly observational studies on a very wide range of possible associations have been publishe...... to a careful evaluation of the indication for PPI treatment....

  13. Evaluation of long-term safety and efficacy of omalizumab in elderly patients with uncontrolled allergic asthma.

    Science.gov (United States)

    Tat, Tugba Songul; Cilli, Aykut

    2016-11-01

    Severe asthma management in elderly patients may be difficult because of increased comorbid conditions, polypharmacy, physiologic changes that occur with aging, incorrect use of inhaler devices, and poor adherence. To evaluate the long-term safety and efficacy of the anti-IgE antibody omalizumab in elderly (aged ≥65 years) patients with uncontrolled allergic asthma. The efficiency and adverse effects of omalizumab treatment were evaluated based on data extracted from medical records. Patients were evaluated monthly for efficacy and adverse reactions. Treatment efficacy was evaluated by level of asthma symptom control, using the Global Initiative for Asthma guideline. Nineteen consecutive elderly patients with asthma (female to male ratio, 14:5) formed our cohort. The mean (SD) age, disease duration, and total IgE level were 69.3 (5.8) years, 19.4 (8.6) years, and 299.1 (197.2) IU/mL, respectively. The mean (SD) duration of omalizumab treatment was 35.6 (17.8) months (range, 9-66 months). All the patients had at least 1 perennial inhalant allergen sensitivity and had uncontrolled allergic asthma. Elderly patients experienced no significantly important adverse reaction considered to be related to omalizumab treatment. Only 1 patient had a local adverse reaction and 1 had myalgia that was considered to be drug related. After omalizumab treatment, asthma symptoms were well controlled in 9 patients (47.4%) and partly controlled in 8 patients (42.1%). Two of the patients (10.5%) still had uncontrolled asthma. Our study found that omalizumab is a well-tolerated and effective therapy for elderly patients with uncontrolled asthma. Copyright © 2016 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  14. US Department of Energy Approach to Probabilistic Evaluation of Long-Term Safety for a Potential Yucca Mountain Repository

    International Nuclear Information System (INIS)

    Dr. R. Dyer; Dr. R. Andrews; Dr. A. Van Luik

    2005-01-01

    Regulatory requirements being addressed in the US geological repository program for spent nuclear fuel and high-level waste disposal specify probabilistically defined mean-value dose limits. These dose limits reflect acceptable levels of risk. The probabilistic approach mandated by regulation calculates a ''risk of a dose,'' a risk of a potential given dose value at a specific time in the future to a hypothetical person. The mean value of the time-dependent performance measure needs to remain below an acceptable level defined by regulation. Because there are uncertain parameters that are important to system performance, the regulation mandates an analysis focused on the mean value of the performance measure, but that also explores the ''full range of defensible and reasonable parameter distributions''...System performance evaluations should not be unduly influenced by...''extreme physical situations and parameter values''. Challenges in this approach lie in defending the scientific basis for the models selected, and the data and distributions sampled. A significant challenge lies in showing that uncertainties are properly identified and evaluated. A single-value parameter has no uncertainty, and where used such values need to be supported by scientific information showing the selected value is appropriate. Uncertainties are inherent in data, but are also introduced by creating parameter distributions from data sets, selecting models from among alternative models, abstracting models for use in probabilistic analysis, and in selecting the range of initiating event probabilities for unlikely events. The goal of the assessment currently in progress is to evaluate the level of risk inherent in moving ahead to the next phase of repository development: construction. During the construction phase, more will be learned to inform a new long-term risk evaluation to support moving to the next phase: accepting waste. Therefore, though there was sufficient confidence of safety

  15. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

    Directory of Open Access Journals (Sweden)

    Pandina Gahan

    2012-06-01

    Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was

  16. NUMO's approach for long-term safety assessment - 59404

    International Nuclear Information System (INIS)

    Ebashi, Takeshi; Kaku, Kenichi; Ishiguro, Katsuhiko

    2012-01-01

    One of NUMO's policies for ensuring safety is staged and flexible project implementation and decision-making based on iterative confirmation of safety. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; a key aspect is uncertainty management. This paper presents NUMO's basic strategies for long-term safety assessment based on the above policy. NUMO's approach considering Japanese boundary conditions is demonstrated as a starting-point for evaluating the long-term safety of an actual site. In Japan, the Act on Final Disposal of Specified Radioactive Waste states that the siting process shall consist of three stages. The Nuclear Waste Management Organization of Japan (NUMO) is responsible for geological disposal of vitrified high-level waste and some types of TRU waste. NUMO has chosen to implement a volunteer approach to siting. NUMO decided to prepare the so-called 2010 technical report, which sets out three safety policies, one of which is staged project implementation and decision-making based on iterative confirmation of safety. Based on this policy, NUMO will gradually integrate relevant interdisciplinary knowledge to build a safety case when a formal volunteer application is received that would allow site investigations to be initiated. The safety assessment takes the central role in multiple lines of reasoning and argumentation by providing a quantitative evaluation of long-term safety; one of a key aspect is uncertainty management. This paper presents the basic strategies for NUMO's long-term safety assessment based on the above policy. In concrete terms, the common procedures involved in safety assessment are applied in a stepwise manner, based on integration of knowledge obtained from site investigations/evaluations and engineered measures. The results of the safety assessment are then reflected in the planning of site investigations and engineered

  17. A security/safety survey of long term care facilities.

    Science.gov (United States)

    Acorn, Jonathan R

    2010-01-01

    What are the major security/safety problems of long term care facilities? What steps are being taken by some facilities to mitigate such problems? Answers to these questions can be found in a survey of IAHSS members involved in long term care security conducted for the IAHSS Long Term Care Security Task Force. The survey, the author points out, focuses primarily on long term care facilities operated by hospitals and health systems. However, he believes, it does accurately reflect the security problems most long term facilities face, and presents valuable information on security systems and practices which should be also considered by independent and chain operated facilities.

  18. Safety analysis SFR 1. Long-term safety

    Energy Technology Data Exchange (ETDEWEB)

    2008-12-15

    An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

  19. Safety analysis SFR 1. Long-term safety

    International Nuclear Information System (INIS)

    2008-12-01

    An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the regulatory

  20. Safety analysis SFR 1. Long-term safety

    Energy Technology Data Exchange (ETDEWEB)

    2008-12-15

    An updated assessment of the long-term safety of SKB's final repository for radioactive operational waste, SFR 1, is presented in this report. The report is included in the safety analysis report for SFR 1. The most recent account of long-term safety was submitted to the regulatory authorities in 2001. The present report has been compiled on SKB's initiative to address the regulatory authorities' viewpoints regarding the preceding account of long-term safety. Besides the new mode of working with safety functions there is another important difference between the 2001 safety assessment and the current assessment: The time horizon in the current assessment has been extended to 100,000 years in order to include the effect of future climate changes. The purpose of this renewed assessment of the long-term safety of SFR 1 is to show with improved data that the repository is capable of protecting human health and the environment against ionizing radiation in a long-term perspective. This is done by showing that calculated risks lie below the risk criteria stipulated by the regulatory authorities. SFR 1 is built to receive, and after closure serve as a passive repository for, low. and intermediate-level radioactive waste. The disposal chambers are situated in rock beneath the sea floor, covered by about 60 metres of rock. The underground part of the facility is reached via two tunnels whose entrances are near the harbour. The repository has been designed so that it can be abandoned after closure without further measures needing to be taken to maintain its function. The waste in SFR 1 is short-lived low- and intermediate-level waste. After 100 years the activity is less than half, and after 1,000 years only about 2% of the original activity remains. The report on long-term safety comprises eleven chapters. Chapter 1 Introduction. The chapter describes the purpose, background, format and contents of SAR-08, applicable regulations and injunctions, and the

  1. Long-term safety and efficacy of stereotactic radiosurgery for vestibular schwannomas: evaluation of 440 patients more than 10 years after treatment with Gamma Knife surgery.

    Science.gov (United States)

    Hasegawa, Toshinori; Kida, Yoshihisa; Kato, Takenori; Iizuka, Hiroshi; Kuramitsu, Shunichiro; Yamamoto, Takashi

    2013-03-01

    Object Little is known about long-term outcomes, including tumor control and adverse radiation effects, in patients harboring vestibular schwannomas (VSs) treated with stereotactic radiosurgery > 10 years previously. The aim of this study was to confirm whether Gamma Knife surgery (GKS) for VSs continues to be safe and effective > 10 years after treatment. Methods A total of 440 patients with VS (including neurofibromatosis Type 2) treated with GKS between May 1991 and December 2000 were evaluable. Of these, 347 patients (79%) underwent GKS as an initial treatment and 93 (21%) had undergone prior resection. Three hundred fifty-eight patients (81%) had a solid tumor and 82 (19%) had a cystic tumor. The median tumor volume was 2.8 cm(3) and the median marginal dose was 12.8 Gy. Results The median follow-up period was 12.5 years. The actuarial 5- and ≥ 10-year progression-free survival was 93% and 92%, respectively. No patient developed treatment failure > 10 years after treatment. According to multivariate analysis, significant factors related to worse progression-free survival included brainstem compression with a deviation of the fourth ventricle (p 13 Gy) and 100% in the low marginal dose group (≤ 13 Gy). Ten patients (2.3%) developed delayed cyst formation. One patient alone developed malignant transformation, indicating an incidence of 0.3%. Conclusions In this study GKS was a safe and effective treatment for the majority of patients followed > 10 years after treatment. Special attention should be paid to cyst formation and malignant transformation as late adverse radiation effects, although they appeared to be rare. However, it is necessary to collect further long-term follow-up data before making conclusions about the long-term safety and efficacy of GKS, especially for young patients with VSs.

  2. Long-term safety issues associated with mixer pump operation

    International Nuclear Information System (INIS)

    Kubic, W.L. Jr.

    1994-01-01

    In this report, we examine several long-term issues: the effect of pump operation on future gas release events (GREs), uncontrolled chemical reactions, chronic toxic gas releases, foaming, and erosion and corrosion. Heat load in excess of the design limit, uncontrolled chemical reactions, chronic toxic gas releases, foaming, and erosion and corrosion have been shown not to be safety concerns. The effect of pump operation on future GREs could not be quantified. The problem with evaluating the long-term effects of pump operation on GREs is a lack of knowledge and uncertainty. In particular, the phenomena governing gas retention, particle size distribution, and settling are not well understood, nor are the interactions among these factors understood. There is a possibility that changes in these factors could increase the size of future GREs. Bounding estimates of the potential increase in size of GREs are not possible because of a lack of engineering data. Proper management of the hazards can reduce, but not eliminate, the possibility of undesirable changes. Maintaining temperature within the historical limits can reduce the possibility of undesirable changes. A monitoring program to detect changes in the gas composition and crust thickness will help detect slowly occurring changes. Because pump operation has be shown to eliminate GREs, continued pump operation can eliminate the hazards associated with future GREs

  3. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    DEFF Research Database (Denmark)

    Thomson, Neil C; Rubin, Adalberto S; Niven, Robert M

    2011-01-01

    Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure.......Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure....

  4. Safety of Long-term Interim Storage Facilities - Workshop Proceedings

    International Nuclear Information System (INIS)

    2014-01-01

    The objective of this workshop was to discuss and review current national activities, plans and regulatory approaches for the safety of long term interim storage facilities dedicated to spent nuclear fuel (SF), high level waste (HLW) and other radioactive materials with prolonged storage regimes. It was also intended to discuss results of experiments and to identify necessary R and D to confirm safety of fuel and cask during the long-term storage. Safety authorities and their Technical Support Organisation (TSO), Fuel Cycle Facilities (FCF) operating organisations and international organisations were invited to share information on their approaches, practices and current developments. The workshop was organised in an opening session, three technical sessions, and a conclusion session. The technical sessions were focused on: - National approaches for long term interim storage facilities; - Safety requirements, regulatory framework and implementation issues; - Technical issues and operational experience, needs for R and D. Each session consisted of a number of presentations followed by a panel discussion moderated by the session Chairs. A summary of each session and subsequent discussion that ensued are provided as well as a summary of the results of the workshop with the text of the papers given and presentations made

  5. Long-term safety for KBS-3 repositories at Forsmark and Laxemar - a first evaluation. Main Report of the SR-Can project

    International Nuclear Information System (INIS)

    Hedin, Allan

    2006-10-01

    effective dose limit of about 1.4x10 -5 Sv/yr. This, in turn, corresponds to around one percent of the effective dose due to natural background radiation in Sweden. The time frame for the assessment is one million years after repository closure, in accordance with regulatory requirements. The above risk limit is applicable as a quantitative regulatory limit during approximately the first one hundred thousand years, and thereafter as a basis for discussing the protective capability of the repository, according to SSI. Following the introductory Chapter 1, this report outlines the methodology for the SR-Can assessment in Chapter 2, and presents in Chapter 3 the handling of features, events and processes, FEPs, of importance for long-term safety. Chapters 4, and 6 present the initial state of the system for both of the sites, and the plans and methods for handling external influences and internal processes, respectively. Safety functions and safety function indicators are discussed in Chapter 7. The collection of input data for the assessment is described in Chapter 8. The Material presented in the first eight chapters is utilised in the analysis of the reference evolution in Chapter 9, focussing on isolation, and Chapter 10, addressing radionuclide transport and dose assessments. Scenarios for the further evaluation of safety are selected in Chapter 11 and the selected scenarios are analysed in Chapter 12. Finally, conclusions and feedback are provided in Chapter 13. References are provided in Chapter 14. Appendix A is an account of how applicable regulations are addressed in the assessment. Miscellaneous calculation models are presented in Appendix B and Material relating to reviews of previous assessments in Appendix C. A glossary of abbreviations and specialised terms used in SR-Can is found in Appendix D

  6. Long-term safety for KBS-3 repositories at Forsmark and Laxemar - a first evaluation. Main Report of the SR-Can project

    Energy Technology Data Exchange (ETDEWEB)

    Hedin, Allan (ed.)

    2006-10-15

    . The risk limit corresponds to an effective dose limit of about 1.4x10{sup -5} Sv/yr. This, in turn, corresponds to around one percent of the effective dose due to natural background radiation in Sweden. The time frame for the assessment is one million years after repository closure, in accordance with regulatory requirements. The above risk limit is applicable as a quantitative regulatory limit during approximately the first one hundred thousand years, and thereafter as a basis for discussing the protective capability of the repository, according to SSI. Following the introductory Chapter 1, this report outlines the methodology for the SR-Can assessment in Chapter 2, and presents in Chapter 3 the handling of features, events and processes, FEPs, of importance for long-term safety. Chapters 4, and 6 present the initial state of the system for both of the sites, and the plans and methods for handling external influences and internal processes, respectively. Safety functions and safety function indicators are discussed in Chapter 7. The collection of input data for the assessment is described in Chapter 8. The Material presented in the first eight chapters is utilised in the analysis of the reference evolution in Chapter 9, focussing on isolation, and Chapter 10, addressing radionuclide transport and dose assessments. Scenarios for the further evaluation of safety are selected in Chapter 11 and the selected scenarios are analysed in Chapter 12. Finally, conclusions and feedback are provided in Chapter 13. References are provided in Chapter 14. Appendix A is an account of how applicable regulations are addressed in the assessment. Miscellaneous calculation models are presented in Appendix B and Material relating to reviews of previous assessments in Appendix C. A glossary of abbreviations and specialised terms used in SR-Can is found in Appendix D.

  7. The Safety Assessment of Long term Interim Storage at Sellafield

    International Nuclear Information System (INIS)

    Buchan, Andrew B.

    2014-01-01

    that are most significant in terms of frequency and unmitigated potential consequences PSA looks at the full range of fault sequences and allows full incorporation of the reliability and failure probability of the safety measures and other features of the design and operations SAA considers significant but unlikely accidents where off-site consequences are likely to significantly affect the critical group and provides information on their progression, within the facility and also beyond the site boundary. The paper will illustrate how these techniques have been utilised to facilitate design, operation, resilience evaluation and accident management of facilities supporting long term interim storage at Sellafield. (author)

  8. Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Wirta D

    2011-06-01

    Full Text Available David Wirta1, Amanda M VanDenburgh2, Emily Weng3, Scott M Whitcup4, Sef Kurstjens5, Frederick C Beddingfield III4,61Private Practice, Newport Beach, CA, USA; 2Clinical Development, 3Biostatistics, 4Research and Development, 5Global Drug Development, Allergan, Inc, Irvine, CA, USA; 6Department of Medicine, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, CA, USABackground: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥ 12months were conducted; however, the aggregate safety profile of the six studies has not been reported.Methods: Adverse events (AEs were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD or twice daily (BID as an eyedrop. AE terms were converted to MedDRA (V.11.0 Preferred Terms and analyzed.Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD and 94.8% (BID of subjects (≤ 12 months of treatment. AEs reported through month 12 (aggregate incidence of ≥ 5% were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment.Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation.Keywords: intraocular pressure, eyelids, pharmacology, clinical trial, medical treatment

  9. Mark I containment long-term program safety evaluation report, resolution of generic technical activity A-7. Report for February 1977-December 1979

    International Nuclear Information System (INIS)

    1980-07-01

    During testing for an advanced Boiling Water Reactor (BWR) containment system design (Mark III), suppression pool hydrodynamic loads were identified which had not been considered in the original design of the Mark I containment system. To address this issue, a Mark I Owners Group was formed and the assessment was divided into a short-term and long-term program. The results of the NRC staff's review of the Mark I Containment Short Term Program are described in NUREG-0408. This report describes the results of the NRC staff's review of the generic Mark I Containment Long Term Program (LTP). The LTP was conducted to provide a generic basis to define suppression pool hydrodynamic loads and the related structural acceptance criteria, such that a comprehensive reassessment of each Mark I containment system would be performed. A series of experimental and analytical programs were conducted by the Mark I Owners Group to provide the necessary bases for the generic load definition and structural assessment techniques. The generic methods proposed by the Mark I Owners Group, as modified by the NRC staff's requirements, will be used to perform plant-unique analyses, which will identify the plant modifications, if any, that will be needed to restore the originally intended margin of safety in the Mark I containment designs

  10. Safety Aspects of Long Term Spent Fuel Dry Storage

    International Nuclear Information System (INIS)

    Botsch, Wolfgang; Smalian, S.; Hinterding, P.; Drotleff, H.; Voelzke, H.; Wolff, D.; Kasparek, E.

    2014-01-01

    As a consequence of the lack of a final repository for spent nuclear fuel (SF) and high level waste (HLW), long term interim storage of SF and HLW will be necessary. As with the storage of all radioactive materials, the long term storage of SF and HLW must conform to safety requirements. Safety aspects such as safe enclosure of radioactive materials, safe removal of decay heat, sub-criticality and avoidance of unnecessary radiation exposure must be achieved throughout the complete storage period. The implementation of these safety requirements can be achieved by dry storage of SF and HLW in casks as well as in other systems such as dry vault storage systems or spent fuel pools, where the latter is neither a dry nor a passive system. After the events of Fukushima, the advantages of passively and inherently safe dry storage systems have become more obvious. In Germany, dry storage of SF in casks fulfils both transport and storage requirements. Mostly, storage facilities are designed as concrete buildings above the ground; one storage facility has also been built as a rock tunnel. In all these facilities the safe enclosure of radioactive materials in dry storage casks is achieved by a double-lid sealing system with surveillance of the sealing system. The safe removal of decay heat is ensured by the design of the storage containers and the storage facility, which also secures to reduce the radiation exposure to acceptable levels. TUV and BAM, who work as independent experts for the competent authorities, inform about spent fuel management and issues concerning dry storage of spent nuclear fuel, based on their long experience in these fields. All relevant safety issues such as safe enclosure, shielding, removal of decay heat and sub-criticality are checked and validated with state-of-the-art methods and computer codes before the license approval. In our presentation we discuss which of these aspects need to be examined closer for a long term interim storage. It is shown

  11. Assessment of the long-term safety for SFR

    Energy Technology Data Exchange (ETDEWEB)

    Greis Dahlberg, Christina; Vahlund, Frederik [Svensk Kaernbraenslehantering AB, Stockholm (Sweden)

    2015-07-01

    During operation and decommissioning of the Swedish nuclear facilities, radioactive waste is generated that must be disposed of. Besides waste from the nuclear facilities, some waste derives from other activities such as industry, research, medical care, etc. Short-lived low- and intermediate-level waste from these activities is disposed of in the final repository for short-lived radioactive waste, SFR, in Forsmark. The facility, which has been in operation since 1988, is owned and operated by Svensk Karnbranslehantering AB, SKB. The existing facility has neither sufficient space nor a license to receive decommissioning waste. SFR must therefore be extended so that shortlived low- and intermediate-level decommissioning waste from the nuclear facilities can also be received. The need for additional capacity has been accentuated by the closure of two reactors in Barseback. These reactors cannot be dismantled until the SFR facility has been extended. The existing repository is built to receive, and after closure serve as a passive repository for, low- and intermediate-level radioactive waste. The disposal rooms are situated in the bedrock beneath the sea floor, covered by about 60 metres of rock. The repository has been designed so that it can be abandoned after closure without requiring further measures to maintain its function. The extension of SFR, is done at the -120 m level immediately adjacent to, and within the same depth range as, the existing facility. The basic function of the existing SFR and of the extended one will be the same. However, a clear difference is the design of the tunnel and the rock vault that are required to permit transport and storage of whole reactor pressure vessels. The application for a license to build this extension includes an assessment of the long-term safety (post-closure safety) of the facility. The safety assessment also contains an updated assessment of the long-term safety of the existing facility. The safety assessment for

  12. Evaluation of long term leaching of borosilicate glasses

    International Nuclear Information System (INIS)

    Lanza, F.; Parnisari, E.

    1978-01-01

    For the evaluation of long term hazard of glass, data on long term glass leaching are needed. Moreover for long term leaching a model of homogeneous dissolution seems reasonable and ask for confirmation. Tests were performed at 30 0 , 80 0 , 100 0 , using an apparatus of the Soxhlet type, to 3.600 hours. Results were obtained as a weight loss and analysed following a relation with time composed by a parabolic and a linear part. Analysis of the surface layer using energy dispersion X ray spectrometry were performed. A critical analysis of the results and of the apparatus is presented

  13. Testosterone Replacement Therapy: Long-Term Safety and Efficacy

    Directory of Open Access Journals (Sweden)

    Giovanni Corona

    2017-08-01

    Full Text Available Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG or late-onset hypogonadism (LOH. The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T therapy (TTh. In addition, concerns related to cardiovascular (CV safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented.

  14. Assessment of the long-term safety of repositories. Scientific basis

    International Nuclear Information System (INIS)

    Noseck, Ulrich; Becker, Dirk; Fahrenholz, Christine

    2008-12-01

    The project contributed to increase the scientific knowledge on the long-term safety assessment and the safety cases of a radioactive waste repository. International guidelines and more recent safety cases from other countries were evaluated. The feasibility study of the three safety indicators ''individual dose rate'', ''radiotoxicity concentration in the biosphere water'' and ''radiotoxicity flux from the geosphere'' showed that due to the independently derived corresponding reference values these indicators describe three different safety statements. The combination of the three values can give a stronger argument for the safety of the repository system. Another important methodological aspect of the safety cases is the definition and selection of scenarios, one of these the human intrusion scenario. Various human intrusion scenarios are considered in the different nations, which differ significantly with respect to type and time scale, the exposition type and exposition pathway. Further progress has been achieved in how to treat human intrusion scenarios in a German post-closure safety case. Another port of the project dealt with the impact of specific geochemical processes on the long-term safety of the repository. The impact of climate changes on the long-term safety of a radioactive waste repository in rock salt was investigated with respect to processes in the overburden and the biosphere where highest impact is expected. Sofa simplified models and only discrete climate estates have been considered

  15. Probabilistic evaluation of scenarios in long-term safety analyses. Results of the project ISIBEL; Probabilistische Bewertung von Szenarien in Langzeitsicherheitsanalysen. Ergebnisse des Vorhabens ISIBEL

    Energy Technology Data Exchange (ETDEWEB)

    Buhmann, Dieter; Becker, Dirk-Alexander; Laggiard, Eduardo; Ruebel, Andre; Spiessl, Sabine; Wolf, Jens

    2016-07-15

    In the frame of the project ISIBEL deterministic analyses on the radiological consequences of several possible developments of the final repository were performed (VSG: preliminary safety analysis of the site Gorleben). The report describes the probabilistic evaluation of the VSG scenarios using uncertainty and sensitivity analyses. It was shown that probabilistic analyses are important to evaluate the influence of uncertainties. The transfer of the selected scenarios in computational cases and the used modeling parameters are discussed.

  16. Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.

    Science.gov (United States)

    Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-06-01

    An open-label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non-inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long-term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long-term treatment of patients with acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

  17. Injection grout for deep repositories. Subproject 1: LowpH cementitious grout for larger fractures, leach testing of grout mixes and evaluation of the long-term safety

    International Nuclear Information System (INIS)

    Vuorinen, U.; Lehikoinen, J.; Imoto, Harutake; Yamamoto, Takeshi; Cruz Alonso, M.

    2005-10-01

    Constructing an underground disposal facility for spent nuclear fuel deep in bedrock requires lowpH cement-based injection grout, because assured data of the extent of a possible high-pH plume in saturated bedrock conditions is lacking. In this work low-pH grout mixes of new design were subjected to leach testing. Before chosen to leach testing the grout mixes had to fulfil certain technical requirements. Leach testing was performed in order to establish that the pH requirement (≤11) set for the leachates was met. For comparison reasons also one conventionally used cement based grout material was included in the tests. Two kinds of lowpH grout cement mixes were tested; mixes with added blast furnace slag (4 mixes) or added silica (6 mixes). All the mixes were not completely tested according to the test plan, because for some mixes during leach testing factors detrimental to the long-term safety of a repository were observed, e.g. too high pH or leached sulphide, which is harmful for copper. Leach testing of the grout mixes was performed in a glove-box (N 2 atmosphere) in order to avoid the interference of atmospheric CO 2 on the alkaline leachates. Two simulated groundwater solutions, saline OL-SO and fresh ALL-MR, were used as leachates. Two leach tests were applied; equilibrium and diffusion tests. In the equilibrium test at each measuring point only a part of the leachate was exchanged, whereas in the diffusion test the entire leachate was exchanged. The pH value of each leachate sample was measured, but total alkalinity was determined only for some leachates. Na, K, Ca, Mg, Al, Fe, Si, SO 4 2- , S TOT , and Cl were analysed in the leach solutions collected in the diffusion test of four grout mixes chosen. Also the corresponding solid specimens were analysed (SEM, XRD, EPMA, MIP, TG) in Japan. A few grout pore fluid pH values were measured in Spain, as well. The simplified thermodynamic model calculations were successful in qualitatively reproducing the

  18. Long-Term Safety and Immunogenicity of a Tetravalent Live-Attenuated Dengue Vaccine and Evaluation of a Booster Dose Administered to Healthy Thai Children.

    Science.gov (United States)

    Watanaveeradej, Veerachai; Simasathien, Sriluck; Mammen, Mammen P; Nisalak, Ananda; Tournay, Elodie; Kerdpanich, Phirangkul; Samakoses, Rudiwilai; Putnak, Robert J; Gibbons, Robert V; Yoon, In-Kyu; Jarman, Richard G; De La Barrera, Rafael; Moris, Philippe; Eckels, Kenneth H; Thomas, Stephen J; Innis, Bruce L

    2016-06-01

    We evaluated the safety and immunogenicity of two doses of a live-attenuated, tetravalent dengue virus vaccine (F17/Pre formulation) and a booster dose in a dengue endemic setting in two studies. Seven children (7- to 8-year-olds) were followed for 1 year after dose 2 and then given a booster dose (F17/Pre formulation), and followed for four more years (Child study). In the Infant study, 49 2-year-olds, vaccinated as infants, were followed for approximately 3.5 years after dose 2 and then given a booster dose (F17) and followed for one additional year. Two clinically notable events were observed, both in dengue vaccine recipients in the Infant study: 1 case of dengue approximately 2.7 years after dose 2 and 1 case of suspected dengue after booster vaccinations. The booster vaccinations had a favorable safety profile in terms of reactogenicity and adverse events reported during the 1-month follow-up periods. No vaccine-related serious adverse events were reported during the studies. Neutralizing antibodies against dengue viruses 1-4 waned during the 1-3 years before boosting, which elicited a short-lived booster response but did not provide a long-lived, multivalent antibody response in most subjects. Overall, this candidate vaccine did not elicit a durable humoral immune response. © The American Society of Tropical Medicine and Hygiene.

  19. Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

    Science.gov (United States)

    Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

    2009-01-01

    Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

  20. Long-term, interventional, open-label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Poland and Russia who completed the global, international CHERISH trial.

    Science.gov (United States)

    Opoka-Winiarska, Violetta; Żuber, Zbigniew; Alexeeva, Ekaterina; Chasnyk, Vyacheslav; Nikishina, Irina; Dębowska, Grażyna; Smolewska, Elżbieta

    2018-04-13

    Efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were demonstrated in juvenile idiopathic arthritis (JIA) with polyarticular course (pJIA) in the CHERISH trial. This observational, III phase study evaluated long-term treatment of TCZ in pJIA patients was conducted by members of the Pediatric Rheumatology International Trials Organization (PRINTO) from Poland and Russia. Forty-one patients, who had completed the CHERISH core study (104 weeks), were extensionally treated with TCZ (8 mg/kg, intravenous infusion every 4 weeks). Total treatment time was from 131 to 193 weeks. The long-term safety (the primary endpoint) and efficacy were evaluated. All patients achieved ACR70 response in the core study and continued to achieve at least ACR50 response up to week 24 of this study. The safety population comprised 46.41 patient-years (PY). Rates per 100 PY of adverse (AEs) and serious events (SAEs) were 181.0 and 6.46, respectively. Pharyngitis and respiratory tract infections were the most common AEs. Except one AE (severe neutropenia), all others were classified as mild (24.4%) or moderate (29.3%). The incidence of SAEs was low (7.3%). No new safety findings were observed. The safety profile of over 2.5-year treatment with TCZ is consistent with the pre-marketing CHERISH clinical trial. Presented data and continued efficacy response support the use of TCZ in pJIA. EUDRACT No: 2011-001607-12. https://clinicaltrials.gov/ct2/show/study/NCT01575769?term=ML27783.

  1. Evaluation of long-term mechanical stability of near field

    International Nuclear Information System (INIS)

    Takaji, Kazuhiko; Sugino, Hiroyuki; Okutsu, Kazuo; Miura, Kazuhiko; Tabei, Kazuto; Noda, Masaru; Takahashi, Shinichi; Sugie, Shigehiko

    1999-11-01

    In the near field, as tunnels and pits are excavated, a redistribution of stresses in the surrounding rock will occur. For a long period of time after the emplacement of waste packages various events will take place, such as the swelling of the buffer, sinking of the overpack under its own weight, deformation arising from expansion of overpack corrosion products and the creep deformation of the rock mass. The evaluation of what effects these changes in the stress-state will have on the buffer and rock mass is a major issue from the viewpoint of safety assessment. Therefore, rock creep analysis, overpack corrosion expansion analysis and overpack sinking analysis have been made in order to examine the long-term mechanical stability of the near field and the interaction of various events that may affect the stability of the near field over a long period of time. As the results, rock creep behavior, the variations of the stress-state and the range of the influence zone differ from the rock strength, strength of buffer in the tunnel and side pressure coefficient etc. about the hard rock system and soft rock system established as basic cases. And the magnitude of the stress variations for buffer by the overpack sinking and rock creep deformation is negligible compared with it by the overpack corrosion expansion. Furthermore, though very limited zone of buffer around the overpack is close to the critical state by the overpack corrosion expansion, the engineered barrier system attains a comparatively stable state for a long period of time. (author)

  2. Safety requirements for long term operation of NPPs

    International Nuclear Information System (INIS)

    Houdre, T.; Osouf, N.; Juvin, J.-C.

    2012-01-01

    In the future, the reactors operating at present will run alongside reactors of the EPR type or their equivalent, designed for a significantly higher level of safety. This raises the question of the acceptability of continued operation of reactors beyond 40 years when there is an available technology that is safer. Two objectives are therefore imperative. First, a re-evaluation of the safety level in the light of that required of EPR type reactors or their equivalent is necessary, with proposals to bring about significant and relevant improvements to the reactors. R and D work in France and elsewhere is already indicating orientations that could lead to answers, and improvements that would provide significant reductions in release in case of severe accident are being studied. Second, strict compliance of the reactors with the applicable regulations must be demonstrated. At the same time, ageing and obsolescence of the equipment will have to be managed. Where these two points are concerned, ASN expects far-reaching proposals from the licensee. With a view to a request for continued operation beyond 40 years, ASN has referred the matter to the Advisory Committee for nuclear reactors which will meet at the end of 2011 to establish the safety requirements for reactors at their fourth ten-yearly outage. (author)

  3. Rationale and design of the VISION study: a randomized, open-label study to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive esophagitis

    Directory of Open Access Journals (Sweden)

    Uemura N

    2018-01-01

    control drug in the healing and maintenance phases, respectively. The primary endpoint of the study is the histopathological evaluation of gastric mucosa for the presence of neoplastic alteration of gastric mucosal epithelial cells. Secondary efficacy endpoints include endoscopic EE recurrence rate and EE healing rate, and secondary safety endpoints include incidence of adverse events (coded using MedDRA terminology and endoscopic evaluation of malignant changes in the gastric mucosa. Patient recruitment started in March 2016 and is now complete. The estimated study completion date is February 2022. Keywords: erosive esophagitis, gastric mucosa, lansoprazole, long-term safety, vonoprazan, K+ competitive channel inhibitor, neoplasia

  4. Comparative Evaluation of the Safety and Efficacy of Long-Term Use of Imidafenacin and Solifenacin in Patients with Overactive Bladder: A Prospective, Open, Randomized, Parallel-Group Trial (the LIST Study

    Directory of Open Access Journals (Sweden)

    Masayoshi Zaitsu

    2011-01-01

    Full Text Available Objectives. Overactive bladder (OAB is a chronic disease, but comparative trials of anticholinergics, which are commonly used for treatment of OAB, have generally been performed for up to 12 weeks only. There is no comparative study of a long-term intervention. Methods. We conducted a 52-week prospective randomized comparative study to evaluate the efficacy and tolerability of two anticholinergics. Results. Forty-one Japanese patients with untreated OAB were randomly assigned to imidafenacin and solifenacin groups. There was no difference in OABSS and KHQ scores between the two groups, but the severity and incidence of adverse events caused by the anticholinergics showed increased differences between the groups with time. The severity of dry mouth and the incidence of constipation were significantly lower in the imidafenacin group (=0.0092 and =0.0013, resp.. Conclusions. This study is the first long-term trial to show differences in the properties of anticholinergics that were not detected in short-term studies. Since OAB is a chronic disease, we conclude that imidafenacin is preferable to solifenacin from a perspective of safety.

  5. Catalytic heat exchangers - a long-term evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Silversand, Fredrik A. [CATATOR AB, Lund (Sweden)

    2003-10-01

    A long-term evaluation concerning catalytic heat exchangers (CHEs) has been performed. The idea concerning CHEs was originally described in a number of reports issued by Catator almost a decade ago. The general idea with CHEs is to combust a fuel with a catalyst inside a heat exchanger to enable an effective heat transfer. The first design approaches demonstrated the function and the possibilities with CHEs but were defective concerning the heat exchanger design. Consequently, a heat exchanger company (SWEP International AB), which was specialised on brazed plate-type heat exchangers, joined the continued development project. Indeed, the new design approach containing Catator's wire-mesh catalysts and SWEP's plate-type heat exchangers enabled us to improve the concept considerably. The new design complied with a number of relevant technical demands, e.g.: Simplicity; Compactness and integration (few parts); High thermal efficiency; Low pressure drop; Excellent emissions; High turn-down ratio; Reasonable production cost. Spurred by the technical progresses, the importance of a long-term test under realistic conditions was clear. A long-term evaluation was initialised at Sydkraft Gas premises in Aastorp. The CHE was installed on a specially designed rig to enable accelerated testing with respect to the number of transients. The rig was operated continuously for 5000 hours and emission mapping was carried out at certain time intervals. Following some problems during the initial phase of the long-term evaluation, which unfortunately also delayed the project, the results indicated very stable conditions of operation. The emissions have been rather constant during the course of the test and we cannot see any tendencies to decreased performances. Indeed, the test verifies the function, operability and reliability of the CHE-concept. Apart from domestic boilers we foresee a number of interesting and relevant applications in heating and process technology. Since

  6. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus.

    Science.gov (United States)

    Merrill, Joan T; Ginzler, Ellen M; Wallace, Daniel J; McKay, James D; Lisse, Jeffrey R; Aranow, Cynthia; Wellborne, Frank R; Burnette, Michael; Condemi, John; Zhong, Z John; Pineda, Lilia; Klein, Jerry; Freimuth, William W

    2012-10-01

    To evaluate the safety profile of long-term belimumab therapy combined with standard therapy for systemic lupus erythematosus (SLE) in patients with active disease. Patients who were randomized to receive intravenous placebo or belimumab 1, 4, or 10 mg/kg, plus standard therapy, and completed the initial 52-week double-blind treatment period were then allowed to enter a 24-week open-label extension phase. During the extension period, patients in the belimumab group either received the same dose or were switched to 10 mg/kg and patients in the placebo group were switched to belimumab 10 mg/kg. Patients who achieved a satisfactory response during the 24-week extension period were allowed to participate in the long-term continuation study of monthly belimumab 10 mg/kg. Adverse events (AEs) and abnormal laboratory results were analyzed per 100 patient-years in 1-year intervals. Of the 364 patients who completed the 52-week double-blind treatment period, 345 entered the 24-week extension, and 296 continued treatment with belimumab in the long-term continuation study. Safety data through 4 years of belimumab exposure (1,165 cumulative patient-years) are reported. Incidence rates of AEs, severe/serious AEs, infusion reactions, infections, malignancies, grades 3/4 laboratory abnormalities, and discontinuations due to AEs were stable or declined during 4-year belimumab exposure. The most common AEs included arthralgia, upper respiratory tract infection, headache, fatigue, and nausea. Serious infusion reactions were rare: only 1 occurred during the 4-year followup period. Rates of serious infection decreased from 5.9/100 patient-years to 3.4/100 patient-years, and no specific type of infection predominated. Belimumab added to standard therapy was generally well-tolerated over the 4-year treatment period in patients with SLE, which suggests that belimumab can be administered long term with an acceptable safety profile. Copyright © 2012 by the American College of Rheumatology.

  7. Radioactive waste disposal system for Cuba. Safety assessment for the long term

    International Nuclear Information System (INIS)

    Peralta Vital, J.L.; Gil Castillo, R.; Mirta Torrez, B.

    1998-01-01

    The present work is performed within the frame of evaluating the radiological impact of the post-closure stage of the facility for disposal of the radioactive wastes generated in Cuba, including a description of the waste disposal systems defined in the country, and taking account of significant elements of their long term safety. The Methodology for Safety Assessment includes: the definition of possible scenarios for evaluation, the identification of principal present uncertainties, the model simulating the release of the radionuclides of the facility, their transport through the geosphere, and their final access to man, evaluating ultimately the radiological impact of the disposal system considering the dose for a critical group. The results obtained allow to demonstrate the radiological safety of the nominative barrier in the design of the system for the particular conditions of Cuba. (author)

  8. Ways of ensuring short/long term safety

    International Nuclear Information System (INIS)

    Boeck, B. de; Baltes, B.; Besnus, F.

    2006-01-01

    Various strategies have been adopted among countries to manage radioactive waste. The present publication gives to this respect a broad overview of the policies and strategies adopted by Germany, Belgium and France. It appears that these may show remarkable differences, but motivated mainly by political and societal considerations. With regard to safety, practices for waste management are consistent and reflect the broad international consensus that has been progressively established. As an illustration, safety practices and possible specificities for the storage and geological disposal of spent fuel and high level radioactive waste from reprocessing are shortly described. (authors)

  9. Long-term criticality safety concerns associated with surplus fissile material disposition

    International Nuclear Information System (INIS)

    Choi, J.S.

    1995-01-01

    A substantial inventory of surplus fissile material would result from ongoing and planned dismantlement of US and Russian nuclear weapons. This surplus fissile material could be dispositioned by irradiation in nuclear reactors, and the resulting spent MOx fuel would be similar in radiation characteristics to regular LWR spent UO2 fuel. The surplus fissile material could also be immobilized into high-level waste forms, such as borosilicate glass, synroc, or metal-alloy matrix. The MOx spent fuel, or the immobilized waste forms, could then be directly disposed of in a geologic repository. Long-term criticality safety concerns arise because the fissile contents (i.e., Pu-239 and its decay daughter U-235) in these waste forms are higher than in LWR spent UO2 fuel. MOx spent fuel could contain 3 to 4 wt% of reactor-grade plutonium, compared to only 0.9 wt% of plutonium in LWR spent UO2 fuel. At some future time (tens of thousand of years), when the waste forms had deteriorated due to intruding groundwater, the water could mix with the long-lived fissile materials to form into a critical system. If the critical system is self-sustaining, somewhat like the natural-occurring reactor in OKLO, fission products produced could readily be available for dissolution and release out to the accessible environment, adversely affecting public health and safety. This paper will address ongoing activities to evaluate long-term criticality safety concerns associated with disposition of fissile material in a geologic setting. Issues to be addressed include the identification of a worst-case water-intrusion scenario and waste-form geometries which present the most concern for long-term criticality safety; and suggests of technical solutions for such concerns

  10. Long term safety requirements and safety indicators for the assessment of underground radioactive waste repositories

    International Nuclear Information System (INIS)

    Vovk, Ivan

    1998-01-01

    This presentation defines: waste disposal, safety issues, risk estimation; describes the integrated waste disposal process including quality assurance program. Related to actinides inventory it shows the main results of calculated activity obtained by deterministic estimation. It includes the Radioactive Waste Safety Standards and requirements; features related to site, design and waste package characteristics, as technical long term safety criteria for radioactive waste disposal facilities. Fundamental concern regarding the safety of radioactive waste disposal systems is their radiological impact on human beings and the environment. Safety requirements and criteria for judging the level of safety of such systems have been developed and there is a consensus among the international community on their basis within the well-established system of radiological protection. So far, however, little experience has been gained in applying long term safety criteria to actual disposal systems; consequently, there is an international debate on the most appropriate nature and form of the criteria to be used, taking into account the uncertainties involved. Emerging from the debate is the increasing conviction that the combined use of a variety of indicators would be advantageous in addressing the issue of reasonable assurance in the different time frames involved and in supporting the safety case for any particular repository concept. Indicators including risk, dose, radionuclide concentration, transit time, toxicity indices, fluxes at different points within the system, and barrier performance have all been identified as potentially relevant. Dose and risk are the indicators generally seen as most fundamental, as they seek directly to describe the radiological impact of a disposal system, and these are the ones that have been incorporated into most national standards to date. There are, however, certain problems in applying them. Application of a variety of different indicators

  11. Statement on safety requirements concerning the long-term operation of the Muehleberg nuclear power station

    International Nuclear Information System (INIS)

    2012-12-01

    This report published by the Swiss Federal Nuclear Safety Inspectorate ENSI investigates the safety requirements with respect to the long-term operation of the Muehleberg nuclear power station in Switzerland. Relevant international requirements and Swiss legal stipulations concerning the long-term operation of the power station are stated. The management of aging processes is looked at. The regular verification of the integrity of various plant components such as containments, piping, steam generation system, etc. is looked at in detail. The state-of-the-art concerning deterministic accident analyses and refitting technology are discussed, as are automated safety systems. The applicable laws, decrees and guidelines are listed in appendices

  12. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.

    NARCIS (Netherlands)

    Leonardi, C.; Strober, B.; Gottlieb, A.B.; Elewski, B.E.; Ortonne, J.P.; Kerkhof, P.C.M. van de; Chiou, C.F.; Dunn, M.; Jahreis, A.

    2010-01-01

    BACKGROUND: In two previous phase 3 studies, up to 60 weeks of etanercept therapy significantly improved the symptoms of psoriasis and was well tolerated. OBJECTIVE: To evaluate the long-term safety of etanercept in an open-label extension study for up to 72 weeks in patients with moderate-to-severe

  13. Long-term evaluation of opioid treatment in fibromyalgia.

    Science.gov (United States)

    Peng, Xiaomei; Robinson, Rebecca L; Mease, Philip; Kroenke, Kurt; Williams, David A; Chen, Yi; Faries, Douglas; Wohlreich, Madelaine; McCarberg, Bill; Hann, Danette

    2015-01-01

    In a 12-month observational study, we evaluated the effect of opioid use on the outcomes in 1700 adult patients with fibromyalgia. Data were evaluated using propensity score matching after patients were divided into cohorts based on their baseline medication use: (1) taking an opioid (concurrent use of tramadol was permitted); (2) taking tramadol (but no opioids); and (3) not taking opioids or tramadol. Changes in outcomes were assessed using the Brief Pain Inventory for severity and pain-related interference (BPI-S, BPI-I), Fibromyalgia Impact Questionnaire (FIQ), Patient Health Questionnaire for depression (PHQ-8), Insomnia Severity Index (ISI), Sheehan Disability Scale (SDS), 7-item Generalized Anxiety Disorder Scale (GAD-7), and economic factors. Time-to-opioid or tramadol discontinuation was analyzed using Kaplan-Meier survival analyses. Compared with the opioid cohort, the nonopioid cohort demonstrated significantly greater reductions (PFIQ, PHQ-8, SDS, and ISI; the tramadol cohort compared with the opioid group showed greater reductions on FIQ and ISI. Reductions in BPI-S and GAD-7 did not differ significantly among cohorts. Compared with the opioid cohort, patients in the tramadol cohort had fewer outpatient visits to health care providers. Few significant differences were found between the tramadol and nonopioid cohorts across outcomes. Although pain severity was reduced over time in all cohorts, opioid users showed less improvement in pain-related interference with daily living, functioning, depression, and insomnia. Overall, the findings show little support for the long-term use of opioid medications in patients with fibromyalgia given the poorer outcomes across multiple assessment domains associated with this cohort.

  14. Long-term efficacy and safety of tacalcitol ointment in patients with chronic plaque psoriasis.

    NARCIS (Netherlands)

    Kerkhof, P.C.M. van de; Berth-Jones, J.; Griffiths, C.E.; Harrison, P.V.; Honigsmann, H.; Marks, R.; Roelandts, R.; Schopf, E.; Trompke, C.

    2002-01-01

    BACKGROUND: As psoriasis patients often require continuous treatment optimal therapy has to provide efficacy and a good safety profile over the long term. OBJECTIVES: The aim of this multicentre study was to assess the efficacy, safety and tolerability of tacalcitol (4 microg g(-1)) ointment

  15. Safety and performance indicators for the assessment of long-term safety of deep geological disposal of radioactive waste

    International Nuclear Information System (INIS)

    Hugi, M.; Schneider, J.W.; Dorp, F. van; Zuidema, P.

    2005-01-01

    The evaluation of the ability to isolate radioactive waste and the assessment of the long-term safety of a deep geological repository is usually done in terms of the calculated dose and/or risk for an average individual of the population which is potentially most affected by the potential impacts of the repository. At present, various countries and international organisations are developing so-called complementary indicators to supplement such calculations. These indicators are called ''safety indicators'' if they refer to the safety of the whole repository system; if they address the isolation capability of individual system components or the whole system from a more technical perspective, they are called ''performance indicators''. The need for complementary indicators follows from the long time frames which characterise the safety assessment of a geological repository, and the corresponding uncertainty of the calculated radiation dose. The main reason for these uncertainties is associated with the uncertain long-term prognosis of the surface environment and the related human behaviour. (orig.)

  16. Long-term storage of radioactive waste: IAEA perspectives on safety and sustainability

    International Nuclear Information System (INIS)

    Rowat, J.H.; Louvat, D.; Metcalf, P.E.

    2006-01-01

    As the amounts of radioactive waste in surface storage have increased, concern has grown over the safety and sustainability of storage in the long term. In response to increasing concerns, the International Atomic Energy Agency (IAEA) has included an action to address the safety implications of the long-term storage (LTS) of radioactive waste in its action plan for waste safety; the action plan was endorsed by the IAEA's Member States in 2001. In 2003, the IAEA published a position paper on the safety and sustainability of LTS as part fulfilment of the action in question. A key theme of the position paper is the contrast of safety and sustainability implications of LTS with those of disposal. The present paper provides a summary of the position paper, describes current IAEA activities that deal with the subject of LTS, and discusses findings from the 2004 Cordoba symposium on disposal of low activity radioactive waste that pertain to LTS. (author)

  17. Long-Term Stability Evaluation and Pillar Design Criterion for Room-and-Pillar Mines

    Directory of Open Access Journals (Sweden)

    Yang Yu

    2017-10-01

    Full Text Available The collapse of abandoned room-and-pillar mines is often violent and unpredictable. Safety concerns often resulted in mine closures with no post-mining stability evaluations. As a result, large amounts of land resources over room-and-pillar mines are wasted. This paper attempts to establish an understanding of the long-term stability issues of goafs (abandoned mines. Considering progressive pillar failures and the effect of single pillar failure on surrounding pillars, this paper proposes a pillar peeling model to evaluate the long-term stability of coal mines and the associated criteria for evaluating the long-term stability of room-and-pillar mines. The validity of the peeling model was verified by numerical simulation, and field data from 500 pillar cases from China, South Africa, and India. It is found that the damage level of pillar peeling is affected by the peel angle and pillar height and is controlled by the pillar width–height ratio.

  18. Backcasting long-term climate data: evaluation of hypothesis

    Science.gov (United States)

    Saghafian, Bahram; Aghbalaghi, Sara Ghasemi; Nasseri, Mohsen

    2018-05-01

    Most often than not, incomplete datasets or short-term recorded data in vast regions impedes reliable climate and water studies. Various methods, such as simple correlation with stations having long-term time series, are practiced to infill or extend the period of observation at stations with missing or short-term data. In the current paper and for the first time, the hypothesis on the feasibility of extending the downscaling concept to backcast local observation records using large-scale atmospheric predictors is examined. Backcasting is coined here to contrast forecasting/projection; the former is implied to reconstruct in the past, while the latter represents projection in the future. To assess our hypotheses, daily and monthly statistical downscaling models were employed to reconstruct past precipitation data and lengthen the data period. Urmia and Tabriz synoptic stations, located in northwestern Iran, constituted two case study stations. SDSM and data-mining downscaling model (DMDM) daily as well as the group method of data handling (GMDH) and model tree (Mp5) monthly downscaling models were trained with National Center for Environmental Prediction (NCEP) data. After training, reconstructed precipitation data of the past was validated against observed data. Then, the data was fully extended to the 1948 to 2009 period corresponding to available NCEP data period. The results showed that DMDM performed superior in generation of monthly average precipitation compared with the SDSM, Mp5, and GMDH models, although none of the models could preserve the monthly variance. This overall confirms practical value of the proposed approach in extension of the past historic data, particularly for long-term climatological and water budget studies.

  19. Resilience Engineering in Critical Long Term Aerospace Software Systems: A New Approach to Spacecraft Software Safety

    Science.gov (United States)

    Dulo, D. A.

    Safety critical software systems permeate spacecraft, and in a long term venture like a starship would be pervasive in every system of the spacecraft. Yet software failure today continues to plague both the systems and the organizations that develop them resulting in the loss of life, time, money, and valuable system platforms. A starship cannot afford this type of software failure in long journeys away from home. A single software failure could have catastrophic results for the spaceship and the crew onboard. This paper will offer a new approach to developing safe reliable software systems through focusing not on the traditional safety/reliability engineering paradigms but rather by focusing on a new paradigm: Resilience and Failure Obviation Engineering. The foremost objective of this approach is the obviation of failure, coupled with the ability of a software system to prevent or adapt to complex changing conditions in real time as a safety valve should failure occur to ensure safe system continuity. Through this approach, safety is ensured through foresight to anticipate failure and to adapt to risk in real time before failure occurs. In a starship, this type of software engineering is vital. Through software developed in a resilient manner, a starship would have reduced or eliminated software failure, and would have the ability to rapidly adapt should a software system become unstable or unsafe. As a result, long term software safety, reliability, and resilience would be present for a successful long term starship mission.

  20. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis

    Directory of Open Access Journals (Sweden)

    Kivelevitch D

    2014-04-01

    Full Text Available Dario Kivelevitch, Bobbak Mansouri, Alan Menter Department of Dermatology, Baylor University Medical Center, Dallas, TX, USA Abstract: Psoriasis is a chronic, immune-mediated inflammatory disease affecting both the skin and joints. Approximately 20% of patients suffer a moderate to severe form of skin disease and up to 30% have joint involvement. Standard therapies for psoriasis include topical medications, phototherapy, and both oral systemic and biological therapies whereas therapies for psoriatic arthritis include nonsteroidal anti-inflammatory drugs followed by disease modifying antirheumatic drugs and/or tumor necrosis factor (TNF-α inhibitors and interleukin-12/23p40 inhibitors. Treatment of both diseases is typically driven by disease severity. In the past decade, major advances in the understanding of the immunopathogenesis of psoriasis and psoriatic arthritis have led to the development of numerous biological therapies, which have revolutionized the treatment for moderate to severe plaque psoriasis and psoriatic arthritis. Anti-TNF-α agents are currently considered as first line biological therapies for the treatment of moderate to severe psoriasis and psoriatic arthritis. Currently approved anti-TNF-α agents include etanercept, adalimumab, and infliximab for psoriasis and psoriatic arthritis as well as golimumab and certolizumab for psoriatic arthritis. In this article, we aim to evaluate the long term safety and efficacy of etanercept in psoriasis and psoriatic arthritis. Keywords: psoriasis, psoriatic arthritis, etanercept, biological therapy, tumor necrosis factor, safety

  1. Safety aspects of long term operation of water moderated reactors. Recommendations on the scope and content of programmes for safe long term operation. Final report of the extrabudgetary programme on safety aspects long term operation of water moderated reactors

    International Nuclear Information System (INIS)

    2007-07-01

    During the last two decades, the number of IAEA Member States giving high priority to continuing the operation of nuclear power plants beyond the time frame originally anticipated is increasing. This is related to the age of nuclear power plants connected to the grid worldwide. The IAEA started to develop guidance on the safety aspects of ageing management in the 1990s. Recognizing the development in a number of its Member States, the IAEA initiated this Extrabudgetary Programme on Safety Aspects of Long Term Operation of Water Moderated Reactors in 2003. The objective of the Programme was to establish recommendations on the scope and content of activities to ensure safe long term operation of water moderated reactors. The term long term operation is used to accommodate various approaches in Member States and is defined as operation beyond an initial time frame set forth in design, standards, licence, and/or regulations, that is justified by safety assessment, considering life limiting processes and features for systems, structures and components. The scope of the Programme included general long term operation framework, mechanical components and materials, electrical components and instrumentation and control, and structural components and structures. The scope of the Programme was limited to physical structures of the NPPs. Four working groups addressed the above indicated technical areas. The Programme steering committee provided coordination and guidance and served as a forum for the exchange of information. The Programme implementation relied on voluntary in kind and financial contributions from the Czech Republic, Hungary, Slovakia, Sweden, the United Kingdom and the USA as well as in kind contributions from Bulgaria, Finland, the Netherlands, the Russian Federation, Spain, the Ukraine, and the European Commission. This report summarizes the main results, conclusions and recommendations of this Programme and provides in the Appendices I-IV detailed

  2. Fulfillment of the long-term safety functions by the different barriers during the main time frames after repository closure

    International Nuclear Information System (INIS)

    Preter, P. de; Lalieux, Ph.

    2002-01-01

    In general terms the basis long-term safety functions of a disposal system (i.e. the engineered barrier system, including the waste forms and the host rock) are the functions that the system as a whole or its constituents must fulfill in order to assure an adequate level of long-term radiological safety. The long-term safety functions of a disposal system constitute a generic and methodological tool that can be used in a double sense. In the first place these functions provide an a priori instrument for designing the system: the implementer must ensure that these safety functions are fulfilled by a series of robust system barriers and components. These functions can also be used as an a posteriori means to describe and assess in general terms the functioning of the system. In this way they are an important qualitative element to help to support the safety case and to identify further R and D priorities. By providing a general description of system functioning they are also a communication tool to stakeholders who are less familiar with the details of a safety case. Instead of limiting the description to a multi-barrier system, the safety functions enable to better explain how the different barriers contribute to one or more safety functions and by which processes this is performed. By doing so the system description moves from multi-barrier to multi-function. The aim of this paper is to provide such a general description of the system functioning for the Belgian case of deep disposal of high-level waste (mainly spent fuel or vitrified waste from fuel reprocessing) in the Boom Clay, o poorly-indurated argillaceous formation. From the detailed safety and performance evaluations the main time frames after repository closure are identified. Each time frame relates to a period during which the successive safety functions play a key role. Also, in each time frame the radiological impact on the environment is distinctly different. (authors)

  3. Long-term safety of the maintenance and decommissioning waste of the encapsulation plant

    International Nuclear Information System (INIS)

    Nummi, O.; Kylloenen, J.; Eurajoki, T.

    2012-12-01

    This report, Long-term safety of the maintenance and decommissioning waste of the encapsulation plant, presents the disposal concept for the low and intermediate level waste (L/ILW) that is generated during the operation and decommissioning of the encapsulation plant, and assesses the long-term safety of the disposal of the waste. Radioactive waste originates from the spent nuclear fuel transferred and dried in the encapsulation plant. Radioactive waste accumulates also in the maintenance of the components and systems of the encapsulation plant. The waste is collected, exempted from control if possible and treated for final disposal if necessary. The waste is disposed of in the L/ILW hall which is currently planned to be located at a depth of -180 meters along the access tunnel to the repository for spent fuel. The main engineered barrier in the L/ILW hall is a concrete basin that encases the dried liquid waste. The safety concept of L/ILW disposal is based on the slow release of radioactivity from the L/ILW hall and its limited transport through the bedrock into biosphere. The release and transport of the radioactivity is described by the assessment scenarios, which include expected evolution and unlikely events affecting the long-term safety. The scenarios act as guidelines according to which the conceptual and mathematical models are formed. The long-term safety of the L/ILW hall is assessed using deterministic and probabilistic modeling. Special issues such as human intrusion and radiation effects on other biota are also assessed. The most significant contributor to the dose rates is the short-lived radionuclide 90 Sr followed by long-lived nuclides 129 I and 108 mAg. The annual doses to the public, and release rates of radioactive substances stay below the regulatory constraints in all analyzed scenarios. (orig.)

  4. Evaluation of a method to measure long term cortisol levels.

    Science.gov (United States)

    Manenschijn, Laura; Koper, Jan W; Lamberts, Steven W J; van Rossum, Elisabeth F C

    2011-01-01

    Elevated levels of cortisol are known to induce various symptoms and diseases, e.g. abdominal obesity, type 2 diabetes, osteoporosis and cardiovascular disease. Measuring serum, saliva and urine cortisol is limited to one time point. Measurement of cortisol in scalp hair is a recently developed method to measure long term cortisol levels. The aim of this study was to investigate whether hair cortisol is a feasible parameter to measure cortisol exposure. We collected hair samples of 195 healthy individuals, 9 hypercortisolemic and one hypocortisolemic patient and measured hair cortisol levels. Cortisol was extracted from scalp hair using methanol and cortisol levels were measured using a salivary ELISA kit. Measurement of waist and hip circumferences and blood pressure was performed in 46 healthy subjects. We found a positive correlation between hair cortisol and both waist circumference (r=0.392, p=0.007) and waist-to-hip ratio (WHR) (r=0.425, p=0.003). No correlations were found between hair cortisol levels and BMI, blood pressure or age. There was no decline in cortisol levels in six consecutive hair segments. Hair cortisol levels were elevated in patients with known hypercortisolism (pcortisol was positively correlated with WHR, suggesting that hair cortisol reflects cortisol exposure at tissue level, which was also supported by elevated hair cortisol levels in hypercortisolemic patients and concordance between hair cortisol levels and clinical disease course. Cortisol levels in hair are slightly influenced by hair treatment but not by natural hair colour, use of hair products, gender or age. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. The basis for confidence in the long-term safety of nuclear waste disposal

    International Nuclear Information System (INIS)

    Allen, C.J.; Whitaker, S.H.

    1993-07-01

    Confidence in the acceptability and the long-term safety of deep geological disposal draws strength from a number of sources: the technical approach, i.e., the use of multiple barriers for redundancy and defence in depth; the adoption of the observational approach to site characterization and to disposal vault design, construction, operation and, eventually, closure; the overall approach, which is based on ongoing review and incremental decision making; and, active and effective involvement of the public in this process

  6. Safety and optimization aspects of radioactive waste long-term storage at the ''Vector'' site

    International Nuclear Information System (INIS)

    Tokarevs'kij, O.V.; Kondrat'jev, S.M.; Aleksjejeva, Z.M.; Ribalka, N.V.

    2015-01-01

    The paper analyzes links between the final disposal option and needs for long-term storage of radioactive waste taking into proposals on possible changes in radwaste classification as regards disposal. It considers the conceptual approach to design facilities for long-term storage of long-lived radioactive waste at the Vector site and approaches to apply requirements of regulatory documents, radiation safety principles and criteria for long-term storage of radwaste and safety assessment.

  7. ComfortPower - System improvements and long-term evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Silversand, Fredrik [Catator AB, Lund (Sweden)

    2011-11-15

    Catator has previously developed a novel heating system abbreviated ComfortPower in a RandD-programme supported by Catator, Swedish Gas Centre (SGC), Swedish Defence Materiel Administration (FMV), Skanska, Nibe and Alfa Laval. The ComfortPower unit comprises a multi fuel reformer system tied to a high-temperature polymer electrolyte fuel cell (HT-PEM) and a heat pump system. Since the residual heat from the fuel cell system can be utilized in a very effective way, it is possible to reach high thermal efficiencies. Indeed, the thermal efficiency in the unit has previously been shown to reach values as high as 175 - 200 % based on the lower heating value of the fuel. In addition to heat, ComfortPower can supply comfort cooling and surplus electricity. This project phase has focused on the following elements: 1. System improvements to further enhance the efficiency with existing fuel cell (HT-PEM). 2. System simplifications (e.g. DC-compressor system) to manage issues with start-up currents. 3. Tests with biogas qualities (various levels of CO{sub 2}) and biogas/air. 4. Long-term test with biogas quality (upgraded biogas). 5. Additional tests with liquid fuels (alcohols and diesel). 6. Map the need for cooling and heating in various applications. 7. Investigate how ComfortPower can reduce the primary energy consumption and reduce the environmental impact. 8. Study the possibility with a SOFC-based system with internal reforming. It was found that the Optiformer technology can be used to derive a suitable reformate gas for the HT-PEM unit from a wide range of fuels. Even if operation with fuel gases is the natural choice in most cases, it is possible also to use alcohols and other liquid fuels (e.g. in Campus applications). The heat pump system was equipped with a 24 V DC-compressor provided by Nibe. The compressor could be directly powered by the accumulator system and start-up currents, harmful to the inverter, could be avoided. Some improvements were made on the

  8. Evaluation of the short- and long-term effectiveness and safety of fully covered self-expandable metal stents for drainage of pancreatic fluid collections: results of a Spanish nationwide registry.

    Science.gov (United States)

    Vazquez-Sequeiros, Enrique; Baron, Todd H; Pérez-Miranda, Manuel; Sánchez-Yagüe, Andres; Gornals, Joan; Gonzalez-Huix, Ferran; de la Serna, Carlos; Gonzalez Martin, Juan Angel; Gimeno-Garcia, Antonio Z; Marra-Lopez, Carlos; Castellot, Ana; Alberca, Fernando; Fernandez-Urien, Ignacio; Aparicio, Jose Ramon; Legaz, Maria Luisa; Sendino, Oriol; Loras, Carmen; Subtil, Jose Carlos; Nerin, Juan; Perez-Carreras, Mercedes; Diaz-Tasende, Jose; Perez, Gustavo; Repiso, Alejandro; Vilella, Angels; Dolz, Carlos; Alvarez, Alberto; Rodriguez, Santiago; Esteban, Jose Miguel; Juzgado, Diego; Albillos, Agustin

    2016-09-01

    Initial reports suggest that fully covered self-expandable metal stents (FCSEMSs) may be better suited for drainage of dense pancreatic fluid collections (PFCs), such as walled-off pancreatic necrosis. The primary aim was to analyze the effectiveness and safety of FCSEMSs for drainage of different types of PFCs in a large cohort. The secondary aim was to investigate which type of FCSEMS is superior. This was a retrospective, noncomparative review of a nationwide database involving all hospitals in Spain performing EUS-guided PFC drainage. From April 2008 to August 2013, all patients undergoing PFC drainage with an FCSEMS were included in a database. The main outcome measurements were technical success, short-term (2 weeks) and long-term (6 months) effectiveness, adverse events, and need for surgery. The study included 211 patients (pseudocyst/walled-off pancreatic necrosis, 53%/47%). The FCSEMSs used were straight biliary (66%) or lumen-apposing (34%). Technical success was achieved in 97% of patients (95% confidence interval [CI], 93%-99%). Short-term- and long-term clinical success was obtained in 94% (95% CI, 89%-97%) and 85% (95% CI, 79%-89%) of patients, respectively. Adverse events occurred in 21% of patients (95% CI, 16%-27%): infection (11%), bleeding (7%), and stent migration and/or perforation (3%). By multivariate analysis, patient age (>58 years) and previous failed drainage were the most important factors associated with negative outcome. An FCSEMS is effective and safe for PFC drainage. Older patients with a history of unsuccessful drainage are more likely to fail EUS-guided drainage. The type of FCSEMS does not seem to influence patient outcome. Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  9. Team safety and innovation by learning from errors in long-term care settings.

    Science.gov (United States)

    Buljac-Samardžić, Martina; van Woerkom, Marianne; Paauwe, Jaap

    2012-01-01

    Team safety and team innovation are underexplored in the context of long-term care. Understanding the issues requires attention to how teams cope with error. Team managers could have an important role in developing a team's error orientation and managing team membership instabilities. The aim of this study was to examine the impact of team member stability, team coaching, and a team's error orientation on team safety and innovation. A cross-sectional survey method was employed within 2 long-term care organizations. Team members and team managers received a survey that measured safety and innovation. Team members assessed member stability, team coaching, and team error orientation (i.e., problem-solving and blaming approach). The final sample included 933 respondents from 152 teams. Stable teams and teams with managers who take on the role of coach are more likely to adopt a problem-solving approach and less likely to adopt a blaming approach toward errors. Both error orientations are related to team member ratings of safety and innovation, but only the blaming approach is (negatively) related to manager ratings of innovation. Differences between members' and managers' ratings of safety are greater in teams with relatively high scores for the blaming approach and relatively low scores for the problem-solving approach. Team coaching was found to be positively related to innovation, especially in unstable teams. Long-term care organizations that wish to enhance team safety and innovation should encourage a problem-solving approach and discourage a blaming approach. Team managers can play a crucial role in this by coaching team members to see errors as sources of learning and improvement and ensuring that individuals will not be blamed for errors.

