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.

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)

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....

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.)

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.)

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

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

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

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.

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.

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.

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)

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

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)

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

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

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.

Long-term health status of Danish women with silicone breast implants

DEFF Research Database (Denmark)

Breiting, Vibeke B; Hölmich, Lisbet R; Brandt, Bodil

2004-01-01

Long-term safety data are important in the evaluation of possible adverse health outcomes related to silicone breast implants. The authors evaluated long-term symptoms and conditions and medication use among 190 Danish women with cosmetic silicone breast implants compared with 186 women who had u...

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

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)

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)

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.

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

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

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.

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.

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.

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)

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

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

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.

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.

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)

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)

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

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.

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.

Challenges in long-term operation of nuclear power plants - Implications for regulatory bodies

International Nuclear Information System (INIS)

Soda, Kunihisa; Van Wonterghem, Frederik; Khouaja, Hatem; Vilpas, Martti; Osouf, Nicolas; Harikumar, S.; Ishigaki, Hiroki; Osaki, Toru; Yamada, Tomoho; Carlsson, Lennart; Shepherd, David; Galloway, Melanie; Liszka, Ervin; Svab, Miroslav; Pereira, Ken; Huerta, Alejandro

2012-01-01

Nuclear power reactors have become a major source of electricity supply in many countries in the past half a century. Based on this experience, many operators have sought and have received authorisation for long-term operation, whereby plant operation continues beyond the period considered in the design of the plant. Acceptance of a nuclear power plant for extended service should be based on assurance of the fitness of the plant and the operator for safe and reliable operation over the entire period considered for long-term operation. This assurance may be obtained by establishment of appropriate regulatory requirements, specification of goals and safety levels and regulatory assessment and oversight of the operator's programme for long-term operation. The operators and regulators should ensure that operating experience continues to be evaluated during long-term operation to ensure that any relevant lessons are effectively applied. Other considerations for assurance of safe operation are effective management of ageing, possible need for safety improvements, application of lessons learnt from operating experience, evaluation of environmental impacts, adequate staff resources and performance, review of security at the plant, action in response to emerging issues, and openness and transparency in the transition to long-term operation. Even though most of these considerations are addressed under the regulatory framework that applies to the initial operating period, additional regulatory activities in these areas may be necessary for long-term operation. Although there can be significant differences in regulatory approaches used by different countries for evaluating acceptability of long-term operation, there is general agreement on the purposes and goals of the regulatory reviews. An authorisation of long-term operation could involve a licence renewal or a periodic safety review or an approach that melds elements of both. This report presents guidance that is intended

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.

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.)

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

High-level Waste Long-term management technology development

International Nuclear Information System (INIS)

Choi, Jong Won; Kang, C. H.; Ko, Y. K.

2012-02-01

The purpose of this project is to develop a long-term management system(A-KRS) which deals with spent fuels from domestic nuclear power stations, HLW from advanced fuel cycle and other wastes that are not admitted to LILW disposal site. Also, this project demonstrate the feasibility and reliability of the key technologies applied in the A-KRS by evaluating them under in-situ condition such as underground research laboratory and provide important information to establish the safety assessment and long-term management plan. To develop the technologies for the high level radioactive wastes disposal, demonstrate their reliability under in-situ condition and establish safety assessment of disposal system, The major objects of this project are the following: Ο An advanced disposal system including waste containers for HLW from advanced fuel cycle and pyroprocess has been developed. Ο Quantitative assessment tools for long-term safety and performance assessment of a radwaste disposal system has been developed. Ο Hydrological and geochemical investigation and interpretation methods has been developed to evaluate deep geological environments. Ο The THMC characteristics of the engineered barrier system and near-field has been evaluated by in-situ experiments. Ο The migration and retardation of radionuclides and colloid materials in a deep geological environment has been investigated. The results from this project will provide important information to show HLW disposal plan safe and reliable. The knowledge from this project can also contribute to environmental conservation by applying them to the field of oil and gas industries to store their wastes safe

Considerations on long-term immuno-intervention in the treatment of multiple sclerosis: an expert opinion.

Science.gov (United States)

Grigoriadis, Nikolaos; Linnebank, Michael; Alexandri, Nektaria; Muehl, Sarah; Hofbauer, Günther F L

2016-10-01

As management of multiple sclerosis (MS) requires life-long treatment with disease-modifying agents, any risks associated with long-term use should be considered when evaluating therapeutic options. Immune cells of the innate and adaptive immune systems play various roles in the pathogenesis of MS. MS therapies affect the immune system, each with a unique mode of action, and consequently possess different long-term safety profiles. Rare, but serious safety concerns, including an increased risk of infection and cancer, have been associated with immunosuppressant use. The risks associated with newer immunosuppressive agents, which target specific elements of MS disease pathophysiology, are not yet fully established as the duration of clinical trials is relatively short and post-marketing experience is limited. Non-immunosuppressants used to treat MS have well-defined safety profiles established over a large number of patient-years demonstrating them to be well-tolerated long-term treatment options. When considering the long-term use of disease-modifying agents for treating MS, classification as immunosuppressants or non-immunosuppressants can be useful when evaluating potential risks associated with chronic use. A successful therapeutic strategy for any serious, chronic disease such as MS should weigh effectiveness versus long-term safety of available treatments.

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

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

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.

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

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

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

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)

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

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

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)

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

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

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...

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

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

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

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

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)

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

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...

Long term integrity of spent fuel and construction materials for dry storage facilities

Energy Technology Data Exchange (ETDEWEB)

Saegusa, T [CRIEPI (Japan)

2012-07-01

In Japan, two dry storage facilities at reactor sites have already been operating since 1995 and 2002, respectively. Additionally, a large scale dry storage facility away from reactor sites is under safety examination for license near the coast and desired to start its operation in 2010. Its final storage capacity is 5,000tU. It is therefore necessary to obtain and evaluate the related data on integrity of spent fuels loaded into and construction materials of casks during long term dry storage. The objectives are: - Spent fuel rod: To evaluate hydrogen migration along axial fuel direction on irradiated claddings stored for twenty years in air; To evaluate pellet oxidation behaviour for high burn-up UO{sub 2} fuels; - Construction materials for dry storage facilities: To evaluate long term reliability of welded stainless steel canister under stress corrosion cracking (SCC) environment; To evaluate long term integrity of concrete cask under carbonation and salt attack environment; To evaluate integrity of sealability of metal gasket under long term storage and short term accidental impact force.

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

Long-term stable, long-term safe storage of residues and radioactive waste. Contribution to discussion to the storage (final storage); Langzeitstabile, langzeitsichere Verwahrung von Rueckstaenden und radioaktiven Abfaellen. Beitrag zur Diskussion um Lagerung (Endlagerung)

Energy Technology Data Exchange (ETDEWEB)

Lersow, Michael [DGGT e.V., Breitenbrunn/Erzgeb. (Germany). Ak 5.5 Tailings; Gellermann, Rainer [Nuclear Control and Consulting GmbH, Braunschweig (Germany)

2015-09-15

In this paper it is presented, where radioactive waste and residues occur, how these materials can be classified, which rules and regulations have to be complied with regarding the disposal and which geotechnical environmental constructions (final repositories) are suitable to guarantee a safe long-term disposal of these materials. Primary protection objective is ''to permanently prevent the transfer of toxic, radioactive contaminations into the biosphere by air, water or rock path or to keep the amount of contamination within a commonly accepted range''. Radionuclide inventories and the given time period considered for long-term safety are compared with. It is shown, that the site-specific disposal solutions cannot be justified by the radioactive inventory deposited there. The given period of 10{sup 6} years is critically evaluated. Based on this it is suggested to subdivide this period into two time periods with different prognosis reliabilities. Results of a specially designed long-term monitoring as part of the site-specific waste disposal solution should be considered for the long-term safety proof. A modular concept for the final storage of High Active Waste (HAW) is derived based on the critical evaluation of the long-term safety, including transmutation, provisional storage and monitoring module. A foundation model is proposed to guarantee the financial resources required for the disposal of HAW.

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)

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.

Long-term health benefits of appetite suppressants remain unproven

Directory of Open Access Journals (Sweden)

Francisco José Roma Paumgartten

2011-12-01

Full Text Available Because of the increasing prevalence of obesity, prevention and treatment of overweight has become a major public health concern. In addition to diet and exercise, drugs are needed for patients who failed to lose weight with behavioral treatment. The current article aimed to summarize recent concerns on the safety and efficacy of appetite suppressants. Several appetite suppressants have been banned for safety reasons. In 2010, sibutramine was withdrawn from the market because a long-term study showed it increased the risks of cardiovascular events. So far no study with a sufficiently large sample size has demonstrated that appetite suppressants can reduce morbidity and mortality associated with overweight. The withdrawal of sibutramine highlights that guidelines for the evaluation of weight control drugs must be more stringent, and studies on their long-term health benefits are needed prior to their marketing.

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.

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

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

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

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

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.

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)

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.

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.

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

International Nuclear Information System (INIS)

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

2008-12-01

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

Risk assessment in long-term storage of spent nuclear fuel

International Nuclear Information System (INIS)

Ahn, T.; Guttmann, J.; Mohseni, A.

2013-01-01

This paper presents probabilistic risk-informed approaches that the Nuclear Regulatory Commission (NRC) staff is planning to consider in preparing regulatory bases for long-term storage of spent nuclear fuel (SNF) for up to 300 years. Due to uncertainties associated with long-term SNF storage, the NRC is considering a probabilistic risk-informed approach as well as a deterministic design-based approach. The uncertainties considered here are primarily associated with materials aging of the canister and SNF in the cask system during long-term storage of SNF. This paper discusses some potential risk contributors involved in long-term SNF storage. Methods of performance evaluation are presented that assess the various types of risks involved. They include deterministic evaluation, probabilistic evaluation, and consequence assessment under normal conditions and the conditions of accidents and natural hazards. Some potentially important technical issues resulting from the consideration of a probabilistic risk-informed evaluation of the cask system performance are discussed for the canister and SNF integrity. These issues are also discussed in comparison with the deterministic approach for comparison purposes, as appropriate. Probabilistic risk-informed methods can provide insights that deterministic methods may not capture. Two specific examples include stress corrosion cracking of the canister and hydrogen-induced cladding failure. These examples are discussed in more detail, in terms of their effects on radionuclide release and nuclear subcriticality associated with the failure. The plan to consider the probabilistic risk-informed approaches is anticipated to provide helpful regulatory insights for long-term storage of SNF that provide reasonable assurance for public health and safety. (authors)

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.

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

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

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

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.

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

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.

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.)

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.

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.

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

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

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

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

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.

Criticality Safety Evaluation of Hanford Site High Level Waste Storage Tanks

Energy Technology Data Exchange (ETDEWEB)

ROGERS, C.A.

2000-02-17

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

Criticality Safety Evaluation of Hanford Site High-Level Waste Storage Tanks

International Nuclear Information System (INIS)

ROGERS, C.A.

2000-01-01

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

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...

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.)

Long-term monitoring FBG-based cable load sensor

Science.gov (United States)

Zhang, Zhichun; Zhou, Zhi; Wang, Chuan; Ou, Jinping

2006-03-01

Stay cables are the main load-bearing components of stayed-cable bridges. The cables stress status is an important factor to the stayed-cable bridge structure safety evaluation. So it's very important not only to the bridge construction, but also to the long-term safety evaluation for the bridge structure in-service. The accurate measurement for cable load depends on an effective sensor, especially to meet the long time durability and measurement demand. FBG, for its great advantage of corrosion resistance, absolute measurement, high accuracy, electro-magnetic resistance, quasi-distribution sensing, absolute measurement and so on, is the most promising sensor, which can cater for the cable force monitoring. In this paper, a load sensor has been developed, which is made up of a bushing elastic supporting body, 4 FBGs uniformly-spaced attached outside of the bushing supporting body, and a temperature compensation FBG for other four FBGs, moreover a cover for protection of FBGs. Firstly, the sensor measuring principle is analyzed, and relationship equation of FBG wavelength shifts and extrinsic load has also been gotten. And then the sensor calibration experiments of a steel cable stretching test with the FBG load sensor and a reference electric pressure sensor is finished, and the results shows excellent linearity of extrinsic load and FBG wavelength shifts, and good repeatability, which indicates that such kind of FBG-based load sensor is suitable for load measurement, especially for long-term, real time monitoring of stay-cables.

Data of long term atmospheric diffusion experiments (Winter, 1992)

Energy Technology Data Exchange (ETDEWEB)

Hayashi, Takashi; Chino, Masamichi; Yamazawa, Hiromi [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment] [and others

1998-10-01

The data were obtained in the long-term atmospheric diffusion experiments in the Tokai area, autumn, 1991 which were a part of the Evaluation Safety Demonstration Experiments of Environmental Radiation entrusted with the Science and Technology Agency. The experiments were conducted by JAERI in cooperation with the Japan Weather Association. The report includes tracer concentration data of surface sampling points and meteorological data. (author)

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

Energy Technology Data Exchange (ETDEWEB)

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

2008-12-15

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

2005 dossier: clay. Tome: safety evaluation of the geologic disposal

International Nuclear Information System (INIS)

2005-01-01

This document makes a status of the researches carried out by the French national agency of radioactive wastes (ANDRA) about the safety aspects of an argilite-type geologic disposal facility for high-level and long-lived (HLLL) radioactive wastes. Content: 1 - safety approach: context and general goals, general safety principles, specificity of the argilite repository safety approach, general approach; 2 - general description: HLLL wastes, geologic context of the Meuse/Haute-Marne site, repository architecture; 3 - safety functions and disposal design: time and space scales, safety approach by functions, functional analysis methodology, analysis of safety functions during the construction, exploitation and observation phases, safety functions analysis during post-closure phase; 4 - operational safety: dosimetric evaluation, risk analysis (explosible gases, fire hazards, lift cage drop, container drop); 5 - long-term efficiency of the disposal facility: normal evolution scenario, from conceptual models to the safety calculation model, description of the safety model, quantitative evaluation of the normal evolution scenario, main lessons learnt from the efficiency analysis; 6 - management of uncertainties: identification, building up of altered situations, mastery of uncertainties; 7 - evaluation of altered evolution scenarios: sealing defect scenario, container defect scenario, drilling scenario, strongly degraded operation scenario; 8 - conclusions: lessons learnt, possible improvements. (J.S.)

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)

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

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

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.

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

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

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.

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.

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.

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.

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...

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)

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)

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.

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.

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.

Long-Term Neurodevelopmental Outcome after Doxapram for Apnea of Prematurity.

Science.gov (United States)

Ten Hove, Christine H; Vliegenthart, Roseanne J; Te Pas, Arjan B; Brouwer, Emma; Rijken, Monique; van Wassenaer-Leemhuis, Aleid G; van Kaam, Anton H; Onland, Wes

2016-01-01

Doxapram has been advocated as a treatment for persistent apnea of prematurity (AOP). To evaluate the effect of doxapram on long-term neurodevelopmental outcome in preterm infants as its safety still needs to be established. From a retrospective cohort of preterm infants with a gestational age (GA) large, well-designed, placebo-controlled randomized trial. © 2016 The Author(s) Published by S. Karger AG, Basel.

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

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

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

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.

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

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

Long-term characteristics of geological conditions in Japan. Pt. 1. Fundamental concept for future's prediction of geological conditions and the subjects

International Nuclear Information System (INIS)

Tanaka, Kazuhiro; Chigira, Masahiro.

1997-01-01

It is very important to evaluate the long-term stability of geological conditions such as volcanic activity, uplift-subsidence, earthquakes, faulting and sea level change when the long-term safety performance of HLW geological disposal is investigated. We proposed the extrapolation method using the geological date obtained in the geologic time of the last 500 ka to predict the future's tectonic movements in Japan. Furthermore, we extract geological conditions that would affect the long-term safety of HLW geological disposal with regard to direct and indirect radionuclide release scenarios. As a result, it was concluded that volcanic activity and tectonic movements including faulting and uplift-subsidence, should be considered and their surveying system and evaluating method should be developed. (author)

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

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)

Emergency planning and long-term care: least paid, least powerful, most responsible.

Science.gov (United States)

Covan, Eleanor Krassen; Fugate-Whitlock, Elizabeth

2010-11-01

As disasters can occur anywhere, planning to avoid emergencies is an international concern. Our research specifically addresses planning for the needs and safety of a vulnerable population, long-term care residents. Our initial purposes in this evaluation research were to assess the utility of a template to gather emergency management information for individual long-term care communities, to report on how prepared they are to cope with emergencies that have occurred elsewhere in areas like ours, and to assess the effectiveness of employing gerontology students in the planning process. As we began analyzing our data, we realized that it is imperative to consider whether it is possible for long-term care communities to respond effectively to disasters. In our findings we focus on the impact of gender in the planning process, the importance of size with regard to template utility, the positive and negative consequences of student aid, and the fact that gathering plans for individual long-term care communities may have detracted from collaborative community planning.

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

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

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.

Long-term storage of Greater-Than-Class C Low-Level Waste

International Nuclear Information System (INIS)

Magleby, M.T.

1990-01-01

Under Federal law, the Department of Energy (DOE) is responsible for safe disposal of Greater-Than-Class C Low-Level Waste (GTCC LLW) generated by licenses of the Nuclear Regulatory commission (NRC) or Agreement States. Such waste must be disposed of in a facility licensed by the NRC. It is unlikely that licensed disposal of GTCC LLW will be available prior to the year 2010. Pending availability of disposal capacity, DOE is assessing the need for collective, long-term storage of GTCC LLW. Potential risks to public health and safety caused by long-term storage of GTCC LLW at the place of generation will be evaluated to determine if alternative facilities are warranted. If warranted, several options will be investigated to determine the preferred alternative for long-term storage. These options include modification of an existing DOE facility, development of a new DOE facility, or development of a facility by the private sector with or without DOE support. Reasonable costs for long-term storage would be borne by the waste generators. 5 refs., 1 fig

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

Long-term risks of kidney living donation

DEFF Research Database (Denmark)

Maggiore, Umberto; Budde, Klemens; Heemann, Uwe

2017-01-01

Two recent matched cohort studies from the USA and Norway published in 2014 have raised some concerns related to the long-term safety of kidney living donation. Further studies on the long-term risks of living donation have since been published. In this position paper, Developing Education Science...... and Care for Renal Transplantation in European States (DESCARTES) board members critically review the literature in an effort to summarize the current knowledge concerning long-term risks of kidney living donation to help physicians for decision-making purposes and for providing information...... to the prospective live donors. Long-term risk of end-stage renal disease (ESRD) can be partially foreseen by trying to identify donors at risk of developing ‘de novo’ kidney diseases during life post-donation and by predicting lifetime ESRD risk. However, lifetime risk may be difficult to assess in young donors...

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

NPP long term operation in Spain - First application for license renewal

International Nuclear Information System (INIS)

Francia, L.; Gorrochategui, I.; Marcos, R.

2007-01-01

Full text: In the operation of the Spanish nuclear power plants (NPP), safety is always the prime consideration. Plant Life Management Programmes have been set up with the strategic objective to operate the NPPs as long as they are considered safe and reliable. The safety of each NPP is reviewed by the Spanish nuclear regulatory authority (CSN) under a continuous process. In addition, experience is gained from operating the plants and from exchanges with operators of similar units. Current Spanish regulatory framework for renewing NPP operating licenses requires performing a Periodic Safety Review (PSR) to be performed every 10 years and submitted when applying for a new renewal of the NPP operating license. A few years ago, CSN issued a document regarding the licensing requirements that nuclear power plants should meet in order to be granted with an operating license for long term operation (i.e, operation beyond the original plant design life, typically 40 years). Besides the traditional PSR requirements, specific requirements regarding to long term operation (LTO) include: - An Aging Management and Evaluation Program, including the identification and evaluation of Time Limited Aging Analysis (TLAA). - An updated Radiological Impact Study. - A review and assessment of regulation/standard applicability. Garona NPP (GE, BWR/3 design) operated by Spanish utility Nuclenor from 1971 has a current operating license up to 2009. A decision was made to apply for a new operating license, being Garona plant the first one in Spain to face with the new long term operation requirements. The paper will provide an overview of the methodology used in Spain to address and perform the required analyses to support the LTO application for the operating license renewal. In particular, focus will be paid on the project developed in Garona (2002-2006) whose result has been the first Spanish application for License Renewal for LTO. Also it will be reported the ongoing work necessary to

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.

