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Sample records for single safety relief

  1. 49 CFR 230.49 - Setting of safety relief valves.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Setting of safety relief valves. 230.49 Section 230.49 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD... Appurtenances Safety Relief Valves § 230.49 Setting of safety relief valves. (a) Qualifications of individual...

  2. LOFT pressurizer safety: relief valve reliability

    Energy Technology Data Exchange (ETDEWEB)

    Brown, E.S.

    1978-01-18

    The LOFT pressurizer self-actuating safety-relief valves are constructed to the present state-of-the-art and should have reliability equivalent to the valves in use on PWR plants in the U.S. There have been no NRC incident reports on valve failures to lift that would challenge the Technical Specification Safety Limit. Fourteen valves have been reported as lifting a few percentage points outside the +-1% Tech. Spec. surveillance tolerance (9 valves tested over and 5 valves tested under specification). There have been no incident reports on failures to reseat. The LOFT surveillance program for assuring reliability is equivalent to nuclear industry practice.

  3. LOFT pressurizer safety: relief valve reliability

    International Nuclear Information System (INIS)

    Brown, E.S.

    1978-01-01

    The LOFT pressurizer self-actuating safety-relief valves are constructed to the present state-of-the-art and should have reliability equivalent to the valves in use on PWR plants in the U.S. There have been no NRC incident reports on valve failures to lift that would challenge the Technical Specification Safety Limit. Fourteen valves have been reported as lifting a few percentage points outside the +-1% Tech. Spec. surveillance tolerance (9 valves tested over and 5 valves tested under specification). There have been no incident reports on failures to reseat. The LOFT surveillance program for assuring reliability is equivalent to nuclear industry practice

  4. Efficacy and Safety of Single Botulinum Toxin Type A (Botox®) Injection for Relief of Upper Trapezius Myofascial Trigger Point: A Randomized, Double-Blind, Placebo-Controlled Study.

    Science.gov (United States)

    Kwanchuay, Photsawee; Petchnumsin, Thavatchai; Yiemsiri, Pichet; Pasuk, Nakkamol; Srikanok, Wannarat; Hathaiareerug, Chanasak

    2015-12-01

    Botulinum toxin injection has been applied for pain relief in various chronic pain syndromes. Recently, systematic review studies reported inconclusive effects of Botulinum toxin in myofascial pain management. The present study aimed to demonstrate the efficacy and safety of Botulinum toxin type A (BTxA) (Botox®) injection for pain reduction in myofascial trigger point (MTrP) of the upper trapezius muscle. Thirty-three patients with 48 MTrP on the upper trapezius muscles over three months with moderate to severe pain intensity diagnosed at physical medicine and rehabilitation outpatient department were recruited between December 2011 and March 2012. Eligible patients were blinded and randomly injected with single 0.2 ml (20 IU) of BTxA for 24 MTrP and 0.2 ml of 0.9% NaCl solution for 24 MTrP at the most tender trigger point on the upper trapezius muscle. All patients were advised for stretching exercise and ergonomic adaptation throughout the study. At 3- and 6-week after injections, visual analogue scale (VAS), the pressure pain threshold (PPT), and reported adverse effects were measured. Both BTxA and control groups demonstrated statistically significant differences in VAS reduction and increased PPT after 3 weeks and 6 weeks compared with before treatment. There were no statistically significant differences in VAS reduction from baseline between the two groups at 3- and 6-week after treatment. A statistically significant difference in improvement of PPT from baseline and 6-week after BTxA injection compared with 0.9% NaCl group was shown (1.0 ± 0.9 and 0.5 ± 0.7, p = 0.036). There was mild degree side-effects that spontaneous resolved within one week in both groups without significant difference in percentage. No severe adverse effects were reported during the study. The efficacy in VAS reduction of a single 20 IU of Botulinum toxin type A (Botox®) injection was not different from 0.9% NaCl for myofascial trigger point at the upper trapezius muscle. However

  5. Study of safety relief valve operation under ATWS conditions

    International Nuclear Information System (INIS)

    Hutmacher, E.S.; Nesmith, B.J.; Brukiewa, J.B.

    1979-01-01

    A literature survey and analysis project has been performed to determine if recent (since mid-1975) data has been reported which could influence the current approach to predicting PWR relief valve capacity under ATWS conditions. This study was conducted by the Energy Technology Engineering Center for NRC. Results indicate that the current relief valve capacity model tends to predict less capacity than actually obtains; however, no experimental verification at PWR ATWS conditions was found. Other project objectives were to establish the availability of methods for evaluating reaction forces and back pressure effects on relief valve capacity, and to determine if facilities exist which are capable of testing PWR relief valves at ATWS conditions

  6. Recent performance experience with US light water reactor self-actuating safety and relief valves

    Energy Technology Data Exchange (ETDEWEB)

    Hammer, C.G.

    1996-12-01

    Over the past several years, there have been a number of operating reactor events involving performance of primary and secondary safety and relief valves in U.S. Light Water Reactors. There are several different types of safety and relief valves installed for overpressure protection of various safety systems throughout a typical nuclear power plant. The following discussion is limited to those valves in the reactor coolant systems (RCS) and main steam systems of pressurized water reactors (PWR) and in the RCS of boiling water reactors (BWR), all of which are self-actuating having a setpoint controlled by a spring-loaded disk acting against system fluid pressure. The following discussion relates some of the significant recent experience involving operating reactor events or various testing data. Some of the more unusual and interesting operating events or test data involving some of these designs are included, in addition to some involving a number of similar events and those which have generic applicability.

  7. Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

    Science.gov (United States)

    Adams, David Z; Gruss, Richard; Abrahams, Alan S

    2017-04-01

    Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. Preliminary planning study for safety relief valve experiments in a Mark III BWR pressure suppression system

    International Nuclear Information System (INIS)

    McCauley, E.W.; Holman, G.S.

    1980-01-01

    In response to a request from the Water Reactor Safety Research Division of the US NRC, a preliminary study is provided which identifies key features and consideration involved in planning a comprehensive in-plant Safety Relief Valve experimental program for a Mark III containment design. The report provides identification of program objectives, measurement system requirements, and some details quantifying expected system response. In addition, a preliminary test matrix is outlined which involves a supporting philosophy intended to enhance the usefulness of the experimental results for all members of the program team: experimentalists, analysts, and plant operator

  9. Deformation relief evolution during sliding friction of Hadfield steel single crystal

    Science.gov (United States)

    Lychagin, D. V.; Filippov, A. V.; Novitskaya, O. S.; Kolubaev, A. V.; Sizova, O. V.

    2017-12-01

    The paper deals with the evolution of the deformation relief formed on lateral faces of single crystals of Hadfield steel during dry sliding friction. The use of single crystals with the predetermined orientation enables to analyze the development of shear systems subject to the duration of tribological tests. As the test duration increases, slip bands are curved and thicken in the near-surface region. After 24 hours of friction, single crystals of Hadfield steel demonstrate the maximum hardening. Afterwards, the wear process begins, which is followed by the repeated strain hardening of the specimens. After 48 hours of friction, the height of the deformation relief nearly halves on all of the three faces, as compared to that observed after 24 hours of friction. Differences in the propagation height of slip bands on the faces occur due to the uneven running-in as well as the complex involvement pattern of shear systems into the deformation process.

  10. The safety and acceptability of intravenous fentanyl versus intramuscular pethidine for pain relief during labour.

    Science.gov (United States)

    Rezk, M; El-Shamy, E S; Massod, A; Dawood, R; Habeeb, R

    2015-01-01

    This trial aimed to ascertain the relative efficacy, adverse effects, and acceptability of fentanyl versus pethidine for pain relief during labour. Parturients (n=80) in the active phase who requested analgesia were randomly assigned to receive either intravenous fentanyl (n=40) or intramuscular pethidine (n=40). Pain scores hourly, maternal and fetal adverse effects, neonatal outcome, and maternal acceptability were assessed. Pain scores decreased in both groups, the decrease varying from mild to moderate, average pain scores remaining above 3.5 in both groups. Pain scores returned towards baseline over time; three hours after the initiation of treatment in the fentanyl group. Pethidine was associated with more maternal nausea and vomiting (p administration when compared to pethidine (p drugs were acceptable for pain relief during labour. Fentanyl is comparable to pethidine for pain relief during labour regarding efficacy and acceptability, but with more neonates with low Apgar scores at one minute and higher need for neonatal resuscitation and naloxone administration. Further larger trials are needed to confirm its safety.

  11. History of aviation safety; the satisfying sighs of relief due to developments in Aviation safety

    NARCIS (Netherlands)

    Stoop, J.A.A.M.

    2014-01-01

    ”Aviation safety is an Integral part of my career. Being part of TU Delft’s impressive record of research on Aviation safety, my career has been with a sense of purpose and a responsibility to equip students to deal with the status quo challenges on Aviation safety, developments, Investigations and

  12. Surface relief grating formation on a single crystal of 4-(dimethylamino)azobenzene

    International Nuclear Information System (INIS)

    Nakano, Hideyuki; Tanino, Takahiro; Shirota, Yasuhiko

    2005-01-01

    Surface relief grating (SRG) formation on an organic single crystal by irradiation with two coherent laser beams has been demonstrated by using 4-(dimethylamino)azobenzene (DAAB). It was found that the SRG formation was greatly depending upon both the coordination of the crystal and the polarization of the writing beams. The dependence of the polarization of writing beams on the SRG formation using the single crystal was found to be quite different from that reported for amorphous polymers and photochromic amorphous molecular materials, suggesting that the mechanism of the SRG formation on the organic crystal is somewhat different from that on amorphous materials

  13. The safety relief valve handbook design and use of process safety valves to ASME and International codes and standards

    CERN Document Server

    Hellemans, Marc

    2009-01-01

    The Safety Valve Handbook is a professional reference for design, process, instrumentation, plant and maintenance engineers who work with fluid flow and transportation systems in the process industries, which covers the chemical, oil and gas, water, paper and pulp, food and bio products and energy sectors. It meets the need of engineers who have responsibilities for specifying, installing, inspecting or maintaining safety valves and flow control systems. It will also be an important reference for process safety and loss prevention engineers, environmental engineers, and plant and process designers who need to understand the operation of safety valves in a wider equipment or plant design context. . No other publication is dedicated to safety valves or to the extensive codes and standards that govern their installation and use. A single source means users save time in searching for specific information about safety valves. . The Safety Valve Handbook contains all of the vital technical and standards informat...

  14. Processing techniques for data from the Kuosheng Unit 1 shakedown safety-relief-valve tests

    International Nuclear Information System (INIS)

    McCauley, E.W.; Rompel, S.L.; Weaver, H.J.; Altenbach, T.J.

    1982-08-01

    This report describes techniques developed at the Lawrence Livermore National Laobratory, Livermore, CA for processing original data from the Taiwan Power Company's Kuosheng MKIII Unit 1 Safety Relief Valve Shakedown Tests conducted in April/May 1981. The computer codes used, TPSORT, TPPLOT, and TPPSD, form a special evaluation system for treating the data from its original packed binary form to ordered, calibrated ASCII transducer files and then to production of time-history plots, numerical output files, and spectral analyses. Using the data processing techniques described, a convenient means of independently examining and analyzing a unique data base for steam condensation phenomena in the MARKIII wetwell is described. The techniques developed for handling these data are applicable to the treatment of similar, but perhaps differently structured, experiment data sets

  15. Relief as a reward: hedonic and neural responses to safety from pain.

    Directory of Open Access Journals (Sweden)

    Siri Leknes

    2011-04-01

    Full Text Available Relief fits the definition of a reward. Unlike other reward types the pleasantness of relief depends on the violation of a negative expectation, yet this has not been investigated using neuroimaging approaches. We hypothesized that the degree of negative expectation depends on state (dread and trait (pessimism sensitivity. Of the brain regions that are involved in mediating pleasure, the nucleus accumbens also signals unexpected reward and positive prediction error. We hypothesized that accumbens activity reflects the level of negative expectation and subsequent pleasant relief. Using fMRI and two purpose-made tasks, we compared hedonic and BOLD responses to relief with responses during an appetitive reward task in 18 healthy volunteers. We expected some similarities in task responses, reflecting common neural substrates implicated across reward types. However, we also hypothesized that relief responses would differ from appetitive rewards in the nucleus accumbens, since only relief pleasantness depends on negative expectations. The results confirmed these hypotheses. Relief and appetitive reward task activity converged in the ventromedial prefrontal cortex, which also correlated with appetitive reward pleasantness ratings. In contrast, dread and pessimism scores correlated with relief but not with appetitive reward hedonics. Moreover, only relief pleasantness covaried with accumbens activation. Importantly, the accumbens signal appeared to specifically reflect individual differences in anticipation of the adverse event (dread, pessimism but was uncorrelated to appetitive reward hedonics. In conclusion, relief differs from appetitive rewards due to its reliance on negative expectations, the violation of which is reflected in relief-related accumbens activation.

  16. Relief as a reward: hedonic and neural responses to safety from pain.

    Science.gov (United States)

    Leknes, Siri; Lee, Michael; Berna, Chantal; Andersson, Jesper; Tracey, Irene

    2011-04-07

    Relief fits the definition of a reward. Unlike other reward types the pleasantness of relief depends on the violation of a negative expectation, yet this has not been investigated using neuroimaging approaches. We hypothesized that the degree of negative expectation depends on state (dread) and trait (pessimism) sensitivity. Of the brain regions that are involved in mediating pleasure, the nucleus accumbens also signals unexpected reward and positive prediction error. We hypothesized that accumbens activity reflects the level of negative expectation and subsequent pleasant relief. Using fMRI and two purpose-made tasks, we compared hedonic and BOLD responses to relief with responses during an appetitive reward task in 18 healthy volunteers. We expected some similarities in task responses, reflecting common neural substrates implicated across reward types. However, we also hypothesized that relief responses would differ from appetitive rewards in the nucleus accumbens, since only relief pleasantness depends on negative expectations. The results confirmed these hypotheses. Relief and appetitive reward task activity converged in the ventromedial prefrontal cortex, which also correlated with appetitive reward pleasantness ratings. In contrast, dread and pessimism scores correlated with relief but not with appetitive reward hedonics. Moreover, only relief pleasantness covaried with accumbens activation. Importantly, the accumbens signal appeared to specifically reflect individual differences in anticipation of the adverse event (dread, pessimism) but was uncorrelated to appetitive reward hedonics. In conclusion, relief differs from appetitive rewards due to its reliance on negative expectations, the violation of which is reflected in relief-related accumbens activation.

  17. Membranes fabricated with a deep single corrugation for package stress reduction and residual stress relief

    NARCIS (Netherlands)

    Spiering, V.L.; Spiering, V.L.; Bouwstra, S.; Bouwstra, S.; Burger, Johannes Faas; Elwenspoek, Michael Curt

    1993-01-01

    Thin square membranes including a deep circular corrugation are realized and tested for application in a strain-based pressure sensor. Package-induced stresses are reduced and relief of the residual stress is obtained, resulting in a larger pressure sensitivity and a reduced temperature sensitivity.

  18. NRC Information No. 90-18: Potential problems with Crosby safety relief valves used on diesel generator air start receiver tanks

    International Nuclear Information System (INIS)

    Rossi, C.E.

    1992-01-01

    On March 31, 1989, Cooper Industries was made aware of circumstances at Perry Unit 1 that led to the Division I EDG being declared inoperable. A Crosby safety relief valve on one of the two EDG starting air receiving tanks was inadvertently hit during maintenance activities. The force of the impact caused the valve to open and blow down both air receiving tanks. The safety relief valve did not reseat until approximately 30 psig below the EDG automatic start lockout signal. On January 12, 1990, Cooper Industries learned that a similar event had occurred at Comanche Peak. On January 17, 1990, Cooper Industries submitted a 10 CFR Part 21 report on the affected safety relief valves (Crosby style JMBU and JRU safety relief valves). Although Crosby-style JMBU and JRU safety relief valves were designed to meet the requirements of Section VIII of the ASME Boiler and Pressure Vessel Code, they were not seismically qualified. In addition, the blowdown characteristics of the valves were not consistent with the functional requirements of the system in which they were installed. Cooper Industries has recommended replacing these valves with seismically qualified valves that have the proper blowdown reseat characteristics

  19. Analysis of pressure oscillations and safety relief valve vibrations in the main steam system of a Boiling Water Reactor

    Energy Technology Data Exchange (ETDEWEB)

    Galbally, David, E-mail: dgalbally@innomerics.com [Innomerics, Calle San Juan de la Cruz 2, 28223 Madrid (Spain); García, Gonzalo [Alava Ingenieros, Calle Albasanz 16, 28037 Madrid (Spain); Hernando, Jesús; Sánchez, Juan de Dios [Iberdrola, Calle Tomás Redondo 1, 28033 Madrid (Spain); Barral, Marcos [Alava Ingenieros, Calle Albasanz 16, 28037 Madrid (Spain)

    2015-11-15

    Highlights: • We analyze the vibratory response of safety relief valves in the main steam system of a Boiling Water Reactor. • We show that valve internals experience acceleration spikes of more than 20 g. • Spikes are caused by impacts between the valve disc and the seating surface of the valve nozzle. • Resonances occur at higher Strouhal numbers than those reported in the literature for tandem side branches. • Valves experience high vibration levels even for resonances caused by second order hydrodynamic modes. - Abstract: Steam flow inside the main steam lines of a Boiling Water Reactor can generate high-amplitude pressure oscillations due to coupling between the separated shear layer at the mouth of the safety relief valves (SRVs) and the acoustic modes of the side branches where the SRVs are mounted. It is known that certain combinations of flow velocities and main steam line geometries are capable of generating self-excited pressure oscillations with very high amplitudes, which can endanger the structural integrity of main steam system components, such as safety valves, or reactor internals such as steam dryers. However, main steam systems may also experience lower amplitude pressure oscillations due, for example, to coupling of higher order hydrodynamic modes with acoustic cavity modes, or to incipient resonances where the free stream velocity is slightly lower than the critical flow velocity required to develop a stable locked-on acoustic resonance. The amplitude of these pressure oscillations is typically insufficient to cause readily observable structural damage to main steam system components, but may still have subtle effects on safety relief valves. The investigation presented in this article focuses on the characterization of the response of SRVs under the effects of pressure oscillations associated with acoustic excitations that are insufficient to cause structural damage to the valves or associated equipment. It is shown that valve

  20. Residual stress measurement inside a dissimilar metal weld mock-up of the pressurizer safety and relief nozzle

    Energy Technology Data Exchange (ETDEWEB)

    Campos, Wagner R.C.; Rabello, Emerson G.; Silva, Luiz L.; Mansur, Tanius R., E-mail: wrcc@cdtn.br, E-mail: egr@cdtn.br, E-mail: silvall@cdtn.br, E-mail: tanius@cdtn.br [Centro de Desenvolvimento da Tecnologia Nuclear (CDTN/CNEN-MG), Belo Horizonte (Brazil). Servico de Integridade Estrutural; Martins, Ketsia S., E-mail: ketshinoda@hotmail.com [Universidade Federal de Minas Gerais (UFMG), Nelo Horizonte (Brazil). Departamento de Engenharia Metalurgica

    2015-07-01

    Residual stresses are present in materials or structural component in the absence of external loads or changes in temperatures. The most common causes of residual stresses being present are the manufacturing or assembling processes. All manufacturing processes, such as casting, welding, machining, molding, heat treatment, among others, introduces residual stresses into the manufactured object. The residual stresses effects could be beneficial or detrimental, depending on its distribution related to the component or structure, its load service and if it is compressive or tensile. In this work, the residual strains and stresses inside a mock-up that simulates the safety and relief nozzle of Angra 1 Nuclear Power Plant pressurizer were studied. The current paper presents a blind hole-drilling method residual stress measurements both at the inner surface of dissimilar metal welds of dissimilar metal weld nozzle mock-up. (author)

  1. Relief Sculpture

    Science.gov (United States)

    Lawrence, Trudy

    2005-01-01

    Relief sculpture is an art form that is midway between painting and sculpture in the round. It is a process in which the subject stands out or projects a surface from the background. The surface has several levels. It can be low relief or high relief (deep or almost round) or anywhere in between. The most common example of low relief is a coin…

  2. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies.

    Science.gov (United States)

    Yue, Yong; Collaku, Agron; Brown, Jean; Buchanan, William L; Reed, Kenneth; Cooper, Stephen A; Otto, James

    2013-09-01

    Paracetamol (APAP), also known as acetaminophen, is the most commonly used over-the-counter analgesic for the treatment of mild-to-moderate pain. However, the speed of onset of pain relief is limited mainly to the standard, immediate-release formulation. Efficacy and speed of onset of pain relief are critical in acute pain situations such as postsurgical dental pain, because reducing pain can improve clinical outcome and reduce the risk of transition from acute pain to more chronic pain. Efficacy and rapid onset also reduce the risk of excessive dosing with the analgesic. We sought to investigate the dose-response efficacy and speed of onset of pain relief of a fast-dissolving APAP formulation compared with lower doses of APAP and placebo in dental patients after impacted third molar extraction. Two single-center, single-dose, randomized, placebo-controlled, double-blind, double-dummy, parallel-group studies (Study I and Study II) were conducted to evaluate the efficacy and speed of onset of pain relief of different doses of a fast-dissolving APAP tablet (FD-APAP), standard APAP, and placebo in patients with postsurgical dental pain following third molar extraction. In Study I, a single dose of FD-APAP 1000 mg, FD-APAP 500 mg, or placebo was given to 300 patients; in Study II, a single dose of FD-APAP 1000 mg, standard APAP 650 mg, or placebo was given to 401 patients. All 701 patients from both studies were included in the analysis and safety assessment. FD-APAP 1000 mg demonstrated significantly greater effect compared with FD-APAP 500 mg, APAP 650 mg, and placebo for all efficacy measurements, including sum of pain relief and pain intensity difference, total pain relief, sum of pain intensity difference, pain intensity difference, and pain relief score during 6 hours after the dose. Onset of confirmed first perceptible relief in subjects treated with FD-APAP 1000 mg was 15 minutes, which was 32% and 25% significantly shorter than onset of pain relief of FD

  3. Aging and service wear of spring-loaded pressure relief valves used in safety-related systems at nuclear power plants

    International Nuclear Information System (INIS)

    Staunton, R.H.; Cox, D.F.

    1995-03-01

    Spring-loaded pressure relief valves (PRVS) are used in some safety-related applications at nuclear power plants. In general, they are used in systems where, during accidents, pressures may rise to levels where pressure safety relief is required for protection of personnel, system piping, and components. This report documents a study of PRV aging and considers the severity and causes of service wear and how it is discovered and corrected in various systems, valve sizes, etc. Provided in this report are results of the examination of the recorded failures and identification of trends and relationships/correlations in the failures when all failure-related parameters are considered. Components that comprise a typical PRV, how those components fail, when they fail, and the current testing frequencies and methods are also presented in detail

  4. Implementation of an enlarged model of the safety valves and relief in the plant integral model for the code RELAP/SCDAPSIM

    International Nuclear Information System (INIS)

    Amador G, R.; Ortiz V, J.; Castillo D, R.; Hernandez L, E. J.; Galeana R, J. C.; Gutierrez, V. H.

    2013-10-01

    The present work refers to the implementation of a new model on the logic of the safety valves and relief in the integral model of the Nuclear Power Plant of Laguna Verde of the thermal-hydraulic compute code RELAP/SCDAPSIM Mod. 3.4. The new model was developed with the compute package SIMULINK-MATLAB and contemplates all the operation options of the safety valves and relief, besides including the availability options of the valves in all the operation ways and of blockage in the ways of relief and low-low. The implementation means the elimination of the old model of the safety valves and to analyze the group of logical variables, of discharge and available control systems to associate them to the model of package SIMULINK-MATLAB. The implementation has been practically transparent and 27 cases corresponding to a turbine discharge were analyzed with the code RELAP/SCDAPSIM Mod. 3.4. The results were satisfactory. (Author)

  5. Technical evaluation report, TMI action NUREG-0737 (II.D.1), relief and safety valve testing, Comanche Peak, Unit 2, Docket No. 50-446

    International Nuclear Information System (INIS)

    Fineman, C.P.

    1993-01-01

    In the past, safety and relief valves installed in the primary coolant system of light water reactors have performed improperly. As a result, the authors of NUREG-0578 (TMI-2 Lessons Learned Task Force Status Report and Short-Term Recommendations) and, subsequently, NUREG-0737 (Clarification of TMI Action Plan Requirements) recommended development and completion of programs to do two things. First, the programs should reevaluate the functional performance capabilities of pressurized water reactor safety, relief, and block valves. Second, they should verify the integrity of the pressurizer safety and relief valve piping systems for normal, transient, and accident conditions. This report documents the review of those programs by EG ampersand G Idaho, Inc. Specifically, this report documents the review of the Comanche Peak, Unit 2, Applicant response to the requirement of NUREG-0578 and NUREG-0737. This review found the Applicant provided an acceptable response reconfirming they met General Design Criteria 14, 15 and 30 of Appendix A to 10 CFR 50 for the subject equipment

  6. ICDE project report: collection and analysis of common-cause failure of safety valves and relief valves

    International Nuclear Information System (INIS)

    2002-01-01

    This report documents a study performed on the set of common cause failures (CCF) of safety and relief valves (SRV). The data studied here were derived from the International CCF Data Exchange (ICDE) database, to which several countries have submitted CCF event data. The purpose of the ICDE is to allow multiple countries to collaborate and exchange CCF data to enhance the quality of risk analyses that include CCF modeling. Because CCF events are typically rare events, most countries do not experience enough CCF events to perform meaningful analyses. Data combined from several countries, however, yields sufficient data for more rigorous analyses. This report is the result of an in-depth review of the SRV events and presents several insights about them. The objective of this document is to look beyond the CCF parameter estimates that can be obtained from the CCF data, to gain further understanding of why CCF events occur and what measures may be taken to prevent, or at least mitigate the effect of, SRV CCF events. The report presents details of the ICDE project, a quantitative presentation of the SRV events, and a discussion of some engineering aspects of the events. This study examined 149 events in the ICDE database by tabulating the data and observing trends. Once trends were identified individual events were reviewed for insights. The database contains information developed during the original entry of the events that was used in this study. The data span a period from 1977 through 1999. The data is not necessarily complete for each country through this period. This information includes root cause, coupling factor, common cause component group (CCCG) size, and corrective action. As part of this study, these events were reviewed again and additional categorizations of the data were included. Those categories included the degree of failure, affected subsystem, and detection method. This study begins with an overview of the entire data set (Section Five). Charts and

  7. 49 CFR 178.345-10 - Pressure relief.

    Science.gov (United States)

    2010-10-01

    ..., including valves, frangible (rupture) disks, vacuum vents and combination devices must certify that the... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... pressure relief valves. A secondary pressure relief system consisting of another pressure relief valve in...

  8. Coincident steam generator tube rupture and stuck-open safety relief valve carryover tests: MB-2 steam generator transient response test program

    International Nuclear Information System (INIS)

    Garbett, K.; Mendler, O.J.; Gardner, G.C.; Garnsey, R.; Young, M.Y.

    1987-03-01

    In PWR steam generator tube rupture (SGTR) faults, a direct pathway for the release of radioactive fission products can exist if there is a coincident stuck-open safety relief valve (SORV) or if the safety relief valve is cycled. In addition to the release of fission products from the bulk steam generator water by moisture carryover, there exists the possibility that some primary coolant may be released without having first mixed with the bulk water - a process called primary coolant bypassing. The MB-2 Phase II test program was designed specifically to identify the processes for droplet carryover during SGTR faults and to provide data of sufficient accuracy for use in developing physical models and computer codes to describe activity release. The test program consisted of sixteen separate tests designed to cover a range of steady-state and transient fault conditions. These included a full SGTR/SORV transient simulation, two SGTR overfill tests, ten steady-state SGTR tests at water levels ranging from very low levels in the bundle up to those when the dryer was flooded, and three moisture carryover tests without SGTR. In these tests the influence of break location and the effect of bypassing the dryer were also studied. In a final test the behavior with respect to aerosol particles in a dry steam generator, appropriate to a severe accident fault, was investigated

  9. Clinical validation of efficacy and safety of herbal cough formulation "Honitus syrup" for symptomatic relief of acute non-productive cough and throat irritation.

    Science.gov (United States)

    Gupta, Arun; Gaikwad, Vaijayanti; Kumar, Satyendra; Srivastava, Ruchi; Sastry, Jln

    2016-01-01

    Acute cough represents the most common illness evaluated in the outpatient settings. Available remedies for its management are generally allopathic combinations of antihistamines and decongestants that achieve antitussive activity, but often with unpleasant side effects prompting the need to explore safer and effective options. Honitus is an Ayurvedic proprietary herbal cough syrup with benefits of honey, intended to provide relief in acute nonproductive cough and throat irritation without causing drowsiness. This study investigated the safety and efficacy of Honitus in reducing acute nonproductive cough and throat irritation in comparison to a standard marketed allopathic cough syrup intended for use in similar conditions. This was a randomized double-blind study conducted in 105 individuals who received orally 2 tsp (10 ml) of either Honitus or marketed cough syrup (MCS) four times a day for 3 days. Response to treatment was evaluated from baseline to the end of treatment period on the basis of changes in day and night frequencies of cough, throat irritation and development of adverse events (AEs). Honitus was found safe and effective in reducing symptoms of acute nonproductive cough, throat irritation, and comparable to MCS in reducing day and night frequencies of cough, the time to relief from cough and throat irritation and the Physician's Global Assessment of cough. Honitus showed comparably better results than MCS on throat irritation, the duration of relief from cough and throat irritation without causing drowsiness. No AEs related to study or study products were reported. Honitus Syrup is safe and effective in reducing the symptoms of acute nonproductive cough and throat irritation without causing drowsiness.

  10. Reconstruction of the Emergency Core Cooling System (ECCS), Confinement Spray System (SSK) and Pressurizer Safety Valves and Relief Line (PVKO)

    International Nuclear Information System (INIS)

    Severa, P.

    2001-01-01

    The paper deals with the results of reconstruction of the ECCS, SSK, and PVKO systems as implemented during the Gradual Upgrading with safety upgrading of the Bohunice V1 nuclear power plant 1997 to 2000. (author)

  11. Alternative medicine - pain relief

    Science.gov (United States)

    Acupuncture - pain relief; Hypnosis - pain relief; Guided imagery - pain relief ... neck, shoulder, knee, or elbow) Osteoarthritis Rheumatoid arthritis Hypnosis is a focused state of concentration. With self- ...

  12. Single intradiscal injection of the interleukin-6 receptor antibody tocilizumab provides short-term relief of discogenic low back pain; prospective comparative cohort study.

    Science.gov (United States)

    Sainoh, Takeshi; Orita, Sumihisa; Miyagi, Masayuki; Inoue, Gen; Yamauchi, Kazuyo; Suzuki, Miyako; Sakuma, Yoshihiro; Kubota, Go; Oikawa, Yasuhiro; Inage, Kazuhide; Sato, Jun; Nakata, Yukio; Aoki, Yasuchika; Takahashi, Kazuhisa; Ohtori, Seiji

    2016-01-01

    Inflammatory cytokines, such as interleukin-6 and tumor necrosis factor-α, are gaining attention as important etiologic factors associated with discogenic low back pain. We conducted a prospective cohort study to evaluate the efficacy and safety of intradiscal injection of the interleukin-6 receptor antibody tocilizumab in patients with discogenic low back pain. Thirty-two consecutive patients were intradiscally injected with 2 mL of 0.5% bupivacaine (control group). Another 31 consecutive patients were intradiscally injected with 40 mg tocilizumab and 1-2 mL of 0.5% bupivacaine (tocilizumab group) at the same time. Prior to treatment, the vertebral origin of low back pain was confirmed in all patients based on pain provocation during discography and pain relief with 1 mL of 1% xylocaine. Numeric rating scale and Oswestry disability index scores were used to evaluate pain level before and after treatment between the 2 groups. The association between pain relief with tocilizumab and intervertebral disc degeneration grade was also determined. At the end of the study (8 weeks after treatment), 30 patients in each group were evaluable. In the tocilizumab group, numeric rating scale and Oswestry disability index scores improved significantly at 2 and 4 weeks after treatment, respectively. Intervertebral disc degeneration was not associated with improvement of numeric rating scale score in the tocilizumab group. Local infection (i.e., discitis) was observed in 1 patient in the tocilizumab group. The results demonstrate the clinical relevance of interleukin-6 in discogenic low back pain. Intradiscal tocilizumab injection was shown to exert a short-term analgesic effect in patients with discogenic low back pain. Further research is required to determine the long-term effects of intradiscal tocilizumab therapy in patients with discogenic low back pain. Copyright © 2015 The Japanese Orthopaedic Association. Published by Elsevier B.V. All rights reserved.

  13. The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial--study protocol.

    Science.gov (United States)

    Lee, Dong-Hyo; Seo, Eun-Sung; Hong, Jin-Tae; Lee, Gang-Tai; You, Young-Kyoung; Lee, Kun-Kook; Jo, Ga-Won; Kim, Nam-Kwen

    2013-11-25

    Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life

  14. The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial- study protocol

    Science.gov (United States)

    2013-01-01

    Background Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition. This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics. Methods/Designs This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs. Discussion This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ

  15. Learning curve, diagnostic yield and safety of single balloon enteroscopy.

    Science.gov (United States)

    Dutta, Amit Kumar; Sajith, Kattiparambil Gangadharan; Joseph, Anjilivelil J; Simon, Ebby George; Chacko, Ashok

    2012-01-01

    Single balloon enteroscopy (SBE) is a recently developed diagnostic modality to assess small bowel mucosa. The data on learning curve of SBE is scanty. We aimed to assess the learning curve, diagnostic yield and safety of SBE. All patients who underwent SBE at our centre from December 2007 to December 2010 were included retrospectively. The clinical details, enteroscopy findings and procedure related details were obtained for each patient from a prospectively maintained database. The extent of small bowel visualised with increasing number of procedures by a single endoscopist (Endoscopist A) who performed most of the procedures was used to estimate the learning curve using locally weighted regression curve. The diagnostic yield and complications rates of SBE were also estimated. The study was approved by the institute review board and ethics committee. Ninety SBEs were performed in 84 patients (age: 42+15 years, 27.4% females). 57 procedures were performed (32 antegrade and 25 retrograde) by endoscopist A. There was gradual improvement in the extent of small bowel visualised during the first 15 procedures via antegrade route followed by flattening of curve. The retrograde route showed no definite trend towards improvement during the procedures performed. The overall diagnostic yield of SBE was 32.1%. There was no complication except for mild self-limiting abdominal pain in one patient. SBE via antegrade route has a higher success rate and better learning curve than the retrograde route. SBE is a safe procedure and helps in establishing a diagnosis in one-third of the patients examined.

  16. Pressure relief, cold foam or static air? A single center, prospective, controlled randomized clinical trial in a Dutch nursing home.

    Science.gov (United States)

    van Leen, Martin; Hovius, Steven; Neyens, Jacques; Halfens, Ruud; Schols, Jos

    2011-02-01

    At present, the evidence regarding the type of mattress that is the best for preventing pressure ulcers is not convincing. In a single center, prospective, controlled trial we compared a static air overlay mattress (no electric pump needed) on top of a cold foam mattress with a cold foam mattress alone on pressure ulcer incidence in nursing home residents. 83 Patients were included in the study with a score lower than 12 points on the Norton scale and no pressure ulcer at the start of the study. 42 Patients received a cold foam mattress and 41 patients received a static air overlay on top of that cold foam mattress. Out of bed we standardized the pressure reduction in sitting position by using a static air cushion in both groups. Patients were checked weekly in both groups for pressure ulcers. Only when there were signs of developing a pressure ulcer grade 2 or higher, repositioning by our nursing home pressure ulcer protocol (PU protocol) was put into practice. Seven patients (17.1%) on a cold foam mattress and two (4.8%) on a static air mattress developed a pressure ulcer grade 2 or more. There was no difference regarding pressure ulcer incidence between patients with a high risk (Norton 5-8) and patients with a medium risk (Norton 9-12). In 5 out of 7 patients who developed a pressure ulcer on a foam mattress the ulcers showed no healing using our PU protocol. In the static air group all pressure ulcers healed by regular treatment according to our PU protocol. In this study, static air overlay mattresses provided a better prevention than cold foam mattresses alone (4.8% versus 17.1%). The Norton scores of the patients in both groups did not change during the 6 month trial period. Our decision to use repositioning only when there were signs of a pressure ulcer seems to be acceptable when a static air overlay is in position. However, the score of 17.1% development (incidence) of pressure ulcers in the foam group may stress the need of repositioning when using only

  17. Technical evaluation report TMI action -- NUREG-0737 (II.D.1). Relief and safety valve testing, Watts Bar Nuclear Plant, Units 1 and 2 (Dockets 50-390 and 50-391)

    International Nuclear Information System (INIS)

    Fineman, C.P.

    1995-02-01

    In the past, safety and relief valves installed in the primary coolant system of light water reactors have performed improperly. As a result, the authors of NUREG-0578 (TMI-2 Lessons Learned Task Force Status Report and Short-Term Recommendations) and, subsequently, NUREG-0737 (Clarification of TMI Action Plan Requirements) recommended development and completion of programs to do two things. First, they should reevaluate the functional performance capabilities of pressurized water reactor safety, relief, and block valves. Second, they should verify the integrity of the pressurizer safety and relief valve piping systems for normal, transient, and accident conditions. This report documents the review of those programs by Lockheed Idaho Technologies Company. Specifically, this report documents the review of the Watts Bar Nuclear Plant, Units 1 and 2, Applicant response to the requirements of NUREG-0578 and NUREG-0737. This review found the Applicant provided an acceptable response reconfirming they met General Design Criteria 14, 15, and 30 of Appendix A to 10 CFR 50 for the subject equipment. It should also be noted Lockheed Idaho performed this review for both Units 1 and 2. However, the applicability of this review to Unit 2 depends on verifying that the Unit 2 as-built system conforms to the Unit 1 design reviewed in this report

  18. Effect of a Single Administration of Focused Extracorporeal Shock Wave in the Relief of Delayed-Onset Muscle Soreness: Results of a Partially Blinded Randomized Controlled Trial.

    Science.gov (United States)

    Fleckenstein, Johannes; Friton, Mara; Himmelreich, Heiko; Banzer, Winfried

    2017-05-01

    To examine the effects of a single administration of focused extracorporeal shock wave therapy on eccentric exercise-induced delayed-onset muscle soreness (DOMS). Three-arm randomized controlled study. University research center. Participants (N=46; 23 women) had a mean age of 29.0±3.0 years and a mean body mass index of 23.8±2.8kg/m 2 . Participants were randomly allocated to verum- (energy flux density, .06-.09mJ/mm 2 ; pulse ratio per point, 200) or sham-focused extracorporeal shock wave therapy (no energy) at 7 equidistant points along the biceps muscle or no intervention. The primary outcome was the difference in pain intensity. Secondary outcomes included maximum isometric voluntary force (MIVF), pressure pain threshold (PPT), and impairment in daily life. Despite descriptive clinically meaningful differences, mixed-effects analysis (group × time) of changes to baseline did not reveal significant differences in the reduction of pain intensity between groups (F 2,42 =2.5, P=.094). MIVF was not significantly different between groups (F 2,43 =1.9, P=.159). PTT (F 2,43 =0.2, P=.854) and daily life impairment (F 2,42 =1.4, P=.248) were not significantly decreased over time, and there were no differences between groups in the post hoc analysis. DOMS is a common symptom in people participating in exercise, sports, or recreational physical activities. A single treatment with focused extracorporeal shock wave therapy causes clinically relevant effects in the relief of pain, increase in force, and improvement of pain-associated impairments of daily living. Still, results need to be cautiously interpreted because of the pilot character of this study. Focused extracorporeal shock wave therapy might present an option in the midterm recovery from DOMS (72h) and be an approach to enhance the return to play in athletes. Copyright © 2017. Published by Elsevier Inc.

  19. 49 CFR 179.400-20 - Pressure relief devices.

    Science.gov (United States)

    2010-10-01

    ...(b). (3) Installation of safety vent and pressure relief valve—(i) Inlet piping. (A) The opening... valve, set as required in § 179.401-1, may be used in lieu of the safety vent, provided it meets the... structure, trucks and safety appliances. Vent or weep holes in pressure relief devices are prohibited. All...

  20. A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour

    Directory of Open Access Journals (Sweden)

    Webster Joan

    2011-03-01

    Full Text Available Abstract Background Almost one third of women suffer continuous lower back pain during labour. Evidence from three systematic reviews demonstrates that sterile water injections (SWI provide statistically and clinically significant pain relief in women experiencing continuous lower back pain during labour. The most effective technique to administer SWI is yet to be determined. Therefore, the aim of this study is to determine if the single injection SWI technique is no less effective than the routinely used four injection SWI method in reducing continuous lower back pain during labour. Methods/design The trial protocol was developed in consultation with an interdisciplinary team of clinical researchers. We aim to recruit 319 women presenting at term, seeking analgesia for continuous severe lower back pain during labour. Participants will be recruited from two major maternity hospitals in Australia. Randomised participants are allocated to receive a four or single intradermal needle SWI technique. The primary outcome is the change in self-reported pain measured by visual analogue scale at baseline and thirty minutes post intervention. Secondary outcomes include VAS change scores at 10, 60, 90 and 120 min, analgesia use, mode of birth and maternal satisfaction. Statistical analysis Sample size was calculated to achieve 90% power at an alpha of 0.025 to detect a non-inferiority margin of ≤ 1 cm on the VAS, using a one-sided, two-sample t-test. Baseline demographic and clinical characteristics will be analysed for comparability between groups. Differences in primary (VAS pain score and secondary outcomes between groups will be analysed by intention to treat and per protocol analysis using Student's t-test and ANOVA. Conclusion This study will determine if a single intradermal SWI technique is no less effective than the routinely used four injection technique for lower back pain during labour. The findings will allow midwives to offer women

  1. 46 CFR 154.802 - Alternate pressure relief settings.