  10. Long-term outcome of eosinophilic fasciitis : A cross-sectional evaluation of 35 patients

    NARCIS (Netherlands)

    Mertens, JS; Thurlings, Rogier M; Kievit, Wietske; Seyger, Marieke M B; Radstake, Timothy R D; de Jong, Elke M G J

    BACKGROUND: Eosinophilic fasciitis (EF) is a connective tissue disease with an unknown long-term course. OBJECTIVE: To evaluate presence and determinants of residual disease damage in patients with EF after long-term follow-up. METHODS: Patients with biopsy-proven EF were included for this

  11. Long-term outcome of eosinophilic fasciitis: A cross-sectional evaluation of 35 patients

    NARCIS (Netherlands)

    Mertens, J.S.; Thurlings, R.M.; Kievit, W.; Seyger, M.M.B.; Radstake, T.R.D.J.; Jong, E.M.G.J. de

    2017-01-01

    BACKGROUND: Eosinophilic fasciitis (EF) is a connective tissue disease with an unknown long-term course. OBJECTIVE: To evaluate presence and determinants of residual disease damage in patients with EF after long-term follow-up. METHODS: Patients with biopsy-proven EF were included for this

  12. Long-Term Safety Analysis of Baldone Radioactive Waste Repository and Updating of Waste Acceptance Criteria

    International Nuclear Information System (INIS)

    2001-12-01

    The main objective of the project was to provide advice to the Latvian authorities on the safety enhancements and waste acceptance criteria for near surface radioactive waste disposal facilities of the Baldone repository. The project included the following main activities: Analysis of the current status of the management of radioactive waste in Latvia in general and, at the Baldone repository in particular Development of the short and long-term safety analysis of the Baldone repository, including: the planned increasing of capacity for disposal and long term storage, the radiological analysis for the post-closure period Development of the Environment Impact Statement, for the new foreseen installations, considering the non radiological components Proposal of recommendations for future updating of radioactive waste acceptance criteria Proposal of recommendations for safety upgrades to the facility. The work programme has been developed in phases and main tasks as follows. Phase 0: Project inception, Phase 1: Establishment of current status, plans and practices (Legislation, regulation and standards, Radioactive waste management, Waste acceptance criteria), Phase 2: Development of future strategies for long-term safety management and recommendations for safety enhancements. The project team found the general approach use at the installation, the basic design and the operating practices appropriate to international standards. Nevertheless, a number of items subject to potential improvements were also identified. These upgrading recommendations deal with general aspects of the management (mainly storage versus disposal of long-lived sources), site and environmental surveillance, packaging (qualification of containers, waste characterization requirements), the design of an engineered cap and strategies for capping. (author)

  13. Long-term safety and efficacy of twice-daily aclidinium bromide in patients with COPD.

    Science.gov (United States)

    Gelb, Arthur F; Tashkin, Donald P; Make, Barry J; Zhong, Xiaoyun; Garcia Gil, Esther; Caracta, Cynthia

    2013-12-01

    Aclidinium is a novel, long-acting muscarinic antagonist indicated for maintenance treatment of COPD. In this 52-week, parallel-group, double-blind study, patients with moderate-to-severe COPD were randomized (1:1) to receive aclidinium twice-daily (BID) 200 μg or 400 μg via a novel, dry powder inhaler (Genuair(®)/Pressair(®)) [Registered trademarks of Almirall, SA, Barcelona, Spain for use within the European Union, Iceland, Norway, and Switzerland as Genuair(®) and within the United States as Pressair(®)]. Safety, the primary objective, was assessed via adverse events (AEs), clinical laboratory tests, vital signs, and 12-lead electrocardiograms. Efficacy was evaluated using spirometry, SGRQ, and rescue medication use. A total of 605 patients were randomized in the study. The percentage of patients reporting any treatment-emergent AE (TEAE) was comparable between groups; most TEAEs were mild or moderate. Anticholinergic TEAEs were reported by low percentages of patients in either treatment group (dry mouth: 200 μg, 1.3%; 400 μg, 2.7%; constipation: 200 μg, 2.9%; 400 μg, 1.7%). Cardiac TEAEs were also reported by a low percentage of patients (<2% for any event in any group) and did not appear to be dose dependent. There were no clinically relevant abnormalities in other safety outcomes. Both aclidinium 200 μg and 400 μg resulted in improvements from baseline to Week 52 in FEV1, with numerically greater increases observed with the higher dose. Clinically important improvements in SGRQ scores and a reduction in rescue medication use were observed throughout the study for both doses. Long-term treatment with aclidinium 200 μg or 400 μg BID was well tolerated, with sustained benefits in lung function and health status in patients with COPD throughout the 1-year study. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. FP7 project LONGLIFE: Treatment of long-term irradiation embrittlement effects in RPV safety assessment

    International Nuclear Information System (INIS)

    May, J.; Hein, H.; Altstadt, E.; Bergner, F.; Viehrig, H.W.; Ulbricht, A.; Chaouadi, R.; Radiguet, B.; Cammelli, S.; Huang, H.; Wilford, K.

    2012-01-01

    The increasing age of European Nuclear Power Plants (NPPs) and envisaged extensions of plant lifetimes from 40 up to 80 years require an improved understanding of ageing phenomena of RPV components. The Network of Excellence NULIFE (Nuclear Plant Life Prediction) has been established to advance the safe and economic long-term operation (LTO) of NPPs by facilitating increased co-operation for applied R and D amongst members of the European nuclear community. The accurate prediction and management of RPV neutron irradiation embrittlement connected with long-term operation is an important aspect of this co-operation. Phenomena that might become important at high neutron fluences (such as flux effects and late blooming effects) have to be considered adequately in safety assessments. However, the surveillance database for prolonged irradiation times and low neutron fluxes is sparse. Consequently, there are significant uncertainties in the treatment of long-term irradiation effects. Therefore, the project LONGLIFE (Treatment of long-term irradiation embrittlement effects in RPV safety assessment) was initiated under the Euratom 7th Framework Programme of the European Commission as an umbrella project of NULIFE. LONGLIFE aims at 1) improved understanding of long-term irradiation phenomena that might compromise RPV integrity, and thereby the LTO of European NPPs, and 2) assessment of the adequacy of current prediction tools, codes, standards and surveillance guidelines for supporting long-term RPV operation. The scope of the work comprises the analysis of LTO boundary conditions; microstructural investigations and supplementary mechanical tests on RPV steels, including RPV steels from decommissioned plants; training activities; and elaboration of recommendations for RPV materials assessment and embrittlement surveillance under LTO conditions. A key part of the technical work is the selection of relevant materials for examination, e.g. which contain different weld and base

  15. Evolution of safety standards for the long-term management of nuclear waste, and their application in Ontario Power Generation

    International Nuclear Information System (INIS)

    Kempe, T.F.

    2006-01-01

    This paper examines the need to develop current radiation protection methodologies further in order to take account of the special features of long-term waste management. The need to expand the scope and nature of regulatory submissions is also addressed. It is concluded that an international consensus is emerging as to requirements for a safety case for long-term waste management, and on safety assessment approaches and criteria to be applied in the regulation of long-term waste management facilities. The application of some of this methodology in preliminary concept assessments carried out by OPG for long-term waste management facilities is described. (author)

  16. Evaluation on Long-term Cooling of CANDU after Sump Blockage using MARS-KS

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Seon Oh; Cho, Yong Jin [KINS, Daejeon (Korea, Republic of); Kim, Sung Joong [Hanyang University, Seoul (Korea, Republic of)

    2016-05-15

    There was a real incident that part of the fibrous insulation debris stripped by steam jet was transported to the pool and clogged the intake strainers of the drywell spray system, which revealed a weakness in the defense-in-depth concept which under other circumstances could have led to the ECCS failing to provide coolant to the core. Since the above Barseback-2 incident in 1992, lots of the international activities have been carried out to identify essential parameters and physical phenomena and to promote consensus on the technical issues, important for safety and possible paths for their resolution. In nuclear power plant under operation, if an unplanned reactor trip or a power reduction occurs, operators are required to maintain the reactor in a stable state according to emergency operating procedure (EOP) and to take diagnosis and appropriate mitigation actions if necessary. Subject to the EOP of Wolsong unit 1 (the first Korean PHWR NPP) under LOCA, intact or broken loops are diagnosed using the available plant information such as pressure and temperature of outlet headers. For the intact loop, effective long-term cooling is envisioned through the operation of shutdown cooling system as implemented in the EOP. In this work, the adequacy of long-term cooling during the recirculation phase of LOCA was evaluated under the postulated condition of the reduced flow path of the recirculation sump due to the inflow of substantial amount of debris released by the break flow with high energy. For the intact loop, although the incipience of boiling in the fuel channel was evaluated to occur, the effective long-term cooling can be achieved through the shutdown cooling system as guided in the EOP.

  17. Study on the system development for evaluating long-term alteration of hydraulic field in Near Field. 3

    International Nuclear Information System (INIS)

    Okutu, Kazuo; Morikawa, Seiji; Taguchi, Katsunori

    2004-02-01

    For the high performance evaluation of reliability of TRU waste repository, the system development for evaluating long-term alteration in consideration of the changes action of barrier materials of hydraulic field in Near Fields is required. In this research, the system development for evaluating the long-term alteration of hydraulic field in near field was examined. The 'Evidential Support logic' for ensuring the long-term stability of the repository was developed and evaluated. Furthermore, the developed chemical/mechanical alteration action analysis system was verified and improved. The system was coupled for the long-term alteration evaluation analysis. The research results of this year are shown below. 1) A logic tree was constructed for the purpose of supporting the high performance evaluation of reliability of a TRU waste repository. The thesis that the long term safety of the TRU waste repository is preserved was ramified into subsidiary theses until all the final theses were supported by objective evidence. The probability of the subsidiary thesis supporting the upper thesis was established by interviewing specialists. The reliability of the thesis was evaluated by applying present knowledge. Furthermore, the sensitivity of the reliability of the highest thesis to increasing reliability of evidence was investigated. Appropriate targets for experiment and analysis were presented based on the sensitivity of evidence. 2) The object of the hydraulic - chemical analysis was determined from the above-mentioned logic tree. The analysis system was improved to perform the 2D analysis. A user interface was developed to simplify the setting of analysis conditions. The system was demonstrated by comparing the results with the experimental results. Furthermore, the system was applied to the near field problem to fix the condition that the safety of the TRU waste repository is preserved. 3) Both the model of bentonite material and the model of cement material were

  18. Regulating the long-term safety of geological disposal of radioactive waste: practical issues and challenges

    International Nuclear Information System (INIS)

    2008-01-01

    Regulating the long-term safety of geological disposal of radioactive waste is a key part of making progress on the radioactive waste management issue. A survey of member countries has shown that differences exist both in the protection criteria being applied and in the methods for demonstrating compliance, reflecting historical and cultural differences between countries which in turn result in a diversity of decision-making approaches and frameworks. At the same time, however, these differences in criteria are unlikely to result in significant differences in long-term protection, as all the standards being proposed are well below levels at which actual effects of radiological exposure can be observed and a range of complementary requirements is foreseen. In order to enable experts from a wide range of backgrounds to debate the various aspects of these findings, the NEA organised an international workshop in November 2006 in Paris, France. Discussions focused on diversity in regulatory processes; the basis and tools for assuring long-term protection; ethical responsibilities of one generation to later generations and how these can be discharged; and adapting regulatory processes to the long time frames involved in implementing geological disposal. These proceedings include a summary of the viewpoints expressed as well as the 22 papers presented at the workshop. (author)

  19. Eurosafe 2006 radioactive waste management: long term safety requirements and societal expectations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    The EUROSAFE Forum is part of the EUROSAFE approach, which consists of two further elements: the EUROSAFE Tribune and the EUROSAFE web site. The general aim of EUROSAFE is to contribute to fostering the convergence of technical nuclear safety practices in a broad European context. This is done by providing technical safety and research organisations, safety authorities, power utilities, the rest of the industry and non-governmental organisations mainly from the European Union and East-European countries, and international organisations with a platform for the presentation of recent analyses and R and D in the field of nuclear safety, to share experiences, exchange technical and scientific opinions, and conduct debates on key issues in the fields of nuclear safety and radiation protection. The EUROSAFE Forum 2006 focuses on 'Radioactive Waste Management: Long Term Safety Requirements and Societal Expectations' from the point of view of the authorities, TSOs and industry and presents the latest work in nuclear installation safety and research, waste management, radiation safety as well as nuclear material and nuclear facilities security carried out by GRS, IRSN, AVN and their partners in the European Union, Switzerland and Eastern Europe. A high level of nuclear safety is a priority for Europe. The technical safety organisations play an important role in contributing to that objective through appropriate approaches to major safety issues as part of their assessments and research activities. The challenges to nuclear safety are international. Changes in underlying technologies such as instrumentation and control, the impact of electricity market deregulation, demands for improved safety and safety management, the ageing of nuclear facilities, waste management, maintaining and improving scientific and technical knowledge, and the need for greater transparency - these are all issues where the value of an international approach is gaining increasing recognition. This

  20. Eurosafe 2006 radioactive waste management: long term safety requirements and societal expectations

    International Nuclear Information System (INIS)

    2006-01-01

    The EUROSAFE Forum is part of the EUROSAFE approach, which consists of two further elements: the EUROSAFE Tribune and the EUROSAFE web site. The general aim of EUROSAFE is to contribute to fostering the convergence of technical nuclear safety practices in a broad European context. This is done by providing technical safety and research organisations, safety authorities, power utilities, the rest of the industry and non-governmental organisations mainly from the European Union and East-European countries, and international organisations with a platform for the presentation of recent analyses and R and D in the field of nuclear safety, to share experiences, exchange technical and scientific opinions, and conduct debates on key issues in the fields of nuclear safety and radiation protection. The EUROSAFE Forum 2006 focuses on 'Radioactive Waste Management: Long Term Safety Requirements and Societal Expectations' from the point of view of the authorities, TSOs and industry and presents the latest work in nuclear installation safety and research, waste management, radiation safety as well as nuclear material and nuclear facilities security carried out by GRS, IRSN, AVN and their partners in the European Union, Switzerland and Eastern Europe. A high level of nuclear safety is a priority for Europe. The technical safety organisations play an important role in contributing to that objective through appropriate approaches to major safety issues as part of their assessments and research activities. The challenges to nuclear safety are international. Changes in underlying technologies such as instrumentation and control, the impact of electricity market deregulation, demands for improved safety and safety management, the ageing of nuclear facilities, waste management, maintaining and improving scientific and technical knowledge, and the need for greater transparency - these are all issues where the value of an international approach is gaining increasing recognition. This

  1. Eurosafe 2006 radioactive waste management: long term safety requirements and societal expectations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    The EUROSAFE Forum is part of the EUROSAFE approach, which consists of two further elements: the EUROSAFE Tribune and the EUROSAFE web site. The general aim of EUROSAFE is to contribute to fostering the convergence of technical nuclear safety practices in a broad European context. This is done by providing technical safety and research organisations, safety authorities, power utilities, the rest of the industry and non-governmental organisations mainly from the European Union and East-European countries, and international organisations with a platform for the presentation of recent analyses and R and D in the field of nuclear safety, to share experiences, exchange technical and scientific opinions, and conduct debates on key issues in the fields of nuclear safety and radiation protection. The EUROSAFE Forum 2006 focuses on 'Radioactive Waste Management: Long Term Safety Requirements and Societal Expectations' from the point of view of the authorities, TSOs and industry and presents the latest work in nuclear installation safety and research, waste management, radiation safety as well as nuclear material and nuclear facilities security carried out by GRS, IRSN, AVN and their partners in the European Union, Switzerland and Eastern Europe. A high level of nuclear safety is a priority for Europe. The technical safety organisations play an important role in contributing to that objective through appropriate approaches to major safety issues as part of their assessments and research activities. The challenges to nuclear safety are international. Changes in underlying technologies such as instrumentation and control, the impact of electricity market deregulation, demands for improved safety and safety management, the ageing of nuclear facilities, waste management, maintaining and improving scientific and technical knowledge, and the need for greater transparency - these are all issues where the value of an international approach is gaining increasing recognition

  2. Evaluating grasses as a long-term energy resource

    Energy Technology Data Exchange (ETDEWEB)

    Christian, D.G.; Riche, A.B.

    2001-07-01

    The work reported here is part of an ongoing project that aims to evaluate the yields of three perennial rhizomatous grasses and determine their suitability as bio-energy crops. The work began in 1993, and the grasses have been monitored continuously since that time. This report covers the period 1999/2000, and includes: the performance of plots of the energy grasses Miscanthus grass, switchgrass and reed canary grass seven years after they were planted; assessment of the yield of 15 genotypes of Miscanthus planted in 1997; monitoring all the species throughout the growing period for the presence of pests, weeds and diseases; measurement of the amount of nitrate leached from below Miscanthus grass; investigating the occurrence of lodging in switchgrass. (Author)

  3. Project Alternative Systems Study - PASS. Analysis of performance and long-term safety of repository concepts

    International Nuclear Information System (INIS)

    Birgersson, L.; Skagius, K.; Wiborgh, M.; Widen, H.

    1992-09-01

    This study is part of the Project on Alternative Systems Study, PASS, with the overall aim to perform a technical/economical ranking of alternative repository concepts and canisters for the final storage of spent nuclear fuel. The comparison should in the first stage separately assess technology in construction and operation, long-term performance and safety, and costs. Three of the repository concepts are assumed to be located at a depth of approximately 500 m in the host rock, KBS-3, Very Long Holes (VLH) and Medium Long Holes (MLH). In the KBS-3 concept the canisters are deposited in vertical deposition holes in a system of parallel storage tunnels. In the VLH concept larger canisters are deposited in long horizontal tunnels. The MLH concept, is an evolution of the two other concepts, with KBS-3 type canisters deposited in horizontal tunnels. Smaller canisters are to be deposited in deep bore holes at a depth between 2000 to 4000 m in the Very Deep Holes (VDH) concept. In all concepts the canisters will be surrounded by a bentonite buffer. The aim of the present study is to analyze and compare the performance and long-term safety of the repository concepts. Only a qualitative comparison of the concepts is made as no calculations of radionuclide releases or dose to man have been performed. The ranking of the repository concepts was carried out by comparing the VDH, VLH and MLH concept with the KBS-3 concept. The performance and long-term safety of the repositories located at 500 m level will be based on a multiple barrier system and the predictions for the concepts will involve similar uncertainties. (54 refs.)

  4. Significance of actinide chemistry for the long-term safety of waste disposal

    International Nuclear Information System (INIS)

    Kim, Jae Il

    2006-01-01

    A geochemical approach to the long-term safety of waste disposal is discussed in connection with the significance of actinides, which shall deliver the major radioactivity inventory subsequent to the relatively short-term decay of fission products. Every power reactor generates transuranic (TRU) elements: plutonium and minor actinides (Np, Am, Cm), which consist chiefly of long-lived nuclides emitting alpha radiation. The amount of TRU actinides generated in a fuel life period is found to be relatively small (about 1 wt% or less in spent fuel) but their radioactivity persists many hundred thousands years. Geological confinement of waste containing TRU actinides demands, as a result, fundamental knowledge on the geochemical behavior of actinides in the repository environment for a long period of time. Appraisal of the scientific progress in this subject area is the main objective of the present paper. Following the introductory discussion on natural radioactivities, the nuclear fuel cycle is briefly brought up with reference to actinide generation and waste disposal. As the long-term disposal safety concerns inevitably with actinides, the significance of the aquatic actinide chemistry is summarized in two parts: the fundamental properties relevant to their aquatic behavior and the geochemical reactions in nanoscopic scale. The constrained space of writing allows discussion on some examples only, for which topics of the primary concern are selected, e.g. apparent solubility and colloid generation, colloid-facilitated migration, notable speciation of such processes, etc. Discussion is summed up to end with how to make a geochemical approach available for the long-term disposal safety of nuclear waste or for the Performance Assessment (PA) as known generally

  5. Influence of the design temperature on long-term safety of a salt dome repository

    International Nuclear Information System (INIS)

    Buhmann, D.; Brenner, J.; Storck, R.

    1993-03-01

    All studies made so far within the framwork of the mixed concept system analysis proceeded from a design temperature of the mine structure of 200 C. The concept based on a design temperature of 150 C was aimed at studying whether it made sense to maintain lower temperatures, if necessary. Deterministic and probabilistic calculations were made in order to determine the influence of the lower design temperature on long-term safety. The calculations were based on concept A of Joint Borehole and Gallery Storage. Assuming reference values of the input parameters, the deterministic calculations do not produce any radionuclide release from the mine structure. If, however, one assumes a lower rate for rock convergence, radionuclides are released at maximum dose rates of about 3.10 -5 Sv/a. Even a larger volume of limited brine inclusions may lead to radionuclide releases, in that case with dose commitments of the order of magnitude of 1.10 -5 Sv/a. The probabilistic calculations show that a design temperature of 150 C for long-term safety is less favourable than a higher design temperature. The share of simulations in the probabilistic calculations with a radionuclide release, and the expected value of dose commitment, are almost double as high as in the concept based on 200 C design temperature. Thus a higher design temperature is preferable with regard to the long-term safety of a salt repository. The most important parameters concerning dose commitment are the volume of limited brine inclusions, the convergence rate, and the permeability of barriers and backfilling rock. (orig./HP) [de

  6. Long-term reliability evaluation of nuclear containments with tendon force degradation

    International Nuclear Information System (INIS)

    Kim, Sang-Hyo; Choi, Moon-Seock; Joung, Jung-Yeun; Kim, Kun-Soo

    2013-01-01

    Highlights: • A probabilistic model on long-term degradation of tendon force is developed. • By using the model, we performed reliability evaluation of nuclear containment. • The analysis is also performed for the case with the strict maintenance programme. • We showed how to satisfy the target safety in the containments facing life extension. - Abstract: The long-term reliability of nuclear containment is important for operating nuclear power plants. In particular, long-term reliability should be clarified when the service life of nuclear containment is being extended. This study focuses not only on determining the reliability of nuclear containment but also presenting the reliability improvement by strengthening the containment itself or by running a strict maintenance programme. The degradation characteristics of tendon force are estimated from the data recorded during in-service inspection of containments. A reliability analysis is conducted for a limit state of through-wall cracking, which is conservative, but most crucial limit state. The results of this analysis indicate that reliability is the lowest at 3/4 height of the containment wall. Therefore, this location is the most vulnerable for the specific limit state considered in this analysis. Furthermore, changes in structural reliability owing to an increase in the number of inspecting tendons are analysed for verifying the effect of the maintenance program's intensity on expected containment reliability. In the last part of this study, an example of obtaining target reliability of nuclear containment by strengthening its structural resistance is presented. A case study is conducted for exemplifying the effect of strengthening work on containment reliability, especially during extended service life

  7. Criticality evaluation of long term for spent fuel, using Scale

    International Nuclear Information System (INIS)

    Esquivel E, J.; Vargas E, S.; Ramirez S, J. R.

    2013-10-01

    Once carried out the spent fuel discharge, of the reactor core, this continues generating decay heat and diverse fission products, reason why is important to store this fuel inside containers able to dissipate the heat generated by the isotopes decay of the fuel and to maintain the fuels arrangement in subcritical condition. This means that: is necessary to assure the sub-criticality of those fuel assemblies in the time. This work, presents a criticality evaluation of fuel assemblies type PWR in a storage generic container. For this purpose have been used two codes: GeeWiz, to carry out the geometric model of the container with the fuel assemblies, and Keno, with which, the criticality of the full container with fuel is determined until a 10 6 years period. These codes are part of the package Scale. The specifications for each one of the analyzed components are based on a Benchmark document of the Nea/OECD, of where, the results that reports are compared with the obtained results by the realized analysis. (Author)

  8. Safety aspects in the dry storage of spent nuclear fuel in long term operation

    Energy Technology Data Exchange (ETDEWEB)

    Nodarim, Claudir J.; Silva, Viviane B. da; Fontes, Gladson S. [Instituto Militar de Engenharia (IME), Rio de Janeiro, RJ (Brazil); Saldanha, Pedro L.C., E-mail: claudirnodari@gmail.com, E-mail: vivisborges@gmail.com, E-mail: gsfontes@hotmail.com, E-mail: Saldanha@cnen.gov.br [Comissão Nacional de Energia Nuclear (CNEN), Rio de Janeiro, RJ (Brazil)

    2017-07-01

    The purpose of the present paper is to discuss the safety assessment of the Dry Storage Unit (DSU), taking into account the long term operation and the operational experience already evidenced in similar facilities. In this sense, the RIDM (Risk-Informed Decision-Making) concept will be adopted for the regulatory decision-making process. Potential technical issues associated with the aging of materials from the dry storage unit will be considered. The work will be done using the rules and requirements of 10 CFR Part 72 and the U.S. NRC (United States Nuclear Regulatory Commission) regulatory guides. (author)

  9. Geoscientific long-term prognosis. Preliminary safety analysis for the site Gorleben

    International Nuclear Information System (INIS)

    Mrugalla, Sabine

    2011-07-01

    The preliminary safety analysis of the site Gorleben includes the following chapters: (1) Introduction; (2) Aim and content of the geoscientific long-term prognosis for the site Gorleben; (3) Boundary conditions at the site Gorleben: climate; geomorphology; overlying rocks and adjoining rocks; hydrogeology; salt deposit Gorleben. (4) Probable future geological developments at the site Gorleben: supraregional developments with effects on the site Gorleben; glacial period developments; developments of the geomorphology, overlying and adjoining rocks; future developments of the hydrological systems at the site Gorleben; future saliniferous specific developments of the salt deposit Gorleben. (5) Commentary on the unlikely or excludable developments of the site Gorleben.

  10. Technical evaluation on high aging, and performance conditions on long-term conservation program

    International Nuclear Information System (INIS)

    Yamashita, Atsushi

    2001-01-01

    In order to secure safety and safe operation of power plants, in every nuclear power plants, conservation actions based on preventive conservation are performed. They contain operative condition monitoring, patrolling inspection, and periodical tests on important systems and apparatus by operators under plant operation and condition monitoring by maintenance workers, and so on, and when finding out their abnormal conditions, their detailed survey is performed to adopt adequate countermeasures such as recovery, exchange, and so on. And, to equipments for nuclear power generation periodical conditions were obliged by legal examinations and by independent inspections. As a result of these conservation actions, even on a plant elapsed about 30 years since beginning of its operation it was thought that the plant was aged with elapsing time even if not recognizing any indication on its aged deterioration at that time. Therefore, for its concrete countermeasure, by supposing long-term operation of a plant with longer operation history, some technical evaluation on aged phenomena were carried out, to investigate on reflection of the obtained results to present conservation actions. Here were described on efforts on the high aging countermeasures, and performing conditions of long-term conservation in the Tsuruga Unit No. 1 Nuclear Power Station. (G.K.)

  11. GATEWAY Report Brief: SSL Demonstration: Long-Term Evaluation of Indoor Field Performance

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2017-02-28

    Report brief summarizing a GATEWAY program evaluation of the long-term performance characteristics (chromaticity change, maintained illuminance, and operations and maintenance) of LED lighting systems in four field installations previously documented in separate DOE GATEWAY reports.

  12. GATEWAY Demonstrations: Long-Term Evaluation of SSL Field Performance in Select Interior Projects

    Energy Technology Data Exchange (ETDEWEB)

    Davis, Tess E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Davis, Robert G. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Wilkerson, Andrea M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2017-02-28

    The GATEWAY program evaluated the long-term performance characteristics (chromaticity change, maintained illuminance, and operations and maintenance) of LED lighting systems in four field installations previously documented in separate DOE GATEWAY reports.

  13. Long-term evaluation of treatment of chronic, therapeutically refractory tinnitus by neurostimulation

    NARCIS (Netherlands)

    Staal, M. J.; Holm, A. F.; Mooij, J. J. A.; Albers, F. W. J.; Bartels, H.

    2007-01-01

    Objective: Long-term evaluation of treatment of chronic, therapeutically refractory tinnitus by means of chronic electrical stimulation of the vestibulocochlear nerve. Patients: Inclusion criteria were severe, chronic, therapeutically refractory, unilateral tinnitus and severe hearing loss at the

  14. Long-term efficacy and safety of ramosetron in the treatment of diarrhea-predominant irritable bowel syndrome

    Directory of Open Access Journals (Sweden)

    Chiba T

    2013-07-01

    Full Text Available Toshimi Chiba, Kazunari Yamamoto, Shoko Sato, Kazuyuki Suzuki Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Morioka, Iwate, Japan Abstract: Irritable bowel syndrome (IBS is a functional disease with persisting gastrointestinal symptoms that has been classified into four subtypes. Serotonin (5-hydroxytryptamine [5-HT] plays important physiological roles in the contraction and relaxation of smooth muscle. Intraluminal distension of the intestine is known to stimulate the release of endogenous 5-HT from enterochromaffin cells, activating 5-HT3 receptors located on primary afferent neurons and leading to increases in intestinal secretions and peristaltic activity. Ramosetron, a potent and selective 5-HT3-receptor antagonist, has been in development for use in patients suffering from diarrhea-predominant IBS. In a double-blind, placebo-controlled, parallel-group study of 418 patients with diarrhea-predominant IBS-D, once-daily 5 µg and 10 µg doses of ramosetron increased the monthly responder rates of IBS symptoms compared to placebo. In a 12-week randomized controlled trial of 539 patients, a positive response to treatment was reported by 47% of a once-daily 5 µg dose of ramosetron-treated individuals compared to 27% of patients receiving placebo (P<0.001. Furthermore, the responder rate was increased in the oral administration of 5 µg of ramosetron for at least 28 weeks (up to 52 weeks, and long-term efficacy for overall improvement of IBS symptoms was also demonstrated. The rate was further increased subsequently. Adverse events were reported by 7% in ramosetron treatment. No serious adverse events, eg, severe constipation or ischemic colitis, were reported for long-term treatment with ramosetron. In conclusion, further studies to evaluate the long-term efficacy and safety of ramosetron are warranted in the form of randomized controlled trials. Keywords: long-term

  15. Outages 1999 and 2000, investments in safety and long-term operation of NE Krsko

    International Nuclear Information System (INIS)

    Sirola, P.; Krajnc, J.; Androjna, F.

    1999-01-01

    Plant outage is an important part of nuclear power plant operation. During that time the conditions are established for the performance of specific activities, such as refueling, tests, inspections, preventive and corrective maintenance and modifications, that are intended to confirm proper condition and availability of safety and other important components and improve overall plant safety and reliability. It is well know that in Nuclear Power Plant Krsko (Nuklearna elektrarna Krsko NEK) during Outage 2000 new Steam Generators (SGs) will be placed in service, while Outage '99 was used for preparatory works. But the importance of those two outages is even greater, because they are implementing a broad number of improvements and establishing a basis for long-term plant operation. Outage '99 required very detailed planning to assure a good control over the outage activities and operational plant systems necessary for safe shutdown. Numerous activities took place in a relatively narrow space in the Reactor Building. Some of these activities will have a big significance for the future. The article treats the status update and summarizes the specifics and importance of the mentioned activities to long-term plant safe and reliable operation.(author)

  16. Long-Term Safety of Drug-Eluting and Bare-Metal Stents

    DEFF Research Database (Denmark)

    Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

    2015-01-01

    BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

  17. Deep geological repositories. Safe operation and long-term safety in the prism of reversibility

    Energy Technology Data Exchange (ETDEWEB)

    Espivent, Camille; Tichauer, Michael [IRSN, Fontenay-aux-Roses (France)

    2015-07-01

    A deep geological repository is the reference solution enshrined in the French law for the long-term management of high-level radioactive waste. The current project is led by Andra, the French radioactive waste management organization. As a technical support organization, IRSN's mission is, on the basis of the safety case produced by Andra, to assess the safety of such a facility at its various stages of development, that is to say the design, construction, operation and post-closure phases of the facility. Such a facility will have to meet specific requirements, within different time frames as stated above. One of the requirements is ''reversibility'': in fact, French law poses that the geological disposal will have to be ''reversible'' for a certain time, yet not fully defined. Reversibility is nevertheless believed encompassing both the decision making process related to the waste emplacement process during operational phase and the ability to retrieve waste, should such a decision be made. Thus, underground structures have to be designed and operated to allow both waste emplacement and removal. Moreover, future decision making about the disposal process will have to rely on a sound technical basis. This implies a data collection scheme and a monitoring program of the facility to check if the disposal process is bound by limits, controls and conditions compatible with (i) a safe operation of the facility and (ii) the state of the facility that the operator wants to achieve at the time of its closure, so that long-term safety is guaranteed. Therefore, technical criteria and key parameters have to be selected and monitored during construction and operation, that is to say for decades. Then, reversibility have to make room for corrective actions, including the retrieval of waste, if something goes wrong and especially if the facility is not seen as safe anymore, especially in the perspective of long-term safety. To

  18. Deep geological repositories. Safe operation and long-term safety in the prism of reversibility

    International Nuclear Information System (INIS)

    Espivent, Camille; Tichauer, Michael

    2015-01-01

    A deep geological repository is the reference solution enshrined in the French law for the long-term management of high-level radioactive waste. The current project is led by Andra, the French radioactive waste management organization. As a technical support organization, IRSN's mission is, on the basis of the safety case produced by Andra, to assess the safety of such a facility at its various stages of development, that is to say the design, construction, operation and post-closure phases of the facility. Such a facility will have to meet specific requirements, within different time frames as stated above. One of the requirements is ''reversibility'': in fact, French law poses that the geological disposal will have to be ''reversible'' for a certain time, yet not fully defined. Reversibility is nevertheless believed encompassing both the decision making process related to the waste emplacement process during operational phase and the ability to retrieve waste, should such a decision be made. Thus, underground structures have to be designed and operated to allow both waste emplacement and removal. Moreover, future decision making about the disposal process will have to rely on a sound technical basis. This implies a data collection scheme and a monitoring program of the facility to check if the disposal process is bound by limits, controls and conditions compatible with (i) a safe operation of the facility and (ii) the state of the facility that the operator wants to achieve at the time of its closure, so that long-term safety is guaranteed. Therefore, technical criteria and key parameters have to be selected and monitored during construction and operation, that is to say for decades. Then, reversibility have to make room for corrective actions, including the retrieval of waste, if something goes wrong and especially if the facility is not seen as safe anymore, especially in the perspective of long-term safety. To

  19. Project JADE. Long-term function and safety. Comparison of repository systems

    International Nuclear Information System (INIS)

    Birgersson, Lars; Pers, K.; Wiborgh, M.

    2001-12-01

    A comparison of the KBS-3 V(ertical deposition), KBS-3 H(orizontal deposition) and MLH repository systems with regard to the long-term repository performance and the radionuclide migration is presented in the report. Several differences between the repository systems have been identified. The differences are mainly related to the: distance between canister and backfilled tunnels, excavated rock volumes, deposition hole direction. The overall conclusion is that the differences are in general quite small with regard to the repository function and safety. None of the differences are of such importance for the long-term repository performance and radionuclide migration that they discriminate any of the repository systems. The differences between the two KBS-3 systems are small. Based on this study, there is no reason to change from the reference system KBS-3 V to KBS-3 H. MLH has the potential to be a very robust system, especially in a long-term perspective. However, the MLH system will require extensive research, development, and analysis before it will be as confident as the reference repository system, KBS-3 V. Although the MLH and KBS-3 H systems are in some ways favourable compared to the reference system KBS-3 V, the overall conclusion is that the KBS-3 V system is still a very attractive system. A major advantage with KBS-3 V is that it is by far the most investigated and developed system. The JADE-project was initiated in 1996, and the main part of the study was carried out during 1997 and 1998. The JADE study is consequently based on presumptions that were valid a few years ago. Some of these presumptions have been modified since then. The new presumptions are however not judged to change the overall conclusions

  20. Evaluation of long term creep-fatigue life for type 304 stainless steel

    International Nuclear Information System (INIS)

    Kawasaki, Hirotsugu; Ueno, Fumiyoshi; Aoto, Kazumi; Ichimiya, Masakazu; Wada, Yusaku

    1992-01-01

    The long term creep-fatigue life of type 304 stainless steel was evaluated by the creep-fatigue life prediction method based on a linear damage fraction rule. The displacement controlled creep-fatigue tests were carried out, and the time to failure of longer than 10000 hours was obtained. The creep damage of long term creep-fatigue was evaluated by taking into account the stress relaxation behavior with elastic follow-up during the hold period. The relationship between life reduction of creep-fatigue and fracture mode was provided by the creep cavity growth. The results of this study are summarized as follows; (1) The long term creep-fatigue data can be reasonably evaluated by the present method. The predicted lives were within a factor of 3 of the observed ones. (2) The present method provides the capability to predict the long term creep-fatigue life at lower temperatures as well as that at the creep dominant temperature. (3) The value of creep damage for the long term creep-fatigue data increased by elastic follow-up. The creep-fatigue damage diagram intercepted between 0.3 and 1 can represent the observed creep-fatigue damages. (4) The cavity growth depends on the hold time. The fracture of long term creep-fatigue is caused by the intergranular cavity growth. The intergranular fracture of creep-fatigue is initiated by the cavity growth and followed by the microcrack propagation along grain boundaries starting from creep cavities. (author)

  1. Long-Term Safety and Effectiveness of the “OptEase” Vena Cava Filter

    International Nuclear Information System (INIS)

    Kalva, Sanjeeva P.; Marentis, Theodore C.; Yeddula, Kalpana; Somarouthu, Bhanusupriya; Wicky, Stephan; Stecker, Michael S.

    2011-01-01

    Purpose: To assess the long-term safety and effectiveness of the OptEase inferior vena cava (IVC) filter. Materials and Methods: In this Institutional Review Board-approved, retrospective study, we reviewed data of 71 patients who received an OptEase filter at our institution from 2002 to 2007. Thirty-nine (55%) patients had symptoms of venous thromboembolism before filter placement. The indications for filter included contraindication to anticoagulation in 31 (44%) patients, prophylaxis against pulmonary embolism (PE) in 29 (41%) patients, and failure of anticoagulation in 11 (15%) patients. Procedure-related complications, such as symptomatic post-filter PE, deep venous thrombosis (DVT), IVC occlusion, and incidental imaging-evident filter-related complications, were recorded. Safety was assessed by the occurrence of filter-related complications during placement and follow-up. Effectiveness was assessed by the occurrence of post-filter PE. Results: Sixty-five (92%) filters were placed under fluoroscopy, and 6 (8%) were placed using intravascular ultrasound guidance. Seventy (99%) filters were placed successfully. Seven (10%) filters were placed in the suprarenal cava. Retrieval was attempted in 14 (20%) patients, and 12 filters were successfully retrieved. Clinical follow-up was available for 20 ± 21 months. Symptoms of postfilter PE and DVT occurred in 15% (n = 11) and 10% (n = 7) patients, respectively. None of these patients had computed tomography (CT)-proven PE, and only one had ultrasound-proven new DVT. One patient had symptomatic IVC occlusion. Follow-up abdominal CT in 20 patients showed thrombus in the filter in two of them. There were no instances of filter migration, filter tilt, or caval wall penetration. Conclusion: The OptEase filter appears to have an acceptable long-term safety profile. The filter was effective against PE.

  2. Long-term safety of rituximab induced peripheral B-cell depletion in autoimmune neurological diseases.

    Directory of Open Access Journals (Sweden)

    Anza B Memon

    Full Text Available B-cells play a pivotal role in several autoimmune diseases, including patients with immune-mediated neurological disorders (PIMND, such as neuromyelitis optica (NMO, multiple sclerosis (MS, and myasthenia gravis (MG. Targeting B-cells has been an effective approach in ameliorating both central and peripheral autoimmune diseases. However, there is a paucity of literature on the safety of continuous B-cell depletion over a long period of time.The aim of this study was to examine the long-term safety, incidence of infections, and malignancies in subjects receiving continuous therapy with a B-cell depleting agent rituximab over at least 3 years or longer.This was a retrospective study involving PIMND who received continuous cycles of rituximab infusions every 6 to 9 months for up to 7 years. The incidence of infection related adverse events (AE, serious adverse events (SAE, and malignancies were observed.There were a total of 32 AE and 4 SAE with rituximab treatment. The 3 SAE were noted after 9 cycles (48 months and 1 SAE was observed after 11 cycles (60 months of rituximab. There were no cases of Progressive multifocal leukoencephalopathy (PML and malignancies observed throughout the treatment period. Rituximab was well tolerated without any serious infusion reactions. Also, rituximab was found to be beneficial in treating PIMND over a 7-year period.This study demonstrates that long-term depletion of peripheral B-cells appears safe and efficacious in treating PIMND. Longer and larger prospective studies with rituximab are needed to carefully ascertain risks associated with chronic B-cell depletion, including malignancies. Recognizing that this is a small, retrospective study, such data nonetheless complement the growing literature documenting the safety and tolerability of B-cell depleting agents in neurological diseases.

  3. Risk evaluation of cosmic-ray exposure in long-term manned space mission

    International Nuclear Information System (INIS)

    Fujitaka, Kazunobu; Majima, Hideyuki; Ando, Koichi; Yasuda, Hiroshi; Suzuki, Masao

    1999-03-01

    Long-term manned space missions are planned to be implemented within the first two decades of the 21st century. The International Space Station (ISS) will be ready to run, and a plan to visit Mars is also under way. Humans will live in space for long periods of time and we are planning to do experiments in space to examine various aspects of space science. The main risk in long-term manned space missions is large exposure to space radiation. Human safety must be ensured in space where exposure to cosmic rays is almost 1 mSv a day. As such missions will inevitably result in significant exposure for astronauts, there is increasing need to protect them adequately based on both physical and biological knowledge. A good method to evaluate realistic risk associated with space missions will be in urgent demand. At the National Institute of Radiological Sciences (NIRS), Chiba, Japan, a research institutes of the Science Technology Agency of Japan, high energy cosmic radiation can be simulated only with heavy ion irradiation accelerated by the particle accelerator, Heavy Ion Medical Accelerator (HIMAC). Research to evaluate risk of space radiation, including physical measurement techniques, protective effects, biological effects and risk adjustment, aging, neuronal cell damage and cancer risk are undergoing. We organized a workshop of the latest topics and experimental results of physics and biology related to space radiation supported by Japan Science and Technology Corporation (JST). This workshop was held as a satellite meeting associated with the 32nd Committee on Space Research (COSPAR) Scientific Assembly (Nagoya, July 12-19th, 1998). This volume is an extended proceedings of the workshop. The proceedings contain six main subjects covering the latest information on Risk Evaluation of Cosmic-Ray Exposure in Long-Term Manned Space Mission'. 1. Risk Estimation of Heavy Ion Exposure in Space. 2. Low Dose-Rate Effects and Microbeam-Related Heavy Ions. 3. Chromosome and

  4. Efficacy and safety of laxatives for chronic constipation in long-term care settings: A systematic review.

    Science.gov (United States)

    Alsalimy, N; Madi, L; Awaisu, A

    2018-06-09

    Constipation is a common disorder among long-term care (LTC) patients due to several factors. However, there are no systematic reviews investigating the use of laxatives for chronic constipation in LTC settings. This study aims to explore the safety and efficacy of laxatives in LTC patients. A systematic review of randomized controlled trials (RCTs) describing the efficacy and safety of laxatives for chronic constipation in LTC patients was conducted using the following databases and search engines: MEDLINE, Cochrane Database of Systematic Reviews, ScienceDirect, ProQuest and Google Scholar. Two of the investigators independently performed the searches, and the data were extracted using a standardized data abstraction tool. Seven RCTs involving 444 patients were included in the review. These studies included senna (with or without fibre, ie Plantago ovata), lactulose, sodium picosulphate, docusate sodium, docusate calcium, isotonic and hypotonic polyethylene glycol and Chinese herbal medicine. Senna and lactulose were the most studied laxatives in LTC patients, and senna was found to be superior to or as effective as other laxatives. Generally, the frequency and severity of adverse drug reactions (ADRs) were similar between the arms of the studies, and no serious ADRs were reported. Considering the short duration of the trials, the lack of trials including newer laxatives and the low quality of some of the included trials, the long-term efficacy and safety of these laxatives are not conclusive. There is a need to conduct more robust RCTs that include newer agents to evaluate long-term outcomes. © 2018 John Wiley & Sons Ltd.

  5. Evaluation of short- and long-term fission product sources at the Fukushima Daiichi NPP

    International Nuclear Information System (INIS)

    Uchida, Shunsuke; Naitoh, Masanori; Suzuki, Hiroaki; Okada, Hidetoshi; Pellegrini, Marco; Achilli, Andrea; Hanamoto, Yukio; Sasaki, Hiroaki

    2014-01-01

    Research on fission product (FP) behaviors used to be one of the most important subjects in water chemistry but it is not done nowadays as a consequence of the increased integrity of nuclear fuels and the minimization of FP release into the environment. Evaluation of FP release into the environment is still one of the key issues for severe accident analysis, though. Although there have been a long quiet period in nuclear safety research, how to detect initiation of severe accidents, how to prevent them and how to mitigate them are still important subjects for nuclear engineering, and how to control the severe accidents after their occurrence, especially how to control FP release into the environment, has seldom been discussed in the water chemistry group recently. The paper is intended to address the issue of fewer activities for FP studies. FP sources are divided into two categories, short- and long-term FP sources. Short-term FP source can be evaluated based on the measured data obtained from monitoring posts (MPs), which give us clear evidence on the importance of radioactive iodine and cesium releases into the environment. It used to be considered that during primary containment vessel (PCV) venting, release of each element, e.g., iodine and cesium, was determined by the suppression pool scrubbing efficiency and most of the cesium would likely be removed in the pool due to its large scrubbing efficiency. But as a result of analyzing the MP data at early stage of the Fukushima Daiichi nuclear power plant (NPP) accident, it was confirmed that the releases of both elements were in proportion to their inventories in the reactors and their scrubbing efficiencies were almost the same. The scrubbing efficiency which increased with the pool water temperature became almost the same for iodine and cesium around the pool water boiling temperature. As a result of the mass balance analysis for FPs in the contaminated water accumulated in the Fukushima Daiichi plant site, it

  6. Long term safety assessment of geological waste disposal systems: issues on release scenarios

    International Nuclear Information System (INIS)

    Khan, S.A.; Qureshi, A.A.

    1995-01-01

    Geological insolation of high level nuclear waste is an attractive waste disposal concept. However, long term safety demonstration of this concept is a major challenge to the operators, regulators and the scientific community. Identification of the factors responsible for the release of radionuclides from geosphere to biosphere,is first step in this regard. Current understanding of the release scenarios indicates that faulting, ground after percolation, seismicity, volcanism and human intrusion are the dominating release factors for most of the candidate rock formations. The major source of uncertainties is the probability values of various release events due to random nature of catastrophic geological events and past poor historical records of the frequencies of such events. There is consensus among the experts that the waste release via human intrusion is the most unpredictable scenario at present state of the knowledge. (author)

  7. Parametric Analysis of PWR Spent Fuel Depletion Parameters for Long-Term-Disposal Criticality Safety

    International Nuclear Information System (INIS)

    DeHart, M.D.

    1999-01-01

    Utilization of burnup credit in criticality safety analysis for long-term disposal of spent nuclear fuel allows improved design efficiency and reduced cost due to the large mass of fissile material that will be present in the repository. Burnup-credit calculations are based on depletion calculations that provide a conservative estimate of spent fuel contents (in terms of criticality potential), followed by criticality calculations to assess the value of the effective neutron multiplication factor (k(sub)eff) for the a spent fuel cask or a fuel configuration under a variety of probabilistically derived events. In order to ensure that the depletion calculation is conservative, it is necessary to both qualify and quantify assumptions that can be made in depletion models

  8. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab.

    Science.gov (United States)

    Topalian, Suzanne L; Sznol, Mario; McDermott, David F; Kluger, Harriet M; Carvajal, Richard D; Sharfman, William H; Brahmer, Julie R; Lawrence, Donald P; Atkins, Michael B; Powderly, John D; Leming, Philip D; Lipson, Evan J; Puzanov, Igor; Smith, David C; Taube, Janis M; Wigginton, Jon M; Kollia, Georgia D; Gupta, Ashok; Pardoll, Drew M; Sosman, Jeffrey A; Hodi, F Stephen

    2014-04-01

    Programmed cell death 1 (PD-1) is an inhibitory receptor expressed by activated T cells that downmodulates effector functions and limits the generation of immune memory. PD-1 blockade can mediate tumor regression in a substantial proportion of patients with melanoma, but it is not known whether this is associated with extended survival or maintenance of response after treatment is discontinued. Patients with advanced melanoma (N = 107) enrolled between 2008 and 2012 received intravenous nivolumab in an outpatient setting every 2 weeks for up to 96 weeks and were observed for overall survival, long-term safety, and response duration after treatment discontinuation. Median overall survival in nivolumab-treated patients (62% with two to five prior systemic therapies) was 16.8 months, and 1- and 2-year survival rates were 62% and 43%, respectively. Among 33 patients with objective tumor regressions (31%), the Kaplan-Meier estimated median response duration was 2 years. Seventeen patients discontinued therapy for reasons other than disease progression, and 12 (71%) of 17 maintained responses off-therapy for at least 16 weeks (range, 16 to 56+ weeks). Objective response and toxicity rates were similar to those reported previously; in an extended analysis of all 306 patients treated on this trial (including those with other cancer types), exposure-adjusted toxicity rates were not cumulative. Overall survival following nivolumab treatment in patients with advanced treatment-refractory melanoma compares favorably with that in literature studies of similar patient populations. Responses were durable and persisted after drug discontinuation. Long-term safety was acceptable. Ongoing randomized clinical trials will further assess the impact of nivolumab therapy on overall survival in patients with metastatic melanoma.

  9. Long-term Safety of a Geologic Repository: What does the public want to know?

    International Nuclear Information System (INIS)

    Kotra, Janet

    2008-01-01

    Janet Kotra of the U.S. NRC recounted the questions most frequently asked of the Commission's staff, concerning the long-term safety of the planned Yucca Mountain repository. The first question was related to who would decide whether the facility is safe enough. The next question linked to it is if regulatory staff is sufficiently qualified, and if they have access to independent sources of information or depend merely on the information provided by the implementer. The subsequent questions were about what criteria the regulator used and whether they were comprehensive enough. A separate group of questions addressed the safety of the technology, including the geologic features of the site, the engineered structures and the packaging of waste. Issues of documentation, operational control, long-term monitoring, oversight, and enforcement were also raised, along with the transparency of such processes and the accessibility of documents to the public. In addition, several questions were related to the fairness of decision making, public involvement, and the flexibility of the implementation process with regard to future knowledge and RD and D. Ms Kotra propounded that a single question was behind those cited above, namely whether one could rely on the regulator or not. Since it is not realistic to expect an overall consensus on the decision of the regulator agency, the goal should rather be to build confidence in the decision-making process. Key factors of confidence include openness on the part of the regulator and other decision-making institutions, and access to trustworthy representatives of these organisations

  10. Long-term opioid treatment of chronic nonmalignant pain: unproven efficacy and neglected safety?

    Directory of Open Access Journals (Sweden)

    Kissin I

    2013-07-01

    Full Text Available Igor Kissin Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA Background: For the past 30 years, opioids have been used to treat chronic nonmalignant pain. This study tests the following hypotheses: (1 there is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective; and (2 the main problem associated with the safety of such treatment – assessment of the risk of addiction – has been neglected. Methods: Scientometric analysis of the articles representing clinical research in this area was performed to assess (1 the quality of presented evidence (type of study; and (2 the duration of the treatment phase. The sufficiency of representation of addiction was assessed by counting the number of articles that represent (1 editorials; (2 articles in the top specialty journals; and (3 articles with titles clearly indicating that the addiction-related safety is involved (topic-in-title articles. Results: Not a single randomized controlled trial with opioid treatment lasting >3 months was found. All studies with a duration of opioid treatment ≥6 months (n = 16 were conducted without a proper control group. Such studies cannot provide the consistent good-quality evidence necessary for a strong clinical recommendation. There were profound differences in the number of addiction articles related specifically to chronic nonmalignant pain patients and to opioid addiction in general. An inadequate number of chronic pain-related publications were observed with all three types of counted articles: editorials, articles in the top specialty journals, and topic-in-title articles. Conclusion: There is no strong evidence-based foundation for the conclusion that long-term opioid treatment of chronic nonmalignant pain is effective. The above identified signs indicating neglect of addiction associated with the

  11. Workplace Violence and Safety Issues in Long-Term Medical Care Facilities: Nurses' Perspectives.

    Science.gov (United States)

    Fasanya, Bankole K; Dada, Emmanuel A

    2016-06-01

    Workplace violence (WPV) is becoming an issue that needs immediate attention in the United States, especially during this period as more states are adopting the "stand your ground laws to promote worker protection." This study was conducted to investigate how WPV has contributed to an unsafe environment for nurses and nursing assistants who work in long-term medical care facilities. A structure questionnaire was used to collect data for the study. Three facilities were sampled and 80 nurses and certified nursing assistants participated in the study. Ninety-two percent (n = 74) were female and 8% (n = 6) were male. Approximately 62% were black or African American, approximately 33% were Caucasians, and only 2% were from other ethnicities. We found that 65% of the participants had experienced WPV while 41% believed that management shows little or no concern for their safety. Approximately 23% of respondents believed that reporting supervisor's WPV act is an unsafe action. In addition, 22% of those who reported that they have experienced WPV believed that the work environment is not safe to perform their duties. This significant difference in perception of workplace safety between those who had experienced WPV and those who had not was significant (t = 3.95, df = 158, p < 0.0001). WPV is an epidemic problem that affects all health-care professionals. The findings of this study could help long-term medical care facilities' management identify the areas to focus on mitigating, controlling, and/or eliminating incidents of WPV.

  12. Rodent model for assessing the long term safety and performance of peripheral nerve recording electrodes

    Science.gov (United States)

    Vasudevan, Srikanth; Patel, Kunal; Welle, Cristin

    2017-02-01

    Objective. In the US alone, there are approximately 185 000 cases of limb amputation annually, which can reduce the quality of life for those individuals. Current prosthesis technology could be improved by access to signals from the nervous system for intuitive prosthesis control. After amputation, residual peripheral nerves continue to convey motor signals and electrical stimulation of these nerves can elicit sensory percepts. However, current technology for extracting information directly from peripheral nerves has limited chronic reliability, and novel approaches must be vetted to ensure safe long-term use. The present study aims to optimize methods to establish a test platform using rodent model to assess the long term safety and performance of electrode interfaces implanted in the peripheral nerves. Approach. Floating Microelectrode Arrays (FMA, Microprobes for Life Sciences) were implanted into the rodent sciatic nerve. Weekly in vivo recordings and impedance measurements were performed in animals to assess performance and physical integrity of electrodes. Motor (walking track analysis) and sensory (Von Frey) function tests were used to assess change in nerve function due to the implant. Following the terminal recording session, the nerve was explanted and the health of axons, myelin and surrounding tissues were assessed using immunohistochemistry (IHC). The explanted electrodes were visualized under high magnification using scanning electrode microscopy (SEM) to observe any physical damage. Main results. Recordings of axonal action potentials demonstrated notable session-to-session variability. Impedance of the electrodes increased upon implantation and displayed relative stability until electrode failure. Initial deficits in motor function recovered by 2 weeks, while sensory deficits persisted through 6 weeks of assessment. The primary cause of failure was identified as lead wire breakage in all of animals. IHC indicated myelinated and unmyelinated axons

  13. Methodology of fuel cycles long-term safety assessment of SNF/HLW geological disposal

    International Nuclear Information System (INIS)

    Pritrsky, J.

    2008-02-01

    Methodology for the long-term safety assessment of nuclear fuel cycles is given in the presented doctoral thesis. The aim of work was to develop a geological repository model for disposal of spent nuclear fuel (SNF) and high level waste (HLW) using an appropriate software code able to calculate the influence of partitioning and transmutation in advanced fuel cycles. The first step in this process was specifying of indicators which can be used to quantify the radiological impact of each fuel cycle. Indicators such as annual effective dose and radiotoxicity of inventory have been quantitatively analysed to determine the potential risk and radiological consequences associated with production of SNF/HLW. Advanced fuel types bring a number of advantages in comparison to uranium oxide fuel UO 2 used worldwide nowadays in terms of safety improvement due to minor actinides transmutation and non-proliferation aspects as well. Within the scope of work, three different fuel cycles are compared from the point of view of long-term safety of deep geological repository. The first considered fuel cycle is the currently used open fuel cycle (UOX) which uses only U-FA (Uranium Fuel Assembly). The second assessed cycle is a closed fuel cycle (MOX) with MOX-FA (Mixed OXides Fuel Assembly) and the third considered one is a partially closed fuel cycle (IMF) with IMC-FA (Inert Matrix Combined Fuel Assembly). Description and input data of advanced fuel cycles have been gained by participation in the EC project RED-IMPACT. Results were calculated using code AMBER, which is a flexible software tool that allows building dynamic compartmental models to represent the migration and fate of contaminants in a system, for example in the surface and sub-surface environment. Contaminants in solid, liquid and gaseous phases can be considered. AMBER gives the user the flexibility to define any number of compartments; any number of contaminants and associated decays; deterministic, probabilistic and

  14. Methodology of fuel cycles long-term safety assessment of SNF/HLW geological disposal

    International Nuclear Information System (INIS)

    Pritrsky, J.

    2008-01-01

    Methodology for the long-term safety assessment of nuclear fuel cycles is given in the presented doctoral thesis. The aim of work was to develop a geological repository model for disposal of spent nuclear fuel (SNF) and high level waste (HLW) using an appropriate software code able to calculate the influence of partitioning and transmutation in advanced fuel cycles. The first step in this process was specifying of indicators which can be used to quantify the radiological impact of each fuel cycle. Indicators such as annual effective dose and radiotoxicity of inventory have been quantitatively analysed to determine the potential risk and radiological consequences associated with production of SNF/HLW. Advanced fuel types bring a number of advantages in comparison to uranium oxide fuel UO 2 used worldwide nowadays in terms of safety improvement due to minor actinides transmutation and non-proliferation aspects as well. Within the scope of work, three different fuel cycles are compared from the point of view of long-term safety of deep geological repository. The first considered fuel cycle is the currently used open fuel cycle (UOX) which uses only U-FA (Uranium Fuel Assembly). The second assessed cycle is a closed fuel cycle (MOX) with MOX-FA (Mixed OXides Fuel Assembly) and the third considered one is a partially closed fuel cycle (IMF) with IMC-FA (Inert Matrix Combined Fuel Assembly). Description and input data of advanced fuel cycles have been gained by participation in the EC project RED-IMPACT. Results were calculated using code AMBER, which is a flexible software tool that allows building dynamic compartmental models to represent the migration and fate of contaminants in a system, for example in the surface and sub-surface environment. Contaminants in solid, liquid and gaseous phases can be considered. AMBER gives the user the flexibility to define any number of compartments; any number of contaminants and associated decays; deterministic, probabilistic and

  15. The Long-Term Safety of S-Flurbiprofen Plaster for Osteoarthritis Patients: An Open-Label, 52-Week Study.

    Science.gov (United States)

    Yataba, Ikuko; Otsuka, Noboru; Matsushita, Isao; Matsumoto, Hideo; Hoshino, Yuichi

    2016-08-01

    The newly developed S-flurbiprofen plaster (SFPP) is a tape-type patch that shows innovative percutaneous absorption. This study was designed to evaluate the safety of a long-term 52-week SFPP application to osteoarthritis (OA) patients. This was a multi-center, open-label, uncontrolled prospective study that included 201 OA patients. SFPP at 40 mg/day was applied to the site of pain in 101 patients and at 80 mg/day (2 patches) in 100 patients at a total of 301 sites for 52 weeks. The affected sites assessed included the knee (192), lumbar spine (66), cervical spine (26), and others (17). Drug safety was evaluated by medical examination, laboratory tests, and examination of vital signs. Efficacy was evaluated by the patient's and clinician's global assessments and clinical symptoms. Most patients (80.1 %) completed the 52-week SFPP application. The majority of drug-related adverse events (AEs) included mild dermatitis at the application sites and occurred in 46.8 % of the sites. No photosensitive dermatitis was observed. Systemic AEs occurred in 9.0 % of the patients; a serious AE (gastric ulcer hemorrhage) occurred in one patient. No clinically significant changes in the laboratory tests and vital signs were observed. The efficacy evaluation showed an improvement from 2 weeks after the SFPP application, which continued during the 52 weeks' treatment. No apparent safety concerns were observed, even during the long-term SFPP application. Therefore, SFPP could be an additional pharmacotherapy in OA treatment.

  16. Realistic integration of sorption processes in transport codes for long-term safety assessments

    Energy Technology Data Exchange (ETDEWEB)

    Noseck, Ulrich; Fluegge, Judith; Britz, Susan; Schneider, Anke [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Brendler, Vinzenz; Stockmann, Madlen; Schikora, Johannes [Helmholtz-Zentrum Dresden-Rossendorf e.V., Dresden (Germany); Lampe, Michael [Frankfurt Univ. (Germany). Goethe Center for Scientific Computing

    2012-09-15

    One important aspect in long-term safety assessment is related to radionuclide transport in geologic formations. In order to assess its consequences over assessment periods of one million years numerical models describing flow and transport are applied. Sorption on mineral surfaces is the most relevant process retarding radionuclide transport. On the one hand an increased transport time might cause a decrease in radionuclide concentration by radioactive decay. On the other hand it might increase concentrations of dose-relevant daughter nuclides in decay chains. In order to treat the radionuclide sorption processes in natural systems close to reality the so-called smart K{sub d}-concept is implemented into the transport program r{sup 3}t, which is applied to large model areas and very long time scales in long-term safety assessment. In the first stage this approach is developed for a typical sedimentary system covering rock salt and clay formations in Northern Germany. The smart K{sub d}-values are based on mechanistic surface complexation models (SCM), varying in time and space and de-pending on the actual geochemical conditions, which might change in the future e. g. due to the impact of climate changes. The concept developed and introduced here is based on a feasible treatment of the most relevant geochemical parameters in the transport code as well as on a matrix of smart K{sub d}-values calculated in dependence on these parameters. The implementation of the concept comprises the selection of relevant elements and minerals to be considered, an experimental program to fill data gaps of the thermody-namic sorption database, an uncertainty and sensitivity analysis to identify the most important environmental parameters influencing sorption of long-term relevant radionu-clides, the creation of a matrix with K{sub d}-values dependent on the selected environmental parameters, and the development and realisation of the conceptual model for treatment of temporal and

  17. Deferasirox: appraisal of safety and efficacy in long-term therapy

    Directory of Open Access Journals (Sweden)

    Chaudhary P

    2013-08-01

    Full Text Available Preeti Chaudhary, Vinod PullarkatJane Ann Nohl Division of Hematology, University of Southern California Keck School of Medicine, Los Angeles, CA, USAAbstract: Deferasirox is a once-daily, oral iron chelator that is widely used in the management of patients with transfusional hemosiderosis. Several Phase II trials along with their respective extension studies as well as a Phase III trial have established the efficacy and safety of this novel agent in transfusion-dependent patients with β-thalassemia, sickle-cell disease and bone marrow-failure syndromes, including myelodysplastic syndrome and aplastic anemia. Data from various clinical trials show that a deferasirox dose of 20 mg/kg/day stabilizes serum ferritin levels and liver iron concentration, while a dose of 30–40 mg/kg/day reduces these parameters and achieves negative iron balance in red cell transfusion-dependent patients with iron overload. Across various pivotal clinical trials, deferasirox was well tolerated, with the most common adverse events being gastrointestinal disturbances, skin rash, nonprogressive increases in serum creatinine, and elevations in liver enzyme levels. Longer-term extension studies have also confirmed the efficacy and safety of deferasirox. However, it is essential that patients on deferasirox therapy are monitored regularly to ensure timely management for any adverse events that may occur with long-term therapy.Keywords: deferasirox, iron overload, thalassemia, sickle-cell disease, myelodysplastic syndrome

  18. Reference biospheres for the long term safety assessment of radioactive waste disposal facilities

    International Nuclear Information System (INIS)

    Crossland, I.G.; Torres, C.

    2002-01-01

    Regulatory guidance on the safety assessment of radioactive waste disposals usually requires the consequences of any radionuclide releases to be considered in terms of their potential impact on human health. This requires consideration of the prevailing biosphere and the habits of the potentially exposed humans within it. However, it could take many thousands of years for migrating radionuclides to reach the surface environment. In these circumstances, an assessment model that was based on the present-day biosphere could be inappropriate while future biospheres would be unpredictable. These and other considerations suggest that a standardised, or reference biosphere, approach may be useful. Theme 1 of the IAEA BIOMASS project was established to develop the concept of reference biospheres into a practical system that can be applied to the assessment of the long term safety of geological disposal facilities for radioactive waste. The technical phase of the project lasted for four years until November 2000 and brought together disparate interests from many countries including waste disposal agencies, regulators and technical experts. Building on the experience from earlier BIOMOVS projects, a methodology was constructed for the logical and defensible construction of mathematical biosphere models that can be used in the total system performance assessment of radioactive waste disposal. The methodology was then further developed through the creation of a series of BIOMASS Example Reference Biospheres ('Examples'). These are stylised biosphere models that, in addition to illustrating the methodology, are intended to be useful assessment tools in their own right. (author)

  19. Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine.

    Directory of Open Access Journals (Sweden)

    Gaston De Serres

    Full Text Available This study assessed the short and the long term safety of the 2009 AS03 adjuvanted monovalent pandemic vaccine through an active web-based electronic surveillance. We compared its safety profile to that of the seasonal trivalent inactivated influenza vaccine (TIV for 2010-2011.Health care workers (HCW vaccinated in 2009 with the pandemic vaccine (Arepanrix ® from GSK or HCW vaccinated in 2010 with the 2010-2011 TIV were invited to participate in a web-based active surveillance of vaccine safety. They completed two surveys the day-8 survey covered the first 7 days post-vaccination and the day-29 survey covered events occurring 8 to 28 days after vaccination. Those who reported a problem were called by a nurse to obtain details. The main outcome was the occurrence of a new health problem or the worsening of an existing health condition that resulted in a medical consultation or work absenteeism. For the pandemic vaccine, a six-month follow-up for the occurrence of serious adverse events (SAE was conducted. Among the 6242 HCW who received the pandemic vaccine, 440 (7% reported 468 events compared to 328 of the 7645 HCW (4.3% who reported 339 events after the seasonal vaccine. The 2009 pandemic vaccine was associated with significantly more local reactions than the 2010-2011 seasonal vaccine (1% vs. 0.03%, p<0.001. Paresthesia was reported by 7 HCW (0.1% after the pandemic vaccine but by none after the seasonal vaccine. For the pandemic vaccine, no clustering of SAE was found in the 6 month follow-up.The 2009 pandemic vaccine seems to have a good safety profile, similar to the 2010-2011 TIV, with the exception of local reactions. This surveillance was adequately powered to identify AE associated with an excess risk ≥1 per 1000 vaccinations but is insufficient to detect rare AE.ClinicalTrials.gov NCT01289418, NCT01318876.

  20. Evaluation of the Long-Term Stability and Temperature Coefficient of Dew-Point Hygrometers

    Science.gov (United States)

    Benyon, R.; Vicente, T.; Hernández, P.; De Rivas, L.; Conde, F.

    2012-09-01

    The continuous quest for improved specifications of optical dew-point hygrometers has raised customer expectations on the performance of these devices. In the absence of a long calibration history, users with a limited prior experience in the measurement of humidity, place reliance on manufacturer specifications to estimate long-term stability. While this might be reasonable in the case of measurement of electrical quantities, in humidity it can lead to optimistic estimations of uncertainty. This article reports a study of the long-term stability of some hygrometers and the analysis of their performance as monitored through regular calibration. The results of the investigations provide some typical, realistic uncertainties associated with the long-term stability of instruments used in calibration and testing laboratories. Together, these uncertainties can help in establishing initial contributions in uncertainty budgets, as well as in setting the minimum calibration requirements, based on the evaluation of dominant influence quantities.

  1. Long-term BPA infusions. Evaluation in the rat brain tumor and rat spinal cord models

    International Nuclear Information System (INIS)

    Coderre, J.A.; Micca, P.L.; Nawrocky, M.M.; Joel, D.D.; Morris, G.M.

    2000-01-01

    In the BPA-based dose escalation clinical trial, the observations of tumor recurrence in areas of extremely high calculated tumor doses suggest that the BPA distribution is non-uniform. Longer (6-hour) i.v. infusions of BPA are evaluated in the rat brain tumor and spinal cord models to address the questions of whether long-term infusions are more effective against the tumor and whether long-term infusions are detrimental in the central nervous system. In the rat spinal cord, the 50% effective doses (ED 50 ) for myeloparesis were not significantly different after a single i.p. injection of BPA-fructose or a 6 hour i.v. infusion. In the rat 9L gliosarcoma brain tumor model, BNCT following 2-hr or 6-hr infusions of BPA-F produced similar levels of long term survival. (author)

  2. Long-term strategic asset allocation: An out-of-sample evaluation

    NARCIS (Netherlands)

    Diris, B.F.; Palm, F.C.; Schotman, P.C.