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

Long-term performance of motor-operated valves

Energy Technology Data Exchange (ETDEWEB)

Scarbrough, T.G.

1996-12-01

The U.S. Nuclear Regulatory Commission (NRC) requires that motor-operated valves (MOVs) important to safety be designed, fabricated, erected, and tested to quality standards commensurate with the importance of the safety functions to be performed. Despite these requirements, operating experience and research revealed problems with the performance of MOVs in operating nuclear power plants. In response to the concerns about MOV performance, the NRC issued Generic Letter (GL) 89-10, {open_quotes}Safety-Related Motor-Operated Valve Testing and Surveillance,{close_quotes} and its supplements. Most licensees have completed the aspects of their GL 89-10 programs associated with the review of MOV design bases, verification of MOV switch settings initially, testing of MOVs under design-basis conditions where practicable, and improvement of evaluations of MOV failures and necessary corrective action. Licensees are establishing processes to ensure that the long-term aspects of their MOV programs, such as periodic verification of MOV capability and the trending of MOV problems, are maintained. The NRC staff is developing a generic letter to address periodic verification of MOV design-basis capability.

Long-term performance of motor-operated valves

International Nuclear Information System (INIS)

Scarbrough, T.G.

1996-01-01

The U.S. Nuclear Regulatory Commission (NRC) requires that motor-operated valves (MOVs) important to safety be designed, fabricated, erected, and tested to quality standards commensurate with the importance of the safety functions to be performed. Despite these requirements, operating experience and research revealed problems with the performance of MOVs in operating nuclear power plants. In response to the concerns about MOV performance, the NRC issued Generic Letter (GL) 89-10, open-quotes Safety-Related Motor-Operated Valve Testing and Surveillance,close quotes and its supplements. Most licensees have completed the aspects of their GL 89-10 programs associated with the review of MOV design bases, verification of MOV switch settings initially, testing of MOVs under design-basis conditions where practicable, and improvement of evaluations of MOV failures and necessary corrective action. Licensees are establishing processes to ensure that the long-term aspects of their MOV programs, such as periodic verification of MOV capability and the trending of MOV problems, are maintained. The NRC staff is developing a generic letter to address periodic verification of MOV design-basis capability

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.

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

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)

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.

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)

Long-term hearing preservation in vestibular schwannoma

DEFF Research Database (Denmark)

Stangerup, Sven-Eric; Thomsen, Jens; Tos, Mirko

2010-01-01

The aim of the present study was to evaluate the long-term hearing during "wait and scan" management of vestibular schwannomas.......The aim of the present study was to evaluate the long-term hearing during "wait and scan" management of vestibular schwannomas....

Projection of primary energy in electricity generation with evaluation of demand and supply of energy in the medium-term horizon (2020), long-term (2035) and very long term (2060)

International Nuclear Information System (INIS)

Mafra, Olga Y.; Alvim, Carlos Feu; Eidelman, Frida; Guimaraes, Leonam dos Santos

2013-01-01

The Global Energy demand and the participation of electricity in scenarios of medium (2020), long (2035) and very long (2060) terms are estimated. It is also evaluated the share of different primary energies in electricity generation and their availability in the country. Three economic scenarios were considered and different hypothesis regarding the participation of nuclear energy were analyzed. (author)

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.

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

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)

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

Long-term monitoring as aging management component in the NPP Grohnde

International Nuclear Information System (INIS)

Reese, Sven H.; Seichter, Johannes

2009-01-01

In the frame of aging management of safety relevant mechanical systems, structures and components (SSC) a classification is performed with respect to the safety relevance. For SSC of group M1 integrity has to be assured, i.e. components must not fail. The other safety relevant components are classified as group M2, i.e. failure is admissible as isolated case. SSC of group M1 in the NPP Grohnde are included into the long-term monitoring system, the annual status report ''fatigue'' has to identify the actual usage value and predict the end-of-life usage. The authors describe the used methodology concerning loading evaluation based on temperature cycling data, the thermal hydraulic modeling using finite element methods for fatigue relevant components.

Long-term plutonium storage: Design concepts

International Nuclear Information System (INIS)

Wilkey, D.D.; Wood, W.T.; Guenther, C.D.

1994-01-01

An important part of the Department of Energy (DOE) Weapons Complex Reconfiguration (WCR) Program is the development of facilities for long-term storage of plutonium. The WCR design goals are to provide storage for metals, oxides, pits, and fuel-grade plutonium, including material being held as part of the Strategic Reserve and excess material. Major activities associated with plutonium storage are sorting the plutonium inventory, material handling and storage support, shipping and receiving, and surveillance of material in storage for both safety evaluations and safeguards and security. A variety of methods for plutonium storage have been used, both within the DOE weapons complex and by external organizations. This paper discusses the advantages and disadvantages of proposed storage concepts based upon functional criteria. The concepts discussed include floor wells, vertical and horizontal sleeves, warehouse storage on vertical racks, and modular storage units. Issues/factors considered in determining a preferred design include operational efficiency, maintenance and repair, environmental impact, radiation and criticality safety, safeguards and security, heat removal, waste minimization, international inspection requirements, and construction and operational costs

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.

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.

Nuclear Energy, Long Term Requirements

International Nuclear Information System (INIS)

Knapp, V.

2006-01-01

There are serious warnings about depletion of oil and gas and even more serious warnings about dangers of climate change caused by emission of carbon dioxide. Should developed countries be called to replace CO2 emitting energy sources as soon as possible, and the time available may not be longer then few decades, can nuclear energy answer the call and what are the requirements? Assuming optimistic contribution of renewable energy sources, can nuclear energy expand to several times present level in order to replace large part of fossil fuels use? Paper considers intermediate and long-term requirements. Future of nuclear power depends on satisfactory answers on several questions. First group of questions are those important for near and intermediate future. They deal with economics and safety of nuclear power stations in the first place. On the same time scale a generally accepted concept for radioactive waste disposal is also required. All these issues are in the focus of present research and development. Safer and more economical reactors are targets of international efforts in Generation IV and INPRO projects, but aiming further ahead these innovative projects are also addressing issues such as waste reduction and proliferation resistance. However, even assuming successful technical development of these projects, and there is no reason to doubt it, long term and large-scale nuclear power use is thereby not yet secured. If nuclear power is to play an essential role in the long-term future energy production and in reduction of CO2 emission, than several additional questions must be replied. These questions will deal with long-term nuclear fuel sufficiency, with necessary contribution of nuclear power in sectors of transport and industrial processes and with nuclear proliferation safety. This last issue is more political then technical, thus sometimes neglected by nuclear engineers, yet it will have essential role for the long-term prospects of nuclear power. The

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)

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.

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.

Environmental effects of the long term management of wastes

International Nuclear Information System (INIS)

Henry, L.C.

1980-08-01

Criteria for interim application in uranium mill tailings management, pending the outcome of a thorough investigation of the tailings problem, are outlined. For a closed-out tailings site only passive or natural barriers are to be used to control releases; surface water recharge is to be limited to that from direct natural precipitation, and no permanent water pool will be allowed; all designed systems must be evaluated in terms of their long-term durability; long-term performance and economic guarantees will be required; access must be limited to the maximum extent practical; and pathway analyses should be performed to determine the health, safety and environmental impacts of the expected level of releases. Releases to water should be no greater than those experienced during the operating phase of the facility. Radon emanation should not exceed 2-10 pCi/m 2 .s, and gamma radiation should be reduced to 10-50 μR/hr at 1 metre above the surface. Particulate emissions originating from the tailings material should be virtually non-existent

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.)

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)

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

Dienogest in long-term treatment of endometriosis

Directory of Open Access Journals (Sweden)

Schindler AE

2011-07-01

Full Text Available Adolf E SchindlerInstitute for Medical Research and Education, Essen, GermanyAbstract: Endometriosis is a chronic disease primarily affecting women of childbearing age, in which endometriotic lesions form outside the uterus, typically leading to painful symptoms, fatigue, and infertility. The symptoms of endometriosis may cause significant impairment in quality of life and represent a substantial economic burden to patients, families, and society. There is no cure for endometriosis; management consists of alleviating pain and other symptoms, reducing endometriotic lesions, and improving quality of life. Recurrence after surgical intervention is common, while the clinical evidence to support the efficacy and safety of many medications currently used in endometriosis is limited. Dienogest is an oral progestin that has been investigated extensively in the treatment of endometriosis in two clinical programs performed in Europe and Japan, including dose-ranging, placebo-controlled, active comparator-controlled, and long-term (up to 65 weeks studies. These studies demonstrated that dienogest 2 mg daily effectively alleviates the painful symptoms of endometriosis, reduces endometriotic lesions, and improves indices of quality of life. Dienogest showed a favorable safety and tolerability profile in these studies, with predictable adverse effects, high rates of patient compliance, and low withdrawal rates. This review article describes the clinical trial evidence that characterizes the efficacy and safety of dienogest in endometriosis, including two studies characterizing dienogest in long-term use. The relevance of these findings to the management of endometriosis in clinical practice is discussed.Keywords: dienogest, endometriosis, progestins, long-term treatment, quality of life, symptoms, pain

Measuring client experiences in long-term care in the Netherlands: a pilot study with the Consumer Quality Index Long-term Care

Directory of Open Access Journals (Sweden)

Kool Rudolf B

2010-04-01

Full Text Available Abstract Background This study aims to describe the development, testing and optimization of a new standard instrument, the Consumer Quality Index (CQ-index® Long-term Care, for measuring client experiences with long-term care in the Netherlands. Methods Three versions of the CQ-index questionnaires and protocols for study sampling and data collection were developed, designed for interviews with residents of nursing or residential care homes and postal surveys among representatives of psychogeriatric residents and homecare clients. From July to November 2006 a pilot study was conducted among 2,697 clients of 68 nursing or residential care homes, 2,164 representatives of clients in 57 psychogeriatric care institutions, and 1,462 clients of 19 homecare organizations. We performed psychometric analyses and descriptive analyses, and evaluated the pilot study. Results The pilot study showed the feasibility and usability of the instruments, supported the multidimensionality of the questionnaires and showed first findings on client experiences and possibilities for quality improvement. Nine scales applied to all care settings: shared decision making, attitude and courtesy, information, body care, competence and safety of care, activities, autonomy, mental well-being, and availability of personnel. The pilot resulted in three optimized questionnaires and recommendations for nationwide implementation. Conclusions The CQ-index® Long-term Care provides a good basis to investigate the quality of nursing homes, residential care homes and homecare from the clients' perspective. This standardized instrument enables a nationwide comparison of the quality of long-term care for the purpose of transparency and quality assurance.

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.

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.

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.

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

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

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

Sexuality and Physical Intimacy in Long Term Care: Sexuality, long term care, capacity assessment

OpenAIRE

Lichtenberg, Peter A.

2014-01-01

Sexuality and sexual needs in older adults remains a neglected area of clinical intervention, particularly so in long term care settings. Because older adults in medical rehabilitation and long term care beds present with significant frailties, and often significant neurocognitive disorders it makes it difficult for occupational therapists and other staff to evaluate the capacity of an older adult resident to participate in sexual relationships. The current paper reviews the current literatur...

Research on geosphere stability for long-term isolation of radioactive waste. Scientific programme for fiscal years 2015-2021

International Nuclear Information System (INIS)

Umeda, Koji; Yasue, Ken-ichi; Saito-Kokubu, Yoko; Niwa, Masakazu; Asamori, Koichi; Fujita, Natsuko; Shimizu, Mayuko; Shimada, Akiomi; Matsubara, Akihiro; Tamura, Hajimu; Yokoyama, Tatsunori; Watanabe, Takahiro; Tokuyasu, Kayoko; Hama, Yuki

2015-08-01

The study on long-term geological stability has three objectives, namely, (1) development of technologies for determining the past and present conditions of the geological environment, (2) development of technologies for long-term prediction and evaluation of impacts and (3) development of dating techniques using advanced equipment on isotope geology and geochronology, in order to make contribution to site investigation and safety assessment for the geological disposal of high-level radioactive waste (HLW). This report is to outline 7 years plan (fiscal years 2015-2021) of research and development (R and D) for geosphere stability for long-term isolation of the HLW in Japan Atomic Energy Agency. Background of this research is clarified with the necessity and the significance for site investigation and safety assessment, and the past progress in this report. The objectives, outline, contents and schedule during the next 7 years are described in detail. In addition, the plan framework is structured into the following categories: (1) Development and Systematization of investigation techniques, (2) Development of models for long-term estimation and effective assessment, (3) Development of dating techniques. (author)

Evaluation of health and safety impacts of defense high-level waste in geologic repositories

International Nuclear Information System (INIS)

Smith, E.D.; Kocher, D.C.; Witherspoon, J.P.

1985-02-01

Pursuant to the requirement of the Nuclear Waste Policy Act of 1982 that the President evaluate the use of commercial high-level waste repositories for the disposal of defense high-level wastes, a comparative assessment has been performed of the potential health and safety impacts of disposal of defense wastes in commercial or defense-only repositories. Simplified models were used to make quantitative estimates of both long- and short-term health and safety impacts of several options for defense high-level waste disposal. The results indicate that potential health and safety impacts are not likely to vary significantly among the different disposal options for defense wastes. Estimated long-term health and safety impacts from all defense-waste disposal options are somewhat less than those from commercial waste disposal, while short-term health and safety impacts appear to be insensitive to the differences between defense and commercial wastes. In all cases, potential health and safety impacts are small because of the need to meet stringent standards promulgated by the US Environmental Protection Agency and the US Nuclear Regulatory Commission. We conclude that health and safety impacts should not be a significant factor in the choice of a disposal option for defense high-level wastes. 20 references, 14 tables

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)

Accumulation of Cd in agricultural soil under long-term reclaimed water irrigation

International Nuclear Information System (INIS)

Chen, Weiping; Lu, Sidan; Peng, Chi; Jiao, Wentao; Wang, Meie

2013-01-01

Safety of agricultural irrigation with reclaimed water is of great concern as some potential hazardous compounds like heavy metals may be accumulated in soils over time. Impacts of long-term reclaimed water on soil Cd pollution were evaluated based on the field investigation in two main crop areas in Beijing with long irrigation history and on simulation results of STEM-profile model. Under long-term reclaimed water, Cd content in the top 20 cm soil layer was greatly elevated and was more than 2 times higher than that in the deep soil layer. There was very small differences between the field measured and model simulated Cd content in the plow layer (top 20 cm) and entire soil layer. Long-term model prediction showed that reclaimed water irrigation had a low environmental risk of soil Cd pollution, but the risk would be aggravated when there were high metal loading from other sources. The risk is also depending on the soil and plant properties. -- Highlights: •Root zone soil Cd content was elevated by one time under long-term reclaimed water irrigation. •The STEM-profile model can well track the Cd balance in the soil profile. •Reclaimed water irrigation plays a limited role on soil Cd accumulation in Beijing croplands. -- There was a low risk of soil Cd pollution under long-term reclaimed water irrigation

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)

[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.

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.

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.

Effect of long-term storage of LWR spent fuel on Pu-thermal fuel cycle

International Nuclear Information System (INIS)

Kurosawa, Masayoshi; Naito, Yoshitaka; Suyama, Kenya; Itahara, Kuniyuki; Suzuki, Katsuo; Hamada, Koji

1998-01-01

According to the Long-term Program for Research, Development and Utilization of Nuclear Energy (June, 1994) in Japan, the Rokkasho Reprocessing Plant will be operated shortly after the year 2000, and the planning of the construction of the second commercial plant will be decided around 2010. Also, it is described that spent fuel storage has a positive meaning as an energy resource for the future utilization of Pu. Considering the balance between the increase of spent fuels and the domestic reprocessing capacity in Japan, it can be expected that the long-term storage of UO 2 spent fuels will be required. Then, we studied the effect of long-term storage of spent fuels on Pu-thermal fuel cycle. The burnup calculation were performed on the typical Japanese PWR fuel, and the burnup and criticality calculations were carried out on the Pu-thermal cores with MOX fuel. Based on the results, we evaluate the influence of extending the spent fuel storage term on the criticality safety, shielding design of the reprocessing plant and the core life time of the MOX core, etc. As the result of this work on long-term storage of LWR spent fuels, it becomes clear that there are few demerits regarding the lifetime of a MOX reactor core, and that there are many merits regarding the safety aspects of the fuel cycle facilities. Furthermore, long-term storage is meaningful as energy storage for effective utilization of Pu to be improved by technological innovation in future, and it will allow for sufficient time for the important policymaking of nuclear fuel cycle establishment in Japan. (author)

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)

1980 Annual status report: safety of nuclear materials

International Nuclear Information System (INIS)

1981-01-01

The programme Safety of Nuclear Materials is essentially dealing with long-term safety aspects of the radioactive waste management. The long-term risk of the radioactive waste is due to the presence of alpha-emitting actinides (plutonium, americium, neptunium) and of some long-lived fission products. Evaluation of long-term risk of radioactive waste disposal; assessment studies on alpha-waste management; non-destructive assay of plutonium

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.

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

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

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

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.

a Method for the Extraction of Long-Term Deformation Characteristics of Long-Span High-Speed Railway Bridges Using High-Resolution SAR Images

Science.gov (United States)

Jia, H. G.; Liu, L. Y.

2016-06-01

Natural causes and high-speed train load will result in the structural deformation of long-span bridges, which greatly influence the safety operation of high-speed railway. Hence it is necessary to conduct the deformation monitoring and regular status assessment for long-span bridges. However for some traditional surveying technique, e.g. control-point-based surveying techniques, a lot of human and material resources are needed to perform the long-term monitoring for the whole bridge. In this study we detected the long-term bridge deformation time-series by persistent scatterer interferometric synthetic aperture radar (PSInSAR) technique using the high-resolution SAR images and external digital elevation model. A test area in Nanjing city in China is chosen and TerraSAR-X images and Tandem-X for this area have been used. There is the Dashengguan bridge in high speed railway in this area as study object to evaluate this method. Experiment results indicate that the proposed method can effectively extract the long-term deformation of long-span high-speed railway bridge with higher accuracy.

A METHOD FOR THE EXTRACTION OF LONG-TERM DEFORMATION CHARACTERISTICS OF LONG-SPAN HIGH-SPEED RAILWAY BRIDGES USING HIGH-RESOLUTION SAR IMAGES

Directory of Open Access Journals (Sweden)

H. G. Jia

2016-06-01

Full Text Available Natural causes and high-speed train load will result in the structural deformation of long-span bridges, which greatly influence the safety operation of high-speed railway. Hence it is necessary to conduct the deformation monitoring and regular status assessment for long-span bridges. However for some traditional surveying technique, e.g. control-point-based surveying techniques, a lot of human and material resources are needed to perform the long-term monitoring for the whole bridge. In this study we detected the long-term bridge deformation time-series by persistent scatterer interferometric synthetic aperture radar (PSInSAR technique using the high-resolution SAR images and external digital elevation model. A test area in Nanjing city in China is chosen and TerraSAR-X images and Tandem-X for this area have been used. There is the Dashengguan bridge in high speed railway in this area as study object to evaluate this method. Experiment results indicate that the proposed method can effectively extract the long-term deformation of long-span high-speed railway bridge with higher accuracy.

