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

International Nuclear Information System (INIS)

Choi, J.S.

1995-01-01

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

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

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.

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

Science.gov (United States)

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

2009-01-01

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

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

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

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.

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

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.

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.

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

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.

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

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

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)

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

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

Science.gov (United States)

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

2010-01-01

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

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.

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

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.

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 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)

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.

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 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.

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.

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)

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...

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)

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....

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.

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

Preclinical rodent toxicity studies for long term use of ceftriaxone

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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.

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.

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...

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

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

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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.

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

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

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 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...

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

International Nuclear Information System (INIS)

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

1998-01-01

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

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.

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

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)

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)

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 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.

Study on behaviour in long term of vitrified materials

International Nuclear Information System (INIS)

Vernaz, E.

1993-01-01

In collaboration with EDF (Electricite de France), after testing fusion of Refiom (Residus d'Epuration des Fumees d'Incineration d'Ordures Menageres), residues from purification of incineration smokes of household rubbish, realised at Porcheville and at the Laboratory of Renardieres with experimental processing of vitrification by plasma, CEA (Centre d'Etudes Atomiques), atomic center of research, began study on resistance in long term of vitrified products. From about thirty five years, CEA carries out research to confine radioactive waste of high activity in stable materials. Glass was the first best one which allowed to incorporate about thirty different chemical elements found in fission products solutions into a stable die with a good chemical durability; three vitrification shops raised, one at Marcoule ('AVM', 1978) in the south of France, the two other ones at La Hague ('R7', 1989 and 'T7', 1992) in Normandy. To determine a possible impact of a deep radioactive waste disposal on human and environment, several studies began. In particular, studies on aqueous corrosion of glasses to determine behaviour in long term of glass package (first barrier of confinement) and to estimate kinetics of releasing confined toxical elements on periods of several thousands years. Principal results are exposed in this conference. Experience shows that safety analysis cannot be based on long term extrapolation of a simple lixiviation result. This analysis must include: a sufficient knowledge in basic mechanisms of alteration to predict the kinetic evolution in a long term. To take in account environment conditions with a normal or accidental scheme (acidity, clay, organic compounds,...). This knowledge broadly developed by CEA for nuclear glasses seems to be easily transposable to different wastes (industrial ones or from hospitals) and takes place in a contract of research CEA/EDF to valorize vitrified products. 9 figs. 4 refs

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...

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.

Study of scenarios of long term management of low-activity long-life wastes

International Nuclear Information System (INIS)

2012-01-01

This document reports the study of scenarios for the management of different low-activity long-life radioactive wastes with reference to different French legal texts. After a presentation of the legal and technical context, the report presents different existing and projected storages (description and safety principles for the Cires and Aube centres and for the Cigeo project of deep geological storage centre). It addresses the various aspects of radiferous and graphite waste management on a long term: inventory, parcel, waste peculiarities, management scenarios, assessment of storage in SCR. It also addresses the case of other wastes such as bituminous coated wastes, those presenting a reinforced natural radioactivity or residues of uranium conversion processing. The last part presents the main orientations for the project

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 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...

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 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.

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.

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

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

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)

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.)

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

Full Text Available Naomi Uemura,1 Yoshikazu Kinoshita,2 Ken Haruma,3 Takashi Yao,4 Ryoji Kushima,5 Tatsuhiro Kanoo6 1Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Kohnodai Hospital, Chiba, Japan; 2Department of Gastroenterology and Hepatology, Faculty of Medicine, Shimane University, Shimane, Japan; 3Department of General Internal Medicine 2, Kawasaki Medical School General Medical Center, Okayama, Japan; 4Department of Human Pathology, Juntendo University Graduate School of Medicine, Tokyo, Japan; 5Department of Clinical Laboratory Medicine, Shiga University of Medical Science Hospital, Shiga, Japan; 6Takeda Pharmaceutical Co., Ltd, Osaka, Japan Abstract: Erosive esophagitis (EE occurs when the epithelial mucosa is damaged due to gastric acid reflux, and the incidence of this disease is increasing in Japan due to changes in diet and lifestyle. The condition can be treated using proton pump inhibitors (PPIs that act by irreversibly blocking the H+,K+-ATPase responsible for acid secretion. Vonoprazan is a K+ competitive channel inhibitor, which reversibly and potently inhibits gastric acid secretion. However, long-term data on vonoprazan use are limited. The aim of the VISION trial is to investigate the long-term efficacy and safety of vonoprazan in comparison with the PPI lansoprazole. This randomized, multicenter, 5-year, open-label study has a planned recruitment of 195 participants (2:1 allocation vonoprazan:lansoprazole from 33 sites in Japan. The study comprises an 8-week “healing” phase (vonoprazan 20 mg or lansoprazole 30 mg p.o. and a 260-week “maintenance” phase (vonoprazan 10 mg or lansoprazole 15 mg. Safety populations in both phases are defined as participants who receive at least one dose of the study or control drug in the healing and maintenance phases, respectively. The full analysis set in both phases is defined as participants who are randomized and receive at least one dose of the study or

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.

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.

Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study.

Science.gov (United States)

Nakamura, Ichiro; Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Uno, Satoshi

2018-02-01

Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.

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.

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 Efficacy of Trabeculectomy on Chinese Patients with Pigmentary Glaucoma: A Prospective Case Series Observational Study

Directory of Open Access Journals (Sweden)

Guo-Ping Qing

2016-01-01

Conclusions: All surgical PG eyes in this study had satisfactory IOP control 8 years after the surgery with well-preserved visual function. The long-term efficacy and safety of trabeculectomy are promising in PG patients.

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.

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

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

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

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

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.

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 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

Hydrotherapy for the long-term ventilated patient: A case study and implications for practice.

Science.gov (United States)

Wegner, Sally; Thomas, Peter; James, Christine

2017-11-01

Hydrotherapy of mechanically ventilated patients has been shown to be safe and feasible in both the acute stages of critical illness and in those requiring long term mechanical ventilation. This case study describes the hydrotherapy sessions of a 36 year old female, who after suffering complications of pneumococcal meningitis, became an incomplete quadriplegic and required long term mechanical ventilation. When implementing hydrotherapy with patients on mechanical ventilation a number of factors should be considered. These include staff resources and training, airway and ventilation management, patient preparation and safety procedures. Hydrotherapy can be safely utilised with mechanically ventilated patients, and may facilitate a patient's ability to participate in active exercise and rehabilitation. Copyright © 2017 Australian College of Critical Care Nurses Ltd. All rights reserved.

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.

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

Perceptions of safety and exposure to violence in public places among working age adults with disabilities or long-term health conditions in the UK: cross sectional study.

Science.gov (United States)

Emerson, E; Krnjacki, L; Llewellyn, G; Vaughan, C; Kavanagh, A

2016-06-01

To examine perceptions of safety and exposure to violence in public places among working age adults with and without disabilities in the UK and to assess the extent to which any between-group differences may be moderated by gender and socio-economic situation. Cross-sectional study. Secondary analysis of data collected in Wave 3 (2011-13) of Understanding Society. Data were extracted on a subsample of 5069 respondents aged 16 to 64 years (28% of whom had a disability/long-term health condition) who were administered a questionnaire module addressing experiences of harassment. Between-group comparisons were made on four self-reported indicators of safety. Respondents with disabilities/long-term health conditions were significantly more likely to have been attacked (adjusted OR 2.30, 95%CI 1.17-4.50, P condition are at significantly increased risk of exposure to interpersonal violence, particularly if they are living in poverty or are women. As such, there is a clear need to develop interventions that are targeted to the particular circumstances and needs of these high risk groups. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

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

Waste Disposal: Long-term Performance Studies for Radioactive Waste Disposal and Hydrogeological Modelling

Energy Technology Data Exchange (ETDEWEB)

Marivoet, J

2000-07-01

The main objectives of SCK-CEN's R and D programme on long-term performance studies are: (1) to develop a methodology and associated tools for assessing the long-term safety of geological disposal of all types of radioactive waste in clay formations and of the shallow-land burial of low-level waste; (2) to assess the performance and to identify the most influential elements of integrated repository systems for the disposal of radioactive waste; (3) to collect geological, piezometric and hydraulic data required for studying the hydrogeological system in north-eastern Belgium; (4) to develop a regional aquifer model for north-easter Belgium and to apply it in the performance assessments for the Mol site; (5) to test, verify and improve computer codes used in the performance assessment calculations of waste disposal concepts and contaminated sites (the computer codes simulate water flow and transport of radionuclides in engineered barriers, aquifers and contaminated sites). The scientific programme and achievements in 1999 are described.

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.

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...

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 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 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

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)

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

International Nuclear Information System (INIS)

Recreo Jimenez, F.; Ruiz Rivas, C.

1997-01-01

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

Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia.

Science.gov (United States)

Spaeth, Michael; Alegre, Cayetano; Perrot, Serge; Wang, Youyu; Guinta, Diane R; Alvarez-Horine, Sarah; Russell, Irwin

2013-11-11

The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a prospective, multicenter, open-label, extension study in patients completing 1 of 2 phase 3 randomized, double-blind, controlled, 14-week trials that examined the efficacy and safety of SXB 4.5 g, SXB 6 g, and placebo for treatment of FM. This extension study comprised an additional 38 weeks of treatment and was carried out at 130 clinical sites in 7 countries. Initial entry criteria for the previous 2 double-blind clinical trials required that patients aged ≥ 18 years met the American College of Rheumatology 1990 criteria for FM, had a body mass index (BMI) Fibromyalgia Impact Questionnaire (FIQ) total scores, and other measures. Responder analyses showed that 68.8% of patients achieved ≥ 30% reduction in pain VAS and 69.7% achieved ≥ 30% reduction in FIQ total score at study endpoint. The long-term safety profile of SXB in FM patients was similar to that in the previously reported controlled clinical trials. Improvement in pain and other FM clinical domains was maintained during long-term use. ClinicalTrials.gov NCT00423605.

Long-term tolerability and maintenance of therapeutic response to sodium oxybate in an open-label extension study in patients with fibromyalgia

Science.gov (United States)

2013-01-01

Introduction The long-term safety and therapeutic response of sodium oxybate (SXB) in fibromyalgia syndrome (FM) patients were assessed for a combined period of up to 1 year in a prospective, multicenter, open-label, extension study in patients completing 1 of 2 phase 3 randomized, double-blind, controlled, 14-week trials that examined the efficacy and safety of SXB 4.5 g, SXB 6 g, and placebo for treatment of FM. Methods This extension study comprised an additional 38 weeks of treatment and was carried out at 130 clinical sites in 7 countries. Initial entry criteria for the previous 2 double-blind clinical trials required that patients aged ≥ 18 years met the American College of Rheumatology 1990 criteria for FM, had a body mass index (BMI) Fibromyalgia Impact Questionnaire (FIQ) total scores, and other measures. Responder analyses showed that 68.8% of patients achieved ≥ 30% reduction in pain VAS and 69.7% achieved ≥ 30% reduction in FIQ total score at study endpoint. Conclusions The long-term safety profile of SXB in FM patients was similar to that in the previously reported controlled clinical trials. Improvement in pain and other FM clinical domains was maintained during long-term use. Trial registration ClinicalTrials.gov NCT00423605. PMID:24286114

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

The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

Science.gov (United States)

Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

2015-06-18

Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

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 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

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.

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

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

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)

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)

Natural analogue studies for the long-term safety of radioactive waste disposal. Lessons learned from the nature

International Nuclear Information System (INIS)

Yusa, Yasuhisa

2002-01-01

'Natural analogues' can be defined as the processes or materials analogous to those operating in the geological disposal system of radioactive waste. Natural analogue studies provide the only means by which long-term data can be obtained under the real natural conditions, and also the most convincing support to the long-term performance assessment of the geological disposal system. The framework of our natural analogue studies concerning the stability of the engineered barrier materials for geological disposal system of high-level radioactive waste is reviewed. One of the results is that the volcanic glass included in a clay bed did not alter during the past one million years. The Tono Uranium Deposits are studied as geochemical analogues of radioactive waste disposal in Japan. We conclude that although the deposits have been subjected to a variety of geological processes and events such as faulting, erosion and uplift/subsidence, the reducing condition has been maintained and uranium has not migrated for at least the past ten million years. Application and further development of the natural analogue studies are also discussed. (author)

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

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)

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.

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.

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

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-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.

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.

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 .

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.

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)

Long-term Study of a Quadrivalent Human Papillomavirus Vaccine

DEFF Research Database (Denmark)

Ferris, Daron; Samakoses, Rudiwilai; Block, Stan L

2014-01-01

BACKGROUND: We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine. METHODS: Sexually naive boys and girls aged 9 to 15 years (N = 1781) were assigned (2:1) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6...... objective was to estimate vaccine effectiveness against HPV6/11/16/18-related persistent infection or disease. RESULTS: For each of the HPV4 vaccine types, vaccination-induced anti-HPV response persisted through month 96. Among 429 subjects who received HPV4 vaccine at a mean age of 12, none developed HPV6....../11/16/18-related disease or persistent infection of ≥12 months' duration. Acquisition of new sexual partners (among those ≥16 years) was ∼1 per year. Subjects receiving HPV4 vaccine at month 30 (mean age 15 years) had a similar baseline rate of seropositivity to ≥1 of the 4 HPV types to those vaccinated at day 1...

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

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

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.

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...

Applicability of short-term accelerated biofouling studies to predict long-term biofouling accumulation in reverse osmosis membrane systems

KAUST Repository

Sanawar, Huma

2018-02-02

Biofouling studies addressing biofouling control are mostly executed in short-term studies. It is unclear whether data collected from these experiments are representative for long-term biofouling as occurring in full-scale membrane systems. This study investigated whether short-term biofouling studies accelerated by biodegradable nutrient dosage to feed water were predictive for long-term biofouling development without nutrient dosage. Since the presence of a feed spacer has an strong effect on the degree of biofouling, this study employed six geometrically different feed spacers. Membrane fouling simulators (MFSs) were operated with the same (i) membrane, (ii) feed flow and (iii) feed water, but with feed spacers varying in geometry. For the short-term experiment, biofilm formation was enhanced by nutrient dosage to the MFS feed water, whereas no nutrient dosage was applied in the long-term experiment. Pressure drop development was monitored to characterize the extent of biofouling, while the accumulated viable biomass content at the end of the experimental run was quantified by adenosine triphosphate (ATP) measurements. Impact of feed spacer geometry on biofouling was compared for the short-term and long-term biofouling study. The results of the study revealed that the feed spacers exhibited the same biofouling behavior for (i) the short-term (9-d) study with nutrient dosage and (ii) the long-term (96-d) study without nutrient dosage. For the six different feed spacers, the accumulated viable biomass content (pg ATP.cm) was roughly the same, but the biofouling impact in terms of pressure drop increase in time was significantly different. The biofouling impact ranking of the six feed spacers was the same for the short-term and long-term biofouling studies. Therefore, it can be concluded that short-term accelerated biofouling studies in MFSs are a representative and suitable approach for the prediction of biofouling in membrane filtration systems after long-term

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)

The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®).

Science.gov (United States)

Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith

2013-01-01

Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. The NordiNet® International Outcome Study (IOS) and the American Norditropin® Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

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

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.

Safety and efficacy of ipragliflozin in elderly versus non-elderly Japanese patients with type 2 diabetes mellitus: a subgroup analysis of the STELLA-LONG TERM study.

Science.gov (United States)

Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Nakamura, Ichiro; Uno, Satoshi

2018-03-01

This subgroup analysis of STELLA-LONG TERM interim data explored the long-term safety and efficacy of ipragliflozin in non-elderly vs. elderly Japanese type 2 diabetes mellitus (T2DM) patients. STELLA-LONG TERM is an ongoing 3-year prospective surveillance study of Japanese T2DM patients receiving ipragliflozin 50 mg once daily. In this subgroup analysis, patient characteristics, laboratory variables, and adverse drug reactions (ADRs) were compared between non-elderly (<65 years) and elderly (≥65 years) patients. Non-elderly patients had significantly higher body mass index and low-density lipoprotein cholesterol than elderly patients (P < 0.001). The proportion of patients with hemoglobin A1c (HbA1c) <8.0% was significantly higher among elderly patients (P < 0.001). HbA1c, fasting plasma glucose, and body weight significantly decreased from baseline to 3 and 12 months in both groups (all P < 0.05 vs. baseline). The ADR incidence was 10.83% vs. 10.42% in non-elderly and elderly patients. The incidence of skin complications was 0.98% vs. 1.65% and that of renal disorder was 0.47% vs. 0.95% in non-elderly and elderly patients (both P = 0.003). Ipragliflozin was effective in non-elderly and elderly Japanese T2DM patients in a real-world clinical setting. The incidence of renal disorder and skin complications was significantly higher in elderly vs. non-elderly patients.

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)

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

Efficacy and safety of nimesulide long term administration in patients with osteoarthritis: results of 12-months open controlled study DINAMO (long term administration of nimesulide in osteoarthritis multifactor assessment

Directory of Open Access Journals (Sweden)

L I Alexeeva

2009-01-01

Full Text Available Objective. To compare efficacy and safety of nimesulide and paracetamol in treatment of patients with osteoarthritis (OA during 12 months. Material and methods. 40 women (mean age 66,8±5,1 years with knee osteoarthritis (II-III stage according to Kellgren-Lawrence having intensive pain (>40 mm on VAS were included. Group 1 pts (n=20 received nimesulide 200-100 mg/day. Group 2 pts were treated with paracetamol till 3 g/day. WOMAC was used as efficacy measure. Safety was assessed with endoscopic examination of upper gastrointestinal tract, ECG, blood pressure and ECG Holter monitoring, clinical and biochemical blood parameters. Statistical significance of differences was assessed with Student’s t-test, χ2 and Fisher exact test Results. WOMAC index decreased during treatment from 1182,7±345,9 to 698,4±351,1 for nimesulide and from 1136,4±313,8 to 1031,6±21 for paracetamol (p<0,05. There were 6 cases of gastrointestinal complications and 4 cases of hypertension development or deterioration in each group. Coronary heart disease developed or deteriorated in 4 patients receiving nimesulide but not in control group. Liver function tests did not deteriorated during treatment with nimesulide. Conclusion. Nimesulide was more effective than paracetamol in treatment of OA. But risk of cardiovascular complications development during treatment with NSAIDs requires serious attention. Nimesulide did not induced liver damage during long term treatment.

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.)

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/.

[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.

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.

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.

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

Sustained weight loss in patients treated with mifepristone for Cushing's syndrome: a follow-up analysis of the SEISMIC study and long-term extension.

Science.gov (United States)

Fein, Henry G; Vaughan, T Brooks; Kushner, Harvey; Cram, David; Nguyen, Dat

2015-10-27

Overweight and obesity are common among patients with Cushing's syndrome (CS) and may persist in some patients even after ostensibly curative surgery, contributing to cardiometabolic dysfunction and increased cardiovascular risk. Mifepristone, a selective glucocorticoid receptor antagonist, was effective in controlling hyperglycemia in a 24-week trial of adults (N = 50) with endogenous CS and associated type 2 diabetes mellitus/impaired glucose tolerance or hypertension who had failed or were not candidates for surgery (SEISMIC, Study of the Efficacy and Safety of Mifepristone in the Treatment of Endogenous Cushing's Syndrome). This analysis examines long-term weight change among patients who received mifepristone in SEISMIC and enrolled in a long-term safety extension (LTE) study. Patients completing the 24-week SEISMIC study and subsequent 6-week off-drug safety evaluation were invited to enroll in the LTE study. Mifepristone doses at the end of SEISMIC were the LTE starting doses. Body weight measures were reviewed at baseline and week 24 of SEISMIC and at LTE month 6, 12, 18, 24, and final visit (last observation collected during the LTE study). Of the 30 patients enrolled in the LTE, evaluable weight data were available for 29 (20/29 female; mean age of 44.7 ± 11.2 years). These patients received mifepristone for a median of 29.2 months (range 8.4-41.9). Mean ± SD weight from SEISMIC baseline to LTE final visit decreased by 10.3 ± 16.3 kg (mean 105.4 ± 34.3 kg to 95.1 ± 32.9 kg), a 9.3 % decrease from baseline weight (P = 0.0008). Of the 29 LTE patients, 18 (62.1 %) lost ≥ 5 % of body weight by the end of the initial 24-week treatment period; this ≥5 % weight loss persisted in 83.3 % (15/18) at LTE final visit. Ten patients (34.5 %) lost ≥ 10 % of initial body weight by week 24 of SEISMIC, which persisted in 80 % at LTE final visit. No new safety signals were detected with long-term mifepristone use. Clinically meaningful weight loss achieved during

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

An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics.