    We evaluate the out-of-sample performance of a long-term investor who follows an optimized dynamic trading strategy. Although the dynamic strategy is able to benefit from predictability out-of-sample, a short-term investor using a single-period market timing strategy would have realized an almost

  3. EVALUATION OF LATE ADVERSE EVENTS IN LONG-TERM WILMS' TUMOR SURVIVORS

    NARCIS (Netherlands)

    van Dijk, Irma W. E. M.; Oldenburger, Foppe; Cardous-Ubbink, Mathilde C.; Geenen, Maud M.; Heinen, Richard C.; de Kraker, Jan; van Leeuwen, Flora E.; van der Pal, Helena J. H.; Caron, Huib N.; Koning, Caro C. E.; Kremer, Leontien C. M.

    2010-01-01

    Purpose: To evaluate the prevalence and severity of adverse events (AEs) and treatment-related risk factors in long-term Wilms' tumor (WT) survivors, with special attention to radiotherapy. Methods and Materials: The single-center study cohort consisted of 185 WT survivors treated between 1966 and

  4. Long-term evaluation of Class II subdivision treatment with unilateral maxillary first molar extraction

    NARCIS (Netherlands)

    Livas, Christos; Pandis, Nikolaos; Booij, Johan Willem; Katsaros, Christos; Ren, Yijin

    Objective: To evaluate the long-term effects of asymmetrical maxillary first molar (M1) extraction in Class II subdivision treatment. Materials and Methods: Records of 20 Class II subdivision whites (7 boys, 13 girls; mean age, 13.0 years; SD, 1.7 years) consecutively treated with the Begg technique

  5. Tapering off benzodiazepines in long-term users : an economic evaluation

    NARCIS (Netherlands)

    Oude Voshaar, Richard C; Krabbe, Paul F M; Gorgels, Wim J M J; Adang, Eddy M M; van Balkom, Anton J L M; van de Lisdonk, Eloy H; Zitman, Frans G

    2006-01-01

    BACKGROUND: Discontinuation of benzodiazepine usage has never been evaluated in economic terms. This study aimed to compare the relative costs and outcomes of tapering off long-term benzodiazepine use combined with group cognitive behavioural therapy (TO+CBT), tapering off alone (TOA) and usual

  6. Confidence in the long-term safety of deep geological repositories. Its development and communication

    International Nuclear Information System (INIS)

    1999-01-01

    The technical aspects of confidence have been the subject of considerable debate, especially the concept of model validation. The safety case that is provided at a particular stage in the planning, construction, operation or closure of a deep geological repository is a part of a broader decision basis that guides the repository-development process. The basic steps for deriving the safety case at various stages of repository development involve: a safety assessment; and the documentation of the safety assessment, a statement of confidence in the safety indicated by the assessment, and the confirmation of the appropriateness of the safety strategy. The approaches to establish confidence in the evaluation of safety should aim to ensure that the decisions taken within the incremental process of repository development are well-founded. Various aspects of confidence in the evaluation of safety, and their integration within a safety case, are presented in detail in the present report. When communicating confidence in the findings of a safety assessment, clarity in the communication of concepts is always required. Consistent with this requirement, key concepts are specifically defined in the main text of the report. (R.P.)

  7. Evaluation of long-term geological and climatic changes in the Spanish programme

    International Nuclear Information System (INIS)

    Torres, T.; Ortiz, J.E.; Cortes, A.; Delgado, A.

    2004-01-01

    The Bio-molecular Stratigraphy Laboratory of the Madrid School of Mines has been largely involved in the analysis of long-term paleo-environmental changes in the Iberian Peninsula during the Quaternary. Some of the research projects were UE funded: Paleo-climatological Revision of Climate Evolution in Western Mediterranean Region. Evaluation of Altered Scenarios, Evidence from Quaternary Infill Paleo-hydrogeology, Sequential Biosphere modelling function of Climate evolution models; Paleo-hydrogeological Data Analysis and Model Testing. Other projects were funded by the National Company for Radioactive Waste Management (ENRESA) and the Spanish Nuclear Safety Council (CSN): 'Paleo-climate reconstruction from Middle Pleistocene times through dating and isotopic analysis of tufa deposits'; 'Paleo-environmental evolution of the southern part of the Iberian Peninsula'; 'Paleo-climate'. On a minor scale the laboratory was also involved in the study of some argillaceous media: 'Organic Geochemistry of some deep Spanish argillaceous formations' and 'Effects of climatic change on the argillaceous series of the Duero and Ebro basins'. Here we will present some of the results obtained from tufa deposits analysis and paleo-environmental information from the Guadix-Baza Basin composite-stratigraphical-type-section study. (authors)

  8. Evaluation of nuclear power development scenarios in romania envisaging the long-term national energy sustainability

    International Nuclear Information System (INIS)

    Margeanu, C.; Apostol, M.; Visan, I.; Prodea, I.

    2015-01-01

    The paper summarizes the results of RATEN ICN Pitesti experts' activities in the IAEA's Collaborative Project INPRO-SYNERGIES. Romanian study proposes to evaluate and analyze development of the nuclear capacity and increasing of its share in national energy sector, envisaging the long term national and regional energy sustainability by keeping options open for the future while bringing solutions to short/medium-term challenges. The study focused on the modelling of national NES (Nuclear Energy System) development on short and medium-term (time horizon 2050), considering the existing NFC (Nuclear Fuel Cycle) infrastructure and legislation, provisions of strategic documents in force and including also the possibility of regional collaboration regarding U/fresh fuel supply and SF (Spent Fuel) storage, as services provided at international market prices. The energy system modelling was realized by using the IAEA's MESSAGE program. The study results offer a clear image and also the possible answer to several key questions regarding: potential of nuclear energy to participate with an important share in national energy mix, in conditions of cost competitiveness, safety and security of supply; impact on national energy mix portfolio of capacities and electricity production; impact on Uranium domestic resources; economic projection/investments needed for new nuclear capacities addition; fresh fuel requirements for nuclear capacities; SF annually discharged and transferred to interim wet storage for cooling; SF volume in interim dry storage, etc. (authors)

  9. Evaluation of post-LOCA long term cooling performance in Korean standard nuclear power plants

    International Nuclear Information System (INIS)

    Bang, Young Seok; Jung, Jae Won; Seul, Kwang Won; Kim, Hho Jung

    2001-01-01

    The post-LOCA long term cooling (LTC) performance of the Korean Standard Nuclear Power Plant (KSNPP) is analyzed for both small break loss-of-coolant accidents (LOCA) and large break LOCA at cold leg. The RELAP5/MOD3.2.2 beta code is used to calculate the LTC sequences based on the LTC plan of the Korean Standard Nuclear Power Plants (KSNPP). A standard input model is developed such that LOCA and the followed LTC sequence can be calculated in a single run for both small break LOCA and large break LOCA. A spectrum of small break LOCA ranging from 0.02 to 0.5 ft 2 of break area and a double-ended guillotine break are analyzed. Through the code calculations, the thermal-hydraulic behavior and the boron behavior are evaluated and the effect of the important action including the safety injection tank (SIT) isolation and the simultaneous injection in LTC procedure is investigated. As a result, it is found that the sufficient margin is available in avoiding the boron precipitation in the core. It is also found that a further specific condition for the SIT isolation action need to be setup and it is recommended that the early initiation of the simultaneous injection be taken for larger break LTC sequences. (author)

  10. Long-term safety and efficacy of autologous platelet lysate drops for treatment of ocular GvHD.

    Science.gov (United States)

    Pezzotta, S; Del Fante, C; Scudeller, L; Rossi, G C; Perotti, C; Bianchi, P E; Antoniazzi, E

    2017-01-01

    Current ocular GvHD (oGvHD) treatments are suboptimal. We investigated the safety and efficacy of long-term continuous treatment with autologous platelet lysate (PL) drops in patients with oGvHD Dry Eye Syndrome (DES) score 2-3 refractory to topical conventional therapy. Ophthalmic evaluation was performed at 6 month intervals. Symptoms were assessed using the Glaucoma Symptom Scale (GSS). Patients were defined 'responders' when showing a reduction at least one grade on National Institutes of Health Eye Score from baseline at the 6 month visit. Thirty-one patients were included, and 16 (51%) completed 36 months of follow-up (range 6.5-72.7). At 6 months all patients were classified as responders: median GSS symptom score decreased from 70 to 41 (33 at 36 months), median GSS function score reduced from 68 to 46 (33 at 36 months) (all P<0.001). Median Tear Break Up Time improved from 3 to 6 s after 6 months and was maintained over time. All signs improved at 6 and 36 months (clinical and statistical significance). No severe adverse events occurred. Long-term treatment with PL drops is secure and effective for oGvHD and can be an efficient therapy option from initial stages of oGvHD to prevent permanent ocular impairment and improving quality of life.

  11. Application of geostatistical methods to long-term safety analyses for radioactive waste repositories

    International Nuclear Information System (INIS)

    Roehlig, K.J.

    2001-01-01

    Long-term safety analyses are an important part of the design and optimisation process as well as of the licensing procedure for final repositories for radioactive waste in deep geological formations. For selected scenarios describing possible evolutions of the repository system in the post-closure phase, quantitative consequence analyses are performed. Due to the complexity of the phenomena of concern and the large timeframes under consideration, several types of uncertainties have to be taken into account. The modelling work for the far-field (geosphere) surrounding or overlaying the repository is based on model calculations concerning the groundwater movement and the resulting migration of radionuclides which possibly will be released from the repository. In contrast to engineered systems, the geosphere shows a strong spatial variability of facies, materials and material properties. The paper presented here describes the first steps towards a quantitative approach for an uncertainty assessment taking into account this variability. Due to the availability of a large amount of data and information of several types, the Gorleben site (Germany) has been used for a case study in order to demonstrate the method. (orig.)

  12. Neuromyelitis optica spectrum disorders: long-term safety and efficacy of rituximab in Caucasian patients.

    Science.gov (United States)

    Radaelli, M; Moiola, L; Sangalli, F; Esposito, F; Barcella, V; Ferrè, L; Rodegher, M; Colombo, B; Fazio, R; Martinelli, V; Comi, G

    2016-04-01

    To assess the long-term benefit-risk profile of repeated courses of rituximab in Caucasian patients affected by neuromyelitis optica (NMO) and related disorders, in everyday clinical practice. This is a prospective observational study performed at San Raffaele Hospital, Milan, Italy. From February 2006, we recruited 21 patients affected by NMO and NMO spectrum of disorders (NMOSD) whom underwent at least one cycle of intravenous (i.v.) rituximab and then were followed for at least 2 years. At a mean follow-up time of 48 months, we observed a significant reduction of the annualized relapse rate (ARR), from 2.0 to 0.16 (p < 0.01); and of the median Expanded Disability Status Scale (EDSS), from 5.5 to 4.0 (p < 0.013). There were 12 patients (57%) who remained disease free during the follow-up period. Five patients (24%) reported mild hematological adverse events. Serious infectious adverse events were reported by another four patients: These were all wheelchair bound at the beginning of their rituximab treatment. A fixed treatment scheme of rituximab, with re-treatment every 6 months, was efficacious for NMO and NMOSD, with a good safety profile; however, to obtain an even better benefit-risk ratio, close monitoring of CD19(+) B cells should be performed before the re-treatment of patients with high-level disability, concomitant leukopenia and hypogammaglobulinemia. © The Author(s), 2015.

  13. Long-Term Marine Traffic Monitoring for Environmental Safety in the Aegean Sea

    Science.gov (United States)

    Giannakopoulos, T.; Gyftakis, S.; Charou, E.; Perantonis, S.; Nivolianitou, Z.; Koromila, I.; Makrygiorgos, A.

    2015-04-01

    The Aegean Sea is characterized by an extremely high marine safety risk, mainly due to the significant increase of the traffic of tankers from and to the Black Sea that pass through narrow straits formed by the 1600 Greek islands. Reducing the risk of a ship accident is therefore vital to all socio-economic and environmental sectors. This paper presents an online long-term marine traffic monitoring work-flow that focuses on extracting aggregated vessel risks using spatiotemporal analysis of multilayer information: vessel trajectories, vessel data, meteorological data, bathymetric / hydrographic data as well as information regarding environmentally important areas (e.g. protected high-risk areas, etc.). A web interface that enables user-friendly spatiotemporal queries is implemented at the frontend, while a series of data mining functionalities extracts aggregated statistics regarding: (a) marine risks and accident probabilities for particular areas (b) trajectories clustering information (c) general marine statistics (cargo types, etc.) and (d) correlation between spatial environmental importance and marine traffic risk. Towards this end, a set of data clustering and probabilistic graphical modelling techniques has been adopted.

  14. Computerised clinical decision support systems to improve medication safety in long-term care homes: a systematic review.

    Science.gov (United States)

    Marasinghe, Keshini Madara

    2015-05-12

    Computerised clinical decision support systems (CCDSS) are used to improve the quality of care in various healthcare settings. This systematic review evaluated the impact of CCDSS on improving medication safety in long-term care homes (LTC). Medication safety in older populations is an important health concern as inappropriate medication use can elevate the risk of potentially severe outcomes (ie, adverse drug reactions, ADR). With an increasing ageing population, greater use of LTC by the growing ageing population and increasing number of medication-related health issues in LTC, strategies to improve medication safety are essential. Databases searched included MEDLINE, EMBASE, Scopus and Cochrane Library. Three groups of keywords were combined: those relating to LTC, medication safety and CCDSS. One reviewer undertook screening and quality assessment. Overall findings suggest that CCDSS in LTC improved the quality of prescribing decisions (ie, appropriate medication orders), detected ADR, triggered warning messages (ie, related to central nervous system side effects, drug-associated constipation, renal insufficiency) and reduced injury risk among older adults. CCDSS have received little attention in LTC, as attested by the limited published literature. With an increasing ageing population, greater use of LTC by the ageing population and increased workload for health professionals, merely relying on physicians' judgement on medication safety would not be sufficient. CCDSS to improve medication safety and enhance the quality of prescribing decisions are essential. Analysis of review findings indicates that CCDSS are beneficial, effective and have potential to improve medication safety in LTC; however, the use of CCDSS in LTC is scarce. Careful assessment on the impact of CCDSS on medication safety and further modifications to existing CCDSS are recommended for wider acceptance. Due to scant evidence in the current literature, further research on implementation and

  15. Safety indicators adopted in the Finnish regulations for long-term safety of spent fuel disposal

    International Nuclear Information System (INIS)

    Ruokola, E.

    2002-01-01

    A regulatory guide for the safety of spent fuel disposal has recently been issued to guide the implementer's programme in the preconstruction phase. The guide is based on dose criteria in the time frame, which is reasonably predictable with respect to assessment of human exposure. For the time frame that involves major climate changes such as permafrost and glaciation, the guide defines constraints for the activity releases to the environment. This paper discusses the rationale for the selected approach and the derivation of the activity release constraints. (author)

  16. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  17. Evaluation of long term radiological impact on population close to remediated uranium mill tailings storages

    International Nuclear Information System (INIS)

    Kerouanton, David; Delgove, Laure

    2008-01-01

    A methodology is elaborated in order to evaluate the long term radiological impact of remediated uranium mill tailings storage. Different scenarios are chosen and modelled to cover future evolution of the tailings storages. Radiological impact is evaluated for different population such as adults and children living in the immediate vicinity or directly on the storage, road workers or walkers on the storage. Equation and methods are detailed. (author)

  18. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology.

    Science.gov (United States)

    Manzoli, Lamberto; La Vecchia, Carlo; Flacco, Maria Elena; Capasso, Lorenzo; Simonetti, Valentina; Boccia, Stefania; Di Baldassarre, Angela; Villari, Paolo; Mezzetti, Andrea; Cicolini, Giancarlo

    2013-09-24

    While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking. From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥ 50 puffs per week since ≥ 6 months); (TC) traditional cigarettes (≥ 1 per day since ≥ 6 m); (Mixed) both electronic and traditional cigarettes (≥ 1 per day since ≥ 6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate

  19. Random fractional ultrapulsed CO2 resurfacing of photodamaged facial skin: long-term evaluation.

    Science.gov (United States)

    Tretti Clementoni, Matteo; Galimberti, Michela; Tourlaki, Athanasia; Catenacci, Maximilian; Lavagno, Rosalia; Bencini, Pier Luca

    2013-02-01

    Although numerous papers have recently been published on ablative fractional resurfacing, there is a lack of information in literature on very long-term results. The aim of this retrospective study is to evaluate the efficacy, adverse side effects, and long-term results of a random fractional ultrapulsed CO2 laser on a large population with photodamaged facial skin. Three hundred twelve patients with facial photodamaged skin were enrolled and underwent a single full-face treatment. Six aspects of photodamaged skin were recorded using a 5 point scale at 3, 6, and 24 months after the treatment. The results were compared with a non-parametric statistical test, the Wilcoxon's exact test. Three hundred one patients completed the study. All analyzed features showed a significant statistical improvement 3 months after the procedure. Three months later all features, except for pigmentations, once again showed a significant statistical improvement. Results after 24 months were similar to those assessed 18 months before. No long-term or other serious complications were observed. From the significant number of patients analyzed, long-term results demonstrate not only how fractional ultrapulsed CO2 resurfacing can achieve good results on photodamaged facial skin but also how these results can be considered stable 2 years after the procedure.

  20. Monitoring the Long-Term Effectiveness of Integrated Safety Management System (ISMS) Implementation Through Use of a Performance Dashboard Process

    International Nuclear Information System (INIS)

    Kinney, Michael D.; Barrick, William D.

    2008-01-01

    This session will examine a method developed by Federal and Contractor personnel at the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) to examine long-term maintenance of DOE Integrated Safety Management System (ISMS) criteria, including safety culture attributes, as well as identification of process improvement opportunities. This process was initially developed in the summer of 2000 and has since been expanded to recognize the importance of safety culture attributes, and associated safety culture elements, as defined in DOE M 450.4-1, 'Integrated Safety Management System Manual'. This process has proven to significantly enhance collective awareness of the importance of long-term ISMS implementation as well as support commitments by NNSA/NSO personnel to examine the continued effectiveness of ISMS processes

  1. Evaluation of long-term interaction between cement and bentonite for geological disposal (1) - Project Overview

    International Nuclear Information System (INIS)

    Owada, Hitoshi; Hayashi, Daisuke; Yahagi, Ryoji; Ishii, Tomoko

    2012-01-01

    Document available in extended abstract form only. Bentonitic and cementitious materials are both planned for use as engineered barrier materials in the geological disposal of high level vitrified waste and TRU (transuranic) waste in Japan. As shown in Figure 1, bentonitic material will be placed around the waste packages as buffer material and a large amount of cementitious material is specified for use as filler, structure, support and grout. Cementitious material supplies an alkaline solution with high calcium concentration through reaction with groundwater. However, the alkaline solution will cause chemical and physical alteration of the bentonitic material. Since many important functions of an engineered barrier system (EBS), such as watertightness, chemical buffering, and sorption of radioactive nuclides, will be maintained by the properties of the buffer material, evaluation of long-term chemical or mechanical alteration of the buffer material is necessary to demonstrate the robustness of the EBS. Although many researches on chemical and mechanical alteration of bentonitic material, there was large uncertainty because the chemical alteration of bentonitic material is very slow and the altered region is very limited. In this project, the dissolution rate of montmorillonite under compaction and the spatial distribution of secondary C-S-H precipitation were obtained and mechanical and hydrological changes caused by the mineralogical change of bentonite material were modeled to reduce the uncertainty in the safety assessment of EBS performance. To improve the accuracy of the long term evaluation of the EBS performance, coupled analyses between hydraulic/mechanical calculations and geochemical-mass transport coupled calculations were performed. Alteration of mechanical properties caused by chemical degradation should be modeled for the coupled calculations. Because the mechanical properties of bentonitic material depend strongly on the montmorillonite content and

  2. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.

    Directory of Open Access Journals (Sweden)

    Joaquin Luna

    Full Text Available Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN and external genital lesions (EGL related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684] or 29 to 50 years of age (in the original placebo group during the base study [n = 651]. This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years from both the original base study and the Colombian follow-up.There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.Clinicaltrials.govNCT00090220.

  3. Pre-clinical evaluation of OxyChip for long-term EPR oximetry.

    Science.gov (United States)

    Hou, Huagang; Khan, Nadeem; Gohain, Sangeeta; Kuppusamy, M Lakshmi; Kuppusamy, Periannan

    2018-03-16

    Tissue oxygenation is a critical parameter in various pathophysiological situations including cardiovascular disease and cancer. Hypoxia can significantly influence the prognosis of solid malignancies and the efficacy of their treatment by radiation or chemotherapy. Electron paramagnetic resonance (EPR) oximetry is a reliable method for repeatedly assessing and monitoring oxygen levels in tissues. Lithium octa-n-butoxynaphthalocyanine (LiNc-BuO) has been developed as a probe for biological EPR oximetry, especially for clinical use. However, clinical applicability of LiNc-BuO crystals is hampered by potential limitations associated with biocompatibility, biodegradation, or migration of individual bare crystals in tissue. To overcome these limitations, we have embedded LiNc-BuO crystals in polydimethylsiloxane (PDMS), an oxygen-permeable biocompatible polymer and developed an implantable/retrievable form of chip, called OxyChip. The chip was optimized for maximum spin density (40% w/w of LiNc-BuO in PDMS) and fabricated in a form suitable for implantation using an 18-G syringe needle. In vitro evaluation of the OxyChip showed that it is robust and highly oxygen sensitive. The dependence of its EPR linewidth to oxygen was linear and highly reproducible. In vivo efficacy of the OxyChip was evaluated by implanting it in rat femoris muscle and following its response to tissue oxygenation for up to 12 months. The results revealed preservation of the integrity (size and shape) and calibration (oxygen sensitivity) of the OxyChip throughout the implantation period. Further, no inflammatory or adverse reaction around the implantation area was observed thereby establishing its biocompatibility and safety. Overall, the results demonstrated that the newly-fabricated high-sensitive OxyChip is capable of providing long-term measurements of oxygen concentration in a reliable and repeated manner under clinical conditions.

  4. Safety case methodology for decommissioning of research reactors. Assessment of the long term impact of a flooding scenario

    International Nuclear Information System (INIS)

    Vladescu, G.; Banciu, O.

    1999-01-01

    The paper contains the assessment methodology of a Safety Case fuel decommissioning of research reactors, taking into account the international approach principles. The paper also includes the assessment of a flooding scenario for a decommissioned research reactor (stage 1 of decommissioning). The scenario presents the flooding of reactor basement, radionuclide migration through environment and long term radiological impact for public. (authors)

  5. Evaluation of Long Term Behaviour of Polymers for Offshore Oil and Gas Applications

    Directory of Open Access Journals (Sweden)

    Le Gac P.-Y.

    2015-02-01

    Full Text Available Polymers and composites are very attractive for underwater applications, but it is essential to evaluate their long term behaviour in sea water if structural integrity of offshore structures is to be guaranteed. Accelerated test procedures are frequently required, and this paper will present three examples showing how the durability of polymers, in the form of fibres, matrix resins in fibre reinforced composites for structural elements, and thermal insulation coatings of flow-lines, have been evaluated for offshore use. The influence of the ageing medium, temperature, and hydrostatic pressure will be discussed first, then an example of the application of ageing test results to predict long term behavior of the thermal insulation coating of a flowline will be presented.

  6. Long-Term Evaluation of SSL Field Performance in Select Interior Projects

    Energy Technology Data Exchange (ETDEWEB)

    Perrin, Tess E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Davis, Robert G. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Wilkerson, Andrea M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2017-02-28

    This GATEWAY project evaluated four field installations to better understand the long-term performance of a number of LED products, which can hopefully stimulate improvements in designing, manufacturing, specifying, procuring, and installing LED products. Field studies provide the opportunity to discover and investigate issues that cannot be simulated or uncovered in a laboratory, but the installed performance over time of commercially available LED products has not been well documented. Improving long-term performance can provide both direct energy savings by reducing the need to over-light to account for light loss and indirect energy savings through better market penetration due to SSL’s competitive advantages over less-efficient light source technologies. The projects evaluated for this report illustrate that SSL use is often motivated by advantages other than energy savings, including maintenance savings, easier integration with control systems, and improved lighting quality.

  7. Long term impacts of nuclear energy: On which purpose do we try to evaluate them?

    International Nuclear Information System (INIS)

    Beutler, Didier

    1998-01-01

    The indicators and the time limits for evaluation of the long term impacts of nuclear energy depend on the purpose: assessing the total cost of electricity generation; comparing different nuclear strategies; responding to public acceptance concerns; elaborating and selecting the most sustainable energy systems. Indicators that can be used are: consumption of non renewable resources; concentrations in the environment; individual exposures; collective dose; potential radiotoxicity. For all of them predicted or conditional values can be applied

  8. Study on crystalline rock for evaluating method of long-term behavior. FY2012 (Contract research)

    International Nuclear Information System (INIS)

    Fukui, Katsunori; Hashiba, Kimihiro; Tanno, Takeo; Hikima, Ryoichi; Sanada, Hiroyuki; Sato, Toshinori

    2013-12-01

    Rock shows time-dependent behavior such as creep/relaxation. With respect to high-level radioactive waste disposal, knowledge of the long-term mechanical stability of shafts and galleries excavated in rock are required, over a period of thousands of years after closure as well as during construction and operation. Therefore, it is very important to understand the time-dependent behavior of rock for evaluating long-term mechanical stability. The purpose of this study is to determine the mechanisms of time-dependent behavior of rock by the precise test (e.g. laboratory creep test), observation and measurement and to develop methods for evaluating long-term mechanical stability. In previous works, testing techniques were established and basic evaluation methods were developed. Recently, some parameters, which required for simulation of time-dependent behavior, were determined for the modeling of biotite granite (Toki granite) distributed around the Mizunami underground research laboratory. However, we were not able to obtain enough data to assess the reliability of the method to evaluate these parameters. This report describes the results of the research activities carried out in fiscal year 2012. In Chapter 1, we provide background and an overview of this study. In Chapter 2, the results of a long-term creep test on Tage tuff, started in fiscal year 1997, are described. In Chapter 3, the experimental results concerning the loading-rate dependency of rock strength were examined to understand the time-dependent behavior of rock. In Chapter 4, the stability of tunnels, under conditions which rock stress is larger than that around a circular tunnel, were examined to obtain useful information on the future plan for in-situ tests in the underground research laboratory. (author)

  9. Fracture Toughness Evaluation of Kori-1 RPV Beltline Weld for a Long-Term Operation

    International Nuclear Information System (INIS)

    Lee, Bong-Sang; Kim, Min-Chul; Ahn, Sang-Bok; Kim, Byung-Chul; Hong, Jun-Hwa

    2007-01-01

    Irradiation embrittlement of RPV (reactor pressure vessel) material is the most important aging issue for a long-term operation of nuclear power plants. KORI unit 1, which is the first PWR in Korea, is approaching its initial licensing life of 30 years. In order to operate the reactor for another 10 years and more, it should be demonstrated that the irradiation embrittlement of the reactor will be adequately managed by ensuring that the fracture toughness properties have a certain level of the safety margin. The current regulation requires Charpy V-notch impact data through conventional surveillance tests. It is based on the assumption that Charpy impact test results are well correlated with the fracture toughness properties of many engineering steels. However, Charpy V-notch impact data may not be adequate to estimate the fracture toughness of certain materials, such as Linde 80 welds. During the last decade, a tremendous number of fracture toughness data on many RPV steels have been produced in accordance with the new standard test method, the so-called master curve method. ASTM E1921 represents a revolutionary advance in characterizing fracture toughness of RPV steels, since it permits establishing the ductile to brittle transition portion of the fracture toughness curve with direct measurements on a relatively small number of relatively small specimens, such as pre-cracked Charpy specimens. Actual fracture toughness data from many different RPV steels revealed that the Charpy test estimations are generally conservative with the exception of a few cases. Recent regulation codes in USA permit the master curve fracture toughness methodology in evaluating an irradiation embrittlement of commercial nuclear reactor vessels

  10. LISA package user guide. Part II: LISA (Long Term Isolation Safety Assessment) program description and user guide

    International Nuclear Information System (INIS)

    Prado, P.; Saltelli, A.; Homma, T.

    1992-01-01

    This manual is subdivided into three parts. In this second part, this document describes the LISA (Long term Isolation Safety Assessment) Code and its submodels. LISA is a tool for analysis of the safety of an underground disposal of nuclear waste. It has the capability to handle nuclide chain of arbitrary length and to evaluate the migration of nuclide through a geosphere medium composed of an arbitrary number of segments. LISA makes use of Monte Carlo methodology to evaluate the uncertainty in the quantity being assessed (eg dose) arising from the uncertainty in the model input parameters. In the present version LISA is equipped with a very simple source term submodel, a relatively complex geosphere and a simplified biosphere. The code is closely associated with its statistical pre-processor code (PREP), which generates the input Monte Carlo sample from the assigned parameter probability density functions and with its post-processor code (SPOP) which provides useful statistics on the output sample (uncertainty and sensitivity analysis). This report describes the general structure of LISA, its subroutines and submodels, the code input ant output files. It is intended to provide the user with enough information to know and run the code as well as the capacity to incorporate different submodels. 15 refs., 6 figs

  11. A review of methodologies applied in Australian practice to evaluate long-term coastal adaptation options

    Directory of Open Access Journals (Sweden)

    Timothy David Ramm

    2017-01-01

    Full Text Available Rising sea levels have the potential to alter coastal flooding regimes around the world and local governments are beginning to consider how to manage uncertain coastal change. In doing so, there is increasing recognition that such change is deeply uncertain and unable to be reliably described with probabilities or a small number of scenarios. Characteristics of methodologies applied in Australian practice to evaluate long-term coastal adaptation options are reviewed and benchmarked against two state-of-the-art international methods suited for conditions of uncertainty (Robust Decision Making and Dynamic Adaptive Policy Pathways. Seven out of the ten Australian case studies assumed the uncertain parameters, such as sea level rise, could be described deterministically or stochastically when identifying risk and evaluating adaptation options across multi-decadal periods. This basis is not considered sophisticated enough for long-term decision-making, implying that Australian practice needs to increase the use of scenarios to explore a much larger uncertainty space when assessing the performance of adaptation options. Two Australian case studies mapped flexible adaptation pathways to manage uncertainty, and there remains an opportunity to incorporate quantitative methodologies to support the identification of risk thresholds. The contextual framing of risk, including the approach taken to identify risk (top-down or bottom-up and treatment of uncertain parameters, were found to be fundamental characteristics that influenced the methodology selected to evaluate adaptation options. The small sample of case studies available suggests that long-term coastal adaptation in Australian is in its infancy and there is a timely opportunity to guide local government towards robust methodologies for developing long-term coastal adaptation plans.

  12. Structural Performance Evaluation of Tsing MA Bridge Deck Using Long-Term Monitoring Data

    Science.gov (United States)

    Ni, Y. Q.; Xia, H. W.; Ko, J. M.

    The Tsing Ma Bridge in Hong Kong is suspension bridge with a main span of 1377 m carrying both highway and railway traffic. After completing its construction in 1997, the bridge was instrumented by the Hong Kong SAR Government Highways Department with a long-term structural health monitoring system comprising about 300 sensors permanently installed on the bridge. As part of this monitoring system, a total of 110 strain gauges have been installed to measure strain at the deck cross-sections and bearings. In this study, a method for real-time structural performance evaluation of the stiffening deck system making use of long-term strain measurement data is proposed and verified using the strain monitoring data from a typical deck cross-section of the Tsing Ma Bridge.

  13. Evaluation of short-term and long-term stability of emulsions by centrifugation and NMR

    International Nuclear Information System (INIS)

    Tcholakova, S.; Denkov, N.; Ivanov, I.; Marinov, R.

    2004-01-01

    The effect of storage time on the coalescence stability and drop size distribution of egg yolk and whey protein concentrate stabilized emulsions is studied. The emulsion stability is evaluated by centrifugation, whereas the drop size distribution is measured by means of NMR and optical microscopy. The experimental results show that there is no general relation between the emulsion stability and the changes in the mean drop diameter upon shelf-storage of protein emulsions. On the other hand, it is shown that the higher short-term stability, measured by centrifugation immediately after emulsion preparation, corresponds to higher long-term stability (after their self-storage up to 60 days) for emulsions stabilized by the same type of emulsifier. In this way, we are able to obtain information for the long-term stability of emulsions in a relatively short period of time.(authors)

  14. Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

    Science.gov (United States)

    Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

    2017-07-01

    Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  15. Evaluation on the long-term durability and leachability of cemented waste form

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Ki Hong; Lee, Jae Won; Ryue, Young Gerl [Korea Atomic Energy Research Institute, Taejon (Korea)

    1998-08-01

    The long-term durability and leachability on the cemented waste form containing boric acids produced in domestic nuclear nuclear power plants were evaluated. Compressive strength of waste form after durability test such as thermal stability and water immersion cycle was higher than before test and consistently increased with increasing of test time in range of 83 of 286 kgf/cm{sup 2}. Long-term leachability was evaluated by standard test methods, leach affecting factors, and prediction of long-term leachability with result data of short-term leach test. In all leach tests, the release of Cs-137 was controlled by diffusion, whereas release of Co-60 was not controlled by diffusion. Leach rate of Cs-137 was relatively constant at standard leach test methods such as NAS 16.1, IAEA, ISO-6961, and MCC-1, but that of Co-60 increased with leachant-renewal frequencies. The leach rate of both Cs-137 and Co-60 increased as test temperature raised. The release of Co-137 decreased in simulated seawater as leachant, but increased with increasing leachant volume. The prediciton of long-term release of Cs-137 from large-scale waste form using the results from short-term leach test of small-scale waste form were within {+-} 5% of actual release. The leachability indexes of Cs-137 were between 6.5 and 7.5 and those of Co-60 were ranged from 11.6 to 13.3, increasing as cumulative leaching time increased. (author). 22 refs., 14 figs., 15 tabs.

  16. Radioembolization for Neuroendocrine Liver Metastases: Safety, Imaging, and Long-Term Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Memon, Khairuddin; Lewandowski, Robert J. [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Mulcahy, Mary F. [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Riaz, Ahsun; Ryu, Robert K.; Sato, Kent T.; Gupta, Ramona; Nikolaidis, Paul; Miller, Frank H.; Yaghmai, Vahid; Gates, Vanessa L.; Atassi, Bassel [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Newman, Steven [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Omary, Reed A. [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Benson, Al B. [Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Salem, Riad, E-mail: r-salem@northwestern.edu [Department of Radiology, Section of Interventional Radiology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States); Department of Medicine, Division of Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL (United States)

    2012-07-01

    Purpose: To present long-term outcomes on the safety and efficacy of Yttrium-90 radioembolization in the treatment of unresectable hepatic neuroendocrine metastases refractory to standard-of-care therapy. Methods and Materials: This study was approved by our institutional review board and was compliant with the Health Insurance Portability and Accountability Act. Forty patients with hepatic neuroendocrine metastases were treated with {sup 90}Y radioembolization at a single center. Toxicity was assessed using National Cancer Institute Common Terminology Criteria v3.0. Response to therapy was assessed by World Health Organization (WHO) guidelines for size and European Association for the Study of the Liver disease (EASL) guidelines for necrosis. Time to response and overall survival were calculated using the Kaplan-Meier method. Univariate and multivariate analyses were performed. Results: The median dose was 113 Gy (29-299 Gy). Clinical toxicities included fatigue (63%), nausea/vomiting (40%), abdominal pain (18%), fever (8%), diarrhea and weight loss (5%); Grade 3 and 4 bilirubin toxicities were experienced by 2 patients and 1 patient, respectively. Different responses were noted by WHO (complete response, 1.2%; partial response, 62.7%) and EASL (complete response, 20.5%; partial response, 43.4%). Median time to response was 4 and 4.9 months by lesion and patient, respectively. The 1-, 2-, and 3-year overall survival rates were 72.5%, 62.5%, and 45%, respectively. Eastern Cooperative Oncology Group (ECOG) performance score 0 (p < 0.0001), tumor burden {<=}25% (p = 0.0019), albumin {>=}3.5 g/dL (p = 0.017), and bilirubin {<=}1.2 mg/dL (p = 0.002) prognosticated survival on univariate analysis; only ECOG performance score 0 and bilirubin {<=}1.2 mg/dL prognosticated better survival outcome on multivariate analysis (p = 0.0001 and p = 0.02). Conclusion: Yttrium-90 therapy for hepatic neuroendocrine metastases leads to satisfactory tumor response and patient survival

  17. Phenomenological study on crystalline rock for evaluating of long-term behavior (Contract research)

    International Nuclear Information System (INIS)

    Okubo, Seisuke; Fukui, Katsunori; Hashiba, Kimihiro; Hikima, Ryoichi; Tanno, Takeo; Sanada, Hiroyuki; Matsui, Hiroya; Sato, Toshinori

    2012-02-01

    Rock, under in situ conditions, shows time-dependent behavior such as creep/relaxation. With respect to high-level radioactive waste disposal, knowledge of the long-term mechanical stability of shafts and galleries excavated in rock is required, not only during construction and operation but also over a period of thousands of years after closure. Therefore, it is very important to understand the time-dependent behavior of rock for evaluating long-term mechanical stability. The purpose of this study is determining the mechanisms of time-dependent behavior of rock by precise testing, observation and measurement in order to develop methods for evaluating long-term mechanical stability of a rock mass. In the previous work, testing techniques have been established and basic evaluation methods were developed. Recently, some parameters needed for simulation of time-dependent behavior were determined at the Mizunami underground research facilities. However, sufficient data to check the reliability of the evaluation method for these parameters were not available. This report describes the results of the activities in fiscal year 2010. In Chapter 1, we provide an overview and the background to this study. In Chapter 2, the results of a long-term creep test on Tage tuff, started in fiscal year 1997 are described. In Chapter 3, the relation of loading-rate dependency of strength and stress dependency of creep life, the relation of time dependency, probability distribution and size effects are discussed to indicate more clearly the meaning of the value of 'n' to express the degree of time dependency of the rock. Furthermore, past studies concerning the value of 'n' are reviewed and the tests that could be carried out in future studies of mechanical properties and time dependency of Toki granite are considered in this Chapter. In Chapter 4, failure criterions of a rock mass considering time dependency are discussed. In Chapter 5, the FEM analysis implemented with a generalized

  18. Long-term (52-week) safety and efficacy of Sacubitril/valsartan in Asian patients with hypertension.

    Science.gov (United States)

    Supasyndh, Ouppatham; Sun, Ningling; Kario, Kazuomi; Hafeez, Kudsia; Zhang, Jack

    2017-05-01

    Sacubitril/valsartan (LCZ696), a first-in-class angiotensin receptor-neprilysin inhibitor, demonstrated significant reductions in office and 24 h ambulatory blood pressure (BP) over 8 weeks in Asian patients with hypertension. This 52-week extension to the 8-week core study was aimed at evaluating the long-term safety, tolerability and efficacy of sacubitril/valsartan. Patients who completed an 8-week randomized study (the core study) were enrolled in this 52-week open-label study and received sacubitril/valsartan 200 mg QD. The sacubitril/valsartan dose was uptitrated to 400 mg QD if BP was uncontrolled (>140/90 mm Hg) after 4 weeks. Subsequently, in patients with uncontrolled BP, treatment was intensified every 4 weeks with amlodipine 5-10 mg followed by hydrochlorothiazide 6.25-25 mg. Of the 341 patients enrolled, 7 (2.1%) discontinued the study drug due to adverse events (AEs). The incidence of AEs and serious AEs were 63.9 and 3.8%, respectively, and no deaths were reported in this study. The most frequent AEs were nasopharyngitis (18.2%) and dizziness (8.8%). Events that were potentially indicative of low BP were infrequent. One patient reported mild transient angioedema (lasting 2.5 h) that resolved without treatment but led to study drug discontinuation. The sacubitril/valsartan-based regimen provided clinically significant mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) reductions from baseline (-24.7/-16.2 mm Hg). The overall BP control, msSBP and msDBP response rates were 75.3, 90.6 and 87.6%, respectively. Long-term use of sacubitril/valsartan was generally safe and well-tolerated in patients with hypertension and provided significant BP reductions from baseline.

  19. Contemporary Reflections on the Safety of Long-Term Aspirin Treatment for the Secondary Prevention of Cardiovascular Disease

    Science.gov (United States)

    Fanaroff, Alexander C.; Roe, Matthew T.

    2018-01-01

    Aspirin has been the cornerstone of therapy for the secondary prevention treatment of patients with cardiovascular disease since landmark trials were completed in the late 1970s and early 1980s that demonstrated the efficacy of aspirin for reducing the risk of ischemic events. Notwithstanding the consistent benefits demonstrated with apirin for both acute and chronic cardiovascular disease, there are a number of toxicities associated with aspirin that have been showcased by recent long-term clinical trials that have included an aspirin monotherapy arm. As an inhibitor of cyclooxygenase, aspirin impairs gastric mucosal protective mechanisms. Prior trials have shown that up to 15–20% of patients developed gastrointestinal symptoms with aspirin monotherapy and roughly 1% of patients per year had a clinically significant bleeding event, including 1 in 1000 patients who suffered an intracranial or fatal bleed. These risks have been shown to be compounded for patients with acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI), who are also treated with other anti-thrombotic agents during the acute care/procedural period, as well as for an extended time period afterwards. Given observations of substantial increases in bleeding rates from many prior long-term clinical trials that have evaluated aspirin together with other oral platelet inhibitors or oral anti-coagulants, the focus of contemporary research has pivoted towards tailored anti-thrombotic regimens that attempt to either shorten the duration of exposure to aspirin or replace aspirin with an alternative anti-thrombotic agent. While these shifts are occurring, the safety profile of aspirin when used for the secondary prevention treatment of patients with established cardiovascular disease deserves further consideration. PMID:27028617

  20. Early aspirin desensitization in unstable patients with acute coronary syndrome: Short and long-term efficacy and safety.

    Science.gov (United States)

    Córdoba-Soriano, Juan Gabriel; Corbí-Pascual, Miguel; López-Neyra, Isabel; Navarro-Cuartero, Javier; Hidalgo-Olivares, Víctor; Barrionuevo-Sánchez, Maria Isabel; Prieto-Mateos, Daniel; Gutiérrez-Díez, Antonio; Gallardo-López, Arsenio; Fuentes-Manso, Raquel; Gómez-Pérez, Alberto; Lafuente-Gormaz, Carlos; Jiménez-Mazuecos, Jesús

    2016-11-01

    Aspirin hypersensitivity is not a rare condition among patients with acute coronary syndrome. However, despite the publication of several successful desensitization protocols, the procedure is not as widespread as expected. We present a cohort of patients with acute coronary syndrome undergoing aspirin desensitization to evaluate its short- and long-term efficacy and safety and to reinforce data from previous studies. Of 1306 patients admitted to our Coronary Care Unit between February 2011 and February 2013, 24 (1.8%) had a history of aspirin hypersensitivity. All 24 patients underwent an eight-dose aspirin desensitization protocol (0.1, 0.3, 1, 3, 10, 25, 50 and 100 mg of aspirin given by mouth every 15 minutes) after premedication with antihistamines and corticosteroids or antileucotrienes. Previously prescribed β blockers and angiotensin-converting enzyme inhibitors were not discontinued. All patients were desensitized within 72 hours of admission. Those requiring urgent catheterization (five patients with ST segment elevation myocardial infarction) were desensitized within 12 hours of catheterization and the remainder before catheterization. All patients were successfully desensitized and only one presented with an urticarial reaction. The five patients with ST segment elevation myocardial infarction were treated with abciximab until desensitization was complete. All but one patient underwent catheterization and 20 underwent percutaneous coronary intervention, most (66%) with the implantation of a bare metal stent. At follow-up (a minimum of 6-24 months), only two patients had discontinued aspirin, both due to gastrointestinal bleeding, and no hypersensitivy reaction had occurred. Aspirin desensitization is effective and safe in unstable patients with acute coronary syndrome in both the short and long term.

  1. Long-term safety of left renal vein division and ligation to expedite complex abdominal aortic surgery.

    Science.gov (United States)

    Samson, Russell H; Lepore, Michael R; Showalter, David P; Nair, Deepak G; Lanoue, Julien B

    2009-09-01

    Left renal vein division and ligation (LRVDAL) is performed to facilitate complex abdominal aortic surgery. Surgeons restore continuity of the vein due to concern that ligation could cause renal compromise or hematuria. However, we report the short and long-term safety of left renal vein division and ligation. Between 1992 and 2007, we divided the left renal vein in 56 patients (40 males, 16 females) ages 57 to 84 (average 74-years-old) who were treated for aortic occlusive disease (9) or abdominal aortic aneurysm (47). Patients requiring concomitant renal artery reconstruction were excluded from this review. Suprarenal cross-clamp was used in 51 patients with temporary vessel-loop control of the renal arteries. Creatinine (Cr) and glomerular filtration rates (eGFR) were measured pre-, post-, and long-term after surgery. Outpatient records of all patients that had survived more than 12 months were also reviewed in order to evaluate the late effects on renal function or symptoms possibly related to LRVDAL. Median procedure duration was 157 (61-375) minutes. Median cross-clamp time was 16 (10-45) minutes. Median intensive care unit (ICU) and hospital length of stays were 2 (1-11) days and 7 (4-58) days, respectively. There were no deaths. There were no complications directly related to renal vein ligation. Hematuria, seen in 2 patients, was a result of traumatic insertion of a Foley catheter. Median pre-op and discharge Cr levels were 1.1 mg/dL (0.7-2.4 mg/dL) and 1.1 mg/dL (0.6-2.1 mg/dL), respectively (P 2.0 mg/dL remained unchanged post-op. Only 2 patients with a Cr of 2.0 mg/dL and both returned to normal by day 3 post-op. Thirty-six patients have been followed for more than a year (median 34.5 months, maximum 144 months) and Cr has remained stable in all but 2 patients. These 2 patients, both with a pre-op Cr of 1.5 mg/dL, subsequently developed Cr levels of 2.1 mg/dL and 2.4 mg/dL but maintained baseline Cr levels for 25 and 34 months, respectively, before

  2. Workplace Violence and Safety Issues in Long-Term Medical Care Facilities: Nurses' Perspectives

    Directory of Open Access Journals (Sweden)

    Bankole K. Fasanya

    2016-06-01

    Conclusion: WPV is an epidemic problem that affects all health-care professionals. The findings of this study could help long-term medical care facilities' management identify the areas to focus on mitigating, controlling, and/or eliminating incidents of WPV.

  3. Evaluation of long-term RD and D programs in the presence of market uncertainties

    International Nuclear Information System (INIS)

    Hazelrigg, G.A. Jr.

    1982-01-01

    Long-term research, development, and demonstration (RD and D) programs such as fusion research can span several decades, progressing through a number of discrete RD and D phases. Pursuit of a technology such as fusion does not mean commitment to the entire RD and D program, but only to the next phase of RD and D. The evaluation of a long-term RD and D program must account for the decision process to continue, modify, or discontinue the program upon completion of each RD and D phase, the technological uncertainties inherent in a long-term RD and D program, and the uncertainty inherent in the future marketplace for the technology if and when it becomes available. Presented here is a methodology that does this. An application of the methodology to fusion research is included. The example application shows that the perceived economic value of fusion research is strongly dependent on market uncertainty, with increasing market uncertainty yielding greatly increased perceived value to the research effort. 7 references, 8 figures, 2 tables

  4. Development of an evaluation method for long-term sealability of the spent fuel storage cask

    International Nuclear Information System (INIS)

    Kato, Osamu; Ito, Chihiro; Saegusa, Toshiari

    1996-01-01

    One of the characteristics of the cask storage method of spent fuel is that containment of radioactive materials is assured by the storage cask itself. Thus, the seal structure of the cask is designed to have a highly reliable multi-barrier system using metallic gaskets instead of the conventional rubber gaskets. Although, it has been reported that the containment feature of the metallic gaskets is influenced by the plastic deformation and stress relaxation of the gaskets for a short-term usage, no research report has been published on the containment feature of the metallic gaskets for a long-term usage. In this paper, the stress relaxation features of the metallic gaskets is investigated which will directly influence the long-term sealability of the storage cask, at first. Next, the relationship between the temperature/time dependence of the plastic deformation and the containment features of the metallic gaskets. Finally, an evaluation method of the long-term sealability from experimental data of a short-term behavior of the metallic gaskets is proposed. (author)

  5. THEREDA - a contribution to long-term safety of repositories of nuclear and non-nuclear wastes

    International Nuclear Information System (INIS)

    Altmaier, M.; Kienzler, B.; Marquardt, C.M.; Neck, V.; Voigt, W.; Wilhelm, S.

    2008-01-01

    Long-term safety analyses of German repositories of radioactive waste as well as underground repositories for chemical toxic waste and other uses (contaminated site remediation) urgently require a standardized, comprehensive thermodynamic reference database. The former 'Thermodynamic Standard Database Working Party' was set up to establish such a database. The activities of that group have been supported within the integrated 'THEREDA' (Thermodynamic Reference Database) project since July 2006 for an initial period of 3 years by the German Federal Ministries of Education and Research, of Economics, and by the Federal Office of Radiation Protection. THEREDA at present is composed of 5 partner institutions essentially representing the key German research institutions in the field of repository safety research. THEREDA is to improve the transparency and validity of safety analyses in Germany and, for the first time, provides consistent thermodynamic datasets for the repository options discussed in Germany. Quality levels are indicated for each thermodynamic quantity on the basis of unambiguously defined evaluation criteria, which allow users to either include or exclude data in accordance with the specific problems at hand. Missing thermodynamic data are substituted in THEREDA by well-founded estimates, thus permitting future model calculations for safety analysis to be carried out on a clearly broader basis of data. The data are managed centrally in a database and will be available to users free of charge on the Internet. Import formats allowing THEREDA to be transferred into the most common modeling codes (EQ3/6, PHREEQC, Geochemist's Workbench, CHEMAPP, etc.) are also made available free of charge. (orig.)

  6. Environmental and other evaluations of alternatives for long-term management of stored INEL transuranic waste

    International Nuclear Information System (INIS)

    1979-02-01

    This study identifies, develops, and evaluates, in a preliminary manner, alternatives for long-term management of TRU waste stored at the Radioactive Waste Management Complex (RWMC) at the INEL. The evaluations concern waste currently at the RWMC and waste expected to be received by the beginning of the year 1985. The effects of waste that might be received after that date are addressed in an appendix. The technology required for managing the waste, the environmental effects, the risks to the public, the radiological and nonradiological hazards to workers, and the estimated costs are discussed

  7. Environmental and other evaluations of alternatives for long-term management of stored INEL transuranic waste

    International Nuclear Information System (INIS)

    1979-12-01

    This study identifies, develops, and evaluates, in a preliminary manner, alternatives for long-term management of TRU waste stored at the Radioactive Waste Management Complex (RWMC) at the INEL. The evaluations concern waste currently at the RWMC and waste expected to be received by the beginning of the year 1985. The effects of waste that might be received after that data are addressed in an appendix. The technology required for managing the waste, the environmental effects, the risks to the public, the radiological and nonradiological hazards to workers, and the estimated costs are discussed

  8. Environmental and other evaluations of alternatives for long-term management of stored INEL transuranic waste

    Energy Technology Data Exchange (ETDEWEB)

    1979-02-01

    This study identifies, develops, and evaluates, in a preliminary manner, alternatives for long-term management of TRU waste stored at the Radioactive Waste Management Complex (RWMC) at the INEL. The evaluations concern waste currently at the RWMC and waste expected to be received by the beginning of the year 1985. The effects of waste that might be received after that date are addressed in an appendix. The technology required for managing the waste, the environmental effects, the risks to the public, the radiological and nonradiological hazards to workers, and the estimated costs are discussed.

  9. Radiological evaluation of long term complications of oral rehabilitations of thin ridges with titanium blade implants

    Directory of Open Access Journals (Sweden)

    P. Diotallevi

    2014-03-01

    Full Text Available Aim: The aim of this study was to assess the sensitivity of orthopantomography (OPT in the diagnosis of long term complications in oral rehabilitations with blade implants. Materials and methods A total of 235 blade implants in 189 patients, inserted between 1988 and 2003, were retrospectively analyzed. The records consisted of a first OPT taken between January and December 2010, and a second one 12 months after. The evaluation of implant health considered: integrity of the blade, normal radiological representation of the bone around the implant, dense and cortical appearance of bone around the implant collar. The evaluation of radiological complications considered: implant fracture, bone resorption around the implant, recession of the bone around the implant collar. Results The sensitivity of the panoramic evaluation was equal to 100%. The complications detected were 5 cases of periimplantitis, 9 cases of bone pericervical bone recession and 3 cases of fracture of the implant body. In cases of pericervical bone resorption the following radiological check up 12 months after the first one showed the progression of the disease in 6 out of 9 cases, with irreversible implant failure. In subjects with a radiological pattern of implant health there were no complications in the subsequent check up after 12 months. In the subjects with complications the specificity was equal to 100%. Conclusion The radiographic evaluation by the means of OPT has shown high sensitivity in the diagnosis of long term complications of oral rehabilitations with blade implants and allows prompt therapeutic interventions. Radiological complications appeared mostly in the long term check ups and mainly consisted in recession of the bone around the neck or around the entire implant. More rarely implant fractures occurred, which, in the case of blades, sometimes were not associated with any clinical symptoms: therefore, postsurgical evaluation should not be separated from

  10. Understanding the differences amongst national regulatory criteria for the long-term safety of radioactive waste disposal

    International Nuclear Information System (INIS)

    Larsson, C.M.; Ferch, R.; Pescatore, C.

    2008-01-01

    Carl-Magnus Larsson detailed then the work of the Regulators' Forum and the origin of the LTSC initiative. He explained that one of the objectives of the LTSC was to identify a set of issues on long-term protection criteria and collate findings in a report. He explained why the idea of a 'collective opinion' was abandoned and why it should be replaced by a common understanding where differences between countries ought to be explained and understood. C.-M. Larsson detailed the different types of approaches to regulating long-term safety and the different approaches for numerical targets. He gave some explanations of the reasons for the differences in regulatory targets between countries (level of conservatism, progress in the safety case methodology, etc.). The regulatory function takes into account the nature of the demonstration (illustrations and societal demands). C.-M. Larsson referred to the evolution of IAEA safety fundamentals and stressed that the 'sustainability' concept, introduced by the Joint Convention, is not mentioned in the new safety standard. The term 'adequately protected' is now preferred in relation to future generations. The ICRP recommends that less emphasis be placed on assessment of doses in the long term. C.-M. Larsson concluded that one of the challenges for the regulator is not to promise nor require the impossible. (authors)

  11. Patient-reported safety incidents in older patients with long-term conditions: a large cross-sectional study.

    Science.gov (United States)

    Panagioti, Maria; Blakeman, Thomas; Hann, Mark; Bower, Peter

    2017-05-30

    Increasing evidence suggests that patient safety is a serious concern for older patients with long-term conditions. Despite this, there is a lack of research on safety incidents encountered by this patient group. In this study, we sought to examine patient reports of safety incidents and factors associated with reports of safety incidents in older patients with long-term conditions. The baseline cross-sectional data from a longitudinal cohort study were analysed. Older patients (n=3378 aged 65 years and over) with a long-term condition registered in general practices were included in the study. The main outcome was patient-reported safety incidents including availability and appropriateness of medical tests and prescription of wrong types or doses of medication. Binary univariate and multivariate logistic regression analyses were undertaken to examine factors associated with patient-reported safety incidents. Safety incidents were reported by 11% of the patients. Four factors were significantly associated with patient-reported safety incidents in multivariate analyses. The experience of multiple long-term conditions (OR=1.09, 95% CI 1.05 to 1.13), a probable diagnosis of depression (OR=1.36, 95% CI 1.06 to 1.74) and greater relational continuity of care (OR=1.28, 95% CI 1.08 to 1.52) were associated with increased odds for patient-reported safety incidents. Perceived greater support and involvement in self-management was associated with lower odds for patient-reported safety incidents (OR=0.95, 95% CI 0.93 to 0.97). We found that older patients with multimorbidity and depression are more likely to report experiences of patient safety incidents. Improving perceived support and involvement of patients in their care may help prevent patient-reported safety incidents. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Risk-based approach to long-term safety assessment for near surface disposal of radioactive waste in Korea

    International Nuclear Information System (INIS)

    Jeong, C.W.; Kim, K.I.; Lee, J.I.

    2000-01-01

    This paper presents the Korean regulatory approach to safety assessment consistent with probabilistic, risk-based long-term safety requirements for near surface disposal facilities. The approach is based on: (1) From the standpoint of risk limitation, normal processes and probabilistic disruptive events should be integrated in a similar manner in terms of potential exposures; and (2) The uncertainties inherent in the safety assessment should be reduced using appropriate exposure scenarios. In addition, this paper emphasizes the necessity of international guidance for quantifying potential exposures and the corresponding risks from radioactive waste disposal. (author)

  13. Workplace Violence and Safety Issues in Long-Term Medical Care Facilities: Nurses' Perspectives

    OpenAIRE

    Bankole K. Fasanya; Emmanuel A. Dada

    2016-01-01

    Background: Workplace violence (WPV) is becoming an issue that needs immediate attention in the United States, especially during this period as more states are adopting the “stand your ground laws to promote worker protection.” This study was conducted to investigate how WPV has contributed to an unsafe environment for nurses and nursing assistants who work in long-term medical care facilities. Methods: A structure questionnaire was used to collect data for the study. Three facilities were...

  14. Long-term evaluation for engineered capping (cover) of radioactive repository or landfill

    International Nuclear Information System (INIS)

    Mohd Jamil Hashim; Mohd Abdul Wahab Yusof

    2010-01-01

    This paper discussed the long-term evaluation of engineered capping for radioactive repository. It was done to gather knowledge and understand the suitability of granitic residual soil. Its resistance to hydrologic cycle and durability through a period of 100 to 300 years was checked. A hydrological program was used with forecast weather and manual checking all layers for hydraulic gradient to verify the results. Overall result shown that the grantic residual soil is able to last a few centuries before surcome to infiltration. (author)

  15. A facility for long term evaluation and quality assurance of LHCb Vertex Detector modules

    CERN Document Server

    Marinho, F; Dimattia, R; Doherty, F; Dumps, R; Gersabeck, M; Melone, J; Parkes, C; Saavedra, A; Tobin, M

    2007-01-01

    This note describes the facility developed for long term evaluation and quality assurance of the LHCb Vertex Detector modules, known as the 'Glasgow Burn-in System'. This facility was developed to ensure that the modules conform to stringent quality levels. The system was able to uncover any weaknesses that could be introduced during the manufacturing and assembly of the components or during the transport of the modules to CERN. The system consisted of: a high resolution microscope for visual inspections; and a burn-in system to operate cooled modules in vacuum. The main components of the burn-in system were a vacuum system, a cooling system and a DAQ system.

  16. Evaluation of flexible membrane liners as long-term barriers for uranium mill tailings

    International Nuclear Information System (INIS)

    1984-07-01

    The National Uranium Tailings Program has commissioned a study to evaluate flexible membrane liners (geomembranes) as long-term barriers for Canadian uranium mill tailings. This study reviews the common liner type and addresses flexible liners (polymeric membranes and asphalt) in detail. Liner fabrication, design, installation, and performance are reviewed. Conceptual designs are presented for basins to accommodate 20 years accumulation of uranium tailings from mills in Elliot Lake and southeastern Athabasca. Nine polymeric and three asphalt liner types have been considered with respect to the physical and chemical environment in the uranium producing areas of Canada. All materials indicate good chemical resistance to uranium wastes but are subject to installation problems

  17. Evaluation of Long-term Performance of Enhanced Anaerobic Source Zone Bioremediation using mass flux

    Science.gov (United States)

    Haluska, A.; Cho, J.; Hatzinger, P.; Annable, M. D.

    2017-12-01

    Chlorinated ethene DNAPL source zones in groundwater act as potential long term sources of contamination as they dissolve yielding concentrations well above MCLs, posing an on-going public health risk. Enhanced bioremediation has been applied to treat many source zones with significant promise, but long-term sustainability of this technology has not been thoroughly assessed. This study evaluated the long-term effectiveness of enhanced anaerobic source zone bioremediation at chloroethene contaminated sites to determine if the treatment prevented contaminant rebound and removed NAPL from the source zone. Long-term performance was evaluated based on achieving MCL-based contaminant mass fluxes in parent compound concentrations during different monitoring periods. Groundwater concertation versus time data was compiled for 6-sites and post-remedial contaminant mass flux data was then measured using passive flux meters at wells both within and down-gradient of the source zone. Post-remedial mass flux data was then combined with pre-remedial water quality data to estimate pre-remedial mass flux. This information was used to characterize a DNAPL dissolution source strength function, such as the Power Law Model and the Equilibrium Stream tube model. The six-sites characterized for this study were (1) Former Charleston Air Force Base, Charleston, SC; (2) Dover Air Force Base, Dover, DE; (3) Treasure Island Naval Station, San Francisco, CA; (4) Former Raritan Arsenal, Edison, NJ; (5) Naval Air Station, Jacksonville, FL; and, (6) Former Naval Air Station, Alameda, CA. Contaminant mass fluxes decreased for all the sites by the end of the post-treatment monitoring period and rebound was limited within the source zone. Post remedial source strength function estimates suggest that decreases in contaminant mass flux will continue to occur at these sites, but a mass flux based on MCL levels may never be exceeded. Thus, site clean-up goals should be evaluated as order

  18. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma

    OpenAIRE

    Lee, Geun Young; Lee, Chong Eun; Lee, Kyoo Won; Seo, Sam

    2017-01-01

    AIM: To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG). METHODS: In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP) values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. RESULTS...

  19. School-based prevention program associated with increased short- and long-term retention of safety knowledge.

    Science.gov (United States)

    Klas, Karla S; Vlahos, Peter G; McCully, Michael J; Piche, David R; Wang, Stewart C

    2015-01-01

    Validation of program effectiveness is essential in justifying school-based injury prevention education. Although Risk Watch (RW) targets burn, fire, and life safety, its effectiveness has not been previously evaluated in the medical literature. Between 2007 and 2012, a trained fire service public educator (FSPE) taught RW to all second grade students in one public school district. The curriculum was delivered in 30-minute segments for 9 consecutive weeks via presentations, a safety smoke house trailer, a model-sized hazard house, a student workbook, and parent letters. A written pre-test (PT) was given before RW started, a post-test (PT#1) was given immediately after RW, and a second post-test (PT#2) was administered to the same students the following school year (ranging from 12 to 13 months after PT). Students who did not complete the PT or at least one post-test were excluded. Comparisons were made by paired t-test, analysis of variance, and regression analysis. After 183 (8.7%) were excluded for missing tests, 1,926 remaining students scored significantly higher (P = .0001) on PT#1 (mean 14.8) and PT#2 (mean 14.7) than the PT (mean 12.1). There was 1 FSPE and 36 school teachers with class size ranging from 10 to 27 (mean 21.4). Class size was not predictive of test score improvement (R = 0%), while analysis of variance showed that individual teachers trended toward some influence. This 6-year prospective study demonstrated that the RW program delivered by an FSPE effectively increased short-term knowledge and long-term retention of fire/life safety in early elementary students. Collaborative partnerships are critical to preserving community injury prevention education programs.

  20. Detecting long-term growth trends using tree rings: a critical evaluation of methods.

    Science.gov (United States)

    Peters, Richard L; Groenendijk, Peter; Vlam, Mart; Zuidema, Pieter A

    2015-05-01

    Tree-ring analysis is often used to assess long-term trends in tree growth. A variety of growth-trend detection methods (GDMs) exist to disentangle age/size trends in growth from long-term growth changes. However, these detrending methods strongly differ in approach, with possible implications for their output. Here, we critically evaluate the consistency, sensitivity, reliability and accuracy of four most widely used GDMs: conservative detrending (CD) applies mathematical functions to correct for decreasing ring widths with age; basal area correction (BAC) transforms diameter into basal area growth; regional curve standardization (RCS) detrends individual tree-ring series using average age/size trends; and size class isolation (SCI) calculates growth trends within separate size classes. First, we evaluated whether these GDMs produce consistent results applied to an empirical tree-ring data set of Melia azedarach, a tropical tree species from Thailand. Three GDMs yielded similar results - a growth decline over time - but the widely used CD method did not detect any change. Second, we assessed the sensitivity (probability of correct growth-trend detection), reliability (100% minus probability of detecting false trends) and accuracy (whether the strength of imposed trends is correctly detected) of these GDMs, by applying them to simulated growth trajectories with different imposed trends: no trend, strong trends (-6% and +6% change per decade) and weak trends (-2%, +2%). All methods except CD, showed high sensitivity, reliability and accuracy to detect strong imposed trends. However, these were considerably lower in the weak or no-trend scenarios. BAC showed good sensitivity and accuracy, but low reliability, indicating uncertainty of trend detection using this method. Our study reveals that the choice of GDM influences results of growth-trend studies. We recommend applying multiple methods when analysing trends and encourage performing sensitivity and reliability

  1. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German–Austrian ABSORB RegIstRy (GABI-R)

    Energy Technology Data Exchange (ETDEWEB)

    Nef, Holger, E-mail: holger.nef@innere.med.uni-giessen.de [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Wiebe, Jens [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Achenbach, Stefan [University of Erlangen, Medizinische Klinik II, Department of Cardiology, Erlangen (Germany); Münzel, Thomas [Department of Medicine II, University Medical Center, Johannes Gutenberg University Mainz, Mainz (Germany); Naber, Christoph [Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen (Germany); Richardt, Gert [Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg (Germany); Mehilli, Julinda [Department of Cardiology, Klinikum Großhadern, Ludwig- Maximilian Universität, Munich (Germany); Wöhrle, Jochen [Department of Internal Medicine II, University of Ulm, Ulm (Germany); Neumann, Till; Biermann, Janine [University of Essen, Department of Cardiology, Essen (Germany); Zahn, Ralf [Abteilung für Kardiologie, Herzzentrum Ludwigshafen, Ludwigshafen (Germany); Kastner, Johannes [Department of Cardiology, University of Vienna Medical School, Vienna (Austria); Schmermund, Axel [CCB, Cardioangiologisches Centrum Bethanien, Frankfurt (Germany); Pfannebecker, Thomas [Abbott Vascular Deutschland GmbH, Wetzlar (Germany); Schneider, Steffen; Limbourg, Tobias [Institut für Herzinfarktforschung, Ludwigshafen (Germany); Hamm, Christian W. [University of Giessen, Medizinische Klinik I, Department of Cardiology, Giessen (Germany); Kerckhoff Heart and Thorax Center, Department of Cardiology, Bad Nauheim (Germany)

    2016-01-15

    Background: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2–4 years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. Methods/design: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German–Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5 years). Conclusion: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information. - Highlights: • The GABI-R addresses a lack of data about bioresorbable scaffolds in daily practice. • 5000 patients with minimal in- and exclusion criteria at 100 sites will

  2. Evaluation of the short- and long-term safety and therapy outcomes of the everolimus-eluting bioresorbable vascular scaffold system in patients with coronary artery stenosis: Rationale and design of the German–Austrian ABSORB RegIstRy (GABI-R)

    International Nuclear Information System (INIS)

    Nef, Holger; Wiebe, Jens; Achenbach, Stefan; Münzel, Thomas; Naber, Christoph; Richardt, Gert; Mehilli, Julinda; Wöhrle, Jochen; Neumann, Till; Biermann, Janine; Zahn, Ralf; Kastner, Johannes; Schmermund, Axel; Pfannebecker, Thomas; Schneider, Steffen; Limbourg, Tobias; Hamm, Christian W.

    2016-01-01

    Background: Third-generation drug-eluting metal stents are the gold standard for treatment of coronary artery disease. The permanent metallic caging of the vessel, however, can result in limited vasomotion, chronic inflammation, and late expansive remodeling, conditions that can lead to late and very late stent thrombosis. The development of bioresorbable scaffolds (BRSs) promises advantages over metal stents due to complete biodegradation within 2–4 years. Theoretically, since vessel scaffolding is temporary and no permanent implant remains in the vessel, BRSs, as opposed to metal stents, once degraded would no longer be potential triggers for stent-related adverse events or side effects. Methods/design: The short- and long-term outcome after implantation of an everolimus-eluting, poly-L-lactic acid-based bioresorbable scaffold system (ABSORB, Abbott Vascular, Santa Clara, CA, USA) in the world-wide greatest all-comers cohort will be evaluated in the prospective, non-interventional, multicenter German–Austrian ABSORB RegIstRy (GABI-R). GABI-R will include over 5000 patients from about 100 study sites in Austria and Germany. Safety endpoints such as cardiac death, myocardial infarction, and clinically driven percutaneous or surgical target lesion and vessel revascularization will be evaluated during hospitalization and in the follow-up period (minimum of 5 years). Conclusion: Although two randomized controlled trials and several registries have documented safety and efficacy as well as non-inferiority of this everolimus-eluting ABSORB device compared with drug-eluting metal stents, the current knowledge regarding clinical application, treatment success, and long-term safety of using this BRS in daily routine is limited. Thus, the goal of GABI-R is to address this lack of information. - Highlights: • The GABI-R addresses a lack of data about bioresorbable scaffolds in daily practice. • 5000 patients with minimal in- and exclusion criteria at 100 sites will

  3. In Vivo Transplantation of Enteric Neural Crest Cells into Mouse Gut; Engraftment, Functional Integration and Long-Term Safety.