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)

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

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

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.

Insights from the U.S. department of Energy plant safety evaluation program of VVER and RBMK reactors

International Nuclear Information System (INIS)

Petri, M.C.; Binder, J.L.; Pasedag, W.F.

2001-01-01

Throughout the years 1990 the U.S. Department of Energy has worked build capability in countries of the former Soviet Union to assess the safety of their VVER and RBMK reactors. Through this Plant Safety Evaluation Program, deterministic and probabilistic analyses have been used to provide a documented plant risk profile to support safe plant operation and to set priorities for safety upgrades. Work has been sponsored at thirteen nuclear power plant sites in eight countries. The Plant Safety Evaluation Program has resulted in immediate and long-term safety benefits for the Soviet-designed nuclear plants. (author)

Stability analysis of roadway embankments supported by stone columns with the presence of water table under short-term and long-term conditions

Directory of Open Access Journals (Sweden)

Kadhim Shaymaa Tareq

2018-01-01

Full Text Available Use of stone column technique to improve soft foundation soils under roadway embankments has proven to increase the bearing capacity and reduce the potential settlement. The potential contribution of stone columns to the stability of roadway embankments against general (i.e. deep-seated failure needs to be thoroughly investigated. Therefore, a two-dimensional finite difference model implemented by FLAC/SLOPE 7.0 software, was employed in this study to assess the stability of a roadway embankment fill built on a soft soil deposit improved by stone column technique. The stability factor of safety was obtained numerically under both short-term and long-term conditions with the presence of water table. Two methods were adopted to convert the three-dimensional model into plane strain condition: column wall and equivalent improved ground methods. The effect of various parameters was studied to evaluate their influence on the factor of safety against embankment instability. For instance, the column diameter, columns’ spacing, soft soil properties for short-term and long-term conditions, and the height and friction angle of the embankment fill. The results of this study are developed in several design charts.

Ethics and Intimate Sexual Activity in Long-Term Care.

Science.gov (United States)

Metzger, Eran

2017-07-01

A case is presented in which the staff of a long-term care facility discovers that the husband of a resident with dementia is engaged in sexual activity with her. The case illustrates a dilemma for long-term care facilities that create a home-like environment with a goal of maximizing residents' autonomy while ensuring their safety. An approach to assessing capacity to consent to intimate sexual activity is described, followed by guidelines that nursing homes can implement to support residents who wish to engage in sexual activity. Recommendations are also offered for supporting long-term care staff and family members of residents who are interested in intimate sexual activity. © 2017 American Medical Association. All Rights Reserved.

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

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.

Preclinical rodent toxicity studies for long term use of ceftriaxone

Directory of Open Access Journals (Sweden)

Elena Ratti

2015-01-01

Ceftriaxone showed rapid absorption with half-life values ranging between 1 and 1.5 h. Additionally, there was no evidence of accumulation and a virtually complete elimination by 16 h after the last dose. Overall there were no toxicologically meaningful drug-related animal findings associated with the long-term administration (6 months of ceftriaxone. These results support safety of long-term use of ceftriaxone in human clinical trials.

Long-term complications of splenectomy in adult immune thrombocytopenia.

Science.gov (United States)

Thai, Lan-Huong; Mahévas, Matthieu; Roudot-Thoraval, Françoise; Limal, Nicolas; Languille, Laetitia; Dumas, Guillaume; Khellaf, Mehdi; Bierling, Philippe; Michel, Marc; Godeau, Bertrand

2016-11-01

The recent large decrease in splenectomy use for chronic immune thrombocytopenia (ITP) is partly due to still-unsolved questions about long-term safety. We performed the first single-center exposed/unexposed cohort study evaluating the long-term incidence of splenectomy complications in patients with primary ITP. Overall, 83 patients who underwent splenectomy more than 10 years ago (exposed) were matched with 83 nonsplenectomized patients (unexposed) on the date of ITP diagnosis ±5 years, age and gender. After a median follow-up of 192 months (range 0.5-528), 43 patients (52%) achieved overall response after splenectomy. Splenectomized patients experienced more venous thromboembolism (VTE) than controls (n = 13 vs n = 2, P = 0.005). On multivariate analysis, splenectomy was an independent risk factor of VTE (hazard ratio = 4.006, P = 0.032 [95% confidence interval: 1.13-14.21]). Splenectomized patients presented more severe infections on long-term follow-up: all required hospitalization, and 5/26 (19%) infections led to severe sepsis or septic shock and to death for 3 cases (none in controls). However, the incidence of malignancy was similar in both groups, as was cardiovascular risk, which appeared to be related more to ITP than splenectomy. Finally, splenectomy did not significantly decrease overall survival. Despite the risk of thrombosis and severe sepsis, splenectomy remains an effective and curative treatment for ITP.

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

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

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

Prevalence of Long-Term Opioid Use in Long-Stay Nursing Home Residents.

Science.gov (United States)

Hunnicutt, Jacob N; Chrysanthopoulou, Stavroula A; Ulbricht, Christine M; Hume, Anne L; Tjia, Jennifer; Lapane, Kate L

2018-01-01

Overall and long-term opioid use among older adults have increased since 1999. Less is known about opioid use in older adults in nursing homes (NHs). Cross-sectional. U.S. NHs (N = 13,522). Long-stay NH resident Medicare beneficiaries with a Minimum Data Set 3.0 (MDS) assessment between April 1, 2012, and June 30, 2012, and 120 days of follow-up (N = 315,949). We used Medicare Part D claims to measure length of opioid use in the 120 days from the index assessment (short-term: ≤30 days, medium-term: >30-89 days, long-term: ≥90 days), adjuvants (e.g., anticonvulsants), and other pain medications (e.g., corticosteroids). MDS assessments in the follow-up period were used to measure nonpharmacological pain management use. Modified Poisson models were used to estimate adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for age, gender, race and ethnicity, cognitive and physical impairment, and long-term opioid use. Of all long-stay residents, 32.4% were prescribed any opioid, and 15.5% were prescribed opioids long-term. Opioid users (versus nonusers) were more commonly prescribed pain adjuvants (32.9% vs 14.9%), other pain medications (25.5% vs 11.0%), and nonpharmacological pain management (24.5% vs 9.3%). Long-term opioid use was higher in women (aPR = 1.21, 95% CI = 1.18-1.23) and lower in racial and ethnic minorities (non-Hispanic blacks vs whites: APR = 0.93, 95% CI = 0.90-0.94) and those with severe cognitive impairment (vs no or mild impairment, aPR = 0.82, 95% CI = 0.79-0.83). One in seven NH residents was prescribed opioids long-term. Recent guidelines on opioid prescribing for pain recommend reducing long-term opioid use, but this is challenging in NHs because residents may not benefit from nonpharmacological and nonopioid interventions. Studies to address concerns about opioid safety and effectiveness (e.g., on pain and functional status) in NHs are needed. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics

Long-term tolerability of inhaled human insulin (Exubera) in patients with poorly controlled type 2 diabetes

DEFF Research Database (Denmark)

Barnett, A H; Lange, P; Dreyer, M

2007-01-01

OBJECTIVE: Inhaled human insulin (Exubera; EXU) has shown encouraging tolerability in short-term trials. We evaluated the safety profile of EXU after long-term exposure. DESIGN: In two, open-label, 2-year studies patients poorly controlled on a sulphonylurea were randomised to adjunctive EXU...... or metformin (study 1) and patients poorly controlled on metformin were randomised to adjunctive EXU or the sulphonylurea, glibenclamide (study 2). PATIENTS: The studies included 446 (study 1) and 476 (study 2) patients with type 2 diabetes, no clinically significant respiratory disease and glycosylated....... There was no discernable effect of long-term EXU therapy on pulmonary gas exchange. Insulin antibody binding reached a plateau at 6 months and did not correlate with HbA(1c) or lung function changes. Glycaemic control was maintained over 2 years. CONCLUSIONS: Exubera was well tolerated during long-term use. Pulmonary...

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.

Long term liquidity analysis of the firm

Directory of Open Access Journals (Sweden)

Jaroslav Gonos

2009-09-01

Full Text Available Liquidity control is a very difficult and important function. If the business is not liquid in the long term, it is under threatof bankruptcy, and on the other hand surplus of the cash in hand threaten its future efficiency, because the cash in hand is a sourceof only limited profitability. Long term liquidity is related to the ability of the short term and long term liabilities payment. Articleis trying to point out to the monitoring and analyzing of the long term liquidity in the concrete business, in this case the printing industrycompany. Hereby at the end of the article mentioned monitored and analyzed liquidity is evaluated in the five years time period.

Comparison of Plant Life Management Approaches for Long Term Operations

International Nuclear Information System (INIS)

Kang, Kisig

2012-01-01

Plant life management can be defined as the integration of ageing and economic planning to maintain a high level of safety and optimize operations. Many Member States have given high priority to long term operation of nuclear power plants beyond the time frame originally anticipated (e. g. 30 or 40 years). Out of a total of 445 (369 GWe) operating nuclear power plants, 349 units (297 GWe) have been in operation for more than 20 years (as of November 2011). The need for engineering support to operation, maintenance, safety review and life management for long term operation as well as education and training in the field is increasingly evident. In addition the Fukushima accident has rendered all stake holders even more attentive to safety concerns and to the provision of beyond safety measures in the preparation and scrutiny of applications for operational design life extensions. In many countries, the safety performance of NPPs is periodically followed and characterized via the periodic safety review (PSR) approach. The regulatory The regulatory review and acceptance of the PSR gives the licensee the permission to operate the plant for up to the end of the next PSR cycle (usually 10 years). In the USA and other countries operating US designed plants, the license renewal application is based on the five pre-requisite requirements and ageing management programme for passive long life system structure and components(SSCs) and active systems is adequately addressed by the maintenance rule (MR) requirements and other established regulatory processes. Other Member States have adopted a combined approach that incorporates elements of both PSR and additional LRA specific requirements primarily focused on time limited ageing analysis. Taking into account this variety of approaches, the international atomic energy agency (IAEA) initiated work for collecting and sharing information among Member States about good practices on plant life management for long term operation in

Long-term surveillance plan for the South Clive disposal site Clive, Utah

International Nuclear Information System (INIS)

1997-09-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project South Clive disposal site in Clive, Utah. This LSTP describes the long-term surveillance program the DOE will implement to ensure the South Clive disposal site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP

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.

Evaluation on the safety of transcatheter uterine artery embolization for uterine myoma

International Nuclear Information System (INIS)

Li Yong; Chen Xiaoming; Du Juan; Zuo Yuewei; Hu Xiaoping; Luo Pengfei

2005-01-01

Objective: To observe complications of transcatheter uterine artery embolization (TUAE) for uterine fibroids and to evaluate its long-term safety. Methods: One hundred and ninety-eight women with uterine fibroids were treated by TUAE. The bilateral TUAE were performed using lipiodol-pingyangmycineemulsion (LPE) and gelatin sponge particles in 186 women. Among them, 138 patients were followed up for 1 to 3 year and complications were observed. Results: Complications included ecchymosis and ulceration on buttock (n=1); ulcer of labia minora (n=1); urinary retention (n=12); urinary tract infection (n=1); expelling of necrotic fibroids via vagina (n=5); secondary infection of chocolate cyst of ovary (n=1); increasing in endometrial thickness and calcification (n=1) and amenorrhea (n=2). Conclusion: TUAE is a treatment with long-term safety, while severe complications or sequelae may occur to a few patients, so strict indication should be insisted in patient selection. (authors)

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.

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.

Review and evaluation of the Millstone Unit 3 probabilistic safety study. Containment failure modes, radiological source - terms and offsite consequences

International Nuclear Information System (INIS)

Khatib-Rahbar, M.; Pratt, W.; Ludewig, H.

1985-09-01

A technical review and evaluation of the Millstone Unit 3 probabilistic safety study has been performed. It was determined that; (1) long-term damage indices (latent fatalities, person-rem, etc.) are dominated by late failure of the containment, (2) short-term damage indices (early fatalities, etc.) are dominated by bypass sequences for internally initiated events, while severe seismic sequences can also contribute significantly to early damage indices. These overall estimates of severe accident risk are extremely low compared with other societal sources of risk. Furthermore, the risks for Millstone-3 are comparable to risks from other nuclear plants at high population sites. Seismically induced accidents dominate the severe accident risks at Millstone-3. Potential mitigative features were shown not to be cost-effective for internal events. Value-impact analysis for seismic events showed that a manually actuated containment spray system might be cost-effective

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.

Long-term management of high-level radioactive waste. The meaning of a demonstration

International Nuclear Information System (INIS)

1983-01-01

The ''demonstration'' of the safe management of high level radioactive waste is a prerequisite for the further development of nuclear energy. It is therefore essential to be clear about both the meaning of the term ''demonstration'' and the practical means to satisfy this request. In the complex sequence of operations necessary to the safe management of high level waste, short term activities can be directly demonstrated. For longer term activities, such as the long term isolation of radioactive waste in deep undergroung structures, demonstration must be indirect. The ''demonstration'' of deep underground disposal for high level radioactive waste involves two steps: one direct, to prove that the system could be built, operated and closed safely and at acceptable costs, and one indirect, to make a convincing evaluation of the system's performance and long term safety on the basis of predictive analyses confirmed by a body of varied technical and scienfic data, much of it deriving from experimental work. The assessment of the evidence collected from current operations, existing experience in related fields and specific research and development activities, calls for specialized scientific expertise. Uncertainties in far future situations and probabilistic events can be taken into account in a scientific assessment. Competent national authorithies will have to satisfy themselves that the proposed waste management solutions can meet long term safety objectives. An element of judgement will always be needed in determining the acceptability of a waste disposal concept. However, the level of confidence in our ability to predict the performance of waste management systems will increase as supporting evidence is collected from current research and development activities and as our predictive techniques improve

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.

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

Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

Science.gov (United States)

Resnik, David B

2007-10-01

Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

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

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.

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.

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.)

Developmental Dyslexia and Explicit Long-Term Memory

Science.gov (United States)

Menghini, Deny; Carlesimo, Giovanni Augusto; Marotta, Luigi; Finzi, Alessandra; Vicari, Stefano

2010-01-01

The reduced verbal long-term memory capacities often reported in dyslexics are generally interpreted as a consequence of their deficit in phonological coding. The present study was aimed at evaluating whether the learning deficit exhibited by dyslexics was restricted only to the verbal component of the long-term memory abilities or also involved…

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)

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.

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)

Conceptual design study for the demonstration reactor of JSFR. (3) Safety design and evaluation

International Nuclear Information System (INIS)

Tani, Akihiro; Shimakawa, Yoshio; Kubo, Shigenobu; Fujimura, Ken; Yamano, Hidemasa

2011-01-01

This paper describes the result of conceptual safety design and evaluation for the demonstration plant of Japan sodium-cooled fast reactor (JSFR), which was preliminarily conducted for providing information necessary to decide the plant specification for further design study. The plant major specifications except for output power and safety design concept are almost the same as those of the commercial JSFR. A set of safety evaluation for typical design basis events (DBEs) is mainly focused here, which was conducted for the 750 MWe design. Safety analyses for DBEs evaluation were performed on the basis of conservative assumptions using a one-dimensional flow network code with point kinetics. For representative DBEs, transient over power type events and loss of flow type events were analyzed. The long-term loss-of-offsite power event was also calculated to evaluate the natural circulation decay heat removal system. All analytical results showed to meet tentative safety criteria, thus it was confirmed that the safety design concept of JSFR is feasible against DBEs. (author)

Medical Underwriting In Long-Term Care Insurance: Market Conditions Limit Options For Higher-Risk Consumers.

Science.gov (United States)

Cornell, Portia Y; Grabowski, David C; Cohen, Marc; Shi, Xiaomei; Stevenson, David G

2016-08-01

A key feature of private long-term care insurance is that medical underwriters screen out would-be buyers who have health conditions that portend near-term physical or cognitive disability. We applied common underwriting criteria based on data from two long-term care insurers to a nationally representative sample of individuals in the target age range (50-71 years) for long-term care insurance. The screening criteria put upper bounds on the current proportion of Americans who could gain coverage in the individual market without changes to medical underwriting practice. Specifically, our simulations show that in the target age range, approximately 30 percent of those whose wealth meets minimum industry standards for suitability for long-term care insurance would have their application for such insurance rejected at the underwriting stage. Among the general population-without considering financial suitability-we estimated that 40 percent would have their applications rejected. The predicted rejection rates are substantially higher than the rejection rates of about 20-25 percent of applicants in the actual market. In evaluating reforms for long-term care financing and their potential to increase private insurance rates, as well as to reduce financial pressure on public safety-net programs, policy makers need to consider the role of underwriting in the market for long-term care insurance. Project HOPE—The People-to-People Health Foundation, Inc.

Are long physician working hours harmful to patient safety?

Science.gov (United States)

Ehara, Akira

2008-04-01

Pediatricians of Japanese hospitals including not only residents but also attending physicians work long hours, and 8% work for >79 h per week. Most of them work consecutively for >or=32 h when they are on call. The aim of the present study was to evaluate the effect of long work hours on patient safety. The electronic databases MEDLINE and EMBASE to searched identify the English- and Japanese-language literature for studies on work hours, medical errors, patient safety, and malpractice for years 1966-2005. Studies that analyzed the relationship between physician work hours and outcomes directly related to patient safety were selected. Seven studies met the criteria. Four studies suggest that reduction of work hours has a favorable effect on patient safety indicators. In the other three studies no significant changes of the indicators were observed, but no report found that shorter work hours were harmful to patient safety. Decrease of physician work hours is not harmful but favorable to patient safety.

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.

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)

Long term results of Epi-LASIK and LASEK for myopia.

Science.gov (United States)

Yuksel, Nilay; Bilgihan, Kamil; Hondur, Ahmet M; Yildiz, Burcin; Yuksel, Erdem

2014-06-01

To evaluate the long term clinical and confocal results of mechanical (Epi-LASIK) versus alcohol-assisted laser epithelial keratomileusis (LASEK) for correction of myopia. Gazi University Medical School, Department of Ophthalmology, Ankara, Turkey. Retrospective study. Twenty-two eyes treated with LASEK and twenty eyes treated with Epi-LASIK were evaluated with a mean follow-up duration of 45 months. Mechanical separation of the epithelium was performed with Lasitome epithelial separator, and alcohol-assisted separation with 25s application of 18% alcohol. Laser ablation was performed with the ESIRIS laser. All patients were examined daily until epithelial closure; at 1, 3, 6, and 12 months; and every year subsequently. Main outcome measures were uncorrected visual acuity (UCVA), manifest refraction, haze, and gray scale value in confocal microscopy, efficacy and safety indexes. Preoperative myopic spherical equivalent refraction was -4.65 ± 1.74 D in the LASEK and -3.87 ± 1.30 D in the Epi-LASIK-treated eyes (p=0.36). Of both LASEK and Epi-LASIK-treated eyes, 95% achieved 20/25 or better final UCVA. The grade of haze and mean gray scale value in confocal microscopy were similar in LASEK and Epi-LASIK-treated eyes at all postoperative periods. The efficacy index was 0.94 in LASEK group and 0.96 in Epi-LASIK group (p=0.44). The safety index was 1.01 in LASEK group and 1.02 in Epi-LASIK group (p=0.42). Both LASEK and Epi-LASIK offer safe and effective correction of myopia in the long term. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

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.