Science.gov (United States)

Johnson, Jeremy R; Lossignol, Dominique; Burnell-Nugent, Mary; Fallon, Marie T

2013-08-01

Chronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex(®)) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group. This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer. In total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two-week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit. The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for "pain severity" and "worst pain" domains showed a decrease (i.e., improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e., improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study. This study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc

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)

Archiving Primary Data: Solutions for Long-Term Studies.

Science.gov (United States)

Mills, James A; Teplitsky, Céline; Arroyo, Beatriz; Charmantier, Anne; Becker, Peter H; Birkhead, Tim R; Bize, Pierre; Blumstein, Daniel T; Bonenfant, Christophe; Boutin, Stan; Bushuev, Andrey; Cam, Emmanuelle; Cockburn, Andrew; Côté, Steeve D; Coulson, John C; Daunt, Francis; Dingemanse, Niels J; Doligez, Blandine; Drummond, Hugh; Espie, Richard H M; Festa-Bianchet, Marco; Frentiu, Francesca; Fitzpatrick, John W; Furness, Robert W; Garant, Dany; Gauthier, Gilles; Grant, Peter R; Griesser, Michael; Gustafsson, Lars; Hansson, Bengt; Harris, Michael P; Jiguet, Frédéric; Kjellander, Petter; Korpimäki, Erkki; Krebs, Charles J; Lens, Luc; Linnell, John D C; Low, Matthew; McAdam, Andrew; Margalida, Antoni; Merilä, Juha; Møller, Anders P; Nakagawa, Shinichi; Nilsson, Jan-Åke; Nisbet, Ian C T; van Noordwijk, Arie J; Oro, Daniel; Pärt, Tomas; Pelletier, Fanie; Potti, Jaime; Pujol, Benoit; Réale, Denis; Rockwell, Robert F; Ropert-Coudert, Yan; Roulin, Alexandre; Sedinger, James S; Swenson, Jon E; Thébaud, Christophe; Visser, Marcel E; Wanless, Sarah; Westneat, David F; Wilson, Alastair J; Zedrosser, Andreas

2015-10-01

The recent trend for journals to require open access to primary data included in publications has been embraced by many biologists, but has caused apprehension amongst researchers engaged in long-term ecological and evolutionary studies. A worldwide survey of 73 principal investigators (Pls) with long-term studies revealed positive attitudes towards sharing data with the agreement or involvement of the PI, and 93% of PIs have historically shared data. Only 8% were in favor of uncontrolled, open access to primary data while 63% expressed serious concern. We present here their viewpoint on an issue that can have non-trivial scientific consequences. We discuss potential costs of public data archiving and provide possible solutions to meet the needs of journals and researchers. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

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

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.

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.

Andra long term memory project - 59277

International Nuclear Information System (INIS)

Charton, Patrick; Boissier, Fabrice; Martin, Guillaume

2012-01-01

Document available in abstract form only. Full text of publication follows: Long term memory of repositories is required by safety, reversibility and social expectations. Thus Andra has implemented since 2010 a long-term memory project to reinforce and diversify its current arrangements in this field, as well as to explore opportunities to extend memory keeping over thousands years. The project includes opportunity studies of dedicated facilities. The 'Ecotheque' and 'Geotheque' projects contribute to memory respectively through environmental and geological samples preservation. The options of creating (i) an archive centre for Andra's interim and permanent archives, (ii) an artist center to study the contribution of arts to memory preservation, (iii) a museum of radioactive waste disposal history and technology (radium industry..., sea disposal, current solutions...) are considered. Other studies provided by the project examine our heritage. This includes the continuity of languages and symbolic systems, the continuity of writing and engraving methods, the archaeology of landscapes (memory of the earths evolution, multi-century memory of industrial and agricultural landscapes), the archaeology practices (how might a future archaeologist be interested in our current activity?), the preservation of historical sites and industrial memory, the continuity of institutional organizations, the memory and history of science evolution as well as broad history

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

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)

Methodology of long term behaviour study of containment materials

International Nuclear Information System (INIS)

Vernaz, E.; Godon, N.

1994-01-01

Here is the presentation of the papers shown in the colloquium on environment and ceramics; the Atomic Energy Commissariat (Cea) have been working for fifteen years on the long term behaviour of fission products glasses on very long periods, about several millions years. The method of studies is detailed. 2 refs

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 studies of the natural history of asthma in childhood

DEFF Research Database (Denmark)

Bisgaard, Hans; Bønnelykke, Klaus

2010-01-01

secondary prevention through the use of inhaled corticosteroids can effectively halt the long-term disease progression in childhood. In conclusion, the natural history of asthma and the associated airway changes is still poorly understood, and we have not managed to translate findings from long-term studies...

Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naïve Patients with HIV-1 Infection: the REMAIN Study.

Science.gov (United States)

Teófilo, Eugénio; Rocha-Pereira, Nuno; Kuhlmann, Birger; Antela, Antonio; Knechten, Heribert; Santos, Jesús; Jiménez-Expósito, Maria Jesús

2016-02-01

Boosted protease inhibitors (PIs), including ritonavir-boosted atazanavir (ATV/r), are a recommended option for the initial treatment of HIV-1 infection based upon clinical trial data; however, long-term real-life clinical data are limited. We evaluated the long-term use of ATV/r as a component of antiretroviral combination therapy in the real-life setting in the REMAIN study. This was an observational cohort study conducted at sites across Germany, Portugal, and Spain. Retrospective historical and prospective longitudinal follow-up data were extracted every six months from medical records of HIV-infected treatment-naïve patients aged ≥ 18 years initiating a first-line ATV/r-containing regimen. Eligible patients (n = 517) were followed up for a median of 3.4 years. The proportion remaining on ATV/r at 5 years was 51.5% with an estimated Kaplan-Meier median time to treatment discontinuation of 4.9 years. Principal reasons for discontinuation were adverse events (15.9%; 8.9% due to hyperbilirubinemia) and virologic failure (6.8%). The Kaplan-Meier probability of not having virologic failure (HIV-1 RNA treatment-emergent major PI resistance occurred. ATV/r was generally well tolerated during long-term treatment with no significant changes in estimated glomerular filtration rate over five years. In a real-life clinical setting over five years, treatment-naïve patients with HIV-1 infection initiating an ATV/r-based regimen showed sustained virologic suppression, an overall treatment persistence rate of 51.5%, an absence of treatment-emergent major PI resistance mutations at virologic failure, a long-term safety profile consistent with that observed in clinical trials, and no significant decline in renal function.

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

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

Directory of Open Access Journals (Sweden)

Bankole K. Fasanya

2016-06-01

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

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

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.)

Open-label study on the long-term efficacy, safety, and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain.

Science.gov (United States)

Wallace, Mark; Thipphawong, John

2010-10-01

To investigate the efficacy, safety, and impact on quality of life of long-term administration of OROS hydromorphone ER (8-128mg) in patients with chronic low back pain. A total of 113 adults with chronic low back pain who completed a 6-week open-label study were enrolled in this 6-month extension study. The primary end point was the daily pain relief rating obtained during monthly study visits. Secondary end points included Investigator and Patient Global Evaluations, Brief Pain Inventory scores obtained at monthly study visits, and quality-of-life measures (Medical Outcomes Study Questionnaire and 36-Item Short-Form Health Survey score) obtained at monthly intervals. Mean±SD change from baseline in pain relief with OROS hydromorphone ER for the Month 6 visit was 0.9±2.55 (P=0.0007) and for the last assessment of the extension study was 0.9±2.53 (P=0.0002). At the Month 6 visit, 81.3% of investigators and 71.0% of patients rated their satisfaction of pain relief with OROS hydromorphone ER treatment as good, very good, or excellent. Changes on the 36-item Short Form Health Survey, a quality-of-life measure, were statistically significant for the physical composite scores for all extension phase time points, including Month 6 (2.1±5.34; Psleep disturbances. Adverse events included gastrointestinal and central nervous system symptoms. The results support the long-term use of OROS hydromorphone ER in managing chronic moderate to severe low back pain. Wiley Periodicals, Inc.

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.

An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan.

Science.gov (United States)

Ichikawa, Hironobu; Hiratani, Michio; Yasuhara, Akihiro; Tsujii, Noa; Oshimo, Takashi; Ono, Hiroaki; Tadori, Yoshihiro

2018-02-01

The purpose of this study was to evaluate the long-term safety and efficacy of aripiprazole in treating irritability in pediatric patients (6-17 years) with autistic disorder (AD) in Japan. In this open-label extension study, patients who had completed a previous randomized, double-blind, placebo-controlled 8-week study were enrolled and were flexibly dosed with aripiprazole (1-15 mg/day) until the new indication of irritability in pediatric autism spectrum disorder was approved in Japan. Seventy (81%) out of 86 enrolled patients completed week-48 assessments. The mean duration of treatment was 694.9 days. The mean daily dose of aripiprazole over the treatment period was 7.2 mg and the mean of the final dose was 8.5 mg. The most common treatment-emergent adverse events (TEAE; ≥20%) included nasopharyngitis, somnolence, influenza, and increased weight. The majority of these TEAE were mild or moderate in severity, and there were no deaths, and no clinically relevant findings in laboratory values except prolactin decrease, vital signs, height, or ECG parameters. At week 48 (observed case), the mean change from baseline in the Irritability subscale score for the Aberrant Behavior Checklist Japanese Version was -6.3 in prior placebo patients and -2.6 in prior aripiprazole patients. Aripiprazole was generally safe, well tolerated, and effective in the long-term treatment of irritability associated with AD in Japanese pediatric patients. © 2017 The Authors. Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.

Comparative study of short- and long-term indoor radon measurements

Energy Technology Data Exchange (ETDEWEB)

Al-Jarallah, M.I. [Department of Physics, King Fahd University of Petroleum and Minerals, Dhahran 31261 (Saudi Arabia)], E-mail: mibrahim@kfupm.edu.sa; Fazal-ur-Rehman,; Abdalla, Khalid [Department of Physics, King Fahd University of Petroleum and Minerals, Dhahran 31261 (Saudi Arabia)

2008-08-15

Short-term indoor radon measurements are used widely. Therefore, it is interesting to find out a correlation between these measurements and long-term measurements which reflect a better average radon concentration of individual measurement. To find the correlation between the two measurements of indoor radon concentrations at low radon levels, a study was carried out at 34 locations of King Fahd University of Petroleum and Minerals (KFUPM), Dhahran, Saudi Arabia using active and passive methods. In the short-term active method, a radon gas analyzer (AlphaGUARD) was used for a duration of 24 h in each measurement. In the long-term passive method, CR-39 based radon dosimeters were utilized for a period of 6 months, from January 2006 to June 2006. The short-term active measurements showed that the average, minimum and maximum radon concentrations were 19, 8 and 58Bqm{sup -3}, respectively, with a standard deviation of 8.6Bqm{sup -3}. The long-term passive measurements showed that the average, minimum and maximum radon concentrations were 25, 10 and 67Bqm{sup -3}, respectively, with a standard deviation of 12Bqm{sup -3}. The two measurements showed a poor correlation (R{sup 2}=0.38). The long-term measurements showed on the average higher concentrations by a factor of 1.3.

Archiving primary data: solutions for long-term studies

NARCIS (Netherlands)

Mills, J.A.; Teplitsky, C.; Arroyo, B.; Charmantier, A.; H. Becker, P.; Birkhead, T.R.; Bize, P.; Blumstein, D.T.; Bonenfant, C.; Boutin, S.; Bushuev, A.; Cam, E.; Cockburn, A.; Côté, S.D.; Coulson, J.C.; Daunt, F.; Dingemanse, N.J.; Doligez, B.; Drummond, H.; Espie, R.H.M.; Festa-Bianchet, M.; Frentiu, F.; Fitzpatrick, J.W.; Furness, R.W.; Garant, D.; Gauthier, G.; Grant, P.R.; Griesser, M.; Gustafsson, L.; Hansson, B.; Harris, M.P.; Jiguet, F.; Kjellander, P.; Korpimäki, E.; Krebs, C.J.; Lens, L.; Linnell, J.D.C.; Low, M.; McAdam, A.; Margalida, A.; Merilä, J.; Møller, A.P.; Nakagawa, S.; Nilsson, J.-Å.; Nisbet, I.C.T.; van Noordwijk, A.J.; Oro, D.; Pärt, T.; Pelletier, F.; Potti, J.; Pujol, B.; Réale, D.; Rockwell, R.F.; Ropert-Coudert, Y.; Roulin, A.; Thébaud, C.; Sedinger, J.S.; Swenson, J.E.; Visser, M.E.; S.Wanless Westneat, D.F.; Wilson, A.J.; Zedrosser, A.

2015-01-01

The recent trend for journals to require open access to primary data included in publications has been embraced by many biologists, but has caused apprehension amongst researchers engaged in long-term ecological and evolutionary studies. A worldwide survey of 73 principal investigators (Pls) with

Archiving primary data : Solutions for long-term studies

NARCIS (Netherlands)

Mills, James A.; Teplitsky, Celine; Arroyo, Beatriz; Charmantier, Anne; Becker, Peter. H.; Birkhead, Tim R.; Bize, Pierre; Blumstein, Daniel T.; Bonenfant, Christophe; Boutin, Stan; Bushuev, Andrey; Cam, Emmanuelle; Cockburn, Andrew; Cote, Steeve D.; Coulson, John C.; Daunt, Francis; Dingemanse, Niels J.; Doligez, Blandine; Drummond, Hugh; Espie, Richard H. M.; Festa-Bianchet, Marco; Frentiu, Francesca; Fitzpatrick, John W.; Furness, Robert W.; Garant, Dany; Gauthier, Gilles; Grant, Peter R.; Griesser, Michael; Gustafsson, Lars; Hansson, Bengt; Harris, Michael P.; Jiguet, Frederic; Kjellander, Petter; Korpimaki, Erkki; Krebs, Charles J.; Lens, Luc; Linne, John D. C.; Low, Matthew; McAdam, Andrew; Margalida, Antoni; Merila, Juha; Moller, Anders P.; Nakagawa, Shinichi; Nilsson, Jan-Ake; Nisbet, Ian C. T.; van Noordwijk, Arie J.; Oro, Daniel; Part, Tomas; Pelletier, Fanie; Potti, Jaime; Pujol, Benoit; Reale, Denis; Rockwel, Robert F.; Ropert-Coudert, Yan; Roulin, Alexandre; Sedinger, James S.; Swenson, Jon E.; Thebaud, Christophe; Visser, Marcel E.; Wanless, Sarah; Westneat, David F.; Wilson, Alastair J.; Zedrosser, Andreas

2015-01-01

The recent trend for journals to require open access to primary data included in publications has been embraced by many biologists, but has caused apprehension amongst researchers engaged in long-term ecological and evolutionary studies. A worldwide survey of 73 principal investigators (PIs) with

Deep repository for long-lived low- and intermediate-level waste. Preliminary safety assessment

International Nuclear Information System (INIS)

1999-11-01

A preliminary safety assessment has been performed of a deep repository for long-lived low- and intermediate-level waste, SFL 3-5. The purpose of the study is to investigate the capacity of the facility to act as a barrier to the release of radionuclides and toxic pollutants, and to shed light on the importance of the location of the repository site. A safety assessment (SR 97) of a deep repository for spent fuel has been carried out at the same time. In SR 97, three hypothetical repository sites have been selected for study. These sites exhibit fairly different conditions in terms of hydrogeology, hydrochemistry and ecosystems. To make use of information and data from the SR 97 study, we have assumed that SFL 3-5 is co-sited with the deep repository for spent fuel. A conceivable alternative is to site SFL 3-5 as a completely separate repository. The focus of the SFL 3-5 study is a quantitative analysis of the environmental impact for a reference scenario, while other scenarios are discussed and analyzed in more general terms. Migration in the repository's near- and far-field has been taken into account in the reference scenario. Environmental impact on the three sites has also been calculated. The calculations are based on an updated forecast of the waste to be disposed of in SFL 3-5. The forecast includes radionuclide content, toxic metals and other substances that have a bearing on a safety assessment. The safety assessment shows how important the site is for safety. Two factors stand out as being particularly important: the water flow at the depth in the rock where the repository is built, and the ecosystem in the areas on the ground surface where releases may take place in the future. Another conclusion is that radionuclides that are highly mobile and long-lived, such as 36 Cl and 93 Mo , are important to take into consideration. Their being long-lived means that barriers and the ecosystems must be regarded with a very long time horizon

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.

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

Preliminary Study on the Development of Quantitative Safety Culture Index

International Nuclear Information System (INIS)

Lee, Young Eal; Kim, Hun Sil; Ahn, Nam Sung

2005-01-01

Safety culture is that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance. Because it needs to be recognized as the most significant consciousness to achieve the nuclear safety performance, Korean government and nuclear power generation company have tried to develop the practical method to improve the safety culture from the long term point view. In this study, based on the site interviews to define the potential issues on organizational behavior for the safe operation and the survey on the level of safety culture of occupied workers are conducted. Survey results are quantified as a few indicators of nuclear safety by the statistical method and it can be simulated by the dynamic modeling as time goes on. Currently index and dynamic modeling are still being developed, however, results can be used to suggest the long term strategy which safety is clearly integrated into all activities in the nuclear organization

Long term stability of power systems

Energy Technology Data Exchange (ETDEWEB)

Kundur, P; Gao, B [Powertech Labs. Inc., Surrey, BC (Canada)

1994-12-31

Power system long term stability is still a developing subject. In this paper we provide our perspectives and experiences related to long term stability. The paper begins with the description of the nature of the long term stability problem, followed by the discussion of issues related to the modeling and solution techniques of tools for long term stability analysis. Cases studies are presented to illustrate the voltage stability aspect and plant dynamics aspect of long term stability. (author) 20 refs., 11 figs.

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

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.

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)

Barrier analogs: Long-term performance issues, preliminary studies, and recommendations

Energy Technology Data Exchange (ETDEWEB)

Waugh, W.J. [Rust Geotech, Inc., Grand Junction, CO (United States). Environmental Sciences Lab.; Chatters, J.C.; Last, G.V.; Bjornstad, B.N.; Link, S.O. [Pacific Northwest Lab., Richland, WA (United States); Hunter, C.R. [Cascade Earth Sciences, La Grande, OR (United States)

1994-02-01

The US Department of Energy`s Hanford Protective Barrier Development Program is funding studies of natural analogs of the long-term performance of waste site covers. Natural-analog studies examine past environments as evidence for projecting the future performance of engineered structures. The information generated by analog studies is needed to (1) evaluate the designs and results of short term experiments and demonstrations, (2) formulate performance-modeling problems that bound expected changes in waste site environments, and (3) understand emergent system attributes that cannot be evaluated with short-term experiments or computer models. Waste site covers will be part of dynamic environmental systems with attributes that transcend the traits of engineered components. This report discusses results of the previously unreported preliminary studies conducted in 1983 and 1984. These results indicate that analogs could play an important role in predicting the long-term behavior of engineered waste covers. Layered exposures of glacial-flood-deposited gravels mantled with silt or sand that resemble contemporary barrier designs were examined. Bergmounds, another anomaly left by cataclysmic glacial floods, were also examined as analogs of surface gravel.