    Science.gov (United States)

    2010-10-01

    ... SAFETY STANDARDS FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Design, Construction and Equipment Cargo Vent Systems § 154.802 Alternate pressure relief settings. Cargo tanks with more than one relief valve setting must have one of the following arrangements: (a) Relief valves that: (1) Are set and...

  2. 46 CFR 154.806 - Capacity of pressure relief valves.

    Science.gov (United States)

    2010-10-01

    ... SAFETY STANDARDS FOR SELF-PROPELLED VESSELS CARRYING BULK LIQUEFIED GASES Design, Construction and Equipment Cargo Vent Systems § 154.806 Capacity of pressure relief valves. Pressure relief valves for each... 46 Shipping 5 2010-10-01 2010-10-01 false Capacity of pressure relief valves. 154.806 Section 154...

  3. 46 CFR 154.801 - Pressure relief systems.

    Science.gov (United States)

    2010-10-01

    ..., except a relief valve may vent to a common tank relief valve header if the back pressure is included in... Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) CERTAIN BULK DANGEROUS CARGOES SAFETY... Vent Systems § 154.801 Pressure relief systems. (a) Each cargo tank that has a volume of 20m3 (706 ft.3...

  4. Humanitarian relief supply chain

    Indian Academy of Sciences (India)

    This paper models a humanitarian relief chain that includes a relief goods supply chain and an evacuation chain in case of a natural disaster. Optimum network flow is studied for both the chains by considering three conflicting objectives, namely demand satisfaction in relief chain, demand satisfaction in evacuation chain ...

  5. Technical evaluation report TMI action: NUREG-0737 (II.D.1) relief and safety valve testing,. Diablo Canyon Units 1 and 2 (Docket Nos. 50-275, 50-323)

    International Nuclear Information System (INIS)

    Miller, G.K.; Magleby, H.L.; Nalezny, C.L.

    1984-07-01

    Light water reactor operators have experienced a number of occurrences of improper performance of safety and relief valves installed in their primary coolant systems. Because of this, the authors of NUREG-0578 (TMI-2 Lessons Learned Task Status Report and Short-Term Recommendations) and subsequently NUREG-0737 (Clarification of TMI Action Plan Requirements) recommended that programs be developed and completed which would reevaluate the functional performance capabilities of Pressurized Water Reactor (PWR) safety, relief, and block valves and which would verify the integrity of the piping systems for normal, transient and accident conditions. This report provides the results of the review of these programs and their results by the Nuclear Regulatory Commission (NRC) and their consultant, EG and G Idaho, Inc. Specifically, this report has examined the response of the Licensee for Diablo Canyon Units 1 and 2, to the requirements of NUREG-0578 and NUREG-0737 and finds that the Licensee has provided an acceptable response, reconfirming that the General Design Criteria 14, 15 and 30 of Appendix A to 10 CRF 50 have been met. 18 refs

  6. Single oral dose safety of D-allulose in dogs.

    Science.gov (United States)

    Nishii, Naohito; Nomizo, Toru; Takashima, Satoshi; Matsubara, Tatsuya; Tokuda, Masaaki; Kitagawa, Hitoshi

    2016-07-01

    Healthy dogs were administered acute oral doses of D-allulose (also called D-psicose) to evaluate its toxicity. Six dogs received oral doses of either a placebo or D-allulose solution (1 and 4 g/kg) on three different study days. One dog experienced vomiting, and five dogs showed transient diarrhea when 4 g/kg of D-allulose was administered. All dogs were active and had a good appetite throughout the study period. Blood glucose concentration slightly decreased without a rise in plasma insulin concentration 2 hr after D-allulose administration. Plasma alkaline phosphatase activities showed a mild increase between 12 and 48 hr after D-allulose administration. These data suggested that a single oral dose of D-allulose does not show severe toxicity in dogs.

  7. An Autologous Anti-Inflammatory Protein Solution Yielded a Favorable Safety Profile and Significant Pain Relief in an Open-Label Pilot Study of Patients with Osteoarthritis

    Directory of Open Access Journals (Sweden)

    Jason Hix

    2017-12-01

    Full Text Available Osteoarthritis (OA is a progressive and degenerative disease, which may result in significant pain and decreased quality of life. Recent updates in our understanding of OA have demonstrated that it is a whole joint disease that has many similarities to an unhealed wound containing inflammatory cytokines. The nSTRIDE Autologous Protein Solution (APS Kit is a medical device under development for the treatment of OA. The APS Kit processes a patient's own blood at the point of care to contain high concentrations of anti-inflammatory cytokines and anabolic growth factors. This study assessed the safety and treatment effects of a single intra-articular injection of APS. Eleven patients were enrolled in this study. Sufficient blood could not be drawn from one patient who was subsequently withdrawn, leaving 10 patients treated. Minor adverse events (AEs were experienced by seven subjects (63.6%. There was one serious AE (diverticulitis unrelated to the device or procedure. One subject experienced AEs that were judged “likely” to be procedure related (arthralgia/musculoskeletal discomfort and all resolved within 6 days of injection. All other AEs were unrelated to the device or procedure. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC pain scores improved significantly over time (ANOVA, p < 0.0001, 12.0 ± 1.2 preinjection, 3.3 ± 2.9 one year postinjection, and 72.5% WOMAC pain improvement. There was significant positive correlation between white blood cell concentration in APS and improvement in WOMAC pain scores.

  8. Once-daily gastroretentive gabapentin for postherpetic neuralgia: integrated efficacy, time to onset of pain relief and safety analyses of data from two phase 3, multicenter, randomized, double-blind, placebo-controlled studies.

    Science.gov (United States)

    Rauck, Richard L; Irving, Gordon A; Wallace, Mark S; Vanhove, Geertrui F; Sweeney, Michael

    2013-08-01

    Treatment options for postherpetic neuralgia (PHN), a complication of herpes zoster, are commonly unsatisfactory and associated with adverse events. To evaluate the efficacy, onset of pain relief, and safety of gastroretentive gabapentin (G-GR) in patients with PHN. In two placebo-controlled studies, 357 patients with PHN were randomized to 1800mg G-GR and 364 patients were randomized to placebo taken with the evening meal. Patients underwent a two week titration, eight weeks of stable dosing, and one week of tapering. Efficacy assessments included change in average daily pain (ADP) score from baseline to Week 10, time to onset of pain relief, the proportion of patients feeling improved using the Patient Global Impression of Change, and the proportion of responders (≥30% pain reduction). At Week 10, patients randomized to G-GR reported greater reductions in ADP score compared with placebo (-37.0% vs. -29.1; P=0.0025). More G-GR patients felt improved compared with placebo (44% vs. 33%; P=0.003) and responded to treatment (54% vs. 41%; P=0.001). As early as Day 2, greater pain reductions were observed for the G-GR group compared with the placebo group (-6.6% vs. -1.6%; P=0.0017). The median time to a one point or greater reduction in ADP score was four days for G-GR and six days for placebo (P<0.0001). The most frequently reported adverse events were dizziness (G-GR, 11%; placebo, 2%) and somnolence (G-GR, 5%; placebo, 3%). PHN pain reduction after G-GR treatment can be observed as early as the second day of dosing and continues for at least 10 weeks. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

  9. SAFETY EVALUATION OF OXALIC ACID WASTE RETRIEVAL IN SINGLE SHELL TANK (SST) 241-C-106

    International Nuclear Information System (INIS)

    SHULTZ, M.V.

    2003-01-01

    This report documents the safety evaluation of the process of retrieving sludge waste from single-shell tank 241-C-106 using oxalic acid. The results of the HAZOP, safety evaluation, and control allocation/decision are part of the report. This safety evaluation considers the use of oxalic acid to recover residual waste in single-shell tank (SST) 241-C-106. This is an activity not addressed in the current tank farm safety basis. This evaluation has five specific purposes: (1) Identifying the key configuration and operating assumptions needed to evaluate oxalic acid dissolution in SST 241-C-106. (2) Documenting the hazardous conditions identified during the oxalic acid dissolution hazard and operability study (HAZOP). (3) Documenting the comparison of the HAZOP results to the hazardous conditions and associated analyzed accident currently included in the safety basis, as documented in HNF-SD-WM-TI-764, Hazard Analysis Database Report. (4) Documenting the evaluation of the oxalic acid dissolution activity with respect to: (A) Accident analyses described in HNF-SD-WM-SAR-067, Tank Farms Final Safety Analysis Report (FSAR), and (B) Controls specified in HNF-SD-WM-TSR-006, Tank Farms Technical Safety Requirements (TSR). (5) Documenting the process and results of control decisions as well as the applicability of preventive and/or mitigative controls to each oxalic acid addition hazardous condition. This safety evaluation is not intended to be a request to authorize the activity. Authorization issues are addressed by the unreviewed safety question (USQ) evaluation process. This report constitutes an accident analysis

  10. REVEALING REGULARITIES OF DISTRIBUTION OF HYDROCARBON DEPOSITS OF AFRICA ON A SINGLE TECTONIC-BASED NETWORK USING MAPS OF RELIEF PLASTIC

    Directory of Open Access Journals (Sweden)

    I. P. Baranov

    2017-01-01

    Full Text Available The main purpose of the article is to present possibilities of the method of relief plastic with the forecast of of oil deposits. The method is developed, formalized and mathematically confirmed by the group of scientists of Pushchino scientific center headed by Professor I.N. Stepanova in the 80-ies of 20th century [Stepanov et al., 1977; Stepanov, 2006] In the process of long-term studies of the behavior of lithodynamic structures and systems, the method was successfully tested in the fields of Krasnodar Region, Astrakhan Region, Western Siberia, Kalmykia, Argentina, Venezuela, Kuwait, USA, etc. Currently, this set of operations is called by scientists-developers of the method lithodynamic or paleostructural analysis. The method includes: the imaging technology of lithodynamic structures and systems in the Earth’s surface by contours of the structural, topographic and bathymetric charts; analysis of the forms of lithodynamic structures and systems; outlook (recommendationsof the provisions of the hydrocarbons. The case study of Africa has highlighted the analysis of the lithodynamic structures identified by the method of relief plastic and the possibility of their use. It is assumed that the largest deposits of hydrocarbons in Africa are interrelated. Our roadmap of lithodynamic systems and linear structures, though just a cartographic model, however, has a high degree of probability that has been proven in research fields not only in Africa but in the West Kuban trough (joint work with JSC “NK Rosneft”, West Siberia (JSC “LUKOIL”, Kalmykia (JSC “NC “Kalmneft”” and other deposits of the globe (Argentina, Kuwait, USA, Kazakhstan. This method can be used in the search for new oil and gas deposits within the earth’s surface.

  11. Clinical impact, safety, and efficacy of single- versus Dual-Coil ICD leads in MADIT-CRT

    DEFF Research Database (Denmark)

    Kutyifa, Valentina; Huth Ruwald, Anne Christine; Aktas, Mehmet K.

    2013-01-01

    Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory.......Current data on efficacy, safety and impact on clinical outcome of single- versus dual-coil implantable cardioverter-defibrillator (ICD) leads are limited and contradictory....

  12. Safety evaluation of interim stabilization of non-stabilized single-shell watch list tanks

    International Nuclear Information System (INIS)

    Stahl, S.M.

    1994-01-01

    This report provides results of a review of recently completed safety analyses related to hazards associated with Interim Stabilization of Single analyses related to hazards included oh the Hanford Site Waste Tank-Watch Shell Tanks (SSTs) that are included on the Hanford List. The purpose of the review was to identify and summarize conclusions regarding the safety of interim stabilization of Watch List SSTs, and to highlight applicable limitations, restrictions, and controls. The scope of this review was restricted to SSTs identified List in the categories of flammable gas ferrocyanide, and organic salts. High heat tanks were not included in the scope. A Watch List tank is defined as an underground storage tank containing waste that requires special safety precautions because it may have a serious potential for release of high level radioactive waste because of uncontrolled increases in temperature or pressure. Special restrictions have been placed on these tanks

  13. SAFETY AND EFFECTIVENESS OF SINGLE ANASTOMOSIS DUODENAL SWITCH PROCEDURE: PRELIMINARY RESULT FROM A SINGLE INSTITUTION.

    Science.gov (United States)

    Nelson, Lars; Moon, Rena C; Teixeira, Andre F; Galvão, Manoel; Ramos, Almino; Jawad, Muhammad A

    Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) was introduced into bariatric surgery by Sanchez-Pernaute et al. as an advancement of the biliopancreatic diversion with duodenal switch. To evaluate the SADI-S procedure with regard to weight loss, comorbidity resolution, and complication rate in the super obese population. A retrospective chart review was performed on initial 72 patients who underwent laparoscopic or robot-assisted laparoscopic SADI-S between December 17th, 2013 and July 29th, 2015. A total of 48 female and 21 male patients were included with a mean age of 42.4±10.0 years (range, 22-67). The mean body mass index (BMI) at the time of procedure was 58.4±8.3 kg/m2 (range, 42.3-91.8). Mean length of hospital stay was 4.3±2.6 days (range, 3-24). Thirty-day readmission rate was 4.3% (n=3), due to tachycardia (n=1), deep venous thrombosis (n=1), and viral gastroenteritis (n=1). Thirty-day reoperation rate was 5.8% (n=4) for perforation of the small bowel (n=1), leakage (n=1), duodenal stump leakage (n=1), and diagnostic laparoscopy (n=1). Percentage of excess weight loss (%EWL) was 28.5±8.8 % (range, 13.3-45.0) at three months (n=28), 41.7±11.1 % (range, 19.6-69.6) at six months (n=50), and 61.6±12.0 % (range, 40.1-91.2) at 12 months (n=23) after the procedure. A total of 18 patients (26.1%) presented with type II diabetes mellitus at the time of surgery. Of these patients, 9 (50.0%) had their diabetes resolved, and six (33.3%) had it improved by 6-12 months after SADI-S. SADI-S is a feasible operation with a promising weight loss and diabetes resolution in the super-obese population. Anastomose única em bypass duodenoileal com gastrectomia vertical (SADI-S) foi introduzida na cirurgia bariátrica por Sanchez-Pernaute et al. como um avanço da derivação biliopancreática com switch duodenal. Avaliar o procedimento SADI-S no que diz respeito à perda de peso, resolução de comorbidades e taxa de complicações na popula

  14. Paper relief architecture

    NARCIS (Netherlands)

    Latka, J.F.

    2014-01-01

    The article presents two contemporary projects of paper structures relief architecture designed and built by Shigeru Ban Architects and Voluntary Architect Network. Author of the article took part in design and construction process of one of the projects. The project of Yaan Nursery School, which

  15. Safety basis for selected activities in single-shell tanks with flammable gas concerns. Revision 1

    International Nuclear Information System (INIS)

    Schlosser, R.L.

    1996-01-01

    This is full revision to Revision 0 of this report. The purpose of this report is to provide a summary of analyses done to support activities performed for single-shell tanks. These activities are encompassed by the flammable gas Unreviewed Safety Question (USQ). The basic controls required to perform these activities involve the identification, elimination and/or control of ignition sources and monitoring for flammable gases. Controls are implemented through the Interim Safety Basis (ISB), IOSRs, and OSDs. Since this report only provides a historical compendium of issues and activities, it is not to be used as a basis to perform USQ screenings and evaluations. Furthermore, these analyses and others in process will be used as the basis for developing the Flammable Gas Topical Report for the ISB Upgrade

  16. Safety and feasibility of single-incision laparoscopic cholecystectomy in obese patients

    Directory of Open Access Journals (Sweden)

    Masaki Wakasugi

    2017-01-01

    Full Text Available Current literature frequently indicates that experienced laparoscopic surgeons can safely perform single-incision laparoscopic cholecystectomy, but there have been few reports evaluating the feasibility and safety of performing single-incision laparoscopic cholecystectomy for obese patients. Therefore, a large single-center database was retrospectively reviewed to evaluate the feasibility and safety of single-incision laparoscopic cholecystectomy for obese patients by comparing the outcomes of normal-weight and obese patients undergoing single-incision laparoscopic cholecystectomy.A retrospective analysis of 608 patients undergoing SILC between May 2009 and May 2015 at Osaka Police Hospital was performed, and the outcomes of obese [body mass index (BMI ≥ 30 kg/m2] and normal-weight patients (18.5 ≤ BMI < 25 kg/m2 were compared.Thirty-eight obese patients (mean BMI 32.5 kg/m2 were compared to 362 normal-weight patients (mean BMI 22.0 kg/m2. The American Society of Anesthesiologists (ASA scores of the obese patients were significantly higher than those of normal-weight patients. The mean operative times in the normal-weight and the obese groups were 110 min vs. 127 min, respectively (p < 0.05. There were no significant differences in the bleeding volume and the conversion rate to a different operative procedure. Perioperative complications were seen in 6% (23/362 of the patients in the normal-weight group and 8% (3/38 of the patients in the obese group (p = 0.7. The mean postoperative hospital stay was 4.5 days for the normal-weight group and 4.4 days for the obese group (p = 0.8.Single-incision laparoscopic cholecystectomy, which offers good cosmetic outcomes, seems feasible and safe in obese patients.•Single-incision laparoscopic cholecystectomy offers good cosmetic outcomes.•Single-incision laparoscopic cholecystectomy seems feasible and safe in obese patients.

  17. Safety and pharmacokinetics of dicloxacillin in healthy Chinese volunteers following single and multiple oral doses

    Directory of Open Access Journals (Sweden)

    Wu GL

    2015-10-01

    Full Text Available Guolan Wu, Yunliang Zheng, Huili Zhou, Xingjiang Hu, Jian Liu, You Zhai, Meixiang Zhu, Lihua Wu, Jianzhong Shentu Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China Background: Dicloxacillin, a semisynthetic isoxazolyl penicillin antibiotic, has antimicrobial activity against a wide variety of gram-positive bacteria including Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus epidermidis, Streptococcus viridans, Streptococcus agalactiae, and Neisseria meningitidis. The objective of this study was to evaluate the safety and pharmacokinetic profile of dicloxacillin after single and multiple oral dose in healthy Chinese volunteers.Methods: A single-center, open-label, randomized, two-phase study was conducted in 16 subjects. In the single-dose phase, subjects were randomly assigned to receive single doses of 0.25, 0.5, 1.0, and 2.0 g of dicloxacillin sodium capsule in a 4-way crossover design with a 5-day washout period between administrations. In the multiple-dose phase, subjects were assigned to receive 0.25 or 0.5 g every 6 hours for 3 days in a 2-way crossover design. Plasma and urine pharmacokinetic samples were assayed by a validated high-performance liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were calculated and analyzed statistically. Safety assessments were conducted throughout the study.Results: Following a single oral dose of 0.25–2.0 g dicloxacillin sodium, the maximum plasma drug concentration (Cmax and the corresponding values for the area under the concentration–time curve from 0 to 10 hours (AUC0–10 h increased in a dose-proportional manner. The mean elimination half-life (t1/2 was in the range of 1.38–1.71 hours. Dicloxacillin was excreted in its unchanged form via the kidney, with no

  18. A safety equipment list for rotary mode core sampling systems operation in single shell flammable gas tanks

    International Nuclear Information System (INIS)

    SMALLEY, J.L.

    1999-01-01

    This document identifies all interim safety equipment to be used for rotary mode core sampling of single-shell flammable gas tanks utilizing Rotary Mode Core Sampling systems (RMCS). This document provides the safety equipment for RMCS trucks HO-68K-4600, HO-68K-4647, trucks three and four respectively, and associated equipment. It is not intended to replace or supersede WHC-SD-WM-SEL-023, (Kelly 1991), or WHC-SD-WM-SEL-032, (Corbett 1994), which classifies 80-68K-4344 and HO-68K-4345 respectively. The term ''safety equipment'' refers to safety class (SC) and safety significant (SS) equipment, where equipment refers to structures, systems and components (SSC's). The identification of safety equipment in this document is based on the credited design safety features and analysis contained in the Authorization Basis (AB) for rotary mode core sampling operations in single-shell flammable gas tanks. This is an interim safety classification since the AB is interim. This document will be updated to reflect the final RMCS equipment safety classification designations upon completion of a final AB which will be implemented with the release of the Final Safety Analysis Report (FSAR)

  19. Venting of gas deflagrations through relief pipes

    OpenAIRE

    Ferrara, Gabriele

    2006-01-01

    Vent devices for gas and dust explosions are often ducted to safety locations by means of relief pipes for the discharge of hot combustion products or blast waves (NFPA 68, 2002). The presence of the duct is likely to increase the severity of the explosion with respect to simply vented vessels posing a problem for the proper design of this venting configuration. The phenomenology of the vented explosion is complicated as the interaction of combustion in the duct with primary combustion in...

  20. Design, operation, and safety of single-room interventional MRI suites: practical experience from two centers.

    Science.gov (United States)

    White, Mark J; Thornton, John S; Hawkes, David J; Hill, Derek L G; Kitchen, Neil; Mancini, Laura; McEvoy, Andrew W; Razavi, Reza; Wilson, Sally; Yousry, Tarek; Keevil, Stephen F

    2015-01-01

    The design and operation of a facility in which a magnetic resonance imaging (MRI) scanner is incorporated into a room used for surgical or endovascular cardiac interventions presents several challenges. MR safety must be maintained in the presence of a much wider variety of equipment than is found in a diagnostic unit, and of staff unfamiliar with the MRI environment, without compromising the safety and practicality of the interventional procedure. Both the MR-guided cardiac interventional unit at Kings College London and the intraoperative imaging suite at the National Hospital for Neurology and Neurosurgery are single-room interventional facilities incorporating 1.5 T cylindrical-bore MRI scanners. The two units employ similar strategies to maintain MR safety, both in original design and day-to-day operational workflows, and between them over a decade of incident-free practice has been accumulated. This article outlines these strategies, highlighting both similarities and differences between the units, as well as some lessons learned and resulting procedural changes made in both units since installation. © 2014 Wiley Periodicals, Inc.

  1. Refuge alternatives relief valve testing and design.

    Science.gov (United States)

    Lutz, T J; Bissert, P T; Homce, G T; Yonkey, J A

    2016-10-01

    The U.S. National Institute for Occupational Safety and Health (NIOSH) has been researching refuge alternatives (RAs) since 2007. RAs typically have built-in pressure relief valves (PRVs) to prevent the unit from reaching unsafe pressures. The U.S. Mine Safety and Health Administration requires that these valves vent the chamber at a maximum pressure of 1.25 kPa (0.18 psi, 5.0 in. H 2 O), or as specified by the manufacturer, above mine atmospheric pressure in the RA. To facilitate PRV testing, an instrumented benchtop test fixture was developed using an off-the-shelf centrifugal blower and ductwork. Relief pressures and flow characteristics were measured for three units: (1) a modified polyvinyl chloride check valve, (2) an off-the-shelf brass/cast-iron butterfly check valve and (3) a commercially available valve that was designed specifically for one manufacturer's steel prefabricated RAs and had been adapted for use in one mine operator's built-in-place RA. PRVs used in tent-style RAs were not investigated. The units were tested with different modifications and configurations in order to check compliance with Title 30 Code of Federal Regulations, or 30 CFR, regulations. The commercially available relief valve did not meet the 30 CFR relief pressure specification but may meet the manufacturer's specification. Alternative valve designs were modified to meet the 30 CFR relief pressure specification, but all valve designs will need further design research to examine survivability in the event of a 103 kPa (15.0 psi) impulse overpressure during a disaster.

  2. Pharmacokinetics and safety of fentanyl sublingual spray and fentanyl citrate intravenous: a single ascending dose study in opioid-naïve healthy volunteers.

    Science.gov (United States)

    Rauck, Richard; Oh, D Alexander; Parikh, Neha; Koch, Christian; Singla, Neil; Yu, Jin; Nalamachu, Srinivas; Vetticaden, Santosh

    2017-11-01

    Fentanyl sublingual spray offers rapid pain relief in opioid-tolerant cancer patients, and may be useful in acute or post-operative pain. Both opioid-naïve and non-tolerant patients are likely to receive opioids in these settings. Understanding the relationship between systemic exposure of fentanyl sublingual spray and effects on respiratory function in opioid-naïve or non-tolerant populations is important to ensure patient safety. This study evaluated single-dose fentanyl sublingual spray in opioid-naïve participants. Participants were randomized to receive single-dose fentanyl sublingual spray (100, 200, 400, 600, 800 mcg) or fentanyl citrate IV in one of five cohorts. Dosing occurred following a 10-h fast, with fasting continuing for 4 h post-dose. Dose proportionality was assessed using analysis of variance and linear regression techniques. PK assessments and safety monitoring were performed through 24 h post-dose. Safety assessments, including adverse event (AE) monitoring, occurred from dosing through Day 7. Fifty participants (19-53 years) received fentanyl sublingual spray or fentanyl citrate IV. Mean maximum plasma concentrations were reached between 0.27-0.60 h post-dose for fentanyl sublingual spray. Peak (C max ) and total (AUC 0- t , AUC 0-∞ ) fentanyl exposures increased in a linear, but more than dose-proportional manner, with higher doses. The most common AEs were somnolence, nausea, and vomiting. All AEs were mild or moderate in severity. Doses at 400, 600, and 800 mcg were associated with nausea and vomiting, requiring pharmacologic intervention. Hypoxia episodes requiring nasal cannula oxygenation were observed with 600mcg and 800mcg doses. Overall, single-dose fentanyl sublingual spray (100-800 mcg) was generally well tolerated, with greater incidences of AEs (e.g. nausea, vomiting, hypoxia) at higher doses. Doses up to 200 mcg may be safely administered to healthy opioid-naïve individuals with routine monitoring; doses

  3. Refuge alternatives relief valve testing and design

    OpenAIRE

    Lutz, T.J.; Bissert, P.T.; Homce, G.T.; Yonkey, J.A.

    2016-01-01

    The U.S. National Institute for Occupational Safety and Health (NIOSH) has been researching refuge alternatives (RAs) since 2007. RAs typically have built-in pressure relief valves (PRVs) to prevent the unit from reaching unsafe pressures. The U.S. Mine Safety and Health Administration requires that these valves vent the chamber at a maximum pressure of 1.25 kPa (0.18 psi, 5.0 in. H2O), or as specified by the manufacturer, above mine atmospheric pressure in the RA. To facilitate PRV testing, ...

  4. Implementation of an enlarged model of the safety valves and relief in the plant integral model for the code RELAP/SCDAPSIM; Implementacion de un modelo ampliado de las valvulas de seguridad y alivio en el modelo integral de planta para el codigo RELAP/SCDAPSIM

    Energy Technology Data Exchange (ETDEWEB)

    Amador G, R.; Ortiz V, J.; Castillo D, R. [ININ, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico); Hernandez L, E. J. [Instituto Tecnologico de Toluca, Av. Tecnologico s/n, Fracc. La Virgen, 52149 Metepec, Estado de Mexico (Mexico); Galeana R, J. C. [Universidad del Valle de Mexico, Campus Toluca, Av. de Las Palmas 136, 52140 Metepec, Estado de Mexico (Mexico); Gutierrez, V. H., E-mail: rodolfo.amador@inin.gob.mx [Universidad Autonoma Metropolitana, Unidad Azcapotzalco, Av. San Pablo 180, Col. Reynosa Tamaulipas, 02200 Mexico D. F. (Mexico)

    2013-10-15

    The present work refers to the implementation of a new model on the logic of the safety valves and relief in the integral model of the Nuclear Power Plant of Laguna Verde of the thermal-hydraulic compute code RELAP/SCDAPSIM Mod. 3.4. The new model was developed with the compute package SIMULINK-MATLAB and contemplates all the operation options of the safety valves and relief, besides including the availability options of the valves in all the operation ways and of blockage in the ways of relief and low-low. The implementation means the elimination of the old model of the safety valves and to analyze the group of logical variables, of discharge and available control systems to associate them to the model of package SIMULINK-MATLAB. The implementation has been practically transparent and 27 cases corresponding to a turbine discharge were analyzed with the code RELAP/SCDAPSIM Mod. 3.4. The results were satisfactory. (Author)

  5. Safety

    International Nuclear Information System (INIS)

    1998-01-01

    A brief account of activities carried out by the Nuclear power plants Jaslovske Bohunice in 1997 is presented. These activities are reported under the headings: (1) Nuclear safety; (2) Industrial and health safety; (3) Radiation safety; and Fire protection

  6. The efficacy of preventive parasternal single injection of bupivacaine on intubation time, blood gas parameters, narcotic requirement, and pain relief after open heart surgery: A randomized clinical trial study

    Directory of Open Access Journals (Sweden)

    Mahmoud Saeidi

    2011-01-01

    Full Text Available Background: Postsurgical pain usually results in some complications in the patients. This study has tried to investigate the effects of parasternal single injection of bupivacaine on postoperative pulmonary and pain consequences in patients after open heart surgery. Methods: : In a prospective double blind clinical study, 100 consenting patients undergoing elective open heart surgery were randomized into two groups. In case group, bupivacaine was injected at both sides of sternum, immediately before sternal closure. In the control group, no intervention was performed. Then, the patients were investigated regarding intubation period, length of ICU stay, arterial blood gas (ABG parameters, morphine requirement, and their severity of postoperative pain using a visual analogue scale (VAS device. Results: No differences were found between the two groups regarding to age, sex, pump time, operation time, and body mass index and preoperative cardiac ejection fraction. Mean intubation length in case group was much shorter than that in control group. Mean PaO 2 in case group was lower in different checking times in postoperative period. The patients in the case group needed less morphine compared to those in the control group during the 24-hour observation period in the ICU. Finally, mean VAS scores of pain in case group were significantly lower than those in control group at 6, 12, and 24 hours postoperatively. Conclusions: Patients′ pain relief by parasternal single injection of bupivacaine in early postoperative period can facilitate earlier ventilator weaning and tracheal extubation after open heart surgery as well as achieving lower pain scores and narcotic requirements.

  7. Safety evaluation of interim stabilization of non-stabilized single-shell watch list tanks

    Energy Technology Data Exchange (ETDEWEB)

    Stahl, S.M.

    1994-12-30

    The report provides a summation of the status of safety issues associated with interim stabilization of Watch List SSTs (organic, ferrocyanide, and flammable gas), as extracted from recent safety analyses, including the Tank Farms Accelerated Safety Analysis efforts.

  8. Safety evaluation of interim stabilization of non-stabilized single-shell watch list tanks

    International Nuclear Information System (INIS)

    Stahl, S.M.

    1994-01-01

    The report provides a summation of the status of safety issues associated with interim stabilization of Watch List SSTs (organic, ferrocyanide, and flammable gas), as extracted from recent safety analyses, including the Tank Farms Accelerated Safety Analysis efforts

  9. The European single market of energy faced with conventional supply safety concepts

    International Nuclear Information System (INIS)

    Belyi, A.

    2004-01-01

    By analysing the context of the creation of the Single Energy Market, this article tries to understand the logic behind the coexistence of two energy safety concepts: (1) the financial gains of international trading; (2) the protection against supply shortage risks using domestic self-sufficiency policies. Both concepts are based on an informative context conditioned by the two crises, which mainly impact the security perceptions of today: the oil crisis in the seventies and the Californian crisis in 2001. They are based on opposite factors: anti-market behaviour in the first case and excessive competition in the second case. The nature of liberalization, of the relation-ship with non-EU producing countries and the perception of the dangers are inherent to such an informative context. (author)

  10. Accelerated safety analyses - structural analyses Phase I - structural sensitivity evaluation of single- and double-shell waste storage tanks

    International Nuclear Information System (INIS)

    Becker, D.L.

    1994-11-01

    Accelerated Safety Analyses - Phase I (ASA-Phase I) have been conducted to assess the appropriateness of existing tank farm operational controls and/or limits as now stipulated in the Operational Safety Requirements (OSRs) and Operating Specification Documents, and to establish a technical basis for the waste tank operating safety envelope. Structural sensitivity analyses were performed to assess the response of the different waste tank configurations to variations in loading conditions, uncertainties in loading parameters, and uncertainties in material characteristics. Extensive documentation of the sensitivity analyses conducted and results obtained are provided in the detailed ASA-Phase I report, Structural Sensitivity Evaluation of Single- and Double-Shell Waste Tanks for Accelerated Safety Analysis - Phase I. This document provides a summary of the accelerated safety analyses sensitivity evaluations and the resulting findings

  11. Single-mode 850-nm vertical-cavity surface-emitting lasers with Zn-diffusion and oxide-relief apertures for > 50 Gbit/sec OOK and 4-PAM transmission

    Science.gov (United States)

    Shi, Jin-Wei; Wei, Chia-Chien; Chen, Jyehong; Ledentsov, N. N.; Yang, Ying-Jay

    2017-02-01

    Vertical-cavity surface-emitting lasers (VCSELs) has become the most important light source in the booming market of short-reach (targeted at 56 Gbit/sec data rate per channel (CEI-56G) with the total data rate up to 400 Gbit/sec. However, the serious modal dispersion of multi-mode fiber (MMF), limited speed of VCSEL, and its high resistance (> 150 Ω) seriously limits the >50 Gbit/sec linking distance (50 Gbit/sec transmission due to that it can save one-half of the required bandwidth. Nevertheless, a 4.7 dB optical power penalty and the linearity of transmitter would become issues in the 4-PAM linking performance. Besides, in the modern OI system, the optics transreceiver module must be packaged as close as possible with the integrated circuits (ICs). The heat generated from ICs will become an issue in speed of VSCEL. Here, we review our recent work about 850 nm VCSEL, which has unique Zn-diffusion/oxide-relief apertures and special p- doping active layer with strong wavelength detuning to further enhance its modulation speed and high-temperature (85°C) performances. Single-mode (SM) devices with high-speed ( 26 GHz), reasonable resistance ( 70 Ω) and moderate output power ( 1.5 mW) can be achieved. Error-free 54 Gbit/sec OOK transmission through 1km MMF has been realized by using such SM device with signal processing techniques. Besides, the volterra nonlinear equalizer has been applied in our 4-PAM 64 Gbit/sec transmission through 2-km OM4 MMF, which significantly enhance the linearity of device and outperforms fed forward equalization (FFE) technique. Record high bit-rate distance product of 128.km is confirmed for optical-interconnect applications.

  12. Antioxidant therapy for pain relief in patients with chronic pancreatitis: systematic review and meta-analysis.

    Science.gov (United States)

    Cai, Guo-Hong; Huang, Jing; Zhao, Yan; Chen, Jing; Wu, Huang-Hui; Dong, Yu-Lin; Smith, Howard S; Li, Yun-Qing; Wang, Wen; Wu, Sheng-Xi

    2013-01-01

    Currently, there is no specific therapy for chronic pancreatitis (CP). The treatment of micronutrient antioxidant therapy for painful CP has been sporadically used for more than 30 years, however, its efficacy are still poorly understood. The purpose of this meta-analysis is to investigate the safety and efficacy of antioxidant therapy for pain relief in patients with CP. University Hospital in China Systematic review and meta-analysis Two authors independently reviewed the search results and extracted data and disagreements were resolved by discussion. Effects were summarized using standardized mean differences (SMDs), weighted mean differences, or odds ratio (OR) according to the suitable effect model. MEDLINE, PsycINFO, Scopus, EMBASE, and the Cochrane Central Register of Controlled Trials  were searched from 1980 through December 2012. Randomized controlled trials (RCTs) that studied antioxidant supplementation for pain relief in patients with CP were analyzed. Nine randomized controlled trials (RCTs) involving 390 patients were included. Overall, there was no association of antioxidant therapy with pain reduction in CP patients (SMD, -0.55; 95% CI, -1.22 to 0.12; P = 0.67). However, antioxidant therapy significantly increased blood levels of antioxidants in CP patients versus the placebo group (SMD, 1.08; 95% CI, 0.74 to 1.43; P pain relief (SMD, -0.93; 95% CI, -1.72 to -0.14; P = 0.02), while the trials in which a single antioxidant was used revealed no significant pain relief (SMD, -0.12; 95% CI, -1.23 to 0.99; P = 0.83) in CP patients. Strong evidence was obtained that the antioxidants increased adverse effects (OR, 6.09; 95% CI, 2.29 to 16.17, P pain relief in CP patients. Measures of total antioxidant status may not help to monitor the efficacy of antioxidant therapy for patients with CP.

  13. SAFETY

    CERN Document Server

    Niels Dupont

    2013-01-01

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

  14. Safety and Palliative Efficacy of Single-Dose 8-Gy Reirradiation for Painful Local Failure in Patients With Stage IV Non-Small Cell Lung Cancer Previously Treated With Radical Chemoradiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Topkan, Erkan, E-mail: docdretopkan@gmail.com [Baskent Department of Radiation Oncology, University Adana Medical Faculty, Adana (Turkey); Yildirim, Berna Akkus; Guler, Ozan Cem; Parlak, Cem [Baskent Department of Radiation Oncology, University Adana Medical Faculty, Adana (Turkey); Pehlivan, Berrin [Koc University, School of Medicine, Department of Radiation Oncology, Istanbul, and American Hospital, University of Texas MD Anderson Radiation Treatment Center, Istanbul (Turkey); Selek, Ugur [Medstar Hospital, Department of Radiation Oncology, Antalya (Turkey)

    2015-03-15

    Purpose: To investigate the safety and efficacy of single-dose 8-Gy palliative chest reirradiation (CRI) in metastatic non-small cell lung cancer (M-NSCLC) patients with painful thoracic failures (TF) within the previous radiation portal. Patients and Methods: We retrospectively analyzed the clinical data of 78 M-NSCLC patients who received single-dose 8-Gy CRI for painful TF after concurrent chemoradiation therapy to a total radiation dose of 52 to 66 Gy between 2007 and 2012. Primary endpoints included significant pain relief (SPR) defined as a ≥2 point decrement in the Visual Analogue Scale for Pain inventory (VAS-P), time to pain relief, and duration of pain control. Secondary objectives were survival and prognostic factors. Results: Treatment was well tolerated, with only 5.1% grade 3 pneumonitis and 1.3% grade 2 esophagitis. Pre-CRI median and post-CRI minimum VAS-P were 7 and 3 (P<.001), respectively. SPR was noted in 67 (85.9%) patients, and only 3 (3.9%) scored progressive pain. Median time to lowest VAS-P and duration of pain control were 27 days and 6.1 months, respectively. Median overall survival (OS) was 7.7 months, and the 1-year OS rate was 26.5%. On multivariate analyses, lower Eastern Cooperative Oncology group score (1-2; P<.001), absence of anemia (P=.001), and fewer metastatic sites (1-2; P<.001) were found to be associated with longer OS. Conclusions: Single-dose 8-Gy CRI provides safe, effective, and durable pain palliation for TF in radically irradiated M-NSCLC patients. Because of its convenience, lower cost, and higher comfort, the present protocol can be considered an appropriate option for patients with limited life spans.

  15. Spontaneous formation of optically induced surface relief gratings

    Energy Technology Data Exchange (ETDEWEB)

    Leblond, H; Barille, R; Ahmadi-Kandjani, S; Nunzi, J-M [Laboratoire POMA, Universite d' Angers, CNRS FRE 2988, 2, Bd Lavoisier, 49045 Angers (France); Ortyl, E; Kucharski, S, E-mail: herve.leblond@univ-angers.f [Wroclaw University of Technology, Faculty of Chemistry, Department of Polymer Engineering and Technology, 50-370 Wroclaw (Poland)

    2009-10-28

    We develop a model based on Fick's law of diffusion as a phenomenological description of the molecular motion, and on the coupled mode theory, to describe single-beam surface relief grating formation in azopolymer thin films. The model allows us to explain the mechanism of spontaneous patterning, and self-organization. It allows us to compute the surface relief profile and its evolution, with good agreement with experiments.

  16. Spontaneous formation of optically induced surface relief gratings

    International Nuclear Information System (INIS)

    Leblond, H; Barille, R; Ahmadi-Kandjani, S; Nunzi, J-M; Ortyl, E; Kucharski, S

    2009-01-01

    We develop a model based on Fick's law of diffusion as a phenomenological description of the molecular motion, and on the coupled mode theory, to describe single-beam surface relief grating formation in azopolymer thin films. The model allows us to explain the mechanism of spontaneous patterning, and self-organization. It allows us to compute the surface relief profile and its evolution, with good agreement with experiments.

  17. Criticality safety validation: Simple geometry, single unit {sup 233}U systems

    Energy Technology Data Exchange (ETDEWEB)

    Putman, V.L.