Long-term real-time structural health monitoring using wireless smart sensor

Science.gov (United States)

Jang, Shinae; Mensah-Bonsu, Priscilla O.; Li, Jingcheng; Dahal, Sushil

2013-04-01

Improving the safety and security of civil infrastructure has become a critical issue for decades since it plays a central role in the economics and politics of a modern society. Structural health monitoring of civil infrastructure using wireless smart sensor network has emerged as a promising solution recently to increase structural reliability, enhance inspection quality, and reduce maintenance costs. Though hardware and software framework are well prepared for wireless smart sensors, the long-term real-time health monitoring strategy are still not available due to the lack of systematic interface. In this paper, the Imote2 smart sensor platform is employed, and a graphical user interface for the long-term real-time structural health monitoring has been developed based on Matlab for the Imote2 platform. This computer-aided engineering platform enables the control, visualization of measured data as well as safety alarm feature based on modal property fluctuation. A new decision making strategy to check the safety is also developed and integrated in this software. Laboratory validation of the computer aided engineering platform for the Imote2 on a truss bridge and a building structure has shown the potential of the interface for long-term real-time structural health monitoring.

Safety evaluation by living probabilistic safety assessment. Procedures and applications for planning of operational activities and analysis of operating experience

International Nuclear Information System (INIS)

Johanson, Gunnar; Holmberg, J.

1994-01-01

Living Probabilistic Safety Assessment (PSA) is a daily safety management system and it is based on a plant-specific PSA and supporting information systems. In the living use of PSA, plant status knowledge is used to represent actual plant safety status in monitoring or follow-up perspective. The PSA model must be able to express the risk at a given time and plant configuration. The process, to update the PSA model to represent the current or planned configuration and to use the model to evaluate and direct the changes in the configuration, is called living PSA programme. The main purposes to develop and increase the usefulness of living PSA are: Long term safety planning: To continue the risk assessment process started with the basic PSA by extending and improving the basic models and data to provide a general risk evaluation tool for analyzing the safety effects of changes in plant design and procedures. Risk planning of operational activities: To support the operational management by providing means for searching optimal operational maintenance and testing strategies from the safety point of view. The results provide support for risk decision making in the short term or in a planning mode. The operational limits and conditions given by technical specifications can be analyzed by evaluating the risk effects of alternative requirements in order to balance the requirements with respect to operational flexibility and plant economy. Risk analysis of operating experience: To provide a general risk evaluation tool for analyzing the safety effects of incidents and plant status changes. The analyses are used to: identify possible high risk situations, rank the occurred events from safety point of view, and get feedback from operational events for the identification of risk contributors. This report describes the methods, models and applications required to continue the process towards a living use of PSA. 19 tabs, 20 figs

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

Overview of waste isoltaion safety assessment program and description of source term characterization task at PNL

International Nuclear Information System (INIS)

Bradley, D.

1977-01-01

A project is being conducted to develop and illustrate the methods and obtain the data necessary to assess the safety of long-term disposal of high-level radioactive waste in geologic formations. The methods and data will initially focus on generic geologic isolation systems but will ultimately be applied to the long-term safety assessment of specific candidate sites that are selected in the NWTS Program. The activities of waste isolation safety assessment (WISAP) are divided into six tasks: (1) Safety Assessment Concepts and Methods, (2) Disruptive Event Analysis, (3) Source Characterization, (4) Transport Modeling, (5) Transport Data and (6) Societal Acceptance

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)

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)

Long-term surveillance plan for the Mexican Hat disposal site Mexican Hat, Utah

International Nuclear Information System (INIS)

1997-06-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Mexican Hat, Utah, disposal site. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Mexican Hat disposal site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP

Long-term surveillance plan for the Estes Gulch disposal site near Rifle, Colorado

International Nuclear Information System (INIS)

1997-07-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Estes Gulch disposal site near Rifle, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Estes Gulch disposal site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP

Long-term surveillance plan for the Cheney disposal site near Grand Junction, Colorado

International Nuclear Information System (INIS)

1997-07-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Cheney Disposal Site near Grand Junction, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Cheney Disposal Site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP

Long term operation of nuclear power plants in the U.S

International Nuclear Information System (INIS)

Young, G.G.

2015-01-01

This series of slides shows that safety, performance, cost, environmental and public opinion factors are favorable for long term operation of U.S. nuclear power plants. In the U.S. 1 reactor has an operating life ranging between 10 and 19 years, 37 reactors have an operating life ranging between 20 and 29 years, 42 reactors between 30 and 39 years and 20 reactors have an operating life over 40 years. The original license term is 40 years and it can be extended by 20 years for each renewal. The application for renewal must be at least 5 years before expiration of the current license. 3 main areas are reviewed by NRC to get the renewal: safety, environmental and adjudicatory. A slide describes the NRC license renewal process and another slide lists the regulatory and industry guidance documents based on lessons learned and operating experience. Research and development efforts around materials aging and safety margin characterization by EPRI, DOE, NRC and industry groups are essential to support and maintain the option of long term operation of nuclear reactors. (A.C.)

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

Long-Term Hydrologic Monitoring Program, Amchitka Island, Alaska

International Nuclear Information System (INIS)

1982-01-01

The purpose of the Long-Term Hydrologic Monitoring Program for Amchitka Island, Alaska, is to obtain data that will assure the public safety, inform the public, the news media, and the scientific community relative to radiological contamination, and to document compliance with federal, state, and local antipollution requirements. Amchitka's geographical setting, climate, geology, hydrology, and ecology are described. Site history including event information for LONG SHOT in 1965, MILROW in 1969, and CANNIKIN in 1971 is described. Event related contamination has been observed only at the LONG SHOT site. At this site, tritium in concentrations below the drinking water standards has been observed in mud pits and wells in the area adjacent to surface ground zero. The Long-Term Hydrologic Monitoring Program for Amchitka is described. No radioactive venting, significant radioactive leakage, or bioenvironmental damage resulted from any of the nuclear tests on Amchitka

Safety evaluation of zotepine for the treatment of schizophrenia.

Science.gov (United States)

Riedel, Michael; Musil, Richard; Seemüller, Florian; Spellmann, Ilja; Möller, Hans-Jürgen; Schennach-Wolff, Rebecca

2010-07-01

Atypical antipsychotics have become the first-line treatment for patients suffering from schizophrenia in the industrialized world. Given the frequent necessity of a life-long enduring antipsychotic treatment, the compounds' safety profile is of great importance for patients and caregivers. Zotepine is an antipsychotic with atypical properties and previous data have suggested a very favorable side effect profile. The aim of this review is to provide a broad knowledge base on the safety profile of zotepine deriving from currently available research results published in English medical databases. The focus of this research reports starts in the 1990s with zotepine's approval in Europe. This paper incorporates data on placebo-controlled studies of zotepine as well as studies with comparator compounds also beyond the diagnostic boarder of schizophrenia regarding zotepine's safety. The take home message of this safety evaluation of zotepine is that compared to typical compounds zotepine induces less extrapyramidal side effects; however, in terms of comparing zotepine's safety with other atypical antipsychotics more studies are needed to draw final conclusions.

Clinical trials with rasagiline: evidence for short-term and long-term effects.

Science.gov (United States)

Siderowf, Andrew; Stern, Matthew

2006-05-23

Rasagiline (N-propargyl-1 (R)-aminoindan) is a selective, potent irreversible inhibitor of MAO-B that possesses neuroprotective and anti-apoptotic properties in a variety of in vitro and in vivo animal models relevant to Parkinson's disease (PD). Several randomized controlled clinical trials have demonstrated the safety and efficacy of rasagiline as monotherapy in PD and as adjunctive therapy for patients receiving levodopa. In addition, the 1-year randomized, delayed-start analysis of the TEMPO study suggests that rasagiline may slow the rate of progression of PD. The randomized delayed-start paradigm has potential to differentiate short-term symptomatic effects from long-term effects of anti-parkinsonian agents. In the future, long-term trials to examine the potential disease-modifying effects of rasagiline, which incorporate biological markers as well as clinical endpoints, may further elucidate the role of rasagiline in the treatment of both early and advanced PD.

Long-dated evaluation of the external costs of the nuclear; L'evaluation des couts externes a long terme de la filiere nucleaire: interets et limites

Energy Technology Data Exchange (ETDEWEB)

Le Dars, A.; Schneider, T

2002-09-01

Since the middle of the years 1990, the European Commission developed an ''ExternE'' methodology to propose an homogenous evaluation of the sanitary and environmental external costs of the various energy sectors in Europe. This document discusses the taking into account of the long-dated and analyzes the interests and the limits of the monetary evaluation, in terms of external costs, of the nuclear choice. It is organized in three chapters: 1. a presentation and a discussion on the various evaluation of the ''ExternE'' methodology; 2. a description of the available methods for the monetary evaluation of the long-dated impacts and more particularly the analysis of the monetary values actualization principle; 3. highlighted of the impacts for which the monetary evaluations exist. (A.L.B.)

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

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.

Long-term EEG in children.

Science.gov (United States)

Montavont, A; Kaminska, A; Soufflet, C; Taussig, D

2015-03-01

Long-term video-EEG corresponds to a recording ranging from 1 to 24 h or even longer. It is indicated in the following situations: diagnosis of epileptic syndromes or unclassified epilepsy, pre-surgical evaluation for drug-resistant epilepsy, follow-up of epilepsy or in cases of paroxysmal symptoms whose etiology remains uncertain. There are some specificities related to paediatric care: a dedicated pediatric unit; continuous monitoring covering at least a full 24-hour period, especially in the context of pre-surgical evaluation; the requirement of presence by the parents, technician or nurse; and stronger attachment of electrodes (cup electrodes), the number of which is adapted to the age of the child. The chosen duration of the monitoring also depends on the frequency of seizures or paroxysmal events. The polygraphy must be adapted to the type and topography of movements. It is essential to have at least an electrocardiography (ECG) channel, respiratory sensor and electromyography (EMG) on both deltoids. There is no age limit for performing long-term video-EEG even in newborns and infants; nevertheless because of scalp fragility, strict surveillance of the baby's skin condition is required. In the specific context of pre-surgical evaluation, long-term video-EEG must record all types of seizures observed in the child. This monitoring is essential in order to develop hypotheses regarding the seizure onset zone, based on electroclinical correlations, which should be adapted to the child's age and the psychomotor development. Copyright © 2015. Published by Elsevier SAS.

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

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)

Development of Long-term Cooling Operation Strategy with H-SIT

International Nuclear Information System (INIS)

Jeon, In Seop; Kang, Hyun Gook

2016-01-01

In the current nuclear power plants (NPPs), most of the critical safety functions are provided by many active safety systems. Long-term cooling of core is an ultimate goal of all mitigation actions for plant safety and feed and bleed (F and B) operation strategy is one of long-term cooling strategies in conventional pressurized water reactor (PWR). The important point of F and B operation is that, in conventional mitigation strategy, injection for feed operation is performed by only high pressure injection (HPSI) pump. Low pressure injection (LPSI) pump such as shut down cooling pump (SCP) cannot be used for F and B operation. Thus, when F and B operation is needed, if high-pressure injection pump fails, core should be damaged. In this study, F and B operation strategy with LPSI and H-SIT is developed. This is a new concept for the long-term cooling operation. If this strategy is applied, low pressure injection pump can be successfully used for F and B operation thus operator has the additional mitigation way. As this strategy make plant safe even though HPSI and PAFS are both failed, it can effectively enhance the plant safety. For this strategy two RCGVSs and two POSRVs are needed as a depressurization system for bleed operation and only one LPSI is enough for feed operation. H-SIT operation is also needed to make up core inventory during bleed operation. For this operation, four H-SITs have to be used to make up core safely. Based on the risk analysis using PSA method, if this strategy is applied, core damage frequency is 1.868e-6 which declined 7 percent from original model.

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

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...

Liabilities identification and long-term management - Review of French situation

International Nuclear Information System (INIS)

2003-01-01

In France, long term liabilities due to nuclear activities concern four main operators: Electricite de France (EDF), AREVA (an industrial group created on September 3, 2001 and covering the entire fuel cycle from ore extraction and transformation to the recycling of spent fuel), the Atomic Energy Commission (CEA, the French public research organism in the nuclear sector) and the French Agency for radioactive waste management (ANDRA, in charge with the long term operation of radioactive waste installations). Long term liabilities are due to the financing of both decommissioning of nuclear installations and radioactive waste long term management. In the current French organisational scheme, the different operators must take the responsibility of these long term liabilities. The setting of national policies and the establishment of the legislation are carried out at a national level by the French state. These include the supervision of the three operators through different Ministries and the regulatory control of safety trough the Nuclear Safety Authority (ASN). EDF, AREVA, CEA and ANDRA are responsible for all aspects of the decommissioning (from a technical and financial point of view). Within a safety regulatory frame, they have their own initiative concerning future expenses, based on estimated costs and the expected operational lifetime of the installations. They are responsible of the definition and implementation of the technical options. Through its supervision activities, the French State regularly requires updating studies of these estimated costs, which are conducted by the operators. A general review of the management of these long-term liabilities is also carried out on a four years basis by the French Court of Accounts. Operators are due to constitute provisions during the life cycle of their installations. Provisions are calculated for each installation on the basis of the decommissioning expenses and of the reasonably estimated lifetime. They are re-evaluated

A Framework for Evaluation of Safety and Generation Effect of Investment Considering Life Cycle Management in Nuclear Power Plants

International Nuclear Information System (INIS)

Yang, Hui Chang; Kim, Joon Hyun; Ahn, Nam Sung

2006-01-01

Along with the increasing pressure to enhance generation availability with low cost or investment, regulatory organization has been focused on the enhancement of safety in performance-based and risk informed regulation framework. Considering this, the most cost-beneficial solution should be found among the short-term and long-term investment plans. The objective of this research is to propose a generalized framework to evaluate safety and generation effect of investment plan for equipment in nuclear power plants

Long-term stabilization considerations for decommissioned and reclaimed uranium sites

International Nuclear Information System (INIS)

Abt, S.R.; Nelson, J.D.; Johnson, T.L.

1988-01-01

The long-term stabilization of decommissioned uranium mill sites and of reclaimed uranium mill tailings sites encompass a broad spectrum of design capabilities. This paper presents a few of the quantitative methodologies recently developed or refined to evaluate physical factors (i.e. precipitation, fluvial geomorphology, stable slope, slope stabilization with riprap and riprap selection) that influence long-term stabilization of uranium mill and mill tailings sites. It is acknowledged that the degree of refinement of these methodologies are in their infancy and that extensive research and development are warranted to increase the level of assurance. However, these methodologies provide an initial guideline for evaluating long-term stabilization that has not been previously existed. The purpose of this paper is to present a review of currently available state-of-the-art engineering techniques and methodologies for the evaluation of reclamation plans designed to provide long-term stability against potential failure modes. In some cases, evaluative techniques have been developed for long-term stabilization where methodologies have not previously existed. Each methodology to be presented represents a starting point upon which additional research and/or development may be warranted

PSA modeling of long-term accident sequences

International Nuclear Information System (INIS)

Georgescu, Gabriel; Corenwinder, Francois; Lanore, Jeanne-Marie

2014-01-01

In the context of the extension of PSA scope to include external hazards, in France, both operator (EDF) and IRSN work for the improvement of methods to better take into account in the PSA the accident sequences induced by initiators which affect a whole site containing several nuclear units (reactors, fuel pools,...). These methodological improvements represent an essential prerequisite for the development of external hazards PSA. However, it has to be noted that in French PSA, even before Fukushima, long term accident sequences were taken into account: many insight were therefore used, as complementary information, to enhance the safety level of the plants. IRSN proposed an external events PSA development program. One of the first steps of the program is the development of methods to model in the PSA the long term accident sequences, based on the experience gained. At short term IRSN intends to enhance the modeling of the 'long term' accident sequences induced by the loss of the heat sink or/and the loss of external power supply. The experience gained by IRSN and EDF from the development of several probabilistic studies treating long term accident sequences shows that the simple extension of the mission time of the mitigation systems from 24 hours to longer times is not sufficient to realistically quantify the risk and to obtain a correct ranking of the risk contributions and that treatment of recoveries is also necessary. IRSN intends to develop a generic study which can be used as a general methodology for the assessment of the long term accident sequences, mainly generated by external hazards and their combinations. This first attempt to develop this generic study allowed identifying some aspects, which may be hazard (or combinations of hazards) or related to initial boundary conditions, which should be taken into account for further developments. (authors)

Long-term Outcomes of Paclitaxel-Eluting Versus Sirolimus-Eluting Stent for Percutaneous Coronary Intervention: A Meta-Analysis

International Nuclear Information System (INIS)

Kong, J.; Liu, P.; Fan, X.; Wen, J.; Zhang, J.; Zhen, Y.; Li, J.; Cui, Y.; Zheng, X.; Ye, Z.

2017-01-01

The relative long-term efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) in multiple comparative studies remains controversial. This report evaluates 29 randomized trials with 18,379 patients in whom long-term (more than 1 year) outcomes were evaluated. The primary outcomes were target lesion revascularization (TLR) and the secondary end points were death, cardiac death, myocardial infarction (MI), major adverse cardiac events (MACEs), target vessel revascularization (TVR)and stent thrombosis (ST). In comparison with PES, SES significantly reduced the long-term risk of TLR (RR=0.68; 95% CI=0.57 to 0.80, p<0.001), TVR (RR=0.69; 95% CI= 0.60 to 0.79, p<0.001) and MACE (RR=0.82; 95% CI= 0.77 to 0.88, p<0.001), while there were no significant difference with respect to death, cardiac death, MI and ST between the two groups. SES performance was significantly better for reducing the former three outcomes and comparable for the majority of the secondary end points when compared against PES. (author)

Long-term outcome for gastric marginal zone lymphoma treated with radiotherapy

DEFF Research Database (Denmark)

Wirth, A; Gospodarowicz, M; Aleman, B M P

2013-01-01

We evaluated the long-term results of radiotherapy for patients with gastric marginal zone lymphoma (GMZL).......We evaluated the long-term results of radiotherapy for patients with gastric marginal zone lymphoma (GMZL)....

Prevention of fall-related injuries in long-term care: a randomized controlled trial of staff education.

Science.gov (United States)

Ray, Wayne A; Taylor, Jo A; Brown, Anne K; Gideon, Patricia; Hall, Kathi; Arbogast, Patrick; Meredith, Sarah

2005-10-24

Fall-related injuries, a major public health problem in long-term care, may be reduced by interventions that improve safety practices. Previous studies have shown that safety practice interventions can reduce falls; however, in long-term care these have relied heavily on external funding and staff. The aim of this study was to test whether a training program in safety practices for staff could reduce fall-related injuries in long-term care facilities. A cluster randomization clinical trial with 112 qualifying facilities and 10,558 study residents 65 years or older and not bedridden. The intervention was an intensive 2-day safety training program with 12-month follow-up. The training program targeted living space and personal safety; wheelchairs, canes, and walkers; psychotropic medication use; and transferring and ambulation. The main outcome measure was serious fall-related injuries during the follow-up period. There was no difference in injury occurrence between the intervention and control facilities (adjusted rate ratio, 0.98; 95% confidence interval, 0.83-1.16). For residents with a prior fall in facilities with the best program compliance, there was a nonsignificant trend toward fewer injuries in the intervention group (adjusted rate ratio, 0.79; 95% confidence interval, 0.57-1.10). More intensive interventions are required to prevent fall-related injuries in long-term care facilities.

Long term storage techniques for 85Kr

International Nuclear Information System (INIS)

Foster, B.A.; Pence, D.T.; Staples, B.A.

1975-01-01

As new nuclear fuel reprocessing plants go on stream, the collection of fission product 85 Kr will be required to avoid potential local release problems and long-term atmospheric buildup. Storage of the collected 85 Kr for a period of at least 100 years will be necessary to allow approximately 99.9 percent decay before it is released. A program designed to develop and evaluate proposed methods for long-term storage of 85 Kr is discussed, and the results of a preliminary evaluation of three methods, high pressure steel cylinders, zeolite encapsulation, and clathrate inclusion are presented. (U.S.)