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.)

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

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

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.

Geosphere Stability for long-term isolation of radioactive waste. Case study for hydrological change with earthquakes and faulting

International Nuclear Information System (INIS)

Niwa, Masakazu

2016-01-01

Appropriate estimation and safety assessment for long-term changes in geological environment are essential to an improvement of reliability for geological disposal. Specifically, study on faults is important for understanding regional groundwater flow as well as an assessment as a trigger of future earthquakes. Here, possibility of changes in permeability of faulted materials induced by earthquakes was examined based on monitoring data of groundwater pressure before and after the 2011 off the Pacific coast of Tohoku Earthquake. (author)

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...

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)

[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

Near-Term Actions to Address Long-Term Climate Risk

Science.gov (United States)

Lempert, R. J.

2014-12-01

Addressing climate change requires effective long-term policy making, which occurs when reflecting on potential events decades or more in the future causes policy makers to choose near-term actions different than those they would otherwise pursue. Contrary to some expectations, policy makers do sometimes make such long-term decisions, but not as commonly and successfully as climate change may require. In recent years however, the new capabilities of analytic decision support tools, combined with improved understanding of cognitive and organizational behaviors, has significantly improved the methods available for organizations to manage longer-term climate risks. In particular, these tools allow decision makers to understand what near-term actions consistently contribute to achieving both short- and long-term societal goals, even in the face of deep uncertainty regarding the long-term future. This talk will describe applications of these approaches for infrastructure, water, and flood risk management planning, as well as studies of how near-term choices about policy architectures can affect long-term greenhouse gas emission reduction pathways.

Laser-assisted endoscopic third ventriculostomy: long-term results in a series of 202 patients

NARCIS (Netherlands)

van Beijnum, Janneke; Hanlo, Patrick W.; Fischer, Kathelijn; Majidpour, Mohsen M.; Kortekaas, Marlous F.; Verdaasdonk, Rudolf M.; Vandertop, W. Peter

2008-01-01

OBJECTIVE: Endoscopic third ventriculostomy is a well-known surgical option in the treatment of noncommunicating hydrocephalus. We studied complications and long-term success in 202 patients to demonstrate the safety and efficacy of laser-assisted endoscopic third ventriculostomy (LA-ETV) using a

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

DEFF Research Database (Denmark)

Chaparro, M; Verreth, A; Lobaton, T

2018-01-01

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

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

Science.gov (United States)

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

2009-09-01

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

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 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.

LOng-term follow-up after liVE kidney donation (LOVE) study: A longitudinal comparison study protocol

NARCIS (Netherlands)

S. Janki (Shiromani); K.W.J. Klop (Karel); H.J.A.N. Kimenai (Hendrikus); J. van de Wetering (Jacqueline); W. Weimar (Willem); E.K. Massey (Emma); A. Dehghan (Abbas); D. Rizopoulos (Dimitris); H. Völzke (Henry); A. Hofman (Albert); J.N.M. IJzermans (Jan)

2016-01-01

textabstractBackground: The benefits of live donor kidney transplantation must be balanced against the potential harm to the donor. Well-designed prospective studies are needed to study the long-term consequences of kidney donation. Methods: The "LOng-term follow-up after liVE kidney donation"

Short-term initiatives for enhancing cyber-safety within South African schools

Directory of Open Access Journals (Sweden)

Elmarie Kritzinger

2016-07-01

Full Text Available The rate of technological development across the globe is dramatic. The decreasing cost and increasing availability of ICT devices means that its users are no longer exclusively industry or government employees – they are now also home users. Home users integrate ICT in their daily lives for education, socialising and information gathering. However, using ICT is associated with risks and threats, such as identity theft and phishing scams. Most home users of ICT do not have the necessary information technology and Internet skills to protect themselves and their information. School learners, in particular, are not sufficiently educated on how to use technological devices safely, especially in developing countries such as South Africa. The national school curriculum in South Africa currently does not make provision for cyber-safety education, and the availability of supporting material and training for ICT teachers in South Africa is limited, resulting in a lack of knowledge and skills regarding cyber-safety. The research in hand focuses on the situation concerning cyber-safety awareness in schools and has adopted a short-term approach towards cyber-safety among teachers and school learners in South Africa until a formal long-term national approach has been implemented. This study takes a quantitative approach to investigating the current options of teachers to enhance cyber-safety among learners in their schools. The research proposes that short-term initiatives (i.e. posters can increase learners’ awareness of cyber-safety until formal cyber-safety awareness methods have been introduced.

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)

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.

HLW Long-term Management Technology Development

International Nuclear Information System (INIS)

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

2010-02-01

Permanent disposal of spent nuclear fuels from the power generation is considered to be the unique method for the conservation of human being and nature in the present and future. In spite of spent nuclear fuels produced from power generation, based on the recent trends on the gap between supply and demand of energy, the advance on energy price and reduction of carbon dioxide, nuclear energy is expected to play a role continuously in Korea. It means that a new concept of nuclear fuel cycle is needed to solve problems on spent nuclear fuels. The concept of the advanced nuclear fuel cycle including PYRO processing and SFR was presented at the 255th meeting of the Atomic Energy Commission. According to the concept of the advanced nuclear fuel cycle, actinides and long-term fissile nuclides may go out of existence in SFR. And then it is possible to dispose of short term decay wastes without a great risk bearing. Many efforts had been made to develop the KRS for the direct disposal of spent nuclear fuels in the representative geology of Korea. But in the case of the adoption of Advanced nuclear fuel cycle, the disposal of PYRO wastes should be considered. For this, we carried out the Safety Analysis on HLW Disposal Project with 5 sub-projects such as Development of HLW Disposal System, Radwaste Disposal Safety Analysis, Feasibility study on the deep repository condition, A study on the Nuclide Migration and Retardation Using Natural Barrier, and In-situ Study on the Performance of Engineered Barriers

Factors related to the high fall rate in long-term care residents with dementia

NARCIS (Netherlands)

Kosse, Nienke M.; de Groot, Maartje H.; Vuillerme, Nicolas; Hortobagyi, Tibor; Lamoth, Claudine J. C.

Background: Falls in long-term care residents with dementia represent a costly but unresolved safety issue. The aim of the present study was to (1) determine the incidence of falls, fall-related injuries and fall circumstances, and (2) identify the relationship between patient characteristics and

Long-Term Engagement in Formal Volunteering and Well-Being: An Exploratory Indian Study.

Science.gov (United States)

Elias, Jereesh K; Sudhir, Paulomi; Mehrotra, Seema

2016-09-27

Sustained engagement in volunteering and its correlates have been examined in many studies across the globe. However, there is a dearth of research that explores the perspectives of long-term formal volunteers on the nature of changes perceived in oneself as a result of volunteering. Moreover, the linkages between psychological well-being and volunteering have been insufficiently explored. The present study was aimed at addressing these gaps. A heterogeneous sample of 20 long-term formal volunteer engaged in volunteering across different voluntary organisations in a southern metropolitan Indian city formed the primary sample for the study. In addition, a group of 21 short-term volunteers, matched on age, income and gender, was utilised for comparison with long-term volunteers on well-being indices. A semi structured interview schedule was used to explore self-perceived changes attributable to volunteering experience. In addition, a few standardised measures were used to comprehensively assess subjective well-being and psychological well-being. The interview data provided rich descriptions of perceived positive changes in self across cognitive, behavioral and emotional domains. Mirroring these patterns, the quantitative analyses indicated that long-term volunteers experienced higher levels of psychological well-being (sense of mastery and competence, self-acceptance and sense of engagement and growth) than short-term volunteers. The potential mechanisms involved in beneficial outcomes of long-term volunteering and implications for further research are highlighted.

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

Energy Technology Data Exchange (ETDEWEB)

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

2012-07-01

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

Deep repository for long-lived low- and intermediate-level waste. Preliminary safety assessment

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-11-01

A preliminary safety assessment has been performed of a deep repository for long-lived low- and intermediate-level waste, SFL 3-5. The purpose of the study is to investigate the capacity of the facility to act as a barrier to the release of radionuclides and toxic pollutants, and to shed light on the importance of the location of the repository site. A safety assessment (SR 97) of a deep repository for spent fuel has been carried out at the same time. In SR 97, three hypothetical repository sites have been selected for study. These sites exhibit fairly different conditions in terms of hydrogeology, hydrochemistry and ecosystems. To make use of information and data from the SR 97 study, we have assumed that SFL 3-5 is co-sited with the deep repository for spent fuel. A conceivable alternative is to site SFL 3-5 as a completely separate repository. The focus of the SFL 3-5 study is a quantitative analysis of the environmental impact for a reference scenario, while other scenarios are discussed and analyzed in more general terms. Migration in the repository's near- and far-field has been taken into account in the reference scenario. Environmental impact on the three sites has also been calculated. The calculations are based on an updated forecast of the waste to be disposed of in SFL 3-5. The forecast includes radionuclide content, toxic metals and other substances that have a bearing on a safety assessment. The safety assessment shows how important the site is for safety. Two factors stand out as being particularly important: the water flow at the depth in the rock where the repository is built, and the ecosystem in the areas on the ground surface where releases may take place in the future. Another conclusion is that radionuclides that are highly mobile and long-lived, such as {sup 36}Cl and {sup 93}Mo , are important to take into consideration. Their being long-lived means that barriers and the ecosystems must be regarded with a very long time horizon.

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.

Science and society: the role of long-term studies in environmental stewardship

Science.gov (United States)

Charles T. Driscoll; Kathleen F. Lambert; F. Stuart Chapin; David J. Nowak; Thomas A. Spies; Frederick J. Swanson; David B. Kittredge; Clarisse M. Hart

2012-01-01

Long-term research should play a crucial role in addressing grand challenges in environmental stewardship. We examine the efforts of five Long Term Ecological Research Network sites to enhance policy, management, and conservation decisions for forest ecosystems. In these case studies, we explore the approaches used to inform policy on atmospheric deposition, public...

A study about the long-term stability of sedimentary rock

International Nuclear Information System (INIS)

Yoshino, Naoto; Miyanomae, Shun-ichi; Inoue, Hiroyuki; Nashimoto, Yutaka

2005-02-01

In this paper, following two issues were examined and estimated, (1) the influence of near field condition factor to the dynamical behavior of sedimentary soft rock, (2) the long term estimation of the dynamical behavior considering the condition of Horonobe area. As the study about the influence of near field condition factor to the dynamical behavior of sedimentary soft rock, the thermal factor was focused on and the laboratory tests using test pieces which were sampled in Horonobe area were carried out under the water temperature were 20 degrees and 80 degrees. As a result, the time dependence parameter in variable-compliance-type constitutive-equation could be obtained. And comparison between creep property under 20 degrees and 80 degrees was conducted. In addition, the general properties of sedimentary soft rock under several conditions were identified by the survey of the literature. And the way how to confirm the dynamical properties of sedimentary soft rock with in-situ test were presented. For the study on the short-term and long-term stability of rock surrounding buffer materials, numerical simulations were carried out assuming several conditions. The direction of disposal tunnels and the ratio of rock strength by initial stress were estimated to be the main factor affecting the short-term stability of rock. Time dependency of rock and the stiffness of buffer material were estimated to be the main factor affecting the long-term stability of rock. (author)

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.

An idealised study for the long term evolution of crescentic bars

Science.gov (United States)

Chen, W. L.; Dodd, N.; Tiessen, M. C. H.; Calvete, D.

2018-01-01

An idealised study that identifies the mechanisms in the long term evolution of crescentic bar systems in nature is presented. Growth to finite amplitude (i.e., equilibration, sometimes referred to as saturation) and higher harmonic interaction are hypothesised to be the leading nonlinear effects in long-term evolution of these systems. These nonlinear effects are added to a linear stability model and used to predict crescentic bar development along a beach in Duck, North Carolina (USA) over a 2-month period. The equilibration prolongs the development of bed patterns, thus allowing the long term evolution. Higher harmonic interaction enables the amplitude to be transferred from longer to shorter lengthscales, which leads to the dominance of shorter lengthscales in latter post-storm stages, as observed at Duck. The comparison with observations indicates the importance of higher harmonic interaction in the development of nearshore crescentic bar systems in nature. Additionally, it is concluded that these nonlinear effects should be included in models simulating the development of different bed patterns, and that this points a way forward for long-term morphodynamical modelling in general.

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)

Mark I containment, short term program. Safety evaluation report

International Nuclear Information System (INIS)

1977-12-01

Presented is a Safety Evaluation Report (SER) prepared by the Office of Nuclear Reactor Regulation addressing the Short Term Program (STP) reassessment of the containment systems of operating Boiler Water Reactor (BWR) facilities with the Mark I containment system design. The information presented in this SER establishes the basis for the NRC staff's conclusion that licensed Mark I BWR facilities can continue to operate safely, without undue risk to the health and safety of the public, during an interim period of approximately two years while a methodical, comprehensive Long Term Program (LTP) is conducted. This SER also provides one of the basic foundations for the NRC staff review of the Mark I containment systems for facilities not yet licensed for operation

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)

Short- versus long-term radon detectors: a comparative study in Galicia, NW Spain

International Nuclear Information System (INIS)

Ruano-Ravina, A.; Castro-Bernardez, M.; Sande-Meijide, M.; Vargas, A.; Barros-Dios, J.M.

2008-01-01

As reported in previous studies, Galicia (NW Spain) is an area of high radon concentrations. This study was sought to analyze the correlation between short-term (activated carbon) and long-term (alpha particle track) detectors in this geographic area, and ascertain whether there were differences in their readings that might be influenced by other variables. A comparison study, as part of a case-control study was designed in which two detectors, one of each type, were placed in the selected homes. A total of 391 homes yielded readings with both detectors. The results indicated that there was a relatively good correlation between both types of monitors (correlation coefficient 0.608; p < 0.001). The highest correlations between both detectors were observed for unventilated homes, coastal sites, and the oldest buildings. Short-term and long-term detectors do not show a similar performance in all settings or situations. It is advisable to use long-term detectors whenever possible

Short- versus long-term radon detectors: a comparative study in Galicia, NW Spain

Energy Technology Data Exchange (ETDEWEB)

Ruano-Ravina, A. [Department of Preventive Medicine and Public Health, School of Medicine, University of Santiago de Compostela, C/San Francisco s/n, 15782 Santiago de Compostela (Spain); Galician Agency for Health Technology Assessment, Galician Health Service, Santiago de Compostela (Spain); CIBER de Epidemiologia y Salud Publica, CIBERESP (Spain)], E-mail: mralbert@usc.es; Castro-Bernardez, M. [Epidemiology Department, Directorate-General for Public Health, Galician Regional Authority (Spain); Sande-Meijide, M. [Preventive Medicine Unit, Ourense Hospital Complex, Galician Health Service (Spain); Vargas, A. [Energy Techniques Institute, Polytechnic University of Catalonia, Barcelona (Spain); Barros-Dios, J.M. [Department of Preventive Medicine and Public Health, School of Medicine, University of Santiago de Compostela, C/San Francisco s/n, 15782 Santiago de Compostela (Spain); CIBER de Epidemiologia y Salud Publica, CIBERESP (Spain); Preventive Medicine Unit, Santiago de Compostela University Hospital, Galician Health Service (Spain)

2008-07-15

As reported in previous studies, Galicia (NW Spain) is an area of high radon concentrations. This study was sought to analyze the correlation between short-term (activated carbon) and long-term (alpha particle track) detectors in this geographic area, and ascertain whether there were differences in their readings that might be influenced by other variables. A comparison study, as part of a case-control study was designed in which two detectors, one of each type, were placed in the selected homes. A total of 391 homes yielded readings with both detectors. The results indicated that there was a relatively good correlation between both types of monitors (correlation coefficient 0.608; p < 0.001). The highest correlations between both detectors were observed for unventilated homes, coastal sites, and the oldest buildings. Short-term and long-term detectors do not show a similar performance in all settings or situations. It is advisable to use long-term detectors whenever possible.

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 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

Long-term efficacy of rasagiline in early Parkinson's disease.

Science.gov (United States)

Lew, Mark F; Hauser, Robert A; Hurtig, Howard I; Ondo, William G; Wojcieszek, Joanne; Goren, Tamar; Fitzer-Attas, Cheryl J

2010-06-01

This study was designed to follow the long-term efficacy, safety, and tolerability of rasagiline for Parkinson's disease (PD) with data collected from all patients who had ever taken rasagiline during the 12-month TEMPO monotherapy trial (N = 398) and subsequent open-label extension. Patients were followed for up to 6.5 years with a mean of 3.5 +/- 2.1 years. After 12 months, additional PD medications were added as required. Of patients remaining in the trial at 2 years, 46% were maintained on rasagiline monotherapy. The majority of patients received a dopamine agonist prior to levodopa as the first additional dopaminergic agent. Analysis using a Kaplan-Meier method indicated that by 5.4 years only 25% of patients progressed to Hoehn & Yahr stage III. Rasagiline was well tolerated, with 11.3% of patients (45/398) withdrawing because of an adverse event. Rasagiline therapy for PD was effective, well tolerated, and safe in this long-term trial.

Preservation of RK and M for Long Term Storage Facilities: The Results of a French Study

International Nuclear Information System (INIS)

Schneider, Thierry

2012-01-01

Due to the specific long lasting radioactivity of high level waste types, new issues may arise for radiation protection. In this perspective, technical, societal and organizational aspects have to be considered. For the two latter aspects, it is interesting to analyse the efficiency of protection systems available in other fields than nuclear waste management, in order either to protect society from specific risk or to preserve world heritage. Few years ago, CEPN together with MUTADIS have performed a specific study, commissioned by CEA (Commissariat a l'Energie Atomique). The presentation briefly presented the case studies performed on long term protection, as well as the key lessons related to the continuity and sustainability of the surveillance and control of radioactive waste facilities, and the effectiveness of financing schemes for the long term management of radioactive waste. This study has identified a set of performance criteria to deal with long term protection. These results were notably discussed within the framework of the European project COWAM 2 in a working group involving experts, authorities, waste managers, locally elected representatives and NGOs. One part of the study was to analyse the characteristics of protection systems used to manage risks associated with the presence of past underground cavities and mines. A case study presented was the following: After the closing of last mines, maintenance also ended, which, years later, caused ground collapses which led to discussions on responsibility. The connection between the safety problems and the loss of economic activities was underlined. In this context, the IGC (Inspection Generale des Carrieres) was set up. An important part of its functioning is the interaction with the building owners of Paris. The arrangement is that the current owners pay for assuring safety, even though the cause of the safety issue goes back long before owners bought the premises. It was pointed out that market value

Long-Term Metastatic Risk after Biopsy of Posterior Uveal Melanoma

DEFF Research Database (Denmark)

Bagger, Mette; Smidt-Nielsen, Isabel; Andersen, Mette K

2018-01-01

PURPOSE: Biopsy of posterior uveal melanoma continues to be intensely debated in terms of the clinical benefits and safety profile. Although several studies have reported a low frequency of ocular complications after tumor biopsy, the potential long-term risk of iatrogenic dissemination remains...... unresolved. The purpose of this study was to assess the risk of metastatic disease after biopsy of posterior uveal melanoma. DESIGN: Retrospective nationwide cohort study linking clinical and histopathologic records to pathology, cancer, and mortality registries. PARTICIPANTS: All patients with posterior...... uveal melanoma treated in Denmark between January 1985 and December 2016. METHODS: For each patient, we recorded detailed information on age, gender, tumor characteristics, and diagnostic and therapeutic measures, including tumor biopsy, if any, and the primary treating hospital. Absolute risk...