    1997-06-01

    Typically used LMITCO criticality safety computational methods are evaluated for suitability when applied to INEEL {sup 233}U systems which reasonably can be modeled as simple-geometry, single-unit systems. Sixty-seven critical experiments of uranium highly enriched in {sup 233}U, including 57 aqueous solution, thermal-energy systems and 10 metal, fast-energy systems, were modeled. These experiments include 41 cylindrical and 26 spherical cores, and 41 reflected and 26 unreflected systems. No experiments were found for intermediate-neutron-energy ranges, or with interstitial non-hydrogenous materials typical of waste systems, mixed {sup 233}U and plutonium, or reflectors such as steel, lead, or concrete. No simple geometry experiments were found with cubic or annular cores, or approximating infinite sea systems. Calculations were performed with various tools and methodologies. Nine cross-section libraries, based on ENDF/B-IV, -V, or -VI.2, or on Hansen-Roach source data, were used with cross-section processing methods of MCNP or SCALE. The k{sub eff} calculations were performed with neutral-particle transport and Monte Carlo methods of criticality codes DANT, MCNP 4A, and KENO Va.

  18. Safety of women in mixed-sex and single-sex medium secure units: staff and patient perceptions.

    Science.gov (United States)

    Mezey, Gillian; Hassell, Yonette; Bartlett, Annie

    2005-12-01

    The development of single-sex medium secure units for women has been driven by concern about the vulnerability of women to sexual abuse and exploitation in mixed-sex secure settings. Less is known about how women patients and staff perceive gender segregation and their experiences in single-sex units. To examine the impact of gender segregation on the safety of women patients detained in medium secure psychiatric facilities. A qualitative study was conducted involving individual interviews with 58 male and female staff and 31 women patients in single-sex and mixed-sex medium secure units throughout England and Wales. Women patients in both types of units reported high levels of actual and threatened physical and sexual violence. Women in single-sex units reported intimidation, threats and abuse by other women patients, although they were less vulnerable to sexual abuse and exploitation and serious physical assault. Further development of single-sex secure units for women may not be justified on the grounds of safety issues alone. Risk assessment of forensic psychiatric patients must include a full assessment of their safety within the psychiatric setting.

  19. Safety

    International Nuclear Information System (INIS)

    2001-01-01

    This annual report of the Senior Inspector for the Nuclear Safety, analyses the nuclear safety at EDF for the year 1999 and proposes twelve subjects of consideration to progress. Five technical documents are also provided and discussed concerning the nuclear power plants maintenance and safety (thermal fatigue, vibration fatigue, assisted control and instrumentation of the N4 bearing, 1300 MW reactors containment and time of life of power plants). (A.L.B.)

  20. Safety

    CERN Multimedia

    2003-01-01

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

  1. Safety and efficacy of high fluence CO2 laser skin resurfacing with a single pass.

    Science.gov (United States)

    Khosh, M M; Larrabee, W F; Smoller, B

    1999-01-01

    Carbon dioxide (CO2) laser skin resurfacing has nearly replaced more traditional methods of superficial skin rejuvenation. Post-treatment erythema is the most common side effect of this method of skin resurfacing. Sublethal thermal damage to the dermis has been proposed as an etiology for post laser erythema. Recent developments in laser resurfacing technology have aimed at minimizing thermal damage to the dermis. To determine depth of skin ablation, extent of thermal injury, and ideal laser parameters for the FeatherTouch laser system. To assess the safety and efficacy of laser resurfacing at high energy fluences with a single pass. Laser resurfacing was performed in the preauricular skin of five patients undergoing rhytidectomy. A total of 60 sites were tested with fluences of 7 to 17 Joules/cm2. Histologic evaluation of excised skin showed maximal thermal injury to be restricted to 60 microns in the papillary dermis. The reticular dermis showed no evidence of injury. Based on these findings, laser resurfacing at 17 J/cm2 (70 watts) was performed on 30 patients (in the periorbital area, a maximum of 9 J/cm2 or 36 watts was used). Follow up ranged between 12 and 18 months. Based on histologic comparison of average and high fluence laser resurfacing, high fluence laser resurfacing did not cause added thermal damage to the reticular dermis. In the clinical group, no major complications such as scarring, scleral show, infection or ectropion were encountered. Transient hyperpigmentation was noted in three patients. Overall patient satisfaction was good to excellent. Post-treatment erythema lasted an average of 4 weeks. We conclude that CO2 laser resurfacing of the face (excluding the periorbital region) can be performed safely and effectively, with the FeatherTouch laser, at 17 J/cm2 with one pass. In our group of patients, laser resurfacing with a single pass at 17 J/cm2 caused less post-operative erythema than two or more passes at 9 J/cm2.

  2. Safety of ventilation/perfusion single photon emission computed tomography for pulmonary embolism diagnosis

    Energy Technology Data Exchange (ETDEWEB)

    Le Roux, Pierre-Yves; Palard, Xavier; Robin, Philippe; Abgral, Ronan; Querellou, Solene; Salaun, Pierre-Yves [Universite Europeenne de Bretagne, Brest (France); Universite de Brest, Brest (France); CHRU de la Cavale Blanche, Service de medecine nucleaire, Brest (France); Delluc, Aurelien; Couturaud, Francis [Universite Europeenne de Bretagne, Brest (France); Universite de Brest, Brest (France); CHRU de la Cavale Blanche, Departement de medecine interne et de pneumologie, Brest (France); Le Gal, Gregoire [Universite Europeenne de Bretagne, Brest (France); University of Ottawa, Ottawa Hospital Research Institute, Ottawa (Canada); CHRU de la Cavale Blanche, Departement de medecine interne et de pneumologie, Brest (France); Universite de Brest, Brest (France)

    2014-10-15

    The aim of this management outcome study was to assess the safety of ventilation/perfusion single photon emission computed tomography (V/Q SPECT) for the diagnosis of pulmonary embolism (PE) using for interpretation the criteria proposed in the European Association of Nuclear Medicine (EANM) guidelines for V/Q scintigraphy. A total of 393 patients with clinically suspected PE referred to the Nuclear Medicine Department of Brest University Hospital from April 2011 to March 2013, with either a high clinical probability or a low or intermediate clinical probability but positive D-dimer, were retrospectively analysed. V/Q SPECT were interpreted by the attending nuclear medicine physician using a diagnostic cut-off of one segmental or two subsegmental mismatches. The final diagnostic conclusion was established by the physician responsible for patient care, based on clinical symptoms, laboratory test, V/Q SPECT and other imaging procedures performed. Patients in whom PE was deemed absent were not treated with anticoagulants and were followed up for 3 months. Of the 393 patients, the prevalence of PE was 28 %. V/Q SPECT was positive for PE in 110 patients (28 %) and negative in 283 patients (72 %). Of the 110 patients with a positive V/Q SPECT, 78 (71 %) had at least one additional imaging test (computed tomography pulmonary angiography or ultrasound) and the diagnosis of PE was eventually excluded in one patient. Of the 283 patients with a negative V/Q SPECT, 74 (26 %) patients had another test. The diagnosis of PE was finally retained in one patient and excluded in 282 patients. The 3-month thromboembolic risk in the patients not treated with anticoagulants was 1/262: 0.38 % (95 % confidence interval 0.07-2.13). A diagnostic management including V/Q SPECT interpreted with a diagnostic cut-off of ''one segmental or two subsegmental mismatches'' appears safe to exclude PE. (orig.)

  3. Pentazocine Pain Relief in Adult Patients With Acute Abdominal ...

    African Journals Online (AJOL)

    jen

    Results: Twenty patients in the PZ group and 9 patients in the control group had a VAS score drop. >12mm. ... investigate the safety of early administration of pentazocine in adult patients with acute abdominal pain. ... significant pain relief compared to a placebo, and whether pentazocine administration to patients with.

  4. Seismic assessment of the Pickering pressure relief duct

    International Nuclear Information System (INIS)

    Ghobarah, A.

    1995-05-01

    The objectives of the study are to examine the structural response of the Pickering pressure relief duct when subjected to earthquake ground motion and to estimate the seismic withstand capacity of various components of the structural system on the basis of performance criteria consistent with the safety function of the duct. (author). 24 refs., 16 tabs., 31 figs

  5. 49 CFR 178.346-3 - Pressure relief.

    Science.gov (United States)

    2010-10-01

    ... Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... with a normal vent. Such vents must be set to open at not less than 1 psig and must be designed to... requirements in § 178.345-10(b), after August 31, 1996, each pressure relief valve must be able to withstand a...

  6. Southern Alaska Coastal Relief Model

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NOAA's National Geophysical Data Center (NGDC) is building coastal-relief models (CRM) for select U.S. coastal regions. Bathymetric, topographic, and shoreline data...

  7. Decongestants: OTC Relief for Congestion

    Science.gov (United States)

    ... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

  8. 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

  9. Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months

    OpenAIRE

    Park, So Yun; Kim, Sung Hoon; Chae, Hee Dong; Kim, Chung-Hoon; Kang, Byung Moon

    2016-01-01

    Objective To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. Methods We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BM...

  10. Experience with pegvisomant treatment in acromegaly in a single Brazilian tertiary reference center: efficacy, safety and predictors of response

    OpenAIRE

    Kasuki,Leandro; Machado,Evelyn de Oliveira; Ogino,Liana Lumi; Coelho,Maria Caroline Alves; Silva,Cintia Marques dos Santos; Wildemberg,Luiz Eduardo Armondi; Lima,Carlos Henrique Azeredo; Gadelha,Mônica R.

    2016-01-01

    ABSTRACT Objective To describe the safety and efficacy of pegvisomant therapy and the predictors of treatment response in acromegaly patients at a single tertiary reference center in Brazil. Materials and methods We retrospectively reviewed the clinical, hormonal and radiological data of acromegaly patients treated with pegvisomant in our center. We also evaluated the presence of the d3 isoform of the growth hormone receptor (d3GHR). Results Twenty-seven patients were included (17 women...

  11. The role of single nucleotide polymorphism of IL-6 and IL-10 cytokine on pain severity and pain relief after radiotherapy in multiple myeloma patients with painful bone destructions

    Directory of Open Access Journals (Sweden)

    Rudzianskiene Milda

    2014-01-01

    Full Text Available Multiple myeloma (MM cells interact with bone marrow stromal cells stimulating transcription and secretion of cytokines like IL-6 and IL-10, which are implicated in the progression and dissemination of MM. Regulation of cytokines secretion is under genetic control through genetic polymorphisms in their coding and promoter sequences. It seems that single nucleotide polymorphism (SNP in the promoter region of various genes may regulate the plasma concentrations of cytokines. Cytokines could be also hypothesized to function as pain modulators as peripheral nociceptors are sensitized by cytokines. The aim was to determine if the SNP of IL-6 and IL-10 cytokines could influence the analgesic response of radiotherapy in the treatment of painful bone destructions in MM patients. 30 patients (19 women and 11 men, median age: 67 years with MM and painful bone destructions were treated with palliative radiotherapy. Pain was evaluated according to the visual analogue scale and analgesics intake. Pain scores and analgesics use were measured prior to radiotherapy as well as 4, 12 and 24 weeks afterward. Opioid analgesics were converted to the morphine-equivalent daily dose (MEDD. Genomic DNA was extracted from peripheral blood leukocytes and IL-6 and IL-10 gene promoter polymorphisms were analysed with polymerase chain reaction. 60% of patients reported severe pain prior to radiotherapy, which decreased to 13% at the first follow-up visit (p <0.001. The MEDD on admission to the hospital was 75 mg/day which decreased to 46 mg/day at the first follow-up visit (p = 0.033. A significant parameter in pain relief was: age < 65 years (p=0.029. We analysed 6 SNPs in the gene promoter region of IL-6 (-597 G/A, -572 G/C, -174 G/C and IL-10 (-592 A/C, -819 C/T, -1082 A/G as well as their relation with pain severity and analgesic consumption. Patients who are IL-10 -1082 A/G carriers are prone to respond better to radiotherapy than other patients (p<0.05. A borderline

  12. EC Hidraulic Drive Cylinder Relief Vlave Test

    Energy Technology Data Exchange (ETDEWEB)

    Wu, J.; /Fermilab

    1991-04-03

    This engineering note documents the testing of the set pressure of the EC hydraulic drive cylinder relief valve. The purpose of the relief valve is to provide a safety measure in the event that oil becomes trapped in the rod side of the cylinder and pressure is applied to the cap side. The note includes an explanation of the procedure used and a summary of the result of the testing done on February 14, 1991 by Gary Trotter. The result was that the cylinder relief valve relieved at the correct set pressure of 10,500 psig. The basic concern is for the protection of the cylinder. The pump is capable of providing up to 10,500 psi of pressure to either side of the cylinder. The cylinder is rated for 10,500 psi. Under normal operating conditions, the valves would be open, and the pumping pressure would automatically flow oil into one side, and remove oil from the other side. If, however, the valve for the other side was closed, so that oil could not be removed, then the pressure would build in that side. If the rod side is pressurized to the maximum pump pressure of 10,500 psi, the cross sectional area ratio of 2.29 results in a pressure of approximately 4600 psi in the cap side, which is well under the rated pressure. If, however, the cap side is pressurized to 10,500 psi, the cross sectional area would produce a pressure of approximately 24,000 psi in the rod side, which could damage the cylinder. Therefore, the pressure on the rod side must be limited to the rated pressure of 10,500 psi. In reality, the maximum operating force on the piston would be under 11,000 Ibs., which would result in the maximum cylinder pressure being under 8000 psi to the rod side, and under 3500 psi to the cap side. Therefore, the relief is only needed as a safety precaution in the case that oil becomes trapped.

  13. Shaded Relief Images for Cartographic Applications.

    Science.gov (United States)

    1981-04-01

    Relief: Cache, OK 133 C18 Orthonormal Shaded Relief Image With Variable Sun Azimuth Merged With SIMCON Contours (20-meters Interval) 134 CI 9 Relief...lines generated by the program SIMCON 3 9 have been overlaid by FTL-developed software. 3 9 Thle next two imiages illustrate the relief contour option of

  14. The pharmacokinetic and safety profiles of blonanserin in healthy Chinese volunteers after single fasting doses and single and multiple postprandial doses.

    Science.gov (United States)

    Chen, Xia; Wang, Hongyun; Jiang, Ji; Chen, Rui; Zhou, Ying; Zhong, Wen; Liu, Hongzhong; Hu, Pei

    2014-03-01

    Blonanserin is a novel atypical antipsychotic drug acting as a mixed serotonin 5-HT2A and dopamine D2 receptor antagonist. This study investigated the pharmacokinetics and safety of blonanserin in healthy Chinese males. This was an open-label trial with two parts. Twenty-four subjects were enrolled in part A to receive a single fasting dose of 4 or 8 mg blonanserin (each n = 12); part B recruited 12 subjects and administered single and sequentially twice-daily multiple postprandial doses of blonanserin 2 mg for 9 days. Serial blood samples were taken for the bioassay of plasma blonanserin and its four metabolites during both sub-studies. Safety was assessed, including repeat measurements of fasting serum prolactin, insulin, triglyceride and cholesterol. Blonanserin was rapidly absorbed, accompanied with immediate plasma concentration elevation of the N-oxide form (M2) and gradual rises of the N-deethylated form (M1) and its downstream metabolites. The mean elimination half-life of blonanserin (7.7-11.9 h) was much longer than that of M2 (1.2-1.3 h) but shorter than that of M1 (26.4-31.4 h) after single fasting doses. After food intake, a single dose of 2 mg blonanserin resulted in total exposure and peak concentrations of blonanserin similar to those observed with a single fasting dose of blonanserin 4 mg. Moreover, the relationship of metabolite over parent compound ratio was different between M1 and M2 after single and multiple postprandial administrations (single dose vs multiple dose: M1, 0.33 vs 0.75; M2, 0.13 vs 0.067). Mild but transient increases of prolactin, insulin and triglyceride were observed. The pharmacokinetics of blonanserin in Chinese subjects were similar to those observed in Japanese subjects. This study suggested that food intake not only increases the bioavailability of blonanserin but differently affects the pharmacokinetics of its metabolites as well. The drug was safe and well tolerated in healthy Chinese males.

  15. Example of a single national regulator responsible for both transport safety and security

    International Nuclear Information System (INIS)

    Karhu, P.; Lahkola, A.; Markkanen, M.; Hellstén, S.

    2016-01-01

    Safety and security in the use of nuclear energy and in the use of radiation, including the transport of nuclear and other radioactive material, share a common objective: to protect people, society, environment, and future generations from the harmful effects of ionizing radiation. Some measures for safety contribute to those for security, and vice versa, while some requirements of one conflict with those of the other. The differences in the requirements arise from the difference in the threat against which the measures are designed: accident vs. intent. A coordinated approach endeavours to take advantage of the similarities and to avoid the problems caused by the differences. One way to implement it is to have one competent authority responsible for the regulatory control of safety and security. It is the experience in Finland that this enables an efficient regulatory system. From the operators’ point of view, a one-stop shop regulatory authority ensures that requirements for safety and security are consistent. Both safety and security require the involvement of and cooperation between several authorities—regulatory, rescue, law enforcement—and operators. The approach in Finland is built on cooperation and a clear division of competences and responsibilities. One regulatory authority provides a fixed point of contact within the professional cooperation network as well as for the public. The one regulatory authority is also easily identifiable, as appropriate, as a point of contact in international cooperation in implementing nuclear and radiation safety and security. Whatever the national regulatory framework and the assignment of responsibilities between authorities, cooperation is essential in house, nationally, and internationally. (author)

  16. Unmanned Aerial Vehicle Systems for Disaster Relief: Tornado Alley

    Science.gov (United States)

    DeBusk, Wesley M.

    2009-01-01

    Unmanned aerial vehicle systems are currently in limited use for public service missions worldwide. Development of civil unmanned technology in the United States currently lags behind military unmanned technology development in part because of unresolved regulatory and technological issues. Civil unmanned aerial vehicle systems have potential to augment disaster relief and emergency response efforts. Optimal design of aerial systems for such applications will lead to unmanned vehicles which provide maximum potentiality for relief and emergency response while accounting for public safety concerns and regulatory requirements. A case study is presented that demonstrates application of a civil unmanned system to a disaster relief mission with the intent on saving lives. The concept utilizes unmanned aircraft to obtain advanced warning and damage assessments for tornados and severe thunderstorms. Overview of a tornado watch mission architecture as well as commentary on risk, cost, need for, and design tradeoffs for unmanned aerial systems are provided.

  17. Evidence of secondary traumatic stress, safety concerns, and burnout among a homogeneous group of judges in a single jurisdiction.

    Science.gov (United States)

    Chamberlain, Jared; Miller, Monica K

    2009-01-01

    Active judges are likely to face numerous work-related experiences (e.g., traumatic cases) that affect performance of their occupational duties. Three occupational experiences (secondary traumatic stress [STS], safety concerns, and burnout) are outlined and applied to the judiciary. Results from nine case study interviews conducted in a single jurisdiction among a homogeneous cohort suggest that judges are at risk of having these experiences. Although no judge demonstrated extreme symptoms, all had low levels of symptoms associated with STS, safety concerns, and/or burnout. Several recommendations are proposed to prevent or minimize these occupational experiences. Recognizing and addressing the problem are essential for the protection of our nation's judges and the integrity of our judicial system.

  18. Stress relief of transition zones

    International Nuclear Information System (INIS)

    Woodward, J.; van Rooyen, D.

    1984-01-01

    This paper considers the problem of intergranular stress corrosion cracking, initiated on the primary side, in the expansion transition region of roller expanded Alloy 600 tubing. In general it is believed that residual stresses, arising from the expansion process, are the cause of the problem. The work reported here concentrated on the identification of an optimal, in-situ stress relief treatment

  19. Fraktalnist deformational relief polycrystalline aluminum

    Directory of Open Access Journals (Sweden)

    М.В. Карускевич

    2006-02-01

    Full Text Available  The possibility of the fractal geometry method application for the analisys of surface deformation structures under cyclic loading is presented.It is shown, that deformation relief of the alclad aluminium alloyes meets the criteria of the fractality. For the fractal demention estimation the method of  “box-counting”can be applied.

  20. Petroleum industry assists hurricane relief

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    This paper reports that the petroleum industry is aiding victims of last month's Hurricane Andrew with cash, clothing, food, water, and other supplies. Cash contributions announced as of last week totaled more than $2.7 million for distribution in South Florida and South Louisiana. Petroleum industry employees were collecting relief items such as bottled water and diapers for distribution in those areas

  1. Guideline adherence to chemotherapy administration safety standards: a survey on nurses in a single institute

    OpenAIRE

    Kim, Kidong; Lee, Hee Sook; Kim, Younha; Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol; Ryu, Sang-Young

    2011-01-01

    Objective Little is known about the guideline adherence of nurses to chemotherapy administration guidelines. We determined the guideline adherence of nurses to the Chemotherapy Administration Safety Standards and the relationship between demographic characteristics and guideline adherence. Methods Survey sheets containing two questions on demographic characteristics and 16 questions on the guideline adherence of nurses regarding chemotherapy administration were distributed to all in-patient d...

  2. Safety of multi-channel stimulation implants: a single blocking capacitor per channel is not sufficient after single-fault failure.

    Science.gov (United States)

    Nonclercq, Antoine; Lonys, Laurent; Vanhoestenberghe, Anne; Demosthenous, Andreas; Donaldson, Nick

    2012-04-01

    One reason given for placing capacitors in series with stimulation electrodes is that they prevent direct current flow and therefore tissue damage under fault conditions. We show that this is not true for multiplexed multi-channel stimulators with one capacitor per channel. A test bench of two stimulation channels, two stimulation tripoles and a saline bath was used to measure the direct current flowing through the electrodes under two different single fault conditions. The electrodes were passively discharged between stimulation pulses. For the particular condition used (16 mA, 1 ms stimulation pulse at 20 Hz with electrodes placed 5 cm apart), the current ranged from 38 to 326 μA depending on the type of fault. The variation of the fault current with time, stimulation amplitude, stimulation frequency and distance between the electrodes is given. Possible additional methods to improve safety are discussed.

  3. The feasibility and safety of single-incision totally extraperitoneal inguinal hernia repair after previous lower abdominal surgery: 350 procedures at a single center.

    Science.gov (United States)

    Wakasugi, Masaki; Suzuki, Yozo; Tei, Mitsuyoshi; Anno, Kana; Mikami, Tsubasa; Tsukada, Ryo; Koh, Masahiro; Furukawa, Kenta; Masuzawa, Toru; Kishi, Kentaro; Tanemura, Masahiro; Akamatsu, Hiroki

    2017-03-01

    To evaluate the feasibility and safety of single-incision laparoscopic surgery for totally extraperitoneal inguinal hernia repair (SILS-TEP) with previous lower abdominal surgery (PLAS). A retrospective analysis of 350 patients undergoing SILS-TEP for a primary inguinal hernia from January 2012 to December 2015 at Osaka Police Hospital was performed, and the outcomes of the patients with and without PLAS were compared. SILS-TEP was performed in 84 patients with PLAS and 266 patients without PLAS. Appendectomy was the most common previous operative procedure. There were more patients with an ASA score of ≥3 in the PLAS group than in the control group (p < 0.05). The mean operative time, and the rates of conversion and postoperative complications were comparable between the two groups. There were no cases of recurrence in either group. SILS-TEP could be safely performed in patients with PLAS and achieved better cosmetic outcomes than conventional laparoscopic surgery.

  4. Efficacy and safety of single versus dual antiplatelet therapy for coiling of unruptured aneurysms.

    Science.gov (United States)

    Nishikawa, Yusuke; Satow, Tetsu; Takagi, Toshinori; Murao, Kenichi; Miyamoto, Susumu; Iihara, Koji

    2013-07-01

    Although the efficacy of antiplatelet therapy for coiling of unruptured cerebral aneurysms has been reported, regimens for this therapy are not yet well established. The aim of this retrospective study was to analyze correlations among the modes of antiplatelet use, aneurysmal configuration, coiling methods, and complications to elucidate the optimal antiplatelet therapy for coiling. The study population comprised 154 patients with unruptured aneurysms who underwent coiling with antiplatelet therapy at our institution between 2001 and 2009. The patients were categorized by mode of antiplatelet therapy (single [n = 64] or dual [n = 90]), neck size (wide [n = 80] or narrow [n = 74]), and technique used (simple [n = 42] or adjunctive [n = 112]). The incidences of hemorrhagic/ischemic complications and abnormalities on postprocedural diffusion-weighted magnetic resonance imaging (DWI) in each group were statistically assessed. Hemorrhagic complications occurred in 1 case (1.5%) with single antiplatelet therapy and in 2 cases (2.2%) with dual antiplatelet therapy. Symptomatic ischemic complications occurred in 5 cases (7.8%) with single therapy and in 4 cases (4.4%) with dual therapy. Abnormalities were detected by DWI in 27 cases (42%) with single therapy and in 31 cases (34%) with dual therapy. No significant difference was found between modes of antiplatelet therapy even when the technique used was taken into account. In cases of wide neck, however, there were significant differences in the rate of symptomatic ischemic complications (single, 21.7%; dual, 3.5%; P = .014) and DWI abnormalities (single, 37.8%; dual, 20.9%; P = .048). Our data suggest that dual antiplatelet therapy may better prevent ischemic complications from coiling for wide-necked aneurysms compared with single antiplatelet therapy. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  5. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

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

  6. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

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

  7. Digital relief generation from 3D models

    Science.gov (United States)

    Wang, Meili; Sun, Yu; Zhang, Hongming; Qian, Kun; Chang, Jian; He, Dongjian

    2016-09-01

    It is difficult to extend image-based relief generation to high-relief generation, as the images contain insufficient height information. To generate reliefs from three-dimensional (3D) models, it is necessary to extract the height fields from the model, but this can only generate bas-reliefs. To overcome this problem, an efficient method is proposed to generate bas-reliefs and high-reliefs directly from 3D meshes. To produce relief features that are visually appropriate, the 3D meshes are first scaled. 3D unsharp masking is used to enhance the visual features in the 3D mesh, and average smoothing and Laplacian smoothing are implemented to achieve better smoothing results. A nonlinear variable scaling scheme is then employed to generate the final bas-reliefs and high-reliefs. Using the proposed method, relief models can be generated from arbitrary viewing positions with different gestures and combinations of multiple 3D models. The generated relief models can be printed by 3D printers. The proposed method provides a means of generating both high-reliefs and bas-reliefs in an efficient and effective way under the appropriate scaling factors.

  8. The Team Approach to Pain Relief

    Science.gov (United States)

    ... Current Issue Past Issues The Team Approach to Pain Relief Past Issues / Fall 2007 Table of Contents For ... with her quality of life, and acupuncture brought relief from severe shoulder pain. "I'm functional again. That's the best way ...

  9. When should a multicampus hospital be considered a single entity for public reporting on patient safety issues?

    Science.gov (United States)

    Naessens, James M; Culbertson, Richard A; Lefante, John J; Campbell, Claudia R

    2007-01-01

    Attempts to provide information to consumers about patient safety on specific hospitals have conflicted with organization self-perceptions and led to confusion among the general public. This article presents organizational theory framework and criteria to classify organizations as single versus multiple reporting entities. Operational definitions are presented. A case study comparing institutions both within and across state boundaries in the Mayo Clinic Health System is used to demonstrate their utility. The study includes analysis of an employee survey on employee satisfaction and patient safety climate in 2004 among nurses and physicians at the 2 Mayo Clinic hospitals in Rochester, Minn. The criteria for a single organization are more strongly supported for the Mayo Clinic hospitals located in the same city than for hospitals in the same system but separated geographically. Although there is debate about the measurement of organizational culture, employee surveys provide some evidence of a commonality across hospitals in the same city. The case study comparing institutions both within and across state boundaries in the Mayo Clinic Health System demonstrate the utility of the proposed criteria.

  10. 47 CFR 69.727 - Regulatory relief.

    Science.gov (United States)

    2010-10-01

    ... customer. (b) Phase II relief. Upon satisfaction of the Phase II triggers specified in §§ 69.709(c) or 69... Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase I... section 272 of the Communications Act of 1934, as amended, or § 64.1903 of this chapter, the price cap LEC...

  11. 28 CFR 36.504 - Relief.

    Science.gov (United States)

    2010-07-01

    ... COMMERCIAL FACILITIES Enforcement § 36.504 Relief. (a) Authority of court. In a civil action under § 36.503, the court— (1) May grant any equitable relief that such court considers to be appropriate, including... disabilities; (2) May award other relief as the court considers to be appropriate, including monetary damages...

  12. Service Learning Through Disaster Relief

    Directory of Open Access Journals (Sweden)

    Donna J. Duerst

    2010-06-01

    Full Text Available The Rock County 4-H Disaster Relief Committee raised $1,550 to aid tsunami victims in Sri Lanka and then turned its attention to Hurricane Katrina relief efforts. Thirty-one 4-H youth participated in a service learning trip to the South with the objectives of helping hurricane victims, learning about new cultures and achieving personal growth during three days of service projects in Louisiana and Mississippi. Their written reflections and other evaluative measures revealed they learned about southern culture, gained a greater appreciation for their lives, gained self confidence and developed a desire to help others more often. The trip was a valuable developmental experience for the youth, and information from the trip could be utilized to create similar experiences based on service learning. This article provides an overview of the trip and describes the evaluation methods used to measure learning and assess personal growth.

  13. New safety valve addresses environmental concerns

    International Nuclear Information System (INIS)

    Taylor, J.; Austin, R.

    1992-01-01

    This paper reports that Conoco Pipeline is using a unique relief valve to reduce costs while improving environmental protection at its facilities. Conoco Pipeline Co. Inc. began testing new relief valves in 1987 to present over-pressuring its pipelines while enhancing the safety, environmental integrity and profitability of its pipelines. Conoco worked jointly with Rupture Pin Technology Inc., Oklahoma City, to seek a solution to a series of safety, environmental, and operational risks in the transportation of crude oil and refined products through pipelines. Several of the identified problems were traced to a single equipment source: the reliability of rupture discs used at pipeline stations to relieve pressure by diverting flow to tanks during over-pressure conditions. Conoco's corporate safety and environmental policies requires solving problems that deal with exposure to hydrocarbon vapors, chemical spills or the atmospheric release of fugitive emissions, such as during rupture disc maintenance. The company had used rupture pin valves as vent relief devices in conjunction with development by Rick Austin of inert gas methods to protect the inner casing wall and outer carrier pipeline wall in pipeline road crossings. The design relies on rupture pin valves set at 5 psi to isolate vent openings from the atmosphere prior to purging the annular space between the pipeline and casing with inert gas to prevent corrosion. Speciality Pipeline Inspection and Engineering Inc., Houston, is licensed to distribute the equipment for the new cased-crossing procedure

  14. Photovoltaic application for disaster relief

    Energy Technology Data Exchange (ETDEWEB)

    Young, W.R. Jr.

    1995-11-01

    Hurricanes, floods, tornados, and earthquakes are natural disasters that can happen at any time destroying homes, businesses, and natural surroundings. One such disaster, Hurricane Andrew, devastated South Florida leaving several hundred-thousand people homeless. Many people were without electrical service, functioning water and sewage systems, communications, and medical services for days, even weeks in the aftermath of the storm. Emergency management teams, the military, and countless public and private organizations staged a massive relief effort. Dependency on electrical utility power became a pronounced problem as emergency services were rendered to survivors and the rebuilding process started. Many of the energy needs of emergency management organizations, relief workers, and the general public can be satisfied with solar electric energy systems. Photovoltaic (PV) power generated from solar energy is quiet, safe, inexhaustible and pollution-free. Previously, photovoltaics have supplied emergency power for Hurricanes Hugo and Andrew, and the earthquake at Northridge in Southern California. This document focuses on photovoltaic technology and its application to disaster relief efforts.

  15. Southern Alaska Coastal Relief Model

    Science.gov (United States)

    Lim, E.; Eakins, B.; Wigley, R.

    2009-12-01

    The National Geophysical Data Center (NGDC), an office of the National Oceanic and Atmospheric Administration (NOAA), in conjunction with the Cooperative Institute for Research in Environmental Sciences (CIRES) at the University of Colorado at Boulder, has developed a 24 arc-second integrated bathymetric-topographic digital elevation model of Southern Alaska. This Coastal Relief Model (CRM) was generated from diverse digital datasets that were obtained from NGDC, the United States Geological Survey, and other U.S. and international agencies. The CRM spans 170° to 230° E and 48.5° to 66.5° N, including the Gulf of Alaska, Bering Sea, Aleutian Islands, and Alaska’s largest communities: Anchorage, Fairbanks, and Juneau. The CRM provides a framework for enabling scientists to refine tsunami propagation and ocean circulation modeling through increased resolution of geomorphologic features. It may also be useful for benthic habitat research, weather forecasting, and environmental stewardship. Shaded-relief image of the Southern Alaska Coastal Relief Model.

  16. Safety data on single application of emu and macadamia nut oil on human skin

    Directory of Open Access Journals (Sweden)

    Tadayoshi Miyashita

    2017-12-01

    Full Text Available This data article provides the results of skin sensitization testing for emu and macadamia nut oil on 20 participants (ages 22–59 years old, including 3 men and 17 women. The test was carried out by performing a standard patch test using a Finn Chamber on Scanpor tape. The oils were applied to the participant's back using the tape and left in place for 24 h. After 1- and 24-h from removal of the tape, the reaction of the participant's skin was judged based on a scoring method recommended by Japanese Patch Test Research Group. Results are shown in table format. Keywords: Emu, Macadamia nut, Safety, Patch test

  17. Safety Evaluation for Packaging for the N Reactor/single pass reactor fuel characterization shipments

    International Nuclear Information System (INIS)

    Stevens, P.F.

    1994-01-01

    The purpose of this Safety Evaluation for Packaging (SEP) is to authorize the ChemNuclear CNS 1-13G packaging to ship samples of irradiated fuel elements from the 100 K East and 100 K West basins to the Postirradiation Testing Laboratory (PTL) in support of the spent nuclear fuel characterization effort. It also authorizes the return of the fuel element samples to the 100 K East facility using the same packaging. The CNS 1-13G cask has been-chosen to transport the fuel because it has a Certificate of Compliance (CoC) issued by the US Nuclear Regulatory Commission (NRC) for transporting irradiated oxide and metal fuel in commerce. It is capable of being loaded and offloaded underwater and may be shipped with water in the payload compartment

  18. Pain relief that matters to patients

    DEFF Research Database (Denmark)

    Olsen, Mette Frahm; Bjerre, Eik; Hansen, Maria Damkjær

    2017-01-01

    relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values. CONCLUSIONS: The MCID in acute pain varied greatly between studies......BACKGROUND: The minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core...... symptom affecting patients across many clinical conditions. METHODS: We identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one...

  19. Does pain relief by CT-guided indirect cervical nerve root injection with local anesthetics and steroids predict pain relief after decompression surgery for cervical nerve root compression?

    Science.gov (United States)

    Antoniadis, Alexander; Dietrich, Tobias J; Farshad, Mazda

    2016-10-01

    The relationship of pain relief from a recently presented CT-guided indirect cervical nerve root injection with local anesthetics and steroids to surgical decompression as a treatment for single-level cervical radiculopathy is not clear. This retrospective study aimed to compare the immediate and 6-week post-injection effects to the short- and long-term outcomes after surgical decompression, specifically in regard to pain relief. Patients (n = 39, age 47 ± 10 years) who had undergone CT-guided indirect injection with local anesthetics and steroids as an initial treatment for single cervical nerve root radiculopathy and who subsequently needed surgical decompression were included retrospectively. Pain levels (VAS scores) were monitored before, immediately after, and 6 weeks after injection (n = 34), as well as 6 weeks (n = 38) and a mean of 25 months (SD ± 12) after surgical decompression (n = 36). Correlation analysis was performed to find potential associations of pain relief after injection and after surgery to investigate the predictive value of post-injection pain relief. There was no correlation between immediate pain relief after injection (-32 ± 27 %) and 6 weeks later (-7 ± 19 %), (r = -0.023, p = 0.900). There was an association by tendency between immediate pain relief after injection and post-surgical pain relief at 6 weeks (-82 ± 27 %), (r = 0.28, p = 0.08). Pain relief at follow-up remained high at -70 ± 21 % and was correlated with the immediate pain amelioration effect of the injection (r = 0.37, p = 0.032). Five out of seven patients who reported no pain relief from injection had a pain relief from surgery in excess of 50 %. The amount of immediate radiculopathic pain relief after indirect cervical nerve root injection is associated with the amount of pain relief achieved at long-term follow-up after surgical decompression of single-level cervical radiculopathy

  20. Large curvature and background scale independence in single-metric approximations to asymptotic safety

    Energy Technology Data Exchange (ETDEWEB)

    Morris, Tim R. [STAG Research Centre & Department of Physics and Astronomy, University of Southampton,Highfield, Southampton, SO17 1BJ (United Kingdom)

    2016-11-25

    In single-metric approximations to the exact renormalization group (RG) for quantum gravity, it has been not been clear how to treat the large curvature domain beyond the point where the effective cutoff scale k is less than the lowest eigenvalue of the appropriate modified Laplacian. We explain why this puzzle arises from background dependence, resulting in Wilsonian RG concepts being inapplicable. We show that when properly formulated over an ensemble of backgrounds, the Wilsonian RG can be restored. This in turn implies that solutions should be smooth and well defined no matter how large the curvature is taken. Even for the standard single-metric type approximation schemes, this construction can be rigorously derived by imposing a modified Ward identity (mWI) corresponding to rescaling the background metric by a constant factor. However compatibility in this approximation requires the space-time dimension to be six. Solving the mWI and flow equation simultaneously, new variables are then derived that are independent of overall background scale.

  1. Guideline adherence to chemotherapy administration safety standards: a survey on nurses in a single institute.

    Science.gov (United States)

    Kim, Kidong; Lee, Hee Sook; Kim, Younha; Kim, Beob-Jong; Kim, Moon-Hong; Choi, Seok-Cheol; Ryu, Sang-Young

    2011-03-31

    Little is known about the guideline adherence of nurses to chemotherapy administration guidelines. We determined the guideline adherence of nurses to the Chemotherapy Administration Safety Standards and the relationship between demographic characteristics and guideline adherence. Survey sheets containing two questions on demographic characteristics and 16 questions on the guideline adherence of nurses regarding chemotherapy administration were distributed to all in-patient departments in our hospital in which chemotherapy was performed. All clinical nurses in the department were recommended to respond. Of 202 nurses, 123 responses were collected (61% response rate). The guideline adherence rate was >70% for 15 of 16 questions, but 55% of respondents indicated that there was no competency monitoring for nurses. Nurses with >7 years of clinical nursing experience felt more competent in performing cardiopulmonary resuscitation (CPR) than nurses with guideline adherence rate of nurses with respect to chemotherapy administration was high, with the exception of the absence of a competency monitoring for nurses. A significant number of nurses with <7 years of clinical nursing experience felt incompetent in performing CPR.

  2. Feasibility and Safety of Bariatric Surgery in High-Risk Patients: A Single-Center Experience

    Directory of Open Access Journals (Sweden)

    Yusef Moulla

    2018-01-01

    Full Text Available Introduction. Despite the feasibility and safety of bariatric procedures nowadays, high-risk patients with vast obesity and severe comorbidities demonstrate relatively high perioperative morbidity and mortality rates and, therefore, form a distinguished challenge for the bariatric surgeons. Methods. We retrospectively analyzed high-risk patients, who underwent bariatric surgery in University Hospital Leipzig between May 2012 and December 2016. High-risk patients were defined when (Bergeat et al., 2016 at least one of the following risk factors was met: age ≥ 70 years, body mass index (BMI > 70 kg/m2, liver cirrhosis, end-organ failure, or immunosuppression by status after organ transplantation along with (Birkmeyer et al., 2010 at least two comorbidities associated with obesity. Our analysis included early postoperative complications. Results. A total of 25 high-risk obese patients were identified. All patients had a standardized postoperative management with a mean length of hospital stay of 4 ± 1.4 days. One patient required an operative revision due to a stapler line leak after sleeve gastrectomy. No other major postoperative complications occurred. Conclusion. Bariatric surgery for severe high-risk patients can be performed safely in high-volume centers following standardized procedures.

  3. Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista)

    Science.gov (United States)

    Packer, Mark; Fry, Luther; Lavery, Kevin T; Lehmann, Robert; McDonald, James; Nichamin, Louis; Bearie, Brian; Hayashida, Jon; Altmann, Griffith E; Khodai, Omid

    2013-01-01

    Purpose To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. Methods This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. Results A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. Conclusion This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score. PMID:24109169

  4. Safety of a DVT chemoprophylaxis protocol following traumatic brain injury: a single center quality improvement initiative.

    Science.gov (United States)

    Nickele, Christopher M; Kamps, Timothy K; Medow, Joshua E

    2013-04-01

    Venous thromboembolism (VTE) is a complication that affects approximately 30 % of moderate and severe traumatic brain injury (TBI) patients when pharmacologic prophylaxis is not used. Following TBI, specifically in the case of contusions, the safety and efficacy of pharmacologic thromboembolism prophylaxis (PTP) has been studied only in small sample sizes. In this study, we attempt to assess the safety and efficacy of a PTP protocol for TBI patients, as a quality improvement (QI) initiative, in the neuroscience intensive care unit (NSICU). Between January 1st and December 31st, 2009, consecutive patients discharged from the University of Wisconsin NSICU after >a 48 h minimum stay were evaluated as part of a QI project. A protocol for the initiation of PTP was designed and implemented for NSICU patients. The protocol did not vary based on type of intracranial injury. The rate of VTE was reported as was heparin-induced thrombocytopenia and PTP-related expansion of intracranial hemorrhage (IH) requiring reoperation. The number of patients receiving PTP and the timing of therapy were tracked. Patients were excluded for persistent coagulopathy, other organ system bleeding (such as the gastrointestinal tract), or pregnancy. Faculty could opt out of the protocol without reason. Using the same criteria, patients discharged during the preceding 6 months, from July 1st to December 31st, 2008, were evaluated as controls as the PTP protocol was not in effect during this time. During the control period, there were 48 head trauma admissions who met the inclusion criteria. In 22 patients (45.8 %), PTP was initiated at an average of 4.9 ± 5.4 days after admission. During the protocol period, there were 87 head trauma admissions taken from 1,143 total NSICU stays who met criteria. In 63 patients (72.4 %), the care team in the NSICU successfully initiated PTP, at an average of 3.4 ± 2.8 days after admission. All 87 trauma patients were analyzed, and the rate of clinically

  5. Pharmacokinetics, Safety and Tolerability of Single Oral or Intravenous Administration of 200 mg Tedizolid Phosphate in Adolescents.