    Directory of Open Access Journals (Sweden)

    Julie E Cooper

    Full Text Available Enteric neuropathies are severe gastrointestinal disorders with unsatisfactory outcomes. We aimed to investigate the potential of enteric neural stem cell therapy approaches for such disorders by transplanting mouse enteric neural crest cells (ENCCs into ganglionic and aganglionic mouse gut in vivo and analysing functional integration and long-term safety.Neurospheres generated from yellow fluorescent protein (YFP expressing ENCCs selected from postnatal Wnt1-cre;R26R-YFP/YFP murine gut were transplanted into ganglionic hindgut of wild-type littermates or aganglionic hindgut of Ednrbtm1Ywa mice (lacking functional endothelin receptor type-B. Intestines were then assessed for ENCC integration and differentiation using immunohistochemistry, cell function using calcium imaging, and long-term safety using PCR to detect off-target YFP expression.YFP+ ENCCs engrafted, proliferated and differentiated into enteric neurons and glia within recipient ganglionic gut. Transplanted cells and their projections spread along the endogenous myenteric plexus to form branching networks. Electrical point stimulation of endogenous nerve fibres resulted in calcium transients (F/F0 = 1.16 ± 0.01;43 cells, n = 6 in YFP+ transplanted ENCCs (abolished with TTX. Long-term follow-up (24 months showed transplanted ENCCs did not give rise to tumours or spread to other organs (PCR negative in extraintestinal sites. In aganglionic gut ENCCs similarly spread and differentiated to form neuronal and glial networks with projections closely associated with endogenous neural networks of the transition zone.Transplanted ENCCs successfully engrafted into recipient ganglionic and aganglionic gut showing appropriate spread, localisation and, importantly, functional integration without any long-term safety issues. This study provides key support for the development and use of enteric neural stem cell therapies.

  4. NAGRA - Long-term safety - The main task of deep repositories for radioactive wastes

    International Nuclear Information System (INIS)

    2015-10-01

    This comprehensive brochure published by the Swiss National Cooperative for the Disposal of Radioactive Waste (NAGRA) examines the necessity for the safe disposal of radioactive wastes in Switzerland and discusses the requirements placed on such long-term waste depositories The effects of ionizing radiation on people and the protection provided by the deep repositories are examined. The construction of such deep repositories is looked at, as are the developments expected in the depositories over thousands of years. A comparison with natural occurrences is made and lessons to be learned from nature are discussed. Ideas for the marking of the depository sites are presented. A glossary of relevant terms completes the report

  5. Long-term Evaluation of Type 2 Thyroplasty with Titanium Bridges for Adductor Spasmodic Dysphonia.

    Science.gov (United States)

    Sanuki, Tetsuji; Yumoto, Eiji

    2017-07-01

    Objectives Standard treatments of adductor spasmodic dysphonia (AdSD) provide temporary relief of symptoms. Type 2 thyroplasty offers a long-term solution; however, long-term voice outcome data are lacking. The objective of this study was to assess the long-term voice outcomes of type 2 thyroplasty with titanium bridges through use of a validated voice questionnaire. Study Design Case series with chart review. Setting University hospital. Subjects and Methods Forty-seven consecutively enrolled patients with AdSD underwent type 2 thyroplasty with titanium bridges between August 2006 and November 2014. Questionnaires were completed during regularly scheduled follow-ups and, in some cases, were sent to patients who missed follow-up appointments. In 2015, questionnaires were mailed to all 47 patients and included a Voice Handicap Index-10 evaluation, as well as questions on postoperative vocal symptoms, surgical site, and status of the implanted titanium bridges. Results Of 47 patients with AdSD, 31 (66%) completed the questionnaires. The average follow-up interval was 41.3 months. No patient reported experiencing an adverse event around the surgical site, and almost all were satisfied with their voices postoperatively. The mean postoperative (>3 years) Voice Handicap Index-10 score improved significantly, from 26.3 to 9.4 (n = 17, P = .0009). Conclusions Type 2 thyroplasty for AdSD significantly improved patient quality of life and voice symptoms and continued to do so long after the surgery. The results of this study suggest that type 2 thyroplasty provides relief from vocal symptoms in patients with AdSD for >3 years.

  6. Evaluation of short- and long-term complications after endoscopically assisted gastropexy in dogs.

    Science.gov (United States)

    Dujowich, Mauricio; Keller, Mattew E; Reimer, S Brent

    2010-01-15

    To determine short- and long-term complications in clinically normal dogs after endoscopically assisted gastropexy. Prospective case series. 24 dogs. Endoscopically assisted gastropexy was performed on each dog. Dogs were evaluated laparoscopically at 1 or 6 months after surgery to assess integrity of the gastropexy. Long-term outcome was determined via telephone conversations conducted with owners > or = 1 year after surgery. Mean +/- SD gastropexy length was 4.5 +/- 0.9 cm, and mean duration of surgery was 22 +/- 5 minutes. One dog had a partially rotated stomach at the time of insufflation, which was corrected by untwisting the stomach with Babcock forceps. Two dogs vomited within 4 weeks after surgery, but the vomiting resolved in both dogs. Four dogs had diarrhea within 4 weeks after surgery, which resolved without medical intervention. In all dogs, the gastropexy site was firmly adhered to the abdominal wall at the level of the pyloric antrum. Long-term follow-up information was available for 23 dogs, none of which had any episodes of gastric dilatation-volvulus a mean of 1.4 years after gastropexy. Endoscopically assisted gastropexy can be a simple, fast, safe, and reliable method for performing prophylactic gastropexy in dogs. At 1 and 6 months after gastropexy, adequate placement and adhesion of the gastropexy site to the body wall was confirmed. Such a procedure could maximize the benefits of minimally invasive surgery, such as decreases in morbidity rate and anesthetic time. This technique appeared to be suitable as an alternative to laparoscopic-assisted gastropexy.

  7. Automated analysis of phantom images for the evaluation of long-term reproducibility in digital mammography

    International Nuclear Information System (INIS)

    Gennaro, G; Ferro, F; Contento, G; Fornasin, F; Di Maggio, C

    2007-01-01

    The performance of an automatic software package was evaluated with phantom images acquired by a full-field digital mammography unit. After the validation, the software was used, together with a Leeds TORMAS test object, to model the image acquisition process. Process modelling results were used to evaluate the sensitivity of the method in detecting changes of exposure parameters from routine image quality measurements in digital mammography, which is the ultimate purpose of long-term reproducibility tests. Image quality indices measured by the software included the mean pixel value and standard deviation of circular details and surrounding background, contrast-to-noise ratio and relative contrast; detail counts were also collected. The validation procedure demonstrated that the software localizes the phantom details correctly and the difference between automatic and manual measurements was within few grey levels. Quantitative analysis showed sufficient sensitivity to relate fluctuations in exposure parameters (kV p or mAs) to variations in image quality indices. In comparison, detail counts were found less sensitive in detecting image quality changes, even when limitations due to observer subjectivity were overcome by automatic analysis. In conclusion, long-term reproducibility tests provided by the Leeds TORMAS phantom with quantitative analysis of multiple IQ indices have been demonstrated to be effective in predicting causes of deviation from standard operating conditions and can be used to monitor stability in full-field digital mammography

  8. Requirements for a long-term safety certification for chemotoxic substances stored in a final storage facility for high radioactive and heat-generating radioactive waste in rock salt formations

    International Nuclear Information System (INIS)

    Tholen, M.; Hippler, J.; Herzog, C.

    2007-01-01

    Within the scope of a project funded by the German Federal Ministry of Economics and Technology (Bundesministerium fuer Wirtschaft und Technologie, BMWi), a safety certification concept for a future permanent final storage for high radioactive and heat-generating radioactive waste (HAW disposal facility) in rock salt formations is being prepared. For a reference concept, compliance with safety requirements in regard to operational safety as well as radiological and non-radiological protection objectives related to long-term safety, including ground water protection, will be evaluated. This paper deals with the requirements for a long-term safety certification for the purpose of protecting ground water from chemotoxic substances. In particular, longterm safety certifications for the permanent disposal of radioactive waste in a HAW disposal facility in rock salt formations and for the dumping of hazardous waste in underground storage facilities in rock salt formations are first discussed, followed by an evaluation as to whether these methods can be applied to the long-term safety certification for chemotoxic substances. The authors find it advisable to apply the long-term safety certification for underground storage facilities to the long-term safety certification for chemotoxic substances stored in a HAW disposal facility in rock salt formations. In conclusion, a corresponding certification concept is introduced. (orig.)

  9. Evaluating the clinical and physiological effects of long term ultraviolet B radiation on guinea pigs (Cavia porcellus).

    Science.gov (United States)

    Watson, Megan K; Stern, Adam W; Labelle, Amber L; Joslyn, Stephen; Fan, Timothy M; Leister, Katie; Kohles, Micah; Marshall, Kemba; Mitchell, Mark A

    2014-01-01

    Vitamin D is an important hormone in vertebrates. Most animals acquire this hormone through their diet, secondary to exposure to ultraviolet B (UVB) radiation, or a combination thereof. The objectives for this research were to evaluate the clinical and physiologic effects of artificial UVB light supplementation on guinea pigs (Cavia porcellus) and to evaluate the long-term safety of artificial UVB light supplementation over the course of six months. Twelve juvenile acromelanic Hartley guinea pigs were randomly assigned to one of two treatment groups: Group A was exposed to 12 hours of artificial UVB radiation daily and Group B received only ambient fluorescent light for 12 hours daily. Animals in both groups were offered the same diet and housed under the same conditions. Blood samples were collected every three weeks to measure blood chemistry values, parathyroid hormone, ionized calcium, and serum 25-hydroxyvitamin D3 (25-OHD3) levels. Serial ophthalmologic examinations, computed tomography scans, and dual energy x-ray absorptiometry scans were performed during the course of the study. At the end of the study the animals were euthanized and necropsied. Mean ± SD serum 25-OHD3 concentrations differed significantly in the guinea pigs (pguinea pigs to UVB radiation long term significantly increased their circulating serum 25-OHD3 levels, and that this increase was sustainable over time. Providing guinea pigs exposure to UVB may be an important husbandry consideration that is not currently recommended.

  10. Safety I and C system platforms - State-of-the-art and long-term available - A contradiction in terms?

    International Nuclear Information System (INIS)

    Richter, Steffen; Martin, Michael

    2006-01-01

    Automation systems, particularly in the field of safety I and C, are subject to conflict between three challenges. Customers' requests for state-of-the-art technology, ever shorter innovation cycles in the electronics industry and computer business and the requirement for long-term spare parts supply demand thorough and sustainable concepts from the supply market. The TELEPERM XS digital safety I and C platform has been applied successfully since 1998 for the modernization of safety I and C systems in over 30 NPP units from different reactor suppliers as well as for new plant construction. The platform is subject to a forward-looking life cycle management program combining an evolutionary and future-oriented approach to platform development with measures for ensuring the long-term support of the installed base. Driven by ever shorter innovation cycles in the electronics and automation industry, the platform is continuously evolved with state-of-the-art technology and enhanced safety features. The continuous innovation process is combined with maximum compatibility of the I and C components that make up the TELEPERM XS system platform. This makes the system future-oriented and simultaneously assures long-term availability of replacement parts. In this way TELEPERM XS meets the customer requirements for up-to-date but proven technology suitable to ensure an operating life of safety I and C equipment spanning several decades. As a matter of course, the platform and component development adheres to the robust and proven architecture of TELEPERM XS, thereby limiting risks for equipment qualification and project licensing to a minimum. (authors)

  11. Safety I and C system platforms - State-of-the-art and long-term available - A contradiction in terms?

    Energy Technology Data Exchange (ETDEWEB)

    Richter, Steffen; Martin, Michael [Framatome ANP GmbH, P.O. Box 3220, Freyeslebenstrasse 1, D-91050 Erlangen (Germany)

    2006-07-01

    Automation systems, particularly in the field of safety I and C, are subject to conflict between three challenges. Customers' requests for state-of-the-art technology, ever shorter innovation cycles in the electronics industry and computer business and the requirement for long-term spare parts supply demand thorough and sustainable concepts from the supply market. The TELEPERM XS digital safety I and C platform has been applied successfully since 1998 for the modernization of safety I and C systems in over 30 NPP units from different reactor suppliers as well as for new plant construction. The platform is subject to a forward-looking life cycle management program combining an evolutionary and future-oriented approach to platform development with measures for ensuring the long-term support of the installed base. Driven by ever shorter innovation cycles in the electronics and automation industry, the platform is continuously evolved with state-of-the-art technology and enhanced safety features. The continuous innovation process is combined with maximum compatibility of the I and C components that make up the TELEPERM XS system platform. This makes the system future-oriented and simultaneously assures long-term availability of replacement parts. In this way TELEPERM XS meets the customer requirements for up-to-date but proven technology suitable to ensure an operating life of safety I and C equipment spanning several decades. As a matter of course, the platform and component development adheres to the robust and proven architecture of TELEPERM XS, thereby limiting risks for equipment qualification and project licensing to a minimum. (authors)

  12. Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naïve Prostate Cancer

    DEFF Research Database (Denmark)

    Tombal, Bertrand; Borre, Michael; Rathenborg, Per

    2015-01-01

    BACKGROUND: Enzalutamide is an androgen receptor inhibitor with a demonstrated overall survival benefit in metastatic castration-resistant prostate cancer. A phase 2 study of enzalutamide monotherapy in patients with hormone-naïve prostate cancer (HNPC) showed a high response rate...... cancer, enzalutamide maintained long-term reductions in prostate-specific antigen, with a minimal impact on total-body bone mineral density. TRIAL REGISTRATION: NCT01302041....... for the prespecified primary endpoint (ie, prostate-specific antigen [PSA] response at week 25), regardless of metastases at baseline, and favorable tolerability. OBJECTIVE: To determine the long-term efficacy and safety of enzalutamide monotherapy at 1 and 2 yr. DESIGN, SETTING, AND PARTICIPANTS: Open-label, single...

  13. Data and methods for studying commercial motor vehicle driver fatigue, highway safety and long-term driver health.

    Science.gov (United States)

    Stern, Hal S; Blower, Daniel; Cohen, Michael L; Czeisler, Charles A; Dinges, David F; Greenhouse, Joel B; Guo, Feng; Hanowski, Richard J; Hartenbaum, Natalie P; Krueger, Gerald P; Mallis, Melissa M; Pain, Richard F; Rizzo, Matthew; Sinha, Esha; Small, Dylan S; Stuart, Elizabeth A; Wegman, David H

    2018-03-09

    This article summarizes the recommendations on data and methodology issues for studying commercial motor vehicle driver fatigue of a National Academies of Sciences, Engineering, and Medicine study. A framework is provided that identifies the various factors affecting driver fatigue and relating driver fatigue to crash risk and long-term driver health. The relevant factors include characteristics of the driver, vehicle, carrier and environment. Limitations of existing data are considered and potential sources of additional data described. Statistical methods that can be used to improve understanding of the relevant relationships from observational data are also described. The recommendations for enhanced data collection and the use of modern statistical methods for causal inference have the potential to enhance our understanding of the relationship of fatigue to highway safety and to long-term driver health. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Evaluation of the long-term evolution of the groundwater system in the Mizunami area, Japan

    International Nuclear Information System (INIS)

    Mizuno, Takashi; Milodowski, Antoni E.; Iwatsuki, Teruki

    2011-01-01

    This study aimed to develop a methodology for assessing the evolution of the long-term groundwater system, using fracture-filling calcite. Fracture-filling calcite mineralization in deep (to ca. 1000 m) granitic rocks in Mizunami area, Japan, was studied. Four generations (I to IV) of calcite precipitation can be differentiated based on their paragenetic relationships, morphological and isotopic characteristics. Carbon and oxygen isotopic ratios suggest that the Calcite I is of hydrothermal origin. On the other hand, Calcite II, IV and III were precipitated from freshwater and marine water, respectively. The Mizunami Group strata (Tertiary), which overly the basement Toki granite (Cretaceous), were initially deposited in a lacustrine environment but later became marine. Lacustrine conditions were re-established during the deposition of the upper Seto Group (Quaternary). It is suggested that both of deposition of the marine upper part of the Mizunami Group and the precipitation of Calcite III were possibly related to the same transgression event. This was followed by the precipitation of Calcite IV during subsequent fresh water flushing of the earlier marine groundwater. In summary, integrated morphological, mineralogical, microchemical and isotopic analysis of multilayered calcite fracture mineralization provides valuable information to evaluate the long-term evolution of groundwater system. (author)

  15. Evaluation of effects of long term exposure on lethal toxicity with mammals.

    Science.gov (United States)

    Verma, Vibha; Yu, Qiming J; Connell, Des W

    2014-02-01

    The relationship between exposure time (LT50) and lethal exposure concentration (LC50) has been evaluated over relatively long exposure times using a novel parameter, Normal Life Expectancy (NLT), as a long term toxicity point. The model equation, ln(LT50) = aLC50(ν) + b, where a, b and ν are constants, was evaluated by plotting lnLT50 against LC50 using available toxicity data based on inhalation exposure from 7 species of mammals. With each specific toxicant a single consistent relationship was observed for all mammals with ν always mammals and then be extended to estimate toxicity at any exposure time with other mammals. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

  16. Groundwater modeling for the long-term safety assessment of uranium tailings ponds

    International Nuclear Information System (INIS)

    Nair, R.N.

    2010-01-01

    Uranium tailings ponds contain naturally occurring long lived radionuclides such as 238 U, 234 U, 230 Th and 226 Ra as sources which are the parents of a very long radionuclide decay chain. Uranium tailings ponds by the virtue of the longevity of its contents may pose as a long-term radiological hazard if not designed and monitored properly. The principal radiation risks from uranium tailings are gamma radiation: windblown radioactive dust dispersion; and radon gas and its progenies. Uranium tailings ponds are also a major source of surface and groundwater contamination due to leaching of radioactive and other toxic elements. In many countries, the tailings ponds are designed to control the radiological hazards for up to 1000 years, to the extent achievable, and in any case for at least 200 years. Stringent regulations stipulations exist worldwide for the safe design, operation and closure of uranium tailings ponds. The long- term radiological impact assessment of uranium tailings ponds, hence, is an extremely important exercise in uranium mining industry. The simulations conducted for uranium over a period of 1000 years indicate that contaminant fronts from the source with a paste permeability of 1x10 -4 m/day would migrate a probable distance of less than 50 m. The maximum computed distance for this case is less than 300 m. Indian studies show that the total annual effective dose to members of the public at 1.0 km from the centre of the tailings pond is trivial up to a period of 4000 y. The estimated dose is 0.01 mSv/y after 10,000 years and it is 10 times lower than 0.1 mSv/y, which is considered as a safe dose limit for drinking water pathway. (author)

  17. Live kidney donation: are concerns about long-term safety justified?—A methodological review

    International Nuclear Information System (INIS)

    Janki, Shiromani; Steyerberg, Ewout W.; Hofman, Albert; IJzermans, Jan N. M.

    2017-01-01

    Live kidney donors are exhaustively screened pre-donation, creating a cohort inherently healthier at baseline than the general population. In recent years, three renowned research groups reported unfavourable outcomes for live kidney donors post-donation that contradicted their previous studies. Here, we compared the study design and analysis of the most recent and previous studies to determine whether the different outcomes were due to methodological design or reflect a real potential disadvantage for living kidney donors. All six studies on long-term risk after live kidney donation were thoroughly screened for the selection of study population, controls, data quality, and statistical analysis. Our detailed review of the methodology revealed key differences with respect to selection of donors and compared non-donors, data quality, follow-up duration, and statistical analysis. In all studies, the comparison group of non-donors was healthier than the donors due to more extensive exclusion criteria for non-donors. Five of the studies used both restriction and matching to address potential confounding. Different matching strategies and statistical analyses were used in the more recent studies compared to previous studies and follow-up was longer. Recently published papers still face bias. Strong points compared to initial analyses are the extended follow-up time, large sample sizes and better analysis, hence increasing the reliability to estimate potential risks for living kidney donors on the long-term. Future studies should focus on equal selection criteria for donors and non-donors, and in the analysis, follow-up duration, matched sets, and low absolute risks among donors should be accounted for when choosing the statistical technique.

  18. Evaluation of effects of long term exposure on lethal toxicity with mammals

    International Nuclear Information System (INIS)

    Verma, Vibha; Yu, Qiming J.; Connell, Des W.

    2014-01-01

    The relationship between exposure time (LT 50 ) and lethal exposure concentration (LC 50 ) has been evaluated over relatively long exposure times using a novel parameter, Normal Life Expectancy (NLT), as a long term toxicity point. The model equation, ln(LT 50 ) = aLC 50 ν + b, where a, b and ν are constants, was evaluated by plotting lnLT 50 against LC 50 using available toxicity data based on inhalation exposure from 7 species of mammals. With each specific toxicant a single consistent relationship was observed for all mammals with ν always <1. Use of NLT as a long term toxicity point provided a valuable limiting point for long exposure times. With organic compounds, the Kow can be used to calculate the model constants a and v where these are unknown. The model can be used to characterise toxicity to specific mammals and then be extended to estimate toxicity at any exposure time with other mammals. -- Highlights: • Model introduces a new parameter, normal life expectancy, to explain changes in toxicity with time. • Model is innovatory as it can be used to calculate toxicity at any, particularly long exposure times. • Toxicity is influenced by normal life expectancy of the organism particularly longer exposure times. • The model was applicable to all the mammals (7 species) evaluated. • The model can be used to predict toxicity at different exposure times with untested mammals species. -- The RLE model provides a mathematical description of the change in toxicity over time for a particular chemical. This represents a major advance on the use of Haber's Rule in toxicology

  19. Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort.

    Science.gov (United States)

    Gonczi, Lorant; Gecse, Krisztina B; Vegh, Zsuzsanna; Kurti, Zsuzsanna; Rutka, Mariann; Farkas, Klaudia; Golovics, Petra A; Lovasz, Barbara D; Banai, Janos; Bene, Laszlo; Gasztonyi, Bea; Kristof, Tunde; Lakatos, Laszlo; Miheller, Pal; Nagy, Ferenc; Palatka, Karoly; Papp, Maria; Patai, Arpad; Salamon, Agnes; Szamosi, Tamas; Szepes, Zoltan; Toth, Gabor T; Vincze, Aron; Szalay, Balazs; Molnar, Tamas; Lakatos, Peter L

    2017-11-01

    It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no

  20. Criteria for the evaluation and certification of long-term digital archives in the earth sciences

    Science.gov (United States)

    Klump, Jens

    2010-05-01

    Digital information has become an indispensable part of our cultural and scientific heritage. Scientific findings, historical documents and cultural achievements are to a rapidly increasing extent being presented in electronic form - in many cases exclusively so. However, besides the invaluable advantages offered by this form, it also carries a serious disadvantage: users need to invest a great deal of technical effort in accessing the information. Also, the underlying technology is still undergoing further development at an exceptionally fast pace. The rapid obsolescence of the technology required to read the information combined with the frequently imperceptible physical decay of the media themselves represents a serious threat to preservation of the information content. Many data sets in earth science research are from observations that cannot be repeated. This makes these digital assets particularly valuable. Therefore, these data should be kept and made available for re-use long after the end of the project from which they originated. Since research projects only run for a relatively short period of time, it is advisable to shift the burden of responsibility for long-term data curation from the individual researcher to a trusted data repository or archive. But what makes a trusted data repository? Each trusted digital repository has its own targets and specifications. The trustworthiness of digital repositories can be tested and assessed on the basis of a criteria catalogue. This is the main focus of the work of the nestor working group "Trusted repositories - Certification". It identifies criteria which permit the trustworthiness of a digital repository to be evaluated, both at the organisational and technical levels. The criteria are defined in close collaboration with a wide range of different memory organisations, producers of information, experts and other interested parties. This open approach ensures a high degree of universal validity, suitability for

  1. Long-term evaluation of a Canadian back pain mass media campaign.

    Science.gov (United States)

    Suman, Arnela; Bostick, Geoffrey P; Schopflocher, Donald; Russell, Anthony S; Ferrari, Robert; Battié, Michele C; Hu, Richard; Buchbinder, Rachelle; Gross, Douglas P

    2017-09-01

    This paper evaluates the long-term impact of a Canadian mass media campaign on general public beliefs about staying active when experiencing low back pain (LBP). Changes in beliefs about staying active during an episode of LBP were studied using telephone and web-based surveys. Logistic regression analysis was used to investigate changes in beliefs over time and the effect of exposure to campaign messaging. The percentage of survey respondents agreeing that they should stay active through LBP increased annually from 58.9 to ~72.0%. Respondents reporting exposure to campaign messaging were statistically significantly more likely to agree with staying active than respondents who did not report exposure to campaign messaging (adjusted OR, 95% CI = 1.96, 1.73-2.21). The mass media campaign had continued impact on public LBP beliefs over the course of 7 years. Improvements over time were associated with exposure to campaign messaging.

  2. Evaluation of long-term stability of low thermal expansion coefficient materials using gauge block interferometers

    Science.gov (United States)

    Hirai, Akiko; Bitou, Youichi; Oike, Yoshiyuki

    2018-06-01

    The long-term stability of NEXCERA™ ceramics having a low coefficient of thermal expansion was evaluated over a period of eight years. Several gauge blocks of differing lengths were prepared, using two types of NEXCERA. Each gauge block was kept wrung to a platen and its absolute length was periodically measured by gauge block interferometer during the eight years. Relative uncertainties of measurement of changes in gauge block length were estimated as 4.1  ×  10‑8 and 2.9  ×  10‑8 for 200 mm and 800 mm gauge blocks, respectively. The experimental results show the trend of expansion and a relative change of less than 0.1  ×  10‑6/year for every gauge block.

  3. Gasbuggy, New Mexico Long-Term Hydrologic Monitoring Program Evaluation Report

    Energy Technology Data Exchange (ETDEWEB)

    None

    2009-06-01

    This report summarizes an evaluation of the Long-Term Hydrologic Monitoring Program (LTHMP) that has been conducted since 1972 at the Gasbuggy, New Mexico underground nuclear detonation site. The nuclear testing was conducted by the U.S. Atomic Energy Commission under the Plowshare program, which is discussed in greater detail in Appendix A. The detonation at Gasbuggy took place in 1967, 4,240 feet below ground surface, and was designed to fracture the host rock of a low-permeability natural gas-bearing formation in an effort to improve gas production. The site has historically been managed under the Nevada Offsites Project. These underground nuclear detonation sites are within the United States but outside of the Nevada Test Site where most of the experimental nuclear detonations conducted by the U.S. Government took place. Gasbuggy is managed by the U.S. Department of Energy (DOE) Office of Legacy Management (LM ).

  4. Long-term safety and efficacy of ramelteon in Japanese patients with chronic insomnia.

    Science.gov (United States)

    Uchiyama, Makoto; Hamamura, Misako; Kuwano, Tomoaki; Nagata, Hiroshi; Hashimoto, Takamasa; Ogawa, Atsushi; Uchimura, Naohisa

    2011-02-01

    To evaluate the safety of ramelteon, a highly selective MT₁/MT₂ melatonin receptor agonist, during 24 weeks' treatment of Japanese patients with chronic insomnia. In a single-blind, flexible-titration, multicenter study incorporating placebo run-in and run-out periods, 190 adults with chronic insomnia received ramelteon 4 or 8 mg, titrated up to 16 mg if necessary, for 24 weeks. Primary endpoints included adverse events, residual effects, rebound insomnia, withdrawal symptoms, and dependence. Secondary endpoints included subjective sleep latency and total sleep time. Drug-related adverse events occurred in 11.6% of patients. No clinically important changes occurred in biochemical, hematological or endocrine parameters. There were no signs of next-day residual effect, rebound insomnia, withdrawal symptoms or dependence. Mean subjective sleep latency decreased significantly, and total sleep time increased significantly; both reached a plateau by week 20 and were sustained thereafter (Pinsomnia and did not cause deterioration of efficacy, residual effects, rebound insomnia, withdrawal symptoms, or dependence after 24 weeks' treatment. Copyright © 2011 Elsevier B.V. All rights reserved.

  5. Long-term safety and efficacy of Gamma Knife surgery in classical trigeminal neuralgia: a 497-patient historical cohort study.

    Science.gov (United States)

    Régis, Jean; Tuleasca, Constantin; Resseguier, Noémie; Carron, Romain; Donnet, Anne; Gaudart, Jean; Levivier, Marc

    2016-04-01

    Gamma Knife surgery (GKS) is one of the surgical alternatives for the treatment of drug-resistant trigeminal neuralgia (TN). This study aims to evaluate the safety and efficacy of GKS in a large population of patients with TN with very long-term clinical follow-up. Between July 1992 and November 2010, 737 patients presenting with TN were treated using GKS. Data were collected prospectively and were further retrospectively evaluated at Timone University Hospital. The frequency and severity of pain, as well as trigeminal nerve function, were evaluated before GKS and regularly thereafter. Radiosurgery using the Gamma Knife (model B, C, 4C, or Perfexion) was performed with the help of both MR and CT targeting. A single 4-mm isocenter was positioned in the cisternal portion of the trigeminal nerve at a median distance of 7.6 mm (range 4-14 mm) anterior to the emergence of the nerve (retrogasserian target). A median maximum dose of 85 Gy (range 70-90 Gy) was prescribed. The safety and efficacy are reported for 497 patients with medically refractory classical TN who were never previously treated by GKS and had a follow-up of at least 1 year. The median age in this series was 68.3 years (range 28.1-93.2 years). The median follow-up period was 43.8 months (range 12-174.4 months). Overall, 456 patients (91.75%) were initially pain free in a median time of 10 days (range 1-180 days). Their actuarial probabilities of remaining pain free without medication at 3, 5, 7, and 10 years were 71.8%, 64.9%, 59.7%, and 45.3%, respectively. One hundred fifty-seven patients (34.4%) who were initially pain free experienced at least 1 recurrence, with a median delay of onset of 24 months (range 0.6-150.1 months). However, the actuarial rate of maintaining pain relief without further surgery was 67.8% at 10 years. The hypesthesia actuarial rate at 5 years was 20.4% and at 7 years reached 21.1%, but remained stable until 14 years with a median delay of onset of 12 months (range 1-65 months

  6. SALTO Peer Review Guidelines. Guidelines for Peer Review of Safety Aspects of Long Term Operation of Nuclear Power Plants

    International Nuclear Information System (INIS)

    2014-01-01

    International peer review is a useful tool for Member States to exchange experiences, learn from each other and apply good practices in the long term operation (LTO) of nuclear power plants (NPPs). The peer review is also an important mechanism through which the IAEA supports Member States in enhancing the safety of NPPs. The IAEA has conducted various types of safety review that indirectly address aspects of LTO, including safety reviews for design, engineering, operation and external hazards. Operational Safety Review Team (OSART) services include review of ageing management programmes. In addition, several Member States have requested Ageing Management Assessment Team (AMAT) missions. Through these experiences, it was recognized that a comprehensive peer review on LTO would be very useful to Member States. The Safety Aspects of Long Term Operation (SALTO) peer review addresses strategy and key elements for the safe LTO of NPPs, which includes AMAT objectives and complements OSART reviews. The SALTO peer review is designed to assist operating organizations in adopting a proper approach to LTP including implementing appropriate activities to ensure that plant safety will be maintained during the LTO period. The SALTO peer review can be tailored to focus on ageing management programmes (AMPs) or on other activities related to LTO to support the Member State in enhancing the safety of its NPPs. The SALTO peer review can also support regulators in establishing or improving regulatory and licensing strategies for the LTO of NPPs. The guidelines in this publication are primarily intended for members of a SALTO review team and provide a basic structure and common reference for peer reviews of LTO. Additionally, the guidelines also provide useful information to the operating organizations of NPPs (or technical support organizations) for carrying out their own self-assessments or comprehensive programme reviews. The guidelines are intended to be generic, as there are

  7. Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads.

    Science.gov (United States)

    Good, Eric D; Cakulev, Ivan; Orlov, Michael V; Hirsh, David; Simeles, John; Mohr, Kelly; Moll, Phil; Bloom, Heather

    2016-06-01

    Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-randomized registries conducted to confirm the long-term safety and reliability of Biotronik leads. ICD and CRT-D patients are followed for Linox and Linox(smart) ICD lead performance and safety for 5 years post-implant. All procedural and system-related adverse events (AEs) were assessed at each follow-up, along with lead electrical parameters. An independent CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The analysis used categories of lead observations per ISO 5841-2 (Third edition). A total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 ± 12.2 years) at 146 US centers. The estimated cumulative survival probability was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) survival functions did not find evidence of a difference (P = 0.2155). The most common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 0.25%), and abnormal pacing impedance (8, 0.20%). Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads. © 2016 Wiley Periodicals, Inc.

  8. Evaluation of the long-term efficacy and safety of an imidacloprid 10%/flumethrin 4.5% polymer matrix collar (Seresto® in dogs and cats naturally infested with fleas and/or ticks in multicentre clinical field studies in Europe

    Directory of Open Access Journals (Sweden)

    Stanneck Dorothee

    2012-03-01

    Full Text Available Abstract Background The objective of these two GCP multicentre European clinical field studies was to evaluate the long-term efficacy and safety of a new imidacloprid/flumethrin collar (Seresto®, Bayer AnimalHealth, Investigational Veterinary Product(IVP in dogs and cats naturally infested with fleas and/or ticks in comparison to a dimpylat collar ("Ungezieferband fuer Hunde/fuer Katzen", Beaphar, Control Product (CP. Methods 232 (IVP and 81 (CP cats and 271(IVP and 129 (CP dogs were treated with either product according to label claims and formed the safety population. Flea and tick counts were conducted in monthly intervals for up to 8 months in the efficacy subpopulation consisting of 118 (IVP + 47 (CP cats and 197 (IVP + 94 (CP dogs. Efficacy was calculated as reduction of infestation rate within the same treatment group and statistically compared between the two treatment groups. Results Preventive efficacy against fleas in cats/dogs varied in the IVP group between 97.4%/94.1% and 100%/100% (overall mean: 98.3%/96.7% throughout the 8 month period and in the CP group between 57.1%/28.2% and 96.1%/67.8% (overall mean: 79.3%/57.9%. Preventive efficacy against ticks in cats/dogs varied in the IVP group between 94.0%/91.2% and 100%/100% (overall mean: 98.4%/94.7% throughout the 8 month period and in the CP group between 90.7%/79.9% and 100%/88.0% (overall mean: 96.9%/85.6%. The IVP group was statistically non-inferior to the CP group, and on various assessment days, statistical superiority was proven for flea and tick count reduction in dogs and cats. Both treatments proved to be safe in dogs and cats with mainly minor local observations at the application site. There was moreover, no incidence of any mechanical problem with the collar in dogs and cats during the entire study period. Conclusions The imidacloprid/flumethrin collar proved to reduce tick counts by at least 90% and flea counts by at least 95% for a period of at least 7-8 months in

  9. Evaluation of the long-term efficacy and safety of an imidacloprid 10%/flumethrin 4.5% polymer matrix collar (Seresto®) in dogs and cats naturally infested with fleas and/or ticks in multicentre clinical field studies in Europe

    Science.gov (United States)

    2012-01-01

    Background The objective of these two GCP multicentre European clinical field studies was to evaluate the long-term efficacy and safety of a new imidacloprid/flumethrin collar (Seresto®, Bayer AnimalHealth, Investigational Veterinary Product(IVP)) in dogs and cats naturally infested with fleas and/or ticks in comparison to a dimpylat collar ("Ungezieferband fuer Hunde/fuer Katzen", Beaphar, Control Product (CP)). Methods 232 (IVP) and 81 (CP) cats and 271(IVP) and 129 (CP) dogs were treated with either product according to label claims and formed the safety population. Flea and tick counts were conducted in monthly intervals for up to 8 months in the efficacy subpopulation consisting of 118 (IVP) + 47 (CP) cats and 197 (IVP) + 94 (CP) dogs. Efficacy was calculated as reduction of infestation rate within the same treatment group and statistically compared between the two treatment groups. Results Preventive efficacy against fleas in cats/dogs varied in the IVP group between 97.4%/94.1% and 100%/100% (overall mean: 98.3%/96.7%) throughout the 8 month period and in the CP group between 57.1%/28.2% and 96.1%/67.8% (overall mean: 79.3%/57.9%). Preventive efficacy against ticks in cats/dogs varied in the IVP group between 94.0%/91.2% and 100%/100% (overall mean: 98.4%/94.7%) throughout the 8 month period and in the CP group between 90.7%/79.9% and 100%/88.0% (overall mean: 96.9%/85.6%). The IVP group was statistically non-inferior to the CP group, and on various assessment days, statistical superiority was proven for flea and tick count reduction in dogs and cats. Both treatments proved to be safe in dogs and cats with mainly minor local observations at the application site. There was moreover, no incidence of any mechanical problem with the collar in dogs and cats during the entire study period. Conclusions The imidacloprid/flumethrin collar proved to reduce tick counts by at least 90% and flea counts by at least 95% for a period of at least 7-8 months in cats and dogs

  10. Improving Service Quality in Long-term Care Hospitals: National Evaluation on Long-term Care Hospitals and Employees Perception of Quality Dimensions

    OpenAIRE

    Kim, Jinkyung; Han, Woosok

    2012-01-01

    Objectives To investigate predictors for specific dimensions of service quality perceived by hospital employees in long-term care hospitals. Methods Data collected from a survey of 298 hospital employees in 18 long-term care hospitals were analysed. Multivariate ordinary least squares regression analysis with hospital fixed effects was used to determine the predictors of service quality using respondents? and organizational characteristics. Results The most significant predictors of employee-...

  11. Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal

    Directory of Open Access Journals (Sweden)

    Lemoine P

    2011-07-01

    Full Text Available Patrick Lemoine1, Doron Garfinkel2, Moshe Laudon3, Tali Nir3, Nava Zisapel3,41The Clinique Lyon-Lumière, Meyzieu, France; 2Geriatric-Palliative Department, Shoham Geriatric Medical Center, Pardes Hanna, Israel; 3Neurim Pharmaceuticals Ltd, Tel-Aviv, Israel; 4Department of Neurobiology Faculty of Life Sciences, Tel Aviv University, Tel Aviv, IsraelBackground: Prolonged-release melatonin (PRM 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation.Objective: To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment.Methods: Data from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary, adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]. Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM.Results: Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as "good" or "very good" was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production

  12. Long-term safety and efficacy of AAV gene therapy in the canine model of glycogen storage disease type Ia.

    Science.gov (United States)

    Lee, Young Mok; Conlon, Thomas J; Specht, Andrew; Coleman, Kirsten E; Brown, Laurie M; Estrella, Ana M; Dambska, Monika; Dahlberg, Kathryn R; Weinstein, David A

    2018-05-25

    Viral mediated gene therapy has progressed after overcoming early failures, and gene therapy has now been approved for several conditions in Europe and the USA. Glycogen storage disease (GSD) type Ia, caused by a deficiency of glucose-6-phosphatase-α, has been viewed as an outstanding candidate for gene therapy. This follow-up report describes the long-term outcome for the naturally occurring GSD-Ia dogs treated with rAAV-GPE-hG6PC-mediated gene therapy. A total of seven dogs were treated with rAAV-GPE-hG6PC-mediated gene therapy. The first four dogs were treated at birth, and three dogs were treated between 2 and 6 months of age to assess the efficacy and safety in animals with mature livers. Blood and urine samples, radiographic studies, histological evaluation, and biodistribution were assessed. Gene therapy improved survival in the GSD-Ia dogs. With treatment, the biochemical studies normalized for the duration of the study (up to 7 years). None of the rAAV-GPE-hG6PC-treated dogs had focal hepatic lesions or renal abnormalities. Dogs treated at birth required a second dose of rAAV after 2-4 months; gene therapy after hepatic maturation resulted in improved efficacy after a single dose. rAAV-GPE-hG6PC treatment in GSD-Ia dogs was found to be safe and efficacious. GSD-Ia is an attractive target for human gene therapy since it is a monogenic disorder with limited tissue involvement. Blood glucose and lactate monitoring can be used to assess effectiveness and as a biomarker of success. GSD-Ia can also serve as a model for other hepatic monogenic disorders.

  13. Long-term follow-up study on the safety of deep brain stimulation for treating Parkinson's disease

    Directory of Open Access Journals (Sweden)

    Xi WU

    2015-10-01

    Full Text Available Objective To evaluate the safety of deep brain stimulation (DBS for treating Parkinson's disease (PD under long-term follow-up and modify the surgical procedure. Methods A total of 362 PD patients underwent DBS, and almost 613 electrodes were implanted into these patients. Both surgical and hardware-related complications of DBS were retrospectively analyzed. Results Perioperative complications included postoperative confusion or delirium in 21 cases (5.80%, intracranial hemorrhage in 4 cases (1.10%; 2 asymptomatic cortical microhemorrhage and 2 basal ganglia trajectory microhemorrhage, generalized tonic-clonic seizures (GTCS in 2 cases (0.55% , urinary tract infection in 4 cases (1.10% , pulmonary infection in 7 cases (1.93%, implantable pulse generator (IPG hematoma in 11 cases (3.04%, IPG seroma in 3 cases (0.83%. All these patients were cured. They were followed-up for 12-146 months (median 34 months. Hardware-related complications included infection of incisional wound and/or skin erosion (9 cases, 2.49% , extension wire fracture caused by IPG displacement (one case, 0.28% , IPG shifting to abdomen due to fixation wire fracture (one case, 0.28%, slightly migrated electrode due to fall (one case, 0.28%, and discomfort about occipital incision (one case, 0.28%. Conclusions The overall risk of both surgical and hardware-related adverse events of DBS for treating PD is acceptably low. DOI: 10.3969/j.issn.1672-6731.2015.10.005

  14. Economic Evaluation of Long-term Operation of NPPs in Korea

    International Nuclear Information System (INIS)

    Lee, Kihyun; Kim, Taeryong; Jeong, Cheolwook

    2015-01-01

    It is inevitable for Korean government to establish the energy policy which can support the energy security and independence since Korea depends on approximately 97% of energy resources from abroad. We selected nuclear power plant to overcome the problem. Since Kori unit 1 began operating as a first nuclear power plant, nuclear power generation has been played a big role in providing about 30% of total electricity supply in Korea. Many researchers and economists have already assessed about safety and economic aspects of the nuclear power generation. This paper will deal with the economic benefits for the contribution of nuclear power generation especially long-term operation of NPPs to the Korean society. In this paper, the economic analysis of the LTO for the existing power plant less than and equal to 1,000MW compared to no extension was investigated. The selected durations of LTO are 10 years, 20 years, and 30 years beyond design life. The result from the analysis is that LTO of NPPs is more beneficial than observance of its design life. In the aspects of utility's electricity sales increase and reducing the new construction of APR1400 NPPs with cost savings, LTO is one of the best option in order to provide electric energy with Korean society

  15. Atrial fibrillation detection and R-wave synchronization by Metrix implantable atrial defibrillator - Implications for long-term efficacy and safety

    NARCIS (Netherlands)

    Tse, HF; Lau, CP; Sra, JS; Crijns, HJGM; Edvardsson, N; Kacet, S; Wyse, DG

    1999-01-01

    Background-The long-term efficacy of atrial fibrillation (AF) detection and R-wave synchronization are critical safety requirements for the development of an implantable atrial defibrillator (LAD) for treatment of AF. Methods and Results The long-term efficacy of the Metrix IAD for AF detection and

  16. Long-term safety and efficacy of fractionated stereotactic body radiation therapy for spinal metastases

    Energy Technology Data Exchange (ETDEWEB)

    Mantel, Frederick; Glatz, Stefan; Toussaint, Andre; Flentje, Michael; Guckenberger, Matthias [University Hospital Wuerzburg, Department of Radiation Oncology, Wuerzburg (Germany)

    2014-12-15

    Patients with long life expectancy despite metastatic status might benefit from long-term local control of spinal metastases. Dose-intensified radiotherapy (RT) is believed to control tumor growth better and thus offers longer pain relief. This single-institution study reports on fractionated stereotactic body radiation therapy (SBRT) for spinal metastases in patients with good life expectancy based on performance status, extent of metastases, histology, and time to metastasis. Between 2004 and 2010, 36 treatment sites in 32 patients (median age 55 years; male 61 %; median Karnofsky performance score 85) were treated with fractionated SBRT. The median treatment dose was 60 Gy (range, 48.5-65 Gy) given in a median of 20 fractions (range, 17-33); the median maximum dose to the planning risk volume for the spinal cord (PRV-SC) was 46.6 Gy. All patients suffering from pain prior to RT reported pain relief after treatment; after a median follow-up of 20.3 months, 61 % of treatment sites were pain-free, another 25 % associated with mild pain. In 86 % of treatments, patients were free from neurological symptoms at the time of the last clinical follow-up. Acute grade 1 toxicities (CTCAE 3.0) were observed in 11 patients. Myelopathy did not occur in any patient. Radiologically controlled freedom from local progression was 92 and 84 % after 12 and 24 months, respectively. Median overall survival (OS) was 19.6 months. Patient selection resulted in long OS despite metastatic disease, and dose-intensified fractionated SBRT for spinal metastases was safe and achieved long-term local tumor control and palliation of pain. (orig.) [German] Patienten mit guter Lebenserwartung trotz metastasierter Erkrankung koennten von einer lang andauernden lokalen Kontrolle von Wirbelsaeulenmetastasen profitieren. Eine dosisintensivierte Radiotherapie (RT) kann vermutlich eine bessere Tumorkontrolle und daher eine laengere Schmerzpalliation erreichen. Ausgewertet wurden die monozentrischen

  17. Methodologies for evaluating long-term stabilization designs of uranium mill tailings impoundments

    International Nuclear Information System (INIS)

    Nelson, J.D.; Abt, S.R.; Volpe, R.L.; Van Zye, D.; Hinkle, N.E.; Staub, W.P.

    1986-06-01

    Uranium mill tailings impoundments require long-term (200 to 1000 years) stabilization. This report reviews currently available methodologies for evaluating factors that can have a significant influence on tailings stabilization and develops methodologies in technical areas where none presently exist. Mill operators can use these methodologies to assist with (1) the selection of sites for mill tailings impoundments, (2) the design of stable impoundments, and (3) the development of reclamation plans for existing impoundments. These methodologies would also be useful for regulatory agency evaluations of proposals in permit or license applications. Methodologies were reviewed or developed in the following technical areas: (1) prediction of the Probable Maximum Precipitation (PMP) and an accompanying Probable Maximum Flood (PMF); (2) prediction of the stability of local and regional fluvial systems; (3) design of impoundment surfaces resistant to gully erosion; (4) evaluation of the potential for surface sheet erosion; (5) design of riprap for protecting embankments from channel flood flow and overland flow; (6) selection of riprap with appropriate durability for its intended use; and (7) evaluation of oversizing required for marginal quality riprap

  18. Evaluation of the long-term performance of six alternative disposal methods for LLRW

    Energy Technology Data Exchange (ETDEWEB)

    Kossik, R.; Sharp, G. [Golder Associates, Inc., Redmond, WA (United States); Chau, T. [Rogers & Associates Engineering Corp., Salt Lake City, UT (United States)

    1995-12-31

    The State of New York has carried out a comparison of six alternative disposal methods for low-level radioactive waste (LLRW). An important part of these evaluations involved quantitatively analyzing the long-term (10,000 yr) performance of the methods with respect to dose to humans, radionuclide concentrations in the environment, and cumulative release from the facility. Four near-surface methods (covered above-grade vault, uncovered above-grade vault, below-grade vault, augered holes) and two mine methods (vertical shaft mine and drift mine) were evaluated. Each method was analyzed for several generic site conditions applicable for the state. The evaluations were carried out using RIP (Repository Integration Program), an integrated, total system performance assessment computer code which has been applied to radioactive waste disposal facilities both in the U.S. (Yucca Mountain, WIPP) and worldwide. The evaluations indicate that mines in intact low-permeability rock and near-surface facilities with engineered covers generally have a high potential to perform well (within regulatory limits). Uncovered above-grade vaults and mines in highly fractured crystalline rock, however, have a high potential to perform poorly, exceeding regulatory limits.

  19. Long-term safety and efficacy of perinatal probiotic intervention: Evidence from a follow-up study of four randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Lundelin, Krista; Poussa, Tuija; Salminen, Seppo; Isolauri, Erika

    2017-03-01

    Societies worldwide are faced with a progressive increase in immune-mediated health problems such as allergic, autoimmune, and inflammatory diseases, as well as obesity. Perinatal administration of specific probiotic bacteria is an attractive approach in reducing the risk of these conditions, but long-term efficacy and safety data are lacking. The aim here was to evaluate the clinical benefit and long-term safety of specific probiotics administered during the perinatal period. The probiotic strains used were Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb-12, Lactobacillus paracasei ST11, and Bifidobacterium longum BL999. The children involved have subsequently undergone prospective long-term follow-up. In addition to physical examination, data were collected by structured questionnaires on non-communicable diseases and continued probiotic use, and growth data from welfare clinics and school nurses. Altogether 303 mother-infant pairs were included in the analysis. Seventy-six of 163 (47%) children receiving perinatal probiotics had developed allergic disease compared with 79 of 140 (56%) receiving placebo (OR 0.67, 95% confidence intervals [CI] 0.43-1.06, p = 0.09). Fifty-nine of 133 (44%) children receiving L. rhamnosus GG perinatally had developed allergic disease, OR 0.62, 95% CI 0.38-0.99, p = 0.047, as compared to placebo. We found no differences in growth or non-communicable disease prevalence between children receiving perinatally probiotics or placebo. Perinatal probiotic administration is safe in long-term follow-up. Children receiving L. rhamnosus GG perinatally tended to have decreased allergy prevalence. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. A synoptic summary approach to better understanding groundwater contamination problems and evaluating long-term environmental consequences

    International Nuclear Information System (INIS)

    Nelson, R.W.

    1990-09-01

    A summary approach has been developed within groundwater hydrology to communicate with a broad audience and more completely evaluate the long-term impacts of subsurface contamination problems. This synoptic approach both highlights the dominant features occurring in subsurface contamination problems and emphasizes the information required to determine the long-term environmental impacts. The special merit of a summary approach is in providing a better understanding of subsurface contamination problems to adjoining technical disciplines, public decision makers, and private citizens. 14 refs

  1. Ocular surface evaluation in eyes with chronic glaucoma on long term topical antiglaucoma therapy

    Directory of Open Access Journals (Sweden)

    Manu Saini

    2017-06-01

    Full Text Available AIM: To evaluate ocular surface changes and its correlation with the central corneal subbasal nerve fibre layer in chronic glaucoma patients. METHODS: A prospective comparative study of ocular surface evaluation was performed in 50 eyes of 25 patients using two or more antiglaucoma medications for at least 6mo and 50 eyes of 25 normal subjects without any ocular problems as controls. The study parameters evaluated included visual acuity, intraocular pressure, ocular surface evaluation parameters [fluorescein break-up time (FTBUT, Schirmer’s I test, ocular surface staining scores and ocular surface disease index score (OSDI], central corneal sensation (Cochet Bonnett aesthesiometer, central subbasal nerve fiber layer density (SBNFLD by confocal microscopy. RESULTS: The mean values in the glaucoma cases and control groups respectively were as follows: OSDI score (35.89±16.07/6.02±3.84; P=0.001, Schirmer’s I test score (7.63±2.64 mm/12.86±1.93 mm; P=0.001, FTBUT (9.44±2.76s/11.8±1.88s; P=0.001, corneal (5.7±2.33/ 1.1±0.58; P=0.001 and conjunctival staining score (5.06±1.94/0.84±0.46; P=0.001, corneal sensitivity (4.68±0.44/5.07±0.37; P=0.076, mean subbasal nerve fiber number (3.58±0.99/5.40±1.70; P=0.001, SBNFL length (1101.44±287.56 μm/1963.70±562.56 μm; P=0.001 and density (6883.94±1798.03 μm/mm2/12 273.15±3516.04 μm/mm2; P=0.001. Dry eye severity of level 2 and 3 was seen in 66% of glaucoma group. Corneal (R²=0.86 and conjunctival staining (R²=0.71 and OSDI score (R²=0.67 showed statistically significant negative correlation with central corneal SBNFLD while FTBUT (R²=0.84, corneal sensitivity (R²=0.52 showed positive correlation to central corneal SBNFLD in the long term topical antiglaucoma medication group. CONCLUSION: Ocular surface changes and antiglaucoma therapy induced dry eye is found to be associated with decreased SBNFLD in eyes on long term topical antiglaucoma medications.

  2. Phenomenological study on crystalline rock for evaluating of long-term behavior (Contract research)

    International Nuclear Information System (INIS)

    Okubo, Seisuke; Seno, Yasuhiro; Hirano, Toru; Matsui, Hiroya; Nakama, Shigeo

    2008-08-01

    The Japan Atomic Energy Agency (JAEA) is conducting the Mizunami Underground Research Laboratory (MIU) Project in order to develop comprehensive geological investigation and engineering techniques for deep underground applications (e.g. repository of HLW). The purpose of this study is to contribute to the evaluation of the mechanical stability of a research drift and to plan the future studies. Rock shows time-dependent behavior such as creep/relaxation. For the shaft and gallery of the geological disposal for the radioactive waste, the mechanical stability over a period of thousands of years is demanded not only during construction and operation but also after back-filling. So, to understand the time-dependent behavior of rock is very important for evaluating the long-term mechanical stability. This study is aiming to find out the mechanism of time-dependent behavior of rock such as creep by the precision test, observation and measurement, to develop the evaluating method of long-term behavior of rock mass, and to get the information for planning the study of the Phase III (Operation Phase) at the Mizunami URL. In the previous work conducted before this fiscal year 2007, we improved the testing technique and started test of Toki granite sampled from target site. Furthermore we studied the in-situ measurement method for evaluating the scatter of rock properties. This report describes the results of the works in the fiscal year 2007. In Chapter 1, we described the overview and background of this study. In Chapter 2, the result of continuing creep test of Tage tuff which was started from the fiscal year 1997 was described. Although there was some annual variability, the precious data were obtained. In Chapter 3, the control program for the generalized relaxation test was developed. The generalized relaxation test of Toki granite was conducted in order to get basically data. In Chapter 4, the extended constitutive equation of variable compliance was analytically

  3. Climate Considerations in Long-Term Safety Assessments for Nuclear Waste Repositories

    Energy Technology Data Exchange (ETDEWEB)

    Naeslund, Jens-Ove; Brandefelt, Jenny; Claesson Liljedahl, Lillemor [Svensk Kaernbraenslehantering AB, Stockholm (Sweden)], E-mail: jens-ove.naslund@skb.se

    2013-05-15

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  4. Climate considerations in long-term safety assessments for nuclear waste repositories.

    Science.gov (United States)

    Näslund, Jens-Ove; Brandefelt, Jenny; Liljedahl, Lillemor Claesson

    2013-05-01

    For a deep geological repository for spent nuclear fuel planned in Sweden, the safety assessment covers up to 1 million years. Climate scenarios range from high-end global warming for the coming 100 000 years, through deep permafrost, to large ice sheets during glacial conditions. In contrast, in an existing repository for short-lived waste the activity decays to low levels within a few tens of thousands of years. The shorter assessment period, 100 000 years, requires more focus on climate development over the coming tens of thousands of years, including the earliest possibility for permafrost growth and freezing of the engineered system. The handling of climate and climate change in safety assessments must be tailor-made for each repository concept and waste type. However, due to the uncertain future climate development on these vast time scales, all safety assessments for nuclear waste repositories require a range of possible climate scenarios.

  5. Long-term Safety of Pregnancy Following Breast Cancer According to Estrogen Receptor Status

    DEFF Research Database (Denmark)

    Lambertini, Matteo; Kroman, Niels; Ameye, Lieveke

    2018-01-01

    Safety of pregnancy in women with history of estrogen receptor (ER)-positive breast cancer remains controversial. In this multicenter case-control study, 333 patients with pregnancy after breast cancer were matched (1:3) to 874 nonpregnant patients of similar characteristics, adjusting for guaran......Safety of pregnancy in women with history of estrogen receptor (ER)-positive breast cancer remains controversial. In this multicenter case-control study, 333 patients with pregnancy after breast cancer were matched (1:3) to 874 nonpregnant patients of similar characteristics, adjusting...

  6. Long-term (5 years), high daily dosage of dietary agmatine--evidence of safety: a case report.

    Science.gov (United States)

    Gilad, Gad M; Gilad, Varda H

    2014-11-01

    There is presently a great interest in the therapeutic potential of agmatine, decarboxylated arginine, for various diseases. Recent clinical studies have already shown that oral agmatine sulfate given for up to 3 weeks provides a safe and, as compared with current therapeutics, more effective treatment for neuropathic pain. These studies have ushered in the use of dietary agmatine as a nutraceutical. However, in view of information paucity, assessment of long-term safety of oral agmatine treatment is now clearly required. The authors of this report undertook to assess their own health status during ongoing consumption of a high daily dosage of oral agmatine over a period of 4-5 years. A daily dose of 2.67 g agmatine sulfate was encapsulated in gelatin capsules; the regimen consists of six capsules daily, each containing 445 mg, three in the morning and three in the evening after meals. Clinical follow-up consists of periodic physical examinations and laboratory blood and urine analyses. All measurements thus far remain within normal values and good general health status is sustained throughout the study period, up to 5 years. This case study shows for the first time that the recommended high dosage of agmatine may be consumed for at least 5 years without evidence of any adverse effects. These initial findings are highly important as they provide significant evidence for the extended long-term safety of a high daily dosage of dietary agmatine--a cardinal advantage for its utility as a nutraceutical.

  7. Pacemaker replacement in nonagenarians: Procedural safety and long-term follow-up.

    Science.gov (United States)

    Loirat, Aurélie; Fénéon, Damien; Behaghel, Albin; Behar, Nathalie; Le Helloco, Alain; Mabo, Philippe; Daubert, Jean-Claude; Leclercq, Christophe; Martins, Raphaël P

    2015-01-01

    The rate of pacemaker implantation is rising. Given that the life expectancy of the population is projected to increase, a large number of elderly patients are likely to be implanted in the future. As pacemaker batteries can last for 8-10years, an increasing number of pacemaker recipients will require replacement of their devices when they become nonagenarians. To analyse the short- and long-term outcomes after device replacement in nonagenarians. Patients aged≥90years referred to a tertiary centre for pacemaker replacement from January 2004 to July 2014 were included retrospectively. Clinical follow-up data were obtained from clinical visits or telephone interviews with patients or their families. The primary clinical endpoint was total mortality. Secondary endpoints included early and delayed procedure-related complications and predictive risk factors for total mortality. Sixty-two patients were included (mean age 93.3±2.9years at time of pacemaker replacement). Mean procedure duration was 35.7±17.2minutes. Mean hospital stay was 2.2±1.1days. One patient died from a perioperative complication. Thirty-seven patients (59.7%) died during a median follow-up of 22.1months (interquartile range, 11.8-39.8months). Survival rates were 84.2% (95% confidence interval [CI] 71.8-91.5%) at 1year, 66.9% (95% CI 51.8-78.2%) at 2years and 22.7% (95% CI 10.6-37.7%) at 5years. Atrial fibrillation (hazard ratio 2.47, 95% CI 1.1-5.6) and non-physiological pacing (i.e. VVI pacing in patients in sinus rhythm) (hazard ratio 2.20, 95% CI 1.0-4.9) were predictors of mortality. Pacemaker replacement in nonagenarians is a safe and straightforward procedure. These data suggest that procedures can be performed securely in this old and frail population, with patients living for a median of 30months afterwards. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  8. Radiological evaluation of cartilage after microfracture treatment: A long-term follow-up study

    International Nuclear Information System (INIS)

    Von Keudell, A.; Atzwanger, J.; Forstner, R.; Resch, H.; Hoffelner, T.; Mayer, M.

    2012-01-01

    Introduction: Recent literature revealed good short-term results after microfracturing (MFX) of isolated focal cartilage defects in the knee joint. Study purpose was a long-term evaluation of patients who received MFX through a multimodal approach, correlating clinical scores and morphological pre- and postoperative MRI-scans. Materials and methods: Between 2000 and 2007 158 patients were treated with MFX for focal femoral or tibial defects at our department. Patients with instabilities, secondary surgical intervention, patellofemoral lesions, a plica mediopatellaris or more than one cartilage defect site and age >55 were excluded. 15 patients were included. Minimum postoperative follow-up (FU) was 18 months (18–78 m). Mean age at surgery was 45 years (27–54), mean FU-interval 48 months (18–78 m). Male to female ratio was 9:6. For clinical assessment the Knee Osteoarthritis Outcome Score (KOOS) and Lysholm Score were used, radiological evaluation was performed with radiographs and 3Tesla-MRI. Results: Clinical knee function was rated good to excellent in 1 patient, fair in 2 and poor in 10 patients. 2/15 patients received full knee replacement due to insufficient cartilage repair through MFX during FU period. Evaluation of pre- and postoperative MRI showed good cartilage repair tissue in 1 (7.7%), moderate repair in 2 (15.4%) and poor fill in 10 patients (76.9%). In these 10 patients the defect size increased. Average defect size preoperatively was 187 mm 2 (range 12–800 mm 2 ) and postoperatively 294 mm 2 (40–800 mm 2 ). The KOOS-Pain averaged 60 (39–94), KOOS-Symptoms 60.6 (21–100), KOOS-ADL 69 (21–91), KOOS-Sports 35.7 (5–60) and KOOS-QUL 37.2 (6–81). The average Lysholm Score was 73.9 (58–94). 10 patients showed a varus leg axis deviation (Ø 5.9°), 3 had a neutral alignment. The alignment correlated positively with KOOS and especially with the Lysholm Score. Conclusion: Our study demonstrated that MFX as a treatment option for cartilage

  9. Evaluating the soil physical quality under long-term field experiments in Southern Italy

    Science.gov (United States)

    Castellini, Mirko; Stellacci, Anna Maria; Iovino, Massimo; Rinaldi, Michele; Ventrella, Domenico

    2017-04-01

    Long-term field experiments performed in experimental farms are important research tools to assess the soil physical quality (SPQ) given that relatively stable conditions can be expected in these soils. However, different SPQ indicators may sometimes provide redundant or conflicting results, making difficult an SPQ evaluation (Castellini et al., 2014). As a consequence, it is necessary to apply appropriate statistical procedures to obtain a minimum set of key indicators. The study was carried out at the Experimental Farm of CREA-SCA (Foggia) in two long-term field experiments performed on durum wheat. The first long-term experiment is aiming at evaluating the effects of two residue management systems (burning, B or soil incorporation of crop residues, I) while the second at comparing the effect of tillage (conventional tillage, CT) and sod-seeding (direct drilling, DD). In order to take into account both optimal and non-optimal soil conditions, five SPQ indicators were monitored at 5-6 sampling dates during the crop season (i.e., between November and June): soil bulk density (BD), macroporosity (PMAC), air capacity (AC), plant available water capacity (PAWC) and relative field capacity (RFC). Two additional data sets, collected on DD plot in different cropping seasons and in Sicilian soils differing for texture, depth and land use (N=140), were also used with the aim to check the correlation among indicators. Impact of soil management was assessed by comparing SPQ evaluated under different management systems with optimal reference values reported in literature. Two techniques of multivariate analysis (principal component analysis, PCA and stepwise discriminant analysis, SDA) were applied to select the most suitable indicator to facilitate the judgment on SPQ. Regardless of the considered management system, sampling date or auxiliary data set, correlation matrices always showed significant negative relationships between RFC and AC. Decreasing RFC at increasing AC is

  10. Dungeness 'A' Nuclear Power Station. The findings of NII's assessment of Nuclear Electric's long term safety review

    International Nuclear Information System (INIS)

    1994-01-01

    The assessment is reported of Nuclear Electrics' Long Term Safety Reviews (LTSR) of the Dungeness A magnox reactors. The assessment was undertaken by the Health and Safety Executive's Nuclear Installations Inspectorate (NII) which is responsible for regulating the safety of nuclear installations in the United Kingdom. This was one of a programme of LTSRs for all the UK magnox reactors. The LTSR for each plant was proceeded by a Generic Issues programme. The results of both the LTSR and the Generic Issues programme have been used by NII in forming the conclusions of this assessment. Overall the safety case for Dungeness A is satisfactory for continued operation. A programme of additional modifications and inspections has been put in place which further enhances the safety justification. Reactor operations will continue to be monitored and regulated in accordance with the inspections required under the licensing arrangements. Provided these requirements and the agreed further analysis, improvements and inspections give satisfactory results it is expected that the station will be able to operate safely till each reactor is at least 30 years old. Beyond this point a further Periodic Safety Review will be required. (UK)

  11. Characterization, Improvement and Long Term Evaluation Of Cementitious Waste Products. An Indian Scenario

    International Nuclear Information System (INIS)

    Yaeotikar, R.G.; Rakesh, R.R.; Shirole, A.; Paul, B.; Valsala, T.P.; Choudhury, D.K.

    2013-01-01

    Cement is a very good matrix for immobilization for different types of wastes. In India, the cementation process has been adopted and used for the last four decades. Depending on the waste composition, there is need to formulate the cement waste matrix appropriately to ensure adequate compressive strength and chemical durability. This has been achieved by using different additives/backfill materials during the cementation process with cements for example Ordinary Portland Cement (OPC) and Slag Based Cements (SBC). Backfill materials studied include vermiculite and bentonite. They were evaluated for sorption characteristics, particle size distribution, water equilibration, etc. They were incorporated in the OPC-CWP (Cement Waste Product) with various waste compositions. The composition developed for ILW generated during reprocessing and during spent solvent hydrolysis were successfully adopted on a plant scale. Some of the compositions which are being developed are also in the process of being adopted in-plant. The long-term evaluation study of the CWP was carried out at actual site conditions where CWP in carbon steel drum, plastic drums and bare CWP were disposed in 2001 and removed in 2010: parameters including compressive strength and release of activity to the soil were measured. (author)

  12. EVALUATION OF RADIONUCLIDE ACCUMULATION IN SOIL DUE TO LONG-TERM IRRIGATION

    International Nuclear Information System (INIS)

    De Wesley Wu

    2006-01-01

    Radionuclide accumulation in soil due to long-term irrigation is an important part of the model for predicting radiation dose in a long period of time. The model usually assumes an equilibrium condition in soil with a constant irrigation rate, so that radionuclide concentration in soil does not change with time and can be analytically solved. This method is currently being used for the dose assessment in the Yucca Mountain project, which requires evaluating radiation dose for a period of 10,000 years. There are several issues associated with the method: (1) time required for the equilibrium condition, (2) validity of constant irrigation rate, (3) agricultural land use for a long period of time, and (4) variation of a radionuclide concentration in water. These issues are evaluated using a numerical method with a simple model built in the GoldSim software. Some key radionuclides, Tc-99, Np-237, Pu-239, and Am-241 are selected as representative radionuclides. The results indicate that the equilibrium model is acceptable except for a radionuclide that requires long time to accumulate in soil and that its concentration in water changes dramatically with time (i.e. a sharp peak). Then the calculated dose for that radionuclide could be overestimated using the current equilibrium method

  13. Long-term monitored catchments in Norway - a hydrologic and chemical evaluation -

    Energy Technology Data Exchange (ETDEWEB)

    Lydersen, E

    1994-10-20

    About 20 years ago, long-term monitoring of small Norwegian catchments were initiated, because of increasing concern regarding acidification of surface water and damage to fish populations. Long range transported air pollutants were considered to be the major acidification factor and so both precipitation and runoff chemistry were included in the monitoring programme. This report contains a thorough hydrologic and chemical evaluation of precipitation and runoff water separately as well as relationships between precipitation chemistry and runoff chemistry. The data comes from four catchments: Birkenes, Storgama, Langtjern and Kaarvatn. The chapters are (1) Sampling and analysis, (2) Description of the catchments, (3) Hydrology, (4) Chemistry, with subsections on wet deposition, dry deposition, concentration of marine compounds with distance from the sea, acid precipitation, runoff chemistry, sulphuric acid and other acidifying compounds, acid neutralizing capacity, and aluminium, (5) Time trends in precipitation and runoff chemistry. The time trends are evaluated in relation to the declining emissions of sulphur compounds in Europe since the late seventies. 134 refs., 213 figs., 54 tabs.