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

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

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)

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

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

Gauging the Purported Costs of Public Data Archiving for Long-Term Population Studies.

Science.gov (United States)

Evans, Simon Robin

2016-04-01

It was recently proposed that long-term population studies be exempted from the expectation that authors publicly archive the primary data underlying published articles. Such studies are valuable to many areas of ecological and evolutionary biological research, and multiple risks to their viability were anticipated as a result of public data archiving (PDA), ultimately all stemming from independent reuse of archived data. However, empirical assessment was missing, making it difficult to determine whether such fears are realistic. I addressed this by surveying data packages from long-term population studies archived in the Dryad Digital Repository. I found no evidence that PDA results in reuse of data by independent parties, suggesting the purported costs of PDA for long-term population studies have been overstated.

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

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.

Very long-term sequelae of craniopharyngioma.

Science.gov (United States)

Wijnen, Mark; van den Heuvel-Eibrink, Marry M; Janssen, Joseph A M J L; Catsman-Berrevoets, Coriene E; Michiels, Erna M C; van Veelen-Vincent, Marie-Lise C; Dallenga, Alof H G; van den Berge, J Herbert; van Rij, Carolien M; van der Lely, Aart-Jan; Neggers, Sebastian J C M M

2017-06-01

Studies investigating long-term health conditions in patients with craniopharyngioma are limited by short follow-up durations and generally do not compare long-term health effects according to initial craniopharyngioma treatment approach. In addition, studies comparing long-term health conditions between patients with childhood- and adult-onset craniopharyngioma report conflicting results. The objective of this study was to analyse a full spectrum of long-term health effects in patients with craniopharyngioma according to initial treatment approach and age group at craniopharyngioma presentation. Cross-sectional study based on retrospective data. We studied a single-centre cohort of 128 patients with craniopharyngioma treated from 1980 onwards (63 patients with childhood-onset disease). Median follow-up since craniopharyngioma presentation was 13 years (interquartile range: 5-23 years). Initial craniopharyngioma treatment approaches included gross total resection ( n  = 25), subtotal resection without radiotherapy ( n  = 44), subtotal resection with radiotherapy ( n  = 25), cyst aspiration without radiotherapy ( n  = 8), and 90 Yttrium brachytherapy ( n  = 21). Pituitary hormone deficiencies (98%), visual disturbances (75%) and obesity (56%) were the most common long-term health conditions observed. Different initial craniopharyngioma treatment approaches resulted in similar long-term health effects. Patients with childhood-onset craniopharyngioma experienced significantly more growth hormone deficiency, diabetes insipidus, panhypopituitarism, morbid obesity, epilepsy and psychiatric conditions compared with patients with adult-onset disease. Recurrence-/progression-free survival was significantly lower after initial craniopharyngioma treatment with cyst aspiration compared with other therapeutic approaches. Survival was similar between patients with childhood- and adult-onset craniopharyngioma. Long-term health conditions were comparable after

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

OpenAIRE

Bankole K. Fasanya; Emmanuel A. Dada

2016-01-01

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

Long-term associative learning predicts verbal short-term memory performance.

Science.gov (United States)

Jones, Gary; Macken, Bill

2018-02-01

Studies using tests such as digit span and nonword repetition have implicated short-term memory across a range of developmental domains. Such tests ostensibly assess specialized processes for the short-term manipulation and maintenance of information that are often argued to enable long-term learning. However, there is considerable evidence for an influence of long-term linguistic learning on performance in short-term memory tasks that brings into question the role of a specialized short-term memory system separate from long-term knowledge. Using natural language corpora, we show experimentally and computationally that performance on three widely used measures of short-term memory (digit span, nonword repetition, and sentence recall) can be predicted from simple associative learning operating on the linguistic environment to which a typical child may have been exposed. The findings support the broad view that short-term verbal memory performance reflects the application of long-term language knowledge to the experimental setting.

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

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.

Microscopic study of rock for estimating long-term behavior

International Nuclear Information System (INIS)

Ichikawa, Yasuaki

2004-02-01

Micro-structure of rock plays an essential role for their long-term behavior. For understanding long-term characteristics of granite we here present the followings: 1) observation of microcrack initiation and propagation by Conforcal Laser Scanning Microscope (CLSM) under uniaxial compression (before loading and at each loading stage), 2) characterization of the mechanism of microcrack initiation and propagation observed by stereoscopic microscope under uniaxial/triaxial compression and relaxation tests, and 3) a study of strong discontinuity analysis included in the homogenization theory to predict the long-term behavior of micro/macro-level stress for granite. First, CLSM was used to acquire clearly focused three-dimensional images of granite specimens, and observed the change of microscale structure including the mineral configuration under applying uniaxial compression stress. Then though microcracks have ever thought to be initiated and propagated on intergranular boundaries, we understand through the CLSM observation that new microcracks are generated from the ends of pre-existing cracks which are distributed in quartz and biotite. Second, we showed the results of stress-relaxation test of granite specimens observed by an optical microscope under water-saturated triaxial compression condition. Since microcrack generation and propagation play an essential role to predict the long-term behavior of rock, we managed the experiments with careful attention of 1) keeping constant edge-displacement and constant strain in the whole specimen accurately, and 2) measuring the relaxed stress exactly. Next, in order to simulate the experimental results which indicate that initiation and propagation of microcracks control the stress-relaxation phenomenon, we introduce a homogenization analysis procedure together with the strong discontinuity analysis which has recently established the mechanical implication and mathematical foundation. The numerical results show that we can

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

Science.gov (United States)

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

2016-04-01

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

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

International Nuclear Information System (INIS)

Nair, R.N.

2010-01-01

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

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

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

Long-term associative learning predicts verbal short-term memory performance

OpenAIRE

Jones, Gary; Macken, Bill

2017-01-01

Studies using tests such as digit span and nonword repetition have implicated short-term memory across a range of developmental domains. Such tests ostensibly assess specialized processes for the short-term manipulation and maintenance of information that are often argued to enable long-term learning. However, there is considerable evidence for an influence of long-term linguistic learning on performance in short-term memory tasks that brings into question the role of a specialized short-term...

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 sickness absence from work due to physical inactivity: A registry-based study.

Science.gov (United States)

Høgsbro, Cecilie; Davidsen, Michael; Sørensen, Jan

2018-01-01

The aim of this study was to explore the relationship between leisure-time physical inactivity and long-term sickness absence in a representative sample of individuals aged 16-54 years, within the labour market and in good health. It was hypothesised that physically inactive individuals have a higher risk of long-term sickness absence and longer duration of sickness absence. The study population was identified from the National Health and Morbidity Survey, 2010. Weekly data on long-term sickness absence were obtained from the National Register on Social Transfer Payments (the DREAM registry). The association of incidence and duration of long-term sickness absence with physical inactivity was explored using logistic and Poisson regression. Data were fitted to models with levels of physical activity, demographic, social and lifestyle characteristics as independent variables. A combined hurdle model was used to estimate the difference in mean number of absence weeks. Logistic regression showed that physically inactive individuals had a 27% higher incidence of long-term sickness absence compared with physically active individuals. The Poisson regression showed that long-term sickness absence was only slightly shorter (1 week less) for moderately active individuals compared with inactive individuals. The hurdle model estimated longer absence periods for inactive individuals (additional 2.5 weeks) in comparison with moderately and highly active individuals. The study showed that physically inactive individuals have a higher incidence of long-term absence and that physically inactive individuals have longer periods with sickness absence than moderately and highly active individuals. When adjustments for social and health behaviour were included, the estimated associations became statistically insignificant.

The long-term use of cyproterone acetate in pedophilia: a case study.

Science.gov (United States)

Cooper, A J; Cernovsky, Z; Magnus, R V

1992-01-01

This investigation reports the long-term use of the antiandrogen cyproterone acetate (CPA) in a pedophile, who was studied continuously over 38 months. Measures of sexual arousal, serum testosterone, and gonadotropin levels were significantly reduced by the drug as compared with placebo and no treatment; prolactin levels were significantly elevated. Some workers have observed that long-term administration of CPA (more than one year, which was then discontinued) produced enduring (in some cases apparently permanent) anti-libidinal effects; however, in the case described, within three weeks of stopping the drug, all measures had returned to pretrial levels. The importance of continuous long-term monitoring in sex offenders receiving an antiandrogen is discussed.

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).

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).

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

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

Directory of Open Access Journals (Sweden)

Geun Young Lee

2017-09-01

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

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

Science.gov (United States)

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

2017-01-01

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

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

Science.gov (United States)

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

2017-01-01

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

Long-term Studies of Marine Halogen Release

Science.gov (United States)

Tschritter, J.; Holla, R.; Frieß, U.; Platt, U.

2009-04-01

Institute of Enviromental Physics, Heidelberg, Germany. Long term measurements of atmospheric trace gases using multi-axis DOAS instruments are pursued at the new SOLAS observatory on the island of Sao Vicente, (Cape Verde). This research is part of the SOPRAN (Surface Ocean Processes in the ANthropocene) project (Fördernummer:03F0462F). Reactive halogen species (RHS) such as bromine- and iodine- containing species play major roles in the chemistry of ozone in both the troposphere and lower stratosphere and thus possibly influence the ozone budget on a global scale. In addition iodine-species emitted from the ocean surface have been shown to be responsible for the production of new atmospheric particles in the marine boundary layer. This may have an effect on cloud formation and radiation transfer on local and global scales. Long term measurements of RHS abundances will help to identify their key regions and processes for formation. A new long term Multi-MAX-DOAS instrument has been installed at the SOLAS observatory on the island of Sao Vicente, (Cape Verde). The main focus of these unique measurements is the investigation of reactive halogen chemistry in the subtropical marine boundary layer based on measurements of BrO, IO, and possibly OIO. Because of its wide spectral range also the use for O4-retrievals to gain aerosol profiles is possible. IO has been detected with mixing ratios up to 1.3 ppt. For BrO an upper limit of 2 ppt could be determined.

Intelligent power wheelchair use in long-term care: potential users' experiences and perceptions.

Science.gov (United States)

Rushton, Paula W; Mortenson, Ben W; Viswanathan, Pooja; Wang, Rosalie H; Miller, William C; Hurd Clarke, Laura

2017-10-01

Long-term care (LTC) residents with cognitive impairments frequently experience limited mobility and participation in preferred activities. Although a power wheelchair could mitigate some of these mobility and participation challenges, this technology is often not prescribed for this population due to safety concerns. An intelligent power wheelchair (IPW) system represents a potential intervention that could help to overcome these concerns. The purpose of this study was to explore a) how residents experienced an IPW that used three different modes of control and b) what perceived effect the IPW would have on their daily lives. We interviewed 10 LTC residents with mild or moderate cognitive impairment twice, once before and once after testing the IPW. Interviews were conducted using a semi-structured interview guide, audio recorded and transcribed verbatim for thematic analyses. Our analyses identified three overarching themes: (1) the difference an IPW would make, (2) the potential impact of the IPW on others and (3) IPW-related concerns. Findings from this study confirm the need for and potential benefits of IPW use in LTC. Future studies will involve testing IPW improvements based on feedback and insights from this study. Implications for rehabilitation Intelligent power wheelchairs may enhance participation and improve safety and feelings of well-being for long-term care residents with cognitive impairments. Intelligent power wheelchairs could potentially have an equally positive impact on facility staff, other residents, and family and friends by decreasing workload and increasing safety.

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.

Microscopic study of rock for estimating long-term behavior

International Nuclear Information System (INIS)

Ichikawa, Yasuaki

2002-03-01

Micro-structure of rock plays a essential role for their long-term behavior. For elucidating long-term characteristics of granite we here present the followings: 1) Conforcal Laser Scanning Microscope (LSM) observation of joint surfaces of granite and Fourier analysis, 2) characterization of the mechanism of microcrack initiation and propagation observed by stereoscopic microscope under uniaxial/triaxial compression and relaxation tests, 3) observation of microcrack initiation and propagation by LSM under uniaxial compression, and 4) a viscoelastic homogenization theory to predict the long-term behavior of micro/macro-level stress for granite. Rock image processing and analysis become a fundamental procedure to determine rock surface discontinuities. But the complexity of rock surface discontinuities seems beyond the manual image processing method. In Chapter 2 a Conforcal Laser Scanning Microscope that can acquire three-dimensional images is introduced to observe the rock roughness of a discontinuity. Then, scanning three-dimensional images are changed its data form in order to adapt various image analysis programs, and granitic rock roughness of discontinuities are displayed by graphic images. For example, these datas are analyzed by Discrete Fourier Transformation (DFT) program and Inverse Discrete Fourier Transformation (IDFT) program. Microcrack generation and propagation play an essential role to predict the long-term behavior of rock. In Chapter 3 a progressive development of cracking in granite is revealed by using stereoscopic microscope under triaxial compression condition and by using LSM under uniaxial compression condition. With a viscoelastic theory applied in homogenization method, we can calculate macro behavior of medium influenced by its micro structure by analyse the long-term time-dependent behavior of granite under the same condition to the relaxation experiment. (author)

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.

Liquid nitrogen spray cryotherapy in Barrett's esophagus with high-grade dysplasia: long-term results.

Science.gov (United States)

Gosain, Sonia; Mercer, Kim; Twaddell, William S; Uradomo, Lance; Greenwald, Bruce D

2013-08-01

Liquid nitrogen endoscopic spray cryotherapy can safely and effectively eradicate high-grade dysplasia in Barrett's esophagus (BE-HGD). Long-term data on treatment success and safety are lacking. To assess the long-term safety and efficacy of spray cryotherapy in patients with BE-HGD. Single-center, retrospective study. Tertiary-care referral center. A total of 32 patients with BE-HGD of any length. Patients were treated with liquid nitrogen spray cryotherapy every 8 weeks until complete eradication of HGD (CE-HGD) and intestinal metaplasia (CE-IM) was found by endoscopic biopsy. Surveillance endoscopy with biopsies was performed for at least 2 years. CE-HGD, CE-IM, durability of response, disease progression, and adverse events. CE-HGD was 100% (32/32), and CE-IM was 84% (27/32) at 2-year follow-up. At last follow-up (range 24-57 months), CE-HGD was 31/32 (97%), and CE-IM was 26/32 (81%). Recurrent HGD was found in 6 (18%), with CE-HGD in 5 after repeat treatment. One patient progressed to adenocarcinoma, downgraded to HGD after repeat cryotherapy. BE segment length ≥3 cm was associated with a higher recurrence of IM (P = .004; odds ratio 22.6) but not HGD. No serious adverse events occurred. Stricture was seen in 3 patients (9%), all successfully dilated. Retrospective study design, small sample size. In patients with BE-HGD, liquid nitrogen spray cryotherapy has an acceptable safety profile and success rate for eliminating HGD and IM and is associated with a low rate of recurrence or progression to cancer with long-term follow-up. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Factors Related to Healthcare Service Quality in Long-term Care Hospitals in South Korea: A Mixed-methods Study.

Science.gov (United States)

Sohn, Minsung; Choi, Mankyu

2017-10-01

The environment of long-term care hospitals (LTCHs) is critical to the management of the quality of their services and to patient safety, as highlighted by international studies. However, there is a lack of evidence on this topic in South Korea. This study aimed to examine the factors affecting healthcare quality in LTCHs and to explore the effectiveness of their quality management. This study used a mixed methods approach with quantitative data collected in a national survey and qualitative data from semi-structured interviews with practice-based managers. The samples included 725 nationally representative LTCHs in South Korea for the quantitative analysis and 15 administrators for the in-depth interviews. A higher installation rate of patient-safety and hygiene-related facilities and staff with longer-tenures, especially nurses, were more likely to have better healthcare quality and education for both employees and patients. The need for patient-safety- and hygiene-related facilities in LTCHs that serve older adults reflects their vulnerability to certain adverse events (e.g., infections). Consistent and skillful nursing care to improve the quality of LTCHs can be achieved by developing relevant educational programs for staff and patients, thereby strengthening the relationships between them.

Long-term particulate matter exposure and mortality: a review of European epidemiological studies

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Boffetta Paolo

2009-12-01

Full Text Available Abstract Background Several studies considered the relation between long-term exposure to particulate matter (PM and total mortality, as well as mortality from cardiovascular and respiratory diseases. Our aim was to provide a comprehensive review of European epidemiological studies on the issue. Methods We searched the Medline database for epidemiological studies on air pollution and health outcomes published between January 2002 and December 2007. We also examined the reference lists of individual papers and reviews. Two independent reviewers classified the studies according to type of air pollutant, duration of exposure and health outcome considered. Among European investigations that examined long-term PM exposure we found 4 cohort studies (considering total and cardiopulmonary mortality, 1 case-control study (considering mortality from myocardial infarction, and 4 ecologic studies (2 studies considering total and cardiopulmonary mortality and 2 studies focused on cardiovascular mortality. Results Measurement indicators of PM exposure used in European studies, including PM10, PM2.5, total suspended particulate and black smoke, were heterogeneous. This notwithstanding, in all analytic studies total mortality was directly associated with long-term exposure to PM. The excesses in mortality were mainly due to cardiovascular and respiratory causes. Three out of 4 ecologic studies found significant direct associations between PM indexes and mortality. Conclusion European studies on long-term exposure to PM indicate a direct association with mortality, particularly from cardiovascular and respiratory diseases.

Long-term Conventionally Dosed Vancomycin Therapy In Patients With Orthopaedic Implant-related Infections Seems As Effective And Safe As Long-term Penicillin Or Clindamycin Therapy. A Retrospective Cohort Study Of 103 Patients.

Science.gov (United States)

Aleman, Jacomien; Moojen, Dirk Jan F; van Ogtrop, Marc L; Poolman, Rudolf W; Franssen, Eric J F

2018-01-01

Objectives : Antimicrobial therapy is one of the cornerstones of orthopaedic implant-related infections (OIRI) treatment. Infections with Gram-positive bacteria are often treated with vancomycin, penicillin or clindamycin. A recent IDSA guideline suggests increasing the dose of vancomycin to increase the trough vancomycin target serum concentrations. This is deemed necessary because of an observed decrease in vancomycin susceptibility among Gram-positive bacteria. However, elevated vancomycin concentrations are correlated with the risk of nephrotoxicity, especially with prolonged therapy. Compared to most countries, rates of resistance against antibiotics among bacteria in the Netherlands are lower for currently available antibiotics, therefore lower target concentrations of vancomycin are probably efficacious for the treatment of infections. In this study we evaluated the efficacy and safety of long-term conventionally dosed vancomycin therapy, as an initial therapy for OIRI, and compared this with long-term penicillin and clindamycin therapy, as initial therapy, in patients with Gram-positive orthopaedic implant-related infections. Methods : A retrospective, observational study was conducted in 103 adult patients treated for OIRI, with vancomycin, penicillin or clindamycin for at least 10 days. The target trough serum concentration of vancomycin was 10-15 mg/l. Results : 74% of our patients were treated successfully with vancomycin, as initial therapy, (no reinfection within 1 year) versus 55% of our patients treated with either an antibiotic of the penicillin class (mostly flucloxacillin) or clindamycin (p=0.08), as initial therapy. For patients treated with vancomycin we observed a serum creatinine increase of 6 μmol/l, for patients treated with either an antibiotic of the penicillin class or clindamycin the serum creatinine increase was 4 μmol/l (p=0.395). Conclusions : In our population of patients with OIRI long-term treatment with conventionally dosed

A Framework for Estimating Long Term Driver Behavior

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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.