    Science.gov (United States)

    Bradley, John S; Flanagan, Shawn D; Arrieta, Antonio C; Jacobs, Richard; Capparelli, Edmund; Prokocimer, Philippe

    2016-06-01

    Tedizolid is a novel oxazolidinone antibacterial US FDA approved for treatment of acute bacterial skin and skin structure infections in adults. This study assessed the pharmacokinetics, safety and tolerability of tedizolid phosphate in adolescents (12-17 years old) after administration of a single intravenous (IV) or oral dose. In this multicenter, open-label study, a single IV infusion (N = 10) or oral dose (N = 10) of 200 mg tedizolid phosphate was administered to adolescents already receiving antibacterial treatment for presumed or documented infection. Blood and urine samples were collected predose and over 24 hours. Tedizolid pharmacokinetics was generally similar after IV or oral administration of 200 mg tedizolid phosphate. Mean (standard deviation) half-life values were similar for oral and IV routes, 8.3 (2.0) and 6.6 (0.7) hours, respectively. Absolute oral bioavailability of tedizolid (90% confidence interval) was 88.8% (70.4%-112.1%). Geometric mean ratio (90% confidence interval) of area under the concentration-time curve values for adolescents relative to values previously reported for adults after 200 mg of single-dose IV or oral administration were 0.847 (0.736-0.975). Tedizolid was well tolerated. Overall pharmacokinetics of tedizolid was similar after administration of a single oral or IV 200 mg dose, and bioavailability was high. Exposure profiles were similar to those in adults. With clinical outcomes based on area under the concentration-time curve/minimum inhibitory concentration and current susceptibility of Gram-positive pathogens, results suggest that the 200 mg daily regimen of tedizolid phosphate can be extended to adolescents for clinical trials, and that dose adjustment may not be required when switching routes.

  6. Examples, clarifications, and guidance on preparing requests for relief from pump and valve inservice testing requirements

    International Nuclear Information System (INIS)

    Ransom, C.B.; Hartley, R.S.

    1996-02-01

    In this report, the Idaho National Engineering Laboratory reviewers discuss related to requests for relief from the American Society of Mechanical Engineers code requirements for inservice testing (IST) of safety-related pumps and valves at commercial nuclear power plants. This report compiles information and examples that may be useful to licensees in developing relief requests submitted to US Nuclear Regulatory Commission (NRC) for their consideration and provides insights and recommendations on related IST issues. The report also gives specific guidance on relief requests acceptable and not acceptable to the NRC and advises licensees in the use of this information for application at their facilities

  7. Long-term safety in living kidney donors for paediatric transplantation. Single-centre prospective study.

    Science.gov (United States)

    Martin Benlloch, J; Román Ortiz, E; Mendizabal Oteiza, S

    There is enough evidence concerning the short-term safety of living donors after kidney transplantation. However, long-term complications continue to be studied, with a particular interest in young donors. Previous studies have been conducted in older donors for adult renal patients. We present a study of long-term complications in kidney donors for our paediatric population. We carried out a long-term donor study for the 54 living kidney-donor transplantations performed at our department from 1979 to June 2014. We monitored the glomerular filtration rate (GFR) on the basis of 24-hour urine creatinine clearance, 24-hour proteinuria and the development of arterial hypertension in the 48 donors who were followed up for more than one year. Only the 39 patients who were exclusively followed up by our department have been included in the results analysis. GFR through creatinine clearance was stable after an initial decrease. No proteinuria was observed in any of the cases. One patient developed chronic kidney disease (CKD), which resulted in a cumulative incidence of 2%. GFR below 60mL/min/1.73 m 2 was not reported in any other patients. Arterial hypertension was diagnosed in 25% of donors, 90% of which were treated with antihypertensives. Risk of CKD and hypertension in living kidney donors for paediatric recipients, who are carefully monitored throughout their evolution, is similar to that of the general population. Therefore, this technique appears to be safe in both the short and long term. Copyright © 2016 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  8. Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials.

    Science.gov (United States)

    Darney, Philip; Patel, Ashlesha; Rosen, Kimberly; Shapiro, Lena S; Kaunitz, Andrew M

    2009-05-01

    To present efficacy, safety, and bleeding profile results from the clinical trials that supported the U.S. Food and Drug Administration filing for the approval of a single-rod etonogestrel (ENG) contraceptive implant (Implanon). Integrated analysis of 11 international clinical trials. Contraceptive clinics in U.S., Chile, Asia, and Europe. A total of 942 healthy women, aged 18 to 40 years. Insertion of an ENG implant. Most women were enrolled in studies lasting either 2 or 3 years. Efficacy was measured by the cumulative Pearl Index in women Safety was primarily assessed by incidence of adverse events. Bleeding profiles were analyzed via reference period analyses. No pregnancies were reported while the ENG implants were in place. Six pregnancies occurred during the first 14 days after ENG implant removal. Including these six pregnancies, the cumulative Pearl Index was 0.38 (year 1 and 2 Pearl Indexes were 0.27 and 0.30, respectively). Common drug-related adverse events were headache, weight gain, acne, breast tenderness, emotional lability, and abdominal pain. Bleeding pattern changes were observed, but no one pattern predominated. The ENG implant is an efficacious and safe method of contraception which does not require patients' consistent action.

  9. Management benefits and safety of computed tomography in patients undergoing extracorporeal membrane oxygenation therapy: experience of a single centre

    International Nuclear Information System (INIS)

    Jepson, S.L.; Harvey, C.; Entwisle, J.J.; Peek, G.J.

    2010-01-01

    Aim: To evaluate the benefits and logistical safety of computed tomography (CT) imaging in patients undergoing extracorporeal membrane oxygenation (ECMO) therapy in a single institution. Materials and methods: Over a period of 25 months, 134 patients (80 neonates, 19 children, and 35 adults) underwent ECMO therapy at this institution. The imaging of these patients was reviewed to identify patients who had undergone CT imaging whilst on ECMO. Patient notes were retrospectively reviewed. CT findings and subsequent decisions were analysed to assess the benefit of CT imaging. Complications arising due to the logistics of performing the scan were analysed to assess the safety of performing CT in ECMO patients. Results: Of 134 patients, 14 (10%) had a total of 15 CT examinations whilst undergoing ECMO therapy. Indications for CT included new neurology, increased respiratory demand, and increasing requirement for high ECMO flows. There were no major complications and two minor complications associated with the logistics of performing a CT examination on an ECMO patient. Significant findings resulted from 73.3% (11/15) of the CT examinations, and in all 15 examinations information was provided that was used in making further management decisions, including, in some cases, withdrawal of ECMO therapy. Conclusion: With an experienced team, CT imaging of patients on ECMO can be performed safely. CT provides valuable information for subsequent management of patients undergoing ECMO therapy.

  10. Pharmacokinetics and Safety of a Single Intravenous Dose of myo-Inositol in Preterm Infants of 23 to 29 weeks

    Science.gov (United States)

    Phelps, Dale L.; Ward, Robert M.; Williams, Rick L.; Watterberg, Kristi L.; Laptook, Abbot R.; Wrage, Lisa A.; Nolen, Tracy L.; Fennell, Timothy R.; Ehrenkranz, Richard A.; Poindexter, Brenda B.; Cotten, C. Michael; Hallman, Mikko K.; Frantz, Ivan D.; Faix, Roger G.; Zaterka-Baxter, Kristin M.; Das, Abhik; Ball, M. Bethany; O’Shea, T. Michael; Lacy, Conra Backstrom; Walsh, Michele C.; Shankaran, Seetha; Sánchez, Pablo J.; Bell, Edward F.; Higgins, Rosemary D.

    2014-01-01

    Background Myo-inositol given to preterm infants with respiratory distress has reduced death, increased survival without bronchopulmonary dysplasia (BPD) and reduced severe retinopathy of prematurity (ROP) in 2 randomized trials. Pharmacokinetic (PK) studies in extremely preterm infants are needed prior to efficacy trials. Methods Infants of 23–29 weeks gestation were randomized to a single intravenous (IV) dose of inositol at 60 or 120 mg/kg or placebo. Over 96 h, serum levels (sparse sampling population PK) and urine inositol excretion were determined. Population PK models were fit using a nonlinear mixed effects approach. Safety outcomes were recorded. Results A 1-compartment model that included factors for endogenous inositol production, allometric size based on weight, gestational age (GA) strata and creatinine clearance fit the data best. The central volume of distribution was 0.5115 l/kg, the clearance 0.0679 l/kg/h, endogenous production 2.67 mg/kg/h and the half life 5.22 h when modeled without the covariates. During the first 12 h renal inositol excretion quadrupled in the 120 mg/kg group, returning to near baseline after 48 h. There was no diuretic side-effect. No significant differences in adverse events occurred between the 3 groups (p > 0.05). Conclusions A single compartment model accounting for endogenous production satisfactorily described the PK of IV inositol. PMID:24067395

  11. Pharmacokinetics and safety of single doses of tabalumab in subjects with rheumatoid arthritis or systemic lupus erythematosus.

    Science.gov (United States)

    Witcher, Jennifer; Fleischmann, Roy; Chindalore, Vishala L; Hansen, Ryan J; Hu, Leijun; Radtke, David; Voelker, James; Gomez, Elisa; McColm, Juliet

    2016-05-01

    Two phase 1 studies evaluated the pharmacokinetics (PK), safety and biological activity of tabalumab, a human monoclonal antibody against B-cell activating factor (BAFF), administered intravenously (i.v.) or subcutaneously (s.c.) in subjects with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). In study A, subjects with RA (n = 23) or SLE (n = 6) received a single i.v. dose of tabalumab (RA 0.01, 0.04, 0.125, 0.5, 2.0, and 8.0 mg kg(-1) and SLE 0.125 or 2.0 mg kg(-1) ) or placebo. In study B, subjects with RA received a single tabalumab dose i.v. (10 mg) (n = 12) or s.c. (20 mg) (n = 12). Serum tabalumab and CD20+ B cells were evaluated and safety was assessed throughout both studies. Tabalumab PK were non-linear across the 0.01 to 8.0 mg kg(-1) dose range. Clearance (CL) decreased from 2.9 to 0.1 l day(-1) and terminal half-life (t1/2 ) increased from about 1.6 to 25 days. Subjects with RA or SLE had similar PK. After s.c. dosing, tabalumab time to maximal concentration (tmax ) was 5.5 days. Absolute bioavailability (F) was approximately 62%. Following tabalumab dosing, CD20+ B cells transiently increased from baseline followed by a progressive decrease below baseline. A single tabalumab dose administered i.v. or s.c. was well tolerated and had non-linear CL over the dose range investigated in subjects with RA and SLE. The non-linearity likely reflects target-mediated CL due to binding to BAFF. Tabalumab showed biological activity based on changes in peripheral CD20+ lymphocyte numbers in both subjects with RA and SLE. © 2015 The British Pharmacological Society.

  12. Single Anastomosis Duodeno-Ileal Switch (SADIS): A Systematic Review of Efficacy and Safety.

    Science.gov (United States)

    Shoar, Saeed; Poliakin, Lauren; Rubenstein, Rebecca; Saber, Alan A

    2018-01-01

    Owing to the possibility of weight regain after the long-term follow-up of gastric bypass patients and because of the high morbidity of biliopancreatic diversion with duodenal switch, single-anastomosis duodeno-ileal switch (SADIS) has emerged as a rescue procedure in bariatric surgery. The purpose of this review is to summarize the literature data on SADIS. University Hospital, NY. A comprehensive literature review was performed through October 2016 to identify English studies on SADIS performed in human subjects. Outcomes of interest were technical considerations, postoperative complications, weight loss outcome, comorbidity resolution rate, and nutritional deficiency after SADIS. A total of 12 studies including 581 SADIS patients (217 males and 364 females) were included. SADIS was a primary procedure in 508 patients (87.4%) and a conversion procedure in 73 patients (12.6%). The length of common limb was 300 cm in 54.2%, 250 cm in 23%, and 200 cm in 13.4% of patients. Anastomosis technique was a linear stapler in 26.7% and a hand sewn suture technique in 73.3% of patients. Diarrhea was the most common complication (1.2%). The average %EWL was 30% at 3 months, 55% at 6 months, 70% at 1 year, and 85% at 2 years. Co-morbidity resolution rate was 74.1% for type 2 diabetes mellitus, 96.3% for hypertension, 68.3% for dyslipidemia, 63.3% for obstructive sleep apnea, and 87.5% for GERD. Overall, vitamin A, selenium, and iron deficiency were the most common nutritional deficiencies with the possibility of the protein malnutrition in up to 34% of the patients when measured. As a modified bariatric procedure, SADIS has promising outcomes for weight loss and comorbidity resolution in morbidly obese patients. When measured, there was a high prevalence of macro-nutrient deficiencies following SADIS. There is a high technical variability, and long-term data are required before any meaningful conclusion can be made.

  13. The Impact of Electronic Medical Records on Hospital-Acquired Adverse Safety Events: Differential Effects Between Single-Source and Multiple-Source Systems.

    Science.gov (United States)

    Bae, Jaeyong; Rask, Kimberly J; Becker, Edmund R

    The objective was to examine differential impacts between single-source and multiple-source electronic medical record (EMR) systems, as measured by number of vendor products, on hospital-acquired patient safety events. The data source was the 2009-2010 State Inpatient Databases of the Healthcare Cost and Utilization Project for California, New York, and Florida, and the Information Technology Supplement to the American Hospital Association's Annual Survey. Multivariable regression analyses were conducted to estimate the differential impacts of EMRs between single-source and multiple-source EMR systems on hospital-acquired patient safety events. In all, 1.98% of adult surgery hospitalizations had at least 1 hospital-acquired patient safety event. Basic EMRs with a single vendor or self-developed EMR systems were associated with a significant decrease in patient safety events by 0.38 percentage point, or 19.2%, whereas basic EMRs with multiple vendors had an insignificant association. A single-source EMR system enhances the impact of EMRs on reducing patient safety events.

  14. Evaluation of the pharmacokinetics and safety of single and multiple ceftaroline fosamil infusions in healthy Chinese and Western subjects.

    Science.gov (United States)

    Yang, Li; Sunzel, Maria; Xu, Peng; Edeki, Timi; Wilson, David; Li, Jianguo; Li, Haiyan

    2015-08-01

    Two phase I studies in healthy Chinese (NCT01458743) and Western (NCT01612507) subjects evaluated the pharmacokinetics (PK) and safety of single and multiple ceftaroline fosamil 600 mg infusions administered every 8 or 12 hours (q8h or q12h). Each study enrolled subjects sequentially into 1 of 2 cohorts (cohort 1: 60-minute infusions; cohort 2: 120-minute infusions). All subjects in the Chinese (n = 26) study received open label ceftaroline fosamil; in the Western study, subjects (n = 41) in each cohort were randomized 3 : 1 to ceftaroline fosamil or placebo infusions. Single infusions were administered on days 1 and 8. On days 2 - 7 (3 - 7 for Chinese study, cohort 1) subjects received q12h or q8h infusions. Plasma and urine were collected on days 1 and 8 for PK analysis. Ceftaroline PK was linear and time-independent following single and multiple doses of ceftaroline fosamil. The magnitude and timing of peak plasma concentrations of ceftaroline (active metabolite), ceftaroline fosamil (prodrug), and ceftaroline M-1 (inactive metabolite) varied according to the ceftaroline fosamil dosing schedule (q12h or q8h) and infusion duration (60 minutes or 120 minutes), but overall plasma ceftaroline exposures within the respective dosing intervals were broadly similar across cohorts. The most frequent adverse events were rash/drug eruption, most of which were of mild-moderate intensity and considered related to treatment. Ceftaroline PK was broadly similar in healthy Chinese and Western subjects receiving equivalent dose regimens. The tolerability profile of ceftaroline fosamil in Chinese and Western subjects was consistent with previous clinical trials.

  15. Does Immediate Pain Relief After an Injection into the Sacroiliac Joint with Anesthetic and Corticosteroid Predict Subsequent Pain Relief?

    Science.gov (United States)

    Schneider, Byron J; Huynh, Lisa; Levin, Josh; Rinkaekan, Pranathip; Kordi, Ramin; Kennedy, David J

    2018-02-01

    To determine if immediate pain response following an injection with local anesthetic and corticosteroid predicts subsequent relief. Prospective observational cohort. An institutional review board-approved prospective study from a single academic medical center. Patients with clinical diagnosis of sacroiliac (SIJ) pain and referred for SIJ injection were enrolled; 1 cc of 2% lidocaine and 1 cc of triamcinolone 40 mg/mL were injected into the SIJ. Pain score on 0-10 numeric rating scale (NRS) during provocation maneuvers was recorded immediately before injection, immediately after injection, and at two and four weeks of follow-up. Oswestry Disability Index (ODI) was also recorded. Various cutoffs were identified to establish positive anesthetic response and successful outcomes at follow-up. These were used to calculated likelihood ratios. Of those with 100% anesthetic response, six of 11 (54.5%, 95% confidence interval [CI]+/-29.4%, +LR 2.6, 95% CI = 1.1-5.9) demonstrated 50% or greater pain relief at follow-up, and four of 11 (36.5%, 95% CI+/-28.4%, +LR 3.00, 95% CI = 1.4-5.1) had 100% relief at two to four weeks. Fourteen of 14 (100%, 95% CI+/-21.5%, -LR 0.0, 95% CI = 0.0-2.1) with an initial negative block failed to achieve 100% relief at follow-up. Patients who fail to achieve initial relief after SIJ injection with anesthetic and steroid are very unlikely to achieve significant pain relief at follow-up; negative likelihood ratios (LR) in this study, based on how success is defined, range between 0 and 0.9. Clinically significant positive likelihood ratios of anesthetic response to SIJ injection are more limited and less robust, but are valuable in predicting 50% relief or 100% relief at two to four weeks. © 2017 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  16. Efficacy and safety of dienogest in patients with endometriosis: A single-center observational study over 12 months.

    Science.gov (United States)

    Park, So Yun; Kim, Sung Hoon; Chae, Hee Dong; Kim, Chung-Hoon; Kang, Byung Moon

    2016-12-01

    To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration. Bone mineral density (BMD) was measured in patients who were prescribed dienogest for more than 18 months. Pain was significantly reduced at 12 months after dienogest medication. In those treated with dienogest due to recurrent endometrioma, the size of the endometrioma was significantly decreased at the 12-month and 18-month follow-ups. We found only one case of sonographic recurrence during dienogest administration among those who were treated postoperatively to prevent recurrence (1 of 114, 0.9%). The most common adverse drug reaction was uterine bleeding (3.2%), and other adverse events were generally tolerable and associated with low discontinuation rates (5.2%). Among the 50 patients in whom BMD was measured, 10 patients (20%) had a Z-score below the expected range for age. The administration of dienogest for a year or more seems to be highly effective in preventing recurrence after surgery, reducing endometriosis-associated pain, and decreasing the size of recurrent endometrioma, with a favorable safety and tolerability profile. However, BMD should be checked in patients on long-term medication due to possible bone loss in some women.

  17. Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista

    Directory of Open Access Journals (Sweden)

    Packer M

    2013-09-01

    Full Text Available Mark Packer,1 Luther Fry,2 Kevin T Lavery,3 Robert Lehmann,4 James McDonald,5 Louis Nichamin,6 Brian Bearie,7,† Jon Hayashida,8 Griffith E Altmann,8 Omid Khodai8 1Department of Ophthalmology, Oregon Health and Science University, Eugene, OR, USA; 2University of Kansas Medical Center, Kansas City, KS, USA; 3Wayne State University, Detroit, MI, USA; 4Baylor College of Medicine, Houston, TX, USA; 5University of Arkansas for Medical Sciences, Little Rock, AR, USA; 6Laurel Eye Clinic, Brookville, PA, USA; 7Grand Rapids Eye Institute, Grand Rapids, MI, USA; 8Bausch & Lomb, Aliso Viejo, CA, USA †Brian Bearie passed away on March 9, 2011 Purpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA when used to correct aphakia following cataract extraction in adults. Methods: This was a prospective case series (NCT01230060 conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1 to have the lens implanted in one of four axis positions in 45° increments. Results: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100% achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive

  18. Single- and Multiple-Dose Study To Determine the Safety, Tolerability, and Pharmacokinetics of Ceftaroline Fosamil in Combination with Avibactam in Healthy Subjects

    OpenAIRE

    Riccobene, Todd A.; Su, Sheng Fang; Rank, Douglas

    2013-01-01

    This study was conducted to determine the safety, tolerability, and pharmacokinetics of intravenous doses of ceftaroline fosamil administered in combination with the novel non-β-lactam β-lactamase inhibitor avibactam in healthy adults. In the single-dose, open-label arm, 12 subjects received single 1-h intravenous infusions of ceftaroline fosamil alone (600 mg), avibactam alone (600 mg), and ceftaroline fosamil in combination with avibactam (600/600 mg) separated by 5-day washout periods. In ...

  19. Exercise Based- Pain Relief Program

    DEFF Research Database (Denmark)

    Zadeh, Mahdi Hossein

    in the current study was to use exercise induced- muscle damage followed by ECC as an acute pain model and observe its effects on the sensitivity of the nociceptive system and blood supply in healthy subjects. Then, the effect of a repeated bout of the same exercise as a healthy pain relief strategy......Exercise-based pain management programs are suggested for relieving from musculoskeletal pain; however the pain experienced after unaccustomed, especially eccentric exercise (ECC) alters people´s ability to participate in therapeutic exercises. Subsequent muscle pain after ECC has been shown...... to cause localized pressure pain and hyperalgesia. A prior bout of ECC has been repeatedly reported to produce a protective adaptation known as repeated bout effect (RBE). One of the main scopes of the current project was to investigate the adaptations by which the RBE can be resulted from. The approach...

  20. Pharmacokinetics and Safety of Tedizolid after Single and Multiple Intravenous/Oral Sequential Administrations in Healthy Chinese Subjects.

    Science.gov (United States)

    Chen, Rui; Shen, Kai; Chang, Xinying; Tanaka, Toshiaki; Li, Li; Hu, Pei

    2016-08-01

    Tedizolid phosphate is a new antibacterial agent under investigation for the treatment of Gram-positive infections in China. This study was conducted to assess the pharmacokinetic (PK) properties, oral bioavailability, and safety of once daily tedizolid phosphate 200 mg in Chinese subjects to support its further clinical development in China. This Phase I single-center study, conducted in 16 healthy Chinese male subjects, consisted of a single-dose administration, 1:1 randomized, two-way, intravenous (IV)/oral (PO) crossover of tedizolid phosphate 200 mg (Part 1) and, after a 7-day washout, a nonrandomized, multiple-dose, 7-day tedizolid phosphate 200 mg once daily administration (IV for 3 days, PO for 4 days; Part 2). Blood samples were collected for up to 72 hours after single dosing and for up to 2 hours on Day 3 and 72 hours on Day 7 of multiple dosing to determine PK parameters. Adverse events (AEs) were recorded throughout the entire study. The Cmax and AUC of tedizolid (the active moiety of tedizolid phosphate) were 3.02 µg/mL and 30.50 µg • h/mL after single IV dosing of tedizolid phosphate, and 2.25 µg/mL and 26.10 µg • h/mL after single PO dosing, respectively, and the mean half-life was 10.1 hours for both administration routes. The oral bioavailability of tedizolid was 85.5%. PK parameters of tedizolid were similar after single and multiple dosing of tedizolid phosphate, indicating no time dependency. Only minor accumulation of tedizolid was observed after multiple dosing (expressed as accumulation ratios RAAUC: 1.18 for PO dosing, and RACmax: 1.16 and 1.05 for IV and PO dosing, respectively). Steady state of tedizolid was reached after about 3 days, and trough concentrations remained constant when switching from IV to PO dosing. Tedizolid phosphate was well tolerated with 6 subjects (37.5%) in Part 1 and 5 subjects (31.3%) in Part 2 experiencing an AE; all AEs but one were related to the study drug assessed by the investigator. All AEs were of

  1. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study.

    Science.gov (United States)

    Bouroubi, Athmane; Donazzolo, Yves; Donath, Franck; Eccles, Ron; Russo, Marc; Harambillet, Nadine; Gautier, Stéphanie; Montagne, Agnès

    2017-09-01

    The aim of this study was to compare the efficacy and safety of a new oromucosal ibuprofen form, ibuprofen 25 mg lozenge, in single and repeat dosing for up to 4 days, to the matched placebo, in the treatment of acute sore throat pain in adults. In this randomised, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (≥5 on the objective Tonsillo-Pharyngitis Assessment 21-point scale and ≥60 mm on the subjective 0-100 mm visual analogue Sore Throat Pain Intensity Scale [STPIS]) were assigned ibuprofen 25 mg (n=194) or matching placebo (n=191) lozenge treatment. Efficacy was assessed (at the investigating centre up to 2 hours after first dosing, then on an ambulatory basis) by parameters derived from patient's scores on scales of pain relief, pain intensity, and global efficacy assessment. The primary efficacy end-point was the time-weighted TOTal PAin Relief (TOTPAR) over 2 hours after first dosing using the Sore Throat Relief Scale (STRS). Safety and local tolerability were assessed. Ibuprofen 25 mg was superior to placebo on numerous pain relief parameters; TOTPAR was significantly higher with ibuprofen 25 mg over 2 hours after first dosing (Ppain (n=128), after an average 4 days (Prelief of sore throat pain and is as well tolerated as placebo. ClinicalTrials.gov, NCT01785862. © 2017 John Wiley & Sons Ltd.

  2. Experience with pegvisomant treatment in acromegaly in a single Brazilian tertiary reference center: efficacy, safety and predictors of response.

    Science.gov (United States)

    Kasuki, Leandro; Machado, Evelyn de Oliveira; Ogino, Liana Lumi; Coelho, Maria Caroline Alves; Silva, Cintia Marques Dos Santos; Wildemberg, Luiz Eduardo Armondi; Lima, Carlos Henrique Azeredo; Gadelha, Mônica R

    2016-10-01

    To describe the safety and efficacy of pegvisomant therapy and the predictors of treatment response in acromegaly patients at a single tertiary reference center in Brazil. We retrospectively reviewed the clinical, hormonal and radiological data of acromegaly patients treated with pegvisomant in our center. We also evaluated the presence of the d3 isoform of the growth hormone receptor (d3GHR). Twenty-seven patients were included (17 women). Pegvisomant was used in combination with octreotide LAR in 20 patients (74%), in combination with cabergoline in one (4%) and as monotherapy in six (22%). IGF-I normalization was achieved in 23 patients (85%). Mild and transitory elevation of liver enzymes was observed in two patients (7.4%), tumor growth in one (3.4%) and lipodystrophy in two (7.4%). One patient stopped the drug due to headaches. The GHR isoforms were evaluated in 14 patients, and the presence of at least one d3GHR allele was observed in 43% of them, but it was not a predictor of treatment response. Only pre-treatment IGF-I level was a predictor of treatment response. Pegvisomant treatment was highly effective and safe in our series of Brazilian patients. A better chance of disease control can be expected in those with lower pre-pegvisomant IGF-I levels.

  3. Safety and efficacy assessment of carotid artery stenting in a high-risk population in a single-centre registry.

    Science.gov (United States)

    Kosowski, Michał; Zimoch, Wojciech; Gwizdek, Tomasz; Konieczny, Radosław; Kübler, Piotr; Telichowski, Artur; Jankowska, Ewa A; Reczuch, Krzysztof

    2014-01-01

    Ischaemic stroke is the primary cause of long-term disability and the third most common cause of death. Internal carotid artery stenosis is an important risk factor for stroke and transient ischaemic attack (TIA). European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines allow carotid artery stenting (CAS) as an alternative to endarterectomy in centres with low rates of death or stroke. To assess the safety and efficacy of CAS in a single-centre observation. We performed a retrospective analysis of all patients treated with CAS between March 2008 and July 2012. Clinical data and outcomes in both asymptomatic and symptomatic patients were analysed. A total of 214 consecutive patients were included in the registry. Symptomatic patients accounted for 57% of the study group and were more likely to have a history of stroke and/or TIA that occurred more than 6 months before the procedure (50% vs. 8%, p likely to have a history of coronary artery disease (88% vs. 61%, p < 0.001), and the rates of previous acute coronary syndrome and revascularisation were also higher in this group (58% vs. 41% and 71% vs. 52%, respectively, both p < 0.05). The symptomatic group had higher incidence of stroke in periprocedural and 30-day observation (4% vs. 0%, p < 0.05). There was no difference in incidence of adverse events in long-term observation. Carotid artery stenting is a safe and efficacious procedure. Every centre performing CAS should monitor the rate of periprocedural complications.

  4. Safety of and tolerance to adenosine infusion for myocardial perfusion single-photon emission computed tomography in a Japanese population.

    Science.gov (United States)

    Hatanaka, Kunihiko; Doi, Masayuki; Hirohata, Satoshi; Kamikawa, Shigeshi; Kaji, Yoko; Katoh, Tsutomu; Kusachi, Shozo; Ninomiya, Yoshifumi; Ohe, Tohru

    2007-06-01

    Adenosine has been available for use in myocardial perfusion single-photon emission computed tomography (SPECT) in Japan since 2005. The purpose of this study was to evaluate the safety of and tolerance to thallium-201 myocardial perfusion SPECT with intravenous adenosine infusion in Japanese patients with suspected coronary artery disease. Two hundred and six consecutive patients who underwent an adenosine infusion (120 mug . kg(-1) . min(-1)) SPECT at Sumitomo Besshi Hospital (Niihama, Japan) were investigated. The effects of adenosine infusion were monitored for each patient. A coronary angiography was performed in 81 patients. Adenosine infusion significantly decreased blood pressure and increased heart rate. Adverse reactions were observed in 161 patients (78.2%). Most reactions were transient, disappearing soon after the termination of adenosine infusion. No serious adverse reactions, such as acute myocardial infarction or death, occurred. Adenosine infusion was terminated in 3 patients (1.5%) because of near syncope or sustained 2:1 atrioventricular block. Electrocardiographic changes occurred in 15 patients (7.3%). Self-assessed scoring after SPECT showed that the patients were very tolerant (74.6% of 177 patients) of adenosine infusion myocardial SPECT. The sensitivity and specificity were 75.0% and 69.7%, respectively. Adenosine infusion myocardial SPECT is safe and well tolerated in the Japanese population, despite the frequent occurrence of minor adverse reactions.

  5. Influence of single-phase heat transfer correlations on safety analysis of research reactors with narrow rectangular fuel channels

    International Nuclear Information System (INIS)

    Rawashdeh, A.; Altamimi, R.; Lee, B.; Chung, Y. J.; Park, S.

    2013-01-01

    The influence of different single-phase heat transfer correlations on the fuel temperature and minimum critical heat flux ratio (MCHFR) during a typical accident of a 5 MW research reactor is investigated. A reactor uses plate type fuel, of which the cooling channels have a narrow rectangular shape. RELAP5/MOD3.3 tends to over-predict the Nusselt number (Nu) at a low Reynolds number (Re) region, and therefore the correlation set is modified to properly describe the thermal behavior at that region. To demonstrate the effect of Nu at a low-Re region on an accident analysis, a two-pump failure accident was chosen as a sample problem. In the accident, the downward core flow decreases by a pump coast-down, and then reverses upward by natural convection. During the pump coast-down and flow reversal, the flow undergoes a laminar flow regime which has a different Nu with respect to the correlation sets. Compared to the results by the original RELAP5/MOD3.3, the modified correlation set predicts the fuel temperature to be a little higher than the original value, and the MCHFR to be a little lower than the original value. Although the modified correlation set predicts the fuel temperature and the MCHFR to be less conservative than those calculated from the original correlation of RELAP5/MOD3.3, the maximum fuel temperature and the MCHFR still satisfy the safety acceptance criteria

  6. Numerical simulation on flow field of nuclear safety grade 2 single-seat pneumatic diaphragm control valve

    International Nuclear Information System (INIS)

    Zhong Yun; Zhang Jige; Wang Dezhong; Shi Jianzhong

    2010-01-01

    The Computational Fluid Dynamics (CFD) method is employed to simulate numerically the steady flow and transient flow under variable openings of the nuclear safety grade 2 single-seat pneumatic diaphragm control valve, which is a sleeve valve. The steady simulations under rated condition tells that there is a large amount of vortex in the valve seat necking and around the valve cone, which leads to a much greater flow impact on the head of the valve cone and uneven pressure distribution on spool face. More consideration should be taken on the characteristics of the valve cone accordingly, when designing a valve of this kind. Then the transient flow under 100% and 40% openings is simulated numerically on the basis of steady simulations. The pulsation of the pressure magnitude at the points with large vorticity, in the valve seat necking and around the valve cone, is monitored. The main pulsation frequencies differ from the low natural frequencies of the model, which means that it is safe from leading to structural resonance. (authors)

  7. Analysis of inservice inspection relief requests

    International Nuclear Information System (INIS)

    Aldrich, D.A.; Cook, J.F.

    1989-08-01

    Nuclear Regulatory Commission (NRC) regulations require inspection (ISI) of boiling or pressurized water-cooled nuclear power plants be performed in accordance with a referenced edition and addenda of Section XI, ''Rules for Inservice Inspection of Nuclear Power Plant components,'' of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code. The regulations permit licensees to request relief from the NRC from specific ASME Code requirements that are determined to be impractical for the specific licensee. The NRC evaluates these requests and may grant such relief, but the NRC may also impose alternative or augmented inspections to assure structural reliability. The purpose,of this task was to evaluate the basis for ISI nondestructive examination (NDE) relief requests and to evaluate the effect of proposed ASME Code changes that would reduce the need for such requests or provide for more complete information in relief requests. This report contains the results of an analysis of an ISI relief request data base that has been expanded to include 1195 ISI relief requests versus the 296 relief requests covered in the first report in April 1987, EGG-SD-7430. Also relief requests were added to the data base which came from both first and second 10-year inspection intervals for several facilities. This provided the means to analyze the effect of recently approved ASME Code cases and updated Code requirements, some of which have been published as a result of earlier work on this task

  8. Pain relief by touch: a quantitative approach.

    Science.gov (United States)

    Mancini, Flavia; Nash, Thomas; Iannetti, Gian Domenico; Haggard, Patrick

    2014-03-01

    Pain relief by touch has been studied for decades in pain neuroscience. Human perceptual studies revealed analgesic effects of segmental tactile stimulation, as compared to extrasegmental touch. However, the spatial organisation of touch-pain interactions within a single human dermatome has not been investigated yet. In 2 experiments we tested whether, how, and where within a dermatome touch modulates the perception of laser-evoked pain. We measured pain perception using intensity ratings, qualitative descriptors, and signal detection measures of sensitivity and response bias. Touch concurrent with laser pulses produced a significant analgesia, and reduced the sensitivity in detecting the energy of laser stimulation, implying a functional loss of information within the ascending Aδ pathway. Touch also produced a bias to judge laser stimuli as less painful. This bias decreased linearly when the distance between the laser and tactile stimuli increased. Thus, our study provides evidence for a spatial organisation of intrasegmental touch-pain interactions. Copyright © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  9. Applying photovoltaics to disaster relief

    Energy Technology Data Exchange (ETDEWEB)

    Young, W. Jr. [Florida Solar Energy Center, Cocoa, FL (United States)

    1996-11-01

    Hurricanes, floods, tornados, earthquakes and other disasters can happen at any time, often with little or no advance warning. They can be as destructive as Hurricane Andrew leaving several hundred-thousand people homeless or as minor as an afternoon thunderstorm knocking down local power lines to your home. Major disasters leave many people without adequate medical services, potable water, electrical service and communications. In response to a natural disaster, photovoltaic (solar electric) modules offer a source of quiet, safe, pollution-free electrical power. Photovoltaic (PV) power systems are capable of providing the electrical needs for vaccine refrigerators, microscopes, medical equipment, lighting, radios, fans, communications, traffic devices and other general electrical needs. Stand alone PV systems do not require refueling and operate for long period of time from the endless energy supplied by the sun, making them beneficial during recovery efforts. This report discusses the need for electrical power during a disaster, and the capability of PV to fill that need. Applications of PV power used during previous disaster relief efforts are also presented.

  10. Safety of cardiac magnetic resonance and contrast angiography for neonates and small infants: a 10-year single-institution experience

    International Nuclear Information System (INIS)

    Rangamani, Sheela; Li, Ling; Harvey, Lisa; Fletcher, Scott E.; Danford, David A.; Kutty, Shelby; Varghese, Joby; Hammel, James M.; Duncan, Kim F.

    2012-01-01

    With increasing applications of cardiac magnetic resonance (CMR) and magnetic resonance angiography (MRA) for evaluation of congenital heart disease (CHD), safety of this technology in the very young is of particular interest. We report our 10-year experience with CMR in neonates and small infants with particular focus on the safety profile and incidence of adverse events (AEs). We reviewed clinical, anesthesia and nursing records of all children ≤120 days of age who underwent CMR. We recorded variables including cardiac diagnosis, study duration, anesthesia type and agents, prostaglandin E1 (PGE1) dependence and gadolinium (Gd) use. Serially recorded temperature, systemic saturation (SpO 2 ) and cardiac rhythm were analyzed. Primary outcome measure was any AE during or 2 drop ≥10% below baseline) and bradycardia (heart rate ≤100 bpm). Secondary outcome measure was unplanned overnight hospitalization of outpatients. Children (n = 143; 74 boys, 69 girls) had a median age of 6 days (1-117), and 98 were ≤30 days at the time of CMR. The median weight was 3.4 kg (1.4-6 kg) and body surface area 0.22 m 2 (0.13-0.32 m 2 ). There were 118 (83%) inpatients (108 receiving intensive care) and 25 (17%) outpatients. Indications for CMR were assessment of aortic arch (n = 57), complex CHD (n = 41), pulmonary veins (n = 15), vascular ring (n = 8), intracardiac mass (n = 8), pulmonary artery (n = 7), ventricular volume (n = 4), and systemic veins (n = 3). CMR was performed using a 1.5-T scanner and a commercially available coil. CMR utilized general anesthesia (GA) in 86 children, deep sedation (DS) in 50 and comforting methods in seven. MRA was performed in 136 children. Fifty-nine children were PGE1-dependent and 39 had single-ventricle circulation. Among children on PGE1, 43 (73%) had GA and 10 (17%) had DS. Twelve children (9%) had adverse events (AEs) - one major and 11 minor. Of those 12, nine children had GA (10%) and three had DS (6%). The single major AE was

  11. Safety of cardiac magnetic resonance and contrast angiography for neonates and small infants: a 10-year single-institution experience

    Energy Technology Data Exchange (ETDEWEB)

    Rangamani, Sheela; Li, Ling; Harvey, Lisa; Fletcher, Scott E.; Danford, David A.; Kutty, Shelby [University of Nebraska College of Medicine/Creighton University School of Medicine, Joint Division of Pediatric Cardiology, Omaha, NE (United States); Varghese, Joby [Children' s Hospital and Medical Center, Division of Pediatric Cardiac Anesthesia, Omaha, NE (United States); Hammel, James M.; Duncan, Kim F. [Children' s Hospital and Medical Center, Division of Cardiothoracic Surgery, Omaha, NE (United States)

    2012-11-15

    With increasing applications of cardiac magnetic resonance (CMR) and magnetic resonance angiography (MRA) for evaluation of congenital heart disease (CHD), safety of this technology in the very young is of particular interest. We report our 10-year experience with CMR in neonates and small infants with particular focus on the safety profile and incidence of adverse events (AEs). We reviewed clinical, anesthesia and nursing records of all children {<=}120 days of age who underwent CMR. We recorded variables including cardiac diagnosis, study duration, anesthesia type and agents, prostaglandin E1 (PGE1) dependence and gadolinium (Gd) use. Serially recorded temperature, systemic saturation (SpO{sub 2}) and cardiac rhythm were analyzed. Primary outcome measure was any AE during or <24 h after the procedure, including minor AEs such as hypothermia (axillary temperature {<=}95 F), desaturation (SpO{sub 2} drop {>=}10% below baseline) and bradycardia (heart rate {<=}100 bpm). Secondary outcome measure was unplanned overnight hospitalization of outpatients. Children (n = 143; 74 boys, 69 girls) had a median age of 6 days (1-117), and 98 were {<=}30 days at the time of CMR. The median weight was 3.4 kg (1.4-6 kg) and body surface area 0.22 m{sup 2} (0.13-0.32 m{sup 2}). There were 118 (83%) inpatients (108 receiving intensive care) and 25 (17%) outpatients. Indications for CMR were assessment of aortic arch (n = 57), complex CHD (n = 41), pulmonary veins (n = 15), vascular ring (n = 8), intracardiac mass (n = 8), pulmonary artery (n = 7), ventricular volume (n = 4), and systemic veins (n = 3). CMR was performed using a 1.5-T scanner and a commercially available coil. CMR utilized general anesthesia (GA) in 86 children, deep sedation (DS) in 50 and comforting methods in seven. MRA was performed in 136 children. Fifty-nine children were PGE1-dependent and 39 had single-ventricle circulation. Among children on PGE1, 43 (73%) had GA and 10 (17%) had DS. Twelve children (9%) had

  12. Pharmacokinetics and Safety of a Single Oral Dose of Mirogabalin in Japanese Subjects With Varying Degrees of Renal Impairment.