  14. Evaluation of long-term creep behaviour on K-cladding tubes

    International Nuclear Information System (INIS)

    Bang, J. G.; Jeong, Y. H.; Jeong, Y. H.

    2003-01-01

    KAERI has developed new zirconium alloys for high burnup fuel cladding. To evaluate the performance of these alloys, various out-pile tests are conducting. At high burnup, the creep resistance as well as corrosion resistance is one of the major factors determining nuclear fuel performance. Long-term creep test was performed at 350 .deg. C and 400 .deg. C and 100, 120, 135, and 150 MPa of applied hoop stress to evaluate the creep properties. The creep resistance was strongly affected by the final heat treatment conditions, while there was no effect of intermediate heat treatment. The creep strain of the recrystallized alloys is higher than that of the stress-relieved alloys by a factor of 3. The alloying elements also influenced the creep behaviour. Increase of Sn content enhanced the creep resistance, while Nb decreased the creep resistance. As a result of texture analysis, basal pole was directed to normal direction, while prism pole was to rolling direction. The development of the deformation texture and the ammealing texture showed almost similar process to Zircaloy cladding

  15. Evaluation of waste management options in view of long-term maintenance-free landfills

    International Nuclear Information System (INIS)

    Brunner, P.H.; Doeberl, G.; Huber, R.; Eder, M.; Pierrard, R.; Schoenbaeck, W.; Fruehwirth, W.; Hutterer, H.; Woeginger, H.

    2001-01-01

    The present case study compares and evaluates different waste management options with special consideration to their long-term implications. Multiple scenarios of these options were created and investigated as to which of term best fulfilled the goals of the Austrian waste management act (Abfallwirtschaftgesetz, AWG). Serving as a basis for this study, an elaborated model of the Austrian waste management, as described in GUA and IFIP (1998, 'Management of Household and Household-like Waste in Austria'), was used. Alterations to the GUA and IFIP study were done in order to best fulfill the needs of this assessment. Household and household-like waste, as well as municipal sewage sludge have been defined as the system input. The following list of scenarios were investigated against an up-dated status-quo (P0): M1 maximum landfilling of untreated waste; M2a maximum incineration without any after treatment; M2b maximum incineration with cement stabilization of the residual material; M2c maximum high temperature process; M3a maximum mechanical-biological treatment with the light fraction from sorting and splitting processed in a fluidized-bed furnace; M3b maximum mechanical-biological treatment with the light fraction from sorting and splitting processed in a rotary kiln for use in the cement industry; M3c maximum mechanical-biological treatment with the high caloric heavy fraction after decomposition processed in a fluidized-bed furnace; M3d maximum mechanical-biological treatment with the high caloric heavy fraction after decomposition processed in a rotary kiln for use in the cement industry. In order to oblige to the precautionary principle of the AWG, each of the scenarios were investigated, with regards to the short, middle, and long-term landfills behaviors of the deposited residual material. The macro-economical Cost-Benefit-Analysis (CBA) was used in the assessment. Additionally a so-called 'modified-Cost-Effect-Analysis' (MCEA) was developed. Unlike the

  16. Cosmetic Evaluation of long term results following intraoperative radiotherapy (IORT) of conservative surgery for breast carcinoma

    International Nuclear Information System (INIS)

    Fussl, C. M.

    2009-01-01

    Introduction In breast conserving therapy (BCT) of breast cancer, cosmetic results have become next to tumor-related outcome parameters a criterion of increasing awareness. The aim of this study is the evaluation of long term cosmetic results after conservative surgery and intraoperative radiotherapy with 10 Gy electrons (IOERT), followed by whole breast radiotherapy (WBRT) with 50-54 Gy. Patients and Methods From October 1998 to October 2005, 818 patients (median age 57.89 years) were treated by IOERT during breast conserving surgery, 12 of them for bilateral cancer. 32 patients were referred to mastectomy within primary treatment, 50 were reported as dead at the beginning of the study, 4 patients had developed an in-breast-recurrence and had been salvaged by secondary mastectomy, and in 41 cases an intercurrent dissemination was noted. All 679 remaining patients were invited in written form to participate in the cosmesis study. 403 of them (59.4%) have answered and were object of the evaluation (August 2006 to April 2007). To provide reproducible examination conditions, a standardized photo-documentation in four positions (frontal, loose-hanging and elevated arms; left and right lateral, elevated arms) was accomplished. Patients and treating physicians evaluated the cosmetic results separately within a 5-point-score (Excellent, Good, Moderate, Bad, Complications). Patient-, tumor- and treatment-related factors were investigated with regard to possible impact on the cosmetic outcome in all patients (group 1). A separate subgroup analysis was carried out for 261 patients with a follow-up of at least three years after completion of local treatment (group 2). For computation of the statistic correlation between the variables and the cosmetic evaluation the rank correlation coefficients Kendall's τ Spearman's ρ were used. A correlation is significant below a p-value of 0.05. Results The self-assessment of the patients in group 1 yielded around 69% excellent, 25

  17. Long-Term Efficacy and Safety of Biodegradable-Polymer Biolimus-Eluting Stents

    DEFF Research Database (Denmark)

    Kaiser, Christoph; Galatius, Søren; Jeger, Raban

    2015-01-01

    -DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined...... secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute...

  18. The UK system for regulating the long-term safety of radioactive waste disposal

    International Nuclear Information System (INIS)

    Duncan, A.

    1997-01-01

    The general system is described for regulation of disposal of solid, long-lived radioactive wastes. The relevant Government policy is outlined, and the framework of legislation and arrangements for implementation, the associated guidance produced by regulatory bodies and the approach to assessment by regulators of a safety case for radioactive waste disposal are reported. Also, for the purposes of discussion in the Workshop, some of the practical issues are considered which are still in development in the UK in regard to regulatory methodology. (author)

  19. Evaluating strategies for sustainable intensification of US agriculture through the Long-Term Agroecosystem Research network

    Science.gov (United States)

    Spiegal, S.; Bestelmeyer, B. T.; Archer, D. W.; Augustine, D. J.; Boughton, E. H.; Boughton, R. K.; Cavigelli, M. A.; Clark, P. E.; Derner, J. D.; Duncan, E. W.; Hapeman, C. J.; Harmel, R. D.; Heilman, P.; Holly, M. A.; Huggins, D. R.; King, K.; Kleinman, P. J. A.; Liebig, M. A.; Locke, M. A.; McCarty, G. W.; Millar, N.; Mirsky, S. B.; Moorman, T. B.; Pierson, F. B.; Rigby, J. R.; Robertson, G. P.; Steiner, J. L.; Strickland, T. C.; Swain, H. M.; Wienhold, B. J.; Wulfhorst, J. D.; Yost, M. A.; Walthall, C. L.

    2018-03-01

    Sustainable intensification is an emerging model for agriculture designed to reconcile accelerating global demand for agricultural products with long-term environmental stewardship. Defined here as increasing agricultural production while maintaining or improving environmental quality, sustainable intensification hinges upon decision-making by agricultural producers, consumers, and policy-makers. The Long-Term Agroecosystem Research (LTAR) network was established to inform these decisions. Here we introduce the LTAR Common Experiment, through which scientists and partnering producers in US croplands, rangelands, and pasturelands are conducting 21 independent but coordinated experiments. Each local effort compares the outcomes of a predominant, conventional production system in the region (‘business as usual’) with a system hypothesized to advance sustainable intensification (‘aspirational’). Following the logic of a conceptual model of interactions between agriculture, economics, society, and the environment, we identified commonalities among the 21 experiments in terms of (a) concerns about business-as-usual production, (b) ‘aspirational outcomes’ motivating research into alternatives, (c) strategies for achieving the outcomes, (d) practices that support the strategies, and (e) relationships between practice outreach and adoption. Network-wide, concerns about business as usual include the costs of inputs, opportunities lost to uniform management approaches, and vulnerability to accelerating environmental changes. Motivated by environmental, economic, and societal outcomes, scientists and partnering producers are investigating 15 practices in aspirational treatments to sustainably intensify agriculture, from crop diversification to ecological restoration. Collectively, the aspirational treatments reveal four general strategies for sustainable intensification: (1) reducing reliance on inputs through ecological intensification, (2) diversifying management

  20. Long-term results of symptomatic fibroids treated with uterine artery embolization: In conjunction with MR evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Man Deuk [Department of Diagnostic Radiology Bundang CHA General Hospital, Pochon CHA University (Korea, Republic of)], E-mail: mdkim@cha.ac.kr; Lee, Hyun Seok [Department of Diagnostic Radiology Bundang CHA General Hospital, Pochon CHA University (Korea, Republic of); Lee, Mee Hwa [Department of Obstetrics and Gynecology, Bundang CHA General Hospital, Pochon CHA University (Korea, Republic of); Kim, Hee Jin [Department of Diagnostic Radiology Bundang CHA General Hospital, Pochon CHA University (Korea, Republic of); Cho, Jin Ho; Cha, Sun Hee [Department of Obstetrics and Gynecology, Bundang CHA General Hospital, Pochon CHA University (Korea, Republic of)

    2010-02-15

    Objective: The aim of the present study is to determine long-term clinical efficacy of uterine fibroid embolization (UFE) for symptomatic fibroids in conjunction with MR evaluation. Materials and methods: Sixteen patients with a follow-up period of 4 years or longer were analyzed retrospectively. Ages ranged from 27 to 45 (mean 39.5) years. Mean follow-up periods were 5.8 years (range: 4.1-6.9 years). The symptom changes, in terms of menorrhagia and dysmenorrhea and bulk-related symptoms, were assessed. The primary embolic agent was polyvinyl alcohol particle (250-710 {mu}m). All patients underwent preprocedural and long-term follow up MR imaging. Uterine volumes were calculated using MRI. Results: Symptom improvements were reported for menorrhagia (8/9, 88.9%), dysmenorrhea (5/5, 100%), and bulk-related symptoms (7/9, 77.8%) at long-term follow up. Two patients (12.5%) had symptom recurrences at long-term follow-up. Tumor regrowth from incomplete infarction was a cause of recurrence in one patient and newly developed leiomyomas in the other one. One patient underwent hysterectomy because endometriosis developed 4 years after UFE. Of the 14 necrotic myomas on short-term follow up MR after UFE, eight (57.1%) demonstrated maintaining necrosis with further shrinkage and six (42.9%) were no longer visualized on long-term follow up MR images. Overall, the mean volume reduction rates of the predominant fibroid and uterus were 80.5%, 36.7% at long-term follow up, respectively. Conclusion: UFE is an effective treatment for symptomatic fibroids with an acceptable long-term success rate. Long-term MR imaging after UFE revealed persistent necrotic fibroid, non-visualization of fibroids and tumor regrowth when incompletely infarcted.

  1. Long-term results of symptomatic fibroids treated with uterine artery embolization: In conjunction with MR evaluation

    International Nuclear Information System (INIS)

    Kim, Man Deuk; Lee, Hyun Seok; Lee, Mee Hwa; Kim, Hee Jin; Cho, Jin Ho; Cha, Sun Hee

    2010-01-01

    Objective: The aim of the present study is to determine long-term clinical efficacy of uterine fibroid embolization (UFE) for symptomatic fibroids in conjunction with MR evaluation. Materials and methods: Sixteen patients with a follow-up period of 4 years or longer were analyzed retrospectively. Ages ranged from 27 to 45 (mean 39.5) years. Mean follow-up periods were 5.8 years (range: 4.1-6.9 years). The symptom changes, in terms of menorrhagia and dysmenorrhea and bulk-related symptoms, were assessed. The primary embolic agent was polyvinyl alcohol particle (250-710 μm). All patients underwent preprocedural and long-term follow up MR imaging. Uterine volumes were calculated using MRI. Results: Symptom improvements were reported for menorrhagia (8/9, 88.9%), dysmenorrhea (5/5, 100%), and bulk-related symptoms (7/9, 77.8%) at long-term follow up. Two patients (12.5%) had symptom recurrences at long-term follow-up. Tumor regrowth from incomplete infarction was a cause of recurrence in one patient and newly developed leiomyomas in the other one. One patient underwent hysterectomy because endometriosis developed 4 years after UFE. Of the 14 necrotic myomas on short-term follow up MR after UFE, eight (57.1%) demonstrated maintaining necrosis with further shrinkage and six (42.9%) were no longer visualized on long-term follow up MR images. Overall, the mean volume reduction rates of the predominant fibroid and uterus were 80.5%, 36.7% at long-term follow up, respectively. Conclusion: UFE is an effective treatment for symptomatic fibroids with an acceptable long-term success rate. Long-term MR imaging after UFE revealed persistent necrotic fibroid, non-visualization of fibroids and tumor regrowth when incompletely infarcted.

  2. Long-term safety and efficacy of etanercept in the treatment of ankylosing spondylitis

    Directory of Open Access Journals (Sweden)

    Senabre-Gallego JM

    2013-09-01

    Full Text Available José Miguel Senabre-Gallego,1 Carlos Santos-Ramirez,2 Gregorio Santos-Soler,1 Esteban Salas-Heredia,1 Mabel Sánchez-Barrioluengo,3 Xavier Barber,4 José Rosas1 On behalf of the AIRE-MB group 1Rheumatology, Hospital Marina Baixa, Villajoyosa, 2Rheumatology, Hospital Marina Salud, Denia, 3INGENIO (Instituto de Gestión de la Inovación y del Conocimiento (CSIC [Consejo Superior de Investigaciones Científicas]-UPV [Universidad Politécnica de Valencia], Universitat Politècnica de València, Valencia, 4CIO (Centro de Investigación Operativa-UMH (Universidad Miguel Hernández, Universidad Miguel Henández, Elche, Spain Abstract: To date, anti-tumor necrosis factor alfa (anti-TNF-α therapy is the only alternative to nonsteroidal anti-inflammatory drugs for the treatment of ankylosing spondylitis. Etanercept is a soluble TNF receptor, with a mode of action and pharmacokinetics different to those of antibodies and distinctive efficacy and safety. Etanercept has demonstrated efficacy in the treatment of ankylosing spondylitis, with or without radiographic sacroiliitis, and other manifestations of the disease, including peripheral arthritis, enthesitis, and psoriasis. Etanercept is not efficacious in inflammatory bowel disease, and its efficacy in the treatment of uveitis appears to be lower than that of other anti-TNF drugs. Studies of etanercept confirmed regression of bone edema on magnetic resonance imaging of the spine and sacroiliac joint, but failed to reduce radiographic progression, as do the other anti-TNF drugs. It seems that a proportion of patients remain in disease remission when the etanercept dose is reduced or administration intervals are extended. Etanercept is generally well tolerated with an acceptable safety profile in the treatment of ankylosing spondylitis. The most common adverse effect of etanercept treatment is injection site reactions, which are generally self-limiting. Reactivation of tuberculosis, reactivation of

  3. Long-term efficacy, safety and tolerability of Remoxy for the management of chronic pain.

    Science.gov (United States)

    Pergolizzi, Joseph V; Zampogna, Gianpietro; Taylor, Robert; Raffa, Robert B

    2015-03-01

    Historically, chronic pain generally went under-treated for a variety of objective and subjective reasons, including difficulty to objectively diagnose and manage over a long period of time, potential serious adverse effects of commonly available medications, and patient, healthcare and societal concerns over opioid medications. More recently, in an effort to redress the under-treatment of pain, the number of prescriptions of opioid analgesics has risen dramatically. However, paralleling the increased legitimate use has been a concomitant increase in opioid abuse, misuse and diversion. Pharmaceutical companies have responded by developing a variety of opioid formulations designed to deter abuse by making the products more difficult to tamper with. One such product is Remoxy(®), an extended-release formulation of the strong opioid oxycodone. We review the efficacy, safety and tolerability of this formulation based on the available published literature.

  4. Long-term safety and efficacy of deferasirox (Exjade) for up to 5 years in transfusional iron-overloaded patients with sickle cell disease.

    Science.gov (United States)

    Vichinsky, Elliott; Bernaudin, Françoise; Forni, Gian Luca; Gardner, Renee; Hassell, Kathryn; Heeney, Matthew M; Inusa, Baba; Kutlar, Abdullah; Lane, Peter; Mathias, Liesl; Porter, John; Tebbi, Cameron; Wilson, Felicia; Griffel, Louis; Deng, Wei; Giannone, Vanessa; Coates, Thomas

    2011-08-01

    To date, there is a lack of long-term safety and efficacy data for iron chelation therapy in transfusion-dependent patients with sickle cell disease (SCD). To evaluate the long-term safety and efficacy of deferasirox (a once-daily oral iron chelator), patients with SCD completing a 1-year, Phase II, randomized, deferoxamine (DFO)-controlled study entered a 4-year extension, continuing to receive deferasirox, or switching from DFO to deferasirox. Average actual deferasirox dose was 19·4 ± 6·3 mg/kg per d. Of 185 patients who received at least one deferasirox dose, 33·5% completed the 5-year study. The most common reasons for discontinuation were withdrawal of consent (23·8%), lost to follow-up (9·2%) and adverse events (AEs) (7·6%). Investigator-assessed drug-related AEs were predominantly gastrointestinal [including nausea (14·6%), diarrhoea (10·8%)], mild-to-moderate and transient in nature. Creatinine clearance remained within the normal range throughout the study. Despite conservative initial dosing, serum ferritin levels in patients with ≥ 4 years deferasirox exposure significantly decreased by -591 μg/l (95% confidence intervals, -1411, -280 μg/l; P = 0·027; n = 67). Long-term deferasirox treatment for up to 5 years had a clinically acceptable safety profile, including maintenance of normal renal function, in patients with SCD. Iron burden was substantially reduced with appropriate dosing in patients treated for at least 4 years. © 2011 Blackwell Publishing Ltd.

  5. Long-term safety and efficacy of deferasirox (Exjade®) for up to 5 years in transfusional iron-overloaded patients with sickle cell disease

    Science.gov (United States)

    Vichinsky, Elliott; Bernaudin, Françoise; Forni, Gian Luca; Gardner, Renee; Hassell, Kathryn; Heeney, Matthew M; Inusa, Baba; Kutlar, Abdullah; Lane, Peter; Mathias, Liesl; Porter, John; Tebbi, Cameron; Wilson, Felicia; Griffel, Louis; Deng, Wei; Giannone, Vanessa; Coates, Thomas

    2011-01-01

    To date, there is a lack of long-term safety and efficacy data for iron chelation therapy in transfusion-dependent patients with sickle cell disease (SCD). To evaluate the long-term safety and efficacy of deferasirox (a once-daily oral iron chelator), patients with SCD completing a 1-year, Phase II, randomized, deferoxamine (DFO)-controlled study entered a 4-year extension, continuing to receive deferasirox, or switching from DFO to deferasirox. Average actual deferasirox dose was 19·4 ± 6·3 mg/kg per d. Of 185 patients who received at least one deferasirox dose, 33·5% completed the 5-year study. The most common reasons for discontinuation were withdrawal of consent (23·8%), lost to follow-up (9·2%) and adverse events (AEs) (7·6%). Investigator-assessed drug-related AEs were predominantly gastrointestinal [including nausea (14·6%), diarrhoea (10·8%)], mild-to-moderate and transient in nature. Creatinine clearance remained within the normal range throughout the study. Despite conservative initial dosing, serum ferritin levels in patients with ≥4 years deferasirox exposure significantly decreased by −591 μg/l (95% confidence intervals, −1411, −280 μg/l; P=0·027; n=67). Long-term deferasirox treatment for up to 5 years had a clinically acceptable safety profile, including maintenance of normal renal function, in patients with SCD. Iron burden was substantially reduced with appropriate dosing in patients treated for at least 4 years. PMID:21592110

  6. Evaluating the marginal utility principle for long-term hydropower scheduling

    International Nuclear Information System (INIS)

    Zhao, Tongtiegang; Zhao, Jianshi; Liu, Pan; Lei, Xiaohui

    2015-01-01

    Highlights: • Analysis of one-, two- and multi-period hydropower scheduling. • Derivation of marginal cost and marginal return of carry-over storage. • Evaluation of the marginal utility principle in a case study of the Three Gorges Reservoir. - Abstract: The conversion of the potential energy of dammed water into hydropower depends on both reservoir storage and release, which are the major difficulties in hydropower reservoir operation. This study evaluates the marginal utility principle, which determines the optimal carry-over storage between periods, for long-term hydropower scheduling. Increasing marginal cost and decreasing marginal return are two important characteristics that determine the marginal utility principle in water supply. However, the notion of decreasing marginal return is inapplicable in hydropower scheduling. Instead, the carry-over storage from one period has an increasing marginal contribution to the power generation in the next period. Although carry-over storage incurs an increasing marginal cost to the power generation in the current period, the marginal return is higher than the marginal cost. The marginal return from the carry-over storage further increases in the multi-period case. These findings suggest saving as much carry-over storage as possible, which is bounded by the operational constraints of storage capacity, environmental flow, and installed capacity in actual hydropower scheduling. The marginal utility principle is evaluated for a case study of the Three Gorges Reservoir, and the effects of the constraints are discussed. Results confirm the theoretical findings and show that the marginal return from carry-over storage is larger than the marginal cost. The operational constraints help determine the optimal carry-over storage.

  7. Nuclear Materials Diversion Safety and the Long-term Future of Nuclear Energy

    International Nuclear Information System (INIS)

    Knapp, V.

    2002-01-01

    Primarily due to irresponsible cold war politics of nuclear weapon countries nuclear proliferation situation is little short of getting out of control. In addition to five nominal nuclear weapon countries there are at present at least three more nuclear weapon countries and several countries with nuclear weapon potential. Non-proliferation treaty (NPT), signed in 1970, has been recognized by most non-nuclear weapon countries as unjust and ineffective. After the initial, deliberate, nuclear weapon developments of five nominal nuclear weapon countries, subsequent paths to nuclear weapons have been preceded by nominal peaceful use of nuclear energy. Uranium enrichment installations as well as reprocessing installations in non-nuclear weapon countries are the weakest spots of fuel cycle for diversion of nuclear materials either by governments or by illicit groups. An energy scenario, which would, by the end of century, replace the large part of fossil fuels use through extension of present nuclear practices, would mean very large increase in a number of such installations, with corresponding increase of the probability of diversion of nuclear materials. Such future is not acceptable from the point of view of proliferation safety. Recent events make it clear, that it cannot be accepted from the requirements of nuclear terrorism safety either. Nuclear community should put it clearly to their respective governments that the time has come to put general interest before the supposed national interest, by placing all enrichment and reprocessing installations under full international control. Such internationalization has a chance to be accepted by non-nuclear weapon countries, only in case should it apply to nuclear weapon countries as well, without exception. Recent terrorist acts, however horrible they were, are child,s play compared with possible acts of nuclear terrorism. Nuclear energy can be made proliferation safe and diversion of nuclear materials safe, and provide

  8. IGSC Experience: Links Between RD and D and Stakeholder Confidence: The Aspect of Long-Term Safety

    International Nuclear Information System (INIS)

    Stroemberg, Bo

    2008-01-01

    Bo Stroemberg from the IGSC Core Group (SKI, Sweden) reported on the International Symposium on the Safety Case organised in 2007 by IGSC. Participants of a session focusing on the role of the safety case in societal dialogue pointed out that in the technical community there is a shared understanding of the issues of long-term safety, which the SC should address. They observed, however, that public concerns may be quite different from these issues. For example, the extremely long timescales are not easily understood by the broader public. Also, technical experts' focus on quantitative indicators is incompatible with the perceptions of non-experts, who tend to give heavier weight to qualitative characteristics of risks. Therefore, conducting a dialogue with the public in which their safety concerns are explored is of key importance. It is not only the technical content but also the presentation of the SC which should be adapted to stakeholders' concerns. At the same time, stakeholder input can improve both the technical basis and the presentation of the SC. Mr Stroemberg went on to present IGSC Core Group answers to questions addressed to them by the FSC: 1. What are the questions about safety and the safety case you feel the public is asking? What kind of reply? Or approach to replying? Do they require? What weight should they be given? 2. How has dialogue with stakeholders improved your safety case? What lessons may be drawn for the technical community to improve on its capability to respond to questions from the general public and other stakeholders? 3. What is the role of RD and D when arguing safety or confidence in safety? Anecdotal experience was received from Europe, Japan and the United States. Common concerns expressed by the public focus on how scientists can 'know they are right' when making safety predictions for the long term, and whether unexpected events can be addressed. Because some concerns fall beyond the topics typically covered by a safety case

  9. Safety of long-term subcutaneous free flap skin banking after skin-sparing mastectomy.

    Science.gov (United States)

    Verstappen, Ralph; Djedovic, Gabriel; Morandi, Evi Maria; Heiser, Dietmar; Rieger, Ulrich Michael; Bauer, Thomas

    2018-03-01

    A persistent problem in autologous breast reconstruction in skin-sparing mastectomies is skin restoration after skin necrosis or secondary oncological resection. As a solution to facilitate reconstruction, skin banking of free-flap skin has been proposed in cases where the overlying skin envelope must be resected, as this technique spares the patient an additional donor site. Herein, we present the largest series to date in which this method was used. We investigated its safety and the possibility of skin banking for prolonged periods of time. All skin-sparing mastectomies and immediate autologous breast reconstructions from December 2009 until June 2013 at our institution were analysed. We identified 31 patients who underwent 33 free flap reconstructions in which skin banking was performed. Our median skin banking period was 7 days, with a maximum duration of 171 days. In 22.5% of cases, the banked skin was used to reconstruct overlying skin defects, and in 9.6% of cases to reconstruct the nipple-areolar complex. Microbiological and histological investigations of the banked skin revealed neither clinical infections nor malignancies. In situ skin banking, even for prolonged periods of time, is a safe and cost-effective method to ensure that skin defects due to necrosis or secondary oncological resection can be easily reconstructed.

  10. Safety of long-term subcutaneous free flap skin banking after skin-sparing mastectomy

    Directory of Open Access Journals (Sweden)

    Ralph Verstappen

    2018-03-01

    Full Text Available Background A persistent problem in autologous breast reconstruction in skin-sparing mastectomies is skin restoration after skin necrosis or secondary oncological resection. As a solution to facilitate reconstruction, skin banking of free-flap skin has been proposed in cases where the overlying skin envelope must be resected, as this technique spares the patient an additional donor site. Herein, we present the largest series to date in which this method was used. We investigated its safety and the possibility of skin banking for prolonged periods of time. Methods All skin-sparing mastectomies and immediate autologous breast reconstructions from December 2009 until June 2013 at our institution were analysed. Results We identified 31 patients who underwent 33 free flap reconstructions in which skin banking was performed. Our median skin banking period was 7 days, with a maximum duration of 171 days. In 22.5% of cases, the banked skin was used to reconstruct overlying skin defects, and in 9.6% of cases to reconstruct the nipple-areolar complex. Microbiological and histological investigations of the banked skin revealed neither clinical infections nor malignancies. Conclusions In situ skin banking, even for prolonged periods of time, is a safe and cost-effective method to ensure that skin defects due to necrosis or secondary oncological resection can be easily reconstructed.

  11. The long term storage of radioactive waste: Safety and sustainability. A position paper of international experts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-06-01

    The purpose of the report is to reflect the currently prevailing views among experts in the field of radioactive waste storage and disposal. It is intended for use as a central and authoritative reference point for national discussions and policy papers. It is therefore potentially useful to national committees and bodies concerned with the management of radioactive waste. It may also be of value to concerned members of the public since it is written in language that should be comprehensible to the informed lay person. It was produced as a result of several meetings of experts in the first part of 2002. Since then, it has been reviewed by the international Waste Safety Standards Committee (WASSC), by the WASSC Subgroup on Principles and Criteria for the Disposal of Radioactive Waste at its meeting in October 2000 and by a technical committee convened specifically to review the paper at a meeting held in November 2002. Finally, the essential conclusions of the paper were presented to and discussed with participants to the International Conference on Issues and Trends in Radioactive Waste Management, held in Vienna in December 2002.

  12. The long term storage of radioactive waste: Safety and sustainability. A position paper of international experts

    International Nuclear Information System (INIS)

    2003-06-01

    The purpose of the report is to reflect the currently prevailing views among experts in the field of radioactive waste storage and disposal. It is intended for use as a central and authoritative reference point for national discussions and policy papers. It is therefore potentially useful to national committees and bodies concerned with the management of radioactive waste. It may also be of value to concerned members of the public since it is written in language that should be comprehensible to the informed lay person. It was produced as a result of several meetings of experts in the first part of 2002. Since then, it has been reviewed by the international Waste Safety Standards Committee (WASSC), by the WASSC Subgroup on Principles and Criteria for the Disposal of Radioactive Waste at its meeting in October 2000 and by a technical committee convened specifically to review the paper at a meeting held in November 2002. Finally, the essential conclusions of the paper were presented to and discussed with participants to the International Conference on Issues and Trends in Radioactive Waste Management, held in Vienna in December 2002

  13. Safety and feasibility of long-term intravenous sodium nitrite infusion in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Ryszard M Pluta

    Full Text Available BACKGROUND: Infusion of sodium nitrite could provide sustained therapeutic concentrations of nitric oxide (NO for the treatment of a variety of vascular disorders. The study was developed to determine the safety and feasibility of prolonged sodium nitrite infusion. METHODOLOGY: Healthy volunteers, aged 21 to 60 years old, were candidates for the study performed at the National Institutes of Health (NIH; protocol 05-N-0075 between July 2007 and August 2008. All subjects provided written consent to participate. Twelve subjects (5 males, 7 females; mean age, 38.8±9.2 years (range, 21-56 years were intravenously infused with increasing doses of sodium nitrite for 48 hours (starting dose at 4.2 µg/kg/hr; maximal dose of 533.8 µg/kg/hr. Clinical, physiologic and laboratory data before, during and after infusion were analyzed. FINDINGS: The maximal tolerated dose for intravenous infusion of sodium nitrite was 267 µg/kg/hr. Dose limiting toxicity occurred at 446 µg/kg/hr. Toxicity included a transient asymptomatic decrease of mean arterial blood pressure (more than 15 mmHg and/or an asymptomatic increase of methemoglobin level above 5%. Nitrite, nitrate, S-nitrosothiols concentrations in plasma and whole blood increased in all subjects and returned to preinfusion baseline values within 12 hours after cessation of the infusion. The mean half-life of nitrite estimated at maximal tolerated dose was 45.3 minutes for plasma and 51.4 minutes for whole blood. CONCLUSION: Sodium nitrite can be safely infused intravenously at defined concentrations for prolonged intervals. These results should be valuable for developing studies to investigate new NO treatment paradigms for a variety of clinical disorders, including cerebral vasospasm after subarachnoid hemorrhage, and ischemia of the heart, liver, kidney and brain, as well as organ transplants, blood-brain barrier modulation and pulmonary hypertension. CLINICAL TRIAL REGISTRATION INFORMATION: http

  14. Evaluating and ranking threats to the long-term persistence of polar bears

    Science.gov (United States)

    Atwood, Todd C.; Marcot, Bruce G.; Douglas, David C.; Amstrup, Steven C.; Rode, Karyn D.; Durner, George M.; Bromaghin, Jeffrey F.

    2015-01-01

    The polar bear (Ursus maritimus) was listed as a globally threatened species under the U.S. Endangered Species Act (ESA) in 2008, mostly due to the significant threat to their future population viability from rapidly declining Arctic sea ice. A core mandate of the ESA is the development of a recovery plan that identifies steps to maintain viable populations of a listed species. A substantive evaluation of the relative influence of putative threats to population persistence is helpful to recovery planning. Because management actions must often be taken in the face of substantial information gaps, a formalized evaluation hypothesizing potential stressors and their relationships with population persistence can improve identification of relevant conservation actions. To this end, we updated a Bayesian network model previously used to forecast the future status of polar bears worldwide. We used new information on actual and predicted sea ice loss and polar bear responses to evaluate the relative influence of plausible threats and their mitigation through management actions on the persistence of polar bears in four ecoregions. We found that polar bear outcomes worsened over time through the end of the century under both stabilized and unabated greenhouse gas (GHG) emission pathways. Under the unabated pathway (i.e., RCP 8.5), the time it took for polar bear populations in two of four ecoregions to reach a dominant probability of greatly decreased was hastened by about 25 years. Under the stabilized GHG emission pathway (i.e., RCP 4.5), where GHG emissions peak around the year 2040, the polar bear population in the Archipelago Ecoregion of High Arctic Canada never reached a dominant probability of greatly decreased, reinforcing earlier suggestions of this ecoregion’s potential to serve as a long-term refugium. The most influential drivers of adverse polar bear outcomes were declines to overall sea ice conditions and to the marine prey base. Improved sea ice conditions

  15. Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease

    DEFF Research Database (Denmark)

    Chaparro, M; Verreth, A; Lobaton, T

    2018-01-01

    OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs...... in utero with that of children who were not exposed to the drugs. METHODS: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNFα medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non......-exposed cohort: children from mothers with IBD not treated with anti-TNFα agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox...

  16. Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry.

    Science.gov (United States)

    Menter, Alan; Thaçi, Diamant; Wu, Jashin J; Abramovits, William; Kerdel, Francisco; Arikan, Dilek; Guo, Dianlin; Ganguli, Arijit; Bereswill, Mareike; Camez, Anne; Valdecantos, Wendell C

    2017-09-01

    ESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term safety, effectiveness, and patient-reported outcomes (PROs) following adalimumab treatment over the first 7 years of the ESPRIT registry. All treatment-emergent (All-TE) adverse events (AE) since the initial (first ever) dose of adalimumab were assessed. Physician Global Assessment (PGA) and PROs (PROs for US patients only) were evaluated during registry participation. As of 30 November 2015, 6051 patients in the ESPRIT registry were analyzed, representing 23,660.1 patient-years (PY) of overall adalimumab exposure. The incidence rates for All-TE serious AEs, serious infections, and malignancies were 4.4, 1.0, and 1.0 events per 100 PY (E/100PY), respectively. The standardized mortality ratio for TE deaths in the registry was 0.27 (95% CI 0.18-0.38). During the registry's first 7 years, PGA "clear" or "minimal" was achieved by >50% of patients at each annual visit, and among US patients, the mean improvement from baseline in different PROs was maintained. No new safety signals were identified during the first 7 years of the registry, and safety was consistent with the known safety profile of adalimumab. The number of TE deaths was below the expected rate. During the registry's first 7 years, most of the patients remained free of All-TE cardiovascular events, serious infections, and malignancy. As-observed effectiveness of adalimumab and improvements from baseline in PROs were maintained through 7 years of registry participation. Abbvie. ClinicalTrials.gov identifier, NCT00799877.

  17. Mathematical models as tools for probing long-term safety of CO2 storage

    Energy Technology Data Exchange (ETDEWEB)

    Pruess, Karsten; Birkholzer, Jens; Zhou, Quanlin

    2009-02-01

    Subsurface reservoirs being considered for storing CO{sub 2} include saline aquifers, oil and gas reservoirs, and unmineable coal seams (Baines and Worden, 2004; IPCC, 2005). By far the greatest storage capacity is in saline aquifers (Dooley et al., 2004), and our discussion will focus primarily on CO{sub 2} storage in saline formations. Most issues for safety and security of CO{sub 2} storage arise from the fact that, at typical temperature and pressure conditions encountered in terrestrial crust, CO{sub 2} is less dense than aqueous fluids. Accordingly, CO{sub 2} will experience an upward buoyancy force in most subsurface environments, and will tend to migrate upwards whenever (sub-)vertical permeable pathways are available, such as fracture zones, faults, or improperly abandoned wells (Bachu, 2008; Pruess, 2008a, b; Tsang et al., 2008). CO{sub 2} injection will increase fluid pressures in the target formation, thereby altering effective stress distributions, and potentially triggering movement along fractures and faults that could increase their permeability and reduce the effectiveness of a caprock in containing CO{sub 2} (Rutqvist et al., 2008; Chiaramonte et al., 2008). Induced seismicity as a consequence of fluid injection is also a concern (Healy et al., 1968; Raleigh et al., 1976; Majer et al., 2007). Dissolution of CO{sub 2} in the aqueous phase generates carbonic acid, which may induce chemical corrosion (dissolution) of minerals with associated increase in formation porosity and permeability, and may also mediate sequestration of CO{sub 2} as solid carbonate (Gaus et al., 2008). Chemical dissolution of caprock minerals could promote leakage of CO{sub 2} from a storage reservoir (Gherardi et al., 2007). Chemical dissolution and geomechanical effects could reinforce one another in compromising CO{sub 2} containment. Additional issues arise from the potential of CO{sub 2} to mobilize hazardous chemical species (Kharaka et al., 2006), and from migration of

  18. Aspects of operational safety and long-term structural stability of the Morsleben repository for radioactive wastes (ERAM)

    International Nuclear Information System (INIS)

    Wernicke, R.S.

    1997-01-01

    The results of safety evaluations and safety reports reveal undoubtedly, that the Morsleben final repository operations is safe and responsible. On the basis of safety-technical evaluations some need was identified for locally optimizing the repository operations and possibly also some geotechnical features of the mine. However, this does not raise safety-related questions for man and the environment. In addition to the control exercised by the supervisory body, continuing evaluations of the repository operations assure, that changes of the safety status will be recognized in a timely manner and that competent action may be taken if necessary. (orig.) [de

  19. Long-term results of radiotherapy for periarthritis of the shoulder: a retrospective evaluation

    International Nuclear Information System (INIS)

    Niewald, Marcus; Fleckenstein, Jochen; Naumann, Susanne; Ruebe, Christian

    2007-01-01

    To evaluate retrospectively the results of radiotherapy for periarthritis of the shoulder In 1983–2004, 141 patients were treated, all had attended at least one follow-up examination. 19% had had pain for several weeks, 66% for months and 14% for years. Shoulder motility was impaired in 137/140 patients. Nearly all patients had taken oral analgesics, 81% had undergone physiotherapy, five patients had been operated on, and six had been irradiated. Radiotherapy was applied using regular anterior-posterior opposing portals and Co-60 gamma rays or 4 MV photons. 89% of the patients received a total dose of 6 Gy (dose/fraction of 1 Gy twice weekly, the others had total doses ranging from 4 to 8 Gy. The patients and the referring doctors were given written questionnaires in order to obtain long-term results. The mean duration of follow-up was 6.9 years [0–20 years]. During the first follow-up examination at the end of radiotherapy 56% of the patients reported pain relief and improvement of motility. After in median 4.5 months the values were 69 and 89%, after 3.9 years 73% and 73%, respectively. There were virtually no side effects. In the questionnaires, 69% of the patients reported pain relief directly after radiotherapy, 31% up to 12 weeks after radiotherapy. 56% of the patients stated that pain relief had lasted for 'years', in further 12% at least for 'months'. Low-dose radiotherapy for periarthropathy of the shoulder was highly effective and yielded long-lasting improvement of pain and motility without side effects

  20. Long Term Evaluation of Yield Stability Trend for Cereal Crops in Iran

    Directory of Open Access Journals (Sweden)

    mehdi nassiri mahalati

    2016-05-01

    Full Text Available During the last few decades cereals yield have increased drastically at the national level however, information about yield stability and its resistance to annual environmental variability are scare. In this study long term stability of grin yield of wheat, barley, rice, corn and overall cereals in Iran were evaluated during a 40-year period (1971-2011. Stability analysis was conducted using two different methods. In the first method the residuals of regression between crop yield and time (years were calculated as stability index. For this different segmented regression models including linear, bi-linear and tri-linear were fitted to yield trend data and the best model for each crop was selected based on statistical measures. Absolute residuals (the difference between actual and predicted yields for each year as well as relative residuals (absolute residuals as percent of predicted yield were estimated. In the second method yield stability was estimated from the slope of the regression line between average annual yield of all cereals (environmental index and the yield of each crop in the same year. Results indicted that in wheat and barley absolute and relative residuals were increased during the study period leading to reduction of stability despite considerable yield increment. However, for rice and corn residuals followed a decreasing trend and therefore yield stability of these crops was increased during the last 40 years. The same result was obtained with the environmental index but in this method reduction of yield stability in barley was lower than wheat. Based on the results, yield and yield stability of cereals crops in Iran increased during the last 40 years. However, the percentage increase in stability is lower than that of yield. Application of nitrogen fertilizers was led to reduction in stability. Yield stability of wheat, barley, rice, corn and overall cereals was improved with increasing their cultivated area.

  1. Long-term functional evaluation of videoarthroscopic treatment of partial injuries of the rotator cuff

    Directory of Open Access Journals (Sweden)

    Glaydson Gomes Godinho

    2015-04-01

    Full Text Available OBJECTIVE: To compare the functional results from high and low-grade isolated partial lesions of the supraspinatus tendon of bursal and articular types, after arthroscopic treatment.METHODS: Sixty-four patients with isolated partial lesions of the supraspinatus tendon were evaluated. The mean length of follow-up was 76 months (range: 29-193. The mean age was 59 years (range: 36-82. The dominant side was affected in 44 patients (68.8%. There were 35 bursal lesions (54.7% and 29 articular lesions (45.3%. We used the Ellman classification and characterized the lesions as low or high-grade according to whether they affected less than or more than 50% of the tendon thickness, respectively. Debridement was performed in 15 patients (23.5%, repair without completing the lesion in 11 (17% and repair after completing the lesion in 38 (59.5%. The functional assessments on the patients were done using the Constant & Murley and UCLA scores.RESULTS: The mean Constant & Murley score among the patients with bursal lesions was 82.64 ± 6.98 (range: 59.3-99 and among those with articular lesions, 83.57 ± 7.58 (range: 66-95, while the mean UCLA score in the bursal lesions was 33.37 ± 2.85 (range: 21-35 and in the articular lesions, 32.83 ± 2.95 (range: 22-35.CONCLUSION: Videoarthroscopic treatment of partial lesions of the rotator cuff presents good or excellent results when the low-grade lesions are debrided and the high-grade lesions are completed and repaired. These results are maintained over the long term, with a high satisfaction rate and few complications.

  2. Accelerated forgetting? An evaluation on the use of long-term forgetting rates in patients with memory problems

    Directory of Open Access Journals (Sweden)

    Sofie eGeurts

    2015-06-01

    Full Text Available The main focus of this review was to evaluate whether long-term forgetting rates (delayed tests days to weeks after initial learning are a more sensitive measure to detect memory problems in various patient groups than standard delayed recall measures. It has been suggested that accelerated forgetting might be characteristic for epilepsy patients, but little research has been performed within other populations. Here, we identified ten studies in a wide range of brain injured patient groups, whose long-term forgetting patterns were compared to that of healthy controls. Signs of accelerated forgetting were found within two studies. The results of seven studies showed normal forgetting over time for the patient groups. However, most of the studies used only a recognition procedure, after optimizing initial learning. Based on the results, we discuss recommendations for assessing long-term forgetting and the need for future research to truly evaluate the usefulness for clinical practice.

  3. Long-term evaluation of intraoperative neurophysiological monitoring-assisted tethered cord surgery

    NARCIS (Netherlands)

    Dulfer, S E; Drost, G; Lange, F; Journee, H L; Wapstra, F H; Hoving, E W

    2017-01-01

    PURPOSE: Patients with tethered spinal cord have been investigated for short-term effects after tethered spinal cord surgery in the past. However, little is known about the long-term effects in this patient group. In this retrospective, longitudinal, observational study, a patient sample of a

  4. Long-term evaluation of home-based pulmonary rehabilitation in patients with COPD

    Directory of Open Access Journals (Sweden)

    Grosbois JM

    2015-09-01

    Full Text Available Jean Marie Grosbois,1,2 Alice Gicquello,3 Carole Langlois,4 Olivier Le Rouzic,3 Frédéric Bart,2 Benoit Wallaert,2,3 Cécile Chenivesse5 1FormAction Santé, rue Pietralunga, Pérenchies, 2Service de Pneumologie, CH Béthune, 3Service de Pneumologie et Immunoallergologie, Centre des Compétences des Maladies Pulmonaires Rares, Hôpital Calmette, CHRU Lille, 4Unité de Biostatistiques, CHRU Lille, 5AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie et Réanimation Médicale, Boulevard de l’Hôpital, Paris, France Introduction: Personalized, global pulmonary rehabilitation (PR management of patients with COPD is effective, regardless of the place in which this rehabilitation is provided. The objective of this retrospective observational study was to study the long-term outcome of exercise capacity and quality of life during management of patients with COPD treated by home-based PR.Methods: Home-based PR was administered to 211 patients with COPD (mean age, 62.3±11.1 years; mean forced expiratory volume in 1 second, 41.5%±17.7%. Home-based PR was chosen because of the distance of the patient’s home from the PR center and the patient’s preference. Each patient was individually managed by a team member once a week for 8 weeks with unsupervised continuation of physical exercises on the other days of the week according to an individual action plan. Exercise conditioning, therapeutic patient education, and self-management were included in the PR program. The home assessment comprised evaluation of the patient’s exercise capacity by a 6-minute stepper test, Timed Up and Go test, ten times sit-to-stand test, Hospital Anxiety and Depression score, and quality of life (Visual Simplified Respiratory Questionnaire, VQ11, Maugeri Respiratory Failure 28.Results: No incidents or accidents were observed during the course of home-based PR. The 6-minute stepper test was significantly improved after completion of the

  5. Longitudinal study to assess the safety and efficacy of a live-attenuated SHIV vaccine in long term immunized rhesus macaques

    International Nuclear Information System (INIS)

    Yankee, Thomas M.; Sheffer, Darlene; Liu Zhengian; Dhillon, Sukhbir; Jia Fenglan; Chebloune, Yahia; Stephens, Edward B.; Narayan, Opendra

    2009-01-01

    Live-attenuated viruses derived from SIV and SHIV have provided the most consistent protection against challenge with pathogenic viruses, but concerns regarding their long-term safety and efficacy have hampered their clinical usefulness. We report a longitudinal study in which we evaluated the long-term safety and efficacy of ΔvpuSHIV PPC , a live virus vaccine derived from SHIV PPC . Macaques were administered two inoculations of ΔvpuSHIV PPC , three years apart, and followed for eight years. None of the five vaccinated macaques developed an AIDS-like disease from the vaccine. At eight years, macaques were challenged with pathogenic SIV and SHIV. None of the four macaques with detectable cellular-mediated immunity prior to challenge had detectable viral RNA in the plasma. This study demonstrates that multiple inoculations of a live vaccine virus can be used safely and can significantly extend the efficacy of the vaccine, as compared to a single inoculation, which is efficacious for approximately three years

  6. Evaluation of long-term water-level declines in basalt aquifers near Mosier, Oregon

    Science.gov (United States)

    Burns, Erick R.; Morgan, David S.; Lee, Karl K.; Haynes, Jonathan V.; Conlon, Terrence D.

    2012-01-01

    are not sustainable, (2) well construction practices that have resulted in leakage from aquifers into springs and streams, and (3) reduction in aquifer recharge resulting from long-term climate variations. Historical well construction practices, specifically open, unlined, uncased boreholes that result in cross-connecting (or commingling) multiple aquifers, allow water to flow between these aquifers. Water flowing along the path of least resistance, through commingled boreholes, allows the drainage of aquifers that previously stored water more efficiently. The study area is in the eastern foothills of the Cascade Range in north central Oregon in a transitional zone between the High Cascades to the west and the Columbia Plateau to the east. The 78-square mile (mi2) area is defined by the drainages of three streams - Mosier Creek (51.8 mi2), Rock Creek (13.9 mi2), and Rowena Creek (6.9 mi2) - plus a small area that drains directly to the Columbia River.The three major components of the study are: (1) a 2-year intensive data collection period to augment previous streamflow and groundwater-level measurements, (2) precipitation-runoff modeling of the watersheds to determine the amount of recharge to the aquifer system, and (3) groundwater-flow modeling and analysis to evaluate the cause of groundwater-level declines and to evaluate possible water resource management strategies. Data collection included the following: 1. Water-level measurements were made in 37 wells. Bi-monthly or quarterly measurements were made in 30 wells, and continuous water-level monitoring instruments were installed in 7 wells. The measurements principally were made to capture the seasonal patterns in the groundwater system, and to augment the available long-term record. 2. Groundwater pumping was measured, reported, or estimated from irrigation, municipal and domestic wells. Flowmeters were installed on 74 percent of all high-capacity irrigation wells in the study area. 3. Borehole geophysical data

  7. Long-term safety of etanercept and adalimumab compared to methotrexate in patients with juvenile idiopathic arthritis (JIA).

    Science.gov (United States)

    Klotsche, Jens; Niewerth, Martina; Haas, Johannes-Peter; Huppertz, Hans-Iko; Zink, Angela; Horneff, Gerd; Minden, Kirsten

    2016-05-01

    Published evidence on the long-term safety of etanercept (ETA) and adalimumab (ADA) in patients with polyarticular juvenile idiopathic arthritis (pJIA) is still limited. To investigate the rates of serious adverse events (SAE) and of events of special interest (ESI) under ETA and ADA treatment. Patients with pJIA were prospectively observed in the national JIA biological register, Biologika in der Kinderrheumatologie, and its follow-up register, Juvenile arthritis Methotrexate/Biologics long-term Observation. We calculated the relative risks of SAE and ESI for ETA and ADA compared with methotrexate (MTX). Among the 1414 patients treated with ETA (n=1414; 4461 exposure years (EY)) and ADA (n=320; 493 EY), significantly more SAE, infections and medically important infections were observed (ETA: 4.5, 5.7, 0.9; ADA: 4.7, 11.4, 0.4 per 100 EY) compared with those treated with MTX alone (n=1455; 2.907 EY; 2.6, 5.5, 0.5 per 100 EY). The risk for malignancies was not significantly increased for ETA and ADA compared with MTX (0.09, 0.27 and 0.07/100 person-years). Patients under ETA monotherapy developed more frequently incident inflammatory bowel disease (IBD) and incident uveitis (0.5 and 0.8/100 EY) than patients treated by ETA in combination with MTX (0.1 and 0.2/100 EY) or MTX alone (0.03 and 0.1/100 EY). Our data confirm the acceptable long-term tolerability of ETA and ADA in pJIA. However, whether the onset of IBD and uveitis during ETA monotherapy is a paradoxical effect or an inadequate response to therapy remains unclear and requires further investigation in this growing cohort. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  8. Development of nuclear fuel cycle technologies - bases of long-term provision of fuel and environmental safety of nuclear power

    International Nuclear Information System (INIS)

    Solonin, M.I.; Polyakov, A.S.; Zakharkin, B.S.; Smelov, V.S.; Nenarokomov, E.A.; Mukhin, I.V.

    2000-01-01

    To-day nuclear power is one of the options, however, to-morrow it may become the main source of the energy, thus, providing for the stable economic development for the long time to come. The availability of the large-scale nuclear power in the foreseeable future is governed by not only the safe operation of nuclear power plants (NPP) but also by the environmentally safe management of spent nuclear fuel, radioactive waste conditioning and long-term storage. More emphasis is to be placed to the closing of the fuel cycle in view of substantial quantities of spent nuclear fuel arisings. The once-through fuel cycle that is cost effective at the moment cannot be considered to be environmentally safe even for the middle term since the substantial build-up of spent nuclear fuel containing thousands of tons Pu will require the resolution of the safe management problem in the nearest future and is absolutely unjustified in terms of moral ethics as a transfer of the responsibility to future generations. The minimization of radioactive waste arisings and its radioactivity is only feasible with the closed fuel cycle put into practice and some actinides and long-lived fission radionuclides burnt out. The key issues in providing the environmentally safe fuel cycle are efficient processes of producing fuel for NPP, radionuclide after-burning included, a long-term spent nuclear fuel storage and reprocessing as well as radioactive waste management. The paper deals with the problems inherent in producing fuel for NPP with a view for the closed fuel cycle. Also discussed are options of the fuel cycle, its effectiveness and environmental safety with improvements in technologies of spent nuclear fuel reprocessing and long-lived radionuclide partitioning. (authors)

  9. Development of nuclear fuel cycle technologies - bases of long-term provision of fuel and environmental safety of nuclear power

    Energy Technology Data Exchange (ETDEWEB)

    Solonin, M I; Polyakov, A S; Zakharkin, B S; Smelov, V S; Nenarokomov, E A; Mukhin, I V [SSC, RF, A.A. Bochvar ALL-Russia Research Institute of Inorganic Materials, Moscow (Russian Federation)

    2000-07-01

    To-day nuclear power is one of the options, however, to-morrow it may become the main source of the energy, thus, providing for the stable economic development for the long time to come. The availability of the large-scale nuclear power in the foreseeable future is governed by not only the safe operation of nuclear power plants (NPP) but also by the environmentally safe management of spent nuclear fuel, radioactive waste conditioning and long-term storage. More emphasis is to be placed to the closing of the fuel cycle in view of substantial quantities of spent nuclear fuel arisings. The once-through fuel cycle that is cost effective at the moment cannot be considered to be environmentally safe even for the middle term since the substantial build-up of spent nuclear fuel containing thousands of tons Pu will require the resolution of the safe management problem in the nearest future and is absolutely unjustified in terms of moral ethics as a transfer of the responsibility to future generations. The minimization of radioactive waste arisings and its radioactivity is only feasible with the closed fuel cycle put into practice and some actinides and long-lived fission radionuclides burnt out. The key issues in providing the environmentally safe fuel cycle are efficient processes of producing fuel for NPP, radionuclide after-burning included, a long-term spent nuclear fuel storage and reprocessing as well as radioactive waste management. The paper deals with the problems inherent in producing fuel for NPP with a view for the closed fuel cycle. Also discussed are options of the fuel cycle, its effectiveness and environmental safety with improvements in technologies of spent nuclear fuel reprocessing and long-lived radionuclide partitioning. (authors)

  10. Evaluating Indicator-Based Methods of "Measuring Long-Term Impacts of a Science Center on Its Community"

    Science.gov (United States)

    Jensen, Eric Allen

    2016-01-01

    This article addresses some of the challenges faced when attempting to evaluate the long-term impact of informal science learning interventions. To contribute to the methodological development of informal science learning research, we critically examine (Falk and Needham (2011) "Journal of Research in Science Teaching," 48: 1-12.) study…

  11. Evaluation of quality of life in long-term survivors of paediatric brain stem tumors, treated with radiotherapy

    International Nuclear Information System (INIS)

    Skowronska-Gardas, Anna; Pedziwiatr, Katarzyna; Chojnacka, Marzanna

    2004-01-01

    The quality of life in long-term survivors of paediatric brain stem tumors, treated with radiotherapy is evaluated. They suffer predominantly from pre-treatment neurological impairments, which seriously influence their quality of life. The most often observed treatment sequelae are pituitary insufficiency and hearing loss

  12. Evaluation of long-term patient satisfaction and experience with the Baha(®) bone conduction implant

    DEFF Research Database (Denmark)

    Rasmussen, Jacob; Olsen, Steen Østergaard; Nielsen, Lars Holme

    2012-01-01

    Objective: Evaluate long-term patient satisfaction with bone-anchored hearing aids (the Baha(R), now referred to by Cochlear as a 'bone conduction implant') in our hospital clinic spanning the eighteen-year period from the inception of our Baha program. The researchers further wished to analyse t...

  13. Safety functions and safety function indicators - key elements in SKB'S methodology for assessing long-term safety of a KBS-3 repository

    International Nuclear Information System (INIS)

    Hedin, A.

    2008-01-01

    The application of so called safety function indicators in SKB safety assessment of a KBS-3 repository for spent nuclear fuel is presented. Isolation and retardation are the two main safety functions of the KBS-3 concept. In order to quantitatively evaluate safety on a sub-system level, these functions need to be differentiated, associated with quantitative measures and, where possible, with quantitative criteria relating to the fulfillment of the safety functions. A safety function is defined as a role through which a repository component contributes to safety. A safety function indicator is a measurable or calculable property of a repository component that allows quantitative evaluation of a safety function. A safety function indicator criterion is a quantitative limit such that if the criterion is fulfilled, the corresponding safety function is upheld. The safety functions and their associated indicators and criteria developed for the KBS-3 repository are primarily related to the isolating potential and to physical states of the canister and the clay buffer surrounding the canister. They are thus not directly related to release rates of radionuclides. The paper also describes how the concepts introduced i) aid in focussing the assessment on critical, safety related issues, ii) provide a framework for the accounting of safety throughout the different time frames of the assessment and iii) provide key information in the selection of scenarios for the safety assessment. (author)

  14. Study on improvement in reliability of inventory assessment in vitrified waste for long-term safety of geological disposal

    International Nuclear Information System (INIS)

    Ishikawa, Masumi; Kaneko, Satoru; Kitayama, Kazumi; Ishiguro, Katsuhiko; Ueda, Hiroyoshi; Wakasugi, Keiichiro; Shinohara, Nobuo; Okumura, Keisuke; Chino, Masamichi; Moriya, Noriyasu

    2009-01-01

    Since quality control issues for vitrified waste are defined mainly with the focus on the transport and interim storage of the waste rather than the long-term safety of geological disposal, they do not cover inventories of long-lived nuclides that are of most interest in the safety assessment of geological disposal. Therefore, we suggest a flow chart for the assessment of inventories of long-lived nuclides in the vitrified waste focusing on the measured values. This includes an indirect assessment with indicative nuclides that have been already measured in the returned vitrified wastes from abroad. In order to apply this flow chart for commercial operation, its applicability should be examined for cases with a variation in burn-up history and with an uncertainty associated with carry-over fraction at reprocessing. We started an R and D program to examine the applicability as well as to improve the reliability of the nuclide generation/decay code and the nuclear data library using liquid waste from spent fuel with a clear irradiation history. To solve the issue of quality control for vitrified waste, a comprehensive study is needed in aspects not only of geological disposal field but also of operation of a nuclear power plant, reprocessing of spent fuel and vitrification of liquid waste. This study is a pioneering study conducted to integrate them. (author)

  15. Pitavastatin demonstrates long-term efficacy, safety and tolerability in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia

    DEFF Research Database (Denmark)

    Stender, Steen; Budinski, Dragos; Hounslow, Neil

    2013-01-01

    Aims: To assess the long-term efficacy, safety and tolerability of pitavastatin (2 and 4 mg) in elderly patients (≥65 years of age) with primary hypercholesterolaemia or combined (mixed) dyslipidaemia.Design: Patients (n = 545) who had completed a 12-week double-blind comparative study (core study...... Cholesterol Education Program Adult Treatment Plan III (NCEP ATP III) targets for low-density lipoprotein cholesterol (LDL-C) was determined.Results: Of the patients enrolled, 539 received at least one dose of pitavastatin (safety population: men, 45.5%; Caucasian, 99.1%; mean age, 70.3 years; range, 65......-89 years). Only 17% of patients required up-titration to pitavastatin 4 mg. After 60 weeks, NCEP ATP III and EAS targets were attained by 93.8% and 89.0% of patients, respectively. Plasma LDL-C declined by 43.4% and high-density lipoprotein cholesterol increased by 9.6% versus core-study baseline values...

  16. Evaluation on biosafety in long-term administration, teratogenicity and local toxicity of developed product

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Sung-Ho; Kim, Jong-Chun; Kim, Se-Ra; Lee, Hae-Jun; Lee, Jin-Hee [Chonnam Nat. Univ., Gwangju (Korea, Republic of)

    2006-01-15

    We performed this study to determine biosafety of developed product in long-term administration and teratogenicity and local toxicity (skin and eye) of developed product (HemoHIM and HemoTonic). It is suggested that long-term administration with the developed products may not exert considerable side effects. It is concluded that the administration of HemoHIM or HemoTonic does not inflict any adverse effect on fetuses of pregnant mice. HemoHIM and HemoTonic could be considered as a no irritating materials to the skin and eye of the test animals. These results indicated that HemoHIM and HemoTonic might be a useful functional food, especially since it is a relatively nontoxic natural product.

  17. Evaluation on biosafety in long-term administration, teratogenicity and local toxicity of developed product

    International Nuclear Information System (INIS)

    Kim, Sung-Ho; Kim, Jong-Chun; Kim, Se-Ra; Lee, Hae-Jun; Lee, Jin-Hee

    2006-01-01

    We performed this study to determine biosafety of developed product in long-term administration and teratogenicity and local toxicity (skin and eye) of developed product (HemoHIM and HemoTonic). It is suggested that long-term administration with the developed products may not exert considerable side effects. It is concluded that the administration of HemoHIM or HemoTonic does not inflict any adverse effect on fetuses of pregnant mice. HemoHIM and HemoTonic could be considered as a no irritating materials to the skin and eye of the test animals. These results indicated that HemoHIM and HemoTonic might be a useful functional food, especially since it is a relatively nontoxic natural product

  18. HANGING BY A THREAD: THE LONG-TERM EFFICACY AND SAFETY OF TRANSSCLERAL SUTURED INTRAOCULAR LENSES IN CHILDREN (AN AMERICAN OPHTHALMOLOGICAL SOCIETY THESIS)

    Science.gov (United States)

    Buckley, Edward G.

    2007-01-01

    Purpose To evaluate the long-term efficacy, safety, and advisability of using transscleral sutured posterior chamber intraocular lenses (IOLs) in pediatric patients with no capsular support and to determine whether 10-0 polypropylene suture should be used for this purpose. Methods A long-term retrospective interventional case series review of 33 eyes of 26 patients who had a sutured IOL at Duke University Eye Center were evaluated for the intraoperative surgical risks, postoperative visual and refractive outcomes, and the number, type, and severity of the postoperative complications. In addition, a survey of pediatric ophthalmologists’ experience with suture breakage was performed. Results Postoperative visual acuity was significantly improved after surgery (P subluxation of the IOL secondary to spontaneous 10-0 polypropylene suture breakage at 3.5, 8, and 9 years after surgery. A survey of pediatric ophthalmologists revealed 10 similar cases (mean, 5 years after surgery). Conclusion Transscleral fixation of an IOL in a child appears to be a safe and effective procedure provided that the suture material used is stable enough to resist significant degradation over time. Caution should be exercised in the use of 10-0 polypropylene suture to fixate an IOL to the sclera in children, and an alternative material or size should be considered. PMID:18427618

  19. Evaluating satellite-derived long-term historical precipitation datasets for drought monitoring in Chile

    Science.gov (United States)

    Zambrano, Francisco; Wardlow, Brian; Tadesse, Tsegaye; Lillo-Saavedra, Mario; Lagos, Octavio

    2017-04-01

    Precipitation is a key parameter for the study of climate change and variability and the detection and monitoring of natural disaster such as drought. Precipitation datasets that accurately capture the amount and spatial variability of rainfall is critical for drought monitoring and a wide range of other climate applications. This is challenging in many parts of the world, which often have a limited number of weather stations and/or historical data records. Satellite-derived precipitation products offer a viable alternative with several remotely sensed precipitation datasets now available with long historical data records (+30years), which include the Climate Hazards Group InfraRed Precipitation with Station (CHIRPS) and Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks-Climate Data Record (PERSIANN-CDR) datasets. This study presents a comparative analysis of three historical satellite-based precipitation datasets that include Tropical Rainfall Measuring Mission (TRMM) Multi-satellite Precipitation Analysis (TMPA) 3B43 version 7 (1998-2015), PERSIANN-CDR (1983-2015) and CHIRPS 2.0 (1981-2015) over Chile to assess their performance across the country and for the case of the two long-term products the applicability for agricultural drought were evaluated when used in the calculation of commonly used drought indicator as the Standardized Precipitation Index (SPI). In this analysis, 278 weather stations of in situ rainfall measurements across Chile were initially compared to the satellite data. The study area (Chile) was divided into five latitudinal zones: North, North-Central, Central, South-Central and South to determine if there were a regional difference among these satellite products, and nine statistics were used to evaluate their performance to estimate the amount and spatial distribution of historical rainfall across Chile. Hierarchical cluster analysis, k-means and singular value decomposition were used to analyze

  20. Long-term evaluation of cardiac and vascular toxicity in patients with Philadelphia chromosome-positive leukemias treated with bosutinib.

    Science.gov (United States)

    Cortes, Jorge E; Jean Khoury, H; Kantarjian, Hagop; Brümmendorf, Tim H; Mauro, Michael J; Matczak, Ewa; Pavlov, Dmitri; Aguiar, Jean M; Fly, Kolette D; Dimitrov, Svetoslav; Leip, Eric; Shapiro, Mark; Lipton, Jeff H; Durand, Jean-Bernard; Gambacorti-Passerini, Carlo

    2016-06-01

    Vascular and cardiac safety during tyrosine kinase inhibitor (TKI) therapy is an emerging issue. We evaluated vascular/cardiac toxicities associated with long-term bosutinib treatment for Philadelphia chromosome-positive (Ph+) leukemia based on treatment-emergent adverse events (TEAEs) and changes in QTc intervals and ejection fraction in two studies: a phase 1/2 study of second-/third-/fourth-line bosutinib for Ph+ leukemia resistant/intolerant to prior TKIs (N = 570) and a phase 3 study of first-line bosutinib (n = 248) versus imatinib (n = 251) in chronic phase chronic myeloid leukemia. Follow-up time was ≥48 months (both studies). Incidences of vascular/cardiac TEAEs in bosutinib-treated patients were 7%/10% overall with similar incidences observed with first-line bosutinib (5%/8%) and imatinib (4%/6%). Few patients had grade ≥3 vascular/cardiac events (4%/4%) and no individual TEAE occurred in >2% of bosutinib patients. Exposure-adjusted vascular/cardiac TEAE rates (patients with events/patient-year) were low for second-line or later bosutinib (0.037/0.050) and not significantly different between first-line bosutinib (0.015/0.024) and imatinib (0.011/0.017; P ≥ 0.267). Vascular/cardiac events were managed mainly with concomitant medications (39%/44%), bosutinib treatment interruptions (18%/21%), or dose reductions (4%/8%); discontinuations due to these events were rare (0.7%/1.0%). Based on logistic regression modelling, performance status >0 and history of vascular or cardiac disorders were prognostic of vascular/cardiac events in relapsed/refractory patients; hyperlipidemia/hypercholesterolemia and older age were prognostic of cardiac events. In newly diagnosed patients, older age was prognostic of vascular/cardiac events; history of diabetes was prognostic of vascular events. Incidences of vascular and cardiac events were low with bosutinib in the first-line and relapsed/refractory settings following long-term treatment in patients

  1. Ophthalmic evaluation of long-term survivors of childhood acute lymphoblastic leukemia

    International Nuclear Information System (INIS)

    Weaver, R.G. Jr.; Chauvenet, A.R.; Smith, T.J.; Schwartz, A.C.

    1986-01-01

    Thirty-four long-term survivors of childhood acute lymphoblastic leukemia (ALL) underwent comprehensive ophthalmic examinations to detect retinopathy or other ocular sequelae. Sixteen of the 34 patients received whole brain radiation (greater than or equal to 2400 rad). All 18 patients in the non-radiated group had normal eye examinations, while 4 of 16 in the radiated group had ocular abnormalities. None of the ocular abnormalities could be definitely attributed to radiation and all patients had normal visual acuity. No radiation retinopathy was found in either group

  2. Evaluation to a long term remediation actions after Goiania radiological accident

    International Nuclear Information System (INIS)

    Rochedo, Elaine R.R.; Rio, Monica A. Pires do; Coutinho, Celia M.C.; Acar, Maria E.D.; Romeiro, Carlos H.