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

Long-term biodosimetry Redux

International Nuclear Information System (INIS)

Simon, Steven L.; Bouville, Andre

2016-01-01

This paper revisits and reiterates the needs, purposes and requirements of bio-dosimetric assays for long-term dose and health risk assessments. While the most crucial need for bio-dosimetric assays is to guide medical response for radiation accidents, the value of such techniques for improving our understanding of radiation health risk by supporting epidemiological (long-term health risk) studies is significant. As new cohorts of exposed persons are identified and new health risk studies are undertaken with the hopes that studying the exposed will result in a deeper understanding of radiation risk, the value of reliable dose reconstruction is underscored. The ultimate application of biodosimetry in long-term health risk studies would be to completely replace model-based dose reconstruction-a complex suite of methods for retrospectively estimating dose that is commonly fraught with large uncertainties due to the absence of important exposure-related information, as well as imperfect models. While biodosimetry could potentially supplant model-based doses, there are numerous limitations of presently available techniques that constrain their widespread application in health risk research, including limited ability to assess doses received far in the past, high cost, great inter-individual variability, invasiveness, higher than preferred detection limits and the inability to assess internal dose (for the most part). These limitations prevent the extensive application of biodosimetry to large cohorts and should be considered a challenge to researchers to develop new and more flexible techniques that meet the demands of long-term health risk research. Events in recent years, e.g. the Fukushima reactor accident and the increased threat of nuclear terrorism, underscore that any event that results in significant radiation exposures of a group of people will also produce a much larger population, exposed at lower levels, but that likewise needs (or demands) an exposure

Nonsurgical Outpatient Therapies for the Management of Female Stress Urinary Incontinence: Long-Term Effectiveness and Durability

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G. Willy Davila

2011-01-01

Results. Thirty-two clinical trial reports were included. Prospective long-term studies of pelvic floor rehabilitation were limited but indicated significant improvements with treatment adherence for at least 12 months. Poor initial tolerability with duloxetine resulted in substantial discontinuation. Most patients receiving transurethral radiofrequency collagen denaturation or urethral bulking agents reported significant long-term improvements, generally good tolerability, and safety. Conclusions. Conservative therapy is an appropriate initial approach for female SUI, but if therapy fails, radiofrequency collagen denaturation or bulking agents may be an attractive intermediate management step or alternative to surgery.

Long term study of mechanical

Directory of Open Access Journals (Sweden)

Ahmed M. Diab

2016-06-01

Full Text Available In this study, properties of limestone cement concrete containing different replacement levels of limestone powder were examined. It includes 0%, 5%, 10%, 15%, 20% and 25% of limestone powder as a partial replacement of cement. Silica fume was added incorporated with limestone powder in some mixes to enhance the concrete properties. Compressive strength, splitting tensile strength and modulus of elasticity were determined. Also, durability of limestone cement concrete with different C3A contents was examined. The weight loss, length change and cube compressive strength loss were measured for concrete attacked by 5% sodium sulfate using an accelerated test up to 525 days age. The corrosion resistance was measured through accelerated corrosion test using first crack time, cracking width and steel reinforcement weight loss. Consequently, for short and long term, the use of limestone up to 10% had not a significant reduction in concrete properties. It is not recommended to use blended limestone cement in case of sulfate attack. The use of limestone cement containing up to 25% limestone has insignificant effect on corrosion resistance before cracking.

Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension.

Science.gov (United States)

Drake, Marcus J; Chapple, Christopher; Sokol, Roman; Oelke, Matthias; Traudtner, Klaudia; Klaver, Monique; Drogendijk, Ted; Van Kerrebroeck, Philip

2015-02-01

Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms (LUTS). The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS (oral controlled absorption system) in Males with Lower Urinary Tract Symptoms (NEPTUNE) II is the first long-term study using solifenacin (Soli) and the oral controlled absorption system formulation of tamsulosin (TOCAS). To evaluate long-term (up to 52 wk) safety and efficacy of flexible dosing of two fixed-dose combinations (FDC) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms. Patients with both storage and voiding LUTS, maximum urinary flow rate of 4.0-12.0 ml/s, prostate size storage and voiding subscores, micturition diary variables, and quality of life parameters. In all, 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II. Treatment-emergent adverse events were reported in 499 (46.8%) patients who participated in NEPTUNE II; most were mild or moderate. Urinary retention occurred in 13 of 1208 (1.1%) patients receiving one or more FDCs in NEPTUNE and/or NEPTUNE II; 8 (0.7%) required catheterisation (acute urinary retention [AUR]). Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment, with mean reductions of 9.0 (standard deviation [SD]: 5.7) and 10.1 (SD: 9.2), respectively, from baseline to end of treatment. Clinically relevant improvements were also observed for secondary efficacy end points. Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS, with a low incidence of AUR. Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms. Improvements in symptoms were achieved after 4 wk of treatment, with further improvements at week 16 maintained for up to 52 wk

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

Investigation of Loop Seal Clearing Phenomena for the ATLAS SBLOCA Long Term Cooling Test using TRACE and MARS-KS

Energy Technology Data Exchange (ETDEWEB)

Hwang, Min Jeong; Park, M. H.; Marigomen Ralph; Sim, S. K. [Environment and Energy Technology, Daejeon (Korea, Republic of)

2016-10-15

During Design Certificate(DC) review of the APR1400, USNRC raised a long term cooling safety issue on the effect of loop seal clearing during cold leg Small Break Loss Of Coolant Accident(SBLOCA) due to relatively deep cross-over loop compared to the US PWRs. The objective of this study is thus to investigate the loop seal clearing phenomena during cold leg slot break SBLOCA long term cooling and resolve the safety issue on the SBLOCA long term cooling related to the APR1400 DC. TRACE and MARS-KS were used to predict the test results and to perform sensitivity studies for the SBLOCA loop seal clearing phenomena. The calculation shows that the TRACE code well predict the sequence of Test LTC-CL-04R. However, compared to the experiment, the TRACE over predicts the primary pressure due to smaller break flow prediction. MARS-KS well predicts major thermal hydraulic parameters during the transient with reasonable agreement. MARS-KS better predicts ATLAS LTC-CL-04R test data with a good agreement than the TRACE due to better prediction of the break flow. Overall, compared to the experiment, the TRACE and MARS-KS Codes show a discrepancy in predicting the loop seal clearing and reformation time. Both TRACE and MARS-KS correctly predicts core water level and fuel cladding temperatures. From this study, it can be said that even though APR1400 cross-over leg design has slightly deeper loop seals, the effect on the safety of the SBLOCA long term cooling is minimal compared to the SBLOCA cladding failure criteria. Further study on the SBLOCA loop seal clearing phenomena is needed.

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

Long-Term Efficacy, Safety, and Pharmacokinetics of Drisapersen in Duchenne Muscular Dystrophy: Results from an Open-Label Extension Study.

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Nathalie M Goemans

Full Text Available Drisapersen induces exon 51 skipping during dystrophin pre-mRNA splicing and allows synthesis of partially functional dystrophin in Duchenne muscular dystrophy (DMD patients with amenable mutations.This 188-week open-label extension of the dose-escalation study assessed the long-term efficacy, safety, and pharmacokinetics of drisapersen (PRO051/GSK2402968, 6 mg/kg subcutaneously, in 12 DMD subjects. Dosing was once weekly for 72 weeks. All subjects had a planned treatment interruption (weeks 73-80, followed by intermittent dosing (weeks 81-188.Subjects received a median (range total dose of 5.93 (5.10 to 6.02 mg/kg drisapersen. After 177 weeks (last efficacy assessment, median (mean [SD] six-minute walk distance (6MWD improved by 8 (-24.5 [161] meters for the 10 subjects able to complete the 6MWD at baseline (mean age [SD]: 9.5 [1.9] years. These statistics include 2 subjects unable to complete the test at later visits and who scored "zero". When only the 8 ambulant subjects at week 177 were taken into account, a median (mean [SD] increase of 64 (33 [121] meters in 6MWD was observed. Of 7 subjects walking ≥330 m at extension baseline, 5 walked farther at week 177. Of 3 subjects walking <330 m, 2 lost ambulation, while 1 declined overall but walked farther at some visits. Over the 188 weeks, the most common adverse events were injection-site reactions, raised urinary α1-microglobulin and proteinuria. Dystrophin expression was detected in all muscle biopsies obtained at week 68 or 72.Drisapersen was generally well tolerated over 188 weeks. Possible renal effects, thrombocytopenia and injection-site reactions warrant continued monitoring. Improvements in the 6MWD at 12 weeks were sustained after 3.4 years of dosing for most patients. For a small, uncontrolled study, the outcomes are encouraging, as natural history studies would anticipate a decline of over 100 meters over a 3-year period in a comparable cohort.ClinicalTrials.gov NCT01910649.

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

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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.

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…

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

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)

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)

Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate

DEFF Research Database (Denmark)

Abrahamsen, Bo; Eiken, Pia; Prieto-Alhambra, Daniel

2016-01-01

OBJECTIVES: To determine the skeletal safety and efficacy of long term (≥10 years) alendronate use in patients with osteoporosis. DESIGN: Open register based cohort study containing two nested case control studies. SETTING: Nationwide study of population of Denmark. PARTICIPANTS: 61 990 men...... ratio (MPR, a proxy for compliance) >80%) compared with poor adherence (MPR

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

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.

A Long-Term Outcome Study of Selective Mutism in Childhood

Science.gov (United States)

Steinhausen, Hans-Christoph; Wachter, Miriam; Laimbock, Karin; Metzke, Christa Winkler

2006-01-01

Objective: Controlled study of the long-term outcome of selective mutism (SM) in childhood. Method: A sample of 33 young adults with SM in childhood and two age- and gender-matched comparison groups were studied. The latter comprised 26 young adults with anxiety disorders in childhood (ANX) and 30 young adults with no psychiatric disorders during…

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....

Long-Term Prognosis of Plantar Fasciitis

DEFF Research Database (Denmark)

Hansen, Liselotte; Krogh, Thøger Persson; Ellingsen, Torkell

2018-01-01

, exercise-induced symptoms, bilateral heel pain, fascia thickness, and presence of a heel spur) could predict long-term outcomes, (3) to assess the long-term ultrasound (US) development in the fascia, and (4) to assess whether US-guided corticosteroid injections induce atrophy of the heel fat pad. Study....... The risk was significantly greater for women (P heel...... regardless of symptoms and had no impact on prognosis, and neither did the presence of a heel spur. Only 24% of asymptomatic patients had a normal fascia on US at long-term follow-up. A US-guided corticosteroid injection did not cause atrophy of the heel fat pad. Our observational study did not allow us...

Study design: two long-term observational studies of the biosimilar filgrastim Nivestim™ (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia

International Nuclear Information System (INIS)

Kamioner, Didier; Fruehauf, Stefan; Maloisel, Fréderic; Cals, Laurent; Lepretre, Stéphane; Berthou, Christian

2013-01-01

407 patients, and NEXT in September 2013 with 2123 patients. Last patient, last visit for each study will be December 2013 and March 2014 respectively. The NEXT and VENICE studies will provide long-term safety, efficacy and practice pattern data in patients receiving Nivestim™ to support myelosuppressive chemotherapy in real world clinical practice. These data will improve our understanding of the performance of Nivestim™ in patients encountered in the general patient population. NEXT http://www.clinicaltrials.gov/ct2/show/NCT01574235?term, VENICE http://www.clinicaltrials.gov/ct2/show/NCT01627990?term

Virtual Models of Long-Term Care

Science.gov (United States)

Phenice, Lillian A.; Griffore, Robert J.

2012-01-01

Nursing homes, assisted living facilities and home-care organizations, use web sites to describe their services to potential consumers. This virtual ethnographic study developed models representing how potential consumers may understand this information using data from web sites of 69 long-term-care providers. The content of long-term-care web…

Developing and analyzing long-term fuel management strategies for an advanced Small Modular PWR

Energy Technology Data Exchange (ETDEWEB)

Hedayat, Afshin, E-mail: ahedayat@aeoi.org.ir

2017-03-15

Highlights: • Comprehensive introduction and supplementary concepts as a review paper. • Developing an integrated long-term fuel management strategy for a SMR. • High reliable 3-D core modeling over fuel pins against the traditional LRM. • Verifying the expert rules of large PWRs for an advanced small PWR. • Investigating large numbers of safety parameters coherently. - Abstract: In this paper, long-term fuel management (FM) strategies are introduced and analyzed for a new advanced Pressurized Light Water Reactor (PWR) type of Small Modular Reactors (SMRs). The FM strategies are developed to be safe and practical for implementation as much as possible. Safety performances, economy of fuel, and Quality Assurance (QA) of periodic equilibrium conditions are chosen as the main goals. Flattening power density distribution over fuel pins is the major method to ensure safety performance; also maximum energy output or permissible discharging burn up indicates economy of fuel fabrication costs. Burn up effects from BOC to EOC have been traced, studied, and highly visualized in both of transport lattice cell calculations and diffusion core calculations. Long-term characteristics are searched to gain periodical equilibrium characteristics. They are fissile changes, neutron spectrum, refueling pattern, fuel cycle length, core excess reactivity, average, and maximum burn up of discharged fuels, radial Power Peaking Factors (PPF), total PPF, radial and axial power distributions, batch effects, and enrichment effects for fine regulations. Traditional linear reactivity model have been successfully simulated and adapted via fine core and burn up calculations. Effects of high burnable neutron poison and soluble boron are analyzed. Different numbers of batches via different refueling patterns have been studied and visualized. Expert rules for large type PWRs have been influenced and well tested throughout accurate equilibrium core calculations.

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.

Long-Term Experience with First-Generation Implantable Neurostimulation Device in Central Sleep Apnea Treatment.

Science.gov (United States)

Fox, Henrik; Bitter, Thomas; Horstkotte, Dieter; Oldenburg, Olaf; Gutleben, Klaus-Jürgen

2017-05-01

Sleep-disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) are associated with shorter survival in patients with heart failure. A novel treatment method for this patient group is unilateral phrenic nerve stimulation by the remedē® system (Respicardia Inc., Minnetonka, MN, USA), a transvenously implantable neurostimulation device, which has recently been studied in a large randomized, controlled trial. Previous literature has shown efficacy and safety of the treatment with this first-generation device, but hardly any data are available on long-term clinical parameters, the remedē® device's battery lifetime, device exchangeability, lead position stability, surgical accessibility, and manageability. We performed remedē® device replacements in consecutive patients for battery depletion, and documented clinical parameters, longevity, operation procedure, complications, and difficulties. All patients were on neurostimulation treatment by phrenic nerve neurostimulation when device replacement became necessary. Apnea-hypopnea index (from 45 ± 4/h to 9 ± 4/h), oxygen-desaturation index (from 35 ± 7/h to 7 ± 6/h), and time spent with oxygen saturation of ray documentation of stable lead positions in a long-term setting, no radiation or contrast dye usage was needed and no major complications occurred. In addition, clinical exercise capacity and sleepiness symptoms improved. Novel remedē® device shows sustained therapy efficacy and safety in terms of stable lead positions over 4 years. Long-term phrenic nerve neurostimulation therapy for central SDB/CSR appears feasible in a clinical routine setting. © 2017 Wiley Periodicals, Inc.

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

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

Anaemia and long term mortality in heart failure patients: a retrospective study

DEFF Research Database (Denmark)

Charlot, Mette; Torp-Pedersen, Christian; Valeur, Nana

2010-01-01

Anaemia has been demonstrated as a risk factor in patients with heart failure over periods of a few years, but long term data are not available. We examined the long-term risk of anaemia in heart failure patients during 15 years of follow-up.......Anaemia has been demonstrated as a risk factor in patients with heart failure over periods of a few years, but long term data are not available. We examined the long-term risk of anaemia in heart failure patients during 15 years of follow-up....

Studying screen interactions long-term : the library as a case

NARCIS (Netherlands)

Kanis, Marije; Groen, Maarten; Meys, W.T.; Veenstra, Mettina

2012-01-01

This paper presents the design and long-term study of BiebBeep, a large interactive touchscreen that has been developed with the aim to augment the information and social function of a library. BiebBeep displays user-generated and context-relevant content, such as information about local events and

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...

Case Reports Showing a Long-Term Effect of Subanesthetic Ketamine Infusion in Reducing L-DOPA-Induced Dyskinesias

Directory of Open Access Journals (Sweden)

Scott J. Sherman

2016-02-01

Full Text Available Ketamine is an FDA-approved drug with a known safety profile. Low-dose subanesthetic intravenous ketamine infusion treatment has led to long-term reduction of treatment-resistant depression and of chronic pain states. We report on low-dose subanesthetic intravenous ketamine infusion treatment in Parkinson's disease (PD patients by 5 case studies and show a long-lasting therapeutic benefit to reduce L-DOPA-induced dyskinesia (LID, improve on time, and reduce depression. Based on the literature we hypothesize that low-dose ketamine may act as a ‘chemical deep brain stimulation', by desynchronizing hypersynchronous oscillatory brain activity, including in the basal ganglia and the motor cortex. The presented PD case reports indicate tolerability, safety and long-term beneficial effects of low-dose ketamine infusion that should be further investigated in a properly controlled prospective clinical trial for treatment of LID, as well as the prevalent nonmotor features pain and depression in PD patients.

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

Long-term safety and outcome of a temporary self-expanding metallic stent for achalasia: a prospective study with a 13-year single-center experience

Energy Technology Data Exchange (ETDEWEB)

Zhao, Jun-Gong; Li, Yong-Dong; Li, Ming-Hua; Shang, Ke-Zhong [Shanghai Tong Ji University, Department of Radiology, Tenth Affiliated People' s Hospital, Shanghai (China); Cheng, Ying-Sheng [Shanghai Tong Ji University, Department of Radiology, Tenth Affiliated People' s Hospital, Shanghai (China); Shanghai Jiao Tong University, Department of Radiology, Sixth Affiliated People' s Hospital, Shanghai (China); Chen, Ni-Wei; Chen, Wei-Xiong [Shanghai Jiao Tong University, Department of Gastroenterology, Sixth Affiliated People' s Hospital, Shanghai (China)

2009-08-15

To prospectively evaluate the long-term clinical safety and efficacy of a newly designed self-expanding metallic stent (SEMS) in the treatment of patients with achalasia. Seventy-five patients with achalasia were treated with a temporary SEMS with a 30-mm diameter. The SEMSs were placed under fluoroscopic guidance and removed by gastroscopy 4-5 days after stent placement. Follow-up data focused on dysphagia score, technique and clinical success, clinical remissions and failures, and complications and was performed at 6 months, 1 year, and within 3 to 5 years, 5 to 8 years, 8 to 10 years, and >10 years postoperatively. Stent placement was technically successful in all patients. Complications included stent migration (n=4, 5.33%), chest pain (n=28, 38.7%), reflux (n=15, 20%), and bleeding (n=9, 12%). No perforation or 30-day mortality occurred. Clinical success was achieved in all patients 1 month after stent removal. The overall remission rates at 6 months, 1, 1-3, 3-5, 5-8, 8-10, and >10 year follow-up periods were 100%, 96%, 93.9%, 90.9%, 100%, 100%, and 83.3%, respectively. Stent treatment failed in six patients, and the overall remission rate in our series was 92%. The median and mean primary patencies were 2.8 {+-} 0.28 years (95% CI: 2.25-3.35) and 4.28 {+-} 0.40 years (95% CI: 3.51-5.05), respectively. The use of temporary SEMSs with 30-mm diameter proved to be a safe and effective approach for managing achalasia with a long-term satisfactory clinical remission rate. (orig.)

Long-Term Safety of Repeated Blood-Brain Barrier Opening via Focused Ultrasound with Microbubbles in Non-Human Primates Performing a Cognitive Task.