    Science.gov (United States)

    Kato, Manabu; Tajima, Naoyuki; Shimizu, Takako; Sugihara, Masahiro; Furihata, Kenichi; Harada, Kazuhiro; Ishizuka, Hitoshi

    2018-01-01

    Mirogabalin (DS-5565) is a novel preferentially selective α 2 δ-1 ligand being developed for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia. The current multicenter open-label study determined the effect of varying degrees of renal impairment on the pharmacokinetics and safety of a single dose of mirogabalin 5 mg in Japanese subjects. A total of 30 subjects (6 subjects per renal function category [normal, mild, moderate, or severe impairment; and end-stage renal disease (ESRD)]) were enrolled and completed the study. The AUC last increased with severity of renal impairment; the geometric least-squares mean ratios of AUC last compared with subjects with normal renal function were 1.3, 1.9, 3.6, and 5.3 for patients with mild, moderate, and severe impairment and ESRD, respectively. In accordance with this AUC last increase, apparent total body clearance (CL/F), renal clearance (CLr), and the cumulative percentage of mirogabalin dose excreted into urine all decreased with severity of renal impairment. There were no deaths and no severe treatment-related adverse events (TEAEs), serious TEAEs, or TEAEs resulting in study discontinuation. Mirogabalin was well tolerated in Japanese subjects with normal renal function and those with mild to severe renal impairment. It was also tolerated in subjects with ESRD but with a higher incidence of TEAEs. The most frequently reported TEAEs were dizziness (ESRD, n = 3), somnolence (ESRD, n = 2), and vomiting (ESRD, n = 2). Based on these data, a mirogabalin dose adjustment will be considered in Japanese subjects with moderate to severe renal impairment and those with ESRD. © 2017, The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  13. TranQuill sling snoreplasty for snoring: A single-arm pilot study for safety and effectiveness.

    Science.gov (United States)

    Murphey, Alexander W; Nguyen, Shaun A; Fuller, Colin; Weber, Aimee C; Camilon, Marc P; Gillespie, M Boyd

    2016-01-01

    Determine safety and efficacy of the TranQuill Sling Snoreplasty (TSS) (Surgical Specialties Corp., Vancouver, BC, Canada) for the treatment of snoring in adults with benign snoring or mild obstructive sleep apnea. Prospective, unblinded, single-center pilot study. From February 2014 to July 2014, 20 adult patients with chronic, disruptive snoring assessed by bed partner were recruited to undergo TSS. Subjects with apnea hypopnea index 85%, and body mass index (BMI) snoring, pain visual analog scales, WatchPAT (Itamar Medical Ltd, Caesarea Ind. Park, Israel) home sleep studies, and flexible endoscopy at baseline and 90-day follow-up. Thirteen males and seven females were enrolled. Average age was 49.1 (range 31-67) and BMI of 25.8 ± 2.66. TranQuill Sling Snoreplasty significantly reduced snoring symptom scores from 8.70 ± 4.27 to 6.42 ± 4.14, P = 0.012. Snoring visual analog scores demonstrated reduction of 17.8 mm (59.4 mm ± 22.1 to 41.6 mm ± 29.2), P = 0.0184. Thirty-five percent (7/20) of subjects reported complications related to the trial, with no serious adverse events. TranQuill Sling Snoreplasty is a safe therapy that improves snoring symptoms in most adult subjects with benign snoring or mild sleep apnea. Further study is required to better identify patients likely to respond to the therapy. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

  14. Efficacy and safety of topical depigmenting agent in healthy human fair skin female volunteers: A single-arm study.

    Science.gov (United States)

    Shah, Saurabh; Chew, Soon-Keong

    2017-11-28

    Skin hyperpigmentation is the darkening of skin due to the increased production of melanin in the body. To evaluate the efficacy and safety of a botanical-based Rosa E pigmentation serum in healthy fair skin female volunteers with wrinkles, skin tone, and pigmentation. This was a single-arm, open label study conducted in healthy Indian females; 18 subjects aged 30-55, having fair Caucasian-like skin with at least 2 dark skin pigments with facial wrinkles diagnosed by dermatologist were selected. Rosa E pigmentation serum was applied twice a day for 84 days. Effect was evaluated by (i) instrumental technique (spectrophotometer ® 2600D), (ii) clinically by dermatologist regarding product efficacy (skin tone, antiwrinkle, pigmentation), and (iii) volunteers self-evaluation. The L* value of spectrophotometer reading represents lightness in the skin pigment. Reduction in the pigment was reported from day 14, with significant reductions observed till day 84 compared with baseline. Significant (P < .0001) skin pigmentation lightening was seen on day 14 (1.11) vastly improving on day 84 (1.94) based on photographic assessments. The significant reduction in skin pigment was 76.85%, Felix von Luschan skin color score was 30.24% (P < .0001) with a 7.38-fold reduction in skin tone and 57% reduction in facial wrinkles at day 84 from baseline. Rosa E pigmentation serum was found safe and effective in significant reduction in skin pigments, improvement of skin tone, and antiwrinkle properties instrumentally, clinically, and self-evaluation by volunteers. In these evaluations, best results were seen the longer the Rosa E was used. © 2017 Wiley Periodicals, Inc.

  15. Laparoscopic Adhesiolysis and Relief of Chronic Pelvic Pain

    OpenAIRE

    Nezhat, Farr R.; Crystal, Ruth Ann; Nezhat, Ceana H.; Nezhat, Camran R.

    2000-01-01

    Objective: To evaluate the short- and long-term results of laparoscopic enterolysis in patients with chronic pelvic pain following hysterectomy. Methods: Forty-eight patients were evaluated at time intervals from 2 weeks to 5 years after laparoscopic enterolysis. Patients were asked to rate postoperative relief of their pelvic pain as complete/near complete relief (80-100% pain relief), significant relief (50-80% pain relief), or less than 50% or no pain relief. Results: We found that after 2...

  16. Safety, efficacy and pharmacokinetics of rVIII-SingleChain in children with severe hemophilia A: results of a multicenter clinical trial.

    Science.gov (United States)

    Stasyshyn, O; Djambas Khayat, C; Iosava, G; Ong, J; Abdul Karim, F; Fischer, K; Veldman, A; Blackman, N; St Ledger, K; Pabinger, I

    2017-04-01

    Essentials rVIII-SingleChain is a novel recombinant factor VIII with covalently bonded heavy and light chains. Efficacy, safety and pharmacokinetics were studied in pediatric patients with severe hemophilia A. Across all prophylaxis regimens, the median annualized spontaneous bleeding rate was 0.00. rVIII-SingleChain showed excellent hemostatic efficacy and a favorable safety profile. Background rVIII-SingleChain is a novel B-domain truncated recombinant factor VIII (rFVIII) comprised of covalently bonded FVIII heavy and light chains, demonstrating a high binding affinity to von Willebrand factor. Objectives This phase III study investigated the safety, efficacy and pharmacokinetics of rVIII-SingleChain in previously treated pediatric patients hemophilia A. Patients/Methods Patients could be assigned to prophylaxis or on-demand therapy by the investigator. For patients assigned to prophylaxis, the treatment regimen and dose were based on the bleeding phenotype. For patients receiving on-demand therapy, dosing was guided by World Federation of Hemophilia recommendations. The primary endpoint was treatment success, defined as a rating of 'excellent' or 'good' on the investigator's clinical assessment of hemostatic efficacy for all treated bleeding events. Results The study enrolled 84 patients (0 to 50 EDs. In the 347 bleeds treated and evaluated by the investigator, hemostatic efficacy was rated as excellent or good in 96.3%. The median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.00, 2.20), and the median annualized bleeding rate was 3.69 (Q1, Q3: 0.00, 7.20) across all prophylaxis regimens. No participant developed an inhibitor. Conclusions rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy and a favorable safety profile in a clinical study in children hemophilia A. © 2017 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and

  17. Levels of reflective thinking and patient safety: an investigation of the mechanisms that impact on student learning in a single cohort over a 5 year curriculum.

    Science.gov (United States)

    Ambrose, Lucy J; Ker, Jean S

    2014-08-01

    Existing research into learning about patient safety focuses on identifying how educational interventions improve educational outcomes but few studies offer evidence that inform educators about the mechanisms involved in learning about patient safety. The current evidence based in undergraduates is also limited to outcomes that relate to knowledge and skills. A realist approach involving three cycles of data collection in a single cohort of students over 5 years used different outcomes in Kirkpatrick's framework to identify the mechanisms that influence students learning about patient safety. Data source 1. Focus groups identified an overarching theoretical model of the mechanisms that influence patient safety learning for medical students. Data source 2 Identified if the mechanisms from data source 1 could be demonstrated at the outcome level of knowledge and attitudes. Data source 3 Established associations between mechanisms and outcomes at skills and behavioural level, in a standardised simulated ward setting. Data source 1: The interpretation of data from seven focus groups involving sixty students identified reflection at two levels of Mezirow's descriptions; reflection and critical reflection as mechanisms that influence learning about error. Data source 2: Sixty-one students participated. The associations found, reflection and knowledge of actions to take for patient safety, r = 0.44 (P = 0.00) and critical reflection and intentions regarding patient safety, r = 0.40 (P = 0.00) Data source 3: Forty-eight students participated. The correlation identified associations between critical reflection and planned changes following feedback was, r = 0.48 (P = 0.00) and reflection and knowledge based errors r = -0.30 (P = 0.03). A realist approach identified two different levels of reflection were associated with different patient safety outcomes for this cohort of students. Critical reflection was associated with attitudes and reflection was associated with

  18. Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study

    Directory of Open Access Journals (Sweden)

    Disala Fernando

    2017-08-01

    Interpretation: These data suggest that similar oxytocin systemic exposure can be achieved with IM and IH administration routes, and no safety concerns were identified with either route. The inhalation route may offer the opportunity to increase access to oxytocin for women giving birth in resource-poor settings.

  19. 30 CFR 18.28 - Devices for pressure relief, ventilation, or drainage.

    Science.gov (United States)

    2010-07-01

    ... drainage. 18.28 Section 18.28 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... Construction and Design Requirements § 18.28 Devices for pressure relief, ventilation, or drainage. (a) Devices..., or drainage shall be constructed of materials that resist corrosion and distortion, and be so...

  20. Effect of tegaserod on quality of life and symptom relief in women ...

    African Journals Online (AJOL)

    Background: Tegaserod is a promotility agent with proven efficacy and safety in patients with irritable bowel syndrome with constipation (IBS-C). AIM: Assess tegaserod's effect on quality of life (QOL) and symptom relief in South African patients. Methods: Women >18 years old meeting Rome II criteria for IBS-C were enrolled ...

  1. U.S. Coastal Relief Model

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  2. U.S. Coastal Relief Model - Hawaii

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  3. Shaded Relief of Minnesota Elevation - Black & White

    Data.gov (United States)

    Minnesota Department of Natural Resources — This file is a product of a shaded relief process on the 30 meter resolution Digital Elevation Model data (dem30im3). This image was created using a custom AML...

  4. Brain Circuits Encoding Reward from Pain Relief.

    Science.gov (United States)

    Navratilova, Edita; Atcherley, Christopher W; Porreca, Frank

    2015-11-01

    Relief from pain in humans is rewarding and pleasurable. Primary rewards, or reward-predictive cues, are encoded in brain reward/motivational circuits. While considerable advances have been made in our understanding of reward circuits underlying positive reinforcement, less is known about the circuits underlying the hedonic and reinforcing actions of pain relief. We review findings from electrophysiological, neuroimaging, and behavioral studies supporting the concept that the rewarding effect of pain relief requires opioid signaling in the anterior cingulate cortex (ACC), activation of midbrain dopamine neurons, and the release of dopamine in the nucleus accumbens (NAc). Understanding of circuits that govern the reward of pain relief may allow the discovery of more effective and satisfying therapies for patients with acute or chronic pain.

  5. Non-Drug Pain Relief: Imagery

    Science.gov (United States)

    PATIENT EDUCATION patienteducation.osumc.edu Non-Drug Pain Relief: Imagery Relaxation helps lessen tension. One way to help decrease pain is to use imagery. Imagery is using your imagination to create a ...

  6. Supply Chain Management in Humanitarian Relief Logistics

    National Research Council Canada - National Science Library

    Rodman, William

    2004-01-01

    Hundreds of millions of people are affected by disasters each year. This thesis explores the use of supply chain management techniques to overcome the barriers encountered by logistics managers during humanitarian relief operations...

  7. Seeking Allergy Relief: When Breathing Becomes Bothersome

    Science.gov (United States)

    ... Issues Subscribe June 2016 Print this issue Seeking Allergy Relief When Breathing Becomes Bothersome En español Send ... Preschoolers Benefit from Peanut Allergy Therapy Wise Choices Allergy Symptoms Runny or stuffy nose Sneezing Itchy nose, ...

  8. Shaded Relief of Minnesota Elevation - Color

    Data.gov (United States)

    Minnesota Department of Natural Resources — This file is a product of a shaded relief process on the 30 meter resolution Digital Elevation Model data (dem30im3). This image was created using a custom AML...

  9. Antidiarrheal Medicines: OTC Relief for Diarrhea

    Science.gov (United States)

    ... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

  10. Lake Bathymetric DEM Shaded Relief Image

    Data.gov (United States)

    Minnesota Department of Natural Resources — Geo-referenced, shaded relief image of lake bathymetry classified at 5-foot depth intervals. This dataset has a cell resolution of 5 meters (occasionally 10m) as...

  11. Evaluating acute pain intensity relief: challenges when using an 11-point numerical rating scale.

    Science.gov (United States)

    Chauny, Jean-Marc; Paquet, Jean; Lavigne, Gilles; Marquis, Martin; Daoust, Raoul

    2016-02-01

    Percentage of pain intensity difference (PercentPID) is a recognized way of evaluating pain relief with an 11-point numerical rating scale (NRS) but is not without flaws. A new metric, the slope of relative pain intensity difference (SlopePID), which consists in dividing PercentPID by the time between 2 pain measurements, is proposed. This study aims to validate SlopePID with 3 measures of subjective pain relief: a 5-category relief scale (not, a little, moderate, very, complete), a 2-category relief question ("I'm relieved," "I'm not relieved"), and a single-item question, "Wanting other medication to treat pain?" (Yes/No). This prospective cohort study included 361 patients in the emergency department who had an initial acute pain NRS > 3 and a pain intensity assessment within 90 minutes after analgesic administration. Mean age was 50.2 years (SD = 19.3) and 59% were women. Area under the curves of receiver operating characteristic curves analyses revealed similar discriminative power for PercentPID (0.83; 95% confidence interval [CI], 0.79-0.88) and SlopePID (0.82; 95% CI, 0.77-0.86). Considering the "very" category from the 5-category relief scale as a substantial relief, the average cutoff for substantial relief was a decrease of 64% (95% CI, 59-69) for PercentPID and of 49% per hour (95% CI, 44-54) for SlopePID. However, when a cutoff criterion of 50% was used as a measure of pain relief for an individual patient, PercentPID underestimated pain-relieved patients by 12.1% (P pain intensity at baseline was an odd number compared with an even number (32.9% vs 45.0%, respectively). SlopePID should be used instead of PercentPID as a metric to evaluate acute pain relief on a 0 to 10 NRS.

  12. Clinical efficacy and safety of a pharmacopial polyherbal Unani formulation in pityriasis versicolor: a comparative randomized single-blind study.

    Science.gov (United States)

    Lone, Azad Hussain; Ahmad, Tanzeel; Anwar, Mohd; Sofi, G

    2012-10-01

    Pityriasis versicolor (PV) is a common superficial fungal infection of skin caused by the fungus, Malassezia furfur. It can occur at any age but occurs mainly during adolescence and typically presents with hypopigmented or hyperpigmented scaling plaques, generally on the trunk and upper arms. It often poses a therapeutic challenge. In the Unani system of medicine, many herbal drugs are used empirically for its treatment. The objective of this study was to evaluate safety and efficacy of a topical Polyherbal Unani formulation in the management of PV on scientific parameters. This was a randomized, single-blind, standard controlled study. This study was performed in the Dermatology Outpatient Department, National Institute of Unani Medicine, Bangalore, India. Forty-six (46) patients with PV were included in the study after taking informed consents and were randomly allocated to test and control groups. In the test group, a polyherbal formulation was advised for topical application while in the control group, sodium thiosulphate lotion (20%) was advised locally for a duration of 1 month. The assessment of the severity of PV and efficacy of treatment in both groups was carried out using the Total Sign and Symptom Score (TSSS) scale. Data were analyzed with the Instat Graph pad. The mean±standard error of the mean (SEM) scores of TSSS in the test group were 7.7±1.174 and 0.9±0.7881 before and after treatment, respectively, while it was 6.9±0.8756 and 1.2±0.7888 in the control group before and after treatment, respectively. Mean±SEM of TSSS of both groups was found to be significantly lowered (p<0.001) after treatment when compared with mean±SEM of TSSS before treatment. However, the polyherbal formulation showed precedence over the standard drug by exhibiting comparatively quicker response. Furthermore, no unpleasant side-effects were observed in the test group during and after the study. This study concluded that polyherbal Unani formulation is safe, effective

  13. A safety assessment of rotary mode core sampling in flammable gas single shell tanks: Hanford Site, Richland, Washington

    Energy Technology Data Exchange (ETDEWEB)

    Raymond, R.E.

    1996-04-15

    This safety assessment (SA) addresses each of the required elements associated with the installation, operation, and removal of a rotary-mode core sampling (RMCS) device in flammable-gas single-shell tanks (SSTs). The RMCS operations are needed in order to retrieve waste samples from SSTs with hard layers of waste for which push-mode sampling is not adequate for sampling. In this SA, potential hazards associated with the proposed action were identified and evaluated systematically. Several potential accident cases that could result in radiological or toxicological gas releases were identified and analyzed and their consequences assessed. Administrative controls, procedures and design changes required to eliminate or reduce the potential of hazards were identified. The accidents were analyzed under nine categories, four of which were burn scenarios. In SSTS, burn accidents result in unacceptable consequences because of a potential dome collapse. The accidents in which an aboveground burn propagates into the dome space were shown to be in the ``beyond extremely unlikely`` frequency category. Given the unknown nature of the gas-release behavior in the SSTS, a number of design changes and administrative controls were implemented to achieve these low frequencies. Likewise, drill string fires and dome space fires were shown to be very low frequency accidents by taking credit for the design changes, controls, and available experimental and analytical data. However, a number of Bureau of Mines (BOM) tests must be completed before some of the burn accidents can be dismissed with high confidence. Under the category of waste fires, the possibility of igniting the entrapped gases and the waste itself were analyzed. Experiments are being conducted at the BOM to demonstrate that the drill bit is not capable of igniting the trapped gas in the waste. Laboratory testing and thermal analysis demonstrated that, under normal operating conditions, the drill bit will not create high

  14. A safety assessment of rotary mode core sampling in flammable gas single shell tanks: Hanford Site, Richland, Washington

    International Nuclear Information System (INIS)

    Raymond, R.E.

    1996-01-01

    This safety assessment (SA) addresses each of the required elements associated with the installation, operation, and removal of a rotary-mode core sampling (RMCS) device in flammable-gas single-shell tanks (SSTs). The RMCS operations are needed in order to retrieve waste samples from SSTs with hard layers of waste for which push-mode sampling is not adequate for sampling. In this SA, potential hazards associated with the proposed action were identified and evaluated systematically. Several potential accident cases that could result in radiological or toxicological gas releases were identified and analyzed and their consequences assessed. Administrative controls, procedures and design changes required to eliminate or reduce the potential of hazards were identified. The accidents were analyzed under nine categories, four of which were burn scenarios. In SSTS, burn accidents result in unacceptable consequences because of a potential dome collapse. The accidents in which an aboveground burn propagates into the dome space were shown to be in the ''beyond extremely unlikely'' frequency category. Given the unknown nature of the gas-release behavior in the SSTS, a number of design changes and administrative controls were implemented to achieve these low frequencies. Likewise, drill string fires and dome space fires were shown to be very low frequency accidents by taking credit for the design changes, controls, and available experimental and analytical data. However, a number of Bureau of Mines (BOM) tests must be completed before some of the burn accidents can be dismissed with high confidence. Under the category of waste fires, the possibility of igniting the entrapped gases and the waste itself were analyzed. Experiments are being conducted at the BOM to demonstrate that the drill bit is not capable of igniting the trapped gas in the waste. Laboratory testing and thermal analysis demonstrated that, under normal operating conditions, the drill bit will not create high

  15. Safety and pharmacokinetics of single and multiple intravenous bolus doses of diclofenac sodium compared with oral diclofenac potassium 50 mg: A randomized, parallel-group, single-center study in healthy subjects.

    Science.gov (United States)

    Munjal, Sagar; Gautam, Anirudh; Okumu, Franklin; McDowell, James; Allenby, Kent

    2016-01-01

    In a randomized, parallel-group, single-center study in 42 healthy adults, the safety and pharmacokinetic parameters of an intravenous formulation of 18.75 and 37.5 mg diclofenac sodium (DFP-08) following single- and multiple-dose bolus administration were compared with diclofenac potassium 50 mg oral tablets. Mean AUC0-inf values for a 50-mg oral tablet and an 18.75-mg intravenous formulation were similar (1308.9 [393.0]) vs 1232.4 [147.6]). As measured by the AUC, DFP-08 18.75 mg and 37.5 mg demonstrated dose proportionality for extent of exposure. One subject in each of the placebo and DFP-08 18.75-mg groups and 2 subjects in the DFP-08 37.5-mg group reported adverse events that were considered by the investigator to be related to the study drug. All were mild in intensity and did not require treatment. Two subjects in the placebo group and 1 subject in the DFP-08 18.75-mg group reported grade 1 thrombophlebitis; no subjects reported higher than grade 1 thrombophlebitis after receiving a single intravenous dose. The 18.75- and 37.5-mg doses of intravenous diclofenac (single and multiple) were well tolerated for 7 days. Additional efficacy and safety studies are required to fully characterize the product. © 2015, The American College of Clinical Pharmacology.

  16. 46 CFR 64.65 - Vacuum relief device.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Vacuum relief device. 64.65 Section 64.65 Shipping COAST... HANDLING SYSTEMS Pressure Relief Devices and Vacuum Relief Devices for MPTs § 64.65 Vacuum relief device. (a) Each MPT that is designed for an external pressure of less than 7.5 psig must have a vacuum...

  17. Safety of ferric carboxymaltose immediately after infliximab administration, in a single session, in inflammatory bowel disease patients with iron deficiency: a pilot study.

    Directory of Open Access Journals (Sweden)

    Xavier Cortes

    Full Text Available To obtain preliminary safety and efficacy data on intravenous (IV administration of infliximab (IFX and ferric carboxymaltose (FCM to inflammatory bowel disease (IBD patients in a single treatment session.A two-phase non-interventional, observational, prospective pilot study was performed to evaluate safety and efficacy of FCM given immediately after IFX. IBD patients were recruited consecutively in the outpatient clinic in two groups. Control group patients (n = 12 received FCM on a separate day from IFX. Subsequently, single-session group patients (n = 33 received FCM after IFX on the same day. All patients received 5mg/kg IFX and 1000mg FCM for iron-restricted anemia (IRA or 500mg FCM for iron deficiency without anemia. Safety assessment was performed by recording adverse events (AEs during and immediately after infusion, 30 minutes afterwards, and via follow-up at 7 days and 8 weeks. For efficacy assessment, hematological parameters were assessed prior to FCM infusion (pre-FCM and after 8 weeks. Economic impact of FCM given immediately after IFX was assessed.All 45 patients (35 Crohn´s disease, 10 ulcerative colitis received IFX 5mg/kg. 21 patients received 500mg FCM and 24 received 1000mg. FCM administration immediately after IFX corrected iron deficiency or IRA as shown by increases in hematological parameters. No AEs were reported during the safety evaluation at the end of FCM or IFX administration, 30 minutes, 7 days and 8 weeks afterwards, in either control or single-session groups. Total cost per patient for single-session administration was 354.63€; for patients receiving IFX and FCM on separate days, it was 531.94€, giving a 177.31€ per-patient cost saving.Single-session administration of FCM after IFX was safe and effective in IBD patients and can offer a good cost-benefit ratio and improve treatment adherence. To our knowledge, this study is the first to evaluate FCM and IFX administration in a single treatment session.

  18. Comparisons of Safety and Clinical Outcomes Between Multiple-level and Single-level Cervical Disk Replacement for Cervical Spondylosis: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Jiang, Lianghai; Tan, Mingsheng; Yang, Feng; Yi, Ping; Tang, Xiangsheng; Hao, Qingying

    2016-12-01

    This is a systematic review and meta-analysis. The aim of this study was to evaluate the efficacy and safety of multiple-level cervical disk replacement (CDR) over single-level CDR for the treatment of cervical spondylosis. Some authors advocate for the multiple-level CDR instead of anterior decompression and fusion in cervical multiple-level spondylosis. However, whether the efficacy and safety of multi-level CDR are as favorable as that of single-level CDR remains controversial. MEDLINE, EMBASE, and Cochrane library databases were searched up to November 2015 for controlled studies that compared the clinical outcomes of single-level and multiple-level CDR for the treatment of cervical spondylosis. The following outcomes were extracted and analyzed: prevalence of heterotopic ossification and reoperation, preoperative and postoperative Neck Disability Index scores, preoperative and postoperative Visual Analog Scale scores, and success rate using the Odom grading system. Ten studies involving 1402 patients were included: including 3 randomized controlled trials, 5 prospective studies, and 3 retrospective studies. No significant differences between single-level and multiple-level groups were found in terms of the prevalence of heterotopic ossification and reoperation rate, Neck Disability Index score, Visual Analog Scale score, and success rate using the Odom grading system. On the basis of this meta-analysis, clinical outcomes of multiple-level CDR are similar to those of single-level CDR for cervical spondylosis, which suggests the multiple-level CDR is as effective and safe as the single-level CDR. Nonetheless, more well-designed studies are needed for further evaluation.

  19. Efficacy and safety of a new microneedle patch for skin brightening: A Randomized, split-face, single-blind study.

    Science.gov (United States)

    Park, Kui Young; Kwon, Hyun Jung; Lee, Changjin; Kim, Daegun; Yoon, Jun Jin; Kim, Myeong Nam; Kim, Beom Joon

    2017-09-01

    Although microneedles are one of the best transdermal drug delivery systems for active compounds, few clinical trials have examined the safety and efficacy of brightening microneedle patches. To determine the efficacy and safety of a newly developed whitening microneedle patch. A split-face study was designed for efficacy assessment with 34 Korean women applying the tested product (a whitening microneedle patch) on one cheek and a control whitening essence on the other. We objectively measured changes in melanin index values and skin brightness by mexameter and chromameter. Each participant also used global assessment to determine skin whitening. In addition, 55 participants were selected for primary skin irritation tests and repeated insult patch tests for safety assessments. Mean skin brightness and melanin indexes improved (Pmicroneedle patch was effective and safe for skin brightening and would be a promising functional cosmetic product. © 2017 Wiley Periodicals, Inc.

  20. Glovebox pressure relief and check valve

    International Nuclear Information System (INIS)

    Blaedel, K.L.

    1986-01-01

    This device is a combined pressure relief valve and check valve providing overpressure protection and preventing back flow into an inert atmosphere enclosure. The pressure relief is embodied by a submerged vent line in a mercury reservior, the releif pressure being a function of the submerged depth. The pressure relief can be vented into an exhaust system and the relieving pressure is only slightly influenced by the varying pressure in the exhaust system. The check valve is embodied by a ball which floats on the mercury column and contacts a seat whenever vacuum exists within the glovebox enclosure. Alternatively, the check valve is embodied by a vertical column of mercury, the maximum back pressure being a function of the height of the column of mercury

  1. Glovebox pressure relief and check valve

    Energy Technology Data Exchange (ETDEWEB)

    Blaedel, K.L.

    1986-03-17

    This device is a combined pressure relief valve and check valve providing overpressure protection and preventing back flow into an inert atmosphere enclosure. The pressure relief is embodied by a submerged vent line in a mercury reservior, the releif pressure being a function of the submerged depth. The pressure relief can be vented into an exhaust system and the relieving pressure is only slightly influenced by the varying pressure in the exhaust system. The check valve is embodied by a ball which floats on the mercury column and contacts a seat whenever vacuum exists within the glovebox enclosure. Alternatively, the check valve is embodied by a vertical column of mercury, the maximum back pressure being a function of the height of the column of mercury.

  2. A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

    Science.gov (United States)

    Hettema, Willem; Wynne, Christopher; Lang, Benjamin; Altendorfer, Mario; Czeloth, Niklas; Lohmann, Ragna; Athalye, Sandeep; Schliephake, Dorothee

    2017-08-01

    This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche). Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early. The primary end point was area under the concentration-time curve (AUC) of the analyte in plasma from time zero extrapolated to infinity (AUC 0-∞ ). Other pharmacokinetic (PK) parameters, safety, and in vitro binding affinity were also evaluated. The interim analysis demonstrated three-way bioequivalence for all comparisons. The confidence intervals around the geometric mean ratios of the primary and secondary PK parameters were within the predefined acceptance ranges. Study drugs were well tolerated with no clinically relevant differences in safety. BI 695502 and US- and EU-approved Avastin showed three-way bioequivalence with similar safety profile. NCT01608087.

  3. Optimal Laser Phototherapy Parameters for Pain Relief.

    Science.gov (United States)

    Kate, Rohit J; Rubatt, Sarah; Enwemeka, Chukuka S; Huddleston, Wendy E

    2018-03-27

    Studies on laser phototherapy for pain relief have used parameters that vary widely and have reported varying outcomes. The purpose of this study was to determine the optimal parameter ranges of laser phototherapy for pain relief by analyzing data aggregated from existing primary literature. Original studies were gathered from available sources and were screened to meet the pre-established inclusion criteria. The included articles were then subjected to meta-analysis using Cohen's d statistic for determining treatment effect size. From these studies, ranges of the reported parameters that always resulted into large effect sizes were determined. These optimal ranges were evaluated for their accuracy using leave-one-article-out cross-validation procedure. A total of 96 articles met the inclusion criteria for meta-analysis and yielded 232 effect sizes. The average effect size was highly significant: d = +1.36 (confidence interval [95% CI] = 1.04-1.68). Among all the parameters, total energy was found to have the greatest effect on pain relief and had the most prominent optimal ranges of 120-162 and 15.36-20.16 J, which always resulted in large effect sizes. The cross-validation accuracy of the optimal ranges for total energy was 68.57% (95% CI = 53.19-83.97). Fewer and less-prominent optimal ranges were obtained for the energy density and duration parameters. None of the remaining parameters was found to be independently related to pain relief outcomes. The findings of meta-analysis indicate that laser phototherapy is highly effective for pain relief. Based on the analysis of parameters, total energy can be optimized to yield the largest effect on pain relief.

  4. Efficacy and safety of rVIII-SingleChain: results of a phase 1/3 multicenter clinical trial in severe hemophilia A

    Science.gov (United States)

    Mahlangu, Johnny; Kuliczkowski, Kazimierz; Karim, Faraizah Abdul; Stasyshyn, Oleksandra; Kosinova, Marina V.; Lepatan, Lynda Mae; Skotnicki, Aleksander; Boggio, Lisa N.; Klamroth, Robert; Oldenburg, Johannes; Hellmann, Andrzej; Santagostino, Elena; Baker, Ross I.; Fischer, Kathelijn; Gill, Joan C.; P’Ng, Stephanie; Chowdary, Pratima; Escobar, Miguel A.; Khayat, Claudia Djambas; Rusen, Luminita; Bensen-Kennedy, Debra; Blackman, Nicole; Limsakun, Tharin; Veldman, Alex; St. Ledger, Katie

    2016-01-01

    Recombinant VIII (rVIII)-SingleChain is a novel B-domain–truncated recombinant factor VIII (rFVIII), comprised of covalently bonded factor VIII (FVIII) heavy and light chains. It was designed to have a higher binding affinity for von Willebrand factor (VWF). This phase 1/3 study investigated the efficacy and safety of rVIII-SingleChain in the treatment of bleeding episodes, routine prophylaxis, and surgical prophylaxis. Participants were ≥12 years of age, with severe hemophilia A (endogenous FVIII <1%). The participants were allocated by the investigator to receive rVIII-SingleChain in either an on-demand or prophylaxis regimen. Of the 175 patients meeting study eligibility criteria, 173 were treated with rVIII-SingleChain, prophylactically (N = 146) or on-demand (N = 27). The total cumulative exposure was 14 306 exposure days (EDs), with 120 participants reaching ≥50 EDs and 52 participants having ≥100 EDs. Hemostatic efficacy was rated by the investigator as excellent or good in 93.8% of the 835 bleeds treated and assessed. Across all prophylaxis regimens, the median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.0, 2.4) and the median overall annualized bleeding rate (ABR) was 1.14 (Q1, Q3: 0.0, 4.2). Surgical hemostasis was rated as excellent/good in 100% of major surgeries by the investigator. No participant developed FVIII inhibitors. In conclusion, rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy in surgery and in the control of bleeding events, low ABR in patients on prophylaxis, and a favorable safety profile in this large clinical study. This trial was registered at www.clinicaltrials.gov as #NCT01486927. PMID:27330001

  5. A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

    2015-11-30

    Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is

  6. Adequacy of Flood Relief Shelters: A Case Study in Perak, Malaysia

    Science.gov (United States)

    Zawani Zahari, Nur; Mustafa Hashim, Ahmad

    2018-03-01

    The recent flood event occurred in 2014 had caused disastrous effects in Peninsular Malaysia in states of Kelantan, Pahang, Terengganu, Perak, Johor and Perlis. Perak state was reported with 12,115 victims from 2,896 families registered at 77 relief shelters. There are several issues encountered by the victims and related agencies which caused inconveniences and interruptions during the flooding period. Besides, the usage of public buildings as relief shelters contributes to deterioration of the infrastructures whereby their suitability, convenient, capacity and safety might not be optimum for longer period of time. This paper focuses on the assessment of relief shelters established in Perak Tengah district, Perak. Standards and guidelines for relief shelters were reviewed according to the most relevant agreed principles for humanitarian response. Data and information in this study were obtained from survey activities, interview sessions and observations. In Perak Tengah, more than 50% of the previous relief shelters were public buildings with low capacity areas. Strategic location of shelters with proper design standards should be established to ensure safe and healthy environment for the victims. Findings from this paper provide important outcomes to serve as better preparation in handling future disaster.

  7. Adequacy of Flood Relief Shelters: A Case Study in Perak, Malaysia

    Directory of Open Access Journals (Sweden)

    Zahari Nur Zawani

    2018-01-01

    Full Text Available The recent flood event occurred in 2014 had caused disastrous effects in Peninsular Malaysia in states of Kelantan, Pahang, Terengganu, Perak, Johor and Perlis. Perak state was reported with 12,115 victims from 2,896 families registered at 77 relief shelters. There are several issues encountered by the victims and related agencies which caused inconveniences and interruptions during the flooding period. Besides, the usage of public buildings as relief shelters contributes to deterioration of the infrastructures whereby their suitability, convenient, capacity and safety might not be optimum for longer period of time. This paper focuses on the assessment of relief shelters established in Perak Tengah district, Perak. Standards and guidelines for relief shelters were reviewed according to the most relevant agreed principles for humanitarian response. Data and information in this study were obtained from survey activities, interview sessions and observations. In Perak Tengah, more than 50% of the previous relief shelters were public buildings with low capacity areas. Strategic location of shelters with proper design standards should be established to ensure safe and healthy environment for the victims. Findings from this paper provide important outcomes to serve as better preparation in handling future disaster.

  8. Emergency networking: famine relief in ant colonies

    NARCIS (Netherlands)

    Sendova-Franks, A.B.; Hayward, R.; Wulf, B.; Klimek, T.; James, R.; Planque, R.; Britton, N.F.; Franks, N.R.

    2009-01-01

    Resource distribution is fundamental to social organization, but it poses a dilemma. How to facilitate the spread of useful resources but restrict harmful substances? This dilemma reaches a zenith in famine relief. Survival depends on distributing food fast but that could increase vulnerability to

  9. Pain Relief in Nonhuman Primate Models of Arthritis.

    Science.gov (United States)

    Vierboom, Michel P M; Breedveld, Elia; Keehnen, Merei; Klomp, Rianne; Bakker, Jaco

    2017-01-01

    Animal models of rheumatoid arthritis are important in the elucidation of etiopathogenic mechanisms of the disease and for the development of promising new therapies. Species specificity of new biological compounds and their mode of action preclude safety and efficacy testing in rodent models of disease. Nonhuman primates (NHP) can fill this niche and provide the only relevant model. Over the last two decades models of collagen-induced arthritis (CIA) were developed in the rhesus monkey and the common marmoset. However, NHP are higher-order animals and complex sentient beings. So especially in models where pain is an intricate part of the disease, analgesia needs to be addressed because of ethical considerations. In our model, a morphine-based pain relief was used that does not interfere with the normal development of disease allowing us to evaluate important mechanistic aspects of the arthritis.

  10. Efficacy and safety of a single oral 150 mg dose of fluconazole for the treatment of vulvovaginal candidiasis in Japan.

    Science.gov (United States)

    Mikamo, Hiroshige; Matsumizu, Miyako; Nakazuru, Yoshiomi; Okayama, Akifumi; Nagashima, Masahito

    2015-07-01

    Vulvovaginal candidiasis is the second most common cause of vaginal infections following bacterial vaginosis. For the treatment of vulvovaginal candidiasis, antifungal agents are used either as topical (vaginal tablets and cream) or oral formulations. A single oral 150 mg dose of fluconazole has been recommended as the standard therapy for uncomplicated, acute vulvovaginal candidiasis in global guidelines; however, in Japan oral fluconazole therapy has not been approved. We conducted a phase 3 study to evaluate the efficacy and safety of a single oral 150 mg dose of fluconazole in Japanese subjects with vulvovaginal candidiasis for regulatory submission. A total of 157 subjects received a single oral 150 mg dose of fluconazole. Candida species (104 strains) were identified by fungal culture from 102 subjects at baseline, including Candida albicans (100 strains). The efficacy rate for the therapeutic outcome (assessed based on a comprehensive evaluation of the clinical and mycological efficacy in each subject) was 74.7% (74/99) on Day 28 in the modified Intent-To-Treat (m-ITT) population. Concerning the clinical and mycological efficacy on Day 28 in the m-ITT population, the cure, cure or improvement, and eradication rates were 81.6%, 95.9%, and 85.9%, respectively. The most common treatment-related adverse events were diarrhea and nausea (1.9% for each). No clinically significant safety issues were reported. A single oral 150 mg dose of fluconazole demonstrated excellent therapeutic efficacy and was well tolerated in Japanese subjects with vulvovaginal candidiasis. NCT01806623. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  11. [The Red Cross System for War Relief during the Second World War and Actual Conditions of Its Efforts in Burma].

    Science.gov (United States)

    Kawahara, Yukari

    2015-12-01

    This paper aims to show the system for relief provided by the Japanese Red Cross relief units during the Second World War, as well as the actual activities of sixteen of its relief units dispatched to Burma. The Red Cross wartime relief efforts involved using personnel and funding prepared beforehand to provide aid to those injured in war, regardless of their status as ally or enemy. Thus they were able to receive support from the army in order to ensure safety and provide supplies. Nurses dispatched to Burma took care of many patients who suffered from malnutrition and physical injuries amidst the outbreak of infectious diseases typical of tropical areas, without sufficient replacement members. Base hospitals not meant for the front lines also came under attack, and the nurses' lives were thus in mortal danger. Of the 374 original members, 29 died or went missing in action.

  12. Reading, Writing and Drawing in Relief: The IPO Relief-Drawing Set.

    Science.gov (United States)

    Melotte, H. E. M.; Engel, F. L.

    1980-01-01

    The article describes an improved relief drawing set designed for use with visually impaired persons that allows durable, tangible, and visible embossed images to be made with a ball-point pen. (Author/PHR)

  13. Preliminary safety and efficacy results with robotic high-intensity focused ultrasound : A single center Indian experience

    Directory of Open Access Journals (Sweden)

    Shashikant Mishra

    2011-01-01

    Full Text Available Background : There are no Indian data of high-intensity focused ultrasound (HIFU. Being an alternative, still experimental modality, reporting short-term safety outcome is paramount. Aims : This study was aimed at to assess the safety and short-term outcome in patients with prostate cancer treated by HIFU. Settings and Design : A retrospective study of case records of 30 patients undergoing HIFU between January 2008 to September 2010 was designed and conducted. Materials and Methods : The procedural safety was analyzed at 3 months. Follow-up consisted of 3 monthly prostate-specific antigen (PSA levels and transrectal biopsy if indicated. All the patients had a minimum follow-up of 6 months. Results : A mean prostate volume of 26.9 ± 8.5 cm 3 was treated in a mean time of 115 ± 37.4 min. There was no intraoperative complication. The postoperative pain visual analogue score at day 0 was 2.1 ± 1.9 and at day 1 was 0.4 ± 0.8 on a scale of 1-10. Mean duration of perurethral catheter removal was 3.9 days. The complications after treatment were: LUTS in seven patients, stress incontinence in two, stricture in two, and symptomatic urinary tract infection in five. Average follow-up duration was 10.4 months (range, 6-20 months. Mean time to obtain PSA nadir was 6 ± 3 months with a median PSA nadir value of 0.3 ng/ml. Two patients had positive prostatic biopsy in the localized (high risk group. Conclusions : HIFU was safe in carcinoma prostate patients. The short-term results were efficacious in localized disease. The low complication rates and favorable functional outcome support the planning of further larger studies.