Desensitization to Oxcarbazepine: Long-Term Efficacy and Tolerability

Science.gov (United States)

Lee, Jiwon; Park, Eu Gene; Lee, Munhyang

2017-01-01

Background and Purpose Antiepileptic drug (AED)-associated cutaneous adverse drug reactions can lead to the discontinuation of medications. The aim of this study was to determine the long-term efficacy and safety of performing desensitization to oxcarbazepine. Methods This study involved 20 patients who exhibited cutaneous adverse drug reactions associated with oxcarbazepine use between July 2009 and March 2016 at Samsung Medical Center. All of the participants had to discontinue oxcarbazepine despite presenting initially positive responses. Human leukocyte antigen genotyping was performed to detect the genetic predisposition to Stevens-Johnson syndrome. The desensitization to oxcarbazepine was performed with a starting dosage of 0.1 mg/day. Efficacy was evaluated by comparing the frequency of seizures before and at 1 and 3 years after desensitization. Adverse events occurring during desensitization and the retention rate after desensitization were also investigated. Results Nineteen patients (95%) safely completed the desensitization protocol. One withdrew owing to emotional problems that appeared to be associated with oxcarbazepine. The follow-up period was 4.6±1.2 years (mean±SD), and oxcarbazepine was maintained for more than 3 years after desensitization in 15 patients (83.3%). The response rates were 84.2% and 77.8% at 1 and 3 years after desensitization, respectively. Eight patients remained seizure-free for 3 years, and two discontinued all AEDs. Transient adverse reactions such as mild rash and itching were reported by five patients during desensitization. Conclusions This study has demonstrated the long-term efficacy and safety of desensitization to oxcarbazepine in patients exhibiting cutaneous adverse drug reactions. This favorable outcome should encourage the implementation of desensitization in patients presenting with hypersensitivity to oxcarbazepine as an alternative strategy in clinical practice. PMID:27730770

Safety evaluation report related to the full-term operating license for San Onofre Nuclear Generating Station, Unit 1 (Docket No. 50-206)

International Nuclear Information System (INIS)

1991-07-01

The safety evaluation report for the full-term operating license application filed by the Southern California Edison Company and the San Diego Gas and Electric Company has been prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission. The facility is located in San Diego County, California. The staff has evaluated the issues related to the conversion of the provisional operating license to a full-term operating license and concluded that the facility can continue to be operated without endangering the health and safety of the public following the license conversion. 43 refs., 3 figs., 3 tabs

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

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)

Interim long-term surveillance plan for the Cheney disposal site near, Grand Junction, Colorado

International Nuclear Information System (INIS)

1997-08-01

This interim long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Cheney Disposal Site in Mesa County near Grand Junction, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Cheney disposal site performs as designed and is cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP

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)

Evaluation of methods and tools to develop safety concepts and to demonstrate safety for an HLW repository in salt. Final report

Energy Technology Data Exchange (ETDEWEB)

Bollingerfehr, W.; Buhmann, D.; Doerr, S.; and others

2017-03-15

Salt formations have been the preferred option as host rocks for the disposal of high level radioactive waste in Germany for more than 40 years. During this period comprehensive geological investigations have been carried out together with a broad spectrum of concept and safety related R and D work. The behaviour of an HLW repository in salt formations, particularly in salt domes, has been analysed in terms of assessment of the total system performance. This was first carried out for concepts of generic waste repositories in salt and, since 1998, for a repository concept with specific boundary conditions, taking the geology of the Gorleben salt dome as an example. Suitable repository concepts and designs were developed, the technical feasibility has been proven and operational and long-term safety evaluated. Numerical modelling is an important input into the development of a comprehensive safety case for a waste repository. Significant progress in the development of numerical tools and their application for long-term safe ty assessment has been made in the last two decades. An integrated approach has been used in which the repository concept and relevant scientific and engineering data are combined with the results from iterative safety assessments to increase the clarity and the traceability of the evaluation. A safety concept that takes full credit of the favourable properties of salt formations was developed in the course of the R and D project ISIBEL, which started in 2005. This concept is based on the safe containment of radioactive waste in a specific part of the host rock formation, termed the containment providing rock zone, which comprises the geological barrier, the geotechnical barriers and the compacted backfill. The future evolution of the repository system will be analysed using a catalogue of Features, Events and Processes (FEP), scenario development and numerical analysis, all of which are adapted to suit the safety concept. Key elements of the

Evaluation of methods and tools to develop safety concepts and to demonstrate safety for an HLW repository in salt. Final report

International Nuclear Information System (INIS)

Bollingerfehr, W.; Buhmann, D.; Doerr, S.

2017-03-01

Salt formations have been the preferred option as host rocks for the disposal of high level radioactive waste in Germany for more than 40 years. During this period comprehensive geological investigations have been carried out together with a broad spectrum of concept and safety related R and D work. The behaviour of an HLW repository in salt formations, particularly in salt domes, has been analysed in terms of assessment of the total system performance. This was first carried out for concepts of generic waste repositories in salt and, since 1998, for a repository concept with specific boundary conditions, taking the geology of the Gorleben salt dome as an example. Suitable repository concepts and designs were developed, the technical feasibility has been proven and operational and long-term safety evaluated. Numerical modelling is an important input into the development of a comprehensive safety case for a waste repository. Significant progress in the development of numerical tools and their application for long-term safe ty assessment has been made in the last two decades. An integrated approach has been used in which the repository concept and relevant scientific and engineering data are combined with the results from iterative safety assessments to increase the clarity and the traceability of the evaluation. A safety concept that takes full credit of the favourable properties of salt formations was developed in the course of the R and D project ISIBEL, which started in 2005. This concept is based on the safe containment of radioactive waste in a specific part of the host rock formation, termed the containment providing rock zone, which comprises the geological barrier, the geotechnical barriers and the compacted backfill. The future evolution of the repository system will be analysed using a catalogue of Features, Events and Processes (FEP), scenario development and numerical analysis, all of which are adapted to suit the safety concept. Key elements of the

Non-intrusive long-term monitoring approaches

International Nuclear Information System (INIS)

Smathers, D.; Mangan, D.

1998-01-01

In order to promote internatinal confidence that the US and Russia are disarming per their commitments under Article 6 of the Non-Proliferation Treaty, an international verification regime may be applied to US and Russian excess fissile materials. Initially, it is envisioned that this verification regime would be applied at storage facilities; however, it should be anticipated that the verification regime would continue throughout any material disposition activities, should such activities be pursued. once the materials are accepted into the verification regime, it is assumed that long term monitoring will be used to maintain continuity of knowledge. The requirements for long term storage monitoring include unattended operation for extended periods of time, minimal intrusiveness on the host nation's safety and security activities, data collection incorporating data authentication, and monitoring redundancy to allow resolution of anomalies and to continue coverage in the event of equipment failures. Additional requirements include effective data review and analysis processes, operation during storage facility loading, procedure for removal of inventory items for safety-related surveillance, and low cost, reliable equipment. A monitoring system might include both continuous monitoring of storagecontainers and continuous area monitoring. These would be complemented with periodic on-site inspections. A fissile material storage facility is not a static operation. The initial studies have shown there are a number of valid reasons why a host nation may need them to remove material from the storage facility. A practical monitoring system must be able to accommodate necessary material movements

Long-term use of adalimumab in the treatment of rheumatic diseases

Directory of Open Access Journals (Sweden)

Charalampos Papagoras

2009-05-01

Full Text Available Charalampos Papagoras, Paraskevi V Voulgari, Alexandros A DrososRheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, GreeceAbstract: Adalimumab, a fully humanized monoclonal antibody against tumor necrosis factor-alpha (TNFα, has been evaluated in various randomized placebo-controlled trials in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. In the short time frame of these trials adalimumab has been shown to be effective in reducing disease activity, slowing radiographic disease progression and improving patients’ quality of life, while at the same time demonstrating an acceptable safety profile. Furthermore, release of adalimumab on the market, prospective observational studies, as well as open-label extensions of the original double-blind trials have provided experience and data about the long-term efficacy and safety of the drug. Initial effectiveness, in terms of reducing disease activity, is sustained, while in most cases patients treated with adalimumab experienced a slower radiographic progression and consequently less disability and improved health-related quality-of-life outcomes. Moreover, long-standing treatment of thousands of patients with adalimumab outside the controlled context of clinical trials was not related to new safety signals, with the most common adverse events being respiratory infections. The most common serious adverse events seem to be tuberculosis reactivation, while a putative association with malignant lymphoma development is not yet proven. Besides, both of these adverse reactions pertain to the whole TNFα blocker group. In conclusion, adalimumab is a safe and effective option for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. Keywords: adalimumab, tumor necrosis factor-alpha, rheumatoid arthritis, ankylosing spondylitis

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/

Long-term surveillance plan for the Burro Canyon disposal cell Slick Rock, Colorado

International Nuclear Information System (INIS)

1997-08-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Burro Canyon disposal cell in San Miguel County, Colorado. This LSTP describes the long-term surveillance program the DOE will implement to ensure the Burro Canyon disposal cell performs as designed and is cared for in a manner that protects the public health and safety and the environment. The program is based on site inspections to identify threats to disposal cell integrity. Before each disposal cell is licensed for custody and long-term care, the Nuclear Regulatory Commission (NRC) requires the DOE to submit such a site-specific LTSP

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.)

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)

The geoforecasting approach and long-term prediction of evolutive nuclide migration

International Nuclear Information System (INIS)

Peaudecerf, P.; D'Alessandro, M.; Canceill, M.; Fourniquet, J.; Godefroy, P.

1985-01-01

Safety analysis of long-lived radioactive waste repositories is dependent on natural site evolution scenarios. This is a complex problem given that there may be a large number of interdependent factors whose occurrence probability is usually very difficult to quantify. A major methodological effort has therefore been undertaken in this field under the terms of the Community's R and D programme. Research teams from the JRC and the BRGM tackled the problems by way of two complementary approaches; A critical analysis of existing methods was also undertaken at the request of the Commission. This paper sets out to summarize the work and, as far as possible, make a methodological evaluation

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...

Long-Term Retardation of Uranium in the KURT Environment

International Nuclear Information System (INIS)

Baik, Min Hoon; Shin, Joo Do; Park, Tae Jin

2016-01-01

One of possibilities resolving this issue is to study the migration and retardation processes of radionuclides in the subsurface environments by using naturally occurring radionuclides as analogues of radioactive waste. To date, however, the long-term behavior of radionuclides in a granitic groundwater system is not yet fully understood. The ubiquitous presence of uranium (U) in rocks makes it an ideal natural analogue for studying the behaviors of radionuclides in a deep geological repository for the final disposal of HLW. In this study, long-term retardation behavior of natural uranium was investigated using granite rock samples taken from the KURT (KAERI Underground Research Tunnel), located in Daejeon city. The distribution of uranium and its binding mechanism in granite samples were investigated using the sequential chemical extraction (SCE) technique combined with X-ray diffraction (XRD) and ICP-MS methods. In this study, the long-term retardation of uranium in the KURT environment was investigated using SCE and EPMA techniques combined with ICP-MS and XRD. Results showed that long-term interaction of rock with groundwater can change U species and mineralize dissolved U, which can consequently contribute to the retardation of U in the fractured granitic rock environment. This study will help us to understand the long-term behavior of radionuclides migrating through the fractured granite rock and then enhance the reliability of the safety assessment for a HLW repository

Space ventures and society long-term perspectives

Science.gov (United States)

Brown, W. M.

1985-01-01

A futuristic evaluation of mankind's potential long term future in space is presented. Progress in space will not be inhibited by shortages of the Earth's physical resources, since long term economic growth will be focused on ways to constrain industrial productivity by changing social values, management styles, or government competence. Future technological progress is likely to accelerate with an emphasis on international cooperation, making possible such large joint projects as lunar colonies or space stations on Mars. The long term future in space looks exceedingly bright even in relatively pessimistic scenarios. The principal driving forces will be technological progress, commercial and public-oriented satellites, space industrialization, space travel, and eventually space colonization.

Inflammatory markers in relation to long-term air pollution

NARCIS (Netherlands)

Mostafavi Montazeri, Nahid|info:eu-repo/dai/nl/375290575; Vlaanderen, Jelle|info:eu-repo/dai/nl/31403160X; Chadeau-Hyam, Marc; Beelen, Rob|info:eu-repo/dai/nl/30483100X; Modig, Lars; Palli, Domenico; Bergdahl, Ingvar A; Vineis, Paolo; Hoek, Gerard|info:eu-repo/dai/nl/069553475; Kyrtopoulos, Soterios Α; Vermeulen, Roel|info:eu-repo/dai/nl/216532620

Long-term exposure to ambient air pollution can lead to chronic health effects such as cancer, cardiovascular and respiratory disease. Systemic inflammation has been hypothesized as a putative biological mechanism contributing to these adverse health effects. We evaluated the effect of long-term

Application of a Long Term Asset Management Strategy for HP Feedwater Heaters

International Nuclear Information System (INIS)

Won, Se Youl; Yun, Eun Sub; Park, Young Sheop

2008-01-01

As the commercial operating year of nuclear power plants is increased, it becomes imperative to develop integrated cost-effective asset management and to improve plans for degraded Structures, Systems, and Components (SSCs) in terms of safety and economical consideration. A long-term asset management (LTAM) strategy can improve the condition of nuclear plants, maximize their value, and optimize their operational life by maintaining their safety. This paper presents an optimized LTAM plan for HP feedwater heaters at a specific nuclear power plant

Audit of long-term and short-term liabilities

Directory of Open Access Journals (Sweden)

Korinko M.D.

2017-03-01

Full Text Available The article determines the importance of long-term and short-term liabilities for the management of financial and material resources of an enterprise. It reviews the aim, objects and information generators for realization of audit of short-term and long-term obligations. The organizing and methodical providing of audit of long-term and short-term liabilities of an enterprise are generalized. The authors distinguish the stages of realization of audit of long-term and short-term liabilities, the aim of audit on each of the presented stages, and recommend methodical techniques. It is fixed that it is necessary to conduct the estimation of the systems of internal control and record-keeping of an enterprise by implementation of public accountant procedures for determination of volume and maintenance of selection realization. After estimating the indicated systems, a public accountant determines the methodology for realization of public accountant verification of long-term and short-term liabilities. The analytical procedures that public accountants are expedient to use for realization of audit of short-term and long-term obligations are determined. The authors suggest the classification of the educed defects on the results of the conducted public accountant verification of short-term and long-term obligations.

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)

Evaluation of Safety Culture Implementation and Socialization Results

International Nuclear Information System (INIS)

Situmorang, Johnny

2003-01-01

Evaluation of safety culture implementation and socialization results has been perform. Evaluation is carried out with specifying safety culture indicators, namely: Meeting between management and employee, system for incidents analysis, training activities related to improving safety, meeting with regulator, contractors, surveys on behavioural attitudes, and resources allocated to promote safety culture. Evaluation is based on observation and visiting the facilities to show the compliance indicator in term of good practices in the frame of safety culture implementation. For three facilities of research reactors, Kartini Yogyakarta, TRIGA Mark II Bandung and MPR-GAS Serpong, implementation of safety culture is considered good enough and progressive. Furthermore some indicator should be considered more intensive, for example the allocated resources, self assesment based on own questionnaire in the frame of improving the safety culture implementation. (author)

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-...

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

Long-term safety and efficacy of a novel once-weekly oral trelagliptin as monotherapy or in combination with an existing oral antidiabetic drug in patients with type 2 diabetes mellitus: A 52-week open-label, phase 3 study.

Science.gov (United States)

Inagaki, Nobuya; Sano, Hiroki; Seki, Yoshifumi; Kuroda, Shingo; Kaku, Kohei

2016-09-01

Trelagliptin is a novel once-weekly oral dipeptidyl peptidase-4 inhibitor for type 2 diabetes mellitus that was first approved in Japan. We evaluated long-term safety and efficacy of trelagliptin in Japanese patients with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label study to evaluate long-term safety and efficacy of trelagliptin. Patients with type 2 diabetes mellitus inadequately controlled despite diet/exercise or treatment with one of the existing oral antidiabetic drugs along with diet/exercise received trelagliptin 100 mg orally once weekly for 52 weeks as monotherapy or combination therapies. The primary end-points were the safety variables, and the secondary end-points were glycosylated hemoglobin and fasting plasma glucose. A total of 680 patients received the following antidiabetic therapies: trelagliptin monotherapy (n = 248), combination with a sulfonylurea (n = 158), a glinide (n = 67), an α-glucosidase inhibitor (n = 65), a biguanide (n = 70), or a thiazolidinedione (n = 72). During the study, 79.8% of the patients experienced at least one adverse event for monotherapy, 87.3% for combination with a sulfonylurea, 77.6% for a glinide, 81.5% for an α-glucosidase inhibitor, 64.3% for a biguanide, and 84.7% for a thiazolidinedione, respectively. Most of the adverse events were mild or moderate. The change in glycosylated hemoglobin from baseline at the end of the treatment period was -0.74 to -0.25% for each therapy. Once-weekly oral trelagliptin provides well-tolerated long-term safety and efficacy in both monotherapy and combination therapies in Japanese patients with type 2 diabetes mellitus. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Short and long term maintenance strategy for reactor vessel head penetrations

International Nuclear Information System (INIS)

Teissier, A.; Heuze, A.

1995-01-01

This paper presents elements based on : surveys, operating inspection, theoretical studies, safety analysis, laboratory results, that enabled to determine maintenance options and short and long term strategies for processing on reactor vessel head leaks. (TEC). 1 tab

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.

China's current status and long-term outlook of nuclear power and radioactive waste disposal management

International Nuclear Information System (INIS)

Li, Zhidong

2015-01-01

This study identified the current status and long-term outlook of China's nuclear power development and radioactive waste disposal management after the 3.11 FUKUSHIMA accidents. China strengthened the actions for achieving nuclear power safety and cost efficiency as well as safety management of radioactive waste. It is a hard work to expand the capacity to 58 GW, the governmental target in 2020. The long-term development will strongly depend on the progress in safety management of nuclear power and radioactive waste and economic competitiveness. (author)

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)

Safety related terms for advanced nuclear plants

International Nuclear Information System (INIS)

1995-12-01

The terms considered in this document are in widespread current use without a universal consensus as to their meaning. Other safety related terms are already defined in national or international codes and standards as well as in IAEA's Nuclear Safety Standards Series. Most of the terms in those codes and standards have been defined and used for regulatory purposes, generally for application to present reactor designs. There is no intention to duplicate the description of such regulatory terms here, but only to clarify the terms used for advanced nuclear plants. The following terms are described in this paper: Inherent safety characteristics, passive component, active component, passive systems, active system, fail-safe, grace period, foolproof, fault-/error-tolerant, simplified safety system, transparent safety

Safety related terms for advanced nuclear plants

International Nuclear Information System (INIS)

1991-09-01

The terms considered in this document are in widespread current use without a universal consensus as to their meaning. Other safety related terms are already defined in national or international codes and standards as well as in IAEA's Nuclear Safety Standards Series. Most of the terms in those codes and standards have been defined and used for regulatory purposes, generally for application to present reactor designs. There is no intention to duplicate the description of such regulatory terms here, but only to clarify the terms used for advanced nuclear plants. The following terms are described in this paper: Inherent safety characteristics, passive component, active component, passive systems, active system, fail-safe, grace period, foolproof, fault-/error-tolerant, simplified safety system, transparent safety

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

Long-term care financing through Federal tax incentives.