Science.gov (United States)

Downs, Matthew E; Buch, Amanda; Sierra, Carlos; Karakatsani, Maria Eleni; Teichert, Tobias; Chen, Shangshang; Konofagou, Elisa E; Ferrera, Vincent P

2015-01-01

Focused Ultrasound (FUS) coupled with intravenous administration of microbubbles (MB) is a non-invasive technique that has been shown to reliably open (increase the permeability of) the blood-brain barrier (BBB) in multiple in vivo models including non-human primates (NHP). This procedure has shown promise for clinical and basic science applications, yet the safety and potential neurological effects of long term application in NHP requires further investigation under parameters shown to be efficacious in that species (500 kHz, 200-400 kPa, 4-5 μm MB, 2 minute sonication). In this study, we repeatedly opened the BBB in the caudate and putamen regions of the basal ganglia of 4 NHP using FUS with systemically-administered MB over 4-20 months. We assessed the safety of the FUS with MB procedure using MRI to detect edema or hemorrhaging in the brain. Contrast enhanced T1-weighted MRI sequences showed a 98% success rate for openings in the targeted regions. T2-weighted and SWI sequences indicated a lack edema in the majority of the cases. We investigated potential neurological effects of the FUS with MB procedure through quantitative cognitive testing of' visual, cognitive, motivational, and motor function using a random dot motion task with reward magnitude bias presented on a touchpanel display. Reaction times during the task significantly increased on the day of the FUS with MB procedure. This increase returned to baseline within 4-5 days after the procedure. Visual motion discrimination thresholds were unaffected. Our results indicate FUS with MB can be a safe method for repeated opening of the BBB at the basal ganglia in NHP for up to 20 months without any long-term negative physiological or neurological effects with the parameters used.

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 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

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

Sleep facilitates long-term face adaptation

OpenAIRE

Ditye, Thomas; Javadi, Amir Homayoun; Carbon, Claus-Christian; Walsh, Vincent

2013-01-01

Adaptation is an automatic neural mechanism supporting the optimization of visual processing on the basis of previous experiences. While the short-term effects of adaptation on behaviour and physiology have been studied extensively, perceptual long-term changes associated with adaptation are still poorly understood. Here, we show that the integration of adaptation-dependent long-term shifts in neural function is facilitated by sleep. Perceptual shifts induced by adaptation to a distorted imag...

The Long-Term Consumption of Oats in Celiac Disease Patients Is Safe: A Large Cross-Sectional Study

Science.gov (United States)

Aaltonen, Katri; Laurikka, Pilvi; Huhtala, Heini; Mäki, Markku; Kaukinen, Katri; Kurppa, Kalle

2017-01-01

A strict gluten-free diet (GFD) can be diversified by non-contaminated oats, but there is a shortage of long-term studies concerning its safety. We compared long-term treatment outcomes and factors associated with the introduction of oats between celiac patients on a GFD with or without oats. Eight hundred sixty-nine previously diagnosed celiac patients were interviewed. The validated Gastrointestinal Symptom Rating Scale (GSRS), Psychological General Well-Being (PGWB), and Short-Form 36 Health Survey (SF-36) questionnaires were used to assess symptoms and quality of life, serological tests were performed, and results of histology were confirmed from patient records. We found the median duration of GFD to be 10 years and 82% using oats. Factors predicting the consumption of oats were diagnosis after the year 2000, advice from a dietitian, detection by screening, and mild clinical presentation. Oat consumers and non-consumers did not differ in dietary adherence (96.5% vs. 97.4%, p = 0.746), the prevalence of symptoms (22.9% vs. 22.5%, p = 0.931), positivity for endomysial antibodies (8.8% vs. 6.0%, p = 0.237), histological recovery after one year (63.1% vs. 60.0%, p = 0.773), malignancy (4.8% vs. 3.3%, p = 0.420), osteoporosis/osteopenia (9.2% vs. 11.0%, p = 0.489), or fractures (26.9% vs. 27.9%, p = 0.791). The oat consumers had better SF-36 physical role limitations and general health scores. Based on our results, the long-term consumption of oats in celiac disease patients is safe and may improve quality of life. PMID:28617328

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)

Long-term effect of galantamine on cognitive function in patients with Alzheimer’s disease versus a simulated disease trajectory: an observational study in the clinical setting

Directory of Open Access Journals (Sweden)

Nakagawa R

2017-04-01

Full Text Available Ryoko Nakagawa,1 Takashi Ohnishi,1 Hisanori Kobayashi,1 Toshio Yamaoka,2 Tsutomu Yajima,3 Ai Tanimura,4 Toshiya Kato,4 Kazutake Yoshizawa1 1Evidence Generation Department, Medical Affairs Division, 2Clinical Data Management Department, R&D Division, 3Biostatistics Department, Quantitative Science Division, 4Drug Surveillance Department, R&D Division, Janssen Pharmaceutical K.K., Tokyo, Japan Background: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer’s disease (AD, but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. Patients and methods: Patients with mild-to-moderate AD received flexible dosing of galantamine (16–24 mg/day during this study. Cognitive function was assessed by the mini mental state examination (MMSE and the clinical status was determined by the Clinical Global Impression-Improvement (CGI-I. Changes of the MMSE score without treatment were estimated in each patient using Mendiondo’s model. Generalized linear mixed model analysis was performed to compare the simulated MMSE scores with the actual scores. Results: Of the 661 patients who were enrolled, 642 were evaluable for safety and 554 were assessed for efficacy. The discontinuation rate was 46.73%. Cognitive decline indicated by the mean change of actual MMSE scores was significantly smaller than the simulated decline. Individual analysis demonstrated that >70% of patients had better actual MMSE scores than their simulated scores. Significant improvement of CGI-I was also observed during the observation period. Adverse events occurred in 28.5% of patients and were serious in 8.41%. The reported events generally corresponded with 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)

Microscopic study of rock for estimating long-term behavior. Research document

International Nuclear Information System (INIS)

Ichikawa, Yasuaki

2003-02-01

Micro-structure of rock plays an essential role for their long-term behavior. For elucidating long-term characteristics of granite we here present the followings: 1) Conformal Lase Scanning Microscope (LSM) observation of configuration of a joint in granite, its Fourier analysis and the change under uniaxial stress condition, 2) characterization of the mechanism of microcrack initiation and propagation observed by stereoscopic microscope under uniaxial/triaxial compression and relaxation tests, 3) observation of microcrack initiation and propagation by LSM under uniaxial compression, and 4) a study of strong discontinuity analysis included in the homogenization theory to predict the long-term behavior of micro/macro-level stress for granite. Rock image processing and analysis become a fundamental procedure to determine rock surface discontinuities. In Chapter 2 LSM that can acquire three-dimensional images is introduced to observe the roughness of discontinuity in a rock specimen. Then, discontinuities appeared on circular sections are identified by LSM and characterized by a Discrete Fourier Transform (DFT) analysis. The change of discontinuities is observed under applying stress. Microcrack generation and propagation play an essential role to predict the long-term behavior of rock. In Chapter 3 a progressive development of cracking in granite is revealed by using stereoscopic microscope under water-saturated triaxial compression condition. Next by using LSM observe the procedure of micro-cracking under uniaxial compression condition. Obviously the micro-crack initiation and propagation controls the time-dependent behavior of granite. We have analysed the behavior by a viscoelastic theory applied in homogenization method. However since it is difficult to determine the inter-granular properties of constituent crystals and to represent the stress-dependent nonlinear characteristics by this method, we study a strong discontinuity analysis included in the

A Long-Term Follow-Up Study of Allogeneic Mesenchymal Stem/Stromal Cell Transplantation in Patients with Drug-Resistant Systemic Lupus Erythematosus

Directory of Open Access Journals (Sweden)

Dandan Wang

2018-03-01

Full Text Available Summary: Allogeneic mesenchymal stem/stromal cells (MSCs have been widely studied as an alternative cell source for regenerative medicine. Here, we report a long-term follow-up study of allogeneic bone marrow and/or umbilical cord MSC transplantation (MSCT in severe and drug-refractory systemic lupus erythematosus (SLE patients. Eighty-one patients were enrolled, and the 5-year overall survival rate was 84% (68/81 after MSCT. At 5-year follow-up, 27% of patients (22/81 were in complete clinical remission and another 7% (6/81 were in partial clinical remission, with a 5-year disease remission rate of 34% (28/81. In total, 37 patients had achieved clinical remission and then 9 patients subsequently relapsed, with 5-year overall rate of relapse of 24% (9/37. SLE Disease Activity Index scores, serum albumin, complement C3, peripheral white blood cell, and platelet numbers, as well as proteinuria levels, continued to improve during the follow-up. Our results demonstrated that allogeneic MSCT is safe and resulted in long-term clinical remission in SLE patients. : In this article, Sun and colleagues show that allogeneic bone marrow and/or umbilical cord-derived mesenchymal stem/stromal cell transplantation both result in good clinical safety and effect in treating drug-refractory systemic lupus erythematosus patients, by introducing a 5- to 8-year follow-up study for all the 81 enrolled patients. Keywords: bone marrow, mesenchymal stem cells, systemic lupus erythematosus, safety, umbilical cord

[Psychosocial issues of long-term cancer survivors].

Science.gov (United States)

Weis, J; Faller, H

2012-04-01

Although cancer incidence rates are increasing, recent statistical studies suggest that cancer patients are showing higher cure rates as well as improved overall survival rates for most cancer locations. These advances are explained by improved strategies in early diagnoses as well as improved cancer therapies. Therefore, the number of long-term cancer survivors has also increased, but only few studies, especially within the last years, have focused on psychosocial issues of this subgroup. Some studies show that overall quality of life of long-term cancer survivors is quite high and comparable to that of the normal population. Nevertheless, a substantial percentage of former patients shows reduced quality of life and suffers from various sequelae of cancer and its treatment. This review focuses on the most common psychosocial issue of long-term survivors such as reduced psychological wellbeing, neuropsychological deficits and cancer-related fatigue syndrome. Finally, recommendations for problem-oriented interventions as well as improvement of psychosocial care of long-term survivors are given.

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

International Nuclear Information System (INIS)

Duncan, A.

1997-01-01

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

State-dependent life-history strategies : A long-term study on oystercatchers

NARCIS (Netherlands)

van de Pol, Martijn

2006-01-01

The research described in this thesis is part of a long-term field study on free-living Oystercatchers (Haematopus ostralegus), on the Dutch Wadden Sea island of Schiermonnikoog.The study was started in 1983 by Jan Hulscher, and since then a lineage of PhDstudents has investigated life-history

Guidance for implementing the long-term surveillance program for UMTRA Project Title I Disposal Sites

International Nuclear Information System (INIS)

1996-02-01

This guidance document has two purposes: it provides guidance for writing site-specific long-term surveillance plans (LTSP) and it describes site surveillance, monitoring, and long-term care techniques for Title I disposal sites of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (42 USC Section 7901 et seq.). Long-term care includes monitoring, maintenance, and emergency measures needed to protect public health and safety and the environment after remedial action is completed. This document applies to the UMTRCA-designated Title I disposal sites. The requirements for long-term care of the Title I sites and the contents of the LTSPs are provided in U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Section 40.27) provided in Attachment 1

Long-term corrosion studies

International Nuclear Information System (INIS)

Gdowski, G.

1998-01-01

The scope of this activity is to assess the long-term corrosion properties of metallic materials under consideration for fabricating waste package containers. Three classes of metals are to be assessed: corrosion resistant, intermediate corrosion resistant, and corrosion allowance. Corrosion properties to be evaluated are general, pitting and crevice corrosion, stress-corrosion cracking, and galvanic corrosion. The performance of these materials will be investigated under conditions that are considered relevant to the potential emplacement site. Testing in four aqueous solutions, and vapor phases above them, and at two temperatures are planned for this activity. (The environmental conditions, test metals, and matrix are described in detail in Section 3.0.) The purpose and objective of this activity is to obtain the kinetic and mechanistic information on degradation of metallic alloys currently being considered for waste package containers. This information will be used to provide assistance to (1) waste package design (metal barrier selection) (E-20-90 to E-20-92), (2) waste package performance assessment activities (SIP-PA-2), (3) model development (E-20-75 to E-20-89). and (4) repository license application

Long-term surveillance plan for the Rifle, Colorado, Disposal site

International Nuclear Information System (INIS)

1996-09-01

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 Estes Gulch disposal site in Garfield County, Colorado. The U.S. Environmental Protection Agency (EPA) has developed regulations for the issuance of a general license by the U.S. Nuclear Regulatory Commission (NRC) 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 Estes Gulch disposal site. The general license becomes effective when the NRC concurs with the DOE's determination of completion of remedial action for the Estes Gulch site and the NRC formally accepts this LTSP

Fondaparinux in the initial and long-term treatment of venous thromboembolism.

Science.gov (United States)

Pesavento, Raffaele; Amitrano, Maria; Trujillo-Santos, Javier; Di Micco, Pierpaolo; Mangiacapra, Sara; López-Jiménez, Luciano; Falgá, Conxita; García-Bragado, Fernando; Piovella, Chiara; Prandoni, Paolo; Monreal, Manuel

2015-02-01

Even in the absence of evidence on its long-term efficacy and safety, a number of patients with venous thromboembolism (VTE) receive long-term therapy with fondaparinux alone in everyday practice. We used the Registro Informatizado de Enfermedad Tromboembólica (RIETE) registry to compare the rate of VTE recurrences and major bleeding at 10 and 90 days in patients with and without cancer. For long-term therapy, fondaparinux was compared with vitamin K antagonists (VKA) in patients without cancer and with low-molecular-weight heparin (LMWH) in those with cancer. Of 47,378 patients recruited, 46,513 were initially treated with heparin, 865 with fondaparinux. Then, 263 patients (78 with cancer) were treated for at least 3 months with fondaparinux. After propensity-score matching, there were no differences between patients receiving initial therapy with heparin or fondaparinux. Among patients with cancer, there were no differences between fondaparinux and LMWH. Among patients without cancer, the long-term use of fondaparinux was associated with an increased risk of major bleeding (3.24 % vs. 0.95 %, p<0.05). An unexpected high rate of major bleeding was observed in non-cancer patients treated with long-term fondaparinux. Our small sample does not allow to derive relevant conclusions on the use of fondaparinux in cancer patients. Copyright © 2014 Elsevier Ltd. All rights reserved.

Long-term memory, sleep, and the spacing effect.

Science.gov (United States)

Bell, Matthew C; Kawadri, Nader; Simone, Patricia M; Wiseheart, Melody

2014-01-01

Many studies have shown that memory is enhanced when study sessions are spaced apart rather than massed. This spacing effect has been shown to have a lasting benefit to long-term memory when the study phase session follows the encoding session by 24 hours. Using a spacing paradigm we examined the impact of sleep and spacing gaps on long-term declarative memory for Swahili-English word pairs by including four spacing delay gaps (massed, 12 hours same-day, 12 hours overnight, and 24 hours). Results showed that a 12-hour spacing gap that includes sleep promotes long-term memory retention similar to the 24-hour gap. The findings support the importance of sleep to the long-term benefit of the spacing effect.

What do implementers need in terms of regulatory safety criteria for the post-closure phase?

International Nuclear Information System (INIS)

Cahen, B.

2010-01-01

Bruno Cahen, Director Safety Division (ANDRA) presented the point of view of the NEA Integration Group for the Safety Case (IGSC) on 'What do implementers need in terms of regulatory safety criteria for the post-closure phase?' B. Cahen acknowledged that the national experience in siting and developing conceptual designs of geological disposal is growing rapidly. It implies increasing opportunities for interactions between implementers and regulators. There has been large development of international guidance in the recent years. Many regulators have already developed a regulatory framework. The implementers need practical, transparent and deliverable regulations. These regulations should draw on experiences gained from development of geological disposal projects. The IGSC has identified five key questions that the RF may focus on: 1. Over what time frame are the waste deemed to present a hazard? 2. Over what time frames are regulatory criteria applied and do they change over time? 3. Over what time frame(s) are safety assessments required to be conducted? 4. How do implementers have to address uncertainties in the long time frames? 5. What happens after cut-offs: are additional analyses needed? What types of arguments are to be used? Stable, understandable and practical criteria mean, namely, that they need to be developed on a strong scientific and societal basis, that there is consistency of safety options and requirements for different types of waste, that, in the longer time frames, the emphasis is given to robust systems, passive safety and multiple safety functions and that the criteria should fit the various phases of the project (siting, designing, operating, closure and post-closure). Experience feedback from safety cases shows that safety priorities depend very much on time frames. The derived safety criteria for the individual components should lead to measurable, verifiable specifications. The assessment of geological repository post-closure safety

Long-term personality data collection in support of spaceflight and analogue research.

Science.gov (United States)

Musson, David M; Helmreich, Robert L

2005-06-01

This is a review of past and present research into personality and performance at the University of Texas (UT) Human Factors Research Project. Specifically, personality trait data collected from astronauts, pilots, Antarctic personnel, and other groups over a 15-yr period is discussed with particular emphasis on research in space and space analogue environments. The UT Human Factors Research Project conducts studies in personality and group dynamics in aviation, space, and medicine. Current studies include personality determinants of professional cultures, team effectiveness in both medicine and aviation, and personality predictors of long-term astronaut performance. The Project also studies the design and effectiveness of behavioral strategies used to minimize error and maximize team performance in safety-critical work settings. A multi-year personality and performance dataset presents many opportunities for research, including long-term and follow-up studies of human performance, analyses of trends in recruiting and attrition, and the ability to adapt research design to operational changes and methodological advances. Special problems posed by such long-duration projects include issues of confidentiality and security, as well as practical limitations imposed by current peer-review and short-term funding practices. Practical considerations for ongoing dataset management include consistency of assessment instruments over time, variations in data acquisition from one year to the next, and dealing with changes in theory and practice that occur over the life of the project. A fundamental change in how research into human performance is funded would be required to ensure the ongoing development of such long-duration research databases.

Is modified brief assertiveness training for nurses effective? A single-group study with long-term follow-up.

Science.gov (United States)

Yoshinaga, Naoki; Nakamura, Yohei; Tanoue, Hiroki; MacLiam, Fionnula; Aoishi, Keiko; Shiraishi, Yuko

2018-01-01

To evaluate the long-term effectiveness of modified brief assertiveness training (with cognitive techniques) for nurses. Most assertiveness training takes a long time to conduct; thus, briefer training is required for universal on-the-job training in the workplace. In this single-group study, nurses received two 90-min training sessions with a 1-month interval between sessions. The degree of assertiveness was assessed by using the Rathus Assertiveness Schedule as the primary outcome, at four time points: pre- and post-training, 3-month follow-up and 6-month follow-up. A total of 33 nurses received the training, and the mean Rathus Assertiveness Schedule score improved from -14.2 (SD = 16.5) pre-training to -10.5 (SD = 18.0) post-training (p open environment for communication leads to improved job satisfaction, improved nursing care and increased patient safety. © 2017 The Authors. Journal of Nursing Management Published by John Wiley & Sons Ltd.

Acute and long-term survival in chronically critically ill surgical patients: a retrospective observational study.

Science.gov (United States)

Hartl, Wolfgang H; Wolf, Hilde; Schneider, Christian P; Küchenhoff, Helmut; Jauch, Karl-Walter

2007-01-01

Various cohort studies have shown that acute (short-term) mortality rates in unselected critically ill patients may have improved during the past 15 years. Whether these benefits also affect acute and long-term prognosis in chronically critically ill patients is unclear, as are determinants relevant to prognosis. We conducted a retrospective analysis of data collected from March 1993 to February 2005. A cohort of 390 consecutive surgical patients requiring intensive care therapy for more than 28 days was analyzed. The intensive care unit (ICU) survival rate was 53.6%. Survival rates at one, three and five years were 61.8%, 44.7% and 37.0% among ICU survivors. After adjustment for relevant covariates, acute and long-term survival rates did not differ significantly between 1993 to 1999 and 1999 to 2005 intervals. Acute prognosis was determined by disease severity during ICU stay and by primary diagnosis. However, only the latter was independently associated with long-term prognosis. Advanced age was an independent prognostic determinant of poor short-term and long-term survival. Acute and long-term prognosis in chronically critically ill surgical patients has remained unchanged throughout the past 12 years. After successful surgical intervention and intensive care, long-term outcome is reasonably good and is mainly determined by age and underlying disease.