    2000-01-01

    Ten years after the Goiania radiological accident, the results obtained by the IRD Environmental Monitoring Program are compared to the values adopted for establishing the intervention levels at the time of the accident occurrence (1987), and to the values of the parameters obtained by European countries, after the Chernobyl accident. Significant differences were observed in parameter values, particularly, those related to a long term prediction of the contamination behaviour in an urban area. This paper shows the importance of the survey for the environmental behaviour of pollutants in tropical climate conditions. (author)

  3. Long-term efficacy and safety of omalizumab in patients with persistent uncontrolled allergic asthma: a systematic review and meta-analysis

    Science.gov (United States)

    Lai, Tianwen; Wang, Shaobin; Xu, Zhiwei; Zhang, Chao; Zhao, Yun; Hu, Yue; Cao, Chao; Ying, Songmin; Chen, Zhihua; Li, Wen; Wu, Bin; Shen, Huahao

    2015-01-01

    Currently, limited information is available to clinicians regarding the long-term efficacy of omalizumab treatment for allergic asthma. In this report, we aimed to (i) systematically review the evidence regarding the long-term efficacy of omalizumab in patients with persistent uncontrolled allergic asthma, and to (ii) discuss the cost-effectiveness evidence published for omalizumab in this patient population. A comprehensive search for randomized controlled trials (RCTs; ≥52 weeks) was performed, and six studies met our final inclusion criteria (n = 2,749). Omalizumab was associated with significant improvements in quality of life and the Global Evaluation of Treatment Effectiveness. Omalizumab also allowed patients to completely withdraw from inhaled corticosteroid therapy and did not increase the overall incidence of adverse events. However, there was insufficient evidence that omalizumab reduced the incidence of exacerbations, and the cost-effectiveness of omalizumab varied across studies. Our data indicated that omalizumab use for at least 52 weeks in patients with persistent uncontrolled allergic asthma was accompanied by an acceptable safety profile, but it lacked effect on the asthma exacerbations. Use of omalizumab was associated with a higher cost than conventional therapy, but these increases may be cost-effective if the medication is used in patients with severe allergic asthma. PMID:25645133

  4. Long-term efficacy and safety of self-intracavernous injection of prostaglandin E1 for treatment of erectile dysfunction in China.

    Science.gov (United States)

    He, L; Wen, J; Jiang, X; Chen, H; Tang, Y

    2011-06-01

    The study evaluated the long-term efficacy and safety profiles of self-intracavernous injection of prostaglandin E1 (PGE1) for erectile dysfunction (ED). Four hundred and sixteen ED patients were treated with self-intracavernous injection of PGE1 from January 1998 to December 2007 in our outpatient service. Follow-up was made to investigate the efficacy and side effects of this treatment. It was found that 261 patients (62.7%) felt satisfied and kept using this treatment due to its advantages of satisfactory efficacy and reasonable expense. Twenty-seven of them (6.5%) got rid of PGE1 treatment after five times injections and did not need any other drugs to maintain satisfactory sexual lives. Two hundred and fourteen (51.4%) patients kept using this treatment for over 1 year, 26 (6.2%) over 5 years, 12 (2.9%) over 8 years and 7 (1.7%) over 10 years. The major complications of self-intracavernous injection of PGE1 include fibrosis of corpus cavernosum (three cases), ecchymosis associated with vascular injury due to injection (23 cases) and pain associated with injection (295 cases). There were no patients displaying priapism. It is concluded that self-intracavernous injection of PGE1 is a safe and effective treatment for ED with various aetiologies and a broad range of severity, and no serious complications were observed after long-term application. © 2011 Blackwell Verlag GmbH.

  5. Long-term follow-up for efficacy and safety of treatment of retinitis pigmentosa with valproic acid.

    Science.gov (United States)

    Bhalla, Sheena; Joshi, Deval; Bhullar, Shaminder; Kasuga, Daniel; Park, Yeonhee; Kay, Christine N

    2013-07-01

    The purpose of this study was to determine the long-term efficacy and safety of valproic acid (VPA) treatment in patients with pigmentary retinal dystrophies. A retrospective chart review was conducted on 31 patients with a diagnosis of pigmentary retinal dystrophy prescribed VPA at a single centre. Visual field (VF), visual acuity (VA), length of treatment, liver enzymes and side effects were analysed. VF areas were defined using Goldmann VF (GVF) tracings recorded before, during and after VPA treatment using the V4e isopter for each eye. Using custom software, planimetric areas of VF were calculated. Five of the patients (10 eyes) had two Goldmann VF tracings, allowing comparison between baseline and follow-up VF. After 9.8 months of VPA, VF decreased by 0.145 cm(2) (26.478%) (p=0.432). For 22 of the patients (41 eyes), VA data was available, and logarithm of the minimum angle of resolution (logMAR) score changed by 0.056 log units (representing a decline in VA) after 14.9 months on VPA (p=0.002). Twelve patients (38.7%) reported negative side effects related to VPA use. VPA plays a complex role in patients with pigmentary retinal dystrophies and may be associated with VA and field decline as well as adverse side effects. Physicians should use caution with using VPA for pigmentary retinal dystrophies.

  6. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma

    Directory of Open Access Journals (Sweden)

    Geun Young Lee

    2017-09-01

    Full Text Available AIM: To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG. METHODS: In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. RESULTS: The number of antiglaucoma medications and the IOP reduction were similar between the 2 groups during the follow-up period. Although the mean IOP was similar, the IOP-fluctuation rate during the early postoperative period was significantly lower in the ExPress group than in the trabeculectomy group (P=0.038. A Kaplan-Meier survival curve analysis showed no significant success-rate difference between the groups (P=0.810. The corneal endothelial cell loss rate, moreover, was significantly lower in the ExPress group (P=0.05. CONCLUSION: ExPress implantation compared with trabeculectomy showed similar IOP-reduction and success rates along with lower IOP fluctuation and endothelial cell loss rates. For this reason, it can be considered to be the treatment of choice for patients with advanced glaucoma or low corneal endothelial cell density.

  7. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma.

    Science.gov (United States)

    Lee, Geun Young; Lee, Chong Eun; Lee, Kyoo Won; Seo, Sam

    2017-01-01

    To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG). In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP) values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. The number of antiglaucoma medications and the IOP reduction were similar between the 2 groups during the follow-up period. Although the mean IOP was similar, the IOP-fluctuation rate during the early postoperative period was significantly lower in the ExPress group than in the trabeculectomy group ( P =0.038). A Kaplan-Meier survival curve analysis showed no significant success-rate difference between the groups ( P =0.810). The corneal endothelial cell loss rate, moreover, was significantly lower in the ExPress group ( P =0.05). ExPress implantation compared with trabeculectomy showed similar IOP-reduction and success rates along with lower IOP fluctuation and endothelial cell loss rates. For this reason, it can be considered to be the treatment of choice for patients with advanced glaucoma or low corneal endothelial cell density.

  8. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma

    Science.gov (United States)

    Lee, Geun Young; Lee, Chong Eun; Lee, Kyoo Won; Seo, Sam

    2017-01-01

    AIM To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG). METHODS In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP) values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. RESULTS The number of antiglaucoma medications and the IOP reduction were similar between the 2 groups during the follow-up period. Although the mean IOP was similar, the IOP-fluctuation rate during the early postoperative period was significantly lower in the ExPress group than in the trabeculectomy group (P=0.038). A Kaplan-Meier survival curve analysis showed no significant success-rate difference between the groups (P=0.810). The corneal endothelial cell loss rate, moreover, was significantly lower in the ExPress group (P=0.05). CONCLUSION ExPress implantation compared with trabeculectomy showed similar IOP-reduction and success rates along with lower IOP fluctuation and endothelial cell loss rates. For this reason, it can be considered to be the treatment of choice for patients with advanced glaucoma or low corneal endothelial cell density. PMID:28944196

  9. [Cardiac surgery in octogenarian patients: evaluation of predictive factors of mortality, long-term outcome and quality of life].

    Science.gov (United States)

    Viana-Tejedor, Ana; Domínguez, Francisco J; Moreno Yangüela, Mar; Moreno, Raúl; López de Sá, Esteban; Mesa, José M; López-Sendón, José

    2008-10-04

    Increasing life expectancy in Western countries in the last decades has resulted in a significant gradual increasing number of octogenarians referred for cardiac surgery. There is a need for a critical evaluation of the long-term surgical outcome and quality of life in the elderly. The aim of this study is to identify risk factors of mortality in octogenarians undergoing cardiac surgery and to assess the long term survival and quality of life. Data were reviewed on 150 patients aged over 80 years--mean age (standard deviation): 82.7 (2.5) years--who underwent cardiac surgery at our institution in the last 26 years. We analyzed clinical and epidemiological variables included in the European System for Cardiac Operative Risk Evaluation (euroSCORE), in-hospital morbidity and mortality, long term survival and quality of life after cardiac surgery. The 30-day mortality rate was 30.1%, with a mean hospital stay of 16.5 days (13-27). Emergent procedure, reparation of postinfarction ventricular ruptures, New York Heart Association functional class IV, chronic renal failure and previous myocardial infarction were independent predictors of in-hospital mortality. Mean follow up was 72.2 (9.9) months with survival rates of 87.3% and 57% at 1 and 5 years, respectively. Late postoperative quality of life in our 53 long-term survivors was significantly better than prior to surgery. New York Heart Association functional class improved from 2.52 to 1.48. Most survivors (97.7%) were satisfied with present quality of life Cardiac surgery in octogenarians is associated with increased in-hospital mortality rate and longer hospital stay. Our findings support that cardiac surgery can be performed in a selected elderly population with good long-term survival and quality of life.

  10. Long-term follow-up of MCL patients treated with single-agent ibrutinib: updated safety and efficacy results.

    Science.gov (United States)

    Wang, Michael L; 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

    2015-08-06

    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. © 2015 by The American Society of Hematology.

  11. Nurse-physician communication in the long-term care setting: perceived barriers and impact on patient safety.

    Science.gov (United States)

    Tjia, Jennifer; Mazor, Kathleen M; Field, Terry; Meterko, Vanessa; Spenard, Ann; Gurwitz, Jerry H

    2009-09-01

    Clear and complete communication between health care providers is a prerequisite for safe patient management and is a major priority of the Joint Commission's 2008 National Patient Safety Goals. The goal of this study was to describe nurses' perceptions of nurse-physician communication in the long-term care (LTC) setting. Mixed-method study including a self-administered questionnaire and qualitative semistructured telephone interviews of licensed nurses from 26 LTC facilities in Connecticut. The questionnaire measured perceived openness to communication, mutual understanding, language comprehension, frustration, professional respect, nurse preparedness, time burden, and logistical barriers. Qualitative interviews focused on identifying barriers to effective nurse-physician communication that may not have previously been considered and eliciting nurses' recommendations for overcoming those barriers. Three hundred seventy-five nurses completed the questionnaire, and 21 nurses completed qualitative interviews. Nurses identified several barriers to effective nurse-physician communication: lack of physician openness to communication, logistic challenges, lack of professionalism, and language barriers. Feeling hurried by the physician was the most frequent barrier (28%), followed by finding a quiet place to call (25%), and difficulty reaching the physician (21%). In qualitative interviews, there was consensus that nurses needed to be brief and prepared with relevant clinical information when communicating with physicians and that physicians needed to be more open to listening. A combination of nurse and physician behaviors contributes to ineffective communication in the LTC setting. These findings have important implications for patient safety and support the development of structured communication interventions to improve quality of nurse-physician communication.

  12. Safety issues in construction of facilities for long-term storage of radioactive waste at vector site

    Energy Technology Data Exchange (ETDEWEB)

    Tokarevskyi, O.; Alekseeva, Z.; Kondratiev, S. [State Scientific and Technical Center for Nuclear and Radiation Safety, Kyiv (Ukraine); Rybalka, N. [State Nuclear Regulatory Inspectorate of Ukraine, Kyiv (Ukraine)

    2013-07-01

    In Ukraine, it is planned to create a number of near-surface facilities for disposal of short-lived RW and long-term (up to 100 years) storage of long-lived RW at the Vector site in the Chernobyl exclusion zone. The expected streams of long-lived RW are analyzed in the paper. According to the analysis of RW streams, in particular, issues are considered on development of RW acceptance criteria, admissible radiological impacts during preparation of RW for long-term storage, reliability of barriers (RW packages, modules and structures, etc.) during long-term storage of RW. (orig.)

  13. Evaluation of the long-term efficacy of CT-guided epidural steroid injection for the treatment of sciatica

    International Nuclear Information System (INIS)

    Tong Guohai; Wang Wei; Chen Wei; Chen Kemin

    2005-01-01

    Objective: To evaluate the long-term efficacy of CT-guided epidural steroid injection for the treatment of sciatica. Methods: CT-guided epidural steroid injection was performed in 180 patients with sciatica from May 1998 to March 2004, and all patients had failure to previous conservative treatment. Visual analogue scale was used to evaluate the pain of the patient before and after the treatment. Results: Follow-up was taken for 112 cases during 1-6 years after the treatment, 89 patients (79.5%) had successful long-term outcome and 80 patients (71.4%) were satisfied. Conclusions: CT-guided epidural steroid injection can reduce low back pain and radical pain. It should be preferentially considered as the first choice when conservative treatments are failed. (authors)

  14. A ductility exhaustion evaluation of some long term creep/fatigue tests on austenitic steel

    International Nuclear Information System (INIS)

    Wood, D.S.; Wynn, J.; Austin, C.; Green, J.G.

    1988-01-01

    A limited number of long term creep/fatigue tests performed on two batches of Type 316 steel and one batch of associated 17Cr8Ni2Mo weld metal are reported. Test durations range from 5000 to 32,000 h and temperatures from 550 to 625 0 C. Subsequent metallographic examination shows the failures to be wholly or predominantly intergranular. The results are analysed using a ductility exhaustion approach and it is shown that the endurances obtained are within a factor of two of predicted values. The results confirm that the design approach to creep/fatigue currently being developed in the U.K. and based on ductility exhaustion is likely to be satisfactory. (author)

  15. Evaluating temporal consistency of long-term global NDVI datasets for trend analysis

    DEFF Research Database (Denmark)

    Tian, Feng; Fensholt, Rasmus; Verbesselt, Jan

    2015-01-01

    -sensor NDVI time series by analyzing the co-occurrence between breaks in the NDVI time series and sensor shifts from GIMMS3g (Global Inventory Modeling and Mapping Studies 3rd generation), VIP3 (Vegetation Index and Phenology version 3), LTDR4 (Long Term Data Record version 4) and SPOT-VGT (Système Pour l......, potentially introducing uncertainties in NDVI trend analysis. Platform/sensor change from VGT-1 to VGT-2 is found to cause a significant positive break in the SPOT-VGT NDVI time series. Potential artifacts exist in humid, dry-subhumid, semi-arid and hyper-arid regions of GIMMS3g NDVI, whereas no signs...

  16. [Long-term evaluation of a psychological training for obese children and their parents (TAKE)].

    Science.gov (United States)

    Roth, Binia; Munsch, Simone; Meyer, Andrea H

    2011-01-01

    Cognitive-behavioral parent-child-programmes have shown the best effects in treating childhood obesity so far. With TAKE (Training adipöser Kinder und ihrer Eltern) we introduce a psychologically-informed training, that includes physical activity, nutrition and eating behavior but also addresses psychological issues like self-confidence, body image, social and anti-bullying skills. Long-term data from up to 64 month-follow-up showed moderate effects on body-mass index standard deviation scores (BMI-SDS), and positive effects on children's psychological wellbeing. Maternal psychopathology predicted the course of BMI-SDS in children. Results underline the importance of psychological treatment for obese children to facilitate weight change and to reduce their psychological vulnerability which in turn may prevent the further development of behavior problems, eating disorders and affective disorders.

  17. Evaluating long-term performance of in situ vitrified waste forms: Methodology and results

    International Nuclear Information System (INIS)

    McGrail, B.P.; Olson, K.M.

    1992-11-01

    In situ vitrification (ISV) is an emerging technology for the remediation of hazardous and radioactive waste sites. The concept relies on the principle of Joule heating to raise the temperature of a soil between an array of electrodes above the melting temperature. After cooling, the melt solidifies into a massive glass and crystalline block similar to naturally occurring obsidian. Determining the long-term performance of ISV products in a changing regulatory environment requires a fundamental understanding of the mechanisms controlling the dissolution behavior of the material. A series of experiments was performed to determine the dissolution behavior of samples produced from the ISV processing of typical soils from the Idaho National Engineering Laboratory subsurface disposal area. Dissolution rate constant measurements were completed at 90 degrees C over the pH range 2 to 11 for one sample obtained from a field test of the ISV process

  18. Evaluation of mid-to-long term basic research for environmental restoration

    International Nuclear Information System (INIS)

    1989-09-01

    This document describes a long-term basic research program for the US Department of Energy (DOE) that complements departmental initiatives in waste management and site cleanup. The most important problems faced by DOE are environmental restoration of waste sites and cleanup of inactive facilities. Environmental restoration is defined in this report as characterization, assessment, remediation, and post-closure verification within the waste/environmental system at DOE sites. Remediation of inactive, contaminated waste-disposal sites is the largest and most expensive task facing DOE. Immobilization, isolation, separation, and destruction of waste, either aboveground or in situ, are difficult and costly tasks. Technologies for these tasks are primitive or do not exist. Departmental problems in the long term are being analyzed scientifically and research needs are being identified. When completed, the Office of Energy Research's (OER's) basis research plan will describe potential scientific research needs for universities, national laboratories, and others as a basis for research proposals to DOE. Extensive interaction with the scientific community is planned to further refine and prioritize research needs. Basic research within DOE is directed toward fundamental knowledge leading to the discovery of new scientific or engineering concepts and principles that may or may not have immediate specific technological applications. However, because DOE is a mission-oriented agency, basic research in DOE is strongly influenced by national energy and environmental policy and may be multidisciplinary in nature. Basic research will provide innovative concepts and the fundamental knowledge base that facilitates the development and application of new and emerging technologies. 41 refs., 5 figs., 9 tabs

  19. RADIATION SAFETY JUSTIFICATION FOR THE LONG-TERM STORAGE OF GAS CONDENSATE IN THE UNDERGROUND RESERVOURS FORMED BY THE NUCLEAR EXPLOSION TECHNOLOGY

    Directory of Open Access Journals (Sweden)

    I. K. Romanovich

    2010-01-01

    Full Text Available The paper presents approaches to the safety justification of the gas condensate and brine long-term storage in the underground reservoirs formed by the nuclear explosion technology. Gas condensate and brine are the intermediate level liquid radioactive waste containing isotopes: 3Н, 137Cs and 90Sr, in traces - 239Pu, 235U, 241Am.Safety of the gas condensate and brine long-term storage in the underground reservoirs is assessed on the base of the multi-barrier principle implementation, used during radioactive waste disposal. It is shown that the gas condensate and brine long-term storage in the sealed underground reservoirs formed by nuclear explosion technologies in salt domes does not lead to the surface radioactive contamination and population exposure.

  20. Long-term Follow-Up of Individuals with Celiac Disease: An Evaluation of Current Practice Guidelines

    Directory of Open Access Journals (Sweden)

    Jocelyn A Silvester

    2007-01-01

    Full Text Available INTRODUCTION: Celiac disease can be treated by following a strict gluten-free diet for life. If properly followed, the diet resolves symptoms and nutritional deficiencies. It is generally recommended that individuals with celiac disease have careful long-term follow-up. However, it is not clear which elements of disease status evaluation, laboratory investigations and self-management support should be included in follow-up.

  1. Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study.

    Science.gov (United States)

    Dobbie, Fiona; Hiscock, Rosemary; Leonardi-Bee, Jo; Murray, Susan; Shahab, Lion; Aveyard, Paul; Coleman, Tim; McEwen, Andy; McRobbie, Hayden; Purves, Richard; Bauld, Linda

    2015-11-01

    NHS Stop Smoking Services (SSSs) provide free at the point of use treatment for smokers who would like to stop. Since their inception in 1999 they have evolved to offer a variety of support options. Given the changes that have happened in the provision of services and the ongoing need for evidence on effectiveness, the Evaluating Long-term Outcomes for NHS Stop Smoking Services (ELONS) study was commissioned. The main aim of the study was to explore the factors that determine longer-term abstinence from smoking following intervention by SSSs. There were also a number of additional objectives. The ELONS study was an observational study with two main stages: secondary analysis of routine data collected by SSSs and a prospective cohort study of service clients. The prospective study had additional elements on client satisfaction, well-being and longer-term nicotine replacement therapy (NRT) use. The setting for the study was SSSs in England. For the secondary analysis, routine data from 49 services were obtained. For the prospective study and its added elements, nine services were involved. The target population was clients of these services. There were 202,804 cases included in secondary analysis and 3075 in the prospective study. A combination of behavioural support and stop smoking medication delivered by SSS practitioners. Abstinence from smoking at 4 and 52 weeks after setting a quit date, validated by a carbon monoxide (CO) breath test. Just over 4 in 10 smokers (41%) recruited to the prospective study were biochemically validated as abstinent from smoking at 4 weeks (which was broadly comparable with findings from the secondary analysis of routine service data, where self-reported 4-week quit rates were 48%, falling to 34% when biochemical validation had occurred). At the 1-year follow-up, 8% of prospective study clients were CO validated as abstinent from smoking. Clients who received specialist one-to-one behavioural support were twice as likely to have

  2. Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab.

    Science.gov (United States)

    McDermott, David F; Drake, Charles G; Sznol, Mario; Choueiri, Toni K; Powderly, John D; Smith, David C; Brahmer, Julie R; Carvajal, Richard D; Hammers, Hans J; Puzanov, Igor; Hodi, F Stephen; Kluger, Harriet M; Topalian, Suzanne L; Pardoll, Drew M; Wigginton, Jon M; Kollia, Georgia D; Gupta, Ashok; McDonald, Dan; Sankar, Vindira; Sosman, Jeffrey A; Atkins, Michael B

    2015-06-20

    Blockade of the programmed death-1 inhibitory cell-surface molecule on immune cells using the fully human immunoglobulin G4 antibody nivolumab mediates tumor regression in a portion of patients with advanced treatment-refractory solid tumors. We report clinical activity, survival, and long-term safety in patients with advanced renal cell carcinoma (RCC) treated with nivolumab in a phase I study with expansion cohorts. A total of 34 patients with previously treated advanced RCC, enrolled between 2008 and 2012, received intravenous nivolumab (1 or 10 mg/kg) in an outpatient setting once every two weeks for up to 96 weeks and were observed for survival and duration of response after treatment discontinuation. Ten patients (29%) achieved objective responses (according to RECIST [version 1.0]), with median response duration of 12.9 months; nine additional patients (27%) demonstrated stable disease lasting > 24 weeks. Three of five patients who stopped treatment while in response continued to respond for ≥ 45 weeks. Median overall survival in all patients (71% with two to five prior systemic therapies) was 22.4 months; 1-, 2-, and 3-year survival rates were 71%, 48%, and 44%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 18% of patients; all were reversible. Patients with advanced treatment-refractory RCC treated with nivolumab demonstrated durable responses that in some responders persisted after drug discontinuation. Overall survival is encouraging, and toxicities were generally manageable. Ongoing randomized clinical trials will further assess the impact of nivolumab on overall survival in patients with advanced RCC. © 2015 by American Society of Clinical Oncology.

  3. Long-term efficacy and safety of vildagliptin add-on therapy in type 2 diabetes mellitus with insulin treatment.

    Science.gov (United States)

    Kanazawa, Ippei; Tanaka, Ken-Ichiro; Notsu, Masakazu; Tanaka, Sayuri; Kiyohara, Nobuaki; Koike, Sayo; Yamane, Yuko; Tada, Yuko; Sasaki, Motofumi; Yamauchi, Mika; Sugimoto, Toshitsugu

    2017-01-01

    The use of dipeptidyl peptidase (DPP)-4 inhibitors in patients with type 2 diabetes treated with insulin may be beneficial. However, the long-term efficacy and safety of vildagliptin add-on therapy in these patients remains unclear. A total of 73 patients with type 2 diabetes treated with insulin were randomly assigned to receive either add-on therapy of vildagliptin (n=37) or conventional therapy without DPP-4 inhibitors (n=36) for glucose control. Hemoglobin A1c (HbA1c) levels, dose and number of insulin injections, number of hypoglycemia episodes, and liver and renal function were monitored for 2years. The baseline characteristics of subjects, including age, dose of insulin injections, or HbA1c levels, did not differ between the two groups. In the vildagliptin group, HbA1c levels significantly decreased and the significance of HbA1c reduction was maintained for 24months (from 8.0±1.2% to 7.4±1.0%, pinsulin injections significantly reduced (-5.6units, p1, and -0.9 times, p1). However, these parameters were unchanged in the control group. The number of patients who experienced three or more episodes of hypoglycemia per year was significantly lower in the vildagliptin group (n=4) than in the control group (n=11) (odds ratio, 0.28; 95% confidence interval, 0.08-0.97; pinsulin treatment for 24months was well tolerated and led to sustained reductions in HbA1c, the dose and number of insulin injections, and the risk of hypoglycemia. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  4. Examination of constitutive model for evaluating long-term mechanical behavior of buffer. 3

    International Nuclear Information System (INIS)

    Takaji, Kazuhiko; Shigeno, Yoshimasa; Shimogouchi, Takafumi; Shiratake, Toshikazu; Tamura, Hirokuni

    2004-02-01

    On the R and D of the high-level radioactive waste repository, it is essential that Engineered Barrier System (EBS) is stable mechanically over a long period of time for maintaining each ability required to EBS. After closing the repository, the various external forces will be affected to buffer intricately for a long period of time. So, to make clear the mechanical deformation behavior of buffer against the external force is important, because of carrying out safety assessment of EBS accurately. In this report, several sets of parameters are chosen for the previously selected two constitutive models, Sekiguchi-Ohta model and Adachi-Oka model, and the element tests and mock-up tests are simulated using these parameters. Through the simulation, applicability of the constitutive models and parameters is examined. Moreover, simulation analyses of EBS using these parameters is examined. Moreover, simulation analyses of EBS using these parameters were carried out, and mechanical behavior is evaluated over a long period of time. Analysis estimated the amount of settlement of the over pack, the stress state of buffer material, the reaction force to a base rock, etc., and the result that EBS is mechanically stable over a long period of time was obtained. Next, in order to prove analyses results a side, literature survey was conducted about geological age, the dynamics history of a Smectite layer. The outline plan was drawn up about the natural analogue verification method and preliminary examination was performed about the applicability of Freezing Sampling'. (author)

  5. An application of RELAP5/MOD3 to the post-LOCA long term cooling performance evaluation

    International Nuclear Information System (INIS)

    Bang, Young Seok; Jung, Jae Won; Seul, Kwang Won; Kim, Hho Jung

    1998-01-01

    A realistic long-term calculation to be used in the post-LOCA long term cooling (LTC) analysis is described in this study, which was required to resolve the post-LOCA LTC issues including the concern on boric acid precipitation in the reactor core. The analysis scope is defined according to the LTC plan of UCN Units 3/4 and the plant calculation model are developed suitable to the LTC procedure. The LTC sequences following the cold leg small break LOCAs of 0.02 ft2 to 0.5 ft2 are calculated by RELAP5/ MOD3.2.2. Based on the calculation results, the establishment of shutdown cooling system entry condition and the behavior of boron transport are evaluated. The effect of model simplification is also investigated

  6. Theoretical study on crystalline rock for evaluating of long-term behavior (Contract research)

    International Nuclear Information System (INIS)

    Ichikawa, Yasuaki; Seno, Yasuhiro; Sato, Toshinori; Nakama, Shigeo

    2008-03-01

    The Japan Atomic Energy Agency (JAEA) is working on the Project of Mizunami Underground Research Laboratory (MIU). The project aims at developing comprehensive techniques of geological investigation and of construction of deep underground space for a repository of HLW and/or TRU. This study contributes to an estimation of long-term stability of underground spaces. Rock materials commonly show time-dependent behavior such as creep and relaxation. The underground structures for geological disposal of radioactive wastes must keep stable not only during construction and operation but also after closing, and then the long-term stability of rock structures (over thousands of years) is essentially important for designing the structures. The true mechanism of time-dependent behavior of rock materials is not yet clearly understood, though the phenomena are widely known. This study aims at elucidating the scientific truth involved in the time-dependent behavior of rock showing creep and relaxation. We used samples of Toki granite and performed precise tests under laser microscope observation, and then developed theories representing the experimental results. These experimental and theoretical results will be served for the design and construction of the Phase III (Operation Phase) of the MIU Project. This is the report worked out in the fiscal year 2006. In this work we performed the following subjects: 1) Uniaxial and stress relaxation tests under observation of a confocal laser scanning microscope (CLSM) by using granite specimens of MIU. 2) Pressure dissolution experiment by using specimens of single crystal quartz and glass beads. 3) Development of the rate of pressure dissolution of quartz and a homogenization analysis for quartz dissolution. In Chapter 2 CLSM was used to acquire clear three-dimensional images of Mizunami granite specimens for uniaxial and stress relaxation tests, and observed the change of microscale structure including the mineral configuration under

  7. A report on evaluation of research and development subjects in fiscal year 2001. Evaluation subject on the 'Middle- and long-term business program'

    International Nuclear Information System (INIS)

    2001-09-01

    The middle- and long-term business program determined by the Japan Nuclear Cycle Development Institute (JNC) is for elucidation of middle- and long-term targets to be expanded by JNC and is a base to promote individual R and D. This program is to be revised at a chance established on new long-term plan on research, development and application of nuclear energy on November, 2000 by the Committee of Atomic Energy under consideration of condition change after March, 1999. This report is a summary of evaluation results on the present middle- and long-term business program established by JNC, especially at a center of its revised portion, as a form of opinion. The evaluated results are described on two forms of the subject evaluation committees on the fast reactor and fuel cycle and on the wastes processing and disposal. (G.K.)

  8. Evaluation of limiting mechanisms for long-term spent fuel dry storage

    Energy Technology Data Exchange (ETDEWEB)

    Rashid, J. [ANATECH Research Corp., San Diego, CA (United States); Machiels, A. [EPRI, Palo Alto, CA (United States)

    2001-07-01

    Several failure mechanisms have been postulated that could become limiting for spent fuel in dry storage. These are: stress Corrosion Cracking (SCC), Delayed Hydride Cracking (DHC) and Creep Rupture (CR). These mechanisms are examined in some detail from two perspectives: their initial environments in which they were developed and applied, and in relation to their applicability to dry storage. Extrapolation techniques are used to transfer the mechanisms from their initial in-reactor and laboratory domains to out-of-reactor spent fuel dry storage environments. This transfer is accomplished both qualitatively where necessary and quantitatively when possible, with fracture toughness used as the transfer function. In this regard, the paper provides useful information on cladding fracture toughness estimates that recognize the specific physical conditions of the cladding, which would not be found elsewhere in the literature. The arguments presented in this paper confirm the general technical consensus that creep is the governing mechanism for spent fuel in long-term dry storage. (author)

  9. Evaluating the feasibility of biological waste processing for long term space missions

    Science.gov (United States)

    Garland, J. L.; Alazraki, M. P.; Atkinson, C. F.; Finger, B. W.; Sager, J. C. (Principal Investigator)

    1998-01-01

    Recycling waste products during orbital (e.g., International Space Station) and planetary missions (e.g., lunar base, Mars transit mission, Martian base) will reduce storage and resupply costs. Wastes streams on the space station will include human hygiene water, urine, faeces, and trash. Longer term missions will contain human waste and inedible plant material from plant growth systems used for atmospheric regeneration, food production, and water recycling. The feasibility of biological and physical-chemical waste recycling is being investigated as part of National Aeronautics and Space Administration's (NASA) Advanced Life Support (ALS) Program. In-vessel composting has lower manpower requirements, lower water and volume requirements, and greater potential for sanitization of human waste compared to alternative bioreactor designs such as continuously stirred tank reactors (CSTR). Residual solids from the process (i.e. compost) could be used a biological air filter, a plant nutrient source, and a carbon sink. Potential in-vessel composting designs for both near- and long-term space missions are presented and discussed with respect to the unique aspects of space-based systems.

  10. Evaluation of outdoor human thermal sensation of local climate zones based on long-term database

    Science.gov (United States)

    Unger, János; Skarbit, Nóra; Gál, Tamás

    2018-02-01

    This study gives a comprehensive picture on the diurnal and seasonal general outdoor human thermal sensation levels in different urban quarters based on long-term (almost 3 years) data series from urban and rural areas of Szeged, Hungary. It is supplemented with a case study dealing with an extreme heat wave period which is more and more frequent in the last decades in the study area. The intra-urban comparison is based on a thermal aspect classification of the surface, namely, the local climate zone (LCZ) system, on an urban meteorological station network and on the utilization of the physiologically equivalent temperature (PET) comfort index with categories calibrated to the local population. The selected stations represent sunlit areas well inside the LCZ areas. The results show that the seasonal and annual average magnitudes of the thermal load exerted by LCZs in the afternoon and evening follow their LCZ numbers. It is perfectly in line with the LCZ concept originally concentrating only on air temperature ( T air) differences between the zones. Our results justified the subdivision of urban areas into LCZs and give significant support to the application possibilities of the LCZ concept as a broader term covering different thermal phenomena.

  11. Long-Term Evaluation of Ocean Tidal Variation Models of Polar Motion and UT1

    Science.gov (United States)

    Karbon, Maria; Balidakis, Kyriakos; Belda, Santiago; Nilsson, Tobias; Hagedoorn, Jan; Schuh, Harald

    2018-04-01

    Recent improvements in the development of VLBI (very long baseline interferometry) and other space geodetic techniques such as the global navigation satellite systems (GNSS) require very precise a-priori information of short-period (daily and sub-daily) Earth rotation variations. One significant contribution to Earth rotation is caused by the diurnal and semi-diurnal ocean tides. Within this work, we developed a new model for the short-period ocean tidal variations in Earth rotation, where the ocean tidal angular momentum model and the Earth rotation variation have been setup jointly. Besides the model of the short-period variation of the Earth's rotation parameters (ERP), based on the empirical ocean tide model EOT11a, we developed also ERP models, that are based on the hydrodynamic ocean tide models FES2012 and HAMTIDE. Furthermore, we have assessed the effect of uncertainties in the elastic Earth model on the resulting ERP models. Our proposed alternative ERP model to the IERS 2010 conventional model considers the elastic model PREM and 260 partial tides. The choice of the ocean tide model and the determination of the tidal velocities have been identified as the main uncertainties. However, in the VLBI analysis all models perform on the same level of accuracy. From these findings, we conclude that the models presented here, which are based on a re-examined theoretical description and long-term satellite altimetry observation only, are an alternative for the IERS conventional model but do not improve the geodetic results.

  12. Toxicological evaluation of long-term intravenous administration of amitraz in horses

    Directory of Open Access Journals (Sweden)

    Queiroz-Neto A.

    2002-01-01

    Full Text Available With the aim of determining the possible toxicity of amitraz after its prolonged use in horses, six English Thoroughbred horses received intravenous injections of amitraz (0.05, 0.10 or 0.15 mg/kg weekly for four months, constituting the experimental group. Eight other animals (control group, via the same route following the same drug administration schedule and period of time, received the vehicle, dimethylformamide. At the end of this period, blood was collected from all the animals, and a comparison was made of the means of the values obtained for the various blood analyses: complete hemogram, alkaline phosphatase, gamma-glutamyltransferase, blood urea nitrogen, lactate dehydrogenase, aspartate aminotransferase, creatine phosphokinase, glucose, albumin, total protein, creatinine, Na+ , K+, Cl- and CO2. The results for the biochemical characteristics showed that only the mean value for urea of the animals submitted to treatment with amitraz was significantly different than the mean value obtained for the control group. The analyses of the hematological characteristics showed that no significant differences between groups were observed. Similarly, the measurement of blood electrolyte levels demonstrated that long-term treatment with amitraz did not cause significant changes in the variables analyzed. The results indicate that amitraz, given in the doses employed in this study, did not show signs of inducing toxic effects in vital organs, even after prolonged administration.

  13. Evaluation of limiting mechanisms for long-term spent fuel dry storage

    International Nuclear Information System (INIS)

    Rashid, J.; Machiels, A.

    2001-01-01

    Several failure mechanisms have been postulated that could become limiting for spent fuel in dry storage. These are: stress Corrosion Cracking (SCC), Delayed Hydride Cracking (DHC) and Creep Rupture (CR). These mechanisms are examined in some detail from two perspectives: their initial environments in which they were developed and applied, and in relation to their applicability to dry storage. Extrapolation techniques are used to transfer the mechanisms from their initial in-reactor and laboratory domains to out-of-reactor spent fuel dry storage environments. This transfer is accomplished both qualitatively where necessary and quantitatively when possible, with fracture toughness used as the transfer function. In this regard, the paper provides useful information on cladding fracture toughness estimates that recognize the specific physical conditions of the cladding, which would not be found elsewhere in the literature. The arguments presented in this paper confirm the general technical consensus that creep is the governing mechanism for spent fuel in long-term dry storage. (author)

  14. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study.

    Science.gov (United States)

    Papp, Kim A; Krueger, James G; Feldman, Steven R; Langley, Richard G; Thaci, Diamant; Torii, Hideshi; Tyring, Stephen; Wolk, Robert; Gardner, Annie; Mebus, Charles; Tan, Huaming; Luo, Yingchun; Gupta, Pankaj; Mallbris, Lotus; Tatulych, Svitlana

    2016-05-01

    Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis. Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. There was no dose comparison beyond week 52. Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  15. Long-term tracking of budding yeast cells in brightfield microscopy: CellStar and the Evaluation Platform.

    Science.gov (United States)

    Versari, Cristian; Stoma, Szymon; Batmanov, Kirill; Llamosi, Artémis; Mroz, Filip; Kaczmarek, Adam; Deyell, Matt; Lhoussaine, Cédric; Hersen, Pascal; Batt, Gregory

    2017-02-01

    With the continuous expansion of single cell biology, the observation of the behaviour of individual cells over extended durations and with high accuracy has become a problem of central importance. Surprisingly, even for yeast cells that have relatively regular shapes, no solution has been proposed that reaches the high quality required for long-term experiments for segmentation and tracking (S&T) based on brightfield images. Here, we present CellStar , a tool chain designed to achieve good performance in long-term experiments. The key features are the use of a new variant of parametrized active rays for segmentation, a neighbourhood-preserving criterion for tracking, and the use of an iterative approach that incrementally improves S&T quality. A graphical user interface enables manual corrections of S&T errors and their use for the automated correction of other, related errors and for parameter learning. We created a benchmark dataset with manually analysed images and compared CellStar with six other tools, showing its high performance, notably in long-term tracking. As a community effort, we set up a website, the Yeast Image Toolkit, with the benchmark and the Evaluation Platform to gather this and additional information provided by others. © 2017 The Authors.

  16. Phenomenological study on crystalline rock aiming at evaluation of long-term behaviour of rock mass

    International Nuclear Information System (INIS)

    Okubo, Seisuke

    2005-02-01

    This study was started on the basis of the outcomes of the research project conducted between 1994 and 2003. In the fiscal year of 1994 when this project was started, a pneumatic creep testing machine was modified. At the end of the fiscal year of 1994, Inada granite was purchased, and the preliminary tests such as P-wave velocity measurement and Schmidt hammer testing were carried out. Through the fiscal year of 1995, a specimen of Tage tuff under water-saturated condition had been loaded in uniaxial condition in the pneumatic creep testing machine. In the fiscal year of 1995, the uniaxial compression and tension tests, and the short-term creep test of Inada granite were also carried out in the servo-controlled testing machines to obtain the complete stress-strain curves. A hydraulic creep testing machine which was planned to use in the next year was modified for long-term creep testing. Finally, a constitutive equation of variable compliance type was examined based on the experimental results. In the fiscal year of 1996, creep, compression and tension tests were carried out. Two types of pressure maintenance equipment (hydraulic and pneumatic types) were developed and examined. In the fiscal year of 1997, creep, compression and tension tests etc. were again carried out on the basis of the results heretofore. The experimental results of long-term creep testing of Tage tuff, middle-term creep testing of Inada granite were described. In both creep tests, samples were submerged in water. In the fiscal year of 1998, creep testing of Tage tuff was conducted. Results of relatively short-term (middle-term) creep conducted on a servo-controlled testing machine were also described. Sample rock was Sirahama sandstone that showed a considerably large creep strain in low stress level such as 17 % of the uniaxial compression strength. Results of triaxial compression test and uniaxial tension test including unloading-reloading tests were described. In the fiscal years of 1999

  17. Cement Waste Matrix Evaluation and Modelling of the Long Term Stability of Cementitious Waste Matrices

    International Nuclear Information System (INIS)

    Martensson, P.; Cronstrand, P.

    2013-01-01

    Cement based materials are often used as a solidification matrix for wet radioactive waste from nuclear power plants such as ion exchange resins, sludge and evaporator concentrates. The mechanical and chemical properties of the cement-waste matrix are affected by the type and the concentration of the waste. For this reason the recipe used in the solidification process has to be carefully adjusted to respond to the variations of the waste. At the Ringhals Nuclear Power Plant (RNPP) an evaporator was to be taken into operation during the mid 2005. As a result of this process an evaporator concentrate containing boric acid was expected. The aims of the present study were to develop a recipe for the solidification of artificial evaporator concentrates, (AEC), containing H 3 BO 3 and measure the compressive strength of the waste/cement matrix over a period of 4 years. The confirmation of the previously reported retarding properties of H 3 BO 3 and the studies of AEC without H 3 BO 3 were also included as a part of this work. Finally, thermodynamic calculations were used as a tool in order to predict the evolution of the mineralogy and integrity for the different cement-waste specimens over very long periods of time, i.e. up to about 100 000 years. The most important finding was that when an optimized waste/cement matrix recipe was used the compressive strength increased during the entire 4 year period and no signs of degradation were noticed. It was also found that the long-term performance of the waste matrices is to a large extent site-specific. In general, the composition of the infiltrating water is more influential than the waste matrices, both on the degradation of the waste matrices itself as well as on the engineered barriers. (author)

  18. Long-term Evaluation of Radiation-Induced Optic Neuropathy After Single-Fraction Stereotactic Radiosurgery

    International Nuclear Information System (INIS)

    Leavitt, Jacqueline A.; Stafford, Scott L.; Link, Michael J.; Pollock, Bruce E.

    2013-01-01

    Purpose: To determine the long-term risk of radiation-induced optic neuropathy (RION) in patients having single-fraction stereotactic radiosurgery (SRS) for benign skull base tumors. Methods and Materials: Retrospective review of 222 patients having Gamma Knife radiosurgery for benign tumors adjacent to the anterior visual pathway (AVP) between 1991 and 1999. Excluded were patients with prior or concurrent external beam radiation therapy or SRS. One hundred twenty-nine patients (58%) had undergone previous surgery. Tumor types included confirmed World Health Organization grade 1 or presumed cavernous sinus meningioma (n=143), pituitary adenoma (n=72), and craniopharyngioma (n=7). The maximum dose to the AVP was ≤8.0 Gy (n=126), 8.1-10.0 Gy (n=39), 10.1-12.0 Gy (n=47), and >12 Gy (n=10). Results: The mean clinical and imaging follow-up periods were 83 and 123 months, respectively. One patient (0.5%) who received a maximum radiation dose of 12.8 Gy to the AVP developed unilateral blindness 18 months after SRS. The chance of RION according to the maximum radiation dose received by the AVP was 0 (95% confidence interval [CI] 0-3.6%), 0 (95% CI 0-10.7%), 0 (95% CI 0-9.0%), and 10% (95% CI 0-43.0%) for patients receiving ≤8 Gy, 8.1-10.0 Gy, 10.1-12.0 Gy, and >12 Gy, respectively. The overall risk of RION in patients receiving >8 Gy to the AVP was 1.0% (95% CI 0-6.2%). Conclusions: The risk of RION after single-fraction SRS in patients with benign skull base tumors who have no prior radiation exposure is very low if the maximum dose to the AVP is ≤12 Gy. Physicians performing single-fraction SRS should remain cautious when treating lesions adjacent to the AVP, especially when the maximum dose exceeds 10 Gy

  19. Long-term Evaluation of Radiation-Induced Optic Neuropathy After Single-Fraction Stereotactic Radiosurgery

    Energy Technology Data Exchange (ETDEWEB)

    Leavitt, Jacqueline A., E-mail: leavitt.jacqueline@mayo.edu [Department of Ophthalmology, Mayo Clinic and Foundation, Rochester, Minnesota (United States); Stafford, Scott L. [Department of Radiation Oncology, Mayo Clinic and Foundation, Rochester, Minnesota (United States); Link, Michael J. [Department of Neurosurgery, Mayo Clinic and Foundation, Rochester, Minnesota (United States); Pollock, Bruce E. [Department of Radiation Oncology, Mayo Clinic and Foundation, Rochester, Minnesota (United States); Department of Neurosurgery, Mayo Clinic and Foundation, Rochester, Minnesota (United States)

    2013-11-01

    Purpose: To determine the long-term risk of radiation-induced optic neuropathy (RION) in patients having single-fraction stereotactic radiosurgery (SRS) for benign skull base tumors. Methods and Materials: Retrospective review of 222 patients having Gamma Knife radiosurgery for benign tumors adjacent to the anterior visual pathway (AVP) between 1991 and 1999. Excluded were patients with prior or concurrent external beam radiation therapy or SRS. One hundred twenty-nine patients (58%) had undergone previous surgery. Tumor types included confirmed World Health Organization grade 1 or presumed cavernous sinus meningioma (n=143), pituitary adenoma (n=72), and craniopharyngioma (n=7). The maximum dose to the AVP was ≤8.0 Gy (n=126), 8.1-10.0 Gy (n=39), 10.1-12.0 Gy (n=47), and >12 Gy (n=10). Results: The mean clinical and imaging follow-up periods were 83 and 123 months, respectively. One patient (0.5%) who received a maximum radiation dose of 12.8 Gy to the AVP developed unilateral blindness 18 months after SRS. The chance of RION according to the maximum radiation dose received by the AVP was 0 (95% confidence interval [CI] 0-3.6%), 0 (95% CI 0-10.7%), 0 (95% CI 0-9.0%), and 10% (95% CI 0-43.0%) for patients receiving ≤8 Gy, 8.1-10.0 Gy, 10.1-12.0 Gy, and >12 Gy, respectively. The overall risk of RION in patients receiving >8 Gy to the AVP was 1.0% (95% CI 0-6.2%). Conclusions: The risk of RION after single-fraction SRS in patients with benign skull base tumors who have no prior radiation exposure is very low if the maximum dose to the AVP is ≤12 Gy. Physicians performing single-fraction SRS should remain cautious when treating lesions adjacent to the AVP, especially when the maximum dose exceeds 10 Gy.

  20. Long-term Evaluation of the Ross Procedure in Acute Infective Endocarditis.

    Science.gov (United States)

    Ratschiller, Thomas; Sames-Dolzer, Eva; Paulus, Patrick; Schimetta, Wolfgang; Müller, Hannes; Zierer, Andreas F; Mair, Rudolf

    2017-10-05

    Optimal valve substitute for young patients with aortic valve endocarditis remains controversial. Given its better resistance to infection, the Ross procedure is an attractive alternative to prosthetic valve replacement or homograft implantation. The objective of this study was to assess long-term outcomes of the Ross procedure in this indication. From January 1991 to April 2017, 190 patients underwent a Ross procedure at our institution. Acute endocarditis was the indication for operation in 19 patients, including 6 patients with a bicuspid aortic valve. The pulmonary autograft was implanted as freestanding root replacement in all patients. The clinical follow-up is 100% complete, with a mean of 12.0 ± 5.7 years. The mean age of the study population was 35.9 ± 11.5 years. Moderate or severe aortic regurgitation was present in 84.2% of the patients. Systemic embolization had occurred in 36.8% of the patients. The mean aortic cross-clamp time was 126 ± 24 minutes. The median length of stay on the intensive care unit was 1 day. Mortality at 30 days was 5.3% (1 patient with gastrointestinal bleeding). Echocardiography at hospital discharge documented no or trivial aortic regurgitation in all patients. No case of recurrent endocarditis affecting the autograft occurred. One patient (0.4% per patient-year) was reoperated 1.8 years after the Ross procedure for homograft endocarditis. Three patients (15.8%) were reoperated for autograft aneurysm. The Ross procedure is a safe and effective alternative to prosthetic valve replacement or homograft implantation in selected young patients with acute endocarditis with a low rate of recurrent infection. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Long-term safety and outcome of a temporary self-expanding metallic stent for achalasia: a prospective study with a 13-year single-center experience

    International Nuclear Information System (INIS)

    Zhao, Jun-Gong; Li, Yong-Dong; Li, Ming-Hua; Shang, Ke-Zhong; Cheng, Ying-Sheng; Chen, Ni-Wei; Chen, Wei-Xiong

    2009-01-01

    To prospectively evaluate the long-term clinical safety and efficacy of a newly designed self-expanding metallic stent (SEMS) in the treatment of patients with achalasia. Seventy-five patients with achalasia were treated with a temporary SEMS with a 30-mm diameter. The SEMSs were placed under fluoroscopic guidance and removed by gastroscopy 4-5 days after stent placement. Follow-up data focused on dysphagia score, technique and clinical success, clinical remissions and failures, and complications and was performed at 6 months, 1 year, and within 3 to 5 years, 5 to 8 years, 8 to 10 years, and >10 years postoperatively. Stent placement was technically successful in all patients. Complications included stent migration (n=4, 5.33%), chest pain (n=28, 38.7%), reflux (n=15, 20%), and bleeding (n=9, 12%). No perforation or 30-day mortality occurred. Clinical success was achieved in all patients 1 month after stent removal. The overall remission rates at 6 months, 1, 1-3, 3-5, 5-8, 8-10, and >10 year follow-up periods were 100%, 96%, 93.9%, 90.9%, 100%, 100%, and 83.3%, respectively. Stent treatment failed in six patients, and the overall remission rate in our series was 92%. The median and mean primary patencies were 2.8 ± 0.28 years (95% CI: 2.25-3.35) and 4.28 ± 0.40 years (95% CI: 3.51-5.05), respectively. The use of temporary SEMSs with 30-mm diameter proved to be a safe and effective approach for managing achalasia with a long-term satisfactory clinical remission rate. (orig.)

  2. Long-term safety and outcome of a temporary self-expanding metallic stent for achalasia: a prospective study with a 13-year single-center experience

    Energy Technology Data Exchange (ETDEWEB)

    Zhao, Jun-Gong; Li, Yong-Dong; Li, Ming-Hua; Shang, Ke-Zhong [Shanghai Tong Ji University, Department of Radiology, Tenth Affiliated People' s Hospital, Shanghai (China); Cheng, Ying-Sheng [Shanghai Tong Ji University, Department of Radiology, Tenth Affiliated People' s Hospital, Shanghai (China); Shanghai Jiao Tong University, Department of Radiology, Sixth Affiliated People' s Hospital, Shanghai (China); Chen, Ni-Wei; Chen, Wei-Xiong [Shanghai Jiao Tong University, Department of Gastroenterology, Sixth Affiliated People' s Hospital, Shanghai (China)

    2009-08-15

    To prospectively evaluate the long-term clinical safety and efficacy of a newly designed self-expanding metallic stent (SEMS) in the treatment of patients with achalasia. Seventy-five patients with achalasia were treated with a temporary SEMS with a 30-mm diameter. The SEMSs were placed under fluoroscopic guidance and removed by gastroscopy 4-5 days after stent placement. Follow-up data focused on dysphagia score, technique and clinical success, clinical remissions and failures, and complications and was performed at 6 months, 1 year, and within 3 to 5 years, 5 to 8 years, 8 to 10 years, and >10 years postoperatively. Stent placement was technically successful in all patients. Complications included stent migration (n=4, 5.33%), chest pain (n=28, 38.7%), reflux (n=15, 20%), and bleeding (n=9, 12%). No perforation or 30-day mortality occurred. Clinical success was achieved in all patients 1 month after stent removal. The overall remission rates at 6 months, 1, 1-3, 3-5, 5-8, 8-10, and >10 year follow-up periods were 100%, 96%, 93.9%, 90.9%, 100%, 100%, and 83.3%, respectively. Stent treatment failed in six patients, and the overall remission rate in our series was 92%. The median and mean primary patencies were 2.8 {+-} 0.28 years (95% CI: 2.25-3.35) and 4.28 {+-} 0.40 years (95% CI: 3.51-5.05), respectively. The use of temporary SEMSs with 30-mm diameter proved to be a safe and effective approach for managing achalasia with a long-term satisfactory clinical remission rate. (orig.)

  3. An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan.

    Science.gov (United States)

    Ichikawa, Hironobu; Hiratani, Michio; Yasuhara, Akihiro; Tsujii, Noa; Oshimo, Takashi; Ono, Hiroaki; Tadori, Yoshihiro

    2018-02-01

    The purpose of this study was to evaluate the long-term safety and efficacy of aripiprazole in treating irritability in pediatric patients (6-17 years) with autistic disorder (AD) in Japan. In this open-label extension study, patients who had completed a previous randomized, double-blind, placebo-controlled 8-week study were enrolled and were flexibly dosed with aripiprazole (1-15 mg/day) until the new indication of irritability in pediatric autism spectrum disorder was approved in Japan. Seventy (81%) out of 86 enrolled patients completed week-48 assessments. The mean duration of treatment was 694.9 days. The mean daily dose of aripiprazole over the treatment period was 7.2 mg and the mean of the final dose was 8.5 mg. The most common treatment-emergent adverse events (TEAE; ≥20%) included nasopharyngitis, somnolence, influenza, and increased weight. The majority of these TEAE were mild or moderate in severity, and there were no deaths, and no clinically relevant findings in laboratory values except prolactin decrease, vital signs, height, or ECG parameters. At week 48 (observed case), the mean change from baseline in the Irritability subscale score for the Aberrant Behavior Checklist Japanese Version was -6.3 in prior placebo patients and -2.6 in prior aripiprazole patients. Aripiprazole was generally safe, well tolerated, and effective in the long-term treatment of irritability associated with AD in Japanese pediatric patients. © 2017 The Authors. Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.

  4. Open-label study on the long-term efficacy, safety, and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain.

    Science.gov (United States)

    Wallace, Mark; Thipphawong, John

    2010-10-01

    To investigate the efficacy, safety, and impact on quality of life of long-term administration of OROS hydromorphone ER (8-128mg) in patients with chronic low back pain. A total of 113 adults with chronic low back pain who completed a 6-week open-label study were enrolled in this 6-month extension study. The primary end point was the daily pain relief rating obtained during monthly study visits. Secondary end points included Investigator and Patient Global Evaluations, Brief Pain Inventory scores obtained at monthly study visits, and quality-of-life measures (Medical Outcomes Study Questionnaire and 36-Item Short-Form Health Survey score) obtained at monthly intervals. Mean±SD change from baseline in pain relief with OROS hydromorphone ER for the Month 6 visit was 0.9±2.55 (P=0.0007) and for the last assessment of the extension study was 0.9±2.53 (P=0.0002). At the Month 6 visit, 81.3% of investigators and 71.0% of patients rated their satisfaction of pain relief with OROS hydromorphone ER treatment as good, very good, or excellent. Changes on the 36-item Short Form Health Survey, a quality-of-life measure, were statistically significant for the physical composite scores for all extension phase time points, including Month 6 (2.1±5.34; Psleep disturbances. Adverse events included gastrointestinal and central nervous system symptoms. The results support the long-term use of OROS hydromorphone ER in managing chronic moderate to severe low back pain. Wiley Periodicals, Inc.

  5. Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children

    NARCIS (Netherlands)

    Wahn, Ulrich; Bos, Jan D.; Goodfield, Mark; Caputo, Ruggero; Papp, Kim; Manjra, Ahmed; Dobozy, Attila; Paul, Carle; Molloy, Stephen; Hultsch, Thomas; Graeber, Michael; Cherill, Robert; de Prost, Yves

    2002-01-01

    OBJECTIVE: Pimecrolimus cream (SDZ ASM 981), a nonsteroid inhibitor of inflammatory cytokines, is effective in atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares. METHODS: Early

  6. The evaluation of the National Long Term Care Demonstration. 1. An overview of the channeling demonstration and its evaluation.

    Science.gov (United States)

    Carcagno, G J; Kemper, P

    1988-04-01

    The channeling demonstration sought to substitute community care for nursing home care to reduce long-term care costs and improve the quality of life of elderly clients and the family members and friends who care for them. Two interventions were tested, each in five sites; both had comprehensive case management at their core. One model added a small amount of additional funding for direct community services to fill the gaps in the existing system; the other substantially expanded coverage of community services regardless of categorical eligibility under existing programs. The demonstration was evaluated using a randomized experimental design to test the effects of channeling on use of community care, nursing homes, hospitals, and informal caregiving, and on measures of the quality of life of clients and their informal caregivers. Data were obtained from interviews with clients and informal caregivers; service use and cost records came from Medicare, Medicaid, channeling, and providers; and death records for an 18-month follow-up period were examined.

  7. Efficacy and safety of nimesulide long term administration in patients with osteoarthritis: results of 12-months open controlled study DINAMO (long term administration of nimesulide in osteoarthritis multifactor assessment

    Directory of Open Access Journals (Sweden)

    L I Alexeeva

    2009-01-01

    Full Text Available Objective. To compare efficacy and safety of nimesulide and paracetamol in treatment of patients with osteoarthritis (OA during 12 months. Material and methods. 40 women (mean age 66,8±5,1 years with knee osteoarthritis (II-III stage according to Kellgren-Lawrence having intensive pain (>40 mm on VAS were included. Group 1 pts (n=20 received nimesulide 200-100 mg/day. Group 2 pts were treated with paracetamol till 3 g/day. WOMAC was used as efficacy measure. Safety was assessed with endoscopic examination of upper gastrointestinal tract, ECG, blood pressure and ECG Holter monitoring, clinical and biochemical blood parameters. Statistical significance of differences was assessed with Student’s t-test, χ2 and Fisher exact test Results. WOMAC index decreased during treatment from 1182,7±345,9 to 698,4±351,1 for nimesulide and from 1136,4±313,8 to 1031,6±21 for paracetamol (p<0,05. There were 6 cases of gastrointestinal complications and 4 cases of hypertension development or deterioration in each group. Coronary heart disease developed or deteriorated in 4 patients receiving nimesulide but not in control group. Liver function tests did not deteriorated during treatment with nimesulide. Conclusion. Nimesulide was more effective than paracetamol in treatment of OA. But risk of cardiovascular complications development during treatment with NSAIDs requires serious attention. Nimesulide did not induced liver damage during long term treatment.

  8. Keep fatigue usage low for LTO. Benefits of load monitoring and related fatigue evaluations for long term operation

    International Nuclear Information System (INIS)

    Rothenhoefer, H.; Koenig, G.

    2012-01-01

    Design fatigue calculations normally cover a service life of 40 years. Based on design transients with a specified number of cycles the evaluations have to prove that the fatigue usage after 40 years will stay below 1. In 40+ years of operation real loads can differ much from design loads so that premature ageing can occur. For long term operation, monitoring of real loads and detailed fatigue analysis for selected locations can be used to optimize operational modes in order to reduce the loads causing fatigue. As a result fatigue usage can be kept below 1 even for 60+ years. (author)

  9. Evaluation of the long-term program plans of the US Division of Controlled Thermonuclear Research. Progress report No. 1

    International Nuclear Information System (INIS)

    Nichols, S.P.; Vanston, J.H. Jr.

    As part of the Partitive Analytical Forecasting (PAF) technique, the Graphical Evaluation and Review Technique (GERTS) IIIZ computer code is used to perform simulations on a logic network describing the DCTR long-term program plan. Logic networks describing the tokamak, mirror, and theta-pinch developments are simulated individually and then together to form an overall DCTR program network. The results of the simulation of the overall network using various funding schemes and strategies are presented. An economic sensitivity analysis is provided for the tokamak logic networks. An analysis is also performed of the fusion-fission hybrid concept in the context of the present DCTR goals

  10. Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

    Directory of Open Access Journals (Sweden)

    Nagamu Inoue

    2017-07-01

    Full Text Available Background/Aims: Intestinal Behçet's disease (BD is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671.Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs were examined. The efficacy was assessed on the basis of marked improvement (MI and complete remission (CR using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.Results: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years. No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

  11. Thin-plate spline analysis of mandibular morphological changes induced by early class III treatment: a long-term evaluation.

    Science.gov (United States)

    Franchi, Lorenzo; Pavoni, Chiara; Cerroni, Silvia; Cozza, Paola

    2014-08-01

    To evaluate the long-term mandibular morphological changes induced by early treatment of class III malocclusion with rapid maxillary expansion (RME) and facial mask (FM). Twenty-five subjects [10 boys, 15 girls; mean age at T1 (start of treatment) 9.3±1.6 years] with class III disharmony were treated with RME and FM therapy followed by fixed appliances. The patients were re-evaluated at the end of growth (T2), about 8.5 years after the end of the treatment (mean age, 18.6±2.0 years). Sixteen subjects with untreated class III malocclusion comprised the control group. Mandibular shape changes were analysed on the lateral cephalograms of the subjects of both groups by means of thin-plate spline (TPS) analysis. Procrustes average mandibular configurations were subjected to TPS analysis by means of both cross-sectional between-group comparisons at T1 and at T2 and longitudinal within-group comparisons. Statistical analysis of shape differences was performed using a generalized Goodall F test. In the long term, the treated group exhibited a significant upward and forward direction of condylar growth. On the contrary, untreated class III subjects showed an upward and backward direction of condylar growth associated with a downward and forward deformation of the mandibular symphysis. Limitations are related to the small sample size of both treated and control groups and to the retrospective nature of the study. Early treatment of class III malocclusion with RME and FM is able to produce significant and favourable long-term mandibular shape changes characterized by an anterior morphogenetic rotation. © The Author 2013. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  12. Long-term child follow-up after large obstetric randomised controlled trials for the evaluation of perinatal interventions: a systematic review of the literature

    NARCIS (Netherlands)

    Teune, M. J.; van Wassenaer, A. G.; Malin, G. L.; Asztalos, E.; Alfirevic, Z.; Mol, B. W. J.; Opmeer, B. C.

    2013-01-01

    Although the hope is that many perinatal interventions are performed with an ultimate aim to improve the long-term health and development of the child, long-term outcome is rarely used as a primary end-point in perinatal randomised controlled trials (RCTs). To evaluate how often and with which tools

  13. Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children.

    Science.gov (United States)

    Wahn, Ulrich; Bos, Jan D; Goodfield, Mark; Caputo, Ruggero; Papp, Kim; Manjra, Ahmed; Dobozy, Attila; Paul, Carle; Molloy, Stephen; Hultsch, Thomas; Graeber, Michael; Cherill, Robert; de Prost, Yves

    2002-07-01

    Pimecrolimus cream (SDZ ASM 981), a nonsteroid inhibitor of inflammatory cytokines, is effective in atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares. Early intervention with pimecrolimus was compared with a conventional AD treatment strategy (ie, emollients and topical corticosteroids). In this 1-year, controlled, double-blind study, 713 AD patients (2-17 years) were randomized 2:1 to a pimecrolimus-based or conventional regimen. Both groups used emollients for dry skin. Early AD signs/symptoms were treated with pimecrolimus cream or, in the conventional treatment group, vehicle to prevent progression to flares. If flares occurred, moderately potent topical corticosteroids were mandated. The primary efficacy endpoint was ranked flares at 6 months. Safety was monitored clinically, and a skin recall-antigen test was performed at study completion. BASELINE CHARACTERISTICS OF THE PATIENTS: The mean age for both groups was approximately 8 years, and the majority of patients had moderate disease at baseline. PATIENT FOLLOW-UP AND EXPOSURE TO STUDY MEDICATION: The mean duration of follow-up (+/-standard error) was 303.7 (+/-5.30) days in the pimecrolimus group and 235.2 (+/-9.40) days in the control group. The discontinuation rate was significantly higher in the control group than in the pimecrolimus group (51.5% vs 31.6% at 12 months), and proportionately more patients with severe or very severe disease discontinued in the control group. The main reason for the higher discontinuation rate in the control group was unsatisfactory therapeutic effect (30.4% vs 12.4%). This resulted in a substantially higher mean number of study medication treatment days in the pimecrolimus group compared with the control group: 211.9 (69.8% of study days) versus 156.0 (66.3% of study days). Of those patients who completed 12 months on study, 14.2% and 7.0% of patients in the

  14. Evaluation of the long-term energy analysis program used for the 1978 EIA Administrator's Report to Congress

    Energy Technology Data Exchange (ETDEWEB)

    Peelle, R. W.; Weisbin, C. R.; Alsmiller, Jr., R. G.

    1981-10-01

    An evaluation of the Long-Term Energy Analysis Program (LEAP), a computer model of the energy portion of the US economy that was used for the 1995-2020 projections in its 1978 Annual Report to Congress, is presented. An overview of the 1978 version, LEAP Model 22C, is followed by an analysis of the important results needed by its users. The model is then evaluated on the basis of: (1) the adequacy of its documentation; (2) the local experience in operating the model; (3) the adequacy of the numerical techniques used; (4) the soundness of the economic and technical foundations of the model equations; and (5) the degree to which the computer program has been verified. To show which parameters strongly influence the results and to approach the question of whether the model can project important results with sufficient accuracy to support qualitative conclusions, the numerical sensitivities of some important results to model input parameters are described. The input data are categorized and discussed, and uncertainties are given for some parameters as examples. From this background and from the relation of LEAP to other available approaches for long-term energy modeling, an overall evaluation is given of the model's suitability for use by the EIA.

  15. Evaluation of long-term natural gas marketing agreements: An application of commodity forward and option pricing theory

    International Nuclear Information System (INIS)

    Salahor, G.S.; Laughton, D.G.

    1993-01-01

    Methods that have been empirically validated in the analysis of short-term traded securities are adapted to evaluate long-term natural gas direct-sale contracts. A sample contract is examined from the perspective of the producer, and analyzed as a series of forward and option contracts. The assessment of contract value is based on the gas price forecast, the volatility in that forecast, and the valuation of risk caused by that volatility. The method presented allows the gas producer to quantify these elements, and to evaluate the variety of terms encountered in direct-sale natural gas agreements, including features such as load factors and penalty charges. The analysis uses as inputs a probabilistic price forecast and a determination of a price of risk for gas prices. Once the forecast volatility is derived from the probabilistic forecast, the forward contracts imbedded in the long-term gas contract can be valued with a risk-discounting model, and optional aspects can be evaluated using the Black-Scholes option pricing method. 10 refs., 3 figs., 2 tabs

  16. Development of Integrity Evaluation Technology for the Long-term Spent Fuel Dry Storage System (1st year Report)

    International Nuclear Information System (INIS)

    Choi, Jong Won; Kook, Dong Hak; Kim, Jun Sub

    2010-05-01

    Korea has operated 16 Pressurized Water Reactors(PWR) and has a plan to construct additional nuclear power reactors as only PWR. This causes a big issue of PWR spent fuel accumulation problem now and in the future. KRMC(Korea Radioactive waste Management Coorporation) which was established in 2009 is charged with managing all kinds of radioactive waste that is produced in Korea. KRMC is considering spent fuel dry storage as an option to solve this spent fuel problem and developing the related engineering techniques. KAERI(Korea Atomic Energy Research Institute) also participated in this development and focused on evaluating the spent fuel dry storage system integrity for a long term operation. This report is the first year research product. The aims of the first year work scope are surveying and analyzing models which could anticipate degradation phenomena of the all dry storage components(spent fuel, structure materials, and equipment materials) and selecting items of the tests which are planned to perform in the next project stage. The major work areas consist of 'spent fuel degradation evaluation model development', 'test senario development', 'long-term evaluation of structural material characteristics', and 'dry storage system structure degradation model development'. These works were successfully achieved. This report is expected to contribute for the second year work which includes degradation model development and test senario development, and next project stage

  17. Development of the international status of science and technology concerning methods and tools for operational and long-term safety cases

    International Nuclear Information System (INIS)

    Seher, Holger; Beuth, Thomas; Bracke, Guido; Kock, Ingo; Mayer, Kim-Marisa; Moog, Helge C.; Uhlmann, Stephan; Weyand, Torben

    2016-09-01

    The project ''development of the international status of science and technology concerning methods and tools for operational and long-term safety cases'' covers the following key aspects: global aspects of the methodology for scenario assumption for the operational phase following closure, potential analysis of the derives safety cases for the project Gorleben, determination of the solid phase composition of high-level radioactive wastes using geochemical modeling calculations, search for an adequate approach for the calculation of density and viscosity of saline solutions for the future use in GRS computer codes, international approaches for an integral analysis for the host rocks clay and granite in relation to the safety requirements of BMUB.