Science.gov (United States)

Moran, D W; Weingart, J M

1988-12-01

Congress and the Administration are currently exploring various methods of promoting access to long-term care. In this article, an inventory of recent legislative proposals for using the Federal tax code to expand access to long-term care services is provided. Proposals are arrayed along a functional typology that includes tax mechanisms to encourage accumulation of funds, promote purchase of long-term care insurance, or induce the diversion of funds accumulated for another purpose (such as individual retirement accounts). The proposals are evaluated against the public policy objective of encouraging risk pooling to minimize social cost.

The challenges facing the long term interim storage

Energy Technology Data Exchange (ETDEWEB)

Iracane, D. [CEA Sacaly, Dir. de la Simulation et des Outils Experimentaux-DSOE, 91 - Gif sur Yvette (France); Marvy, A. [CEA Saclay, Dir. du Developpement et de l' Innovation Nucleares-DDIN, 91 - Gif Sur Yvette (France)

2001-07-01

In France electricity generation by means of commercial nuclear power plants has come to a point where it contributes to the national demand at a level of 80%. The safety performance of the production system has also reached a high level of both maturity and reliability taking advantage of the cumulative effect of a 30 years long learning experience and ever more stringent safety requirements. The policy to reprocess spent fuel has been overriding but no final decision has yet been made regarding the ultimate disposition of the waste streams. Although studies on deep geological disposal are ongoing, France is also looking at whether and under which conditions a long-term interim storage may provide an effective flexibility to the fuel cycle back-end. We discuss thereafter the needs and the paramount objectives of this latter R and D program. Results are being framed as potential guiding criteria for decision makers and various stakeholders. In first part, we propose a general analysis which emphasises that a long term interim storage is more than a classical nuclear facility because it explicitly requires long-lasting control and creates a burden for Society during many generations. Then, in second part, we offer an overview of the technical results from the R and D program as they stand at the time of writing. As an answer to the Government request, a strong emphasis has been put on this research for three years. Conclusion is an attempt to outline the societal context in which future decisions will have to be made. (author)

The challenges facing the long term interim storage

International Nuclear Information System (INIS)

Iracane, D.; Marvy, A.

2001-01-01

In France electricity generation by means of commercial nuclear power plants has come to a point where it contributes to the national demand at a level of 80%. The safety performance of the production system has also reached a high level of both maturity and reliability taking advantage of the cumulative effect of a 30 years long learning experience and ever more stringent safety requirements. The policy to reprocess spent fuel has been overriding but no final decision has yet been made regarding the ultimate disposition of the waste streams. Although studies on deep geological disposal are ongoing, France is also looking at whether and under which conditions a long-term interim storage may provide an effective flexibility to the fuel cycle back-end. We discuss thereafter the needs and the paramount objectives of this latter R and D program. Results are being framed as potential guiding criteria for decision makers and various stakeholders. In first part, we propose a general analysis which emphasises that a long term interim storage is more than a classical nuclear facility because it explicitly requires long-lasting control and creates a burden for Society during many generations. Then, in second part, we offer an overview of the technical results from the R and D program as they stand at the time of writing. As an answer to the Government request, a strong emphasis has been put on this research for three years. Conclusion is an attempt to outline the societal context in which future decisions will have to be made. (author)

The approaches of safety design and safety evaluation at HTTR (High Temperature Engineering Test Reactor)

International Nuclear Information System (INIS)

Iigaki, Kazuhiko; Saikusa, Akio; Sawahata, Hiroaki; Shinozaki, Masayuki; Tochio, Daisuke; Honma, Fumitaka; Tachibana, Yukio; Iyoku, Tatsuo; Kawasaki, Kozo; Baba, Osamu

2006-06-01

Gas Cooled Reactor has long history of nuclear development, and High Temperature Gas Cooled Reactor (HTGR) has been expected that it can be supply high temperature energy to chemical industry and to power generation from the points of view of the safety, the efficiency, the environment and the economy. The HTGR design is tried to installed passive safety equipment. The current licensing review guideline was made for a Low Water Reactor (LWR) on safety evaluation therefore if it would be directly utilized in the HTGR it needs the special consideration for the HTGR. This paper describes that investigation result of the safety design and the safety evaluation traditions for the HTGR, comparison the safety design and safety evaluation feature for the HTGT with it's the LWR, and reflection for next HTGR based on HTTR operational experiment. (author)

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

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.)

Long-term follow-up study and long-term care of childhood cancer survivors

Directory of Open Access Journals (Sweden)

Hyeon Jin Park

2010-04-01

Full Text Available The number of long-term survivors is increasing in the western countries due to remarkable improvements in the treatment of childhood cancer. The long-term complications of childhood cancer survivors in these countries were brought to light by the childhood cancer survivor studies. In Korea, the 5-year survival rate of childhood cancer patients is approaching 70%; therefore, it is extremely important to undertake similar long-term follow-up studies and comprehensive long-term care for our population. On the basis of the experiences of childhood cancer survivorship care of the western countries and the current Korean status of childhood cancer survivors, long-term follow-up study and long-term care systems need to be established in Korea in the near future. This system might contribute to the improvement of the quality of life of childhood cancer survivors through effective intervention strategies.

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

Long-term storage or disposal of HLW-dilemma

International Nuclear Information System (INIS)

Ninkovic, M. M.; Raicevic, J.

1995-01-01

In this paper, a new concept approach to HLW management founded on deterministic safety philosophy - i.e. long-term storage with final objective of destroying was justified and proposed instead of multi barrier concept with final disposal in extra stable environmental conditions, which are founded on probabilistic safety approach model. As a support to this new concept some methods for destruction of waste which are now accessible, on scientific stage only, as transmutation in fast reactors and accelerators of heavy ions were briefly discussed . It is justified to believe that industrial technology for destruction of HLW would be developed in not so far future. (author).

Musical and Verbal Memory in Alzheimer's Disease: A Study of Long-Term and Short-Term Memory

Science.gov (United States)

Menard, Marie-Claude; Belleville, Sylvie

2009-01-01

Musical memory was tested in Alzheimer patients and in healthy older adults using long-term and short-term memory tasks. Long-term memory (LTM) was tested with a recognition procedure using unfamiliar melodies. Short-term memory (STM) was evaluated with same/different judgment tasks on short series of notes. Musical memory was compared to verbal…

Experimental Researches on Long-Term Strength of Granite Gneiss

Directory of Open Access Journals (Sweden)

Lin Liu

2015-01-01

Full Text Available It is important to confirm the long-term strength of rock materials for the purpose of evaluating the long-term stability of rock engineering. In this study, a series of triaxial creep tests were conducted on granite gneiss under different pore pressures. Based on the test data, we proposed two new quantitative methods, tangent method and intersection method, to confirm the long-term strength of rock. Meanwhile, the isochronous stress-strain curve method was adopted to make sure of the accuracy and operability of the two new methods. It is concluded that the new methods are suitable for the study of the long-term strength of rock. The effect of pore pressure on the long-term strength of rock in triaxial creep tests is also discussed.

PEBS. Long-term performance of engineered barrier systems

Energy Technology Data Exchange (ETDEWEB)

Wieczorek, Klaus; Czaikowski, Oliver; Miehe, Ruediger

2014-12-15

The evolution of the engineered barrier system (EBS) of geological repositories for radioactive waste has been the subject of many national and international research programmes. The emphasis of the research activities was on the elaboration of a detailed understanding of the complex THMC processes, which are expected to evolve in the early post closure period in the near field. From the perspective of radiological long-term safety, an in-depth understanding of these coupled processes is of great significance, because the evolution of the EBS during the early post-closure phase may have a non-negligible impact on the radiological safety functions at the time when the canisters breach. Unexpected process interactions during the resaturation phase could impair the safety-relevant parameters in the EBS (e. g. swelling pressure, hydraulic conductivity, diffusivity).

Long-term complications in Hodgkin's lymphoma survivors.

Science.gov (United States)

Kilickap, Saadettin; Barista, Ibrahim; Ulger, Sukran; Celik, Ismail; Selek, Ugur; Güllü, Ibrahim; Yildiz, Ferah; Kars, Ayse; Ozisik, Yavuz; Tekuzman, Gülten

2012-01-01

Background. Although patients with Hodgkin's lymphoma (HL) achieve prolonged survival, long-term complications are a major cause of morbidity and mortality among long-term survivors of HL. Methods. We retrospectively evaluated long-term complications in 336 HL survivors treated between January 1990 and January 2006 at the Department of Medical Oncology of the Hacettepe University Institute of Oncology who were >16 years old at presentation. All patients were regularly followed up every 3 months for the first 2 years after complete response, biannually for 3 years, and annually after 5 years. Results. Median follow-up was 8.5 years. The mean age (±SD) of the patients at the time of diagnosis was 35.7 ± 13.1 years. The male to female ratio was 61%/39%. During follow-up, 29 second malignancies (8.6%) were diagnosed in 28 patients with HL; 22 were solid tumors and 7 were hematological malignancies. Forty-seven (14.0%) of all patients with HL were found to have thyroid abnormalities. During follow-up, 54 (16.1%) patients developed cardiovascular complications. Overall, 29 (8.6%) patients developed late pulmonary toxicities. The cumulative number of chronic viral infections was 13 (3.9%). Conclusions. Long-term survivors of HL need to be properly followed up not only for disease control but also for evaluation of possible late morbidities to minimize the consequences.

Mechanistic facility safety and source term analysis

International Nuclear Information System (INIS)

PLYS, M.G.

1999-01-01

A PC-based computer program was created for facility safety and source term analysis at Hanford The program has been successfully applied to mechanistic prediction of source terms from chemical reactions in underground storage tanks, hydrogen combustion in double contained receiver tanks, and proccss evaluation including the potential for runaway reactions in spent nuclear fuel processing. Model features include user-defined facility room, flow path geometry, and heat conductors, user-defined non-ideal vapor and aerosol species, pressure- and density-driven gas flows, aerosol transport and deposition, and structure to accommodate facility-specific source terms. Example applications are presented here

Probabilistic safety assessment for a generic deep geological repository for high-level waste and long-lived intermediate-level waste in clay

International Nuclear Information System (INIS)

Resele, G.; Holocher, J.; Mayer, G.; Hubschwerlen, N.; Niemeyer, M.; Beushausen, M.; Wollrath, J.

2010-01-01

Document available in extended abstract form only. In the selection procedure for the search of a final site location for the disposal of radioactive wastes, the comparison and evaluation of different potentially suitable repository systems in different types of host rocks will be an essential and crucial step. Since internationally accepted guidelines on how to perform such quantitative comparisons between repository systems with regard to their long-term safety behaviour are still lacking, in 2007 the German Federal Office for Radiation Protection launched the project 'VerSi' (Vergleichende Sicherheitsanalysen - Comparing Safety Assessments) that aims at the development of a methodology for the comparison of long-term safety assessments. A vital part of the VerSi project is the performance of long-term safety assessments for the comparison of two repository systems. The comparison focuses on a future repository for heat-generating, i.e. high-level and long-lived intermediate-level radioactive wastes in Germany. Rock salt is considered as a potential host rock for such a repository, and one repository system in VerSi is defined similarly to the potential site located in the Gorleben salt dome. Another suitable host rock formation may be clay. A generic location within the lower Cretaceous clays in Northern Germany is therefore chosen for the comparison of safety assessments within the VerSi project. The long-term safety assessment of a repository system for heat-generating radioactive waste at the generic clay location comprises different steps, amongst others: - Identifying the relevant processes in the near-field, in the geosphere and in the biosphere which are relevant for the long-term safety behaviour. - Development of a safety concept for the repository system. - Deduction of scenarios of the long-term evolution of the repository system. - Definition of statistic weights, i. e. the likelihood of occurrence of the scenarios. - Performance of a

The Safety of Melatonin in Humans

DEFF Research Database (Denmark)

Andersen, Lars Peter Holst; Gögenür, Ismayil; Rosenberg, Jacob

2016-01-01

Exogenous melatonin has been investigated as treatment for a number of medical and surgical diseases, demonstrating encouraging results. The aim of this review was to present and evaluate the literature concerning the possible adverse effects and safety of exogenous melatonin in humans. Furthermore...... been reported. No studies have indicated that exogenous melatonin should induce any serious adverse effects. Similarly, randomized clinical studies indicate that long-term melatonin treatment causes only mild adverse effects comparable to placebo. Long-term safety of melatonin in children...

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

Long term mineralogical changes in salt formations due to water and brine interactions

International Nuclear Information System (INIS)

Herbert, H.J.; Brewitz, W.

1996-01-01

Four very common long term mineralogical changes in salt formations are discussed in the view of the safety considerations for underground repositories. Two of these processes, the 'Hartsalz' and 'Carnallite' dissolution were studied in two scale in situ experiments. The results are presented and compared with the results of the geochemical modelling with the computer code EQ3/6. Furthermore the reactions leading to the formation of the gypsum cap rock on the top of the Zechstein salt formations and to the polyhalitization of anhydrite are discussed. Geological field observations and mineral assemblages agree well with the results of the geochemical modelling employing the Pitzer formalism along with the Harvie, Moller and Weare database. We conclude that once the mechanisms of the chemical reactions are well understood it becomes possible to evaluate realistically whether such processes, when encountered in the repository, are still active or whether they are finished. It also becomes possible to estimate the volume changes associated with the reactions and thus the impact of these reactions on the integrity and the geomechanical stability of the salt formation. The intimate knowledge of the reaction mechanisms of the short and long term changes in the mineralogical assemblages and the associated brine chemistry is a first prerequisite for the correct evaluation of the origin of brines. Thus, it is essential for the correct assessment of the hazards which brine inflows may pose for the safety of a repository in salt formations. (authors). 8 refs., 14 figs., 8 tabs

Postoperative CPAP use impacts long-term weight loss following bariatric surgery.

Science.gov (United States)

Collen, Jacob; Lettieri, Christopher J; Eliasson, Arn

2015-03-15

Obstructive sleep apnea (OSA) is common among bariatric surgery candidates. After surgical weight loss, OSA frequently persists and untreated OSA can lead to weight gain. Long-term continuous positive airway pressure (CPAP) adherence is unclear and poor adherence may worsen weight loss outcomes. We sought to determine the impact of CPAP use on long-term weight-loss outcomes in a cohort of bariatric patients. Long-term observational study of bariatric surgery patients with OSA. Patients were evaluated with polysomnography preoperatively and one-year postoperatively. The cohort was again evaluated a mean of 7.2 years later to determine the relationship between long-term CPAP use and subsequent regain of weight. Twenty-four consecutive patients (aged 48.5 ± 9.4 years at time of surgery; 73% female) were included in the initial assessment, and long-term outcome data were available on 22 subjects. Persistent OSA was documented in 21 of 22 subjects (95%) one year postoperatively. Final evaluation occurred 7.2 ± 2.3 years following surgery. Weight (213.3 ± 39.1 to 235.3 ± 47.1 lb, p = 0.10) and BMI (32.5 ± 5.4 to 37.3 ± 8.2 kg/m(2), p = 0.03) increased in most (n = 19, 86.4%) from postoperative to final evaluation. CPAP use declined from 83.3% (preoperatively) to 38.1% (one year) and to 23.8% (final evaluation). BMI increased among those not using CPAP at long-term follow-up compared to those with continued CPAP use (6.8% v -1.8%, p = 0.05). In our cohort of bariatric patients with OSA, long-term adherence to CPAP therapy was poor, and non-adherence was associated with weight gain. Ongoing follow-up of OSA in this population may help to preserve initial achievements after surgical weight loss. © 2014 American Academy of Sleep Medicine.

Treatment options for nonalcoholic steatohepatitis - a safety evaluation.

Science.gov (United States)

Issa, Danny; Wattacheril, Julia; Sanyal, Arun J

2017-08-01

There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis. Expert opinion: Current therapies continue to remain suboptimal. Weight loss is effective but hard to achieve. Traditional and endoscopic bariatric procedures are promising although more randomized trials are needed and the long-term safety remains to be established. Clinical trials have demonstrated the efficacy of several drugs for the treatment of NASH. Of these, there remains some uncertainty about the long-term safety of vitamin E. Pioglitazone is associated with osteopenia, fluid retention and weight gain. Obeticholic acid causes pruritus in a substantial proportion of subjects and elafibranor has been associated with transient rises in creatinine. Several exciting therapies are under development and results of clinical and post-marketing trials will help elucidate their safety.

Long pulsed Nd: YAG laser with inbuilt cool sapphire tip for long term hair reduction on type- IV and V skin: A prospective analysis of 200 patients

Directory of Open Access Journals (Sweden)

Nanda Soni

2010-01-01

Full Text Available Background: Laser hair reduction has become a very popular means to get rid of unwanted hair. Aims: We conducted the current study to evaluate the safety and efficacy of Nd: YAG laser on dark skin. We also evaluated the effect of increasing the gap between sessions on the long term efficacy of hair reduction achieved with long pulsed Nd: YAG laser. Methods: A prospective study was conducted on 200 consecutive female patients who underwent laser hair reduction for unwanted hair over the face, at Kaya skin clinic Delhi, with long pulsed Nd: YAG laser, from May 2006 to May 2009. The gap between sessions was increased from 2 nd session itself. Results were evaluated 6 months after 6 sessions. Also a note was made of worsening of hair growth or any side effects experienced the patient during any of the sessions. Results: A total of 200 female patients (160 skin type IV and 40 skin type V were followed up. Of these, 64 enrolled for lower face, 88 for chin or upper neck and 48 for upper lip. 6 months after 6 sessions, more than 50% improvement was seen in 68.7% of lower face, 89.69% cases of chin and 59% of upper lip cases. None of the patients had any worsening. Conclusions: The current study shows that long pulsed Nd: YAG is a very safe and effective means of hair reduction in skin types IV and V. Adequate fluences and increasing the gap between sessions from the 2 nd session could be the key to achieving long term hair reduction with Nd: YAG laser. Adequate cooling and proper shaving are the key factors determining the safety.

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

A Framework for Estimating Long Term Driver Behavior

Directory of Open Access Journals (Sweden)

Vijay Gadepally

2017-01-01

Full Text Available We present a framework for estimation of long term driver behavior for autonomous vehicles and vehicle safety systems. The Hybrid State System and Hidden Markov Model (HSS+HMM system discussed in this article is capable of describing the hybrid characteristics of driver and vehicle coupling. In our model, driving observations follow a continuous trajectory that can be measured to create continuous state estimates. These continuous state estimates can then be used to estimate the most likely driver state using decision-behavior coupling inherent to the HSS+HMM system. The HSS+HMM system is encompassed in a HSS structure and intersystem connectivity is determined by using signal processing and pattern recognition techniques. The proposed method is suitable for a number of autonomous and vehicle safety scenarios such as estimating intent of other vehicles near intersections or avoiding hazardous driving events such as unexpected lane changes. The long term driver behavior estimation system involves an extended HSS+HMM structure that is capable of including external information in the estimation process. Through the grafting and pruning of metastates, the HSS+HMM system can be dynamically updated to best represent driver choices given external information. Three application examples are also provided to elucidate the theoretical system.

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.

Road network safety evaluation using Bayesian hierarchical joint model.

Science.gov (United States)

Wang, Jie; Huang, Helai

2016-05-01

Safety and efficiency are commonly regarded as two significant performance indicators of transportation systems. In practice, road network planning has focused on road capacity and transport efficiency whereas the safety level of a road network has received little attention in the planning stage. This study develops a Bayesian hierarchical joint model for road network safety evaluation to help planners take traffic safety into account when planning a road network. The proposed model establishes relationships between road network risk and micro-level variables related to road entities and traffic volume, as well as socioeconomic, trip generation and network density variables at macro level which are generally used for long term transportation plans. In addition, network spatial correlation between intersections and their connected road segments is also considered in the model. A road network is elaborately selected in order to compare the proposed hierarchical joint model with a previous joint model and a negative binomial model. According to the results of the model comparison, the hierarchical joint model outperforms the joint model and negative binomial model in terms of the goodness-of-fit and predictive performance, which indicates the reasonableness of considering the hierarchical data structure in crash prediction and analysis. Moreover, both random effects at the TAZ level and the spatial correlation between intersections and their adjacent segments are found to be significant, supporting the employment of the hierarchical joint model as an alternative in road-network-level safety modeling as well. Copyright © 2016 Elsevier Ltd. All rights reserved.