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

International Nuclear Information System (INIS)

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

2017-01-01

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

Long-Term Results of Targeted Intraoperative Radiotherapy (Targit) Boost During Breast-Conserving Surgery

Energy Technology Data Exchange (ETDEWEB)

Vaidya, Jayant S., E-mail: jayant.vaidya@ucl.ac.uk [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Baum, Michael [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Tobias, Jeffrey S. [Department of Radiation Oncology, University College London Hospitals, London (United Kingdom); Wenz, Frederik [Radiation Oncology and Gynaecology, University Medical Centre of Mannheim (Germany); Massarut, Samuele [Surgery and Radiation Oncology, Centro di Riferimento Oncologico (CRO), Aviano (Italy); Keshtgar, Mohammed [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Hilaris, Basil [Radiation Oncology, Our Lady of Mercy, New York Medical College, New York (United States); Saunders, Christobel [Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia (Australia); Williams, Norman R.; Brew-Graves, Chris [Research Department of Surgery, Division of Surgery and Interventional Science, University College London, London (United Kingdom); Corica, Tammy [Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia (Australia); Roncadin, Mario [Surgery and Radiation Oncology, Centro di Riferimento Oncologico (CRO), Aviano (Italy); Kraus-Tiefenbacher, Uta; Suetterlin, Marc [Radiation Oncology and Gynaecology, University Medical Centre of Mannheim (Germany); Bulsara, Max [Institute of Health and Rehabilitation Research, University of Notre Dame, Fremantle, Western Australia (Australia); Joseph, David [Radiation Oncology, Sir Charles Gairdner Hospital and School of Surgery, University of Western Australia, Perth (Australia)

2011-11-15

Purpose: We have previously shown that delivering targeted radiotherapy to the tumour bed intraoperatively is feasible and desirable. In this study, we report on the feasibility, safety, and long-term efficacy of TARGeted Intraoperative radioTherapy (Targit), using the Intrabeam system. Methods and Materials: A total of 300 cancers in 299 unselected patients underwent breast-conserving surgery and Targit as a boost to the tumor bed. After lumpectomy, a single dose of 20 Gy was delivered intraoperatively. Postoperative external beam whole-breast radiotherapy excluded the usual boost. We also performed a novel individualized case control (ICC) analysis that computed the expected recurrences for the cohort by estimating the risk of recurrence for each patient using their characteristics and follow-up period. Results: The treatment was well tolerated. The median follow up was 60.5 months (range, 10-122 months). Eight patients have had ipsilateral recurrence: 5-year Kaplan Meier estimate for ipsilateral recurrence is 1.73% (SE 0.77), which compares well with that seen in the boosted patients in the European Organization for Research and Treatment of Cancer study (4.3%) and the UK STAndardisation of breast RadioTherapy study (2.8%). In a novel ICC analysis of 242 of the patients, we estimated that there should be 11.4 recurrences; in this group, only 6 recurrences were observed. Conclusions: Lumpectomy and Targit boost combined with external beam radiotherapy results in a low local recurrence rate in a standard risk patient population. Accurate localization and the immediacy of the treatment that has a favorable effect on tumour microenvironment may contribute to this effect. These long-term data establish the long-term safety and efficacy of the Targit technique and generate the hypothesis that Targit boost might be superior to an external beam boost in its efficacy and justifies a randomized trial.

Pre-hospital thrombolytic therapy with either alteplase or streptokinase. : Practical applications, complications and long-term results in 529 patients.

NARCIS (Netherlands)

E.W.M. Grijseels (Els); M.J.M. Bouten; J.W. Deckers (Jaap); A.W. Hoes (Arno); J.A.M. Hartman; E. van der Does (Emiel); M.L. Simoons (Maarten); T. Lenderink (Timo)

1995-01-01

markdownabstractOBJECTIVE: To assess the practical application, safety and long-term outcome of pre-hospital thrombolytic intervention with either alteplase or streptokinase in patients with extensive myocardial infarction. DESIGN: Prospective study. SUBJECTS: Patients with chest pain of more

Competitive short-term and long-term memory processes in spatial habituation.

Science.gov (United States)

Sanderson, David J; Bannerman, David M

2011-04-01

Exposure to a spatial location leads to habituation of exploration such that, in a novelty preference test, rodents subsequently prefer exploring a novel location to the familiar location. According to Wagner's (1981) theory of memory, short-term and long-term habituation are caused by separate and sometimes opponent processes. In the present study, this dual-process account of memory was tested. Mice received a series of exposure training trials to a location before receiving a novelty preference test. The novelty preference was greater when tested after a short, rather than a long, interval. In contrast, the novelty preference was weaker when exposure training trials were separated by a short, rather than a long interval. Furthermore, it was found that long-term habituation was determined by the independent effects of the amount of exposure training and the number of exposure training trials when factors such as the intertrial interval and the cumulative intertrial interval were controlled. A final experiment demonstrated that a long-term reduction of exploration could be caused by a negative priming effect due to associations formed during exploration. These results provide evidence against a single-process account of habituation and suggest that spatial habituation is determined by both short-term, recency-based memory and long-term, incrementally strengthened memory.

Long Term Financing of Infrastructure

OpenAIRE

Sinha, Sidharth

2014-01-01

Infrastructure projects, given their long life, require long term financing. The main sources of long term financings are insurance and pension funds who seek long term investments with low credit risk. However, in India household financial savings are mainly invested in bank deposits. Insurance and pension funds account for only a small percentage of household financial savings. In addition most infrastructure projects do not qualify for investment by insurance and pension funds because of t...

A Cohort Study on Long-Term Adverse Effects of Parental Drinking: Background and Study Design

Directory of Open Access Journals (Sweden)

Ingunn Olea Lund

2015-01-01

Full Text Available Although many studies have addressed adverse outcomes in children of parents with alcohol abuse/dependence, less is known about the possible long-term effects of more normative patterns of parental alcohol consumption, including drinking at lower risk levels and heavy episodic or binge drinking. The extent of harm from parental drinking may therefore be underestimated. With this research proposal, we describe a project that aims to assess possible long-term adverse effects of parental drinking by combining survey and nationwide registry data. Advantages of a longitudinal general population cohort design include that it allows for detailed information on parental drinking through survey data and identification of possible negative long-term health and social outcomes from exposure to parental drinking 1–19 years after exposure through continuously updated nationwide registers. The rich information available from combining survey and registry data allows us to take into account important confounders, mediators, and moderators.

Investigation of the long term stability and corrosion resistance of engineering barriers

International Nuclear Information System (INIS)

Aoyama, Eri; Tachikawa, Hirokazu; Shimizu, Akihiko

2005-03-01

The Japan Nuclear Cycle Development Institute submitted 'Second Progress Report on Research and Development for the Geological Disposal of HLW in Japan' to the Japanese government. This report contains investigations of the long term behavior of alteration of bentonite, and of the corrosion life time of overpack on the basis of experimental data and past research, assuming the ranging geological environment of Japan. However some subjects, such as the behavior of the bentonite and overpack under high pH conditions and the behavior of the engineering barrier with change of near-field environmental condition with time for promoting reliability have still been left. To take into account these conditions, expert committees composed of clay science and metal corrosion science experts were established in the Nuclear Safety Research Association and past research outcomes and the theory of safety assessment were investigated from the view points of long term stability and corrosion resistance of engineering barrier. (author)

Long-term studies of the natural history of asthma in childhood

DEFF Research Database (Denmark)

Bisgaard, Hans; Bønnelykke, Klaus

2010-01-01

Segmentation of children with asthma and other wheezy disorders remains the main research challenge today, as it was when described 2 centuries ago. Early childhood wheezy disorders follow different temporal trajectories, probably representing different underlying mechanisms (endophenotypes...... secondary prevention through the use of inhaled corticosteroids can effectively halt the long-term disease progression in childhood. In conclusion, the natural history of asthma and the associated airway changes is still poorly understood, and we have not managed to translate findings from long-term studies......). Prospective identification of endophenotypes allowing accurate prediction of the clinical course is currently not possible. The variability of the clinical course remains an enigma and difficult to predict. Three of 4 school-aged children with asthma have outgrown disease by midadulthood. The risk...

Long-term postoperative cognitive dysfunction in the elderly: ISPOCD1 study

NARCIS (Netherlands)

Moller, J.T.; Cluitmans, P.J.M.; Rasmussen, L.S.; Houx, P.J.; Rasmussen, H.; Canet, J.; Rabbitt, P.; Jolles, J.; Larsen, K.; Hanning, C.D.; Langeron, O.; Johnson, T.; Lauven, P.M.; Kristensen, P.A.; Biedler, A.; Beem, van H.; Fraidakis, O.; Silverstein, J.H.; Beneken, J.E.W.; Gravenstein, J.S.

1998-01-01

Summary Background Long-term postoperative cognitive dysfunction may occur in the elderly. Age may be a risk factor and hypoxaemia and arterial hypotension causative factors. We investigated these hypotheses in an international multicentre study. Methods 1218 patients aged at least 60 years

A study on shear behavior of R/C beams subjected to long-term heating

International Nuclear Information System (INIS)

Maruta, M.; Yamazaki, M.

1993-01-01

In nuclear power plants, many structural members are subjected to long term heating. There are few experimental data available on the behavior especially in shear of reinforced concrete (R/C) members subjected to long term heating. This paper describes a study aimed at experimentally determining the shear behavior of R/C members in nuclear power plant facilities following sustained heating at high temperatures

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 effects of childbirth in MS

NARCIS (Netherlands)

D'hooghe, M.B.; Nagels, G.; Uitdehaag, B.M.J.

2010-01-01

Background: The uncertainty about long-term effects of childbirth presents MS patients with dilemmas. Methods: Based on clinical data of 330 female MS patients, the long-term effects of childbirth were analysed, using a cross-sectional study design. Four groups of patients were distinguished: (1)

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.

Long-term safety and outcome of a temporary self-expanding metallic stent for achalasia: a prospective study with a 13-year single-center experience

International Nuclear Information System (INIS)

Zhao, Jun-Gong; Li, Yong-Dong; Li, Ming-Hua; Shang, Ke-Zhong; Cheng, Ying-Sheng; Chen, Ni-Wei; Chen, Wei-Xiong

2009-01-01

To prospectively evaluate the long-term clinical safety and efficacy of a newly designed self-expanding metallic stent (SEMS) in the treatment of patients with achalasia. Seventy-five patients with achalasia were treated with a temporary SEMS with a 30-mm diameter. The SEMSs were placed under fluoroscopic guidance and removed by gastroscopy 4-5 days after stent placement. Follow-up data focused on dysphagia score, technique and clinical success, clinical remissions and failures, and complications and was performed at 6 months, 1 year, and within 3 to 5 years, 5 to 8 years, 8 to 10 years, and >10 years postoperatively. Stent placement was technically successful in all patients. Complications included stent migration (n=4, 5.33%), chest pain (n=28, 38.7%), reflux (n=15, 20%), and bleeding (n=9, 12%). No perforation or 30-day mortality occurred. Clinical success was achieved in all patients 1 month after stent removal. The overall remission rates at 6 months, 1, 1-3, 3-5, 5-8, 8-10, and >10 year follow-up periods were 100%, 96%, 93.9%, 90.9%, 100%, 100%, and 83.3%, respectively. Stent treatment failed in six patients, and the overall remission rate in our series was 92%. The median and mean primary patencies were 2.8 ± 0.28 years (95% CI: 2.25-3.35) and 4.28 ± 0.40 years (95% CI: 3.51-5.05), respectively. The use of temporary SEMSs with 30-mm diameter proved to be a safe and effective approach for managing achalasia with a long-term satisfactory clinical remission rate. (orig.)

Safety, Efficacy, and Persistence of Long-Term Mirabegron Treatment for Overactive Bladder in the Daily Clinical Setting: Interim (1-Year) Report from a Japanese Post-Marketing Surveillance Study.

Science.gov (United States)

Kato, Daisuke; Tabuchi, Hiromi; Uno, Satoshi

2017-08-01

To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan-Meier analysis. Eighty-one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed "effective" in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3 months, 6 months, and 1 year, or at discontinuation (P similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n = 908) compared with those aged <65 years (59.8%; n = 231; log-rank test: P = 0.032). Long-term OAB treatment with mirabegron was well-tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years. © 2017 John Wiley & Sons Australia, Ltd.

RBMK-1500 accident management for loss of long-term core cooling

International Nuclear Information System (INIS)

Uspuras, E.; Kaliatka, A.

2001-01-01

Results of the Level 1 probabilistic safety assessment of the Ignalina NPP has shown that in topography of the risk, transients dominate above the accidents with LOCAs and failure of the core long-term cooling are the main factors to frequency of the core damage. Previous analyses have shown, that after initial event, as a rule, the reactivity control, as well as short-term and intermediate cooling are provided. However, the acceptance criteria of the long-term cooling are not always carried out. It means that from this point of view the most dangerous accident scenarios are the scenarios related to loss of the core long-term cooling. On the other hand, the transition to the core condition due to loss of the long-term cooling specifies potential opportunities for the management of the accident consequences. Hence, accident management for the mitigation of the accident consequences should be considered and developed. The most likely initiating event, which probably leads to the loss of long term cooling accident, is station blackout. The station blackout is the loss of normal electrical power supply for local needs with an additional failure on start-up of all diesel generators. In the case of loss of electrical power supply MCPs, the circulating pumps of the service water system and MFWPs are switched-off. At the same time, TCV of both turbines are closed. Failure of diesel generators leads to the non-operability of the ECCS long-term cooling subsystem. It means the impossibility to feed MCC by water. The analysis of the station blackout for Ignalina NPP was performed using RELAP5 code. (author)

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.

Long-term Exon Skipping Studies With 2′-O-Methyl Phosphorothioate Antisense Oligonucleotides in Dystrophic Mouse Models

Directory of Open Access Journals (Sweden)

Christa L Tanganyika-de Winter

2012-01-01

Full Text Available Antisense-mediated exon skipping for Duchenne muscular dystrophy (DMD is currently tested in phase 3 clinical trials. The aim of this approach is to modulate splicing by skipping a specific exon to reframe disrupted dystrophin transcripts, allowing the synthesis of a partly functional dystrophin protein. Studies in animal models allow detailed analysis of the pharmacokinetic and pharmacodynamic profile of antisense oligonucleotides (AONs. Here, we tested the safety and efficacy of subcutaneously administered 2′-O-methyl phosphorothioate AON at 200 mg/kg/week for up to 6 months in mouse models with varying levels of disease severity: mdx mice (mild phenotype and mdx mice with one utrophin allele (mdx/utrn+/−; more severe phenotype. Long-term treatment was well tolerated and exon skipping and dystrophin restoration confirmed for all animals. Notably, in the more severely affected mdx/utrn+/− mice the therapeutic effect was larger: creatine kinase (CK levels were more decreased and rotarod running time was more increased. This suggests that the mdx/utrn+/− model may be a more suitable model to test potential therapies than the regular mdx mouse. Our results also indicate that long-term subcutaneous treatment in dystrophic mouse models with these AONs is safe and beneficial.

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

Validation of traffic-related air pollution exposure estimates for long-term studies

NARCIS (Netherlands)

Van Roosbroeck, S.

2007-01-01

This thesis describes a series of studies that investigate the validity of using outdoor concentrations and/or traffic-related indicator exposure variables as a measure for exposure assessment in epidemiological studies on the long-term effect of traffic-related air pollution. A pilot study was

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

A study about long-term deformation of soft rock. 2

International Nuclear Information System (INIS)

Inoue, Hiroyuki; Yoshino, Naoto; Miyanomae, Shunichi; Mizutani, Kazuhiko; Noda, Kenji

2004-02-01

In this study, the laboratory mechanical tests of sedimentary soft rock sampled at Horonobe area in Hokkaido prefecture were conducted in order to build the confidence of Okubo model for long term deformation of sedimentary rock. And the stability of rock around tunnel in building under the condition assumed the underground of Horonobe area was examined by numerical simulation using information of boring data obtained before 2002 year. As a result, authors could obtain many values of parameter in Okubo model under various conditions. These conditions have the difference of temperature and water saturation. In addition, the life time in creep predicted by Okubo model could be compared with the real one. And numerical simulations, assuming various conditions such as stiffness of buffer material and yielding of support, had been carried out to evaluate the long-term stability of rock surrounding buffer material. Results show the decreasing tendency of time dependency of rock. (author)

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

Science.gov (United States)

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

2013-07-01

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

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

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

Long-Term Memory and Learning

Science.gov (United States)

Crossland, John

2011-01-01

The English National Curriculum Programmes of Study emphasise the importance of knowledge, understanding and skills, and teachers are well versed in structuring learning in those terms. Research outcomes into how long-term memory is stored and retrieved provide support for structuring learning in this way. Four further messages are added to the…

Long-term properties of bituminized waste products

International Nuclear Information System (INIS)

Snellman, M.; Valkiainen, M.

1985-10-01

This study is a survey of the factors of importance for the long term behaviour of bituminized ion exchange resins. Phenomena occurring in bituminized waste products affected by the treatment, storage and disposal are identified. Test methods have been developed for characterizing product properties, which are important for the long-term behaviour. The long-term properties of bituminized ion-exchange resins are studied in a repository environment with access of water equilibrated with concrete. In these circumstances the most important properties are related to the interactions of bituminized waste with the surrounding barriers. The most important phenomena are water uptake due to rehydration of the resins and subsequent swelling of the product

Long-term properties of bituminized waste products

International Nuclear Information System (INIS)

Snellman, M.; Valkiainen, M.

1985-10-01

This study is a survey of the factors of importance for long term behaviour of bituminized ion exchange resins. Phenomena occurring in bituminized waste products affected by the treatment, storage and disposal are identified. Test methods have been developed for characterizing product properties, which are important for the long-term behaviour. The long-term properties of bituminized ion-exchange resins are studied in a repository environment with access of water equilibrated with concrete. In these circumstances the most important properties are ralated to the interactions of bituminized waste with the surrounding barriers. The most important phenomena are water uptake due to rehydration of the resins and subsequent swelling of the product. (author)

Long-Term Dynamics of Autonomous Fractional Differential Equations

Science.gov (United States)

Liu, Tao; Xu, Wei; Xu, Yong; Han, Qun

This paper aims to investigate long-term dynamic behaviors of autonomous fractional differential equations with effective numerical method. The long-term dynamic behaviors predict where systems are heading after long-term evolution. We make some modification and transplant cell mapping methods to autonomous fractional differential equations. The mapping time duration of cell mapping is enlarged to deal with the long memory effect. Three illustrative examples, i.e. fractional Lotka-Volterra equation, fractional van der Pol oscillator and fractional Duffing equation, are studied with our revised generalized cell mapping method. We obtain long-term dynamics, such as attractors, basins of attraction, and saddles. Compared with some existing stability and numerical results, the validity of our method is verified. Furthermore, we find that the fractional order has its effect on the long-term dynamics of autonomous fractional differential equations.

Xerostomia and medication: a cross-sectional study in long-term geriatric wards.

Science.gov (United States)

Desoutter, A; Soudain-Pineau, M; Munsch, F; Mauprivez, C; Dufour, T; Coeuriot, J-L

2012-01-01

The purpose of this study was to determine the prevalence of xerostomia in old people living in long-term geriatric wards, and to measure the relationship between xerostomia and etiologic factors such as age and medication (total number of medications, xerogenic medications, anticholinergic medications and medications that induce hypersialorrhea). An observational retrospective, comparative, multicentre epidemiological study. Long-term geriatric wards, in Reims, France. 769 old people living in long-term geriatric wards. Prevalence of xerostomia assessed from age, total number of medications, xerogenic medications, anticholinergic medications and those that induce hypersialorrhea. Multivariable logistic regression was used to calculate Odds Ratios (OR) and their 95% Confidence Intervals (95% CI). Among 769 old people (average age 84.6±8.4 years old), 287 residents suffered from xerostomia (37.3%). Significant predictors of xerostomia were: resident's age OR=1.56, 95% CI (1.30-1.88), pxerostomia identified was medications that induce hypersialorrhea OR=0.81, 95% CI (0.67-0.98), p=0.03. The total number of medications and xerogenic medications did not play a significant role in xerostomia. Increasing Age and anticholinergic medications induce a dry mouth. Conversely, the total number of medications and xerogenic medications do not influence xerostomia. Medications that induce hypersialorrhea protect against the occurrence of dry mouth.