  14. Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3-month formulation in patients with schizophrenia: A phase-1, single-dose, randomized, open-label study.

    Science.gov (United States)

    Ravenstijn, Paulien; Remmerie, Bart; Savitz, Adam; Samtani, Mahesh N; Nuamah, Isaac; Chang, Cheng-Tao; De Meulder, Marc; Hough, David; Gopal, Srihari

    2016-03-01

    This multicenter, randomized, open-label, parallel-group, phase-1 study assessed the pharmacokinetics (PK), safety, and tolerability of the investigational intramuscular paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia or schizoaffective disorder. A total of 328 patients (men or women, aged 18-65 years) were enrolled in 1 of 4 separately conducted panels (A to D). Each panel had 2 single-dose treatment periods (period 1, 1 mg intramuscular paliperidone immediate release [IR]; period 2, intramuscular PP3M 75-525 mg eq) separated by a washout of 7-21 days. Overall, 245 of 308 (79.5%) PP3M-dosed patients completed the study. Because the PK studies of panels A and C were compromised by incomplete injection in some patients, PK data from only panels B and D are presented. Safety data from all panels are presented. Peak paliperidone plasma concentration was achieved between 23 and 34 days, and apparent half-life was ∼2-4 months. Mean plasma AUC∞ and Cmax of paliperidone appeared to be dose-proportional. Relative bioavailability in comparison with paliperidone was ∼100% independent of the dose and injection site. Headache and nasopharyngitis were the most common (>7%) treatment-emergent adverse events. Overall, safety and tolerability were similar to those of the 1-month formulation. Results support a once-every-3-months dosing interval in patients with schizophrenia or schizoaffective disorder. © 2015, The American College of Clinical Pharmacology.

  15. The beta-hCG+erythropoietin in acute stroke (BETAS) study: a 3-center, single-dose, open-label, noncontrolled, phase IIa safety trial.

    Science.gov (United States)

    Cramer, Steven C; Fitzpatrick, Camille; Warren, Michael; Hill, Michael D; Brown, David; Whitaker, Laura; Ryckborst, Karla J; Plon, Lawrence

    2010-05-01

    Animal data suggest the use of beta-human chorionic gonadotropin followed by erythropoietin to promote brain repair after stroke. The current study directly translated these results by evaluating safety of this sequential growth factor therapy through a 3-center, single-dose, open-label, noncontrolled, Phase IIa trial. Patients with ischemic stroke 24 to 48 hours old and National Institutes of Health Stroke Scale score of 6 to 24 started a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation). This study also evaluated performance of serially measured domain-specific end points. A total of 15 patients were enrolled. Two deaths occurred, neither related to study medications. No safety concerns were noted among clinical or laboratory measures, including screening for deep vein thrombosis and serial measures of serum hemoglobin. In several instances, domain-specific end points provided greater insight into impairments as compared with global outcome measures. Results support the safety of this sequential, 2-growth factor therapy initiated 24 to 48 hours after stroke onset.

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

    Science.gov (United States)

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

    2012-11-01

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

  17. Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial.

    Science.gov (United States)

    Yu, Jianchun; Wu, Guohao; Tang, Yun; Ye, Yingjiang; Zhang, Zhongtao

    2017-08-01

    Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time. This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded. In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (Δ Prealb(StudyGroup) = 2.65 mg/dL, P values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t (StudyGroup) = 4.90 ± 4.41 minutes vs t (ControlGroup) = 12.13 ± 5.62 minutes, P bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

  18. Single center prospective study of tacrolimus efficacy and safety in the treatment of various manifestations in systemic lupus erythematosus.

    Science.gov (United States)

    Suzuki, Katsuya; Kameda, Hideto; Amano, Koichi; Nagasawa, Hayato; Takei, Hirofumi; Nishi, Eiko; Okuyama, Ayumi; Tsuzaka, Kensei; Takeuchi, Tsutomu

    2011-06-01

    The aim of this study was to prospectively evaluate the efficacy and safety of tacrolimus (TAC) in various manifestations of systemic lupus erythematosus (SLE) patients in daily clinical practice. Each of the 21 TAC-treated patients with SLE in our care over 2 years was enrolled in this open-label trial. Patients were administered TAC at a dosage of 1-6 mg once daily, followed up for 24 weeks. Efficacy and safety were evaluated utilizing clinical and laboratory findings. As treatment targets, TAC was preferentially used with oral corticosteroid administration for mild active manifestations such as arthritis, skin eruptions, or asymptomatic nephritis. In efficacy, the mean value of the SLE disease activity index was significantly reduced to 4.1, 2.7, 1.8, and 1.2 (N=21, 20, 16 and 13) at 0, 4, 12, and 24 weeks, respectively. In eight cases, treatment was discontinued within 24 weeks due to insufficient effects (6 cases) and side effects (2 cases). Non-serious side effects were observed in only five cases (23.8%) over 24 weeks. TAC can be considered both effective and safe for the treatment of various manifestations of SLE.

  19. Robotic versus human camera holding in video-assisted thoracic sympathectomy: a single blind randomized trial of efficacy and safety.

    Science.gov (United States)

    Martins Rua, Joaquim Fernando; Jatene, Fabio Biscegli; de Campos, José Ribas Milanez; Monteiro, Rosangela; Tedde, Miguel Lia; Samano, Marcos Naoyuki; Bernardo, Wanderley M; Das-Neves-Pereira, João Carlos

    2009-02-01

    Our objective is to compare surgical safety and efficacy between robotic and human camera control in video-assisted thoracic sympathectomy. A randomized-controlled-trial was performed. Surgical operation was VATS sympathectomy for hyperhidrosis. The trial compared a voice-controlled robot for holding the endoscopic camera robotic group (Ro) to human assisted group (Hu). Each group included 19 patients. Sympathectomy was achieved by electrodessication of the third ganglion. Operations were filmed and images stored. Two observers quantified the number of involuntary and inappropriate movements and how many times the camera was cleaned. Safety criteria were surgical accidents, pain and aesthetical results; efficacy criteria were: surgical and camera use duration, anhydrosis, length of hospitalization, compensatory hyperhidrosis and patient satisfaction. There was no difference between groups regarding surgical accidents, number of involuntary movements, pain, aesthetical results, general satisfaction, number of lens cleaning, anhydrosis, length of hospitalization, and compensatory hyperhidrosis. The number of contacts of the laparoscopic lens with mediastinal structures was lower in the Ro group (Probotic arm in VATS sympathectomy for hyperhidrosis is as safe but less efficient when compared to a human camera-holding assistant.

  20. Safety, Tolerability, and Pharmacokinetics of SMT C1100, a 2-Arylbenzoxazole Utrophin Modulator, following Single- and Multiple-Dose Administration to Pediatric Patients with Duchenne Muscular Dystrophy.

    Directory of Open Access Journals (Sweden)

    Valeria Ricotti

    Full Text Available SMT C1100 is a utrophin modulator being evaluated as a treatment for Duchenne muscular dystrophy (DMD. This study, the first in pediatric DMD patients, reports the safety, tolerability and PK parameters of single and multiple doses of SMT C1100, as well as analyze potential biomarkers of muscle damage.This multicenter, Phase 1 study enrolled 12 patients, divided equally into three groups (A-C. Group A were given 50 mg/kg on Days 1 and 11, and 50 mg/kg bid on Days 2 to 10. Group B and C received 100 mg/kg on Days 1 and 11; Group B and Group C were given 100 mg/kg bid and 100 mg/kg tid, respectively, on Days 2 to 10. A safety review was performed on all patients following the single dose and there was at least 2 weeks between each dose escalation, for safety and PK review. Adverse events (AEs were monitored throughout the study.Most patients experienced mild AEs and there were no serious AEs. Two patients required analgesia for pain (headache, ear pain and toothache. One patient experienced moderate psychiatric AEs (abnormal behaviour and mood swings. Plasma concentrations of SMT C1100 at Days 1 and 11 indicated a high degree of patient variability regardless of dose. Unexpectedly the SMT C1100 levels were significantly lower than similar doses administered to healthy volunteers in an earlier clinical study. In general, individual baseline changes of creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase levels fell with SMT C1100 dosing.SMT C1100 was well tolerated in pediatric DMD patients.ClinicalTrials.gov NCT02383511.

  1. Safety, Tolerability, and Pharmacokinetics of SMT C1100, a 2-Arylbenzoxazole Utrophin Modulator, following Single- and Multiple-Dose Administration to Pediatric Patients with Duchenne Muscular Dystrophy.

    Science.gov (United States)

    Ricotti, Valeria; Spinty, Stefan; Roper, Helen; Hughes, Imelda; Tejura, Bina; Robinson, Neil; Layton, Gary; Davies, Kay; Muntoni, Francesco; Tinsley, Jonathon

    2016-01-01

    SMT C1100 is a utrophin modulator being evaluated as a treatment for Duchenne muscular dystrophy (DMD). This study, the first in pediatric DMD patients, reports the safety, tolerability and PK parameters of single and multiple doses of SMT C1100, as well as analyze potential biomarkers of muscle damage. This multicenter, Phase 1 study enrolled 12 patients, divided equally into three groups (A-C). Group A were given 50 mg/kg on Days 1 and 11, and 50 mg/kg bid on Days 2 to 10. Group B and C received 100 mg/kg on Days 1 and 11; Group B and Group C were given 100 mg/kg bid and 100 mg/kg tid, respectively, on Days 2 to 10. A safety review was performed on all patients following the single dose and there was at least 2 weeks between each dose escalation, for safety and PK review. Adverse events (AEs) were monitored throughout the study. Most patients experienced mild AEs and there were no serious AEs. Two patients required analgesia for pain (headache, ear pain and toothache). One patient experienced moderate psychiatric AEs (abnormal behaviour and mood swings). Plasma concentrations of SMT C1100 at Days 1 and 11 indicated a high degree of patient variability regardless of dose. Unexpectedly the SMT C1100 levels were significantly lower than similar doses administered to healthy volunteers in an earlier clinical study. In general, individual baseline changes of creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase levels fell with SMT C1100 dosing. SMT C1100 was well tolerated in pediatric DMD patients. ClinicalTrials.gov NCT02383511.

  2. Mechanical Designs for Relief Valves for Cryogenic Apparatuses and Installations

    CERN Multimedia

    CERN. Geneva

    2016-01-01

    There are also pressure relief valves with warm seat available on which the set pressure is based on an adjustment of forces by permanent magnets. Pressure vessel rules allows also the choice for an active triggered pressure relief valve (Cont...

  3. Anti-Seizure Medications: Relief from Nerve Pain

    Science.gov (United States)

    ... from other drug classes with distinct mechanisms of pain relief (such as antidepressants) may be used in combination ... disabling, but anti-seizure drugs may provide moderate pain relief. Neuropathic pain. Merck Manual Professional Version. https://www. ...

  4. Medications for Pain Relief during Labor and Delivery

    Science.gov (United States)

    ... FAQ086 LABOR, DELIVERY, AND POSTPARTUM CARE Medications for Pain Relief During Labor and Delivery • What types of medications for pain relief are used during labor and delivery? • What are ...

  5. Safety and immunogenicity of a candidate bioconjugate vaccine against Shigella dysenteriae type 1 administered to healthy adults: A single blind, partially randomized Phase I study.

    Science.gov (United States)

    Hatz, Christoph F R; Bally, Bettina; Rohrer, Susanne; Steffen, Robert; Kramme, Stefanie; Siegrist, Claire-Anne; Wacker, Michael; Alaimo, Cristina; Fonck, Veronica Gambillara

    2015-08-26

    Shigellae cause severe disease in endemic countries, especially in children. Several efficacy trials have been conducted with candidate vaccines against Shigellae, but the lack of protection, the safety concerns, or manufacturing challenges hindered successful market approval. Conjugated vaccines have been shown to be safe and effective for different pathogens (i.e., Neisseria meningitidis, Shigella pneumonia, Haemophilus influenzae). The bio-conjugation technology, exploited here for the Shigella dysenteriae candidate vaccine, offers a novel and potentially simpler way to develop and produce vaccines against one of the major causes of morbidity and mortality in developing countries. A novel S. dysenteriae bioconjugate vaccine (GVXN SD133) made of the polysaccharide component of the Shigella O1 lipopolysaccharide, conjugated to the exotoxin protein A of Pseudomonas aeruginosa (EPA), was evaluated for immunogenicity and safety in healthy adults in a single blind, partially randomized Phase I study. Forty subjects (10 in each dose group; 2 μg or 10 μg with or without aluminium adjuvant) received two injections 60 days apart and were followed-up for 150 days. Both doses and formulations were well tolerated; the safety and reactogenicity profiles were consistent with that of other conjugated vaccines, adjuvanted or not, independent of the dose and the number of injections. The GVXN SD133 vaccine elicited statistically significant O1 specific humoral responses at all time points in all vaccination groups. Between-group comparisons did not show statistically significant differences in geometric mean titers of immunoglobulin G and A at any post-vaccination time point. This study demonstrated that the GVXN SD133 vaccine has a satisfactory safety profile. It elicited a significant humoral response to Shigella O1 polysaccharides at all doses tested. The protein carrier also elicited functional antibodies, showing the technology's advantages in preserving both sugar and

  6. Compartmentalized liquid crystal alignment induced by sparse polymer ribbons with surface relief gratings.

    Science.gov (United States)

    Ji, Zhichao; Zhang, Xinzheng; Shi, Bin; Li, Wei; Luo, Weiwei; Drevensek-Olenik, Irena; Wu, Qiang; Xu, Jingjun

    2016-01-15

    We report on the liquid crystal (LC) alignment induced by sparse polymer ribbons fabricated by the two-photon polymerization-based direct laser writing method. Each ribbon is fabricated by a single scan of the laser through the photoresist and possesses surface relief gratings on both sides. The relief gratings are caused by the optical interference between the incident and reflected laser beams. With the aid of these relief gratings, LC molecules can be well aligned along the selected direction of the ribbons. LC cells with the Z-shaped and checkerboard-type microstructures are constructed based on the sparse out-of-plane polymeric ribbons. Our results show that with such polymer ribbons a compartmentalized LC alignment in the arbitrary microstructures can be realized.

  7. Single- and multiple-dose study to determine the safety, tolerability, and pharmacokinetics of ceftaroline fosamil in combination with avibactam in healthy subjects.

    Science.gov (United States)

    Riccobene, Todd A; Su, Sheng Fang; Rank, Douglas

    2013-03-01

    This study was conducted to determine the safety, tolerability, and pharmacokinetics of intravenous doses of ceftaroline fosamil administered in combination with the novel non-β-lactam β-lactamase inhibitor avibactam in healthy adults. In the single-dose, open-label arm, 12 subjects received single 1-h intravenous infusions of ceftaroline fosamil alone (600 mg), avibactam alone (600 mg), and ceftaroline fosamil in combination with avibactam (600/600 mg) separated by 5-day washout periods. In the multiple-dose, placebo-controlled, double-blind arm, 48 subjects received intravenous infusions of ceftaroline fosamil/avibactam at 600/600 mg every 12 h (q12h), 400/400 mg q8h, 900/900 mg q12h, 600/600 mg q8h, or placebo for 10 days. Ceftaroline and avibactam levels in plasma and urine were measured by liquid chromatography coupled with tandem mass spectrometry. No significant differences in systemic exposure of ceftaroline or avibactam were observed when the drugs were administered alone versus concomitantly, indicating that there was no apparent pharmacokinetic interaction between ceftaroline fosamil and avibactam administered as a single dose. No appreciable accumulation of either drug occurred with multiple intravenous doses of ceftaroline fosamil/avibactam, and pharmacokinetic parameters for ceftaroline and avibactam were similar on days 1 and 10. Infusions of ceftaroline fosamil/avibactam were well tolerated at total daily doses of up to 1,800 mg of each compound, and all adverse events (AEs) were mild to moderate in severity. Infusion-site reactions were the most common AEs reported with multiple dosing. The pharmacokinetic and safety profiles of ceftaroline fosamil/avibactam demonstrate that the 2 drugs can be administered concomitantly to provide an important broad-spectrum antimicrobial treatment option.

  8. 46 CFR 64.59 - Spring loaded pressure relief valve.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Spring loaded pressure relief valve. 64.59 Section 64.59 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MARINE PORTABLE TANKS AND CARGO HANDLING SYSTEMS Pressure Relief Devices and Vacuum Relief Devices for MPTs § 64.59 Spring...

  9. 46 CFR 64.71 - Marking of pressure relief devices.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Marking of pressure relief devices. 64.71 Section 64.71 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MARINE PORTABLE TANKS AND CARGO HANDLING SYSTEMS Pressure Relief Devices and Vacuum Relief Devices for MPTs § 64.71 Marking...

  10. 46 CFR 64.57 - Acceptance of pressure relief devices.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Acceptance of pressure relief devices. 64.57 Section 64.57 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MARINE PORTABLE TANKS AND CARGO HANDLING SYSTEMS Pressure Relief Devices and Vacuum Relief Devices for MPTs § 64...

  11. Crisis Communication Practices at an International Relief Agency

    Science.gov (United States)

    Genova, Gina L.

    2006-01-01

    When a disaster strikes, the affected population relies upon the swift response and aid rendered by relief organizations such as the California-based Direct Relief International. Since 1948, Direct Relief's mission has been to provide essential material resources to locally run health programs in areas affected by natural disasters, wars, and…

  12. Libraries and information provision for African relief

    Directory of Open Access Journals (Sweden)

    Elsemieke Wishart

    2012-09-01

    Full Text Available This research article explores the concept that libraries as communication centres in sub-Saharan Africa can play a vital role in bringing poverty relief by providing greater access to information through modern technology. It discusses the patrons who can benefit from community information centres and explores their particular needs. I have researched how modern tools like the Internet, computers, e-readers and cell phones can bring valuable information to impoverished citizens. My research was conducted through reading research papers using article databases, books and Internet websites. The future for libraries in sub-Saharan Africa is bright, as new technology opens up vast opportunities to share information in a way that is accessible, affordable and adaptable to the needs of the African people. I recommend that librarians and relief organisations in Southern Africa seriously consider using modern technology to provide information that will empower its citizens.

  13. Photobiomodulation: Implications for Anesthesia and Pain Relief.

    Science.gov (United States)

    Chow, Roberta T; Armati, Patricia J

    2016-12-01

    This review examines the evidence of neural inhibition as a mechanism underlying pain relief and anesthetic effect of photobiomodulation (PBM). PBM for pain relief has also been used for more than 30 years; however, the mechanism of its effectiveness has not been well understood. We review electrophysiological studies in humans and animal models and cell culture studies to examine neural responses to PBM. Evidence shows that PBM can inhibit nerve function in vivo, in situ, ex vivo, and in culture. Animal studies using noxious stimuli indicate nociceptor-specific inhibition with other studies providing direct evidence of local conduction block, leading to inhibited translation of pain centrally. Evidence of PBM-disrupted neuronal physiology affecting axonal flow, cytoskeleton organization, and decreased ATP is also presented. PBM changes are reversible with no side effects or nerve damage. This review provides strong evidence in neuroscience identifying inhibition of neural function as a mechanism for the clinical application of PBM in pain and anesthesia.

  14. Spatially Uniform ReliefF (SURF for computationally-efficient filtering of gene-gene interactions

    Directory of Open Access Journals (Sweden)

    Greene Casey S

    2009-09-01

    Full Text Available Abstract Background Genome-wide association studies are becoming the de facto standard in the genetic analysis of common human diseases. Given the complexity and robustness of biological networks such diseases are unlikely to be the result of single points of failure but instead likely arise from the joint failure of two or more interacting components. The hope in genome-wide screens is that these points of failure can be linked to single nucleotide polymorphisms (SNPs which confer disease susceptibility. Detecting interacting variants that lead to disease in the absence of single-gene effects is difficult however, and methods to exhaustively analyze sets of these variants for interactions are combinatorial in nature thus making them computationally infeasible. Efficient algorithms which can detect interacting SNPs are needed. ReliefF is one such promising algorithm, although it has low success rate for noisy datasets when the interaction effect is small. ReliefF has been paired with an iterative approach, Tuned ReliefF (TuRF, which improves the estimation of weights in noisy data but does not fundamentally change the underlying ReliefF algorithm. To improve the sensitivity of studies using these methods to detect small effects we introduce Spatially Uniform ReliefF (SURF. Results SURF's ability to detect interactions in this domain is significantly greater than that of ReliefF. Similarly SURF, in combination with the TuRF strategy significantly outperforms TuRF alone for SNP selection under an epistasis model. It is important to note that this success rate increase does not require an increase in algorithmic complexity and allows for increased success rate, even with the removal of a nuisance parameter from the algorithm. Conclusion Researchers performing genetic association studies and aiming to discover gene-gene interactions associated with increased disease susceptibility should use SURF in place of ReliefF. For instance, SURF should be

  15. Immunogenicity and safety of single-dose, 13-valent pneumococcal conjugate vaccine in pediatric and adolescent oncology patients.

    Science.gov (United States)

    Hung, Te-Yu; Kotecha, Rishi S; Blyth, Christopher C; Steed, Sarah K; Thornton, Ruth B; Ryan, Anne L; Cole, Catherine H; Richmond, Peter C

    2017-11-01

    Children receiving immunosuppressive treatment for cancer are at high risk for invasive pneumococcal disease. The 13-valent pneumococcal conjugate vaccine (PCV13) can prevent pneumococcal disease in healthy children; however, there is an absence of literature regarding the benefit of PCV13 in immunocompromised children with cancer. A prospective, open-label cohort study recruited children between ages 1 and 18 years who were receiving active immunosuppressive therapy (AIT) or were within 12 months after completing immunosuppressive therapy (CIT). Blood samples were taken before and 4 weeks after the administration of single-dose PCV13. Serotype-specific immunoglobulin G antibody titers were measured, and titers ≥0.35 μg/mL were considered protective. Solicited side effects were recorded in a 7-day diary after vaccination. Eighty-five children were recruited. At baseline, ≤50% had protective antibody titers against Streptococcus pneumoniae for 10 serotypes in the AIT group and for 8 serotypes in the CIT group. Postvaccination, ≥70% had protective antibody titers for 9 and 11 serotypes in the AIT and CIT groups, respectively. Both groups had comparable responses to PCV7 serotypes, whereas a significantly higher proportion in the CIT group achieved protective antibody titers to PCV13 serotypes. There was a low rate of serious adverse events (3.5%). A single-dose of PCV13 is safe and immunogenic in children diagnosed with cancer. All children who are receiving therapy for cancer should receive a single dose of PCV13 as soon as possible after diagnosis, regardless of prior PCV exposure. The current data support the recommendation for an additional dose of PCV13 after the completion of immunosuppressive therapy to provide additional protection against invasive pneumococcal disease. Cancer 2017;123:4215-4223. © 2017 American Cancer Society. © 2017 American Cancer Society.

  16. Assessment of the efficacy and safety of single platelet-rich plasma injection on different types and grades of facial wrinkles.

    Science.gov (United States)

    Elnehrawy, Naema Y; Ibrahim, Zeinab A; Eltoukhy, Azza M; Nagy, Hala M

    2017-03-01

    Platelet-rich plasma (PRP) is considered as a growing modality for tissue regeneration and a developing research area for clinicians and researchers. PRP injection treatment provides supraphysiological concentrations of growth factors that may help in accelerated tissue remodeling and regeneration. To evaluate the efficacy and safety of single autologous PRP intradermal injection for treatment of facial wrinkles and for facial rejuvenation. A total of 20 subjects with different types of facial wrinkles were included in this study. All subjects received single PRP intradermal injection and were clinically assessed before and after treatment for a period of 8 weeks using Wrinkle Severity Rating Scale (WSRS), Skin Homogeneity and Texture (SHnT) Scale, Physician Assessment Scale, and Subject Satisfaction Scale. The mean value of WSRS reduced from 2.90 ± 0.91 before treatment to 2.10 ± 0.79 after 8 weeks of treatment. The most significant results were with younger subjects that have mild and moderate wrinkles of the nasolabial folds (NLFs). Fourteen of seventeen subjects with NLFs showed more than 25% improvement in their appearance. Side effects of PRP treatment were minimal to mild and with excellent tolerability. Single PRP intradermal injection is well tolerated and capable of rejuvenating the face and producing a significant correction of wrinkles especially the NLFs. © 2016 Wiley Periodicals, Inc.

  17. Safety and Efficacy of Single-site Phacotrabeculectomy With Mitomicin C Using Nylon and Polyglactin Suture for Scleral Tunnel Closure.

    Science.gov (United States)

    Vijaya, Lingam; David, Rathini L

    2015-01-01

    To evaluate the efficacy of polyglactin use along with nylon suture in scleral tunnel closure after single-site phacotrabeculectomy. This retrospective case series included 139 eyes of 139 patients who had scleral tunnel closure with 1 polyglactin and 1 nylon suture after single-site phacotrabeculectomy with a low dose of mitomycin C between 2002 and 2005. The intraocular pressure (IOP), the visual acuity, the number of glaucoma medications, postoperative complications, and interventions were the outcomes measured. The majority of them had primary open-angle glaucoma (93 eyes, 67%), 93 eyes (67%) had severe glaucomatous optic neuropathy, and 77 eyes (55.3%) had severe visual-field loss. The IOP decreased from a mean preoperative value of 18.1±5.3 mm Hg on a mean number of 1.8±0.8 glaucoma medications to mean IOPs of 13.3±4.6, 14.0±4.3, and 11.8±3.9 mm Hg on a mean number of 0.2±0.6, 0.3±0.7, 0.5±1.0 glaucoma medications (PNylon suturelysis with laser was performed in 16 eyes (11.5%). The technique used here seems to be effective in controlling the IOP and has very minimal associated complications.

  18. Single and multiple exposure tolerance study of polystyrene sulfonate gel: a Phase I safety and colposcopy study

    Science.gov (United States)

    Mauck, Christine K.; Weiner, Debra H.; Ballagh, Susan A.; Creinin, Mitchell D.; Archer, David F.; Schwartz, Jill L.; Pymar, Helen C.; Lai, Jaim-Jou; Rencher, William F.; Callahan, Marianne M.

    2010-01-01

    Objectives To evaluate symptoms and signs of genital irritation, vaginal leakage and acceptability of polystyrene sulfonate (PSS), which is being studied as a vaginal contraceptive and microbicide. Methods Forty-nine women applied 2.5 mL of either 5% PSS, 10% PSS, PSS vehicle, or Conceptrol® (a marketed spermicidal product containing 4% nonoxynol-9) for 6 consecutive days. Results All women completed the study except one in the Conceptrol group who experienced vaginal symptoms after her first use and was discontinued. After both the first use and after all uses, irritation was seen among more women in the Conceptrol group than in the PSS groups, reaching statistical significance with regard to any evidence of irritation, signs of irritation and product-related irritation. There were no adverse events that were serious, unexpected and related to product use in any group. The 5% concentration of PSS may be preferable in terms of leakage and acceptability. Conclusion The results suggest that PSS has a safety profile comparable to that of the marketed nonoxynol-9 product, Conceptrol, and appears to be associated with less genital irritation. PMID:15208057

  19. Time Headway Modelling of Motorcycle-Dominated Traffic to Analyse Traffic Safety Performance and Road Link Capacity of Single Carriageways

    Directory of Open Access Journals (Sweden)

    D. M. Priyantha Wedagama

    2017-04-01

    Full Text Available This study aims to develop time headway distribution models to analyse traffic safety performance and road link capacities for motorcycle-dominated traffic in Denpasar, Bali. Three road links selected as the case study are Jl. Hayam Wuruk, Jl.Hang Tuah, and Jl. Padma. Data analysis showed that between 55%-80% of motorists in Denpasar during morning and evening peak hours paid less attention to the safe distance with the vehicles in front. The study found that Lognormal distribution models are best to fit time headway data during morning peak hours while either Weibull (3P or Pearson III distributions is for evening peak hours. Road link capacities for mixed traffic predominantly motorcycles are apparently affected by the behaviour of motorists in keeping safe distance with the vehicles in front. Theoretical road link capacities for Jl. Hayam Wuruk, Jl. Hang Tuah and Jl. Padma are 3,186 vehicles/hour, 3,077 vehicles/hour and 1935 vehicles/hour respectively.

  20. [Safety Evaluation of Rare Sugar Syrup: Single-dose Oral Toxicity in Rats, Reverse Mutation Assay, Chromosome Aberration Assay, and Acute Non-Effect Level for Diarrhea of a Single Dose in Humans].

    Science.gov (United States)

    Yamada, Takako; Iida, Tetsuo; Takamine, Satoshi; Hayashi, Noriko; Okuma, Kazuhiro

    2015-01-01

    The safety of rare sugar syrup obtained from high-fructose corn syrup under slightly alkaline conditions was studied. Mutagenicity of rare sugar syrup was assessed by a reverse mutation assay using Salmonella typhimurium and Escherichia coli, and an in vitro chromosomal aberration assay using Chinese hamster lung cell line (CHL/IU). No mutagenicity of rare sugar syrup was detected under these experimental conditions. Oral administration of single dose (15,000 mg/kg) of rare sugar syrup to rats caused no abnormalities, suggesting no adverse effect of rare sugar syrup. In humans, the acute non-effect level of rare sugar syrup for causing diarrhea was estimated as 0.9 g/kg body weight as dry solid base in both males and females.

  1. Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of an Omega-3-Carboxylic Acid Formulation in Healthy Male Japanese Subjects: A Phase 1 Single-Blind, Randomized, Placebo-Controlled Trial.

    Science.gov (United States)

    Noda, Yoshinori; Nilsson, Catarina; Shimada, Hitoshi; Kim, Hyosung; Lundström, Torbjörn; Yajima, Toshitaka

    2018-02-01

    OM3-CA (omega-3-carboxylic acids) is a complex mixture of omega-3 carboxylic acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is approved in the United States for the treatment of hypertriglyceridemia. As part of its clinical development in Japan, we performed a phase 1 study to investigate the safety, tolerability, and pharmacokinetics after single and multiple doses of OM3-CA in healthy male Japanese subjects. Eighteen Japanese subjects were allocated to receive 2 or 4 g/day OM3-CA, or placebo (n = 6 per group). In addition, 6 white subjects received 4 g/day OM3-CA. The primary objective was to determine the safety and tolerability of OM3-CA. Plasma concentrations of EPA and DHA were adjusted for baseline values for pharmacokinetic analysis. Overall, OM3-CA was well tolerated in healthy Japanese subjects. Two Japanese subjects in each group and 5 white subjects experienced adverse events (AEs). Alanine aminotransferase increase was the most common AE in Japanese subjects, also seen with placebo, and diarrhea was the most common AE in white subjects. The maximum plasma concentrations of EPA and DHA were observed 5-6 hours postdose. The pharmacokinetic profiles of EPA and DHA after administration of OM3-CA were comparable between Japanese and white subjects. © 2017, The American College of Clinical Pharmacology.

  2. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate After Single-dose Administration in Healthy Korean Male Subjects.

    Science.gov (United States)

    Kim, Yun; Kim, Anhye; Lee, SeungHwan; Choi, Sung-Hak; Lee, Dae Young; Song, Ji-Su; Lee, Howard; Jang, In-Jin; Yu, Kyung-Sang

    2017-09-01

    Tedizolid phosphate is a next-generation oxazolidinone prodrug that is transformed into the active moiety tedizolid. Its indication is acute bacterial skin and skin structure infections caused by gram-positive species, including methicillin-resistant Staphylococcus aureus. Although tedizolid phosphate has been marketed in Korea, no data on the pharmacokinetic (PK) properties or tolerability of tedizolid phosphate in Korean subjects are available. This study was designed to evaluate the PK properties, oral bioavailability, and tolerability with a single-dose oral and intravenous administration of tedizolid phosphate in healthy Korean male subjects. A block-randomized, double-blind, placebo-controlled, single-dose study was conducted in 3 groups (200, 400, and 600 mg; 10 subjects in each group). In the second part of the study, subjects from the 200-mg group received administration orally and intravenously (1-hour infusion) via 2-way crossover for the evaluation of absolute bioavailability. There was a 7-day washout period between treatments in the absolute bioavailability part of the study. Serial blood samples for PK analysis were collected for up to 72 hours. Tolerability was assessed by analysis of adverse events. Thirty healthy Korean subjects completed the study and were included in the PK and tolerability analyses. Tedizolid phosphate was rapidly converted into tedizolid. After a single oral dose, the T max of tedizolid was observed to be 1.5 to 2.5 hours, and the plasma concentration-time curve of tedizolid showed a 2-phase elimination pattern, with a half-life of ~11 hours. Dose-dependent increases were observed in the AUC last value (29,441-78,062 μg · h/L) and in the C max value ( 2679-6980 μg/L) with the administration of tedizolid phosphate 200 to 600 mg PO. The absolute bioavailability of tedizolid was 95.2% (90% CI, 92.7%-97.8%) in the 200-mg administration group. There were no serious adverse events or clinically significant changes in the

  3. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45.

    Science.gov (United States)

    McCarty, James M; Lock, Michael D; Hunt, Kristin M; Simon, Jakub K; Gurwith, Marc

    2018-02-01

    The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera diarrhea in volunteer challenge studies. We performed a phase 3, placebo controlled, double blind, multi-center study to further assess the safety, immunogenicity, and lot-to-lot consistency of PXVX0200. Adult volunteers 18-45 years of age were randomized 8:1 to receive a single dose of 1 × 10 9 CFU of PXVX0200 from three production lots or saline placebo. Immunogenicity endpoints included SVA and anti-cholera toxin (CT) antibody levels on days 1, 11, 29, 91 and 181. Safety was assessed by comparing solicited signs and symptoms on days 1-8, unsolicited adverse events through day 29 and serious adverse events through day 181. A total of 3146 participants were enrolled, including 2795 vaccine and 351 placebo recipients. The SVA seroconversion rates at day 11 were 94% and 4% in the PXVX0200 and placebo recipients, respectively (P < .0001). Cumulative SVA seroconversion occurred among 96% of vaccine recipients. PXVX0200 SVA GMTs peaked on day 11 and remained significantly higher than placebo through day 181 while the fold-rise over baseline in PXVX0200 anti-CT antibody was significantly greater than placebo at every post-vaccination time point. Most reactogenicity was mild and resolved within 1-3 days with headache and diarrhea more frequently reported in PXVX0200 recipients. There were no differences in unsolicited adverse events and no study-related serious adverse events. Immunogenicity and safety endpoints were equivalent between the three production lots. PXVX0200 is immunogenic and well tolerated across multiple production lots. Clinicaltrials.gov NCT02094586. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Feasibility and Safety of a Powered Exoskeleton for Assisted Walking for Persons With Multiple Sclerosis: A Single-Group Preliminary Study.

    Science.gov (United States)

    Kozlowski, Allan J; Fabian, Michelle; Lad, Dipan; Delgado, Andrew D

    2017-07-01

    To examine the feasibility, safety, and secondary benefit potential of exoskeleton-assisted walking with one device for persons with multiple sclerosis (MS). Single-group longitudinal preliminary study with 8-week baseline, 8-week intervention, and 4-week follow-up. Outpatient MS clinic, tertiary care hospital. Participants (N=13; age range, 38-62y) were mostly women with Expanded Disability Status Scale scores ranging from 5.5 to 7.0. Exoskeleton-assisted walk training. Primary outcomes were accessibility (enrollment/screen pass), tolerability (completion/dropout), learnability (time to event for standing, walking, and sitting with little or no assistance), acceptability (satisfaction on the device subscale of the Quebec User Evaluation of Satisfaction with Assistive Technology version 2), and safety (event rates standardized to person-time exposure in the powered exoskeleton). Secondary outcomes were walking without the device (timed 25-foot walk test and 6-minute walk test distance), spasticity (Modified Ashworth Scale), and health-related quality of life (Patient-Reported Outcomes Measurement and Information System pain interference and Quality of Life in Neurological Conditions fatigue, sleep disturbance, depression, and positive affect and well-being). The device was accessible to 11 and tolerated by 5 participants. Learnability was moderate, with 5 to 15 sessions required to walk with minimal assistance. Safety was good; the highest adverse event rate was for skin issues at 151 per 1000 hours' exposure. Acceptability ranged from not very satisfied to very satisfied. Participants who walked routinely improved qualitatively on sitting, standing, or walking posture. Two participants improved and 2 worsened on ≥1 quality of life domain. The pattern of spasticity scores may indicate potential benefit. The device appeared feasible and safe for about a third of our sample, for whom routine exoskeleton-assisted walking may offer secondary benefits. Copyright

  5. Efficacy and safety of apatinib as second-line therapy for advanced gastric cancer: a single-center observational study.

    Science.gov (United States)

    Zhang, Yong; Gou, Miaomiao; Han, Chun; Li, Juan; Wang, Lijie; Qiao, Qian; Hu, Yi; Bai, Li; Liu, Zhefeng

    2017-12-05

    Apatinib has been proven to be effective and safe among patients in the third-line treatment of advanced gastric cancer in phase II and III trials. We aimed to evaluate its efficacy and safety in second-line practice, and to explore the factors associated with efficacy. Between April 2015 and May 2017, a total of 23 patients with advanced gastric adenocarcinoma or adenocarcinoma of gastroesophageal junction were enrolled and followed up retrospectively after failing the first line of systemic therapy. The median progression-free survival was 4.43 months (95% confidence interval: 1.63-7.22) and the median overall survival was 9.11 months (95% confidence interval: 8.22-9.99). Two patients achieved a partial response and 14 patients achieved stable disease. The disease control rate was 69.6% and the objective response rate was 8.7%. The most common adverse events over grade 3 were hypertension (8.7%) and thrombocytopenia (8.7%). No treatment-related death was documented during the drug administration. Apatinib is an effective regimen for the second-line treatment of advanced gastric and gastroesophageal cancer with manageable toxicity.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/.

  6. Long-term safety and stability of angiogenesis induced by balanced single-vector co-expression of PDGF-BB and VEGF164 in skeletal muscle

    Science.gov (United States)

    Gianni-Barrera, Roberto; Burger, Maximilian; Wolff, Thomas; Heberer, Michael; Schaefer, Dirk J.; Gürke, Lorenz; Mujagic, Edin; Banfi, Andrea

    2016-01-01

    Therapeutic angiogenesis by growth factor delivery is an attractive treatment strategy for ischemic diseases, yet clinical efficacy has been elusive. The angiogenic master regulator VEGF-A can induce aberrant angiogenesis if expressed above a threshold level. Since VEGF remains localized in the matrix around expressing cells, homogeneous dose distribution in target tissues is required, which is challenging. We found that co-expression of the pericyte-recruiting factor PDGF-BB at a fixed ratio with VEGF from a single bicistronic vector ensured normal angiogenesis despite heterogeneous high VEGF levels. Taking advantage of a highly controlled gene delivery platform, based on monoclonal populations of transduced myoblasts, in which every cell stably produces the same amount of each factor, here we rigorously investigated a) the dose-dependent effects, and b) the long-term safety and stability of VEGF and PDGF-BB co-expression in skeletal muscle. PDGF-BB co-expression did not affect the normal angiogenesis by low and medium VEGF doses, but specifically prevented vascular tumors by high VEGF, yielding instead normal and mature capillary networks, accompanied by robust arteriole formation. Induced angiogenesis persisted unchanged up to 4 months, while no tumors appeared. Therefore, PDGF-BB co-expression is an attractive strategy to improve safety and efficacy of therapeutic angiogenesis by VEGF gene delivery. PMID:26882992

  7. Safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in healthy Japanese subjects.

    Science.gov (United States)

    Sarashina, Akiko; Koiwai, Kazuki; Seman, Leo J; Yamamura, Norio; Taniguchi, Atsushi; Negishi, Takahiro; Sesoko, Shogo; Woerle, Hans J; Dugi, Klaus A

    2013-01-01

    This randomized, placebo-controlled within dose groups, double-blind, single rising dose study investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of 1 mg to 100 mg doses of empagliflozin in 48 healthy Japanese male subjects. Empagliflozin was rapidly absorbed, reaching peak levels in 1.25 to 2.50 h; thereafter, plasma concentrations declined in a biphasic fashion, with mean terminal elimination half-life ranging from 7.76 to 11.7 h. Increase in empagliflozin exposure was proportional to dose. Oral clearance was dose independent and ranged from 140 to 172 mL/min. In the 24 h following 100 mg empagliflozin administration, the mean (%CV) amount of glucose excreted in urine was 74.3 (17.1) g. The amount and the maximum rate of glucose excreted via urine increased with dose of empagliflozin. Nine adverse events, all of mild intensity, were reported by 8 subjects (7 with empagliflozin and 1 with the placebo). No hypoglycemia was reported. In conclusion, 1 mg to 100 mg doses of empagliflozin had a good safety and tolerability profile in healthy Japanese male subjects. Exposure to empagliflozin was dose proportional. The amount and rate of urinary glucose excretion were higher with empagliflozin than with the placebo, and increased with empagliflozin dose.