  18. Long-term safety for the final repository for spent nuclear fuel at Forsmark. Main report of the SR-Site project

    Energy Technology Data Exchange (ETDEWEB)

    2011-03-15

    The central conclusion of the safety assessment SR-Site is that a KBS-3 repository that fulfils long-term safety requirements can be built at the Forsmark site. This conclusion is reached because the favourable properties of the Forsmark site ensure the required long-term durability of the barriers of the KBS-3 repository. In particular, the copper canisters with their cast iron inserts have been demonstrated to provide a sufficient resistance to the mechanical and chemical loads to which they may be subjected in the repository environment. The conclusion is underpinned by: - The reliance of the KBS-3 repository on i) a geological environment that exhibits long-term stability with respect to properties of importance for long-term safety, i.e. mechanical stability, low groundwater flow rates at repository depth and the absence of high concentrations of detrimental components in the groundwater, and ii) the choice of naturally occurring materials (copper and bentonite clay) for the engineered barriers that are sufficiently durable in the repository environment to provide the barrier longevity required for safety. - The understanding, through decades of research at SKB and in international collaboration, of the phenomena that affect long-term safety, resulting in a mature knowledge base for the safety assessment. - The understanding of the characteristics of the site through several years of surface-based investigations of the conditions at depth and of scientific interpretation of the data emerging from the investigations, resulting in a mature model of the site, adequate for use in the safety assessment. - The detailed specifications of the engineered parts of the repository and the demonstration of how components fulfilling the specifications are to be produced in a quality assured manner, thereby providing a quality assured initial state for the safety assessment. The detailed analyses demonstrate that canister failures in a one million year perspective are rare

  19. Long-term safety for the final repository for spent nuclear fuel at Forsmark. Main report of the SR-Site project

    International Nuclear Information System (INIS)

    2011-03-01

    The central conclusion of the safety assessment SR-Site is that a KBS-3 repository that fulfils long-term safety requirements can be built at the Forsmark site. This conclusion is reached because the favourable properties of the Forsmark site ensure the required long-term durability of the barriers of the KBS-3 repository. In particular, the copper canisters with their cast iron inserts have been demonstrated to provide a sufficient resistance to the mechanical and chemical loads to which they may be subjected in the repository environment. The conclusion is underpinned by: - The reliance of the KBS-3 repository on i) a geological environment that exhibits long-term stability with respect to properties of importance for long-term safety, i.e. mechanical stability, low groundwater flow rates at repository depth and the absence of high concentrations of detrimental components in the groundwater, and ii) the choice of naturally occurring materials (copper and bentonite clay) for the engineered barriers that are sufficiently durable in the repository environment to provide the barrier longevity required for safety. - The understanding, through decades of research at SKB and in international collaboration, of the phenomena that affect long-term safety, resulting in a mature knowledge base for the safety assessment. - The understanding of the characteristics of the site through several years of surface-based investigations of the conditions at depth and of scientific interpretation of the data emerging from the investigations, resulting in a mature model of the site, adequate for use in the safety assessment. - The detailed specifications of the engineered parts of the repository and the demonstration of how components fulfilling the specifications are to be produced in a quality assured manner, thereby providing a quality assured initial state for the safety assessment. The detailed analyses demonstrate that canister failures in a one million year perspective are rare

  20. Evaluation of Thermal Creep and Hydride Re-orientation Properties of High Burnup Spent Fuel Cladding under Long Term Dry storage

    Energy Technology Data Exchange (ETDEWEB)

    Kamimura, K [JNES (Japan)

    2012-07-01

    In Japan, spent fuels will be reprocessed as recyclable energy source at a reprocessing plant. The first commercial plant is under-constructing and will start operation in 2008. It is necessary that spent fuels should be stored in the independent interim storage facilities (ISF) until reprocessing. Utilities plan the operation of the first ISF in 2010. JNES has a mission to support the safety body by researching the data of technical standard and regulation. Investigating of spent fuel integrity during long term dry storage is one of them. The objectives are: 1) Evaluation of the effects of material design changes on creep properties of high burnup spent fuel cladding; 2) Evaluation of the effects of alloy elements and texture of irradiated Zircaloy on hydride re-orientation properties and the effects of radial hydrides on cladding mechanical properties; 3) Evaluation of the effects of temperature on irradiation hardening recovery.

  1. Associations Among Health Care Workplace Safety, Resident Satisfaction, and Quality of Care in Long-Term Care Facilities.

    Science.gov (United States)

    Boakye-Dankwa, Ernest; Teeple, Erin; Gore, Rebecca; Punnett, Laura

    2017-11-01

    We performed an integrated cross-sectional analysis of relationships between long-term care work environments, employee and resident satisfaction, and quality of patient care. Facility-level data came from a network of 203 skilled nursing facilities in 13 states in the eastern United States owned or managed by one company. K-means cluster analysis was applied to investigate clustered associations between safe resident handling program (SRHP) performance, resident care outcomes, employee satisfaction, rates of workers' compensation claims, and resident satisfaction. Facilities in the better-performing cluster were found to have better patient care outcomes and resident satisfaction; lower rates of workers compensation claims; better SRHP performance; higher employee retention; and greater worker job satisfaction and engagement. The observed clustered relationships support the utility of integrated performance assessment in long-term care facilities.

  2. Study on the system development for evaluating long-term alteration of hydraulic field in near field

    International Nuclear Information System (INIS)

    Okutu, Kazuo; Morikawa, Seiji; Takamura, Hisashi

    2002-02-01

    For the high performance evaluation of reliability of TRU waste repository, the system development for evaluating long-term alteration in consideration of the changes action of barrier materials of hydraulic field in Near Field is required. In this research, system development for evaluating long-term alteration of hydraulic field in Near Field was examined. Examination of the basic specification of chemical/dynamic alteration action analysis system used as the composition element of this system and a whole system were performed. The research result of this year is shown below. 1) The system by which the chemical changes happened by Near Field as influence of the exudation liquid from cement material are evaluated was examined. In this year, document investigation about the various processes about chemical alteration and extraction of a choice, presentation of the uncertainty about a model or data, preliminary modeling, a simple analysis tool creation and sensitivity analysis, extraction of the process which should be taken into consideration in a system valuation modeling and a phenomenon analysis model, and a corresponding mathematics model, optimization of the software composition for development of a system valuation modeling, the exercise by the preliminary system analysis model, the experiment plan for the corroboration of a model were shown. 2) In consideration of change of the physical characteristic accompanying chemical alteration of bentonite material and cement material, the system by which dynamic changes action of repository is evaluated was examined. In this year, arrangement of the dynamics action of repository for long-term were shown. Extraction of a phenomenon made applicable to evaluation was shown. And the dynamic models were investigated and the prototype of the dynamics model that can take into consideration the characteristic of bentonite material was shown. And the basic composition of a dynamic changes action analysis system was shown. 3

  3. Long-term evaluation of individualized marketing programs for travel demand management

    Science.gov (United States)

    2010-07-01

    This research examines the use of individualized marketing as a transportation demand : management (TDM) strategy, using the City of Portlands SmartTrips program. This research : project has two specific aims: (1) to evaluate whether the benefits ...

  4. Root length and alveolar bone level of impacted canines and adjacent teeth after orthodontic traction: a long-term evaluation

    Science.gov (United States)

    da SILVA, Aldir Cordeiro; CAPISTRANO, Anderson; de ALMEIDA-PEDRIN, Renata Rodrigues; CARDOSO, Maurício de Almeida; CONTI, Ana Cláudia de Castro Ferreira; CAPELOZZA, Leopoldino

    2017-01-01

    Abstract Objective The aim of this retrospective study was to evaluate the long-term effects of orthodontic traction on root length and alveolar bone level in impacted canines and adjacent teeth. Material and Methods Sample consisted of 16 patients (nine males and seven females), mean initial age 11 years and 8 months presenting with unilaterally maxillary impacted canines, palatally displaced, treated with the same surgical and orthodontic approach. Teeth from the impacted-canine side were assigned as Group I (GI), and contralateral teeth as control, Group II (GII). The mean age of patients at the end of orthodontic treatment was 14 years and 2 months and the mean post-treatment time was 5 years and 11 months. Both contralateral erupted maxillary canines and adjacent teeth served as control. Root length and alveolar bone level (buccal and palatal) were evaluated on cone-beam computed tomography (CBCT) images. The comparison of root length and alveolar bone level changes between groups were assessed by applying paired t-test, at a significance level of 5% (p<0.05). Results There were no statistically significant differences in root length and buccal and palatal bone levels of canines and adjacent teeth among groups. Conclusions Impacted canine treatment by closed-eruption technique associated with canine crown perforation, has a minimal effect on root length and buccal and palatal alveolar bone level in both canine and adjacent teeth, demonstrating that this treatment protocol has a good long-term prognosis. PMID:28198979

  5. GEOSAF Part II. Demonstration of the operational and long-term safety of geological disposal facilities for radioactive waste. IAEA international intercomparison and harmonization project

    Energy Technology Data Exchange (ETDEWEB)

    Kumano, Yumiko; Bruno, Gerard [International Atomic Energy Agency, Vienna (Austria). Vienna International Centre; Tichauer, Michael [IRSN, Institut de Radioprotection et de Surete Nucleaire, Fontenay-aux-Roses (France); Hedberg, Bengt [Swedish Radiation Safety Authority, Stockholm (Sweden)

    2015-07-01

    International intercomparison and harmonization projects are one of the mechanisms developed by the IAEA for examining the application and use of safety standards, with a view to ensuring their effectiveness and working towards harmonization of approaches to the safety of radioactive waste management. The IAEA has organized a number of international projects on the safety of radioactive waste management; in particular on the issues related to safety demonstration for radioactive waste management facilities. In 2008, GEOSAF, Demonstration of The Operational and Long-Term Safety of Geological Disposal Facilities for Radioactive Waste, project was initiated. This project was completed in 2011 by delivering a project report focusing on the safety case for geological disposal facilities, a concept that has gained in recent years considerable prominence in the waste management area and is addressed in several international safety standards. During the course of the project, it was recognized that little work was undertaken internationally to develop a common view on the safety approach related to the operational phase of a geological disposal although long-term safety of disposal facility has been discussed for several decades. Upon completion of the first part of the GEOSAF project, it was decided to commence a follow-up project aiming at harmonizing approaches on the safety of geological disposal facilities for radioactive waste through the development of an integrated safety case covering both operational and long-term safety. The new project was named as GEOSAF Part II, which was initiated in 2012 initially as 2-year project, involving regulators and operators. GEOSAF Part II provides a forum to exchange ideas and experience on the development and review of an integrated operational and post-closure safety case for geological disposal facilities. It also aims at providing a platform for knowledge transfer. The project is of particular interest to regulatory

  6. A long-term, open-label safety study of single-entity hydrocodone bitartrate extended release for the treatment of moderate to severe chronic pain

    Directory of Open Access Journals (Sweden)

    Nalamachu S

    2014-11-01

    Full Text Available Srinivas Nalamachu,1,2 Richard L Rauck,3 Martin E Hale,4 Orlando G Florete Jr,5 Cynthia Y Robinson,6 Stephen J Farr,6 1International Clinical Research Institute, Overland Park, KS, USA; 2Kansas University Medical Center, Kansas City, KS, USA; 3Carolinas Pain Institute, Center for Clinical Research, Wake Forest University School of Medicine, Winston-Salem, NC, USA; 4Gold Coast Research, LLC, Weston, FL, USA; 5Institute of Pain Management, Jacksonville, FL, USA; 6Zogenix, Inc., Emeryville, CA, USA Objective: To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. Methods: This multicenter, open-label study started with a conversion/titration phase (≤6 weeks where subjects (n=638 were converted to individualized doses (range 20–300 mg of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424. The primary objective (safety and tolerability and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain were monitored throughout the study. Results: Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator's discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%, nausea (10.7% and 9.9%, vomiting (4.1% and 9.7%, and somnolence (7

  7. Evaluation of long-term post-accident core cooling of Three Mile Island Unit 2

    Energy Technology Data Exchange (ETDEWEB)

    None

    1979-04-15

    On the basis of current understanding of the accident scenario and available data, the staff reports here on its evaluation of the condition of the core and the core flow resistance as it might affect ability to cool the core by natural circulation. The natural circulation cooling capability of TMI-2 for the estimated core flow resistance and a variety of other conditions is evaluated and a comparison of the Base Case and off-nominal plant configurations is presented. The potential for and effects of natural convection core cooling are addressed, and the staff recommendations for reactor performance acceptance criteria upon initiation of natural convection are presented.

  8. Evaluation of long-term creep-fatigue life of stainless steel weldment based on a microstructure degradation model

    International Nuclear Information System (INIS)

    Asayama, Tai; Hasebe, Shinichi

    1997-01-01

    This paper describes a newly developed analytical method of evaluation of creep-fatigue strength of stainless weld metals. Based on the observation that creep-fatigue crack initiates adjacent to the interface of sigma-phase/delta-ferrite and matrix, a mechanistic model which allows the evaluation of micro stress/strain concentration adjacent to the interface was developed. Fatigue and creep damage were evaluated using the model which describes the microstructure after exposed to high temperatures for a long time. Thus it was made possible to predict analytically the long-term creep-fatigue life of stainless steel metals whose microstructure is degraded as a result of high temperature service. (author)

  9. Rolls-Royce I and C long term support a dedicated solution to manage plant condition, optimize operating life and maximize plant value while improving safety

    International Nuclear Information System (INIS)

    Baillonmartos, F.

    2010-01-01

    Rolls-Royce supplied safety I and C equipment as Original Equipment Manufacturer (OEM) for 200 reactors in operation from 1970', including various technological steps (analog to digital hardware). The hardware scope covers various systems, either more than 500 hardware references, either more than 150000 parts in operation. Rolls-Royce contributes to life time extension ensuring system availability and reliability on long term basis by determining the optimum solution between different maintenance approaches: maintenance and repair with limited retrofit or major system retrofit. Based on Long Term Support (LTS) agreement with customers, Rolls-Royce commits to maintain the capability to manufacture, modify, repair, test, at board, rack and systems level over a long time period. This means finding solution to hardware ageing, technology evolution, skills and tools maintenance. This paper describes how Rolls-Royce has built a global process based on delivering a package of services and developing long term support engineering solutions and tools. Our main experience on EDF partnership will serve to illustrate Rolls-Royce I and C Long Term Support activity. (authors)

  10. Long-term prospective evaluation of intestinal anastomosis using stainless steel staples in 14 dogs.

    Science.gov (United States)

    Benlloch-Gonzalez, Manuel; Gomes, Eymeric; Bouvy, Bernard; Poncet, Cyrill

    2015-07-01

    This prospective clinical study evaluated the use, complications, and clinical and ultrasonographic follow-ups of end-to-end intestinal anastomoses with skin staples in naturally occurring diseases in canine small and large intestines. Intestinal anastomoses were performed in 14 dogs and pre-, peri-, and postoperative data were recorded. Postoperative clinical and ultrasound evaluations were performed at regular intervals for 1 year. The mean time taken to construct the anastomosis was 5 min. There were no intraoperative complications. Hemorrhage and colonic stricture were the main postoperative complications. Staple loss occurred in 2 cases. Absence of wall layering and focal wall thickening were observed in all cases at each ultrasonographic follow-up. Hyperechoic fat was observed in all but 1 of the cases at month 1. Nine dogs were alive with normal digestive function at the end of the study. The skin stapler technique enabled rapid construction of consistent anastomoses with inexpensive stapling material.

  11. Pediatric Sport-Related Concussion Education: Effectiveness and Long-Term Retention of the Head Safety in Youth Sports (HSYS) Program for Youth Athletes Aged 11-16

    Science.gov (United States)

    Elliott, Ross-Jordon S.; Batiste, Oliver; Hitto, Imran; Walker, Bridget; Leary, Linda D.

    2016-01-01

    Objective: The goals of this study are to evaluate the effectiveness of the curriculum for youth athletes and determine long-term retention in those who have previously participated. Design: Prospective cohort study. Setting: Middle schools. Participants: 887 male and female sixth- through eighth-grade Physical Education students, ranging from…

  12. Evaluation of the long-term power generation mix: The case study of South Korea's energy policy

    International Nuclear Information System (INIS)

    Min, Daiki; Chung, Jaewoo

    2013-01-01

    This paper presents a practical portfolio model for the long-term power generation mix problem. The proposed model optimizes the power generation mix by striking a trade-off between the expected cost of power generation and its variability. We use Monte Carlo simulation techniques to consider the uncertainty associated with future electricity demand, fuel prices and their correlations, and the capital costs of power plants. Unlike in the case of conventional power generation mix models, we employ CVaR (Conditional Value-at-Risk) in designing variability to consider events that are rare but enormously expensive. A comprehensive analysis on South Korea's generation policy using the portfolio model shows that a large annual cost is additionally charged to substitute a portion of nuclear energy with other alternatives. Nonetheless, if Korea has to reduce its dependency on nuclear energy because of undermined social receptivity from the Fukushima disaster, it turns out that LNG or coal could be a secure candidate from an economic perspective. - Author-Highlights: • We develop a stochastic optimization model for long-term power generation mix. • Monte Carlo sampling method and scenario trees are used to solve the model. • The model is verified using the data provided by Korean government. • We evaluate Korea's existing nuclear expansion policy. • We analyze the cost of replacing nuclear energy with others in South Korea

  13. Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry.

    Science.gov (United States)

    Torres-Villalobos, Gonzalo; Coss-Adame, Enrique; Furuzawa-Carballeda, Janette; Romero-Hernández, Fernanda; Blancas-Breña, Blanca; Torres-Landa, Samuel; Palacios-Ramírez, Axel; Alejandro-Medrano, Edgar; Hernández-Ávila, Axel; Flores-Najera, Athenea; Ávila Escobedo, Lourdes Margarita; Ramírez Angulo, Cecilia; Rodríguez-Garcés, Angélica; Valdovinos, Miguel Ángel

    2018-01-01

    Laparoscopic Heller myotomy (LHM) with partial fundoplication is an effective treatment for achalasia. However, the type of fundoplication is still a subject of debate. The aim of the study is to identify which partial fundoplication leads to better control of acid exposure, manometric parameters, and symptoms scores. A randomized controlled trial was performed to compare Dor vs Toupet fundoplication after LHM. The preoperative diagnosis was made by high-resolution manometry (HRM), upper endoscopy, and barium esophagogram. Preoperative and postoperative symptoms were evaluated with Eckardt, GERD-HRQL, and EAT-10 questionnaires. Seventy-three patients were randomized, 38 underwent Dor and 35 Toupet. Baseline characteristics were similar between groups. Postoperative HRM showed that the integrated relaxation pressure (IRP) and basal lower esophageal sphincter (LES) pressure were similar at 6 and 24 months. The number of patients with abnormal acid exposure was significantly lower for Dor (6.9%) than that of Toupet (34.0%) at 6 months, but it was not different at 12 or 24 months. No differences were found in postoperative symptom scores at 1, 6, or 24 months. There were no differences in symptom scores or HRM between fundoplications in the long term. A higher percentage of abnormal 24-h pH test were found for the Toupet group, with no difference in the long term.

  14. Insertion of a self-expandable metallic stent in canine lacrimal Sac : a long-term evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Song, Ho Young; Sung, Kyu Bo; Yoon, Hyun Ki [Univ. of Ulsan, Ulsan (Korea, Republic of). College of Medicine; Kwon, Soon Tae [Chungnam National Univ., Taejon (Korea, Republic of). Medical School; Lee, Ho Jung; Lee, In Chul; Kim, Tae Hyung; Park, Sang Soo; Huh, Soo Jin [Univ. of Ulsan, Ulsan (Korea, Republic of). College of Medicine

    1998-01-01

    To evaluate the feasibility and long-term outcome of the use of self-expandable metallic Z-stents in the canine lacrimal sac. Stent placement was technically successful and well tolerated in all but one lacrimal sac, in which the stent was misplaced. At three and six months after stent placement, stent wires were not encased by epithelium, but at nine months, and one, two and three years after placement, six of the 12 stents had become encased in a proliferation of this where the stent wires contacted the lacrimal sac wall. In no lacrimal system in which stent placement had been successful was migration, stenosis or obstruction of the lacrimal system observed. One misplaced stent caused obstruction of the lacrimal sac, however . In 11 of 12 case (92%), fluoroscopic placement of an expandable metallic stent in the canine lacrimal sac was successful: in 6 of 8 cases (75%), the stent wires became encased by a proliferation of mucosa, but during long-term follow-up of 9 months to 3 years, no obstruction was observed. (author). 20 refs., 1 tab., 5 figs.

  15. Insertion of a self-expandable metallic stent in canine lacrimal Sac : a long-term evaluation

    International Nuclear Information System (INIS)

    Song, Ho Young; Sung, Kyu Bo; Yoon, Hyun Ki; Kwon, Soon Tae; Lee, Ho Jung; Lee, In Chul; Kim, Tae Hyung; Park, Sang Soo; Huh, Soo Jin

    1998-01-01

    To evaluate the feasibility and long-term outcome of the use of self-expandable metallic Z-stents in the canine lacrimal sac. Stent placement was technically successful and well tolerated in all but one lacrimal sac, in which the stent was misplaced. At three and six months after stent placement, stent wires were not encased by epithelium, but at nine months, and one, two and three years after placement, six of the 12 stents had become encased in a proliferation of this where the stent wires contacted the lacrimal sac wall. In no lacrimal system in which stent placement had been successful was migration, stenosis or obstruction of the lacrimal system observed. One misplaced stent caused obstruction of the lacrimal sac, however . In 11 of 12 case (92%), fluoroscopic placement of an expandable metallic stent in the canine lacrimal sac was successful: in 6 of 8 cases (75%), the stent wires became encased by a proliferation of mucosa, but during long-term follow-up of 9 months to 3 years, no obstruction was observed. (author). 20 refs., 1 tab., 5 figs

  16. Evaluation of sanitary impact of the urban air pollution. Avignon area impact at short and long term; Evaluation de l'impact sanitaire de la pollution atmospherique urbaine. Zone d'Avignon impact a court et long terme

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    An health impact assessment of air pollution based on the I.n.V.S. guidelines has been conducted in Avignon according to the Regional Plan for the quality of air in the region of Provence Alpes Cote d'Azur. Short term impact of atmospheric pollution has been estimated in term of mortality (total, cardiovascular and respiratory mortality) and hospital admissions (for respiratory, cardiovascular and cardiac reasons) attributable to air pollution. Long-term impact was also assessed by the number of deaths due to atmospheric pollution. The study has been carried out in seven cities homogeneously exposed belonging to Vaucluse (Avignon, Le Pontet, Morieres les Avignon, Sorgues and Vedene) and two cities of the Gard department (les Angles and Villeneuve les Avignon) representing a study population of 153,624 inhabitants. Two period of study have been defined: period 1999-2000 for short and long term evaluations on the mortality and the year 2001 for the morbidity analysis. This study rests on methodological principles of E.I.S. (evaluation of sanitary impact) of urban air pollution whom methodology is in four steps: identification of dangers, exposure estimation, choice of exposure-risk relationship and risk characterisation. The pollutions indicators are built from four pollutants nitrogen dioxide, ozone, sulfur dioxide and PM{sub 10}. The exposure-risk relationships used come from epidemiological studies realised in general population, by preferring the multi centers studies and European ones. The number of deaths by year due to air pollution is 23, whom 10 by cardiovascular diseases, 2 by respiratory diseases. The most efficient scenario are these ones corresponding to air pollution decreases of 25% in the considered pollutant. About the long term sanitary benefits, the different scenario show that the European norm forecasted for 2005 is respected. The respect of the European norm expected for 2010 should allow to avoid 10 deaths on the totality of registered

  17. Evaluation of residual life of material of power plant construction elements after long-term operation

    International Nuclear Information System (INIS)

    Osasyuk, V.V.

    1989-01-01

    Existing methods are analyzed for estimation of residual resource of elements of constructions, working in creep conditions. A suggested and experimentally verified new method of residual durability forecasting is described permitting the value of the supplementary resource to be specified according to the real state of the material after preoperation. Evaluation results are given for residual life of steam lines received by different methods and advantages of the technique proposed are shown. Reliability of the new technique is confirmed by steam line operation at thermal power plants

  18. Evaluation of long term effects of thermal effluents on stream biota

    International Nuclear Information System (INIS)

    Sublette, J.E.

    1980-10-01

    In order to evaluate the effects of energy related developments in aquatic ecosystems, a normal water data base must be established. One approach used is the selection of indicator communities on species with fairly well known environmental tolerances and requirements. The Chironomidae (Order Diptera) dominate the macrobenthic assemblages of many streams. The group offers great potential for water quality assessment. The studies in this report determine the species composition of Chironomidae at stream sites in New Mexico, across the relationship of species composition to water quality parameters, and map karyotypes for the chironomus decorus group

  19. Retrospective Evaluation of the Long-Term CSEP-Italy Earthquake Forecasts

    Science.gov (United States)

    Werner, M. J.; Zechar, J. D.; Marzocchi, W.; Wiemer, S.

    2010-12-01

    On 1 August 2009, the global Collaboratory for the Study of Earthquake Predictability (CSEP) launched a prospective and comparative earthquake predictability experiment in Italy. The goal of the CSEP-Italy experiment is to test earthquake occurrence hypotheses that have been formalized as probabilistic earthquake forecasts over temporal scales that range from days to years. In the first round of forecast submissions, members of the CSEP-Italy Working Group presented eighteen five-year and ten-year earthquake forecasts to the European CSEP Testing Center at ETH Zurich. We considered the twelve time-independent earthquake forecasts among this set and evaluated them with respect to past seismicity data from two Italian earthquake catalogs. Here, we present the results of tests that measure the consistency of the forecasts with the past observations. Besides being an evaluation of the submitted time-independent forecasts, this exercise provided insight into a number of important issues in predictability experiments with regard to the specification of the forecasts, the performance of the tests, and the trade-off between the robustness of results and experiment duration.

  20. Long-term efficacy and safety of otilonium bromide in the management of irritable bowel syndrome: a literature review

    Directory of Open Access Journals (Sweden)

    Triantafillidis JK

    2014-04-01

    Full Text Available John K Triantafillidis, George Malgarinos Inflammatory Bowel Disease Unit, IASO General Hospital, Athens, Greece Abstract: Irritable bowel syndrome (IBS is a very common functional gastrointestinal disorder characterized by abdominal pain or discomfort and altered bowel habits. The disease affects a large part of the world population. The clinical course is mostly characterized by a cyclic recurrence of symptoms. Therefore, IBS patients should receive, as an initial therapeutic approach, a short course of treatment, and long-term treatment should be reserved for those patients with recurrent symptoms. The available clinical trials show that significant improvement of the symptoms over placebo could be achieved with various drugs, although this improvement is frequently time dependent and with high relapse rates after the cessation of the treatment. In a proportion of patients, clinically obvious relapse could appear long after stopping the treatment. Some of the available pharmacologic agents, including otilonium bromide (OB, are able to significantly prolong the time to the appearance of relapse, compared with placebo. As a consequence, some authors suggest that a cyclic treatment could be of benefit. Antispasmodic drugs have been used for many years in an effort to control the symptoms of IBS. OB is a poorly absorbed spasmolytic drug, exerting significantly greater control of the symptoms of IBS compared with placebo. Recent data suggest that the drug could effectively be used for the long-term management of patients with IBS. The aim of this review is to provide the reader with an evidence-based overview of the efficacy and tolerability of OB in the long-term management of IBS patients, based on the results of the clinical trials published so far. Keywords: irritable bowel syndrome, IBS, treatment, otilonium bromide

  1. Safety aspects of long-term dry interim storage of Type B spent fuel and high-level transport casks

    International Nuclear Information System (INIS)

    Wolff, D.; Probst, U.; Voelzke, H.; Droste, B.; Roedel, R.

    2004-01-01

    Based on the German decision to minimise transport of spent fuel casks between nuclear power plants, reprocessing plants and central storage facilities several on-site storage facilities were licensed until the end of 2003. Because of the large amount of Type B(U) transport casks which are going to be used for long-term interim storage the question of time-limited Type B(U) licence maintenance during the storage period of up to 40 years has been discussed under different aspects. This paper describes present technical aspects of the discussion. A main aspect of qualification of transport casks for interim storage is the long-term behaviour of the metallic seal-lid system. Here we present results from current long-term experimental tests with metallic 'Helicoflex' seals in which pool water is enclosed. This series of tests has been performed by the Federal Institute for Materials Research and Testing (BAM) on behalf of the Federal Office for Radiation Protection (BfS) since 2001. Finally, the paper presents a German concept for an exchange of experience, know-how and state-of-the-art between authorities and technical experts with regard to cask dispatch in nuclear facilities. BAM has taken over a central role in this so-called 'coordinating institution for cask dispatching information' ('KOBAF') which entails management of an online database of cask-specific documents and a technical working group meeting twice a year. The goal is to keep comparable technical standards for all nuclear sites and storage facilities which are going to load and dispatch casks of the same or similar types under the responsibility of different German state governments for the coming decades. (author)

  2. Safety aspects of long-term dry interim storage of type-B spent fuel and HLW transport casks

    International Nuclear Information System (INIS)

    Wolff, D.; Probst, U.; Voelzke, H.; Droste, B.; Roedel, R.

    2004-01-01

    Based on the German decision to minimise transports of spent fuel casks between nuclear power plants, reprocessing plants and central storage facilities several on-site storage facilities have been licensed till the end of 2003. Because of the large amount of type-B transport casks which are going to be used for long-term interim storage the question of time limited type-B license maintenance during the storage period of up to 40 years has been discussed under different aspects. This paper describes present technical aspects of the discussion. A main aspect of transport cask qualification for interim storage is the long-term behaviour of the metallic seal lid system. Concerning this results from current experimental long-term tests with metallic ''Helicoflex''-seals in which pool water is enclosed are presented. The test series has been performed by the Federal Institute for Materials Research and Testing (BAM) on behalf of the Federal Office for Radiation Protection (BfS) since 2001. Finally, the paper presents a German concept for an authorities' and technical experts' exchange of experience, know-how and state of the art referring to cask dispatch in nuclear facilities. BAM has taken over a central role in this so-called ''co-ordinating institution for cask dispatching information'' (''KOBAF'') which contains an online data base and a technical working group meeting twice a year. The goal is to keep comparable technical standards for all nuclear sites and storage facilities which are going to load and dispatch casks of the same or similar types under the responsibility of different German state governments for the next decades

  3. Long-term effectiveness and safety of stereotactic gamma knife surgery as a primary sole treatment in the management of glomus jagulare tumor.

    Science.gov (United States)

    Hafez, Raef F A; Morgan, Magad S; Fahmy, Osama M; Hassan, Hamdy T

    2018-05-01

    This study aims to report and confirm long-term effectiveness and safety of stereotactic Gamma Knife Surgery as a primary sole treatment in the management of 40 glomus jagulare tumors patients. Retrospective analysis of clinical and radiological outcomes of 40 GJTs consecutive patients treated with GKS as primary sole treatment at International Medical Center (IMC), Cairo-Egypt from the beginning of 2005 till the end of 2014,with mean follow-up period of 84 months (range 36-156 months), mean tumor volume was 6.5 cc, and mean peripheral radiation dose of 15 Gy, to mean isodose curve of 38%. The most common neurological deficit at initial evaluation was bulbar symptoms in 24 patients, followed by pulsatile tinnitus in 22, deterioration of hearing in 20 patients. The overall clinical control achieved in 92.5% of patients, while actuarial tumor size control rate post- GKS was 97.5% at 3 years, 97% at 5 years and 92% at 10 years of follow-up period. Gamma knife surgery could be used effectively and safely as a primary sole treatment tool in the management of glomus jugulare tumors. Copyright © 2018 Elsevier B.V. All rights reserved.

  4. Long-term safety and efficacy of a cholesterol-lowering diet in children with elevated low-density lipoprotein cholesterol : Seven-year results of the Dietary Intervention Study in Children (DISC)

    NARCIS (Netherlands)

    Obarzanek, E; Kimm, SYS; Barton, BA; Van Horn, L; Kwiterovich, PO; Simons-Morton, DG; Hunsberger, SA; Lasser, NL; Robson, AM; Franklin, FA; Lauer, RM; Stevens, VJ; Friedman, LA; Dorgan, JF; Greenlick, MR

    Objective. Diets reduced in fat and cholesterol are recommended for children over 2 years of age, yet long-term safety and efficacy are unknown. This study tests the long-term efficacy and safety of a cholesterol-lowering dietary intervention in children. Methods. Six hundred sixty-three children 8

  5. Evaluation and summary of a study of the long-term multiaxial creep behavior of concrete

    International Nuclear Information System (INIS)

    Kennedy, T.W.

    1975-12-01

    The creep behavior of concrete subjected to triaxial compressive stresses and elevated temperature was evaluated. Strains were measured in cylindrical specimens subjected to 58 test conditions: 0--3600 psi compressions; curing times of 90, 183, and 365 days; two curing histories (air-dried and as-cast); and two temperatures (75 and 150 0 F). The 90-day-cwed specimens were loaded for 12 months, followed by 5-month recovery. The other specimens were uniaxially stressed to 600 or 2400 psi for 5.25 or 4.75 years at 75 0 F, followed by 77-day recovery. Strain measurements were made during the curing, loaded, and unloaded-recovery periods. This report describes the experiment setup and summarizes the results and recommendations

  6. Long-term evaluation of fluoroelastomer O-rings in UF6

    International Nuclear Information System (INIS)

    Russell, R.G.; Otey, M.G.; Dippo, G.L.

    1986-01-01

    A major component in the gaseous centrifuge enrichment plant (GCEP) was fluoroelastomer O-rings, which were used to seal the uranium hexafluoride (UF 6 ) gas system. A program utilizing accelerated test conditions was used to help identify the best material out of four selected candidates and to predict the service life of these materials at GCEP conditions. The tests included accelerated temperatures, mechanical stress, and UF 6 exposure. Data were evaluated using the Newman--Keuls 1 ranking system to identify the best material and a zero-order reaction rate equation to help predict service life. This presentation includes a description of the test facility, the materials tested, the types of tests, objectives of the study, service life predictions, and conclusions. The O-rings are predicted to last approx. 30 years, and a high-molecular-weight polymer had the best performance ranking

  7. Long term evaluation of mesenchymal stem cell therapy in a feline model of chronic allergic asthma

    Science.gov (United States)

    Trzil, Julie E; Masseau, Isabelle; Webb, Tracy L; Chang, Chee-hoon; Dodam, John R; Cohn, Leah A; Liu, Hong; Quimby, Jessica M; Dow, Steven W; Reinero, Carol R

    2014-01-01

    Background Mesenchymal stem cells (MSCs) decrease airway eosinophilia, airway hyperresponsiveness (AHR), and remodeling in murine models of acutely induced asthma. We hypothesized that MSCs would diminish these hallmark features in a chronic feline asthma model. Objective To document effects of allogeneic, adipose-derived MSCs on airway inflammation, airway hyperresponsiveness (AHR), and remodeling over time and investigate mechanisms by which MSCs alter local and systemic immunologic responses in chronic experimental feline allergic asthma. Methods Cats with chronic, experimentally-induced asthma received six intravenous infusions of MSCs (0.36–2.5X10E7 MSCs/infusion) or placebo bimonthly at the time of study enrollment. Cats were evaluated at baseline and longitudinally for one year. Outcome measures included: bronchoalveolar lavage fluid cytology to assess airway eosinophilia; pulmonary mechanics and clinical scoring to assess AHR; and thoracic computed tomographic (CT) scans to assess structural changes (airway remodeling). CT scans were evaluated using a scoring system for lung attenuation (LA) and bronchial wall thickening (BWT). To assess mechanisms of MSC action, immunologic assays including allergen-specific IgE, cellular IL-10 production, and allergen-specific lymphocyte proliferation were performed. Results There were no differences between treatment groups or over time with respect to airway eosinophilia or AHR. However, significantly lower LA and BWT scores were noted in CT images of MSC-treated animals compared to placebo-treated cats at month 8 of the study (LA p=0.0311; BWT p=0.0489). No differences were noted between groups in the immunologic assays. Conclusions and Clinical Relevance When administered after development of chronic allergic feline asthma, MSCs failed to reduce airway inflammation and AHR. However, repeated administration of MSCs at the start of study did reduce computed tomographic measures of airway remodeling by month 8, though

  8. Ultrastructural Analysis and Long-term Evaluation of Composite-Zirconia Bond Strength.

    Science.gov (United States)

    Aboushelib, Moustafa N; Ragab, Hala; Arnaot, Mohamed

    2018-01-01

    To evaluate the influence of different aging techniques on zirconia-composite microtensile bond strength using different surface treatments over a 5-year follow-up period. Zirconia disks received three surface treatments: airborne-particle abrasion with 50-μm aluminum oxide particles, selective infiltration etching (SIE), or fusion sputtering (FS). The specimens were bonded to pre-aged composite disks using a composite cement containing phosphate monomers (Panavia F2.0). Bonded specimens were sectioned into microbars (1 x 1 x 6 mm) using a precision cutting machine, and all microbars received thermocycling (15,000 cycles between 5°C and 55°C). Initial microtensile bond strength was evaluated, and the test was repeated after storage in the following media for five years (artificial saliva, 20% ethanol, 5% NaOH, 4% acetic acid, and 5% phosphoric acid). The test was repeated every 12 months for 5 years. Scanning electron microscopic images were used to analyze the zirconia-composite interface. A repeated measures ANOVA and Bonferroni post-hoc tests were used to analyze the data (n = 20, α = 0.05). Significantly higher microtensile bond strength was observed for SIE compared to fusion sputtering and airborne particle abrasion. Five years of artificial aging resulted in significant reduction of zirconia-composite bond strength for all tested specimens. Zirconia-composite bond strength was more sensitive to storage in sodium hydroxide and phosphoric acid, while it was least affected when stored under saliva. These changes were related to the mechanism of ultra-structural interaction between surface treatment and adhesive, as deterioration of the hybrid layer (composite-infiltrated ceramic) was responsible for bond degeneration. Zirconia-composite bond strength was influenced by 5 years of artificial aging.

  9. Development of comprehensive long-term-dry stored Spent Fuel INtegrity EvaLuator [SFINEL] - I

    International Nuclear Information System (INIS)

    Kwon, H. M.; Yang, Y. S.; Kim, Y. S.; You, K. S.; Min, D. K.; No, S. K.

    1999-01-01

    Safe management of spent nuclear fuels is socially, technically, and economically very important in terms of environmental protection and utilization of recyclable resources. One of the most critical parts in the management is to establish the comprehensive monitoring system which can maintain and confirm the integrity of the spent fuels, whenever necessary, until final policy is determined on the their treatment and disposal. Especially in the first stage of maturing up the system, it is essential to secure a computing tool or code which can evaluate the integrity of the fuel cladding based on its power history and cladding degradation mechanisms. SFINEL code, an integrated computer program for predicting the spent fuel rod integrity based on burn-up history and major degradation mechanisms, has been developed in this research. This code can sufficiently simulate the power history of a fuel rod during the reactor operation and estimate the degree of deterioration of spent fuel cladding using the recently-developed models on the degradation mechanisms

  10. Empirical evaluation of the conceptual model underpinning a regional aquatic long-term monitoring program using causal modelling

    Science.gov (United States)

    Irvine, Kathryn M.; Miller, Scott; Al-Chokhachy, Robert K.; Archer, Erik; Roper, Brett B.; Kershner, Jeffrey L.

    2015-01-01

    Conceptual models are an integral facet of long-term monitoring programs. Proposed linkages between drivers, stressors, and ecological indicators are identified within the conceptual model of most mandated programs. We empirically evaluate a conceptual model developed for a regional aquatic and riparian monitoring program using causal models (i.e., Bayesian path analysis). We assess whether data gathered for regional status and trend estimation can also provide insights on why a stream may deviate from reference conditions. We target the hypothesized causal pathways for how anthropogenic drivers of road density, percent grazing, and percent forest within a catchment affect instream biological condition. We found instream temperature and fine sediments in arid sites and only fine sediments in mesic sites accounted for a significant portion of the maximum possible variation explainable in biological condition among managed sites. However, the biological significance of the direct effects of anthropogenic drivers on instream temperature and fine sediments were minimal or not detected. Consequently, there was weak to no biological support for causal pathways related to anthropogenic drivers’ impact on biological condition. With weak biological and statistical effect sizes, ignoring environmental contextual variables and covariates that explain natural heterogeneity would have resulted in no evidence of human impacts on biological integrity in some instances. For programs targeting the effects of anthropogenic activities, it is imperative to identify both land use practices and mechanisms that have led to degraded conditions (i.e., moving beyond simple status and trend estimation). Our empirical evaluation of the conceptual model underpinning the long-term monitoring program provided an opportunity for learning and, consequently, we discuss survey design elements that require modification to achieve question driven monitoring, a necessary step in the practice of

  11. MULTIDIMETIONAL OUTCOME AND LONG-TERM EVALUATION OF NON-AVOIDANCE STUTTERUNG THERAPY

    Directory of Open Access Journals (Sweden)

    Dobrinka GEORGIEVA

    2015-11-01

    Full Text Available nternational Classification of Functioning, Disability, and Health (ICF, WHO, 2001 is a constructive framework for quality assessment and treatment in Logopedics (Speech Language Therapy. The current research study makes an attempt to introduce this standard into logopedical practice and applied research to measure the quality of life of persons with fluency disorders, such as stuttering. The quality of life is a modern multidimensional construct that covers health-medical, psychological, social and economic factors. Good level of communication and stabilized fluency is of key importance to improve the quality of life of persons who stutter. The purpose of the study was to show a model of assessment, treatment and evaluation of the efficacy of the non-avoidance approach in adult stuttering therapy. According to the results of the Index of disability, 47% of the people with multiple sclerosis have limited independence in providing daily activities leading up to 31% of the examinees with rare participation in the everyday social activities, the result obtained by the Frenchay Index of activities. We can conclude that the Index of disability is higher with older respondents and it is often followed by a drop of the daily activity frequency. Methods: CharlesVan Riper’s non-avoidance approach for an intensive therapy. Participants were 15 adults who stutter with an average age 25.2 years. Results: Specific significant decreasing of the two main parameters: index of dysfluencies immediately after the intensive therapy as well as duration of disfluences in seconds. The changes in speech fluency before and after the intensive therapy as well as 3 years after this therapy were obtained regarding the duration of disfluencies and index of dysfluency. Conclusion: The present model of an intensive non-avoidance therapy format for adults with stuttering disorders was successfully applied for the Bulgarian conditions. Improved fluency is an important factor

  12. Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product

    Directory of Open Access Journals (Sweden)

    Abdalla A

    2017-03-01

    Full Text Available Abuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland Purpose: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. Patients and methods: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Results: Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9, mean disease duration 14.79 years (9.7, median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3 months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively. There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7% patients discontinued the biosimilar infliximab. Conclusion: Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. Keywords: biologic therapy, rheumatic diseases, biosimilar exchange, infliximab, adult

  13. Life-long diseases need life-long treatment: long-term safety of ciclosporin in canine atopic dermatitis

    Science.gov (United States)

    Nuttall, Tim; Reece, Douglas; Roberts, Elizabeth

    2014-01-01

    Ciclosporin (Atopica; Novartis Animal Health) has been licensed for canine atopic dermatitis (AD) since 2002. Adverse events (AEs) have been reported in 55 per cent of 759 dogs in 15 clinical trials, but are rare in pharmacovigilance data (71.81 AEs/million capsules sold). Gastrointestinal reactions were most common, but were mild and rarely required intervention. Other AEs were rare (≤1 per cent in clinical trials; metabolism is not clinically significant for normal dogs. Concomitant treatment with most drugs is safe. Effects on cytochrome P450 and MDR1 P-glycoprotein activity may elevate plasma ciclosporin concentrations, but short-term changes are not clinically significant. Monitoring of complete blood counts, urinalysis or ciclosporin levels is not justified except with higher than recommended doses and/or long-term concurrent immunosuppressive drugs. Ciclosporin is not a contraindication for killed (including rabies) vaccines, but the licensed recommendation is that live vaccination is avoided during treatment. In conclusion, ciclosporin has a positive risk-benefit profile for the long-term management of canine AD. PMID:24682696

  14. Long-term safety, efficacy, and patient acceptability of teriparatide in the management of glucocorticoid-induced osteoporosis

    Directory of Open Access Journals (Sweden)

    Dore RK

    2013-05-01

    Full Text Available Robin K DoreDavid Geffen School of Medicine, University of California, Los Angeles, CA, USAAbstract: Glucocorticoids are commonly prescribed medications to treat multiple diseases across many medical specialties. One of the most common yet largely unappreciated side effect of glucocorticoid use is increased risk of fracture. Many different therapies are indicated to prevent and treat this condition; many guidelines exist that suggest appropriate use of both glucocorticoids and the medications approved to prevent this common side effect of glucocorticoid therapy. Nevertheless, 30%–50% of patients on long-term glucocorticoid therapy sustain a fracture. Teriparatide, recombinant human parathyroid hormone (1–34, is a daily self-injectable therapy for 24 months approved for use in patients taking long-term glucocorticoids. Teriparatide has been shown to increase bone mineral density and reduce vertebral fracture risk in glucocorticoid-treated patients. Glucocorticoids have many adverse effects on bone that teriparatide has been shown to prevent or negate. Given the fact that preventive therapy for glucocorticoid-induced osteoporosis is often not prescribed, one wonders whether a daily self-injectable therapy for this condition would be prescribed by physicians and accepted by patients. This article reviews the epidemiology, pathophysiology, treatment, guidelines, and persistence data (when available for patients with glucocorticoid-induced osteoporosis treated with teriparatide.Keywords: glucocorticoid-induced osteoporosis, teriparatide, anabolic, PTH, parathyroid hormone

  15. Natural analogue studies for the long-term safety of radioactive waste disposal. Lessons learned from the nature

    International Nuclear Information System (INIS)

    Yusa, Yasuhisa

    2002-01-01

    'Natural analogues' can be defined as the processes or materials analogous to those operating in the geological disposal system of radioactive waste. Natural analogue studies provide the only means by which long-term data can be obtained under the real natural conditions, and also the most convincing support to the long-term performance assessment of the geological disposal system. The framework of our natural analogue studies concerning the stability of the engineered barrier materials for geological disposal system of high-level radioactive waste is reviewed. One of the results is that the volcanic glass included in a clay bed did not alter during the past one million years. The Tono Uranium Deposits are studied as geochemical analogues of radioactive waste disposal in Japan. We conclude that although the deposits have been subjected to a variety of geological processes and events such as faulting, erosion and uplift/subsidence, the reducing condition has been maintained and uranium has not migrated for at least the past ten million years. Application and further development of the natural analogue studies are also discussed. (author)

  16. Long-Term Changes in Refractive Error and Clinical Evaluation in Partially Accommodative Esotropia after Surgery.

    Directory of Open Access Journals (Sweden)

    Shin Yeop Oh

    Full Text Available We investigate the changes in refractive error and clinical evaluation in partially accommodative esotropia(PAET after surgery. A total of 68 patients PAET who received at least 2 years of follow-up after surgery were enrolled in this study. We performed a retrospective study in patients who underwent unilateral or bilateral medial rectus recession for a non-accommodative component of PAET between January 2005 and March 2013. Patients were divided into groups according to the presence of dominancy (dominant, non-dominant, alternative eye, and presence of amblyopia (amblyopic, fellow, normal eye. Changes and changing pattern in SE refractive error were analyzed in all patients and compared between groups. Patients were divided into two groups, those weaned off of hyperopic glasses and those who continued using them, then factors that significantly influenced the continued use of glasses were analyzed. The changes and changing pattern in SE refractive error according to time after operation and presence of amblyopia or dominancy. The mean length of follow-up was 4.89±1.74 years after surgery and the mean change in SE refractive error rate per year was -0.284±0.411 diopters (D. The pattern of changes in the mean SE refractive error for those with dominant, non-dominant, and alternative eyes was not significantly different (p = 0.292. The pattern of changes in the mean SE refractive error for those with amblyopic, fellow, and normal eyes was significantly different (p = 0.0002. Patients were successfully weaned off of hyperopic glasses at an average age of 9.41±2.74 years. The average SE refractive error in the group weaned off of hyperopic glasses was significantly lower than that in the group maintained on hyperopic glasses (p = 0.0002. The change of SE refractive error in amblyopic eyes decreased less than that in fellow or normal eyes, which may be correlated with the presence of amblyopia. Patients with a smaller esodeviated angle without

  17. Carbamazepine treatment of bipolar disorder: a retrospective evaluation of naturalistic long-term outcomes

    Directory of Open Access Journals (Sweden)

    Chen Chia-Hui

    2012-05-01

    Full Text Available Abstract Background Carbamazepine (CBZ has been used in the treatment of bipolar disorder, both in acute mania and maintenance therapy, since the early 1970s. Here, we report a follow-up study of CBZ-treated bipolar patients in the Taipei City Psychiatric Centre. Methods Bipolar patients diagnosed according to the DSM-IV system and treated with CBZ at the Taipei City Psychiatric Centre had their charts reviewed to evaluate the efficacy and side effects of this medication during an average follow-up period of 10 years. Results A total of 129 bipolar patients (45 males, mean age: 45.7 ± 10.9 year were included in the analysis of CBZ efficacy used alone (n = 63 or as an add-on after lithium (n = 50 or valproic acid (n = 11, or the both of them (n = 5. The mean age of disease onset was 24.6 ± 9.5 years. The mean duration of CBZ use was 10.4 ± 5.2 year. The mean dose used was 571.3 ± 212.6 mg/day with a mean plasma level of 7.8 ± 5.9 μg/mL. Mean body weight increased from 62.0 ± 13.4 kg to 66.7 ± 13.1 kg during treatment. The frequencies of admission per year before and after CBZ treatment were 0.33 ± 0.46 and 0.14 ± 0.30, respectively. The most common side effects targeted the central nervous system (24%, including dizziness, ataxia and cognitive impairment. Other common side effects were gastrointestinal disturbances (3.6%, tremor (3.6%, skin rash (2.9%, and blurred vision (2.9%. Eighty-eight patients (68.2% were taking antipsychotics concomitantly. Ninety-six patients (74.4% needed to use benzodiazepines concomitantly. Sixty-three (48.8% patients had zero episodes in a 10-year follow-up period, compared to all patients having episodes prior to treatment. Using variable analysis, we found better response to CBZ in males than in females. Conclusions CBZ is efficacious in the maintenance treatment of bipolar disorder in naturalistic clinical practice, either as monotherapy

  18. Decellularized allogeneic heart valves demonstrate self-regeneration potential after a long-term preclinical evaluation.

    Directory of Open Access Journals (Sweden)

    Laura Iop

    Full Text Available Tissue-engineered heart valves are proposed as novel viable replacements granting longer durability and growth potential. However, they require extensive in vitro cell-conditioning in bioreactor before implantation. Here, the propensity of non-preconditioned decellularized heart valves to spontaneous in body self-regeneration was investigated in a large animal model. Decellularized porcine aortic valves were evaluated for right ventricular outflow tract (RVOT reconstruction in Vietnamese Pigs (n = 11 with 6 (n = 5 and 15 (n = 6 follow-up months. Repositioned native valves (n = 2 for each time were considered as control. Tissue and cell components from explanted valves were investigated by histology, immunohistochemistry, electron microscopy, and gene expression. Most substitutes constantly demonstrated in vivo adequate hemodynamic performances and ex vivo progressive repopulation during the 15 implantation months without signs of calcifications, fibrosis and/or thrombosis, as revealed by histological, immunohistochemical, ultrastructural, metabolic and transcriptomic profiles. Colonizing cells displayed native-like phenotypes and actively synthesized novel extracellular matrix elements, as collagen and elastin fibers. New mature blood vessels, i.e. capillaries and vasa vasorum, were identified in repopulated valves especially in the medial and adventitial tunicae of regenerated arterial walls. Such findings correlated to the up-regulated vascular gene transcription. Neoinnervation hallmarks were appreciated at histological and ultrastructural levels. Macrophage populations with reparative M2 phenotype were highly represented in repopulated valves. Indeed, no aspects of adverse/immune reaction were revealed in immunohistochemical and transcriptomic patterns. Among differentiated elements, several cells were identified expressing typical stem cell markers of embryonic, hematopoietic, neural and mesenchymal lineages in significantly

  19. Long-term evaluation of immediately loaded implants in the edentulous mandible using fixed bridges and platform shifting.

    Science.gov (United States)

    Romanos, Georgios E; Gaertner, Kathrin; Nentwig, Georg H

    2014-08-01

    The immediate loading concept has been extensively documented in the anterior part of the mandible when six primary stable implants are placed, splinted with a fixed prosthesis. The aim of this study was to evaluate the long-term success of immediately occlusal loaded implants with a progressive thread design and platform shifting in the edentulous mandible. Seventy-eight implants placed in 13 patients and were connected with their abutments immediately after surgery. The implants were splinted using a fixed temporary restoration having occlusal contacts in the centric and group function in the lateral movements of the mandible (immediate occlusal loading). The patients were advised to use soft/liquid diet for the first 6 to 8 weeks of healing in order to reduce excessive loading in the bone-to-implant interface. Abutment level impressions were taken without removing the abutments in order to fabricate the final prostheses. The final restorations were delivered 4 to 8 weeks after surgery and cemented temporarily in order to evaluate the peri-implant soft tissue condition at the different time intervals after removal of the restoration. Clinical stability and radiological indices were evaluated at the start of loading, at 3-month interval after loading, and then annually. After a mean loading period of 75.29 (± 38.18) months, no implant was lost (100% success rate). All clinical indices had values in normal levels. The Periotest values demonstrated a continuous reduction, representing high stability. The crestal bone level was relatively stable and only minimal crestal bone loss was observed in some implants. Long-term success and stability of the peri-implant tissues around immediately loaded mandibular implants are expected when implants with platform shifting are restored with bridges without abutment removal. © 2013 Wiley Periodicals, Inc.

  20. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    Directory of Open Access Journals (Sweden)

    Nobuyuki Yagi

    2014-05-01

    Full Text Available Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7% of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%. No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

  1. Safety relevant aspects of the long-term intermediate storage of spent fuel elements and vitrified high-level radioactive wastes; Sicherheitstechnische Aspekte der langfristigen Zwischenlagerung von bestrahlten Brennelementen und verglastem HAW

    Energy Technology Data Exchange (ETDEWEB)

    Ellinger, A.; Geupel, S.; Gewehr, K.; Gmal, B.; Hannstein, V.; Hummelsheim, K.; Kilger, R.; Wagner, M. [Gesellschaft fuer Anlagen- und Reaktorsicherheit mbH (GRS), Koeln (Germany); Schmidt, G.; Spieth-Achtnich, A. [Oeko-Institut e.V. - Institut fuer angewandte Oekolgie (Germany)

    2010-04-15

    The currently in Germany pursued concept for management of spent fuel from nuclear power plants provides intermediate dry cask storage at the NPP sites until direct disposal in a deep geologic repository. In addition the earlier commissioned centralized dry storage facilities are being used for storage of high level radioactive waste returned from foreign reprocessing of German spent fuel performed so far. The dry interim storage facilities are licensed for 40 years of operation time. According to the German regulations a full scope periodic safety review is not required so far, neither practical experience on dry storage for this period of time is available. With regard to this background the report at hand is dealing with long term effects, which may affect safety of the interim storage during the 40 years period or beyond if appropriate, and with the question, whether additional analyses or monitoring measures may be required. Therefore relevant publications have been evaluated, calculations have been performed as well as a systematic screening with regard to loads and possible ageing effects has been applied to structures and components important for safety of the storage, in order to identify relevant long term effects, which may not have been considered sufficiently so far and to provide proposals for an improved ageing management. The report firstly provides an overview on the current state of technology describing shortly the national and international practice and experience. In the following chapters safety aspects of interim storage with regard to time dependent effects and variations are being analyzed and discussed. Among this not only technical aspects like the long term behavior of fuel elements, canisters and storage systems are addressed, but also operational long term aspects regarding personnel planning, know how conservation, documentation and quality management are taken into account. A separate chapter is dedicated to developing and describing

  2. The long-term safety and performance analyses of the surface disposal facility for the Belgian category a waste at Dessel

    Energy Technology Data Exchange (ETDEWEB)

    Cool, Wim; Vermarien, Elise; Wacquier, William [ONDRAF/NIRAS Avenue des Arts 14, BE-1210 Bruxelles (Belgium); Perko, Janez [SCK-CEN Boeretang 200, BE-2400 Mol (Belgium)

    2013-07-01

    ONDRAF/NIRAS, the Belgian Agency for Radioactive Waste and Enriched Fissile Materials, and its partners have developed long-term safety and performance analyses in the framework of the license application for a surface disposal facility for low level radioactive waste (category A waste) at Dessel, Belgium. This paper focusses on the methodology of the safety assessments and on key results from the application of this methodology. An overview is given (1) of the performance analyses for the containment safety function of the disposal system and (2) of the radiological impact analyses confirming that radiological impacts are below applicable reference values and constraints and leading to radiological criteria for the waste and the facility. In this discussion, multiple indicators for performance and safety are used to illustrate the multi-faceted nature of long-term performance and safety of the surface disposal. This contributes to the multiple lines of reasoning for confidence building that a positive decision to proceed to the next stage of construction is justified. (authors)

  3. The evaluation of the National Long Term Care Demonstration. 1. An overview of the channeling demonstration and its evaluation.

    OpenAIRE

    Carcagno, G J; Kemper, P

    1988-01-01

    The channeling demonstration sought to substitute community care for nursing home care to reduce long-term care costs and improve the quality of life of elderly clients and the family members and friends who care for them. Two interventions were tested, each in five sites; both had comprehensive case management at their core. One model added a small amount of additional funding for direct community services to fill the gaps in the existing system; the other substantially expanded coverage of ...

  4. [Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].

    Science.gov (United States)

    Klug, B; Reinhardt, J; Schröder, C

    2010-01-01

    Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP regulation is the requirement for long-term follow-up on safety and efficacy of patients enrolled in clinical trials with ATMPs, which is beyond the routine requirements on pharmacovigilance. For gene therapy medicinal products, a guideline on long-term follow-up, which lays down the technical requirements, is available. A further key element of the ATMP regulation is the traceability of the starting materials used to manufacture the ATMP. A common European coding system is imperative to ensure the traceability of starting materials, especially across the borders of European Member States.

  5. Evaluation of long-term patient satisfaction and experience with the Baha(®) bone conduction implant

    DEFF Research Database (Denmark)

    Rasmussen, Jacob; Olsen, Steen Østergaard; Nielsen, Lars Holme

    2012-01-01

    Objective: Evaluate long-term patient satisfaction with bone-anchored hearing aids (the Baha(R), now referred to by Cochlear as a 'bone conduction implant') in our hospital clinic spanning the eighteen-year period from the inception of our Baha program. The researchers further wished to analyse...... the various factors leading to patient satisfaction/dissatisfaction with their Baha. We developed a new questionnaire to obtain a comprehensive impression of individual patient practices, general satisfaction, and experiences with their Baha in respect to time spent using Baha, sound quality, annoyance from...... noise disturbance, ease of communication, cosmetic appearance, and satisfaction with the Baha amongst patient relatives, an aspect not previously investigated. Design: The study design was retrospective and executed as a postal questionnaire. The questionnaire was developed by the authors of this paper...

  6. Evaluating the Impact of an Active Labour Market Policy on Employment: Short- and Long-Term Perspectives

    Directory of Open Access Journals (Sweden)

    José M. Cansino

    2018-04-01

    Full Text Available The Labour Market Insertion Contract was an Active Labour Market Policy introduced in Spain. It was aimed at individuals who had difficulties entering the labour market, and it was introduced with the purpose of reducing the rate of unemployment. This article provides an estimation of the average impact that this contract had on the employability of individuals in the short and long term. A microeconomic analysis was carried out based on causal statistical inference by using propensity score matching and kernel and radial estimators. Data was taken from the most comprehensive database available, which is the Continuous Sample of Work Histories. Results are consistent with literature reports and show that the employability of participants was inferior to that of individuals with similar, temporary-type contracts. This research contributes to the literature by evaluating whether there was empirical evidence to support the political decision to revoke or replace this kind of direct employment programme.

  7. Measuring Success in Obesity Prevention: A Synthesis of Health Promotion Switzerland's Long-Term Monitoring and Evaluation Strategy

    Directory of Open Access Journals (Sweden)

    Günter Ackermann

    2015-01-01

    Full Text Available Aims: Since 2007, Health Promotion Switzerland has implemented a national priority program for a healthy body weight. This article provides insight into the methodological challenges and results of the program evaluation. Methods: Evaluation of the long-term program required targeted monitoring and evaluation projects addressing different outcome levels. The evaluation was carried out according to the Swiss Model for Outcome Classification (SMOC, a model designed to classify the effects of health promotion and prevention efforts. Results: The results presented in this article emphasize both content and methods. The national program successfully achieved outcomes on many different levels within complex societal structures. The evaluation system built around the SMOC enabled assessment of program progress and the development of key indicators. However, it is not possible to determine definitively to what extent the national program helped stabilize the prevalence of obesity in Switzerland. Conclusion: The model has shown its utility in providing a basis for evaluation and monitoring of the national program. Continuous analysis of data from evaluation and monitoring has made it possible to check the plausibility of suspected causal relationships as well as to establish an overall perspective and assessment of effectiveness supported by a growing body of evidence.

  8. Clinical evaluation of the JPEG2000 compression rate of CT and MR images for long term archiving in PACS

    International Nuclear Information System (INIS)

    Cha, Soon Joo; Kim, Sung Hwan; Kim, Yong Hoon

    2006-01-01

    We wanted to evaluate an acceptable compression rate of JPEG2000 for long term archiving of CT and MR images in PACS. Nine CT images and 9 MR images that had small or minimal lesions were randomly selected from the PACS at our institute. All the images are compressed with rates of 5:1, 10:1, 20:1, 40:1 and 80:1 by the JPEG2000 compression protocol. Pairs of original and compressed images were compared by 9 radiologists who were working independently. We designed a JPEG2000 viewing program for comparing two images on one monitor system for performing easy and quick evaluation. All the observers performed the comparison study twice on 5 mega pixel grey scale LCD monitors and 2 mega pixel color LCD monitors, respectively. The PSNR (Peak Signal to Noise Ratio) values were calculated for making quantitative comparisions. On MR and CT, all the images with 5:1 compression images showed no difference from the original images by all 9 observers and only one observer could detect a image difference on one CT image for 10:1 compression on only the 5 mega pixel monitor. For the 20:1 compression rate, clinically significant image deterioration was found in 50% of the images on the 5M pixel monitor study, and in 30% of the images on the 2M pixel monitor. PSNR values larger than 44 dB were calculated for all the compressed images. The clinically acceptable image compression rate for long term archiving by the JPEG2000 compression protocol is 10:1 for MR and CT, and if this is applied to PACS, it would reduce the cost and responsibility of the system

  9. Long-term efficacy and safety of anastrozole for adjuvant treatment of early breast cancer in postmenopausal women

    Directory of Open Access Journals (Sweden)

    Sharath Gangadhara

    2009-04-01

    Full Text Available Sharath Gangadhara, Gianfilippo BertelliSouth West Wales Cancer Institute, Singleton Hospital, Swansea, UKAbstract: For more than 20 years, tamoxifen has been the gold standard for the adjuvant treatment of postmenopausal women with hormone-responsive early breast cancer. However, recent randomized trials have shown efficacy and tolerability benefits with the third-generation aromatase inhibitor anastrozole, resulting in an increased use of this agent in the adjuvant setting. Data on anastrozole’s long-term efficacy and tolerability are therefore of interest in clinical practice and will be reviewed here, especially in the light of the 100-month analysis of the ATAC (Anastrozole, Tamoxifen Alone or in Combination trial.Keywords: anastrozole, aromatase inhibitors, breast cancer, adjuvant therapy 

  10. Evaluation of long-term prognosis in patients with heart failure. Is cardiac imaging with iodine-123 metaiodobenzylguanidine useful?

    International Nuclear Information System (INIS)

    Narita, Michihiro; Kurihara, Tadashi

    1998-01-01

    The effect of cardiac sympathetic activity on long-term prognosis in patients with heart failure was evaluated by cardiac imaging with 123 I-MIBG in 46 patients admitted for the first episode of heart failure. Cardiac imaging was performed with 123 I-MIBG and 201 Tl at rest on separate days before discharge. Using whole body imaging, the ratio of cardiac uptake of the isotope to total injected dose was calculated (percentage uptake). The cardiac uptake ratio of 123 I-MIBG (percentage uptake of 123 I-MIBG divided by percentage uptake of 201 Tl) and percentage washout of 123 I-MIBG from the heart over 3 hours were calculated as scintigraphic parameters. Cardiac events were defined as cardiac death or deterioration of heart failure requiring readmission. Scintigraphic parameters, clinical parameters, left ventricular function obtained by echocardiography and neurohumoral parameters were compared between the event group and event-free group. During the follow-up period, cardiac events developed in 14 patients (30%). Univariate analysis showed uptake ratio and washout rate of 123 I-MIBG, percentage uptake of 201 Tl, New York Heart Association class at discharge, fractional shortening of the left ventricle, serum norepinephrine and atrial natriuretic peptide levels differed significantly between the two groups. Cox proportional-hazard analysis showed that the uptake ratio was an independent predictor of cardiac events. When a cut-off point in the uptake ratio equal to or less than 0.50 and age equal to or more than 65 years old were included in the Cox proportional-hazard analysis instead of actual numbers, relative risks of cardiac events by each index were 31.2 and 4.2, respectively. These data suggest that cardiac uptake of 123 I-MIBG is a strong and independent predictor of long-term prognosis in patients with heart failure. (K.H.)

  11. Evaluation of the success of obstructive sleep apnea surgery using criteria based on long-term symptoms and incident hypertension.

    Science.gov (United States)

    Lim, Jae Hyun; Park, Pona; Wee, Jee Hye; Gelera, January E; Shrestha, Kundan Kumar; Rhee, Chae-Seo; Kim, Jeong-Whun

    2018-04-01

    To identify appropriate success criteria, based on long-term symptoms and incident hypertension, after surgery for obstructive sleep apnea (OSA). This observational cohort study included 97 adult OSA patients (90 men) who underwent surgical treatment at our tertiary medical center. Subjective symptoms [witnessed sleep apnea and snoring, and Epworth sleepiness scale (ESS) scores] were evaluated through a telephone survey, and incident hypertension was assessed from medical records. The subjects were divided into success and failure groups according to seven different criteria, and data were analyzed to identify the criteria that could significantly differentiate the success from failure groups. The participants had a mean age of 48.8 ± 11.9 years and a mean preoperative body mass index of 26.5 ± 3.5 kg/m 2 . The mean preoperative and postoperative apnea-hypopnea index (AHI) values were 36.1/h and 19.4/h, respectively. The mean follow-up duration was 77.0 ± 31.1 months. Postoperative witnessed apnea, snoring, and the ESS scores decreased significantly compared to preoperative scores in both the success and failure groups based on most of the seven criteria. Among the seven criteria, success and failure groups based on a postoperative AHI cutoff of 15 or 20/h differed significantly in witnessed apnea, snoring, or ESS scores. Kaplan-Meier survival analysis based on incident hypertension revealed that no criterion could significantly distinguish between the two groups. Our results suggest that some of the success criteria analyzed may be more useful in differentiating between success and failure groups after surgery, in terms of long-term improvement of subjective OSA-related symptoms.