The Structure and Content of Long-Term and Short-Term Mate Preferences

Directory of Open Access Journals (Sweden)

Peter K. Jonason

2013-12-01

Full Text Available This study addresses two limitations in the mate preferences literature. First, research all-too-often relies on single-item assessments of mate preferences precluding more advanced statistical techniques like factor analysis. Second, when factor analysis could be done, it exclusively has done for long-term mate preferences, at the exclusion of short-term mate preferences. In this study (N = 401, we subjected 20 items designed to measure short- and long-term mate preferences to both principle components (n = 200 and confirmatory factor analysis (n = 201. In the long-term context, we replicated previous findings that there are three different categories of preferences: physical attractiveness, interpersonal warmth, and social status. In the short-term context, physical attractiveness occupied two parts of the structure, social status dropped out, and interpersonal warmth remained. Across short- and long-term contexts, there were slight changes in what defined the shared dimensions (i.e., physical attractiveness and interpersonal warmth, suggesting prior work that applies the same inventory to each context might be flawed. We also replicated sex differences and similarities in mate preferences and correlates with sociosexuality and mate value. We adopt an evolutionary paradigm to understand our results.

Long-term characteristics of nuclear emulsion

International Nuclear Information System (INIS)

Naganawa, N; Kuwabara, K

2010-01-01

Long-term characteristics of the nuclear emulsion so called 'OPERA film' used in the neutrino oscillation experiment, OPERA, has been studied for 8 years since its production or refreshing after it. In the results, it turned out to be excellent in sensitivity, amount of random noise, and refreshing characteristics. The retention capacity of latent image of tracks was also studied. The result will open the way to the recycling of 7,000,000 emulsion films which will remain not developed after 5 years of OPERA's run, and other long-term experiments with emulsion.

Long-term characteristics of nuclear emulsion

Science.gov (United States)

Naganawa, N.; Kuwabara, K.

2010-02-01

Long-term characteristics of the nuclear emulsion so called ``OPERA film'' used in the neutrino oscillation experiment, OPERA, has been studied for 8 years since its production or refreshing after it. In the results, it turned out to be excellent in sensitivity, amount of random noise, and refreshing characteristics. The retention capacity of latent image of tracks was also studied. The result will open the way to the recycling of 7,000,000 emulsion films which will remain not developed after 5 years of OPERA's run, and other long-term experiments with emulsion.

Microcrack growing and long-term mechanical stability in a HLW deep-borehole repository in granite

International Nuclear Information System (INIS)

Biurrun, E.; Hahne, K.

1989-01-01

The long-term host rock integrity assessment of a deep borehole emplacement for HLW in granite has been addressed with a detailed new constitutive model considering temperature and pressure effects on microscale phenomena (as microcracking) under repository conditions. The results of these finite element calculations have been compared with results obtained using conventional, state-of-the-art constitutive modelling. While the results of conventional modelling did suggest the existence of an important safety margin before failure, the improved calculations with the new model predict a thin but very long region of degradated host rock along the waste canister column. The results obtained up to now may well be considered as safety relevant, because they suggest that the actual long-term granite strength lies well below the conventionally determined failure limits, thus challenging the barrier properties of this host rock if the actual strength is not properly considered in the repository design

Retention of gene expression in porcine islets after agarose encapsulation and long-term culture

International Nuclear Information System (INIS)

Dumpala, Pradeep R.; Holdcraft, Robert W.; Martis, Prithy C.; Laramore, Melissa A.; Parker, Thomas S.; Levine, Daniel M.; Smith, Barry H.; Gazda, Lawrence S.

2016-01-01

Agarose encapsulation of porcine islets allows extended in vitro culture, providing ample time to determine the functional capacity of the islets and conduct comprehensive microbiological safety testing prior to implantation as a treatment for type 1 diabetes mellitus. However, the effect that agarose encapsulation and long-term culture may have on porcine islet gene expression is unknown. The aim of the present study was to compare the transcriptome of encapsulated porcine islets following long-term in vitro culture against free islets cultured overnight. Global gene expression analysis revealed no significant change in the expression of 98.47% of genes. This indicates that the gene expression profile of free islets is highly conserved following encapsulation and long-term culture. Importantly, the expression levels of genes that code for critical hormones secreted by islets (insulin, glucagon, and somatostatin) as well as transcripts encoding proteins involved in their packaging and secretion are unchanged. While a small number of genes known to play roles in the insulin secretion and insulin signaling pathways are differentially expressed, our results show that overall gene expression is retained following islet isolation, agarose encapsulation, and long-term culture. - Highlights: • Effect of agarose encapsulation and 8 week culture on porcine islets was analyzed. • Transcriptome analysis revealed no significant change in a majority (98%) of genes. • Agarose encapsulation allows for long-term culture of porcine islets. • Islet culture allows for functional and microbial testing prior to clinical use.

Retention of gene expression in porcine islets after agarose encapsulation and long-term culture

Energy Technology Data Exchange (ETDEWEB)

Dumpala, Pradeep R., E-mail: pdumpala@rixd.org [The Rogosin Institute – Xenia Division, 740 Birch Road, Xenia, OH 45385 (United States); Holdcraft, Robert W.; Martis, Prithy C.; Laramore, Melissa A. [The Rogosin Institute – Xenia Division, 740 Birch Road, Xenia, OH 45385 (United States); Parker, Thomas S.; Levine, Daniel M. [The Rogosin Institute, 505 East 70th Street, New York, NY 10021 (United States); Smith, Barry H. [The Rogosin Institute, 505 East 70th Street, New York, NY 10021 (United States); NewYork-Presbyterian Hospital, Weill Medical College of Cornell University, 1300 York Avenue, New York, NY 10021 (United States); Gazda, Lawrence S. [The Rogosin Institute – Xenia Division, 740 Birch Road, Xenia, OH 45385 (United States)

2016-08-05

Agarose encapsulation of porcine islets allows extended in vitro culture, providing ample time to determine the functional capacity of the islets and conduct comprehensive microbiological safety testing prior to implantation as a treatment for type 1 diabetes mellitus. However, the effect that agarose encapsulation and long-term culture may have on porcine islet gene expression is unknown. The aim of the present study was to compare the transcriptome of encapsulated porcine islets following long-term in vitro culture against free islets cultured overnight. Global gene expression analysis revealed no significant change in the expression of 98.47% of genes. This indicates that the gene expression profile of free islets is highly conserved following encapsulation and long-term culture. Importantly, the expression levels of genes that code for critical hormones secreted by islets (insulin, glucagon, and somatostatin) as well as transcripts encoding proteins involved in their packaging and secretion are unchanged. While a small number of genes known to play roles in the insulin secretion and insulin signaling pathways are differentially expressed, our results show that overall gene expression is retained following islet isolation, agarose encapsulation, and long-term culture. - Highlights: • Effect of agarose encapsulation and 8 week culture on porcine islets was analyzed. • Transcriptome analysis revealed no significant change in a majority (98%) of genes. • Agarose encapsulation allows for long-term culture of porcine islets. • Islet culture allows for functional and microbial testing prior to clinical use.

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

Safety objectives and basic design for surface centres for long-term storage of solid radioactive waste with short or medium half-life and low or medium specific activity

International Nuclear Information System (INIS)

1984-06-01

RFS or Regles Fondamentales de Surete (Basic Safety Rules) applicable to certain types of nuclear facilities lay down requirements with which compliance, for the type of facilities and within the scope of application covered by the RFS, is considered to be equivalent to compliance with technical French regulatory practice. The object of the RFS is to take advantage of standardization in the field of safety, while allowing for technical progress in that field. They are designed to enable the operating utility and contractors to know the rules pertaining to various subjects which are considered to be acceptable by the Service Central de Surete des Installations Nucleaires, or the SCSIN (Central Department for the Safety of Nuclear Facilities). These RFS should make safety analysis easier and lead to better understanding between experts and individuals concerned with the problems of nuclear safety. The SCSIN reserves the right to modify, when considered necessary, any RFS and specify, if need be, the terms under which a modification is deemed retroactive. The role of this RFS is to define the safety objectives and the basic design philosophy for surface centres for long-term storage of packages of radioactive waste with short or medium half-life and with low or medium specific activity

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 e-cigarette use and smoking cessation: a longitudinal study with US population.

Science.gov (United States)

Zhuang, Yue-Lin; Cummins, Sharon E; Sun, Jessica Y; Zhu, Shu-Hong

2016-10-01

E-cigarettes have grown popular. The most common pattern is dual use with conventional cigarettes. Dual use has raised concerns that it might delay quitting of cigarette smoking. This study examined the relationship between long-term use of e-cigarettes and smoking cessation in a 2-year period. A nationally representative sample of 2028 US smokers were surveyed in 2012 and 2014. Long-term e-cigarette use was defined as using e-cigarettes at baseline and follow-up. Use of e-cigarettes only at baseline or at follow-up was defined as short-term use. Non-users did not use e-cigarettes at either survey. Quit attempt rates and cessation rates (abstinent for 3 months or longer) were compared across the three groups. At 2-year follow-up, 43.7% of baseline dual users were still using e-cigarettes. Long-term e-cigarette users had a higher quit attempt rate than short-term or non-users (72.6% vs 53.8% and 45.5%, respectively), and a higher cessation rate (42.4% vs 14.2% and 15.6%, respectively). The difference in cessation rate between long-term users and non-users remained significant after adjusting for baseline variables, OR=4.1 (95% CI 1.5 to 11.4) as did the difference between long-term users and short-term users, OR=4.8 (95% CI 1.6 to 13.9). The difference in cessation rate between short-term users and non-users was not significant, OR=0.9 (95% CI 0.5 to 1.4). Among those making a quit attempt, use of e-cigarettes as a cessation aid surpassed that of FDA-approved pharmacotherapy. Short-term e-cigarette use was not associated with a lower rate of smoking cessation. Long-term use of e-cigarettes was associated with a higher rate of quitting smoking. 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/.

Stability of rapid maxillary expansion and facemask therapy: a long-term controlled study.

Science.gov (United States)

Masucci, Caterina; Franchi, Lorenzo; Defraia, Efisio; Mucedero, Manuela; Cozza, Paola; Baccetti, Tiziano

2011-10-01

The aim of this prospective controlled study was to evaluate the long-term effects of rapid maxillary expansion and facemask therapy in Class III subjects. Twenty-two subjects (9 boys, 13 girls; mean age, 9.2 years ± 1.6) with Class III disharmony were treated consecutively with rapid maxillary expansion and facemask therapy followed by fixed appliances. The patients were reevaluated at the end of the 2-phase treatment (mean age, 14.5 years ± 1.9) and then recalled about 8.5 years after the end of rapid maxillary expansion and facemask treatment (mean age, 18.7 years ± 2.1). Two groups of controls with untreated Class III malocclusion were used for statistical comparisons of the short-term and long-term intervals. Statistical comparisons were performed with the Mann-Whitney U test. In the long term, no significant differences in maxillary changes were recorded, whereas the treatment group showed significantly smaller increases in mandibular protrusion. The sagittal maxillomandibular skeletal variables maintained significant improvements in the treatment group vs the control groups. In the long term, rapid maxillary expansion and facemask therapy led to successful outcomes in about 73% of the Class III patients. Favorable skeletal changes were mainly due to significant improvements in the sagittal position of the mandible. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Sleep Quality, Short-Term and Long-Term CPAP Adherence

Science.gov (United States)

Somiah, Manya; Taxin, Zachary; Keating, Joseph; Mooney, Anne M.; Norman, Robert G.; Rapoport, David M.; Ayappa, Indu

2012-01-01

Study Objectives: Adherence to CPAP therapy is low in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS). The purpose of the present study was to evaluate the utility of measures of sleep architecture and sleep continuity on the CPAP titration study as predictors of both short- and long-term CPAP adherence. Methods: 93 patients with OSAHS (RDI 42.8 ± 34.3/h) underwent in-laboratory diagnostic polysomnography, CPAP titration, and follow-up polysomnography (NPSG) on CPAP. Adherence to CPAP was objectively monitored. Short-term (ST) CPAP adherence was averaged over 14 days immediately following the titration study. Long-term (LT) CPAP adherence was obtained in 56/93 patients after approximately 2 months of CPAP use. Patients were grouped into CPAP adherence groups for ST ( 4 h) and LT adherence ( 4 h). Sleep architecture, sleep disordered breathing (SDB) indices, and daytime outcome variables from the diagnostic and titration NPSGs were compared between CPAP adherence groups. Results: There was a significant relationship between ST and LT CPAP adherence (r = 0.81, p CPAP adherence groups had significantly lower %N2 and greater %REM on the titration NPSG. A model combining change in sleep efficiency and change in sleep continuity between the diagnostic and titration NPSGs predicted 17% of the variance in LT adherence (p = 0.006). Conclusions: These findings demonstrate that characteristics of sleep architecture, even on the titration NPSG, may predict some of the variance in CPAP adherence. Better sleep quality on the titration night was related to better CPAP adherence, suggesting that interventions to improve sleep on/prior to the CPAP titration study might be used as a therapeutic intervention to improve CPAP adherence. Citation: Somiah M; Taxin Z; Keating J; Mooney AM; Norman RG; Rapoport DM; Ayappa I. Sleep quality, short-term and long-term CPAP adherence. J Clin Sleep Med 2012;8(5):489-500. PMID:23066359

An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain

Directory of Open Access Journals (Sweden)

Onouchi K

2014-07-01

Full Text Available Kenji Onouchi,1 Hiroaki Koga,2 Kazumasa Yokoyama,3 Tamotsu Yoshiyama4 1Aida Memorial Rehabilitation Hospital, Moriya, Japan; 2Kumamoto Rehabilitation Hospital, Kikuchi-Gun, Japan; 3Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan; 4Pfizer Japan Inc., Tokyo, Japan Purpose: Studies of pregabalin for the treatment of central neuropathic pain have been limited to double-blind trials of 4–17 weeks in duration. The purpose of this study was to assess the long-term safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. The efficacy of pregabalin was also assessed as a secondary measure. Patients and methods: This was a 53-week, multicenter, open-label trial of pregabalin (150–600 mg/day in Japanese patients with central neuropathic pain due to spinal cord injury, multiple sclerosis, or cerebral stroke. Results: A total of 103 patients received pregabalin (post-stroke =60; spinal cord injury =38; and multiple sclerosis =5. A majority of patients (87.4% experienced one or more treatment-related adverse events, most commonly somnolence, weight gain, dizziness, or peripheral edema. The adverse event profile was similar to that seen in other indications of pregabalin. Most treatment-related adverse events were mild (89.1% or moderate (9.2% in intensity. Pregabalin treatment improved total score, sensory pain, affective pain, visual analog scale (VAS, and present pain intensity scores on the Short-Form McGill Pain Questionnaire (SF-MPQ and ten-item modified Brief Pain Inventory (mBPI-10 total score at endpoint compared with baseline. Improvements in SF-MPQ VAS and mBPI-10 total scores were evident in all patient subpopulations. Mean changes from baseline in SF-MPQ VAS and mBPI-10 scores at endpoint were –20.1 and –1.4, respectively. Conclusion: These findings demonstrate that pregabalin is generally well tolerated and provides sustained efficacy over a 53-week treatment period in

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 urethral catheterisation.

Science.gov (United States)

Turner, Bruce; Dickens, Nicola

This article discusses long-term urethral catheterisation, focusing on the relevant anatomy and physiology, indications for the procedure, catheter selection and catheter care. It is important that nurses have a good working knowledge of long-term catheterisation as the need for this intervention will increase with the rise in chronic health conditions and the ageing population.

Guidance for implementing the UMTRA Project long-term surveillance program

International Nuclear Information System (INIS)

1992-09-01

The US Nuclear Regulatory Commission (NRC) has issued a general license for the custody and long-term care of US Department of Energy (DOE) Uranium Mill Tailings Remedial Action (UMTRA) Project permanent disposal sites. The purpose of this general license is to ensure that the UMTRA disposal sites will be cared for in such a manner as to protect the public health and safety and the environment upon completion of remedial actions. The general license will be in effect for a disposal site when NRC accepts the disposal site long-term surveillance plan (LTSP) that meets the requirements of 10 CFR 40.27. The site LTSP describes in detail the long-term surveillance program, including any monitoring, maintenance, and emergency measures necessary to fulfill the conditions of the general license. This guidance document provides (1) instructions for preparing the disposal site LTSPs and (2) instructions for carrying out the UMTRA Project long-term surveillance program, including any monitoring that may be required. The information provided in this document also is in accordance with the regulatory requirements set forth in 40 CFR 192. On January 5, 1985, the US Tenth Circuit Court of Appeals remanded the groundwater standards, 40 CFR 192.02. Proposed groundwater standards were issued for comment on September 24, 1987 (52 FR 3600). When the groundwater standards become final, this document will be revised, as appropriate. This document also will be updated in response to any changes to 10 CFR 40, or in response to changes in the manner in which the long-term care of the licensed disposal sites is carried out

The long term storage of advanced gas-cooled reactor (AGR) fuel

International Nuclear Information System (INIS)

Standring, P.N.

1999-01-01

The approach being taken by BNFL in managing the AGR lifetime spent fuel arisings from British Energy reactors is given. Interim storage for up to 80 years is envisaged for fuel delivered beyond the life of the Thorp reprocessing plant. Adopting a policy of using existing facilities, to comply with the principles of waste minimisation, has defined the development requirements to demonstrate that this approach can be undertaken safely and business issues can be addressed. The major safety issues are the long term integrity of both the fuel being stored and structure it is being stored in. Business related issues reflect long term interactions with the rest of the Sellafield site and storage optimisation. Examples of the development programme in each of these areas is given. (author)

Essays on long-term mortality and interest rate risk

NARCIS (Netherlands)

de Kort, J.P.

2017-01-01

This dissertation comprises a study of long-term risks which play a major role in actuarial science. In Part I we analyse long-term mortality risk and its impact on consumption and investment decisions of economic agents, while Part II focuses on the mathematical modelling of long-term interest

Nagra technical report 14-02, geological basics - Dossier III - Long-term geological developments

International Nuclear Information System (INIS)

Schnellmann, M.; Madritsch, H.

2014-01-01

This dossier is the third of a series of eight reports concerning the safety and technical aspects of locations for the disposal of radioactive wastes in Switzerland. Dossier III takes a look at long-term geological developments. Developments in the topography and river networks of northern Switzerland over the past five million years are looked at. Data and information derived from high-resolution models and compilations of gravel deposition, glacier developments and moraines are reviewed. Tectonic developments, seismological aspects and erosion are discussed. Their consequences for the long-term geological developments in the proposed depository areas are looked at

Long-term surveillance plan for the South Clive Disposal Site, Clive, Utah

International Nuclear Information System (INIS)

1996-03-01

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 South Clive disposal site in Clive, Utah. 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 CRF 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 South Clive disposal site. The general license becomes effective when the NRC concurs with the DOE's determination of completion of remedial action for the South Clive site and the NRC formally accepts this LTSP. This LTSP describes the long-term surveillance program the DOE will implement to ensure that the South Clive disposal site performs as designed. The program's primary activity is site inspections to identify threats to disposal cell integrity