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)

Transuranic waste: long-term planning

International Nuclear Information System (INIS)

Young, K.C.

1985-07-01

Societal concerns for the safe handling and disposal of toxic waste are behind many of the regulations and the control measures in effect today. Transuranic waste, a specific category of toxic (radioactive) waste, serves as a good example of how regulations and controls impact changes in waste processing - and vice versa. As problems would arise with waste processing, changes would be instituted. These changes improved techniques for handling and disposal of transuranic waste, reduced the risk of breached containment, and were usually linked with regulatory changes. Today, however, we face a greater public awareness of and concern for toxic waste control; thus, we must anticipate potential problems and work on resolving them before they can become real problems. System safety analyses are valuable aids in long-term planning for operations involving transuranic as well as other toxic materials. Examples of specific system safety analytical methods demonstrate how problems can be anticipated and resolution initiated in a timely manner having minimal impacts upon allocation of resource and operational goals. 7 refs., 1 fig

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)

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.

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

Long-term clinical evaluation of a 800-nm long-pulsed diode laser with a large spot size and vacuum-assisted suction for hair removal.

Science.gov (United States)

Ibrahimi, Omar A; Kilmer, Suzanne L

2012-06-01

The long-pulsed diode (800-810-nm) laser is one of the most commonly used and effective lasers for hair removal. Limitations of currently available devices include a small treatment spot size, treatment-associated pain, and the need for skin cooling. To evaluate the long-term hair reduction capabilities of a long-pulsed diode laser with a large spot size and vacuum assisted suction. Thirty-five subjects were enrolled in a prospective, self-controlled, single-center study of axillary hair removal. The study consisted of three treatments using a long-pulsed diode laser with a large spot size and vacuum-assisted suction at 4- to 6-week intervals with follow-up visits 6 and 15 months after the last treatment. Hair clearance was quantified using macro hair-count photographs taken at baseline and at 6- and 15-month follow-up visits. Changes in hair thickness and color, levels of treatment-associated pain, and adverse events were additional study endpoints. There was statistically significant hair clearance at the 6 (54%) and 15-month (42%) follow-up visits. Remaining hairs were thinner and lighter at the 15-month follow-up visit, and the majority of subjects reported feeling up to mild to moderate pain during treatment without the use of pretreatment anesthesia or skin cooling. A long-pulsed diode laser with a large spot size and vacuum-assisted suction is safe and effective for long-term hair removal. This is the largest prospective study to evaluate long-term hair removal and the first to quantify decreases in hair thickness and darkness with treatment. © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

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.

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

Long-term surveillance plan for the Maybell, Colorado Disposal Site

International Nuclear Information System (INIS)

1997-09-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Maybell disposal site in Moffat County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites are cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Maybell disposal site. The general license becomes effective when the NRC concurs with the DOE's determination that remedial action is complete for the Maybell site and the NRC formally accepts this LTSP. This document describes the long-term surveillance program the DOE will implement to ensure the Maybell disposal site performs as designed. The program is based on site inspections to identify threats to disposal cell integrity. The LTSP is based on the UMTRA Project long-term surveillance program guidance document and meets the requirements of 10 CFR section 40.27(b) and 40 CFR section 192.03

Peripheral arteriovenous fistula as vascular access for long-term chemotherapy.

Science.gov (United States)

Kovalyov, Oleksiy O; Kostyuk, Oleksandr G; Tkachuk, Tetyana V

To provide long-term vascular access in clinical oncology peripheral forearm veins (up to 95% of patients in Ukraine), central venous access and "complete implanted vascular systems" are used most often. Many oncology patients have contraindications to catheterization of superior vena cava. Besides, exploitation of central veins is associated with potential technical and infectious complications. The aim - to study short-term and long-term results of arteriovenous fistula exploitation as vascular access for continuous anticancer therapy. Peripheral venous bed status in 41 oncology patients taking long-term chemotherapy treatment is analyzed in the article. Doppler sonography, morphologic and immune histochemical analyses were used in the study. Doppler sonography found qualitative and quantitative changes in forearm veins at different time periods after initiation of chemotherapy in the majority of patients. The major morphologic manifestations of venous wall damage were chemical phlebitis, local or extended hardening of venous wall, venous thrombosis and extravasations with necrosis and subsequent paravasal tissue sclerosis. Alternative vascular access created in 12 patients completely met the adequacy criteria (safety, multiple use, longevity, realization of the designed therapy program). The conclusion was made about inapplicability of forearm veins for long-term administration of cytostatic agents. If it is impossible to use central veins, arteriovenous fistula can become an alternative vascular access.

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)

[Long-term psychiatric hospitalizations].

Science.gov (United States)

Plancke, L; Amariei, A

2017-02-01

Long-term hospitalizations in psychiatry raise the question of desocialisation of the patients and the inherent costs. Individual indicators were extracted from a medical administrative database containing full-time psychiatric hospitalizations for the period 2011-2013 of people over 16 years old living in the French region of Nord-Pas-de-Calais. We calculated the proportion of people who had experienced a hospitalization with a duration of 292 days or more during the study period. A bivariate analysis was conducted, then ecological data (level of health-care offer, the deprivation index and the size of the municipalities of residence) were included into a multilevel regression model in order to identify the factors significantly related to variability of long-term hospitalization rates. Among hospitalized individuals in psychiatry, 2.6% had had at least one hospitalization of 292 days or more during the observation period; the number of days in long-term hospitalization represented 22.5% of the total of days of full-time hospitalization in psychiatry. The bivariate analysis revealed that seniority in the psychiatric system was strongly correlated with long hospitalization rates. In the multivariate analysis, the individual indicators the most related to an increased risk of long-term hospitalization were: total lack of autonomy (OR=9.0; 95% CI: 6.7-12.2; P<001); diagnoses of psychological development disorders (OR=9.7; CI95%: 4.5-20.6; P<.001); mental retardation (OR=4.5; CI95%: 2.5-8.2; P<.001): schizophrenia (OR=3.0; CI95%: 1.7-5.2; P<.001); compulsory hospitalization (OR=1.7; CI95%: 1.4-2.1; P<.001); having experienced therapeutic isolation (OR=1.8; CI95%: 1.5-2.1; P<.001). Variations of long-term hospitalization rates depending on the type of establishment were very high, but the density of hospital beds or intensity of ambulatory activity services were not significantly linked to long-term hospitalization. The inhabitants of small urban units had

TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals

NARCIS (Netherlands)

Reynes, Jacques; Arastéh, Keikawus; Clotet, Bonaventura; Cohen, Calvin; Cooper, David A.; Delfraissy, Jean-François; Eron, Joseph J.; Henry, Keith; Katlama, Christine; Kuritzkes, Daniel R.; Lalezari, Jacob P.; Lange, Joep; Lazzarin, Adriano; Montaner, Julio S. G.; Nelson, Mark; O' Hearn, Mary; Stellbrink, Hans-Jürgen; Trottier, Benoit; Walmsley, Sharon L.; Buss, Neil E.; DeMasi, Ralph; Chung, Jain; Donatacci, Lucille; Guimaraes, Denise; Rowell, Lucy; Valentine, Adeline; Wilkinson, Martin; Salgo, Miklos P.

2007-01-01

The additional 48-week optional treatment extension of the T-20 versus Optimized Regimen Only (TORO) studies evaluated long-term safety and efficacy of enfuvirtide (ENF) through week 96 in patients receiving ENF plus optimized background (OB) and patients switching to ENF plus OB from OB alone.

Periodic safety review of the experimental fast reactor JOYO. Review of aging management

International Nuclear Information System (INIS)

Isozaki, Kazunori; Ogawa, To-ru; Nishino, Kazunari

2005-05-01

Periodic safety review (Review of the aging management) which consisted of ''Technical review on aging for the safety related structures, systems and components'' and ''Establishment a long term maintenance program'' was carried out up to April 2005. 1. Technical review on aging for the safety related structures, systems and components. It was technically confirmed to prevent the loss of function of the safety related structures, systems and components due to aging phenomena, which (1) irradiation damage, (2) corrosion, (3) abrasion and erosion, (4) thermal aging, (5) creep and fatigue, (6) Stress Corrosion Cracking, (7) insulation deterioration and (8) general deterioration, under the periodic monitoring or renewal of them. 2. Establishment of long term maintenance program. The long term maintenance during JFY2005 to 2014 were established based on the technical review on aging for the safety related structures, systems and components. It was evaluated that the inspection and renewal based on the long term maintenance program, in addition to the spontaneous inspection of the long term voluntary long-term inspection plan, could prevent the loss of function of the safety related structures, systems and components. (author)

Long-term surveillance plan for the Gunnison, Colorado, disposal site

International Nuclear Information System (INIS)

1996-05-01

This long-term surveillance plan (LTSP) describes the US Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The US Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment.For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE's determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP

A study of the long-term effect of malar fat repositioning in face lift surgery: short-term success but long-term failure.

Science.gov (United States)

Hamra, Sam T

2002-09-01

In 1990, the author reported on a series of 403 cases of deep plane face lifts, the first published technique describing the repositioning of the cheek fat, known as malar fat, in face lift surgery. This study examines the long-term results of 20 of the original series in an attempt to determine what areas of the rejuvenated face (specifically, the malar fat) showed long-term improvement. The results were judged by comparing the preoperative and long-term postoperative views in a half-and-half same-side hemiface photograph. The anatomy of the jawline (superficial musculoaponeurotic system [SMAS]), the nasolabial fold (malar fat), and the periorbital diameter were evaluated. The results confirmed that repositioning of the SMAS remained for longer than improvement in the nasolabial fold and that the vertical diameter of the periorbit did not change at all. The early results of malar fat repositioning shown at 1 to 2 years were successful, but the long-term results showed failure of the early improvement, manifested by recurrence of the nasolabial folds. There was, however, continuation of the improved results of the forehead lift and SMAS maneuvers of the original procedure. The conclusion is that only a direct excision will produce a permanent correction of the aging nasolabial fold.

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…

Long-term effect of urethral dilatation and internal urethrotomy for urethral strictures.

Science.gov (United States)

Veeratterapillay, Rajan; Pickard, Rob S

2012-11-01

Urethral dilatation and direct visual internal urethrotomy (DVIU) are widely used minimally invasive options to manage men with urethral strictures. Advances in open urethroplasty with better long-term cure rates have fuelled the continuing debate as to which treatment is best for primary and recurrent urethral strictures. We reviewed recent literature to identify contemporary practice of urethral dilatation and DVIU and the long-term outcome of these procedures. Systematic literature search for the period January 2010 to December 2011 showed that urethral dilatation and DVIU remain frequently used treatment options as confirmed by surveys of urologists in the USA and the Netherlands. Multiple reports of laser DVIU confirm the safety of this approach but long-term data were lacking. Stricture free rates from urethra dilatation and DVIU vary from 10 to 90% at 12 months, although adjunctive intermittent self-dilatation can reduce time to recurrence. Although quality-of-life benefit appears good in the short term, repeated procedures may harm sexual function in the long-term. Urethral dilatation and DVIU remain widely used in urethral stricture management but high-level comparative evidence of benefit and harms against urethroplasty in the short and long-term is still lacking.

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

The establishment of a method for evaluating the long-term water-tightness durability of underground concrete structure taking into account some deteriorations

International Nuclear Information System (INIS)

Hironaga, Michihiko; Kawanishi, Motoi

1996-01-01

To establish a method of evaluating the long-term water-tightness durability of underground concrete structures, the authors firstly studied a deterioration evaluation model to express the deterioration condition of concrete structures and constructed, on the basis of this model, a function evaluation model to estimate the lowering of functions due to deterioration, consequently indicating a 'concept for evaluating the deterioration and functions of concrete structures' which will make it possible to perform the functional evaluation of concrete structures. Based on this concept, the authors then discusses a technique for evaluating the long-term water-tightness durability of underground concrete structures, specifically indicating the technique by means of illustrations. (author)

[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.

Utilization of control rod drive (CRD) system for long term core cooling

International Nuclear Information System (INIS)

Huerta B, A.

1991-01-01

In this paper we consider an application of Probabilistic Risk Assessment (PRA) to risk management. Foreseeable risk management strategies to prevent core damage are constrained by the availability of first line systems as well as support systems. The actual trend in the evaluation of risk management options can be performed in a number of ways. An example is the identification of back-up systems which could be used to perform the same safety functions. In this work we deal with the evaluation of the feasibility, for BWR's, to use the Control Rod Drive system to maintain an adequate reactor core long term cooling in some accident sequences. This preliminary evaluation is carried out as a part of the Internal Events Analysis for Laguna Verde Nuclear Power Plant (LVNPP) that is currently under way by the Mexican Nuclear Regulatory Body. This analysis addresses the evaluation and incorporation of all the systems, including the safety related and the back-up non safety related systems, that are available for the operator in order to prevent core damage. As a part of this analysis the containment venting capability is also evaluated as a back-up of the containment heat removal function. This will prevent the primary containment overpressurization and loss of certain core cooling systems. A selection of accident sequences in which the Control Rod Drive system could be used to mitigate the accident and prevent core damage are discussed. A personal computer transient analysis code is used to carry out thermohydraulic simulations in order to evaluate the Control Rod Drive system performance, the corresponding results are presented. Finally, some preliminary conclusions are drawn. (author). 9 refs, 5 figs

Long-term behaviour of radioactive nuclides in the environment

International Nuclear Information System (INIS)

Brechignac, F.; Moberg, L.; Suomela, M.

1999-01-01

Report of recent advances in Europe, regarding the long-term development of radioactive nuclides in the environment. The corresponding scientific findings from three projects - Peace, Landscape and Epora (involving 18 European laboratories) - have been collected together. These projects were managed by the IPSN for the European Commission (DG XII) in the framework of the programme 'Surete de la fission nucleaire' (Nuclear fission safety programme). (author)

Long-term potentiation and long-term depression: a clinical perspective

Directory of Open Access Journals (Sweden)

Timothy V.P. Bliss

2011-01-01

Full Text Available Long-term potentiation and long-term depression are enduring changes in synaptic strength, induced by specific patterns of synaptic activity, that have received much attention as cellular models of information storage in the central nervous system. Work in a number of brain regions, from the spinal cord to the cerebral cortex, and in many animal species, ranging from invertebrates to humans, has demonstrated a reliable capacity for chemical synapses to undergo lasting changes in efficacy in response to a variety of induction protocols. In addition to their physiological relevance, long-term potentiation and depression may have important clinical applications. A growing insight into the molecular mechanisms underlying these processes, and technological advances in non-invasive manipulation of brain activity, now puts us at the threshold of harnessing long-term potentiation and depression and other forms of synaptic, cellular and circuit plasticity to manipulate synaptic strength in the human nervous system. Drugs may be used to erase or treat pathological synaptic states and non-invasive stimulation devices may be used to artificially induce synaptic plasticity to ameliorate conditions arising from disrupted synaptic drive. These approaches hold promise for the treatment of a variety of neurological conditions, including neuropathic pain, epilepsy, depression, amblyopia, tinnitus and stroke.

Long-term surveillance plan for the Gunnison, Colorado disposal site. Revision 2

International Nuclear Information System (INIS)

1997-02-01

This long-term surveillance plan (LTSP) describes the US Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The US Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed, the NRC requires the DOE to submit a site-specific LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance

Short-term and long-term effects of GDP on traffic deaths in 18 OECD countries, 1960-2011.

Science.gov (United States)

Dadgar, Iman; Norström, Thor

2017-02-01

Research suggests that increases in gross domestic product (GDP) lead to increases in traffic deaths plausibly due to the increased road traffic induced by an expanding economy. However, there also seems to exist a long-term effect of economic growth that is manifested in improved traffic safety and reduced rates of traffic deaths. Previous studies focus on either the short-term, procyclical effect, or the long-term, protective effect. The aim of the present study is to estimate the short-term and long-term effects jointly in order to assess the net impact of GDP on traffic mortality. We extracted traffic death rates for the period 1960-2011 from the WHO Mortality Database for 18 OECD countries. Data on GDP/capita were obtained from the Maddison Project. We performed error correction modelling to estimate the short-term and long-term effects of GDP on the traffic death rates. The estimates from the error correction modelling for the entire study period suggested that a one-unit increase (US$1000) in GDP/capita yields an instantaneous short-term increase in the traffic death rate by 0.58 (pGDP leads to an immediate increase in traffic deaths. However, after the mid-1970s this short-term effect is more than outweighed by a markedly stronger protective long-term effect, whereas the reverse is true for the period before the mid-1970s. 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/.

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.

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 ).

Strategies to meet the need for long-term data.

Science.gov (United States)

Chalmers, John; Woodward, Mark; Borghi, Claudio; Manolis, Athanasios; Mancia, Giuseppe

2016-08-01

Chronic diseases afflict patients for many years, often to the end of life, and there is increasing need for estimating lifelong risk and for evaluating the effects of treatment in the long term. Yet recommendations for lifelong treatment are most frequently based on findings from randomized clinical trials lasting only a few years. There is therefore a clear need for much longer term data, and here we present the advantages and disadvantages of many strategies, including the use of long-term posttrial follow-up, of long-term prospective cohort studies, registry databases, and of administrative databases. We also emphasize the need for long-term cost-effectiveness studies. One of the most promising strategies comes from linkage of data gathered through the ever-expanding pool of administrative databases worldwide with data from other sources, including randomized trials and the many forms of observational study.

Long-term stability analysis of the left bank abutment slope at Jinping I hydropower station

Directory of Open Access Journals (Sweden)

Long Zhang

2016-06-01

Full Text Available The time-dependent behavior of the left bank abutment slope at Jinping I hydropower station has a major influence on the normal operation and long-term safety of the hydropower station. To solve this problem, a geomechanical model containing various faults and weak structural planes is established, and numerical simulation is conducted under normal water load condition using FLAC3D, incorporating creep model proposed based on thermodynamics with internal state variables theory. The creep deformations of the left bank abutment slope are obtained, and the changes of principal stresses and deformations of the dam body are analyzed. The long-term stability of the left bank abutment slope is evaluated according to the integral curves of energy dissipation rate in domain and its derivative with respect to time, and the non-equilibrium evolution rules and the characteristic time can also be determined using these curves. Numerical results show that the left bank abutment slope tends to be stable in a global sense, and the stress concentration is released. It is also indicated that more attention should be paid to some weak regions within the slope in the long-term deformation process.

Assessment of long-term creep strength of grade 91 steel

Energy Technology Data Exchange (ETDEWEB)

Kimura, Kazuhiro; Sawada, Kota; Kushima, Hideaki [National Inst. for Materials Science, Tsukuba, Ibaraki (Japan)

2010-07-01

In 2004 and 2005 long-term creep rupture strength of ASME Grade 91 type steels of plate, pipe, forging and tube materials was evaluated in Japan by means of region splitting analysis method in consideration of 50% of 0.2% offset yield stress. According to the evaluated 100,000h creep rupture strength of 94MPa for plate, pipe and forging steels and 92MPa for tube steel at 600 C, allowable tensile stress of the steels regulated in the Interpretation for the Technical Standard for Thermal Power Plant was slightly reduced. New creep rupture data of the steels obtained in the long-term indicate further reduction of long-term creep rupture strength. Not only creep rupture strength, but also creep deformation property of the ASME Grade 91 steel was investigated and need of reevaluation of long-term creep strength of Grade 91 steel was indicated. A refinement of region splitting analysis method for creep rupture like prediction was discussed. (orig.)