  12. Evaluation of long-term cosmetic results and complications following breast conserving surgery and radiation therapy for breast cancer

    International Nuclear Information System (INIS)

    Fujishiro, Satsuki; Mitsumori, Michihide; Kokubo, Masaki; Nagata, Yasushi; Sasai, Keisuke; Hiraoka, Masahiro; Kodama, Hiroshi

    1999-01-01

    Long-term cosmetic outcomes and complications were evaluated in 109 patients with breast cancer who had been treated by breast conservation therapy. Patients received radiation therapy at Kyoto University Hospital following quadrantectomy and level II or III axillary node dissection. Factors that might influence long-term cosmetic results were also analyzed. Irradiation to the breast was administered in 2 Gy fractions, 5 times a week for a total of 50 Gy in all patients. Cobalt-60 γ-rays were used in 108 patients with the exception of 1 patient who received 6 Mev X-ray. Some patients with positive or close margins received boost irradiation of 10 Gy using electron beams to the primary tumor bed. Cosmetic outcome was assessed by both a scoring method and breast retraction assessment (BRA). Forty-seven percent of patients were assessed as excellent to good before radiation therapy. The percent of excellent to good decreased shortly after termination of radiation therapy, but gradually improved and stabilized by 3 years. Seventy percent of patients showed a score of excellent to good 5 years after treatment. The average BRA of the 109 patients was 3.0 cm. This did not change between 3 and 5 years after treatment. A significant correlation between cosmetic score and BRA was shown at all follow-up times. Factors such as age over 50 years (p=0.008), tumor location in the outer quadrant (p=0.02) and boost irradiation (p=0.03) significantly affected the cosmetic score. Arm edema and restriction of shoulder movement were observed in 22% and 49% at the start of radiation therapy, these improved within approximately 3 years and 1 year after treatment, respectively. Mild skin change was observed in 60% of patients even 5 years after treatment. The results indicate that cosmetic outcome after breast conservation therapy is clinically acceptable, and the complication rate is low. (author)

  13. Evaluation of long-term prognosis in patients with heart failure. Is cardiac imaging with iodine-123 metaiodobenzylguanidine useful?

    Energy Technology Data Exchange (ETDEWEB)

    Narita, Michihiro; Kurihara, Tadashi [Sumitomo Hospital, Osaka (Japan)

    1998-06-01

    The effect of cardiac sympathetic activity on long-term prognosis in patients with heart failure was evaluated by cardiac imaging with {sup 123}I-MIBG in 46 patients admitted for the first episode of heart failure. Cardiac imaging was performed with {sup 123}I-MIBG and {sup 201}Tl at rest on separate days before discharge. Using whole body imaging, the ratio of cardiac uptake of the isotope to total injected dose was calculated (percentage uptake). The cardiac uptake ratio of {sup 123}I-MIBG (percentage uptake of {sup 123}I-MIBG divided by percentage uptake of {sup 201}Tl) and percentage washout of {sup 123}I-MIBG from the heart over 3 hours were calculated as scintigraphic parameters. Cardiac events were defined as cardiac death or deterioration of heart failure requiring readmission. Scintigraphic parameters, clinical parameters, left ventricular function obtained by echocardiography and neurohumoral parameters were compared between the event group and event-free group. During the follow-up period, cardiac events developed in 14 patients (30%). Univariate analysis showed uptake ratio and washout rate of {sup 123}I-MIBG, percentage uptake of {sup 201}Tl, New York Heart Association class at discharge, fractional shortening of the left ventricle, serum norepinephrine and atrial natriuretic peptide levels differed significantly between the two groups. Cox proportional-hazard analysis showed that the uptake ratio was an independent predictor of cardiac events. When a cut-off point in the uptake ratio equal to or less than 0.50 and age equal to or more than 65 years old were included in the Cox proportional-hazard analysis instead of actual numbers, relative risks of cardiac events by each index were 31.2 and 4.2, respectively. These data suggest that cardiac uptake of {sup 123}I-MIBG is a strong and independent predictor of long-term prognosis in patients with heart failure. (K.H.)

  14. Evaluation of retinal nerve fiber layer thickness in vernal keratoconjunctivitis patients under long-term topical corticosteroid therapy.

    Science.gov (United States)

    Cingu, Abdullah Kursat; Cinar, Yasin; Turkcu, Fatih Mehmet; Sahinoglu-Keskek, Nedime; Sahin, Alparslan; Sahin, Muhammed; Yuksel, Harun; Caca, Ihsan

    2014-09-01

    The aim of this study was to evaluate the retinal nerve fiber layer (RNFL) thickness in vernal keratoconjunctivitis (VKC) patients who were under long-term topical corticosteroid therapy. Thirty-six eyes of 36 VKC patients with clear cornea and normal videokeratography and 40 eyes of 40 age- and gender-matched normal children were included in the study. Clinical and demographic characteristics of the patients were noted and detailed ophthalmological examination was performed. Visual acuity (VA), spherical equivalent (SE), axial length (AL) and RNFL thickness measurements were compared between the groups. To correct ocular magnification effect on RNFL, we used Littmann's formula. All VKC patients had history of topical corticosteroid use and the mean duration of the topical corticosteroid use was 23.8 ± 9.09 months. There was no significant difference between the groups in terms of intraocular pressure (IOP). VKC group had significantly worse VA, greater SE and AL and thinner mean global, superior and inferior RNFL thickness. There were significant negative correlations between the duration of topical corticosteroid use and the mean global, superior and temporal RNFL thickness in VKC group. After correction of magnification effect, VKC group still had thinner mean global, superior and inferior RNFL thickness, and significant difference between the groups in inferior RNFL thickness did not disappear. Significant RNFL thickness difference between the groups suggests a possible effect of long-term corticosteroid use in VKC patients. Because visual field (VF) analysis in pediatric patients is difficult to perform and IOP may be illusive, RNFL thickness measurements in addition to routine examinations in VKC patients may help clinicians in their practice.

  15. Factors affecting the course of body and kidney growth in infants with urolithiasis: A critical long-term evaluation

    Directory of Open Access Journals (Sweden)

    Kemal Sarica

    2016-12-01

    Full Text Available Objective: To investigate the possible effects of dietary, patient and stone related factors on the clinical course of the stone disease as well as the body and renal growth status of the infants. Patients and Methods: A total of 50 children with an history of stone disease during infancy period were studied. Patient (anatomical abnormalities, urinary tract infection - UTI, associated morbidities, stone (obstruction, UTI and required interventions and lastly dietary (duration of sole breast feeding, formula feeding related factors which may affect the clinical course of the disease were all evaluated for their effects on the body and renal growth during long-term follow-up. Results: Mean age of the children was 2.40 ± 2.65 years. Our findings demonstrated that infants receiving longer period of breast feeding without formula addition seemed to have a higher rate of normal growth percentile values when compared with the other children. Again, higher frequency of UTI and stone attacks affected the growth status of the infants in a remarkable manner than the other cases. Our findings also demonstrated that thorough a close follow-up and appropriately taken measures; the possible growth retardation as well as renal growth problems could be avoided in children beginning to suffer from stone disease during infancy period. Conclusions: Duration of breast feeding, frequency of UTI, number of stone attacks and stone removal procedures are crucial factors for the clinical course of stone disease in infants that may affect the body as well as kidney growth during long-term follow-up.

  16. Study on the system development for evaluating long-term alteration of hydraulic field in Near Field 2

    International Nuclear Information System (INIS)

    Okutu, Kazuo; Morikawa, Seiji; Takamura, Hisashi

    2003-02-01

    For the high performance evaluation of reliability of TRU waste repository, the system development for evaluating long-term alteration in consideration of the changes action of barrier materials of hydraulic field in Near Field is required. In this research, the system development for evaluating long-term alteration of hydraulic field in Near Field was examined. The model evaluating each phenomena and the prototype system for chemical/mechanical analysis system were developed, and the method of coupling chemical with dynamic analysis was examined. To improve accuracy and propriety of this analysis system in the future, necessary development elements were arranged. The research result of this year is shown below. 1) Knowledge concerning the chemical phenomena in the near field evolution was rearranged. Experimental approaches and analysis methods were applied to the phenomena of which the knowledge can be obtained. Approaches to focus the model were applied to the phenomena for which knowledge is essentially difficult to obtain. The analysis model was improved using knowledge from natural analog and computational analyses. An analysis system was developed and the propriety of the model was demonstrated. 2) The model of bentonite material was developed by focusing attention on nonlinear swelling behavior. And the model of cement material was developed by focusing attention on deformation behavior influenced by leaching of calcium element which cause reducing of rigidity and strength. With regard to the bentonite model, to testify its propriety, the trial analysis result compared with the consolidation properties test data. Furthermore, the dynamic alteration action analysis system consisted of bentonite and cement model was developed, and trial analysis was performed. In this trial analysis, parameters of cation exchange ratio of Na-bentonite for Ca ion and leaching ratio of Ca from cement material were considered. On the one hand, as concerns rock, to include the

  17. Study on crystalline rock aiming at evaluation method of long-term behavior of rock mass (Joint research)

    International Nuclear Information System (INIS)

    Fukui, Katsunori; Hashiba, Kimihiro; Matsui, Hiroya

    2017-11-01

    It is important to evaluate the stability of a repository for high-level radioactive waste not only during the design, construction and operation phases, but also during the post-closure period, for time frames likely exceeding several millennia or longer. The rock mass around the tunnels could be deformed through time in response to time dependent behavior such as creep and stress relaxation. Therefore, development of methodology to evaluate the past long-term behavior of rock mass is considered to be an issue. In view of above points, this study has been started as a collaboration study with the University of Tokyo from Fiscal Year 2016. In FY 2016, creep testing on Tage tuff was continuously conducted. Existing theory of rate process and stochastic process was modified to be applied to evaluate effects of water, and then the modified theory was validated based on the results of strength and creep tests performed under dry and wet conditions. Furthermore, effects of water contents on stress-strain curves were examined by uniaxial compression testing under various water content conditions. (author)

  18. Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction

    DEFF Research Database (Denmark)

    Taniwaki, Masanori; Radu, Maria D; Garcia-Garcia, Hector M

    2015-01-01

    We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI in the s......We assessed the feasibility and the procedural and long-term safety of intracoronary (i.c) imaging for documentary purposes with optical coherence tomography (OCT) and intravascular ultrasound (IVUS) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary PCI...... in the setting of IBIS-4 study. IBIS4 (NCT00962416) is a prospective cohort study conducted at five European centers including 103 STEMI patients who underwent serial three-vessel coronary imaging during primary PCI and at 13 months. The feasibility parameter was successful imaging, defined as the number...... of pullbacks suitable for analysis. Safety parameters included the frequency of peri-procedural complications, and major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and any clinically-indicated revascularization at 2 years. Clinical outcomes were compared...

  19. Geoscientific long-term prognosis. Preliminary safety analysis for the site Gorleben; Geowissenschaftliche Langzeitprognose. Bericht zum Arbeitspaket 2. Vorlaeufige Sicherheitsanalyse fuer den Standort Gorleben

    Energy Technology Data Exchange (ETDEWEB)

    Mrugalla, Sabine [Bundesanstalt fuer Geowissenschaften und Rohstoffe, Hannover (Germany)

    2011-07-15

    The preliminary safety analysis of the site Gorleben includes the following chapters: (1) Introduction; (2) Aim and content of the geoscientific long-term prognosis for the site Gorleben; (3) Boundary conditions at the site Gorleben: climate; geomorphology; overlying rocks and adjoining rocks; hydrogeology; salt deposit Gorleben. (4) Probable future geological developments at the site Gorleben: supraregional developments with effects on the site Gorleben; glacial period developments; developments of the geomorphology, overlying and adjoining rocks; future developments of the hydrological systems at the site Gorleben; future saliniferous specific developments of the salt deposit Gorleben. (5) Commentary on the unlikely or excludable developments of the site Gorleben.

  20. Evaluation of bleeding following dental extraction in patients on long-term antiplatelet therapy: A clinical trial

    Directory of Open Access Journals (Sweden)

    K George Varghese

    2015-01-01

    Conclusion: Hence, we recommend routine single tooth extractions in patients on long-term antiplatelet medication, without interruption or alteration of their medication. Such patients do not have an increased risk of prolonged or excessive postoperative bleeding.

  1. Evaluating strategies for sustainable intensification of U.S. agriculture through the Long-Term Agroecosystem Research network

    Science.gov (United States)

    Sustainable intensification is an emerging model for agriculture designed to reconcile accelerating global demand for agricultural products with long-term environmental stewardship. Defined here as increasing agricultural production while maintaining or improving environmental quality, sustainable i...

  2. Environmental management: Integrating ecological evaluation, remediation, restoration, natural resource damage assessment and long-term stewardship on contaminated lands

    International Nuclear Information System (INIS)

    Burger, Joanna

    2008-01-01

    Ecological evaluation is essential for remediation, restoration, and Natural Resource Damage Assessment (NRDA), and forms the basis for many management practices. These include determining status and trends of biological, physical, or chemical/radiological conditions, conducting environmental impact assessments, performing remedial actions should remediation fail, managing ecosystems and wildlife, and assessing the efficacy of remediation, restoration, and long-term stewardship. The objective of this paper is to explore the meanings of these assessments, examine the relationships among them, and suggest methods of integration that will move environmental management forward. While remediation, restoration, and NRDA, among others, are often conducted separately, it is important to integrate them for contaminated land where the risks to ecoreceptors (including humans) can be high, and the potential damage to functioning ecosystems great. Ecological evaluations can range from inventories of local plants and animals, determinations of reproductive success of particular species, levels of contaminants in organisms, kinds and levels of effects, and environmental impact assessments, to very formal ecological risk assessments for a chemical or other stressor. Such evaluations can range from the individual species to populations, communities, ecosystems or the landscape scale. Ecological evaluations serve as the basis for making decisions about the levels and kinds of remediation, the levels and kinds of restoration possible, and the degree and kinds of natural resource injuries that have occurred because of contamination. Many different disciplines are involved in ecological evaluation, including biologists, conservationists, foresters, restoration ecologists, ecological engineers, economists, hydrologist, and geologists. Since ecological evaluation forms the basis for so many different types of environmental management, it seems reasonable to integrate management options

  3. Evaluating methods for estimating space-time paths of individuals in calculating long-term personal exposure to air pollution

    Science.gov (United States)

    Schmitz, Oliver; Soenario, Ivan; Vaartjes, Ilonca; Strak, Maciek; Hoek, Gerard; Brunekreef, Bert; Dijst, Martin; Karssenberg, Derek

    2016-04-01

    Air pollution is one of the major concerns for human health. Associations between air pollution and health are often calculated using long-term (i.e. years to decades) information on personal exposure for each individual in a cohort. Personal exposure is the air pollution aggregated along the space-time path visited by an individual. As air pollution may vary considerably in space and time, for instance due to motorised traffic, the estimation of the spatio-temporal location of a persons' space-time path is important to identify the personal exposure. However, long term exposure is mostly calculated using the air pollution concentration at the x, y location of someone's home which does not consider that individuals are mobile (commuting, recreation, relocation). This assumption is often made as it is a major challenge to estimate space-time paths for all individuals in large cohorts, mostly because limited information on mobility of individuals is available. We address this issue by evaluating multiple approaches for the calculation of space-time paths, thereby estimating the personal exposure along these space-time paths with hyper resolution air pollution maps at national scale. This allows us to evaluate the effect of the space-time path and resulting personal exposure. Air pollution (e.g. NO2, PM10) was mapped for the entire Netherlands at a resolution of 5×5 m2 using the land use regression models developed in the European Study of Cohorts for Air Pollution Effects (ESCAPE, http://escapeproject.eu/) and the open source software PCRaster (http://www.pcraster.eu). The models use predictor variables like population density, land use, and traffic related data sets, and are able to model spatial variation and within-city variability of annual average concentration values. We approximated space-time paths for all individuals in a cohort using various aggregations, including those representing space-time paths as the outline of a persons' home or associated parcel

  4. Characterization, Long-Term Behavior Evaluation and Thermomechanical Properties of Untreated and Treated Flax Fiber-Reinforced Composites

    Science.gov (United States)

    Amiri, Ali

    In recent years there has been a resurgence of interest in the usage of natural fiber reinforced composites in more advanced structural applications. Consequently, the need for improving their mechanical properties as well as service life and long-term behavior modeling and predictions has arisen. In a step towards further development of these materials, in this study, two newly developed biobased resins, derived from soybean oil, methacrylated epoxidized sucrose soyate and double methacrylated epoxidized sucrose soyate are combined with untreated and alkaline treated flax fiber to produce novel biocomposites. Vinyl ester reinforced with flax fiber is used as control in addition to comparing properties of biobased composites against commercial pultruded composites. Effects of alkaline treatment of flax fiber as well as addition of 1% acrylic resin to vinyl ester and the two mentioned biobased resins on mechanical properties are studied. Properties are evaluated in short-term and also, after being exposed to accelerated weathering (i.e. UV and moisture). Moreover, long-term creep of these novel biobased composites and effect of fiber and matrix treatment on viscoelastic behavior is investigated using Time-temperature superposition (TTS) principle. Based on the results of this study, the TTS provides an accelerated method for evaluation of mechanical properties of biobased composites, and satisfactory master curves are achieved by use of this principle. Also, fiber and matrix treatments were effective in increasing mechanical properties of biobased composites in short-term, and treatments delayed the creep response and slowed the process of creep in composites under study in the steady state region. Overall, results of this study reveal the successful production of biocomposites having properties that meet or exceed those of conventional pultruded members while maintaining high biocontent. Composites using treated flax fiber and newly developed resins showed less

  5. Long-term safety of radioactive waste disposal. Radioactive analysis of samples from spent fuel leaching experiments

    International Nuclear Information System (INIS)

    Geckeis, H.; Degering, D.; Goertzen, A.; Geyer, F.W.; Dressler, P.

    1995-09-01

    In order to assess the long-term performance of spent fuel during direct disposal, high burnup fuel (50 MWd/kg U) has been exposed to non-buffered brine solutions and to deionized water under static anaerobic conditions at 25 C. The leaching behaviour of several radionuclides has been observed over periods of approximately 500 d. Currently used radiometric methods (α-, β-, γ-spectrometry) were applied to the analysis of sample solutions. Due to its low specific activity, uranium was determined using ICP-mass-spectrometry (ICP-MS) or laser induced fluorescence spectrometry (LFS). In order to determine radionuclide concentrations without interferences a preceeding radiochemical separation by ion-exchange, solvent-extraction or extraction chromatography was necessary in most cases. The Sc-isotopes 134/137, which are present in a high excess over other γ-emitting nuclides, were separated using the inorganic ion exchanger ammonium molybdato phosphate (AMP). This step allowed the subsequent γ-spectrometric determination of Am-241, Ag-110m, Ru-106, Sb-125 and Eu-154/155. Activity concentrations of pure β-emitters like Sr-90, Tc-99, I-129 and Pu-241 were determined by liquid scintillation counting (LSC) after selective separation using extraction chromatography or solvent extraction. The actinides Am-241, Cm-242/244, Pu-238/239/240 and Np-237 were analysed by α-spectrometry again after selective separation. The direct analysis of uranium by LFS or ICP-MS was hampered by high salt concentrations. Therefore a separation by extraction chromatography turned out to be necessary, too. The analytical procedures used throughout this work are described in detail. (orig.) [de

  6. Epicondylopathia humeri (EPH) and peritendinitis humeroscapularis (PHS): evaluation of radiation therapy long-term results and literature review

    International Nuclear Information System (INIS)

    Seegenschmiedt, M.H.; Keilholz, L.

    1998-01-01

    Background: The effectiveness of radiotherapy (RT) for degenerative inflammatory disorders has been clinically documented in historical studies, but long-term follow-up and assessment with objective criteria are still not available. Patients and methods: From 1986 to 1991, 200 consecutive patients with symptomatic epicondylopathia humeri (EPH, n=104) and peritendinitis humeroscapularis (PHS, n=96) were referred to our clinic. All patients were refractory to conventional therapy prior to irradiation. One hundred fifty-six patients with 192 sites (due to bilateral symptoms) received a full treatment course and were available for long-term follow-up, i.e. 83 patients with 93 elbows and 73 patients with 89 shoulders. The treatment response was evaluated with regard to pain symptoms grouped into five categories (pain at strain, pain at night, persistent pain during daytime, pain at rest and morning stiffness) and four grades (none, mild, moderate and severe) and with regard to established orthopedic scores (Morrey score and Constant and Murley score). The analysis was performed before and 6 weeks after RT and at last follow-up. All joints received two RT series applied in three weekly fractions (EPH, 6x1 Gy (total 12 Gy); PHS, 6x0.5 Gy (total 6 Gy)). The second RT series started 6 weeks after the first RT series. The minimum follow-up was 1 year for both groups and the mean follow-up reached 4 years (range 1-8 years). Results: Fifty elbows (43 patients) and 44 shoulders (39 patients) achieved complete pain relief in all pain categories; 24 elbows and 28 shoulders substantially improved, i.e. had only minor symptoms. Thus, 74 elbows and 72 shoulders responded to RT. Nineteen elbows (17 patients) had surgery after RT due to persisting symptoms or subjective dissatisfaction; 17 shoulders (12 patients) were non-responders and five of those were operated on; seven elbows and one shoulder were completely free of pain after surgery. The mean Morrey score improved by 18 points

  7. Key Performance Criteria Affecting the Most the Safety of a Nuclear Waste Long Term Storage : A Case Study Commissioned by CEA

    International Nuclear Information System (INIS)

    Marvy, A.; Lioure, A; Heriard-Dubreuil, G.; Gadbois, S.; Schneider, T.; Schieber, C.

    2003-01-01

    As part of the work scope set in the French law on high level long lived waste R and D passed in 1991, CEA is conducting a research program to establish the scientific basis and assess the feasibility of long term storage as an option for the safe management of nuclear waste for periods as long as centuries. This goal is a significant departure from the current industrial practice where storage facilities are usually built to last only a few decades. From a technical viewpoint such an extension in time seems feasible provided care and maintenance is exercised. Considering such long periods of time, the risk for Society of loosing oversight and control of such a facility is real, which triggers the question of whether and how long term storage safety can be actually achieved. Therefore CEA commissioned a study (1) in which MUTADIS Consultants (2) and CEPN (3) were both involved. The case study looks into several past and actual human enterprises conducted over significant periods o f time, one of them dating back to the end of the 18th century, and all identified out of the nuclear field. Then-prevailing societal behavior and organizational structures are screened out to show how they were or are still able to cope with similar oversight and control goals. As a result, the study group formulated a set of performance criteria relating to issues like responsibility, securing funds, legal and legislative implications, economic sustainable development, all being areas which are not traditionally considered as far as technical studies are concerned. These criteria can be most useful from the design stage onward, first in an attempt to define the facility construction and operating guiding principles, and thereafter to substantiate the safety case for long term storage and get geared to the public dialogue on that undertaking should it become a reality

  8. Key Performance Criteria Affecting the Most the Safety of a Nuclear Waste Long Term Storage : A Case Study Commissioned by CEA

    Energy Technology Data Exchange (ETDEWEB)

    Marvy, A.; Lioure, A; Heriard-Dubreuil, G.; Gadbois, S.; Schneider, T.; Schieber, C.

    2003-02-24

    As part of the work scope set in the French law on high level long lived waste R&D passed in 1991, CEA is conducting a research program to establish the scientific basis and assess the feasibility of long term storage as an option for the safe management of nuclear waste for periods as long as centuries. This goal is a significant departure from the current industrial practice where storage facilities are usually built to last only a few decades. From a technical viewpoint such an extension in time seems feasible provided care and maintenance is exercised. Considering such long periods of time, the risk for Society of loosing oversight and control of such a facility is real, which triggers the question of whether and how long term storage safety can be actually achieved. Therefore CEA commissioned a study (1) in which MUTADIS Consultants (2) and CEPN (3) were both involved. The case study looks into several past and actual human enterprises conducted over significant periods o f time, one of them dating back to the end of the 18th century, and all identified out of the nuclear field. Then-prevailing societal behavior and organizational structures are screened out to show how they were or are still able to cope with similar oversight and control goals. As a result, the study group formulated a set of performance criteria relating to issues like responsibility, securing funds, legal and legislative implications, economic sustainable development, all being areas which are not traditionally considered as far as technical studies are concerned. These criteria can be most useful from the design stage onward, first in an attempt to define the facility construction and operating guiding principles, and thereafter to substantiate the safety case for long term storage and get geared to the public dialogue on that undertaking should it become a reality.

  9. A look at new key performance criteria that could most affect the safety of long term storage of nuclear waste. A case study commissioned by CEA

    International Nuclear Information System (INIS)

    Marvy, A.; Lioure, A.; Heriard-Dubreuil, G.; Gadbois, S.; Schneider, T.; Schieber, C

    2002-01-01

    As part of the work scope set in the French law on high level long lived waste R and D passed in 1991, CEA is conducting research work to establish the scientific basis and assess the feasibility of long term storage as an option for the safe management of nuclear waste for periods as long as a few centuries. This goal is a significant departure from current industrial practice where storage facilities are usually built to last only a few decades. From a technical viewpoint such an extension in time seems feasible provided care and maintenance is exercised. Considering such long periods of time risk for Society of loosing oversight and control of such a facility is real which triggers the question of whether and how long term storage safety can be actually achieved. Therefore CEA commissioned a study in which MUTADIS Consultants and CEPN were both involved. The case study looks into several past and actual human enterprises conducted over significant periods of time - one dating back to the end of the 18th century - and identified off the nuclear field. Then-prevailing societal behaviour and organizational structures are screened out to show how they were and are still able to cope with similar oversight and control goals. As a result the study group obtained a set of performance criteria relating to issues like responsibility, securing funds, legal and legislative implications, economic sustainable development, all being areas which are not traditionally considered when technical studies are conducted. These criteria can be most useful from the design stage onward, first in an attempt to define the facility construction and operating guiding principles, and thereafter to substantiate the safety case for long term storage and get geared to the public dialogue on that undertaking should it become a reality. (author)

  10. Perceptions of safety and exposure to violence in public places among working age adults with disabilities or long-term health conditions in the UK: cross sectional study.

    Science.gov (United States)

    Emerson, E; Krnjacki, L; Llewellyn, G; Vaughan, C; Kavanagh, A

    2016-06-01

    To examine perceptions of safety and exposure to violence in public places among working age adults with and without disabilities in the UK and to assess the extent to which any between-group differences may be moderated by gender and socio-economic situation. Cross-sectional study. Secondary analysis of data collected in Wave 3 (2011-13) of Understanding Society. Data were extracted on a subsample of 5069 respondents aged 16 to 64 years (28% of whom had a disability/long-term health condition) who were administered a questionnaire module addressing experiences of harassment. Between-group comparisons were made on four self-reported indicators of safety. Respondents with disabilities/long-term health conditions were significantly more likely to have been attacked (adjusted OR 2.30, 95%CI 1.17-4.50, P condition are at significantly increased risk of exposure to interpersonal violence, particularly if they are living in poverty or are women. As such, there is a clear need to develop interventions that are targeted to the particular circumstances and needs of these high risk groups. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  11. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment

    NARCIS (Netherlands)

    Fineman, M.S.; Mace, K.F.; Diamant, M.; Darsow, T.; Cirincione, B.B.; Porter, T.K.B.; Kinninger, L.A.; Trautmann, M.E.

    2012-01-01

    Aims: Antibody formation to therapeutic peptides is common. This analysis characterizes the time-course and cross-reactivity of anti-exenatide antibodies and potential effects on efficacy and safety. Methods: Data from intent-to-treat patients in 12 controlled (n = 2225,12-52weeks) and 5

  12. Evaluation of long-term behavior of concretes in high level waste repositories. An accelerated leaching test

    Directory of Open Access Journals (Sweden)

    Hidalgo, A.

    2004-04-01

    Full Text Available The present work describes an accelerated leaching method that with a rapid process allows to develop and evaluate cements for use in a nuclear disposal, and the understanding of the long term effects. The method has been developed to study the stability of cementitious materials in contact with bentonite, to be used in high level radioactivity waste repositories. Nitric acid has been selected to simulate in an accelerated way the pH decreasing produced when concrete is in contact with groundwaters.

    El presente trabajo describe un ensayo acelerado de lixiviación, que mediante un proceso rápido, permite desarrollar y evaluar cementos para su uso en instalaciones nucleares, y la comprensión de su comportamiento a largo plazo. El método se ha desarrollado para estudiar la estabilidad de materiales de base cemento, en contacto con bentonita, que serán utilizados en almacenamientos de resíduos radiactivos de alta actividad. Como agente lixiviante se seleccionó el ácido nítrico, con objeto de simular de forma acelerada, la disminución del pH que se produce cuando el hormigón entra en contacto con aguas subterráneas.

  13. Evaluation of the Universal Viral Transport system for long-term storage of virus specimens for microbial forensics.

    Science.gov (United States)

    Hosokawa-Muto, Junji; Fujinami, Yoshihito; Mizuno, Natsuko

    2015-08-01

    Forensic microbial specimens, including bacteria and viruses, are collected at biocrime and bioterrorism scenes. Although it is preferable that the pathogens in these samples are alive and kept in a steady state, the samples may be stored for prolonged periods before analysis. Therefore, it is important to understand the effects of storage conditions on the pathogens contained within such samples. To evaluate the capacity to preserve viable virus and the viral genome, influenza virus was added to the transport medium of the Universal Viral Transport system and stored for over 3 months at various temperatures, after which virus titrations and quantitative analysis of the influenza hemagglutinin gene were performed. Although viable viruses became undetectable 29 days after the medium was stored at room temperature, viruses in the medium stored at 4°C were viable even after 99 days. A quantitative PCR analysis indicated that the hemagglutinin gene was maintained for 99 days at both 4°C and room temperature. Therefore, long-term storage at 4°C has little effect on viable virus and viral genes, so the Universal Viral Transport system can be useful for microbial forensics. This study provides important information for the handling of forensic virus specimens. Copyright © 2015 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  14. Holistic countermeasures evaluation and the sustainable restoration and long-term management of contaminated rural, urban and industrial ecosystems

    International Nuclear Information System (INIS)

    Beresford, N.A.; Wright, S.M.; Barnett, C.L.; Howard, B.J.; Cox, G.; Crout, N.M.J.

    2002-01-01

    Emergency planning as conducted by most national authorities is often focussed upon short-term response (few days - weeks) and addresses issues such as the need for evacuation, problems associated with 1 31I and immediate requirements for restrictions on food and water. There is limited systematic consideration of the long-term management of contaminated areas to ensure their sustainability. Experience following the Chernobyl accident, most especially within the countries of the former Soviet Union (fSU) but also in Scandinavia and the United Kingdom, have demonstrated that countermeasures may have to be employed for a number of decades. The evaluation criteria for the many countermeasures which have been developed needs to be extended from simply effectiveness and radiological protection criteria to a more integrated, holistic approach. Specifically, there needs to be an assessment as to whether countermeasures: can be practically applied; incur considerable direct or side-effect costs; have significant environmental side-effects; and are acceptable to society. In addition, suitable approaches for successfully communicating with a wide range of stake holders must be explored. This is an essential step in developing a decision framework and avoiding problems previously experienced in emergency management. This paper presents results from an ongoing project (see www.strategy-ec.org.uk) to develop a framework for the identification of strategies for the sustainable management of contaminated urban, rural and industrial areas

  15. Long-term evaluation of orbital dynamics in the Sun-planet system considering axial-tilt

    Science.gov (United States)

    Bakhtiari, Majid; Daneshjou, Kamran

    2018-05-01

    In this paper, the axial-tilt (obliquity) effect of planets on the motion of planets’ orbiter in prolonged space missions has been investigated in the presence of the Sun gravity. The proposed model is based on non-simplified perturbed dynamic equations of planetary orbiter motion. From a new point of view, in this work, the dynamic equations regarding a disturbing body in elliptic inclined three-dimensional orbit are derived. The accuracy of this non-simplified method is validated with dual-averaged method employed on a generalized Earth-Moon system. It is shown that the neglected short-time oscillations in dual-averaged technique can accumulate and propel to remarkable errors in the prolonged evolution. After validation, the effects of the planet’s axial-tilt on eccentricity, inclination and right ascension of the ascending node of the orbiter are investigated. Moreover, a generalized model is provided to study the effects of third-body inclination and eccentricity on orbit characteristics. It is shown that the planet’s axial-tilt is the key to facilitating some significant changes in orbital elements in long-term mission and short-time oscillations must be considered in accurate prolonged evaluation.

  16. Evaluation of biostimulation and Tween 80 addition for the bioremediation of long-term DDT-contaminated soil.

    Science.gov (United States)

    Betancur-Corredor, Bibiana; Pino, Nancy J; Cardona, Santiago; Peñuela, Gustavo A

    2015-02-01

    The bioremediation of a long-term contaminated soil through biostimulation and surfactant addition was evaluated. The concentrations of 1,1,1-trichloro-2,2-bis(4-chlorophenyl) ethane (DDT) and its metabolites 1,1-dichloro-2,2-bis(4-chlorophenyl) ethane (DDD) and 1,1-dichloro-2,2-bis(4-chlorophenyl) ethylene (DDE) were monitored during an 8-week remediation process. Physicochemical characterization of the treated soil was performed before and after the bioremediation process. The isolation and identification of predominant microorganisms during the remediation process were also carried out. The efficiency of detoxification was evaluated after each bioremediation protocol. Humidity and pH and the heterotrophic microorganism count were monitored weekly. The DDT concentration was reduced by 79% after 8 weeks via biostimulation with surfactant addition (B+S) and 94.3% via biostimulation alone (B). Likewise, the concentrations of the metabolites DDE and DDD were reduced to levels below the quantification limits. The microorganisms isolated during bioremediation were identified as Bacillus thuringiensis, Flavobacterium sp., Cuprivadius sp., Variovorax soli, Phenylobacterium sp. and Lysobacter sp., among others. Analysis with scanning electron microscopy (SEM) allowed visualization of the colonization patterns of soil particles. The toxicity of the soil before and after bioremediation was evaluated using Vibrio fischeri as a bioluminescent sensor. A decrease in the toxic potential of the soil was verified by the increase of the concentration/effect relationship EC50 to 26.9% and 27.2% for B+S and B, respectively, compared to 0.4% obtained for the soil before treatment and 2.5% by natural attenuation after 8 weeks of treatment. Copyright © 2014. Published by Elsevier B.V.

  17. Introduction: Long term prediction

    International Nuclear Information System (INIS)

    Beranger, G.

    2003-01-01

    Making a decision upon the right choice of a material appropriate to a given application should be based on taking into account several parameters as follows: cost, standards, regulations, safety, recycling, chemical properties, supplying, transformation, forming, assembly, mechanical and physical properties as well as the behaviour in practical conditions. Data taken from a private communication (J.H.Davidson) are reproduced presenting the life time range of materials from a couple of minutes to half a million hours corresponding to applications from missile technology up to high-temperature nuclear reactors or steam turbines. In the case of deep storage of nuclear waste the time required is completely different from these values since we have to ensure the integrity of the storage system for several thousand years. The vitrified nuclear wastes should be stored in metallic canisters made of iron and carbon steels, stainless steels, copper and copper alloys, nickel alloys or titanium alloys. Some of these materials are passivating metals, i.e. they develop a thin protective film, 2 or 3 nm thick - the so-called passive films. These films prevent general corrosion of the metal in a large range of chemical condition of the environment. In some specific condition, localized corrosion such as the phenomenon of pitting, occurs. Consequently, it is absolutely necessary to determine these chemical condition and their stability in time to understand the behavior of a given material. In other words the corrosion system is constituted by the complex material/surface/medium. For high level nuclear wastes the main features for resolving problem are concerned with: geological disposal; deep storage in clay; waste metallic canister; backfill mixture (clay-gypsum) or concrete; long term behavior; data needed for modelling and for predicting; choice of appropriate solution among several metallic candidates. The analysis of the complex material/surface/medium is of great importance

  18. Long-term efficiency and safety of trans-catheter uterine artery embolization by lipiodol-pingyingmycin emulsion for uterine fibroids

    International Nuclear Information System (INIS)

    Du Juan; Zuo Yuewei; Hong Nanhua; Chen Xiaoming; Li Yong

    2009-01-01

    Objective: To investigate the long-term efficiency and safety of trans-catheter uterine artery embolization using lipiodol-pingyingmycin emulsion (LPE-TUAE) for uterine fibroids. Methods: Two hundred and forty-three patients with uterine fibroids were treated by LPE-TUAE. Fourteen of them underwent hysterectomy or myomectomy 3 days to 6 months after LPE-TUAE. The specimens were studied pathologically. Another 229 patients were followed up for 1 to 4 years to observe the long-term outcomes. Results: Menorrhagia became normal or improved markedly in 96.0% (193/201). Lumbago and lower abdominal pain disappeared or relieved markedly in 949% (94/99). Bulk-related symptoms disappeared or lessened markedly in 96.0% (48/50). Ultrasound revealed that the average decreased rate in the largest fibroid volume were 60.7% at 1 year, 63.3% at 2 year, 65.6% at 3 year and 67.4% at 4 year after embolization, and the average decreased rate in the largest uterine volume were 49.6% at 1 year, 54.3% at 2 year, 55.2% at 3 year and 57.1% at 4 year after embolization. Reoccurrence rate of myoma was 10.8% 3-4 year after embolization. No significant difference was found in hormone level between pre- and post-embolization. Pathological studies of specimens showed that lipiodol was only accumulated in fibroids and was not seen in myometrium. Spotty necrosis 2 weeks after embolization and extensive patchy necrosis 3 weeks after embolization were occurred in fibroids. Necrosis was not showed in myometrium. No serious complications occurred. Conclusion: LPE-TUAE possesses a good long-term effectiveness for uterine fibroids, which doesn't cause the damage on ovarian function and normal myometrium or serious complications. (authors)

  19. Safety and efficacy of ipragliflozin in elderly versus non-elderly Japanese patients with type 2 diabetes mellitus: a subgroup analysis of the STELLA-LONG TERM study.

    Science.gov (United States)

    Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Nakamura, Ichiro; Uno, Satoshi

    2018-03-01

    This subgroup analysis of STELLA-LONG TERM interim data explored the long-term safety and efficacy of ipragliflozin in non-elderly vs. elderly Japanese type 2 diabetes mellitus (T2DM) patients. STELLA-LONG TERM is an ongoing 3-year prospective surveillance study of Japanese T2DM patients receiving ipragliflozin 50 mg once daily. In this subgroup analysis, patient characteristics, laboratory variables, and adverse drug reactions (ADRs) were compared between non-elderly (<65 years) and elderly (≥65 years) patients. Non-elderly patients had significantly higher body mass index and low-density lipoprotein cholesterol than elderly patients (P < 0.001). The proportion of patients with hemoglobin A1c (HbA1c) <8.0% was significantly higher among elderly patients (P < 0.001). HbA1c, fasting plasma glucose, and body weight significantly decreased from baseline to 3 and 12 months in both groups (all P < 0.05 vs. baseline). The ADR incidence was 10.83% vs. 10.42% in non-elderly and elderly patients. The incidence of skin complications was 0.98% vs. 1.65% and that of renal disorder was 0.47% vs. 0.95% in non-elderly and elderly patients (both P = 0.003). Ipragliflozin was effective in non-elderly and elderly Japanese T2DM patients in a real-world clinical setting. The incidence of renal disorder and skin complications was significantly higher in elderly vs. non-elderly patients.

  20. Post-assessment of pre-stressed containment structures by evaluation of monitored long term deformation results

    International Nuclear Information System (INIS)

    Wienand, B.

    2015-01-01

    The comparison of monitored long term deformations of containment structures with calculated values achieved by using design material parameters shows occasionally considerable deviations, partly caused by conservative assumptions in the containments design phase. Systematic post-assessment and adaption of the decisive parameters attains better coincidence. In the present investigation measured long-term deformations are first of all compared to pre-calculated values based on the material parameters defined in the design phase. Afterwards, the deformations deviations are minimized by repeating the calculation with assessed material parameters. This method appears to be a suitable method to predict the future containment structure long-term behavior and to achieve a possible life-time extension. The presented investigation was performed as part of NUGENIA ACCEPPT project which researches the ageing of concrete containment structures in nuclear power plants

  1. The IAEA Biomass programme: reference biospheres for long-term safety assessment of high level waste disposal facilities

    International Nuclear Information System (INIS)

    Metcalf, Phil; Crossland, Ian; Torres, Carlos; Crossland, Ian J.

    2002-01-01

    Phil Metcalf and Ian Crossland presented the IAEA Biomass project. Phil Metcalf explained that the Biomass project, begun in 1996, by an international forum organised by the IAEA was a very good exercise for exchanging information through technical meetings and documentation such as Biomass newsletters or CD Rom. Ian Crossland continued by giving a presentation of the Biomass theme 1 that concerns the radioactive waste disposal topic. Its objective was mainly to develop the reference biosphere methodology and to demonstrate its usefulness through some exercises related to the development of a practical set of example biospheres such as: 1. drinking water well, 2. agricultural irrigation, with a well source and 3. Set of natural groundwater discharges to natural, semi-natural systems. Input data would always change to accommodate a given repository simulation and location. Thus this project must be seen as a good exercise for the application of a methodology and should be considered as a good source of reference biospheres that might be viewed as a benchmark for comparison with site-specific safety assessments for a selected number of radionuclides. The main conclusion from the Biomass theme 1 project was that there appears to be an international consensus on preparing generic reference biospheres for postclosure safety assessment but waste management organisations should also consider the specific requirements of regulators and other stakeholders

  2. Fractional carbon dioxide laser for the treatment of facial atrophic acne scars: prospective clinical trial with short and long-term evaluation.

    Science.gov (United States)

    Elcin, Gonca; Yalici-Armagan, Basak

    2017-12-01

    The aim of this study was to evaluate the efficacy and safety of fractional carbon dioxide laser for the treatment of acne scars. Thirty-one participants, 15 female and 16 male, whose mean age was 34.84 ± 10.94 years, were included in this prospective study. The study took place between 2012 and 2016. Participants were evaluated with the "ECCA Grading Scale" before the first session, 3 months (short-term evaluation) and 3 years after the last session (long-term evaluation). Participants received two or three treatment sessions at 4-week intervals, with a 10,600 nm fractional carbon dioxide laser with pulse energies ranging between 100 and 160 mJ, 120 spot type, 75-100 spot/cm 2 density, and 30 W power. Self-assessments by the participants were done 3 months and 3 years after the last session. The mean ECCA score was 107.90 ± 39.38 before the first session, and 82.17 ± 36.23 at the time of short-term evaluation (p = 0.000). The grade of improvement at the short-term evaluation was as follows: no improvement, mild, moderate, and significant improvement for 7 (22.6%), 11 (35.5%), 9 (29%), and 4 (12.9%) of the participants, respectively. Regarding self-assessments, 80.6 and 61.3% of the participants rated themselves as having at least mild improvement at the short-term and the long-term follow-up periods, respectively. The results of this study suggest that fractional carbon dioxide laser is an efficient treatment option for acne scars. Furthermore, self-assessment results show that more than half of the participants still experience at least mild improvement at the end of 3 years.

  3. Long-term Satellite NDVI Data Sets: Evaluating Their Ability to Detect Ecosystem Functional Changes in South America.

    Science.gov (United States)

    Baldi, Germán; Nosetto, Marcelo D; Aragón, Roxana; Aversa, Fernando; Paruelo, José M; Jobbágy, Esteban G

    2008-09-03

    In the last decades, South American ecosystems underwent important functional modifications due to climate alterations and direct human intervention on land use and land cover. Among remotely sensed data sets, NOAA-AVHRR "Normalized Difference Vegetation Index" (NDVI) represents one of the most powerful tools to evaluate these changes thanks to their extended temporal coverage. In this paper we explored the possibilities and limitations of three commonly used NOAA-AVHRR NDVI series (PAL, GIMMS and FASIR) to detect ecosystem functional changes in the South American continent. We performed pixel-based linear regressions for four NDVI variables (average annual, maximum annual, minimum annual and intra-annual coefficient of variation) for the 1982-1999 period and (1) analyzed the convergences and divergences of significant multi-annual trends identified across all series, (2) explored the degree of aggregation of the trends using the O-ring statistic, and (3) evaluated observed trends using independent information on ecosystem functional changes in five focal regions. Several differences arose in terms of the patterns of change (the sign, localization and total number of pixels with changes). FASIR presented the highest proportion of changing pixels (32.7%) and GIMMS the lowest (16.2%). PAL and FASIR data sets showed the highest agreement, with a convergence of detected trends on 71.2% of the pixels. Even though positive and negative changes showed substantial spatial aggregation, important differences in the scale of aggregation emerged among the series, with GIMMS showing the smaller scale (≤11 pixels). The independent evaluations suggest higher accuracy in the detection of ecosystem changes among PAL and FASIR series than with GIMMS, as they detected trends that match expected shifts. In fact, this last series eliminated most of the long term patterns over the continent. For example, in the "Eastern Paraguay" and "Uruguay River margins" focal regions, the

  4. Methodology of proving long-term safety of a salt dome repository with existing insecurities forming the background

    International Nuclear Information System (INIS)

    Storck, R.

    1992-01-01

    Existing methods to prove safety can consider the insecurities of input data within the framework of probabilistic analyses. The results of application calculations show that inspite of considerable band widths of input data the scattering widths of radiation exposures are comparably limited, and calculated radiation exposures are clearly below acceptable limits. Moreover it can be demonstrated that in the event of an assumed brine influx into the repository radionuclides are released only if parameter combinations are unfavourable. Therefore such incident in general does not have any radiological consequences. Insecurities in model approaches can be taken into consideration only partly so far by using alternative models, or indirectly through data insecurities. (orig./DG) [de

  5. Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study.

    Science.gov (United States)

    Hanke, A A; Joch, C; Görlinger, K

    2013-05-01

    The rapid reversal of the effects of vitamin K antagonists is often required in cases of emergency surgery and life-threatening bleeding, or during bleeding associated with high morbidity and mortality such as intracranial haemorrhage. Increasingly, four-factor prothrombin complex concentrates (PCCs) containing high and well-balanced concentrations of vitamin K-dependent coagulation factors are recommended for emergency oral anticoagulation reversal. Both the safety and efficacy of such products are currently in focus, and their administration is now expanding into the critical care setting for the treatment of life-threatening bleeding and coagulopathy resulting either perioperatively or in cases of acute trauma. After 15 yr of clinical use, findings of a pharmacovigilance report (February 1996-March 2012) relating to the four-factor PCC Beriplex P/N (CSL Behring, Marburg, Germany) were analysed and are presented here. Furthermore, a review of the literature with regard to the efficacy and safety of four-factor PCCs was performed. Since receiving marketing authorization (February 21, 1996), ~647 250 standard applications of Beriplex P/N have taken place. During this time, 21 thromboembolic events judged to be possibly related to Beriplex P/N administration have been reported, while no incidences of viral transmission or heparin-induced thrombocytopenia were documented. The low risk of thromboembolic events reported during the observation period (one in ~31 000) is in line with the incidence observed with other four-factor PCCs. In general, four-factor PCCs have proven to be well tolerated and highly effective in the rapid reversal of vitamin K antagonists.

  6. Long-term collections

    CERN Multimedia

    Collectes à long terme

    2007-01-01

    The Committee of the Long Term Collections (CLT) asks for your attention for the following message from a young Peruvian scientist, following the earthquake which devastated part of her country a month ago.

  7. Prediction of concentration and model validation - key issues in assessment of long term safety for radioactive waste disposal

    International Nuclear Information System (INIS)

    Xu, S.; Dverstorp, B.; Woerman, A.

    2008-01-01

    Post-closure safety assessments for nuclear waste repositories involve radioecological modelling for en,underground source term. In this paper we discuss critical aspects concerning process understanding and justification of simplified radioecological models used for such safety assessments. This study is part of the Swedish Radiation Protection Authority's (SSI) work on reviewing the Swedish Nuclear Fuel and Waste Management Co's (SKB) most recent safety assessment, SR-Can. One of the most challenging tasks in assessments of environmental doses and risk from an underground repository is to estimate radionuclide activity concentrations in various geologic strata in the future. For example, little is known about transport pathways through the quaternary deposits to the discharge points in surface waters and other recipients in the biosphere. Traditionally simplified compartmental models are used in safety assessment to describe the fate of radio-nuclides in surface environment. The possibility to test such models against more detailed process models and site specific data is of key importance for confidence in the safety assessment. As part of SSI's review of SR-Can, alternative modelling approaches were developed to explore the importance of transport process descriptions in the assessment models. The modelling results were compared with the Landscape Dose Factors (LDFs) derived by SKB in SR-Can. LDFs is a new methodology adapted by SKB in SR-Can. The LDFs are defined in the units of Sv/y per Bq/y and express all the radiological information about individual epository sites and ecosystems as a single, radionuclide-specific, number that relates geosphere releases to radiological dose. Further, we suggest a method for validating model parameters using data from field tracer tests. In two companion papers we present the underlying model framework for pathway analyses and a newly developed numerical module within the numerical software Ecolego Toolbox. Transport models

  8. Evaluation of adverse effects of long-term oral administration of carprofen, etodolac, flunixin meglumine, ketoprofen, and meloxicam in dogs.

    Science.gov (United States)

    Luna, Stelio P L; Basílio, Ana C; Steagall, Paulo V M; Machado, Luciana P; Moutinho, Flávia Q; Takahira, Regina K; Brandão, Cláudia V S

    2007-03-01

    To evaluate adverse effects of long-term oral administration of carprofen, etodolac, flunixin meglumine, ketoprofen, and meloxicam in dogs. 36 adult dogs. Values for CBC, urinalysis, serum biochemical urinalyses, and occult blood in feces were investigated before and 7, 30, 60, and 90 days after daily oral administration (n = 6 dogs/group) of lactose (1 mg/kg, control treatment), etodolac (15 mg/kg), meloxicam (0.1 mg/kg), carprofen (4 mg/kg), and ketoprofen (2 mg/kg for 4 days, followed by 1 mg/kg daily thereafter) or flunixin (1 mg/kg for 3 days, with 4-day intervals). Gastroscopy was performed before and after the end of treatment. For serum gamma-glutamyltransferase activity, values were significantly increased at day 30 in dogs treated with lactose, etodolac, and meloxicam within groups. Bleeding time was significantly increased in dogs treated with carprofen at 30 and 90 days, compared with baseline. At 7 days, bleeding time was significantly longer in dogs treated with meloxicam, ketoprofen, and flunixin, compared with control dogs. Clotting time increased significantly in all groups except those treated with etodolac. At day 90, clotting time was significantly shorter in flunixin-treated dogs, compared with lactose-treated dogs. Gastric lesions were detected in all dogs treated with etodolac, ketoprofen, and flunixin, and 1 of 6 treated with carprofen. Carprofen induced the lowest frequency of gastrointestinal adverse effects, followed by meloxicam. Monitoring for adverse effects should be considered when nonsteroidal anti-inflammatory drugs are used to treat dogs with chronic pain.

  9. Evaluating privacy-preserving record linkage using cryptographic long-term keys and multibit trees on large medical datasets.

    Science.gov (United States)

    Brown, Adrian P; Borgs, Christian; Randall, Sean M; Schnell, Rainer

    2017-06-08

    Integrating medical data using databases from different sources by record linkage is a powerful technique increasingly used in medical research. Under many jurisdictions, unique personal identifiers needed for linking the records are unavailable. Since sensitive attributes, such as names, have to be used instead, privacy regulations usually demand encrypting these identifiers. The corresponding set of techniques for privacy-preserving record linkage (PPRL) has received widespread attention. One recent method is based on Bloom filters. Due to superior resilience against cryptographic attacks, composite Bloom filters (cryptographic long-term keys, CLKs) are considered best practice for privacy in PPRL. Real-world performance of these techniques using large-scale data is unknown up to now. Using a large subset of Australian hospital admission data, we tested the performance of an innovative PPRL technique (CLKs using multibit trees) against a gold-standard derived from clear-text probabilistic record linkage. Linkage time and linkage quality (recall, precision and F-measure) were evaluated. Clear text probabilistic linkage resulted in marginally higher precision and recall than CLKs. PPRL required more computing time but 5 million records could still be de-duplicated within one day. However, the PPRL approach required fine tuning of parameters. We argue that increased privacy of PPRL comes with the price of small losses in precision and recall and a large increase in computational burden and setup time. These costs seem to be acceptable in most applied settings, but they have to be considered in the decision to apply PPRL. Further research on the optimal automatic choice of parameters is needed.

  10. Bulk density of an alfisol under cultivation systems in a long-term experiment evaluated with gamma ray computed tomography

    International Nuclear Information System (INIS)

    Bamberg, Adilson Luis; Silva, Thiago Rech da; Pauletto, Eloy Antonio; Pinto, Luiz Fernando Spinelli; Lima, Ana Claudia Rodrigues de; Timm, Luis Carlos

    2009-01-01

    The sustainability of irrigated rice (Oryza sativa L.) in lowland soils is based on the use of crop rotation and succession, which are essential for the control of red and black rice. The effects on the soil properties deserve studies, particularly on soil compaction. The objective of this study was to identify compacted layers in an albaqualf under different cultivation and tillage systems, by evaluating the soil bulk density (Ds) with Gamma Ray Computed Tomography (TC). The analysis was carried out in a long-term experiment, from 1985 to 2004, at an experimental station of EMBRAPA Clima Temperado, Capao do Leao, RS, Brazil, in a random block design with seven treatments, with four replications (T1 - one year rice with conventional tillage followed by two years fallow; T2 - continuous rice under conventional tillage; T4 - rice and soybean (Glycine Max L.) rotation under conventional tillage; T5 - rice, soybean and corn (Zea maize L.) rotation under conventional tillage; T6 - rice under no-tillage in the summer in succession to rye-grass (Lolium multiflorum L.) in the winter; T7 - rice under no-tillage and soybean under conventional tillage rotation; T8 - control: uncultivated soil). The Gamma Ray Computed Tomography method did not identify compacted soil layers under no tillage rice in succession to rye-grass; two fallow years in the irrigated rice production system did not prevent the formation of a compacted layer at the soil surface; and in the rice, soybean and corn rotation under conventional tillage two compacted layers were identified (0.0 to 1.5 cm and 11 to 14 cm), indicating that they may restrict the agricultural production in this cultivation system on Albaqualf soils. (author)

  11. Taxane-induced peripheral neuropathy has good long-term prognosis: a 1- to 13-year evaluation.

    Science.gov (United States)

    Osmani, Karima; Vignes, Stéphane; Aissi, Mouna; Wade, Fatou; Milani, Paolo; Lévy, Bernard I; Kubis, Nathalie

    2012-09-01

    Taxane-induced neuropathy is a frequent complication, in particular in women with breast cancer. The incidence can be variable and ranges from 11 to 87%, depending on the taxane used and identified risk factors, such as cumulative dose, additional neurotoxic chemotherapy agents and previous nerve fragility. However, little is known about long-term outcome and interference with daily life activities. The objective of this study was to assess clinical and electrophysiological neurological evaluation (ENMG) in a cohort of patients, 1-13 years (median 3 years) after the end of the last cure. Sixty-nine women were enrolled in the lymphology unit of Cognacq-Jay's Hospital. They were 58 ± 9 years old (mean age ± SD) and had been treated by docetexel (n = 56), paclitaxel (n = 10) or both (n = 3), 1-13 years before. Sensory neuropathy occurred in 64% and totally disappeared within months for only 14% after cessation of treatment. However, if symptoms were still present at the time of examination, they were considered as minor by almost all patients, with no interference with daily life activities (grade 2 CTCAE v.3.0). ENMG was accepted by 14 patients; it was normal in 7, and showed sensory axonal neuropathy in 5 and sensory-motor neuropathy in 2. The incidence of taxane-induced neuropathy is high, more frequent with paclitaxel than docetaxel, and is characterized by minor or moderate axonal sensory polyneuropathy. When persistent, it is extremely well tolerated by the patient. When clinical motor signs occur, the patient should be referred to a neurologist.

  12. Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naïve Patients with HIV-1 Infection: the REMAIN Study.

    Science.gov (United States)

    Teófilo, Eugénio; Rocha-Pereira, Nuno; Kuhlmann, Birger; Antela, Antonio; Knechten, Heribert; Santos, Jesús; Jiménez-Expósito, Maria Jesús

    2016-02-01

    Boosted protease inhibitors (PIs), including ritonavir-boosted atazanavir (ATV/r), are a recommended option for the initial treatment of HIV-1 infection based upon clinical trial data; however, long-term real-life clinical data are limited. We evaluated the long-term use of ATV/r as a component of antiretroviral combination therapy in the real-life setting in the REMAIN study. This was an observational cohort study conducted at sites across Germany, Portugal, and Spain. Retrospective historical and prospective longitudinal follow-up data were extracted every six months from medical records of HIV-infected treatment-naïve patients aged ≥ 18 years initiating a first-line ATV/r-containing regimen. Eligible patients (n = 517) were followed up for a median of 3.4 years. The proportion remaining on ATV/r at 5 years was 51.5% with an estimated Kaplan-Meier median time to treatment discontinuation of 4.9 years. Principal reasons for discontinuation were adverse events (15.9%; 8.9% due to hyperbilirubinemia) and virologic failure (6.8%). The Kaplan-Meier probability of not having virologic failure (HIV-1 RNA treatment-emergent major PI resistance occurred. ATV/r was generally well tolerated during long-term treatment with no significant changes in estimated glomerular filtration rate over five years. In a real-life clinical setting over five years, treatment-naïve patients with HIV-1 infection initiating an ATV/r-based regimen showed sustained virologic suppression, an overall treatment persistence rate of 51.5%, an absence of treatment-emergent major PI resistance mutations at virologic failure, a long-term safety profile consistent with that observed in clinical trials, and no significant decline in renal function.

  13. Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Bai C

    2017-11-01

    Full Text Available Chunxue Bai,1 Masakazu Ichinose,2 Sang Haak Lee,3 Kwan Ho Lee,4 Olaf Jöns,5 Ulrich Bothner,6 Yihua Zhao,7 Roland Buhl8 1Department of Pulmonary Medicine, Shanghai Respiratory Research Institute, Zhongshan Hospital, Fudan University, Shanghai, China; 2Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 3Department of Internal Medicine, St Paul’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea; 4Department of Internal Medicine, Yeungnam University Medical Center, Daegu, South Korea; 5Department of Medicine TA Respiratory Diseases, 6Department of Pharmacovigilance, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany; 7Department of Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 8Pulmonary Department, Mainz University Hospital, Mainz, Germany Background and purpose: While the efficacy and safety of combined tiotropium and olodaterol in patients with COPD was established in a large clinical trial program, it is important to assess whether clinical data can be applied to geographic patient groups, particularly for East Asian patients who may have a different phenotypic profile to the global trial population. This study aimed to compare the lung function and safety profiles of tiotropium/olodaterol and monocomponents in East Asian and global populations from the TONADO® trials.Materials and methods: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase III TONADO studies, patients received tiotropium/olodaterol, tiotropium, or olodaterol. We assessed the forced expiratory volume in 1 second (FEV1 area under the curve from 0 to 3 hours (AUC0–3 response and trough FEV1 response at 24 weeks for the approved doses, tiotropium/olodaterol 5/5 µg, tiotropium 5 µg, and olodaterol 5 µg. Treatment-emergent adverse events were recorded throughout treatment and ≤21 days

  14. The marker: A precious link between generations and a part of the long-term safety story

    International Nuclear Information System (INIS)

    Massart, Cecile

    2014-01-01

    High-level radioactive waste brings us face to face with a social, emotional, ethical, political and environmental situation at the heart of which lies the security of the living world. From now on, mankind has to make commitments to protect itself. Building an artistic device, a continuous creation that links and reveals the situation will inform and shed some light on the objectives. In co-operation with industries that manage geological repositories, the installation of markers above ground introduces non-technical aspects that can increase safety. In the art world, many works of art produced throughout the 20. century associate art with waste as vestiges for keeping. The use of waste has shaken the nature of art since Marcel Duchamp, the eye of Man Ray as well as the definition of the artist. The waste recycling industry has modified the way we see it. For what is waste? It embodies above all the imperfect and also a 'time capsule'. In the case that concerns us, waste stays buried in our doubt, secured by our current financial means that are substantial. The notion of time for its decay is calculated and, at the end, it vanishes. Its visibility is next to nil, whereas its presence remains very powerful and thrills the imagination. The hosting community is permeated with it. At the same time the laboratory at the disposal facility provides economic dynamism, an analysis of upheavals in this territory, an exhibition of artistic devices and an awareness of danger. The proposals that are described here are the result of a decade of research. It seems that from the beginning there has been negligence on the part of the nuclear industry regarding the storage of high-level radioactive waste. The general public is not very knowledgeable about the subject. Projects for geological disposal often give the local population the feeling of an ablation of a piece of territory. To sum it up, in the long run, we consider the study of two barriers for the safety of high

  15. Evaluation of risk of falls and orthostatic hypotension in older, long-term topical beta-blocker users

    NARCIS (Netherlands)

    Ramdas, Wishal D.; van der Velde, Nathalie; van der Cammen, Tischa J. M.; Wolfs, Roger C. W.

    2009-01-01

    Falls are a serious problem in the elderly, and have recently been described as cardiovascular-mediated side effects of beta-blocker eye drops. Therefore, we investigated the possible association between the long-term use of beta-blockers, prostaglandins and their combinations in eye drops, and

  16. Evaluation of risk of falls and orthostatic hypotension in older, long-term topical beta-blocker users

    NARCIS (Netherlands)

    W.D. Ramdas (Wishal); N. van der Velde (Nathalie); T.J.M. van der Cammen (Tischa); R.C.W. Wolfs (Roger)

    2009-01-01

    textabstractBackground: Falls are a serious problem in the elderly, and have recently been described as cardiovascular-mediated side effects of beta-blocker eye drops. Therefore, we investigated the possible association between the long-term use of beta-blockers, prostaglandins and their

  17. Long-term follow-up of syndromic craniosynostosis after Le Fort III halo distraction: a cephalometric and CT evaluation.

    Science.gov (United States)

    Meazzini, Maria Costanza; Allevia, Fabiana; Mazzoleni, Fabio; Ferrari, Luca; Pagnoni, Mario; Iannetti, Giorgio; Bozzetti, Alberto; Brusati, Roberto

    2012-04-01

    Midface distraction osteogenesis (DO) in craniofacial synostosis (CFS) patients has been described by several authors. However, very few cephalometric and computed tomography (CT) long-term follow-up studies are available. A total of 40 consecutive patients affected by CFS subjected to Le Fort III and rigid external distraction (RED) were examined. All patients had pre-DO cephalometric records, immediately post-DO and 6-12 months post-DO. Twenty-seven patients had mid-term records (3 years post-DO) and 20 patients had long-term records (5-10 years post-DO). Fourteen patients had CT data within 1-year of DO, while 10 patients had long-term CT data (range 5-9 years). Excellent post-surgical stability was recorded. Short- and long-term CT data demonstrated excellent ossification at the osteotomy sites post-DO. In the growing patients, surface resorption in the zygomatic-temporal and in the subspinal area (p term follow-up, as well as a mild increment of the corrected exorbitism (p term, in growing patients, in general a class III malocclusion does not re-occur, but physiological remodelling processes at the maxillary-zygomatic level, not coupled with sutural growth, tend to mildly re-express the original midfacial phenotype and the exorbitism. Copyright © 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  18. Method selection and evaluation of midtrimester and long-term therapeutic efficiency of achalasia with three methods of interventional procedure

    International Nuclear Information System (INIS)

    Cheng Yingsheng; Yang Renjie; Li Minghua; Chen Weixiong; Shang Kezhong; Zhuang Qixin; Xu Jianrong; Chen Niwei; Zhu Yude

    2000-01-01

    Objective: To study method selection and evaluation of midtrimester and long-term therapeutic efficiency of achalasia with three methods of interventional procedure. Method: 50 cases achalasia with 30 cases performing with balloon dilation (group A) and 5 cases with permanent metallic internal stent dilation (group B) and 15 cases with temporary metallic internal stent dilation (group C) under fluoroscopy. Results: 30 cases of group A had 56 times of dilations (mean 1.9 times). The mean diameter of cardia was (2.4 +- 1.2) mm before dilation and (9.7 +- 3.0) mm after dilation. The mean dysphagia scores were 2.4 +- 1.2 grades before dilation and 1.0 +- 0.3 grades after dilation. Complications in 30 cases included chest pain (n = 9), reflux (n = 8) and bleeding (n = 3). 18(60%) of 30 cases showed dysphagia relapse during follow-up over 6 months, 18(90%) of 20 cases showed dysphagia relapse during follow-up over 12 months. 5 uncovered expandable metal stents were permanently placed in 5 cases of group B. The mean diameter of cardia was (3.2 +- 2.0) mm before dilation and (18.4 +- 1.7) mm after dilation. The mean dysphagia scores were (2.4 +- 1.1) grade before dilation and (0.4 +- 0.2) grade after dilation. Complications in 5 cases included chest pain (n = 3), reflux (n = 4), bleeding (n = 1) and hyperplasia of granulation tissue (n 2). 3(60%) in 5 cases showed dysphagia relapse during follow-up over 6 months, 1(50%) in 2 cases were dysphagia relapse during follow-up over 12 months. 15 covered expandable metal stents were temporarily placed in 15 cases of group C and drawn out at the 3-7 days via gastroscopy. The mean diameter of cardia was (3.4 +- 2.9) mm before dilation and (14.7 +- 2.9) mm after dilation. The mean dysphagia scores were (2.5 +- 1.1) grades before dilation and (0.6 +- 0.3) grades after dilation. Complications in 15 cases included chest pain (n = 3), reflux (n = 3) and bleeding (n = 2). 3(20%) in 15 cases showed dysphagia relapse during follow-up over 6

  19. Long term safety, efficacy, and patient acceptability of hyaluronic acid injection in patients with painful osteoarthritis of the knee

    Science.gov (United States)

    McArthur, Benjamin A; Dy, Christopher J; Fabricant, Peter D; Valle, Alejandro Gonzalez Della

    2012-01-01

    The increasing prevalence of painful knee osteoarthritis has created an additional demand for pharmacologic management to prevent or delay surgical management. Viscosupplementation, via intraarticular injection of hyaluronic acid (HA), aims to restore the favorable milieu present in the nonarthritic joint. The safety profile of intraarticular HA injections for painful knee osteoarthritis is well established, with the most common adverse effect being a self-limited reaction at the injection site. Although acceptance of the early literature has been limited by publication bias and poor study quality, more recent and rigorous meta-analysis suggests that intraarticular HA injection is superior to placebo injection for pain relief and matches, if not surpasses, the effect size of other nonoperative treatments, such as nonsteroidal anti-inflammatory medication. Intraarticular HA injection is effective in providing temporary pain relief in patients with painful knee osteoarthritis. Future investigations should focus on optimizing the composition and administration of HA agents to provide prolonged relief of painful osteoarthritis in the knee and other joints. PMID:23271899

  20. Long-term results of radiotherapy for pituitary adenomas. Evaluation of tumor control and hypopituitarism after radiotherapy

    International Nuclear Information System (INIS)

    Tsuchida, Emiko; Sakai, Kunio; Matsumoto, Yasuo; Sugita, Tadashi; Sasamoto, Ryuta

    1999-01-01

    years were 48.6%, 22.8%, and 75.1%, respectively. Conventional radiotherapy was effective in preventing tumor growth of pituitary adenomas. But the effect of reducing hormone levels in functioning adenomas appeared to require several years after radiotherapy in most cases. Because hypopituitarism occurs in the late period after radiotherapy, long-term follow-up is necessary and mandatory. (author)

  1. Evaluation of urban air pollution impact. Agglomeration of Toulon impact at short and long term; Evaluation de l'impact sanitaire de la pollution atmospherique urbaine. Agglomeration de Toulon impact a cour et long terme

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    A health impact assessment of air pollution based on the I.n.V.S. guidelines has been conducted in Toulon according to the Regional Plan for the quality of air in the region of Provence-Alpes-Cote d Azur. Short-term effects on morbidity (hospital admissions) and mortality and long-term effects on mortality were estimated. Four cities were included in the study area: Toulon, La Garde, La Seyne-sur-mer and La Valette-du-Var (population: 267.808 inhabitants. Two periods of study have been defined: 1999 for the mortality analysis and 2000 for the morbidity analysis and the long- term effects. For 1999, number of advanced deaths due to air pollution is around 84 for total mortality including 30 deaths due to cardio-vascular diseases and 10 deaths due to respiratory diseases. The different scenarios of air pollution reduction showed that the most effective ones are those which lead to reduce of 25% the mean of the involved pollutant. Regarding long-term effects, the different scenario showed that the respect of the European Community limits value for the year 2010 would allow to avoid 118 deaths over one year. Results showed that air pollution are even resulting in health effects for some levels of pollution lo