  8. The safety and efficacy of high dose ferric carboxymaltose in patients with chronic kidney disease: A single center study

    Directory of Open Access Journals (Sweden)

    S Vikrant

    2015-01-01

    Full Text Available Ferric carboxymaltose (FCM is a parenteral, dextran-free iron formulation designed to overcome the limitations of existing intravenous (IV iron preparations. We investigated the safety and efficacy of high dose administration of FCM in our anemic chronic kidney disease (CKD patients. It was a prospective observational study from June 2011 to August 2013. FCM was administered as IV infusion 1000 mg in 250 ml of normal saline over 15-30 min. Efficacy was evaluated by comparing the Hb and/or serum iron status at the first follow-up visit after the infusion with that at the baseline. A total of 500 infusions were administered to 450 patients. All patients had a successful administration of the FCM. None of the patients had any serious drug-related AE. AE of mild to moderate severity observed or reported after the infusion were: accelerated hypertension (0.2%, feeling abnormal (0.6%, headache and bodyaches (0.6% each, and infusion site reaction (0.8%. 261 patients had a follow up Hb, which showed an increase of 1.7 ± 1.5 g/dl after a period of 11 ± 7.2 weeks (P = 0.001; 188 (72% patients had a rise in Hb of ≥1 g/dl. The increase in Hb was observed uniformly across all stages of CKD. Proportions of patients with an Hb of above 10 and 11 g/dl increased from 30.2% to 62.8% and 16.1% to 37.9%, respectively (P = 0.001. Iron status evaluation done in 44 patients after a follow up period of 15.1 ± 11.5 weeks showed increases in Hb of 1.6 ± 2.2 g/dl (P = 0.001, transferrin saturation of 9.1 ± 16.9% (P = 0.001, and ferritin of 406 ± 449 ng/ml (P = 0.001. We conclude high dose administration of FCM is safe and well-tolerated. It was effective in the treatment of iron deficiency in nondialysis and peritoneal dialysis CKD patients.

  9. Efficacy and safety of the single-capsule combination of fluticasone/formoterol in patients with persistent asthma: a non-inferiority trial

    Directory of Open Access Journals (Sweden)

    Marti Antilla

    2014-12-01

    Full Text Available OBJECTIVE: Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR, fluticasone alone (FLU, and the single-capsule combination of fluticasone/formoterol (FLU/FOR on lung function in patients with mild-to-moderate persistent asthma. METHODS: This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 (in L at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use. RESULTS: We randomized 243 patients to three groups: FLU/FOR (n = 79, BUD/FOR (n = 83, and FLU (n = 81. In terms of the mean FEV1 after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: −0.06 to 0.49, whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: −0.002 to 0.52. Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (−0.06 vs. −0.002. The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations. CONCLUSIONS: The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety, making it a new treatment option for persistent asthma.

  10. A Randomized controlled trial on safety and efficacy of single intramuscular versus staggered oral dose of 600 000IU Vitamin D in treatment of nutritional rickets.

    Science.gov (United States)

    Mondal, Krishanu; Seth, Anju; Marwaha, Raman K; Dhanwal, Dinesh; Aneja, Satinder; Singh, Ritu; Sonkar, Pitambar

    2014-06-01

    Comparison of efficacy and safety of two different regimens of vitamin D-600 000 IU as a single intramuscular dose, and 60 000IU orally once a week for 10 weeks-in treatment of nutritional rickets. Children with nutritional rickets (age: 0.5-5 years, n = 61) were randomized to receive either 60 000IU vitamin D orally once a week for 10 weeks or 600 000IU single intramuscular injection. Serum calcium, phosphate, alkaline phosphatase, urinary calcium/creatinine ratio, serum 25 hydroxy vitamin D and radiological score were compared at 12-week follow-up. No difference was found in efficacy of the two regimens on comparing biochemical and radiological parameters. Serum 25 hydroxy vitamin D >100 ng/ml was found in two children in the oral group and one child in the intramuscular group. No child developed hypercalcemia or hypercalciuria after starting treatment. Staggered oral and one-time intramuscular administrations of 600 000IU vitamin D are equally effective and safe in treatment of nutritional rickets. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  11. Pharmacokinetics and Safety of DW1029M, a Botanical Drug for the Treatment of Diabetic Nephropathy, Following Single Doses in Healthy Subjects.

    Science.gov (United States)

    Kim, Yunjeong; Jeon, Ji-Young; Kim, Eun-Young; Lim, Cheol-Hee; Jang, Hwan Bong; Kim, Min-Gul

    2017-09-01

    DW1029M is a botanical extract of Morus albalinne root bark and Puerariae radix that is used for the treatment of diabetic nephropathy. This study evaluated the safety and pharmacokinetics of DW1029M following its administration in healthy Korean subjects. We conducted a randomized, open-label, single-dose, crossover phase 1 clinical study. During each period, subjects received 300, 600, or 1200 mg oral doses of DW1029M. Plasma concentrations of puerarin, daidzin, and daidzein were analyzed using a liquid chromatography-tandem mass spectrometry. Six healthy male subjects completed the study. The maximum concentration of the drug in the plasma (C max ) and area under the plasma drug concentration-time curve to the last measurable concentration (AUC last ) for puerarin, daidzin, and daidzein were assessed after oral administration of DW1029M. No serious adverse events or clinically or statistically significant adverse events associated with any of the drug levels were observed. The results of the measurement of vital signs, electrocardiogram, laboratory tests, and physical examinations indicated that no clinically significant changes occurred during this study. The DW1029M tablet was safe and well tolerated over a single dose range of 300-1200 mg. This pharmacokinetic study of a botanical drug may aid in the development of DW1029M. © 2017, The American College of Clinical Pharmacology.

  12. Safety of atrial fibrillation ablation with novel multi-electrode array catheters on uninterrupted anticoagulation-a single-center experience.

    LENUS (Irish Health Repository)

    Hayes, Christopher Ruslan

    2012-02-01

    INTRODUCTION: A recent single-center report indicated that the performance of atrial fibrillation ablation in patients on uninterrupted warfarin using a conventional deflectable tip electrode ablation catheter may be as safe as periprocedural discontinuation of warfarin and bridging with heparin. Novel multi-electrode array catheters for atrial fibrillation ablation are currently undergoing clinical evaluation. While offering the possibility of more rapid atrial fibrillation ablation, they are stiffer and necessitate the deployment of larger deflectable transseptal sheaths, and it remains to be determined if they increase the risk of cardiac perforation and vascular injury. Such potential risks would have implications for a strategy of uninterrupted periprocedural anticoagulation. METHOD AND RESULTS: We audited the safety outcomes of our atrial fibrillation ablation procedures using multi-electrode array ablation catheters in patients on uninterrupted warfarin (CHADS2 score>or=2) and in patients not on warfarin (uninterrupted aspirin). Two bleeding complications occurred in 49 patients on uninterrupted warfarin, both of which were managed successfully without longterm sequelae, and no bleeding complication occurred in 32 patients not on warfarin (uninterrupted aspirin). There were no thromboembolic events or other complication with either anticoagulant regimen. CONCLUSION: Despite the larger diameter and increased stiffness of multi-electrode array catheters and their deflectable transseptal sheaths, their use for catheter ablation in patients with atrial fibrillation on uninterrupted warfarin in this single-center experience does not appear to be unsafe, and thus, an adequately powered multicenter prospective randomized controlled trial should be considered.

  13. Technology and information sharing in disaster relief

    DEFF Research Database (Denmark)

    Bjerge, Benedikte Alkjærsig; Clark, Nathan Edward; Fisker, Peter Kielberg

    2016-01-01

    This paper seeks to examine the extent to which technological advances can enhance inter-organizational information sharing in disaster relief. Our case is the Virtual OSOCC (On-Site Operations Coordination Centre) which is a part of the Global Disaster Alert and Coordination System (GDACS) under...... the United Nations Office for Coordination of Humanitarian Affairs (UN OCHA). The online platform, which has been developing for more than a decade, provides a unique insight into coordination behaviour among disaster management agencies and individual actors. We build our study on the analysis of a complete...

  14. Music as a form of stress relief

    OpenAIRE

    Čadež, Nežka

    2014-01-01

    The aim of this paper is to find out, whether the modern music has a relaxing effect on today’s youngsters. The theoretical part will present the period of adolescence and especially all the challenges they face during this time. These challenges can represent a high amount of stress in a youngster’s life, and one of the ways of stress relief is music. In addition to having a relaxing effect, music also enables them to shape their identity and to integrate into groups of people that share the...

  15. [Body integrity identity disorder, relief after amputation].

    Science.gov (United States)

    Blom, R M; Braam, A W; de Boer-Kreeft, N; Sonnen, M P A M

    2014-01-01

    Body integrity identity disorder (BIID) is a rare condition in which a person, for no apparent physical reason, is tormented by the experience that a body-part, such as a limb, does not really belong to the body. Patients experience an intense desire for the limb to be amputated (a 'desire' formerly referred to as 'apotemnophilia'). We report on a 58-year-old male patient with BIID who froze one of his legs so that he could amputate it himself. A surgeon ultimately intervened and amputated the leg professionally. The patient was extremely relieved and was still experiencing relief at a follow-up three years later.

  16. Shaded Relief of Rio Sao Francisco, Brazil

    Science.gov (United States)

    2000-01-01

    This topographic image acquired by SRTM shows an area south of the Sao Francisco River in Brazil. The scrub forest terrain shows relief of about 400 meters (1300 feet). Areas such as these are difficult to map by traditional methods because of frequent cloud cover and local inaccessibility. This region has little topographic relief, but even subtle changes in topography have far-reaching effects on regional ecosystems. The image covers an area of 57 km x 79 km and represents one quarter of the 225 km SRTM swath. Colors range from dark blue at water level to white and brown at hill tops. The terrain features that are clearly visible in this image include tributaries of the Sao Francisco, the dark-blue branch-like features visible from top right to bottom left, and on the left edge of the image, and hills rising up from the valley floor. The San Francisco River is a major source of water for irrigation and hydroelectric power. Mapping such regions will allow scientists to better understand the relationships between flooding cycles, forestation and human influences on ecosystems.This shaded relief image was generated using topographic data from the Shuttle Radar Topography Mission. A computer-generated artificial light source illuminates the elevation data to produce a pattern of light and shadows. Slopes facing the light appear bright, while those facing away are shaded. On flatter surfaces, the pattern of light and shadows can reveal subtle features in the terrain. Shaded relief maps are commonly used in applications such as geologic mapping and land use planning.The Shuttle Radar Topography Mission (SRTM), launched on February 11, 2000, uses the same radar instrument that comprised the Spaceborne Imaging Radar-C/X-Band Synthetic Aperture Radar (SIR-C/X-SAR) that flew twice on the Space Shuttle Endeavour in 1994. The mission is designed to collect three-dimensional measurements of the Earth's surface. To collect the 3-D data, engineers added a 60-meter-long (200

  17. Relief memory consolidation requires protein synthesis within the nucleus accumbens.

    Science.gov (United States)

    Bruning, Johann E A; Breitfeld, Tino; Kahl, Evelyn; Bergado-Acosta, Jorge R; Fendt, Markus

    2016-06-01

    Relief learning refers to the association of a stimulus with the relief from an aversive event. The thus-learned relief stimulus then can induce, e.g., an attenuation of the startle response or approach behavior, indicating positive valence. Previous studies revealed that the nucleus accumbens is essential for the acquisition and retrieval of relief memory. Here, we ask whether the nucleus accumbens is also the brain site for consolidation of relief memory into a long-term form. In rats, we blocked local protein synthesis within the nucleus accumbens by local infusions of anisomycin at different time points during a relief conditioning experiment. Accumbal anisomycin injections immediately after the relief conditioning session, but not 4 h later, prevented the consolidation into long-term relief memory. The retention of already consolidated relief memory was not affected by anisomycin injections. This identifies a time window and site for relief memory consolidation. These findings should complement our understanding of the full range of effects of adverse experiences, including cases of their distortion in humans such as post-traumatic stress disorder and/or phobias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Pain relief by Cyberknife radiosurgery for spinal metastasis.

    Science.gov (United States)

    Lee, Sunyoung; Chun, Mison

    2012-01-01

    To report pain relief effect in patients with spinal metastases treated with Cyberknife® and to analyze the factors associated with pain relapse after initial pain relief. We retrospectively analyzed patients with spinal metastasis treated with stereotactic body radiosurgery between April 2007 and June 2009. A total of 57 patients with 73 lesions were available for analysis with a median follow-up of 6.8 months (range, 1-30). Pain was assessed by a verbal/visual analogue scale at each visit: from 0 to 10. Pain relief was defined as a decrease of at least three levels of the pain score without an increase in analgesic use. Complete relief was defined as no analgesics or a score 0 or 1. Pain relief was achieved in 88% of the lesions, with complete relief in 51% within 7 days from the start of radiosurgery. The median duration of pain relief was 3.2 months (range, 1-30). Pain reappeared in 16 patients (27%). Spinal cord compression (P = 0.001) and performance status (P = 0.01) were predictive of pain relapse by multivariate Cox analysis. All 6 patients treated with solitary spinal metastasis experienced pain relief; 5 of them were alive without evidence of disease at a median of 16 months (range, 7-30). As previous studies have shown, our study confirms that pain relief with spinal radiosurgery is around 90%. In particular, long-term pain relief and disease control was observed in patients with solitary spinal metastasis.

  19. Wood creosote, the principal active ingredient of seirogan, an herbal antidiarrheal medicine: a single-dose, dose-escalation safety and pharmacokinetic study.

    Science.gov (United States)

    Kuge, Tomoo; Shibata, Takashi; Willett, Michael S

    2003-11-01

    To assess the safety, tolerability and pharmacokinetics of escalating single doses of wood creosote, an herbal antidiarrheal and antispasmodic agent. Randomized, double-blind, placebo-controlled study. Clinical research center. Forty (32 men, 8 women) healthy volunteers aged 19-42 years. By random assignment, 22 men and 8 women received escalating single doses of wood creosote (45, 90, 135, 180, and 225 mg) and 10 men received placebo (for each of the five dose levels, 6 subjects received active substance and 2 subjects received placebo). Vital signs, laboratory tests, and electrocardiograms were assessed; no dose-related or clinically significant changes were noted. Serial blood samples were obtained to determine the pharmacokinetics of four major active components of wood creosote: total (conjugated plus free) guaiacol, creosol, o-cresol, and 4-ethylguaiacol. The most common adverse events were mild headache and dizziness, with no dose-related trends being apparent. Area under the concentration-time curve from time zero to infinity increased in a dose-proportional manner for total guaiacol, creosol, and o-cresol and was not assessed for total 4-ethylguaiacol owing to lack of data at the low dose level. No apparent differences by sex were noted for any of the four active components. All four components were rapidly eliminated. Single oral doses of wood creosote up to 225 mg were safe and well tolerated in healthy men and women. Also, the doses of wood creosote were rapidly absorbed, conjugated, and eliminated. Such a rapid onset and short duration of action would appear desirable in the treatment of acute nonspecific diarrhea.

  20. Iraq's Debt Relief: Procedure and Potential Implications for International Debt Relief

    National Research Council Canada - National Science Library

    Weiss, Martin A

    2009-01-01

    .... Reducing this debt to a sustainable level has been a priority of the U.S. government. Since 2003, debt relief negotiations have taken place in a variety of fora and led to the cancellation of a significant amount of Iraq's external debt...

  1. Pharmacokinetic properties and safety profile of histamine dihydrochloride injection in Chinese healthy volunteers: a phase I, single-center, open-label, randomized study.

    Science.gov (United States)

    Li, Jiapeng; Huang, Xiaojun; Wang, Qian; Jing, Shan; Jiang, Hao; Wei, Zhongna; Zang, Yannan; Liu, Yang; Zhao, Libo; Fang, Yi; Feng, Wanyu

    2015-10-01

    Histamine dihydrochloride (HDC) injection has been approved in Europe for the treatment of adults with acute myeloid leukemia, used in combination therapy with the T-cell-derived cytokine interleukin-2. Despite years of clinical applications of HDC in Europe, no data are available on its tolerability and pharmacokinetic properties in Chinese patients. The objective of this study was to determine the safety profile and pharmacokinetic properties of HDC in Chinese healthy volunteers (HVs). In this Phase I, single-center, open-label, randomized study, 20 Chinese HVs were randomized to receive a single dose of 0.5 or 1.0 mg HDC via a 10-minute subcutaneous injection. Whole-blood and urine samples were collected at designated time points after dosing. Plasma and urine concentrations of histamine and metabolite N-methyl histamine were measured using a validated HPLC-MS/MS method. Pharmacokinetic parameters were estimated through noncompartmental procedures based on concentration-time data. Adverse events and evaluation of clinical laboratory tests were used to assess the safety profile. The pharmacokinetic profile for a single-dose of 1.0 mg HDC in Chinese HVs was compared with that in Western HVs. No severe adverse events occurred in this study, and the severity of all adverse events was grade I according to the Common Terminology Criteria for Adverse Events, version 4.0. For the pharmacokinetic parameters of histamine at the 0.5-mg and 1.0-mg dose levels, t½ was 0.50 and 1.02 hours; Tmax was 0.15 and 0.14 hours; mean Cmax was 26.59 and 71.01 nmol/L; AUC0-t was 8.35 and 20.43 nmol/h/L; AUC0-∞ was 9.61 and 22.69 nmol/h/L; accumulated amount excreted in urine within 24 hours was 125.93 and 145.52 nmol; and maximum urine excretion rates were 21.85 and 38.94 nmol/h, respectively. For N-methyl histamine at the 0.5-mg and 1.0-mg dose levels, t½ was 0.58 and 0.66 hours; Tmax was 0.28 and 0.26 hours; mean Cmax was 17.01 and 23.54 nmol/L; AUC0-t was 7.72 and 17.08 nmol

  2. Comparison of the immunogenicity and safety of the purified chick embryo cell rabies vaccine manufactured in India and Germany: A randomized, single blind, multicentre, phase IV clinical study

    Science.gov (United States)

    Sampath, Gadey; Banzhoff, Angelika; Deshpande, Alaka; Malerczyk, Claudius; Arora, Ashwani Kumar; Vakil, Hoshang; Preiss, Scott

    2017-01-01

    ABSTRACT This phase IV, single blind study assessed the immunogenicity and safety of India-manufactured purified chick embryo cell rabies vaccine (PCECV), compared with a German-manufactured batch obtained by the same production process. A total of 340 participants enrolled at 2 study sites in India were randomized (1:1:1:1) in 4 groups to receive a 5-dose Essen regimen with either 1 of the 3 Indian batches (PCECV-I) or the German batch (PCECV-G), administered on Days (D) 0, 3, 7, 14 and 30. The lot-to-lot consistency of PCECV-I batches in terms of induced immune response at D14 was demonstrated. The immune response elicited by PCECV-I was shown to be non-inferior to that induced by PCECV-G, as the lower limit of the 95% confidence interval for the ratio (PCECV-I/PCECV-G) of rabies virus neutralising antibody (RVNA) geometric mean concentrations was higher than 0.5 at D14. At least 96% of participants developed adequate RVNA concentrations (≥ 0.5 IU/mL) by D14 and all achieved RVNA concentrations ≥ 0.5 IU/mL by D90. RVNA levels were comparable across all groups throughout the entire study. Solicited local and general symptoms had a similar incidence in all groups. Unsolicited adverse events (AEs) were reported by 11% of participants. Only 1 serious AE (leg fracture) was reported and was not related to vaccination. No deaths and no rabies cases were recorded during the 90 days of observation. The study showed that the 3 PCECV-I and the PCECV-G batches induced a similar immune response and had a comparable safety profile when administered according to a 5-dose schedule. PMID:28406752

  3. Assessment of the Pharmacokinetics, Pharmacodynamics, and Safety of Single Doses of TV-1106, a Long-Acting Growth Hormone, in Healthy Japanese and Caucasian Subjects.

    Science.gov (United States)

    Cohen-Barak, Orit; Barkay, Hadas; Rasamoelisolo, Michele; Butler, Kathleen; Yamada, Kazumasa; Bassan, Merav; Yoon, Esther; Spiegelstein, Ofer

    2017-07-01

    TV-1106 is a human serum albumin genetically fused to recombinant human growth hormone, designed to provide a long-acting alternative to daily growth hormone (GH) injections in patients with GH deficiency. This study investigated the pharmacokinetics, pharmacodynamics, and safety of single subcutaneous doses of TV-1106 (7.5, 15, 50, and 100 mg) in Japanese (n = 44) and caucasian (n = 44) healthy subjects. TV-1106 pharmacokinetics and pharmacodynamics were comparable in Japanese and caucasian populations. TV-1106 demonstrated relatively slow absorption (median t max , 10-30 hours) and a mean elimination half-life of 26-36 hours. Apparent clearance and volume of distribution decreased with increasing TV-1106 doses in both populations and appeared to increase more than dose proportionality across the tested doses. Insulin-like growth factor-1 (IGF-1) and IGF binding protein-3 (IGFBP-3) increased in a dose-related manner, with maximum responses observed at 33-96 and 42-109 hours, respectively. IGF-1 and IGFBP-3 returned to baseline values at 168 hours following 7.5 and 15 mg of TV-1106, and 336 hours following 50 and 100 mg of TV-1106. TV-1106 appeared safe in both populations. There was no evidence of differences in pharmacokinetics, pharmacodynamics, or safety of TV-1106 between Japanese and caucasian populations. The data also demonstrate long-acting growth hormone properties of TV-1106 and support its potential for once-weekly dosing. © 2016, The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  4. Safety and treatment outcomes of first-line pazopanib in renal cell carcinoma: A prospective observational study in a single Malaysia tertiary hospital

    Directory of Open Access Journals (Sweden)

    Azmi Nor Mohd Farez Ahmat

    2017-12-01

    Full Text Available Introduction: Pazopanib is the standard of care for metastatic renal cell carcinoma (mRCC. Previous studies on this indication were limited to patients who were selected on the basis of a fairly preserved performance status and normal organ function. Thus, the clinical trial population may not be representative of all patients seen in real-world practice. Based on these considerations, this prospective single-centre observational study was designed to evaluate the treatment outcomes and safety profile of pazopanib in Malaysian population. Patients and methods: Patients prescribed with pazopanib between June 2015 and June 2017 were recruited and followed up for 2-years or till death whichever comes first. Progression-free survival (PFS and overall survival (OS were evaluated. Multivariate and survival analysis were performed. Results: Twenty-seven patients were treated with pazopanib where 89% had clear cell histology.  Sixteen patients (59% were intermediate risk and 41% were poor risk based on Memorial Sloan Kettering Cancer Center (MSKCC criteria. All patients experienced at least one adverse event. The most common were cutaneous toxicity (92% followed by proteinuria, hypertension, diarrhoea and mucositis. Treatment interruption was needed in 15 patients. The median PFS and OS were 9.57 months and 15.5 months, respectively. In multivariate analysis, MSKCC risk score demonstrates strong predictive treatment outcome. The median PFS was 14.5 months in intermediate risk and 3.96 months in poor risk (OR: 0.2, p<0.001. However, the median OS is still immature to be reported since 63% of intermediate risk group is still alive at 2-years follow-up. Conclusion: In mRCC patients, treatment with pazopanib was effective in patients with intermediate risk group. In terms of safety, patient tolerated pazopanib quite well with mostly experienced grade 1 to 2 adverse events.

  5. Safety and immunogenicity of a single intramuscular dose of a tetanus-diphtheria toxoid (Td) vaccine (BR-TD-1001) in healthy Korean adult subjects.

    Science.gov (United States)

    Hong, Taegon; Chung, Yong-Ju; Kim, Tae-Yeon; Kim, Ik-Hwan; Choe, Yong-Kyung; Lee, Jongtae; Jeon, Sangil; Han, Seunghoon; Yim, Dong-Seok

    2015-01-01

    BR-TD-1001 was developed as a booster for the immunity maintenance of diphtheria and tetanus. The aim of this study was to evaluate the safety and immunogenicity of BR-TD-1001 (test vaccine) in comparison with placebo and an active comparator in healthy Korean adults. A randomized, double-blind, placebo-controlled, active comparator, phase I clinical trial was conducted. Fifty subjects were randomly assigned to one of 3 treatment groups in a ratio of 2:2:1, and were administered a single intramuscular dose of test vaccine, active comparator, or placebo, respectively. All subjects were monitored for 4 weeks after injection. The antibody titers of the patients 2 and 4 weeks after vaccination were compared with the baseline. The frequencies of all adverse events including adverse drug reactions in the test group were not statistically different from those of the other treatment groups (P = 0.4974, 0.3061). No serious adverse event occurred, and no subject was withdrawn from the study for safety. The seroprotection rates against both tetanus and diphtheria at 4 weeks after vaccination were over 0.95. For anti-tetanus antibody, the geometric mean titer in the test group was significantly higher than those of the other groups (P = 0.0364, 0.0033). The geometric mean titer of anti-diphtheria antibody in the test group was significantly higher than the value of the placebo (P = 0.0347) while it was not for the value of the active comparator (P = 0.8484). In conclusion, BR-TD-1001 was safe, well-tolerated, and showed sufficient immunogenicity as a booster for diphtheria and tetanus.

  6. [Efficacy and safety of deferasirox in aplastic anemia patients with iron overload: a single arm, multi-center,prospective study in China].

    Science.gov (United States)

    Shi, Jun; Chang, Hong; Zhang, Li; Shao, Yinqi; Nie, Neng; Zhang, Jing; Huang, Jinbo; Zhang, Li; Tang, Xudong; Quan, Richeng; Zheng, Chunmei; Xiao, Haiyan; Hu, Dengming; Hu, Lingyan; Liu, Feng; Zhou, Yongming; Zheng, Yizhou; Zhang, Fengkui

    2016-01-01

    To explore the efficacy and safety of deferasirox in aplastic anemia (AA)patients with iron overload. A single arm, multi- center, prospective, open- label study was conducted to evaluate absolute change in serum ferritin (SF)from baseline to 12 months of deferasirox administration, initially at a dose of 20 mg·kg(-1)·d(-1), and the safety in 64 AA patients with iron overload. All patients started their deferasirox treatment with a daily dose of 20 mg · kg(-1) ·d(-1). The mean actual dose was (18.6±3.60) mg · kg(-1)·d(-1). The median SF decreased from 4 924 (2 718- 6 765)μg/L at baseline (n=64) to 3 036 (1 474- 5 551)μg/L at 12 months (n=23) with the percentage change from baseline as 38%. A median SF decrease of 651 (126-2 125)μg/L was observed at the end of study in 23 patients who completed 12 months' treatment, the median SF level decreased by 1 167(580-4 806)μg/L [5 271(3 420-8 278)μg/L at baseline; 3 036(1 474-5 551)μg/L after 12 months' treatment; the percentage change from baseline as 42% ] after 12 months of deferasirox treatment. The most common adverse events (AEs) were increased serum creatinine levels (40.98%), gastrointestinal discomfort (40.98%), elevated liver transaminase (ALT: 21.31%; AST: 13.11%)and proteinuria (24.59%). The increased serum creatinine levels were reversible and non-progressive. Of 38 patients with concomitant cyclosporine use, 12(31.8%)patients had two consecutive values >ULN, 10(26.3%)patients had two consecutive values >1.33 baseline values, but only 1(2.6%)patient's serum creatinine increased more than 1.33 baseline values and exceeded ULN. For both AST and ALT, no patients experienced two post- baseline values >5 ×ULN or >10 × ULN during the whole study. In AA patients with low baseline PLT count (less than 50 × 10(9)/L), there was no decrease for median PLT level during 12 months' treatment period. AA patients with iron overload could achieve satisfactory efficacy of iron chelation by deferasirox treatment

  7. Azithromycin To Prevent Bronchopulmonary Dysplasia in Ureaplasma-Infected Preterm Infants: Pharmacokinetics, Safety, Microbial Response, and Clinical Outcomes with a 20-Milligram-per-Kilogram Single Intravenous Dose

    Science.gov (United States)

    Othman, Ahmed A.; Hassan, Hazem E.; Eddington, Natalie D.; Abebe, Elias; Terrin, Michael L.; Kaufman, David A.; Waites, Ken B.

    2013-01-01

    Ureaplasma respiratory tract colonization is associated with bronchopulmonary dysplasia (BPD) in preterm infants. Previously, we demonstrated that a single intravenous (i.v.) dose of azithromycin (10 mg/kg of body weight) is safe but inadequate to eradicate Ureaplasma spp. in preterm infants. We performed a nonrandomized, single-arm open-label study of the pharmacokinetics (PK) and safety of intravenous 20-mg/kg single-dose azithromycin in 13 mechanically ventilated neonates with a gestational age between 24 weeks 0 days and 28 weeks 6 days. Pharmacokinetic data from 25 neonates (12 dosed with 10 mg/kg i.v. and 13 dosed with 20 mg/kg i.v.) were analyzed using a population modeling approach. Using a two-compartment model with allometric scaling of parameters on body weight (WT), the population PK parameter estimates were as follows: clearance, 0.21 liter/h × WT(kg)0.75 [WT(kg)0.75 indicates that clearance was allometrically scaled on body weight (in kilograms) with a fixed exponent of 0.75]; intercompartmental clearance, 2.1 liters/h × WT(kg)0.75; central volume of distribution (V), 1.97 liters × WT (kg); and peripheral V, 17.9 liters × WT (kg). There was no evidence of departure from dose proportionality in azithromycin exposure over the tested dose range. The calculated area under the concentration-time curve over 24 h in the steady state divided by the MIC90 (AUC24/MIC90) for the single dose of azithromycin (20 mg/kg) was 7.5 h. Simulations suggest that 20 mg/kg for 3 days will maintain azithromycin concentrations of >MIC50 of 1 μg/ml for this group of Ureaplasma isolates for ≥96 h after the first dose. Azithromycin was well tolerated with no drug-related adverse events. One of seven (14%) Ureaplasma-positive subjects and three of six (50%) Ureaplasma-negative subjects developed physiologic BPD. Ureaplasma was eradicated in all treated Ureaplasma-positive subjects. Simulations suggest that a multiple-dose regimen may be efficacious for microbial clearance

  8. Safety, efficacy, and patient acceptability of single-dose fosaprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting

    Directory of Open Access Journals (Sweden)

    Celio L

    2013-05-01

    Full Text Available Luigi Celio, Francesca Ricchini, Filippo De BraudMedical Oncology Unit 1, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, ItalyAbstract: Control of chemotherapy-induced nausea and vomiting (CINV is a crucial factor in ensuring that patients undergoing cancer chemotherapy can get the full benefit of therapy. Current antiemetic guidelines recommend that the neurokinin-1 receptor (NK-1R antagonist aprepitant should be used as part of a combination regimen with dexamethasone and a serotonin receptor antagonist for the prevention of CINV in patients receiving highly emetogenic chemotherapy (HEC. Fosaprepitant is a water-soluble N-phosphoryl derivative of aprepitant that, when infused, is rapidly metabolized back to an active aprepitant. The existing literature in PubMed about fosaprepitant was screened and selected in order to address the emerging data from two randomized clinical trials evaluating the efficacy and safety of a single-dose fosaprepitant regimen. These phase III trials demonstrated that fosaprepitant given as a single intravenous dose of 150 mg was either noninferior to the conventional 3-day aprepitant or significantly superior to placebo for the prevention of acute and delayed CINV in patients receiving high-dose cisplatin. In both trials, fosaprepitant was well tolerated although more frequent infusion-site adverse events were observed with fosaprepitant. The new dosage regimen of fosaprepitant, therefore, would be an option for CINV control in patients receiving cisplatin-based chemotherapy. The clinical efficacy is consistent with the findings from a time-on-target, positron-emission tomography study evaluating the NK-1R occupancy in the central nervous system (CNS over 5 days after a single-dose infusion of 150 mg fosaprepitant in healthy participants. The single-dose regimen is capable of blocking more than 90% of the NK-1Rs in the CNS for at least 48 hours after infusion, which is sufficient

  9. Concurrent administration of donepezil HCl and sertraline HCl in healthy volunteers: assessment of pharmacokinetic changes and safety following single and multiple oral doses

    Science.gov (United States)

    Nagy, Christa F; Kumar, Dinesh; Perdomo, Carlos A; Wason, Suman; Cullen, Edward I; Pratt, Raymond D

    2004-01-01

    Aim This study evaluated the safety and pharmacokinetics (PK) of donepezil HCl and sertraline HCl when administered separately and in combination. Methods This was a randomized, open-label, three-period crossover study. In consecutive dosing periods separated by washout periods of ≥3 weeks, healthy volunteers received either oral donepezil HCI 5 mg once daily for 15 days, oral sertraline HCl 50 mg once daily for 5 days followed by 10 days of once-daily sertraline HCl 100 mg, or the simultaneous administration of oral donepezil HCl and sertraline HCl. Plasma donepezil and sertraline concentrations were determined by high performance liquid chromatography/mass spectrometry. Safety was evaluated by physical and laboratory evaluations and the monitoring of adverse events (AEs). Results A total of 19 volunteers (16 male and three female) were enrolled. Three male subjects withdrew from the study prematurely due to AEs (one case of nausea/stomach cramps and one case of eosinophilia during combination treatment, and one upper respiratory tract infection during treatment with sertraline HCl alone). In subjects who completed all three treatment periods (n = 16), the concurrent administration of donepezil HCl and sertraline HCl did not alter the steady-state (day 15) PK parameters of donepezil HCl. A small (<12%) but statistically significant (P = 0.02) increase in donepezil Cmax was seen after single doses of sertraline HCl and donepezil HCl on day 1 but this was not thought to be clinically meaningful. No significant differences in the tmax or AUC0–24 h of donepezil were observed between the donepezil HCl only or donepezil HCl plus sertraline HCl groups on day 1. No significant changes in sertraline PK parameters were observed either on day 1 (single dose) or on day 15 (steady state) when sertraline HCl was co-administered with donepezil HCl. Generally, the concurrent administration of donepezil HCl and sertraline HCl was well tolerated, with no serious AEs reported

  10. Doubling Your Payoff: Winning Pain Relief Engages Endogenous Pain Inhibition

    Science.gov (United States)

    Becker, Susanne; Gandhi, Wiebke; Kwan, Saskia; Ahmed, Alysha-Karima; Schweinhardt, Petra

    2015-01-01

    When in pain, pain relief is much sought after, particularly for individuals with chronic pain. In analogy to augmentation of the hedonic experience ("liking") of a reward by the motivation to obtain a reward ("wanting"), the seeking of pain relief in a motivated state might increase the experience of pain relief when obtained. We tested this hypothesis in a psychophysical experiment in healthy human subjects, by assessing potential pain-inhibitory effects of pain relief "won" in a wheel of fortune game compared with pain relief without winning, exploiting the fact that the mere chance of winning induces a motivated state. The results show pain-inhibitory effects of pain relief obtained by winning in behaviorally assessed pain perception and ratings of pain intensity. Further, the higher participants scored on the personality trait novelty seeking, the more pain inhibition was induced. These results provide evidence that pain relief, when obtained in a motivated state, engages endogenous pain-inhibitory systems beyond the pain reduction that underlies the relief in the first place. Consequently, such pain relief might be used to improve behavioral pain therapy, inducing a positive, perhaps self-amplifying feedback loop of reduced pain and improved functionality.

  11. Sharing Information among Various Organizations in Relief Efforts

    National Research Council Canada - National Science Library

    Costur, Gurkan

    2005-01-01

    .... An analysis is presented of the December 2004 Indian Ocean tsunami relief effort; specifically, how different organizations such as the military, United Nations, and non-governmental organizations...

  12. Safety and pharmacodynamics of venetoclax (ABT-199) in a randomized single and multiple ascending dose study in women with systemic lupus erythematosus.

    Science.gov (United States)

    Lu, P; Fleischmann, R; Curtis, C; Ignatenko, S; Clarke, S H; Desai, M; Wong, S L; Grebe, K M; Black, K; Zeng, J; Stolzenbach, J; Medema, J K

    2018-02-01

    Objective The anti-apoptotic protein B-cell lymphoma 2 (Bcl-2) may contribute to the pathogenesis of systemic lupus erythematosus. The safety, tolerability, and pharmacodynamics of the selective Bcl-2 inhibitor venetoclax (ABT-199) were assessed in women with systemic lupus erythematosus. Methods A phase 1, double-blind, randomized, placebo controlled study evaluated single ascending doses (10, 30, 90, 180, 300, and 500 mg) and multiple ascending doses (2 cycles; 30, 60, 120, 240, 400, and 600 mg for 1 week, and then 3 weeks off per cycle) of orally administered venetoclax. Eligible participants were aged 18-65 years with a diagnosis of systemic lupus erythematosus for 6 months or more receiving stable therapy for systemic lupus erythematosus (which could have included corticosteroids and/or stable antimalarials). Results All patients (48/48) completed the single ascending dose, 25 continued into the multiple ascending dose, and 44/50 completed the multiple ascending dose; two of the withdrawals (venetoclax 60 mg and 600 mg cohorts) were due to adverse events. Adverse event incidences were slightly higher in the venetoclax groups compared with the placebo groups, with no dose dependence. There were no serious adverse events with venetoclax. The most common adverse events were headache, nausea, and fatigue. Venetoclax 600 mg multiple ascending dose treatment depleted total lymphocytes and B cells by approximately 50% and 80%, respectively. Naive, switched memory, and memory B-cell subsets enriched in autoreactive B cells exhibited dose-dependent reduction of up to approximately 80%. There were no consistent or marked changes in neutrophils, natural killer cells, hemoglobin, or platelets. Conclusions Venetoclax was generally well tolerated in women with systemic lupus erythematosus and reduced total lymphocytes and disease-relevant subsets of antigen-experienced B cells. Registration ClinicalTrials.gov: NCT01686555.

  13. VA administrators breahe a sigh of relief

    Directory of Open Access Journals (Sweden)

    Robbins RA

    2014-06-01

    Full Text Available No abstract available. Article truncated at 150 words. On May 30, Eric Shinseki, the Secretary for Veterans Affairs (VA, resigned under pressure amidst a growing scandal regarding falsification of patient wait times at nearly 40 VA medical centers. Before leaving office Shinseki fired Sharon Helman, the former hospital director at the Phoenix VA, where the story first broke, along with her deputy and another unnamed administrator. In addition, Susan Bowers, director of VA Veterans Integrated Service Network (VISN 18 and Helman’s boss, resigned. Robert Petzel, undersecretary for the Veterans Health Administration (VHA, head of the VA hospitals and clinics, had resigned earlier. You could hear the sigh of relief from the VA administrators. With their bosses resigning left and right, the VA leadership in shambles and the reputation of the VA soiled for many years to come, why are the VA administrators relieved? The simple answer is that nothing has really changed. There for a moment it looked ...

  14. Dimentional welding control using vibratory stress relief

    Directory of Open Access Journals (Sweden)

    Fernando Casanova García

    2008-01-01

    Full Text Available The effectiveness of applying vibratory stress relief to controlling deformations due to internal stresses on plates pro-duced by welding was evaluated in this research. The magnitude of distortion produced in three groups of specimens which had been treated with vibration during and after welding was also evaluated. The specimens consisted of aus-tenitic stainless steel plates which tend to become deformed due to high expansion and shrinkage coefficient and low thermal conductivity during arc welding. Their deformation was quantified by measuring the vertical distance which the end of the plate moved after the welding bead was applied. The magnitude of stress produced by the effect of vi-bration was measured too. The results revealed a clear reduction of the final deformation in treated specimens com-pared to non-treated ones. It was also found that the magnitude of stress produced during vibration had no impor-tant effect on the treatment’s effectiveness.

  15. 38 CFR 61.20 - Life Safety Code capital grants.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) VA HOMELESS PROVIDERS GRANT AND PER DIEM PROGRAM § 61.20 Life Safety Code capital grants. (a) This section sets forth provisions for obtaining a Life Safety Code capital grant under 38 U.S.C. 2012... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Life Safety Code capital...

  16. Safety, pharmacokinetics, and pharmacodynamics of TV-1380, a novel mutated butyrylcholinesterase treatment for cocaine addiction, after single and multiple intramuscular injections in healthy subjects.

    Science.gov (United States)

    Cohen-Barak, Orit; Wildeman, Jacqueline; van de Wetering, Jeroen; Hettinga, Judith; Schuilenga-Hut, Petra; Gross, Aviva; Clark, Shane; Bassan, Merav; Gilgun-Sherki, Yossi; Mendzelevski, Boaz; Spiegelstein, Ofer

    2015-05-01

    Human plasma butyrylcholinesterase (BChE) contributes to cocaine metabolism and has been considered for use in treating cocaine addiction and cocaine overdose. TV-1380 is a recombinant protein composed of the mature form of human serum albumin fused at its amino terminus to the carboxy-terminus of a truncated and mutated BChE. In preclinical studies, TV-1380 has been shown to rapidly eliminate cocaine in the plasma thus forestalling entry of cocaine into the brain and heart. Two randomized, blinded phase I studies were conducted to evaluate the safety, pharmacokinetics, and pharmacodynamics of TV-1380, following single and multiple administration in healthy subjects. TV-1380 was found to be safe and well tolerated with a long half-life (43-77 hours) and showed a dose-proportional increase in systemic exposure. Consistent with preclinical results, the ex vivo cocaine hydrolysis, TV-1380 activity clearly increased upon treatment in a dose-dependent manner. In addition, there was a direct relationship between ex vivo cocaine hydrolysis (kel ) and TV-1380 serum concentrations. There was no evidence that TV-1380 affected heart rate, the uncorrected QT interval, or the heart-rate-corrected QTcF interval. TV-1380, therefore, offers a safe once-weekly therapy to increase cocaine hydrolysis. © 2015 The Authors. The Journal of Clinical Pharmacology Published by Wiley Periodicals, Inc. on behalf of American College of Clinical Pharmacology.