Long-term capital planning considering nuclear plant life-cycle management

International Nuclear Information System (INIS)

Negin, C.A.; Simpson, J.M.; Hostetler, D.R.

1992-09-01

The creation of a Life Cycle Management (LCM) group at utilities to evaluate the long term capital refurbishment needs is gaining favor. Among the functions of such groups can be the responsibility for recommending long term capital planning projects based on results of evaluations of systems, structures, and components that are not only essential to achieving the full current license term of operation, but also to extend the service life of the plant. Making such recommendations, in content and timing, requires the ability to view all recommendations in the context of an overall capital budget and long range outage impacts. This report illustrates an approach for creating a Long-Term Capital Plan with methods for deciding on, compiling, integrating, and presenting projects from the perspective of an LCM program for a nuclear power plant. It also addresses a rationale for capitalization of LCM program activities that would not be allowed under current accounting treatment

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

Long-term α-hazard of high activity waste from nuclear fuel reprocessing

International Nuclear Information System (INIS)

Girardi, F.; Bertozzi, G.

1974-01-01

The concentration and decay of α-emitters in high activity waste arising from spent nuclear fuel reprocessing was calculated under specified reference conditions. An attempt to evaluate the long-term hazard of such waste is being made by applying the ''barrier'' approach derived from reactor safety studies. Four barriers were identified, which could be evaluated in a probabilistic way by taking into account the great uncertainties present in each of them. The barriers are: 1) quality of the segregation afforded by deep geological formations, 2) stability of conditioned waste (chemical and physical), 3) retention by immediate surrounding, 4) distribution pattern of actinides in the environment. The analysis of a fictional accident showed that the uncertainties connected with the evaluation of the barriers' value are rather large. Additional studies particularly on the stability of conditioned waste and ecological properties of the environment towards actinides, would considerably improve our knowledge of the value of the barrier system. Chemical separation of actinides from high activity waste would be an additional option of undoubted value for the disposal of high activity waste. Its value for the overall safety of the entire waste inventory depends on many factors which need better evaluation, such as safety of the disposal of the separated actinides and the amount and quality of the additional waste generated by the separation process. An analysis of various levels of possible separations suggests that a reasonable target might be: Pu, Am and Cm, decontamination factor 10 3 ; Np, coextraction with U and Pu with a 90% yield

Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis in long-term care patients

Directory of Open Access Journals (Sweden)

Argoff CE

2011-09-01

Full Text Available Charles E Argoff1, F Michael Gloth2 1Albany Medical College and Comprehensive Pain Center, Albany Medical Center, Albany, NY, USA; 2Johns Hopkins University School of Medicine, Baltimore, MD, USA Abstract: Osteoarthritis is common in patients ≥65 years of age. Although nonsteroidal anti-inflammatory drugs (NSAIDs are often prescribed for osteoarthritis pain, they pose age-related cardiovascular, renal, and gastrointestinal risks. Two topical NSAIDs, diclofenac sodium 1% gel (DSG and diclofenac sodium 1.5% in 45.5% dimethylsulfoxide solution (D-DMSO, are approved in the US for the treatment of osteoarthritis pain. Topical NSAIDs have shown efficacy and safety in knee (DSG, D-DMSO and hand (DSG osteoarthritis. Analyses of data from randomized controlled trials of DSG in hand and knee osteoarthritis demonstrate significant improvement of pain and function in both younger patients (<65 years and older patients (≥65 years and suggest good safety and tolerability. However, long-term safety data in older patients are limited. Topical NSAIDs can ease medication administration and help address barriers to pain management in older patients, such as taking multiple medications and inability to swallow, and are a valuable option for long-term care providers. Keywords: nonsteroidal anti-inflammatory drugs, long-term care, nursing homes, chronic pain, topical analgesics

Impact of long-term and short-term therapies on seminal parameters

Directory of Open Access Journals (Sweden)

Jlenia Elia

2013-04-01

Full Text Available Aim: The aim of this work was: i to evaluate the prevalence of male partners of subfertile couples being treated with long/short term therapies for non andrological diseases; ii to study their seminal profile for the possible effects of their treatments on spermatogenesis and/or epididymal maturation. Methods: The study group was made up of 723 subjects, aged between 25 and 47 years. Semen analysis was performed according to World Health Organization (WHO guidelines (1999. The Superimposed Image Analysis System (SIAS, which is based on the computerized superimposition of spermatozoa images, was used to assess sperm motility parameters. Results: The prevalence of subjects taking pharmacological treatments was 22.7% (164/723. The prevalence was 3.7% (27/723 for the Short-Term Group and 18.9% (137/723 for the Long-Term Group. The subjects of each group were also subdivided into subgroups according to the treatments being received. Regarding the seminal profile, we did not observe a significant difference between the Long-Term, Short-Term or the Control Group. However, regarding the subgroups, we found a significant decrease in sperm number and progressive motility percentage in the subjects receiving treatment with antihypertensive drugs compared with the other subgroups and the Control Group. Conclusions: In the management of infertile couples, the potential negative impact on seminal parameters of any drugs being taken as Long-Term Therapy should be considered. The pathogenic mechanism needs to be clarified.

Safety Evaluation Report related to the full-term operating license for Millstone Nuclear Power Station, Unit No. 1 (Docket No. 50-245). Supplement No. 1

International Nuclear Information System (INIS)

1986-08-01

This report, prepared by the Office of Nuclear Reactor Regulation of the US Nuclear Regulatory Commission, supplements the Safety Evaluation Report (NUREG-1143, October 1985). It fulfills a commitment to provide the Advisory Committee on Reactor Safeguards report, identifies the changes that have occurred since the Safety Evaluation Report was issued, and specifies the effective lifetime for the Full-Term Operating License

Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

Science.gov (United States)

Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

2017-03-31

Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

Development Perspective of Regulatory Audit Code System for SFR Nuclear Safety Evaluation

Energy Technology Data Exchange (ETDEWEB)

Bae, Moo Hoon; Lee, Gil Soo; Shin, An Dong; Suh, Nam Duk [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2012-05-15

A sodium-cooled fast reactor (SFR) in Korea is based on the KALIMER-600 concept developed by KAERI. Based on 'Long-term R and D Plan for Future Reactor Systems' which was approved by the Korea Atomic Energy Commission in 2008, the KAERI designer is scheduled to apply the design certification of the prototype SFR in 2017. In order to establish regulatory infrastructure for the licensing of a prototype SFR, KINS has develop the regulatory requirements for the demonstration SFR since 2010, and are scheduled to develop the regulatory audit code systems in regard to core, fuel, and system, etc. since 2012. In this study, the domestic code systems used for core design and safety evaluation of PWRs and the nuclear physics and code system for SFRs were briefly reviewed, and the development perspective of regulatory audit code system for SFR nuclear safety evaluation were derived

Long-Term Symbolic Learning

National Research Council Canada - National Science Library

Kennedy, William G; Trafton, J. G

2007-01-01

What are the characteristics of long-term learning? We investigated the characteristics of long-term, symbolic learning using the Soar and ACT-R cognitive architectures running cognitive models of two simple tasks...

Pediatric polytrauma : Short-term and long-term outcomes

NARCIS (Netherlands)

vanderSluis, CK; Kingma, J; Eisma, WH; tenDuis, HJ

Objective: To assess the short-term and long-term outcomes of pediatric polytrauma patients and to analyze the extent to which short-term outcomes can predict long-term outcomes. Materials and Methods: Ail pediatric polytrauma patients (Injury Severity Score of greater than or equal to 16, less than

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

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.

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

Sexuality and physical intimacy in long-term care.

Science.gov (United States)

Lichtenberg, Peter A

2014-01-01

Sexuality and sexual needs in older adults remains a neglected area of clinical intervention, particularly so in long-term care settings. Because older adults in medical rehabilitation and long-term care beds present with significant frailties, and often significant neurocognitive disorders, it makes it difficult for occupational therapists and other staff to evaluate the capacity of an older adult resident to participate in sexual relationships. The current paper reviews the current literature on sexuality and aging, examines some of the clinical practices and guidelines regarding sexual expression in long-term care, and presents two case examples. A semistructured interview and decision tree is presented to assist therapists in making careful and informed decisions and thereby balancing the needs for protection with the needs for autonomy.

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.

Long-term Results of Endovascular Stent Graft Placement of Ureteroarterial Fistula

Energy Technology Data Exchange (ETDEWEB)

Okada, Takuya, E-mail: okabone@gmail.com; Yamaguchi, Masato, E-mail: masato03310402@yahoo.co.jp [Kobe University Hospital, Department of Radiology (Japan); Muradi, Akhmadu, E-mail: muradiakhmadu@gmail.com; Nomura, Yoshikatsu, E-mail: y_katsu1027@yahoo.co.jp [Kobe University Hospital, Center for Endovascular Therapy (Japan); Uotani, Kensuke, E-mail: uotani@tenriyorozu.jp [Tenri Hospital, Department of Radiology (Japan); Idoguchi, Koji, E-mail: idoguchi@ares.eonet.ne.jp [Kobe University Hospital, Center for Endovascular Therapy (Japan); Miyamoto, Naokazu, E-mail: naoka_zu@yahoo.co.jp; Kawasaki, Ryota, E-mail: kawaryo1999@yahoo.co.jp [Hyogo Brain and Heart Center at Himeji, Department of Radiology (Japan); Taniguchi, Takanori, E-mail: tan9523929@yahoo.co.jp [Tenri Hospital, Department of Radiology (Japan); Okita, Yutaka, E-mail: yokita@med.kobe-u.ac.jp [Kobe University Hospital, Department of Cardiovascular Surgery (Japan); Sugimoto, Koji, E-mail: kojirad@med.kobe-u.ac.jp [Kobe University Hospital, Department of Radiology (Japan)

2013-08-01

PurposeTo evaluate the safety, efficacy, and long-term results of endovascular stent graft placement for ureteroarterial fistula (UAF).MethodsWe retrospectively analyzed stent graft placement for UAF performed at our institution from 2004 to 2012. Fistula location was assessed by contrast-enhanced computed tomography (CT) and angiography, and freedom from hematuria recurrence and mortality rates were estimated.ResultsStent graft placement for 11 UAFs was performed (4 men, mean age 72.8 {+-} 11.6 years). Some risk factors were present, including long-term ureteral stenting in 10 (91 %), pelvic surgery in 8 (73 %), and pelvic radiation in 5 (45 %). Contrast-enhanced CT and/or angiography revealed fistula or encasement of the artery in 6 cases (55 %). In the remaining 5 (45 %), angiography revealed no abnormality, and the suspected fistula site was at the crossing area between urinary tract and artery. All procedures were successful. However, one patient died of urosepsis 37 days after the procedure. At a mean follow-up of 548 (range 35-1,386) days, 4 patients (36 %) had recurrent hematuria, and two of them underwent additional treatment with secondary stent graft placement and surgical reconstruction. The hematuria recurrence-free rates at 1 and 2 years were 76.2 and 40.6 %, respectively. The freedom from UAF-related and overall mortality rates at 2 years were 85.7 and 54.9 %, respectively.ConclusionEndovascular stent graft placement for UAF is a safe and effective method to manage acute events. However, the hematuria recurrence rate remains high. A further study of long-term results in larger number of patients is necessary.

Long-term integrity of buildings and systems

International Nuclear Information System (INIS)

Antoine, P.

1985-01-01

The present study relates to the conditions of holding nuclear power stations in a safe state after their final shutdown. To assess the reasonable duration of the waiting period before complete dismantling of the installations, it was deemed necessary: to investigate the causes and consequences of the ageing of a nuclear power station, with particular regard to the safety-relevant constituents such as the barriers against the dispersion of contamination, and to evaluate the possible problems of safety, maintenance and decommissioning cost. In the present document, the methodology is developed that is to apply in the particular case of a power station finally shut down which is to be decommissioned and dismantled later. For a detailed exercise of this methodology, the Framatome 900 MWe Pressurized Water Reactor station has been taken as a reference plant. The plan which has been elaborated for this study and for the examination of the technical problems has been conceived so as to suggest to the author of a similar study for a particular power station, all the points he has to consider. One chapter of this document has been devoted to showing the basic differences between the 900 MWe PWR reference plant and the other types of nuclear power station existing in the European Community (e.g., BWR, GCR, FBR) and to identify the consequences concerning the decommissioning and the long-term integrity of the installations. 84 refs [fr

Long-term surveillance plan for the Gunnison, Colorado disposal site

International Nuclear Information System (INIS)

1996-04-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE's determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR section 40.27(b) and 40 CFR section 192.03

Long-term surveillance plan for the Gunnison, Colorado, disposal site

International Nuclear Information System (INIS)

1997-04-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE's determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR section 40.27(b) and 40 CFR section 192.03

Long-term surveillance plan for the Gunnison, Colorado disposal site

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-04-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

Long-term surveillance plan for the Gunnison, Colorado, disposal site

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-04-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. Before each disposal site is licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

Long-term surveillance plan for the Gunnison, Colorado, disposal site

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-05-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy`s (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE`s determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR {section}40.27(b) and 40 CFR {section}192.03.

Long-term management of GERD in the elderly with pantoprazole

Directory of Open Access Journals (Sweden)

Carlo Calabrese

2007-04-01

Full Text Available Carlo Calabrese, Anna Fabbri, Giulio Di FeboDepartment of Internal Medicine and Gastroenterology, University of Bologna, ItalyAbstract: The prevalence of gastroesophageal reflux disease (GERD increases with age and elderly are more likely to develop severe disease. Older patients often complain of less severe or frequent heartburn than younger patients and they may present with atypical symptoms such as dysphagia, weight loss, or extraesophageal symptoms. Proton pump inhibitors (PPIs are central in the management of GERD and are unchallenged with regards to their efficacy. They are considered safe and more effective than histamine receptor antagonists for healing esophagitis and for preventing its recurrence using a long term maintenance treatment. PPI have minimal side effects and few slight drug interactions and are considered safe for long term treatment. Pantoprazole is significantly effective both for acute and long-term treatment with excellent control of relapse and symptoms. It is well tolerated even for long-term therapy and its tolerability is optimal. Pantoprazole shows to have minimal interactions with other drugs because of a lower affinity for cytocrome P450 than older PPIs. Although the majority of elderly has concomitant illnesses and receive other drugs, this does not adversely effect the efficacy of pantoprazole because of its pharmacokinetics, which are independent of patient age. Clinical practice suggests that a low dose maintenance of PPIs should be used in older patients with GERD.Keywords: GERD, long-term management, pantoprazole, safety, efficacy, tolerability

Long-term surveillance plan for the Gunnison, Colorado, disposal site

International Nuclear Information System (INIS)

1996-05-01

This long-term surveillance plan (LTSP) describes the U.S. Department of Energy's (DOE) long-term care program for the Uranium Mill Tailings Remedial Action (UMTRA) Project Gunnison disposal site in Gunnison County, Colorado. The U.S. Nuclear Regulatory Commission (NRC) has developed regulations for the issuance of a general license for the custody and long-term care of UMTRA Project disposal sites in 10 CFR Part 40. The purpose of this general license is to ensure that the UMTRA Project disposal sites will be cared for in a manner that protects the public health and safety and the environment. For each disposal site to be licensed, the NRC requires the DOE to submit a site-specific LTSP. The DOE prepared this LTSP to meet this requirement for the Gunnison disposal site. The general license becomes effective when the NRC concurs with the DOE's determination of completion of remedial action for the Gunnison site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the Gunnison disposal site performs as designed. The program is based on two distinct activities: (1) site inspections to identify threats to disposal cell integrity, and (2) ground water monitoring to demonstrate disposal cell performance. The LTSP is based on the UMTRA Project long-term surveillance program guidance and meets the requirements of 10 CFR section 40.27(b) and 40 CFR section 192.03

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

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

Evolution of sorption properties in large-scale concrete structures accounting for long-term physical-chemical concrete degradation - 59297

International Nuclear Information System (INIS)

Perko, Janez; Jacques, Diederik; Mallants, Dirk; Seetharam, Suresh

2012-01-01

Long-term safety of radioactive waste disposal facilities relies on the longevity of natural or engineered barriers designed to minimize the migration of contaminants from the facility into the environment. Especially near surface disposal facilities, such as planned by ONDRAF/NIRAS for the Dessel site in Belgium, long-term safety relies almost exclusively on the containment ability of the engineered barriers (EB) with concrete being the most important EB material used. Concrete is preferred over other materials mainly due to its favourable chemical properties resulting in a high chemical retention capacity, and owing to its good hydraulic isolation properties. However, due to the long time frames typically involved in safety assessment, the chemical, physical and mechanical properties of concrete evolve in time. The alterations in concrete mineralogy also cause changes in pH and sorption behaviour for many radionuclides during chemical degradation processes. Application of dynamic sorption of concrete requires an adequate knowledge of long-term concrete degradation processes, knowledge of the effect of changing mineralogy to sorption of radionuclides and knowledge of large-scale system behaviour over time. Moreover, when applied to safety assessment models, special attention is required to assure robustness and transparency of the implementation. The discussion in this paper focuses on the sorption properties of concrete; selection of data, rescaling issues and on the hypotheses used to build a robust and yet transparent dynamic model for large-scale concrete structures for assessing the long-term performance. In this paper we summarize the steps required for the appropriate use of sorption values for large-scale cementitious components accounting for long-term concrete degradation in safety assessment studies. Four steps were recognized through the safety assessment in the framework of the license application for the near-surface disposal facility in Dessel

Long term creep behavior of concrete

International Nuclear Information System (INIS)

Kennedy, T.W.

1975-01-01

This report presents the findings of an experimental investigation to evaluate the long term creep behavior of concrete subjected to sustained uniaxial loads for an extended period of time at 75 0 F. The factors investigated were (1) curing time (90, 183, and 365 days); (2) curing history (as-cast and air-dried); and (3) uniaxial stress (600 and 2400 psi). The experimental investigation applied uniaxial compressive loads to cylindrical concrete specimens and measured strains with vibrating wire strain gages that were cast in the concrete specimen along the axial and radial axes. Specimens cured for 90 days prior to loading were subjected to a sustained load for a period of one year, at which time the loads were removed; the specimens which were cured for 183 or 365 days, however, were not unloaded and have been under load for 5 and 4.5 years, respectively. The effect of each of the above factors on the instantaneous and creep behavior is discussed and the long term creep behavior of the specimens cured for 183 or 365 days is evaluated. The findings of these evaluations are summarized. (17 figures, 10 tables) (U.S.)

Long-term safety assessment of trench-type surface repository at Chernobyl, Ukraine - computer model and comparison with results from simplified models

International Nuclear Information System (INIS)

Haverkamp, B.; Krone, J.; Shybetskyi, I.

2013-01-01

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, the surface repository for solid low and intermediate level waste (LILW) is still being operated but its maximum capacity is nearly reached. Long-existing plans for increasing the capacity of the facility shall be implemented in the framework of the European Commission INSC Programme (Instrument for Nuclear Safety Co-operation). Within the first phase of this project, DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) for a future extended facility based on the planned enlargement. In addition to a detailed mathematical model, also simplified models have been developed to verify results of the former one and enhance confidence in the results. Comparison of the results show that - depending on the boundary conditions - simplifications like modeling the multi trench repository as one generic trench might have very limited influence on the overall results compared to the general uncertainties associated with respective long-term calculations. In addition to their value in regard to verification of more complex models which is important to increase confidence in the overall results, such simplified models can also offer the possibility to carry out time consuming calculations like probabilistic calculations or detailed sensitivity analysis in an economic manner. (authors)