  17. Efficacy and safety of Tinospora cordifolia lotion in Sarcoptes scabiei var hominis-infected pediatric patients: A single blind, randomized controlled trial.

    Science.gov (United States)

    Castillo, Agnes L; Osi, Marina O; Ramos, John Donnie A; De Francia, Jean L; Dujunco, Marylaine U; Quilala, Peter F

    2013-01-01

    To evaluate the clinical efficacy and safety of Tinospora cordifolia lotion including its cure rate and clearance time compared with permethrin lotion. A single blind, randomized, controlled, pilot clinical study was performed in three government institutions to investigate clinical efficacy of T. cordifolia lotion in sixty-six clinically-diagnosed scabies-infected patients. The patients were treated with T. cordifolia or permethrin lotions for three consecutive days for two weeks and clinical assessment of each patient was performed for five weeks. T. cordifolia lotion and permethrin significantly reduced the mean global evaluation score after four weeks of treatment. The two lotions showed comparable effects as anti-scabies agent. Moreover, the clearance time (days) and cure rate using the two lotions did not differ. Clinical improvement, mean clearance time and cure rate of T. cordifolia lotion are comparable with permethrin. Tinospora cordifolia lotion exhibits anti-scabies activity comparable with permethrin. Its incorporation as therapeutic reagent in Sarcoptes scabiei infections is highly recommended.

  18. Safety and effectiveness of a single and repeat intramuscular injection of a GnRH vaccine (GonaCon™) in adult female domestic cats.

    Science.gov (United States)

    Vansandt, L M; Kutzler, M A; Fischer, A E; Morris, K N; Swanson, W F

    2017-04-01

    Sterilization is a key strategy to reduce the number of domestic cats entering and killed in shelters each year. However, surgical sterilization is expensive and labour-intensive and cannot fully address the 70 million free-roaming cats estimated to exist in the United States. GonaCon™ is a gonadotropin-releasing hormone vaccine originally developed for use as a wildlife immunocontraceptive. An earlier formulation was tested in domestic cats and found to be safe and effective for long-term contraception. However, the current Environmental Protection Agency (EPA)-registered formulation consists of a different antigen-carrier protein and increased antigen concentration and has never been tested in cats. A pilot study was undertaken to evaluate the short-term safety of a single GonaCon immunization, assess the consequences of vaccinated cats receiving an accidental second GonaCon injection and determine the humoral immune response to immunization. During Phase 1, cats in Group A (n = 3) received a single intramuscular injection of GonaCon and Group B (n = 3) received a single intramuscular injection of saline. During Phase 2, Group A received a second GonaCon injection and Group B received their initial GonaCon injection. All cats developed GnRH antibodies within 30 days of vaccine administration. The endpoint titre (1:1,024,000) was similar among all cats, and levels remained high throughout the duration of the study. Four cats developed a sterile, painless, self-limiting mass at the site of injection. The mean number of days to mass development was 110.3 (range, 18-249 days). In conclusion, this preliminary study suggests that the EPA-registered GonaCon formulation is safe for continued testing in domestic cats, an accidental revaccination should not increase the risk of a vaccine reaction and the EPA-registered formulation effectively elicits a strong humoral immune response. © 2016 Blackwell Verlag GmbH.

  19. Safety and efficacy of dual-lead thalamic deep brain stimulation for patients with treatment-refractory multiple sclerosis tremor: a single-centre, randomised, single-blind, pilot trial.

    Science.gov (United States)

    Oliveria, Seth F; Rodriguez, Ramon L; Bowers, Dawn; Kantor, Daniel; Hilliard, Justin D; Monari, Erin H; Scott, Bonnie M; Okun, Michael S; Foote, Kelly D

    2017-09-01

    Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. We did a single centre, single-blind, prospective, randomised pilot trial at the University of Florida Center for Movement Disorders and Neurorestoration clinic (Gainesville, FL, USA). We recruited adult patients with a clinical diagnosis of multiple sclerosis tremor refractory to previous medical therapy. Before surgery to implant both leads, we randomly assigned patients (1:1) to receive 3 months of optimised single-lead DBS-either VIM or VO. We did the randomisation with a computer-generated sequence, using three blocks of four patients, and independent members of the Center did the assignment. Patients and all clinicians other than the DBS programming nurse were masked to the choice of lead. Patients underwent surgery 1 month after their baseline visit for implantation of the dual lead DBS system. A pulse generator and two extension cables were implanted in a second surgery 3-4 weeks later. Patients then received an initial 3-month period of continuous stimulation of either the VIM or VO lead followed by blinded safety assessment of their tremor with the Tolosa-Fahn-Marin Tremor Rating Scale (TRS) during optimised VIM or VO lead stimulation at the end of the 3 months. After this visit, both leads were activated in all patients for an additional 3 months, and optimally programmed during serial visits as dictated by a prespecified programming algorithm. At the 6-month follow-up visit, TRS score was measured, and mood and psychological batteries were administered under four

  20. [Deep Relief sonophoresis in degenerative changes of the knee joint].

    Science.gov (United States)

    Zjuzin, Nada; Muftić, Mirsad; Avdić, Dijana; Zubcević, Haris; Stefanovski, Mihajlo; Stefanovski, Gordana; Lukać, Tamara; Hotić, Asia; Halilbegović, Emir; Kapidzić, Nedima

    2004-01-01

    We analysed 130 persons with osteoarthritis of knee and compared efficiency Deep Relief gel with sonophoresis and ultrasound with standard gel. Deep Relief has significant better effect for less pain and better improvement of functional capacity in comparison with ultrasound. Results of examination are statistic significant.

  1. Reward, motivation and emotion of pain and its relief

    Science.gov (United States)

    Porreca, Frank; Navratilova, Edita

    2016-01-01

    The experience of pain depends on interpretation of context and past experience that guide the choice of an immediate behavioral response and influence future decisions of actions to avoid harm. The aversive qualities of pain underlie its physiological role in learning and motivation. In this review, we highlight findings from human and animal investigations that suggest that both pain, and the relief of pain, are complex emotions that are comprised of feelings and their motivational consequences. Relief of aversive states, including pain, is rewarding. How relief of pain aversiveness occurs is not well understood. Termination of aversive states can directly provide relief as well as reinforce behaviors that result in avoidance of pain. Emerging preclinical data also suggests that relief may elicit a positive hedonic value that results from activation of neural cortical and mesolimbic brain circuits that may also motivate behavior. Brain circuits mediating the reward of pain relief, as well as relief-induced motivation are significantly impacted as pain becomes chronic. In chronic pain states, the negative motivational value of nociception may be increased while the value of the reward of pain relief may decrease. As a consequence, the impact of pain on these ancient, and conserved brain limbic circuits suggest a path forward for discovery of new pain therapies. PMID:28106670

  2. 46 CFR 95.15-40 - Pressure relief.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Pressure relief. 95.15-40 Section 95.15-40 Shipping... EQUIPMENT Carbon Dioxide Extinguishing Systems, Details § 95.15-40 Pressure relief. (a) Where necessary... suitable means for relieving excessive pressure accumulating within the compartment when the carbon dioxide...

  3. 46 CFR 76.15-40 - Pressure relief.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 3 2010-10-01 2010-10-01 false Pressure relief. 76.15-40 Section 76.15-40 Shipping... Carbon Dioxide Extinguishing Systems, Details § 76.15-40 Pressure relief. (a) Where necessary, relatively... means for relieving excessive pressure accumulating within the compartment when the carbon dioxide is...

  4. Donation to disaster relief campaigns: underlying social cognitive factors exposed

    NARCIS (Netherlands)

    Oosterhof, Liesbeth; Heuvelman, A.; Peters, O.

    2009-01-01

    number of very serious natural disasters have put an enormous pressure on relief organizations in the last few years. The present study exposes underlying social cognitive factors for donation to relief campaigns. A causal model was constructed, based on social cognitive theory, research on

  5. 30 CFR 203.53 - What relief will MMS grant?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What relief will MMS grant? 203.53 Section 203.53 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE...-Life Leases § 203.53 What relief will MMS grant? (a) If we approve your application and you meet...

  6. 47 CFR 52.19 - Area code relief.

    Science.gov (United States)

    2010-10-01

    ... meetings to which the telecommunications industry and the public are invited on area code relief for a... 47 Telecommunication 3 2010-10-01 2010-10-01 false Area code relief. 52.19 Section 52.19 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES (CONTINUED) NUMBERING...

  7. 78 FR 49242 - Relief From Joint and Several Liability

    Science.gov (United States)

    2013-08-13

    .... These notices or letters do not include notices issued pursuant to section 6223 relating to Tax Equity... contains proposed regulations relating to relief from joint and several tax liability under section 6015 of the Internal Revenue Code (Code) and relief from the Federal income tax liability resulting from the...

  8. A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

    Science.gov (United States)

    Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

    2016-04-06

    To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

  9. The control of tonic pain by active relief learning.

    Science.gov (United States)

    Zhang, Suyi; Mano, Hiroaki; Lee, Michael; Yoshida, Wako; Kawato, Mitsuo; Robbins, Trevor W; Seymour, Ben

    2018-02-27

    Tonic pain after injury characterises a behavioural state that prioritises recovery. Although generally suppressing cognition and attention, tonic pain needs to allow effective relief learning to reduce the cause of the pain. Here, we describe a central learning circuit that supports learning of relief and concurrently suppresses the level of ongoing pain. We used computational modelling of behavioural, physiological and neuroimaging data in two experiments in which subjects learned to terminate tonic pain in static and dynamic escape-learning paradigms. In both studies, we show that active relief-seeking involves a reinforcement learning process manifest by error signals observed in the dorsal putamen. Critically, this system uses an uncertainty ('associability') signal detected in pregenual anterior cingulate cortex that both controls the relief learning rate, and endogenously and parametrically modulates the level of tonic pain. The results define a self-organising learning circuit that reduces ongoing pain when learning about potential relief. © 2018, Zhang et al.

  10. The control of tonic pain by active relief learning

    Science.gov (United States)

    Mano, Hiroaki; Lee, Michael; Yoshida, Wako; Kawato, Mitsuo; Robbins, Trevor W

    2018-01-01

    Tonic pain after injury characterises a behavioural state that prioritises recovery. Although generally suppressing cognition and attention, tonic pain needs to allow effective relief learning to reduce the cause of the pain. Here, we describe a central learning circuit that supports learning of relief and concurrently suppresses the level of ongoing pain. We used computational modelling of behavioural, physiological and neuroimaging data in two experiments in which subjects learned to terminate tonic pain in static and dynamic escape-learning paradigms. In both studies, we show that active relief-seeking involves a reinforcement learning process manifest by error signals observed in the dorsal putamen. Critically, this system uses an uncertainty (‘associability’) signal detected in pregenual anterior cingulate cortex that both controls the relief learning rate, and endogenously and parametrically modulates the level of tonic pain. The results define a self-organising learning circuit that reduces ongoing pain when learning about potential relief. PMID:29482716

  11. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study

    Directory of Open Access Journals (Sweden)

    Si TM

    2015-06-01

    Full Text Available Tianmei Si,1 Kerang Zhang,2 Jisheng Tang,3 Maosheng Fang,4 Keqing Li,5 Jianmin Zhuo,6 Yu Feng6 1Peking University Institute of Mental Health, Key Laboratory of Mental Health, Ministry of Health, Beijing, People’s Republic of China; 2Shanxi Medical University First Hospital, Shanxi, People’s Republic of China; 3Mental Health Center of Shandong Province, Shandong, People’s Republic of China; 4Mental Health Center, Tongji Medical College, Huazhong University of Science and Technology, Hubei, People’s Republic of China; 5Mental Health Center of Hebei Province, Hebei, People’s Republic of China; 6Janssen Research and Development, Beijing, People’s Republic of China Abstract: This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75–150 mg eq, deltoid/gluteal injection in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score ≥70, who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period. Primary efficacy endpoint was percentage of patients with ≥30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions–Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2% completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years. Total, 443/610 (72.6%, full analysis set patients achieved primary endpoint (mean [standard deviation] change from baseline: –30.9 [19.51]. All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5

  12. A Phase II, Multicenter, Single-Arm Study to Evaluate the Safety and Efficacy of Deferasirox after Hematopoietic Stem Cell Transplantation in Children with β-Thalassemia Major.

    Science.gov (United States)

    Yesilipek, Mehmet Akif; Karasu, Gulsun; Kaya, Zuhre; Kuskonmaz, Baris B; Uygun, Vedat; Dag, Ilkiz; Ozudogru, Onur; Ertem, Mehmet

    2018-03-01

    We conducted a prospective, phase II, multicenter, single-arm study to evaluate the efficacy and safety of deferasirox in patients age >2 to 1000 µg/L; cardiac MRI T2* deferasirox at an initial dose of 10 mg/kg/day, with up-titration to a maximum of 20 mg/kg/day. The study continued for 52 weeks and included a total of 27 patients (mean age, 9.1 ± 3.8 years; 70.4% male). One patient (3.7%) was lost to follow-up. The majority of patients (n = 20; 74.1%) were able to achieve the intended dose of 20 mg/kg/day. No deaths occurred. A total of 134 adverse events (AEs) were reported in 25 patients (92.6%) during the study. The majority of patients had grade 1 or 2 AEs, with only 8 patients (29.6%) experiencing grade 3 AEs. Only 10 AEs occurring in 4 patients (14.8%) were suspected to be related to deferasirox (ALT/AST increase, n = 4; urinary tract infection, n = 1). The deferasirox dose had to be adjusted or interrupted for 6 AEs occurring in 4 patients (14.8%). A total of 6 serious AEs occurred in 3 patients (11.1%), none of which were suspected to be related to deferasirox. From baseline to week 52, there were decreases in median concentrations of alanine aminotransferase (ALT), from 30.0 to 17.0 IU/L, and aspartate aminotransferase (AST), from 35.5 to 26.0 IU/L. Median serum creatinine and cystatin C concentrations were similar at baseline and week 52. There was a continuous and significant decrease in median serum ferritin level from 1718.0 µg/L at baseline to 845.3 µg/L following 52 weeks of therapy (P deferasirox treatment at doses up to 20 mg/kg/day reduces the iron burden in children with TM post-HSCT, with a manageable safety profile. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  13. Shaded relief, color as height, Fiji

    Science.gov (United States)

    2000-01-01

    The Sovereign Democratic Republic of the Fiji Islands, commonly known as Fiji, is an independent nation consisting of some 332 islands surrounding the Koro Sea in the South Pacific Ocean. This topographic image shows Viti Levu, the largest island in the group. With an area of 10,429 square kilometers (about 4000 square miles), it comprises more than half the area of the Fiji Islands. Suva, the capital city, lies on the southeast shore. The Nakauvadra, the rugged mountain range running from north to south, has several peaks rising above 900 meters (about 3000 feet). Mount Tomanivi, in the upper center, is the highest peak at 1324 meters (4341 feet). The distinct circular feature on the north shore is the Tavua Caldera, the remnant of a large shield volcano that was active about 4 million years ago. Gold has been mined on the margin of the caldera since the 1930's. The Nadrau plateau is the low relief highland in the center of the mountain range. The coastal plains in the west, northwest and southeast account for only 15 percent of Viti Levu's area but are the main centers of agriculture and settlement.This shaded relief image was generated using topographic data from the Shuttle Radar Topography Mission. A computer-generated artificial light source illuminates the elevation data to produce a pattern of light and shadows. Slopes facing the light appear bright, while those facing away are shaded. On flatter surfaces, the pattern of light and shadows can reveal subtle features in the terrain. Colors show the elevation as measured by SRTM. Colors range from green at the lowest elevations top ink at the highest elevations. This image contains about 1300 meters(4300 feet) of total relief.The Shuttle Radar Topography Mission (SRTM), launched on February 11,2000, uses the same radar instrument that comprised the Spaceborne Imaging Radar-C/X-Band Synthetic Aperture Radar (SIR-C/X-SAR) that flew twice on the Space Shuttle Endeavour in 1994. The mission is designed to collect

  14. Slipping processes in residual badlands reliefs

    Science.gov (United States)

    Díaz-Hernández, Jose Luis; Yepes, Jorge

    2010-05-01

    We define slips as structures developed by more or less saturated colloidal suspension that slide down the walls of residual reliefs found in badlands. These suspensions seem to originate in the soils crowning gully reliefs and also from rainwater dripping onto the walls of poorly cemented sediments such as siltstone. We call this process slipping and the resulting morphologies represent a group of minor badlands forms, often linked to piping and fluting. Slipping occurs according to the following sequence of forms: 1. Mud droplets. These are irregular linear structures caused by mud droplets sliding down sub-vertical walls. The droplet is usually found at the end of a small channel. These morphologies represent the course of the sliding droplets that become fossilized and not the impact of the droplets on the sediment. 2. Slips sensu stricto. These are uninterrupted surface structures covering sub-vertical walls to a greater or lesser extent. The thickness of this type of covering varies from a few millimetres to 5cm. The inner structure of the slips consists of small laminas (» 100mm) and on the exterior they often present drip channels. A special case of these forms is butterfly structures, which appear in isolation, with repetitive patterns and the appearance of a winged insect stuck to the wall. 3. Pseudo-stalactites. These are free-standing conical regrowths with some similarity to stalactites in a karst cave. They occur when slips grow to over 5cm thick. The growth of these forms is similar to that of slips, with external superposition of fine, concentric layers with no central pore. A variety of these pseudo-stalactites are nodulous stalactites whose genesis is unknown. In this context, we should mention the existence of occasional stalagmites. In other cases, curtains of pseudo-stalactites can be found where these patterns are repeated finely. A more evolved stage of this form is the coalescence of pseudo-stalactites, representing a massive advance of

  15. Periarticular infiltration for pain relief after total hip arthroplasty: a comparison with epidural and PCA analgesia.

    Science.gov (United States)

    Pandazi, Ageliki; Kanellopoulos, Ilias; Kalimeris, Konstantinos; Batistaki, Chrysanthi; Nikolakopoulos, Nikolaos; Matsota, Paraskevi; Babis, George C; Kostopanagiotou, Georgia

    2013-11-01

    Epidural and intravenous patient-controlled analgesia (PCA) are established methods for pain relief after total hip arthroplasty (THA). Periarticular infiltration is an alternative method that is gaining ground due to its simplicity and safety. Our study aims to assess the efficacy of periarticular infiltration in pain relief after THA. Sixty-three patients undergoing THA under spinal anaesthesia were randomly assigned to receive postoperative analgesia with continuous epidural infusion with ropivacaine (epidural group), intraoperative periarticular infiltration with ropivacaine, clonidine, morphine, epinephrine and corticosteroids (infiltration group) or PCA with morphine (PCA group). PCA morphine provided rescue analgesia in all groups. We recorded morphine consumption, visual analog scale (VAS) scores at rest and movement, blood loss from wound drainage, mean arterial pressure (MAP) and adverse effects at 1, 6, 12, 24 h postoperatively. Morphine consumption at all time points, VAS scores at rest, 6, 12 and 24 h and at movement, 6 and 12 h postoperatively were lower in infiltration group compared to PCA group (p PCA group (p PCA with morphine after THA, providing better pain relief and lower opioid consumption postoperatively. Infiltration seems to be equally effective to epidural analgesia without having the potential side effects of the latter.

  16. Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe.

    Science.gov (United States)

    van der Straten, Ariane; Moore, Jie; Napierala, Sue; Clouse, Kate; Mauck, Christine; Hammond, Nii; Padian, Nancy

    2008-06-01

    We examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during a 6-month safety trial in Zimbabwe. Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use and consistent use (use at every sexual act during the previous 3 months) were measured on the last visit by face-to-face interview. Predictors of consistent use were examined using multivariate logistic regression analyses. In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01-1.16], consistent condom use (AOR=3.85; 95% CI=1.54-9.63) and having a partner who approves of product use (AOR=2.66; 95% CI=1.10-6.39). Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods.

  17. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  18. SAFETY PROFILE OF ANTI-TNF THERAPY IN CROHN'S DISEASE MANAGEMENT: A BRAZILIAN SINGLE-CENTER DIRECT RETROSPECTIVE COMPARISON BETWEEN INFLIXIMAB AND ADALIMUMAB.

    Science.gov (United States)

    Bau, Mariella; Zacharias, Patricia; Ribeiro, Diogo Araújo; Boaron, Larissa; Steckert Filho, Alvaro; Kotze, Paulo Gustavo

    2017-12-01

    Infliximab and adalimumab are considered effective drugs in the management of Crohn's disease. However, due to significant immunossupression, they can cause important adverse events, mostly infections. The aim of this study was to quantify and describe adverse events derived from adalimumab and infliximab use in Crohn's disease patients, and to compare the safety profile between these two agents. This was an observational, single-center, longitudinal, retrospective study with Crohn's disease patients under infliximab or adalimumab therapy. Variables analyzed: demographic characteristics (including the Montreal classification), type of agent used, concomitant immunomodulators, presence and types of adverse events observed. Patients were allocated in two groups (infliximab and adalimumab) and had their adverse events accessed and subsequently compared. A total of 130 patients were included (68 in infliximab and 62 in adalimumab groups, respectively). The groups were fully homogeneous in all baseline characteristics, with a median follow-up of 47.21±36.52 months in the infliximab group and 47.79±35.09 in the adalimumab group (P=0.512). Adverse events were found in 43/68 (63.2%) and 40/62 (64.5%) in each group, respectively (P=0.879). There were no differences between the groups regarding infections (P=0.094) or treatment interruption (P=0.091). There were higher rates of infusion reactions in the infliximab group (P=0.016). Cephalea and injection site reactions were more prevalent in adalimumab patients. Adverse events were found in approximately two thirds of Crohn's disease patients under anti-TNF therapy, and there were no significant differences between infliximab or adalimumab.

  19. Evaluation of reward from pain relief

    Science.gov (United States)

    Navratilova, Edita; Xie, Jennifer Yanhua; King, Tamara; Porreca, Frank

    2014-01-01

    The human experience of pain is multidimensional and comprises sensory, affective, and cognitive dimensions. Preclinical assessment of pain has been largely focused on the sensory features that contribute to nociception. The affective (aversive) qualities of pain are clinically significant but have received relatively less mechanistic investigation in preclinical models. Recently, operant behaviors such as conditioned place preference, avoidance, escape from noxious stimulus, and analgesic drug self-administration have been used in rodents to evaluate affective aspects of pain. An important advance of such operant behaviors is that these approaches may allow the detection and mechanistic investigation of spontaneous neuropathic or ongoing inflammatory/nociceptive (i.e., nonevoked) pain that is otherwise difficult to assess in nonverbal animals. Operant measures may allow the identification of mechanisms that contribute differentially to reflexive hypersensitivity or to pain affect and may inform the decision to progress novel mechanisms to clinical trials for pain therapy. Additionally, operant behaviors may allow investigation of the poorly understood mechanisms and neural circuits underlying motivational aspects of pain and the reward of pain relief. PMID:23496247

  20. Technology and Information Sharing in Disaster Relief.

    Science.gov (United States)

    Bjerge, Benedikte; Clark, Nathan; Fisker, Peter; Raju, Emmanuel

    2016-01-01

    This paper seeks to examine the extent to which technological advances can enhance inter-organizational information sharing in disaster relief. Our case is the Virtual OSOCC (On-Site Operations Coordination Centre) which is a part of the Global Disaster Alert and Coordination System (GDACS) under the United Nations Office for Coordination of Humanitarian Affairs (UN OCHA). The online platform, which has been developing for more than a decade, provides a unique insight into coordination behaviour among disaster management agencies and individual actors. We build our study on the analysis of a complete database of user interaction including more than 20,000 users and 11,000 comments spread across approximately 300 disaster events. Controlling for types and severities of the events, location-specific vulnerabilities, and the overall trends, we find that the introduction of new features have led to increases in user activity. We supplement the data-driven approach with evidence from semi-structured interviews with administrators and key users, as well as a survey among all users specifically designed to capture and assess the elements highlighted by both interviews and data analysis.

  1. Effects of wave energy, topographic relief and sediment transport on the distribution of shallow-water gorgonians of Puerto Rico

    Science.gov (United States)

    Yoshioka, Paul M.; Yoshioka, Beverly Buchanan

    1989-12-01

    Environmental factors controlling the distribution of shallow-water gorgonians of Puerto Rico were inferred from a Reciprocal Averaging ordination analysis. The data set included several samples taken before and after the passage of Hurricane David and the mass mortality of the sea urchin Diadema antillarum. We could infer only a single environmental gradient associated with the distribution of gorgonians. Stations at opposite extremes of this gradient were characterized by combinations of high wave action with low topographic relief, or low wave action with high topographic relief. This gradient was also associated with sediment transport across the bottom (bedload). A detailed examination of ordination results in relation to Hurricane David and the Diadema mortality indicated that sediment transport, rather than water movement and topographic relief, is more directly related to the distribution of shallow-water gorgonians.

  2. Donation to disaster relief campaigns: underlying social cognitive factors exposed.

    Science.gov (United States)

    Oosterhof, Liesbeth; Heuvelman, Ard; Peters, Oscar

    2009-05-01

    A number of very serious natural disasters have put an enormous pressure on relief organizations in the last few years. The present study exposes underlying social cognitive factors for donation to relief campaigns. A causal model was constructed, based on social cognitive theory, research on attitudes, and the impact of media exposure. The aim was to expand and improve an already existing model by Cheung and Chan [Cheung, C. K., & Chan, C. M. (2000). Social-cognitive factors of donating money to charity, with special attention to an international relief organisation. Evaluation and Program Planning, 23, 241-253]. The expanded model showed a better fit. Furthermore, the expanded model explained two-thirds of the variance of the intention to donate to a disaster relief campaign. The greatest predictor of the intention to donate proved to be "Past donation to disaster relief campaigns." The factor "News exposure" was indicated to be a valuable additional factor, as it had a significant direct effect on "Awareness of a disaster relief campaign" and was the only factor that had a total effect on all other factors, including "Intention to donate to a disaster relief campaign."

  3. 78 FR 8691 - Notice of Availability of Emergency Relief Funds in Response to Hurricane Sandy

    Science.gov (United States)

    2013-02-06

    ... through a recipient. II. Emergency Relief Program Information for Hurricane Sandy Relief A. Description... Relief Funds in Response to Hurricane Sandy AGENCY: Federal Transit Administration (FTA), DOT. ACTION... impacted by Hurricane Sandy, which [[Page 8692

  4. Assessment of plantar pressure in forefoot relief shoes of different designs.

    Science.gov (United States)

    Carl, Hans-Dieter; Pfander, David; Swoboda, Bernd

    2006-02-01

    After reconstructive forefoot surgery, patients require complete or partial forefoot relief, which can be obtained with a variety of shoe designs. The aim of this study was to evaluate the effectiveness of two different types of forefoot-relief shoes frequently used after surgery, especially their safety against unintentional forefoot load. Ten healthy volunteers were asked to perform five trials on a treadmill at self-selected speeds. In the first trial, mean peak pressure values in mass-produced shoes and insoles were evaluated and considered as 100%. Two different shoe designs (short heel-short sole, ii: short heel-complete sole) were compared in two trials each with appropriate and inappropriate use (attempting to put weight on the forefoot) gait pattern. Plantar pressure values were obtained using the Pedar cable system (Novel Inc., Munich, Germany). For analysis, pedobarographic pictures were subdivided into midfoot (31% to 60% of the total insole length) and forefoot (61% to 100% of the total insole length). ANOVA was used for statistical analysis, and p values less than 0.01 were considered significant. With the short-soled shoe, forefoot and midfoot relief was 100% in both compliant and in noncompliant use. With wearing a complete sole, compliant use led to a significant reduction (p shoe produced mean peak pressure values significantly higher (p shoes under the forefoot, but not under the midfoot. Forefoot-relief shoes are effective in reducing both mean and peak plantar pressures. Shoes with a nonsupported midfoot and forefoot may be safer with inappropriate use than shoes with a complete sole. The kind of forefoot shoe should be carefully chosen to regulate weightbearing after reconstructive forefoot surgery.

  5. Efficacy and safety of primaquine and methylene blue for prevention of Plasmodium falciparum transmission in Mali: a phase 2, single-blind, randomised controlled trial.

    Science.gov (United States)

    Dicko, Alassane; Roh, Michelle E; Diawara, Halimatou; Mahamar, Almahamoudou; Soumare, Harouna M; Lanke, Kjerstin; Bradley, John; Sanogo, Koualy; Kone, Daouda T; Diarra, Kalifa; Keita, Sekouba; Issiaka, Djibrilla; Traore, Sekou F; McCulloch, Charles; Stone, Will J R; Hwang, Jimee; Müller, Olaf; Brown, Joelle M; Srinivasan, Vinay; Drakeley, Chris; Gosling, Roly; Chen, Ingrid; Bousema, Teun

    2018-02-05

    Primaquine and methylene blue are gametocytocidal compounds that could prevent Plasmodium falciparum transmission to mosquitoes. We aimed to assess the efficacy and safety of primaquine and methylene blue in preventing human to mosquito transmission of P falciparum among glucose-6-phosphate dehydrogenase (G6PD)-normal, gametocytaemic male participants. This was a phase 2, single-blind, randomised controlled trial done at the Clinical Research Centre of the Malaria Research and Training Centre (MRTC) of the University of Bamako (Bamako, Mali). We enrolled male participants aged 5-50 years with asymptomatic P falciparum malaria. G6PD-normal participants with gametocytes detected by blood smear were randomised 1:1:1:1 in block sizes of eight, using a sealed-envelope design, to receive either sulfadoxine-pyrimethamine and amodiaquine, sulfadoxine-pyrimethamine and amodiaquine plus a single dose of 0·25 mg/kg primaquine, dihydroartemisinin-piperaquine, or dihydroartemisinin-piperaquine plus 15 mg/kg per day methylene blue for 3 days. Laboratory staff, investigators, and insectary technicians were masked to the treatment group and gametocyte density of study participants. The study pharmacist and treating physician were not masked. Participants could request unmasking. The primary efficacy endpoint, analysed in all infected patients with at least one infectivity measure before and after treatment, was median within-person percentage change in mosquito infectivity 2 and 7 days after treatment, assessed by membrane feeding. This study is registered with ClinicalTrials.gov, number NCT02831023. Between June 27, 2016, and Nov 1, 2016, 80 participants were enrolled and assigned to the sulfadoxine-pyrimethamine and amodiaquine (n=20), sulfadoxine-pyrimethamine and amodiaquine plus primaquine (n=20), dihydroartemisinin-piperaquine (n=20), or dihydroartemisinin-piperaquine plus methylene blue (n=20) groups. Among participants infectious at baseline (54 [68%] of 80), those in the

  6. Levels of Reflective Thinking and Patient Safety: An Investigation of the Mechanisms that Impact on Student Learning in a Single Cohort over a 5 Year Curriculum

    Science.gov (United States)

    Ambrose, Lucy J.; Ker, Jean S.

    2014-01-01

    Existing research into learning about patient safety focuses on identifying how educational interventions improve educational outcomes but few studies offer evidence that inform educators about the mechanisms involved in learning about patient safety. The current evidence based in undergraduates is also limited to outcomes that relate to knowledge…

  7. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... assessed by a visual analogue scale, birth experience and satisfaction with delivery, and pain relief evaluated at 2 months postpartum. Secondary obstetric outcomes were duration of labor, use of oxytocin, mode of delivery, postpartum hemorrhage, Apgar score, and umbilical cord pH value. Analysis complied...... to existing pain relief methods....

  8. South America, Shaded Relief and Colored Height

    Science.gov (United States)

    2003-01-01

    This image of South America was generated with data from the Shuttle Radar Topography Mission (SRTM). For this broad view the resolution of the data was first reduced to 30 arcseconds (about 928 meters north-south but variable east-west), matching the best previously existing global digital topographic data set called GTOPO30. The data were then resampled to a Mercator projection with approximately square pixels (about one kilometer, or 0.6 miles, on each side). Even at this decreased resolution the variety of landforms comprising the South American continent is readily apparent.Topographic relief in South America is dominated by the Andes Mountains, which extend all along the Pacific Coast. These mountains are created primarily by the convergence of the Nazca and South American tectonic plates. The Nazca Plate, which underlies the eastern Pacific Ocean, slides under western South America resulting in crustal thickening, uplift, and volcanism. Another zone of plate convergence occurs along the northwestern coast of South America where the Caribbean Plate also slides under the South American Plate and forms the northeastern extension of the Andes Mountains.East of the Andes, much of northern South America drains into the Amazon River, the world's largest river in terms of both watershed area and flow volume. Topographic relief is very low in much of the Amazon Basin but SRTM data provide an excellent detailed look at the basin's three-dimensional drainage pattern, including the geologic structural trough (syncline) that hosts the eastern river channel.North of the Amazon, the Guiana Highlands commonly stand in sharp contrast to the surrounding lowlands, indeed hosting the world's tallest waterfall, Angel Falls (979 meters or 3212 feet). Folded and fractured bedrock structures are distinctive in the topographic pattern.South of the Amazon, the Brazilian Highlands show a mix of landforms, including some broad areas of consistent topographic patterns that indicate the

  9. Ibuprofen is superior to paracetamol for pain relief following third molar removal.

    Science.gov (United States)

    Ferraiolo, Debra M; Veitz-Keenan, Analia

    2014-12-01

    The Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase and the metaRegister of Controlled Trials were searched with no language restrictions. Randomised controlled double-blinded clinical trials using the third molar model were included. Two review authors independently and in duplicate extracted data. The proportion of patients with at least 50% pain relief (based on total pain relief (TOTPAR) and summed pain intensity difference (SPID) data) was calculated for all three drugs at both two and six hours post-dosing and meta-analysed for comparison. Seven studies involving 2241 patients were included. Two studies were considered to be at low risk of bias, three at high risk and two unclear risk of bias. Ibuprofen was found to be a superior analgesic to paracetamol at several doses, with high quality evidence suggesting that ibuprofen 400 mg is superior to 1000 mg paracetamol based on pain relief (estimated from TOTPAR data) and the use of rescue medication meta-analyses. Risk ratio (RR) for at least 50% pain relief (based on TOTPAR) at six hours was 1.47 (95% confidence interval (CI) 1.28 to 1.69; five trials) favouring 400 mg ibuprofen over 1000 mg paracetamol, RR for not using rescue medication (also favouring ibuprofen) was 1.50 (95% CI 1.25 to 1.79; four trials). For combined drug RR for at least 50% of the maximum pain relief over six hours of 1.77 (95% CI 1.32 to 2.39) (paracetamol 1000 mg and ibuprofen 400 mg) (one trial; moderate quality evidence). RR not using rescue medication 1.60 (95% CI 1.36 to 1.88) (two trials; moderate quality evidence). Adverse events were comparable between the treatment groups, but no formal analysis could be undertaken. There is high quality evidence that ibuprofen is superior to paracetamol at doses of 200 mg to 512 mg and 600 mg to 1000 mg respectively based on pain relief and use of rescue medication data collected at six hours postoperatively. The

  10. U.S. Coastal Relief Model - Southern California

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  11. U.S. Coastal Relief Model - Central Pacific

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  12. U.S. Coastal Relief Model - Puerto Rico

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  13. U.S. Coastal Relief Model - Central Gulf of Mexico

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  14. U.S. Coastal Relief Model - Western Gulf of Mexico

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  15. U.S. Coastal Relief Model - Southern California Version 2

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides a comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a seamless...

  16. U.S. Coastal Relief Model - Northeast Atlantic

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  17. U.S. Coastal Relief Model - Southeast Atlantic

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  18. U.S. Coastal Relief Model - Northwest Pacific

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NGDC's U.S. Coastal Relief Model (CRM) provides the first comprehensive view of the U.S. coastal zone integrating offshore bathymetry with land topography into a...

  19. Optimized Positioning of Pre-Disaster Relief Force and Assets

    National Research Council Canada - National Science Library

    Tean, Ee S

    2006-01-01

    .... This thesis develops a two-stage stochastic optimization model to provide guidance in the pre-positioning of relief units and assets, where budget, physical limitations and logistics are taken into account...

  20. Decision-making tools for distribution networks in disaster relief.

    Science.gov (United States)

    2011-08-05

    The devastation caused by the 2010 earthquake in Haiti was compounded by the significant logistical : challenges of distributing relief to those in need. Unfortunately this is the case with many disasters. : Rapid and efficient distribution of water,...

  1. Antiemetic Medicines: OTC Relief for Nausea and Vomiting

    Science.gov (United States)

    ... CorrectlyPain Relievers: Understanding Your OTC OptionsAntacids and Acid Reducers: OTC Relief for Heartburn and Acid RefluxOTC Cough ... Loss and Diet Plans Nutrients and Nutritional Info Sugar and Sugar Substitutes Exercise and Fitness Exercise Basics ...

  2. Analgesic efficacy and safety of intravenous paracetamol (acetaminophen) administered as a 2g starting dose following third molar surgery

    DEFF Research Database (Denmark)

    Juhl, Gitte Irene; Nørholt, Sven E.; Tønnesen, Else Kirstine

    2006-01-01

    BACKGROUND: The recommended dose for intravenous (IV) paracetamol injection in adults is 1g, however pharmacokinetic and pharmacodynamic findings suggest that a better analgesia could be obtained with a 2g starting dose. METHODS: A single-centre, randomised, double-blind, placebo-controlled, 3......-parallel group study was performed to demonstrate the analgesic efficacy and safety of IV paracetamol 2g. Following third molar surgery, patients reporting moderate to severe pain received a single 15-min infusion of either IV paracetamol 2g, IV paracetamol 1g or placebo. Efficacy and safety were evaluated...... over 8h. Laboratory tests were performed before and 48h after drug administration. RESULTS: Two hundred and ninety seven patients (132=IV paracetamol 2g; 132=IV paracetamol 1g; 33=placebo) were randomised and completed the study. The summed pain relief over 6h (TOTPAR6) was significantly superior...

  3. Efficacy and safety of Everolimus in children with TSC - associated epilepsy – Pilot data from an open single-center prospective study

    Directory of Open Access Journals (Sweden)

    Sharon Samueli

    2016-11-01

    Full Text Available Abstract Background Epilepsy occurs in up to 90 % of all individuals with tuberous sclerosis complex (TSC. In 67 % disease onset is during childhood. In ≥ 50 % seizures are refractory to currently available treatment options. The mTOR-Inhibitor Everolimus (Votubia® was approved for the treatment of subependymal giant cell astrocytoma (SEGA and renal angiomyolipoma (AML in Europe in 2011. It’s anticonvulsive/antiepileptic properties are promising, but evidence is still limited. Study aim was to evaluate the efficacy and safety of Everolimus in children and adolescents with TSC-associated epilepsies. Methods Inclusion-criteria of this investigator-initiated, single-center, open, prospective study were: 1 the ascertained diagnosis of TSC; 2 age ≤ 18 years; 3 treatment indication for Votubia® according to the European Commission guidelines; 4 drug-resistant TSC-associated epilepsy, 5 prospective continuous follow-up for at least 6 months after treatment initiation and 6 informed consent to participate. Votubia® was orally administered once/day, starting with 4.5 mg/m2 and titrated to achieve blood trough concentrations between 5 and 15 ng/ml. Primary endpoint was the reduction in seizure frequency of ≥ 50 % compared to baseline. Results Fifteen patients (nine male with a median age of six (range; 1–18 years fulfilled the inclusion criteria. 26 % (4/15 had TSC1, 66 % (10/15 had TSC2 mutations. In one patient no mutation was found. Time of observation after treatment initiation was median 22 (range; 6–50 months. At last observation, 80 % (12/15 of the patients were responders, 58 % of them (7/12 were seizure free. The overall reduction in seizure frequency was 60 % in focal seizures, 80 % in generalized tonic clonic seizures and 87 % in drop attacks. The effect of Everolimus was seen already at low doses, early after treatment initiation. Loss of efficacy over time was not observed. Transient side effects were seen in 93

  4. Efficacy and safety of thalidomide for the treatment of severe recurrent epistaxis in hereditary haemorrhagic telangiectasia: results of a non-randomised, single-centre, phase 2 study.

    Science.gov (United States)

    Invernizzi, Rosangela; Quaglia, Federica; Klersy, Catherine; Pagella, Fabio; Ornati, Federica; Chu, Francesco; Matti, Elina; Spinozzi, Giuseppe; Plumitallo, Sara; Grignani, Pierangela; Olivieri, Carla; Bastia, Raffaella; Bellistri, Francesca; Danesino, Cesare; Benazzo, Marco; Balduini, Carlo L

    2015-11-01

    Hereditary haemorrhagic telangiectasia is a genetic disease that leads to multiregional angiodysplasia. Severe recurrent epistaxis is the most common presentation, frequently leading to severe anaemia. Several therapeutic approaches have been investigated, but they are mostly palliative and have had variable results. We aimed to assess the efficacy of thalidomide for the reduction of epistaxis in patients with hereditary haemorrhagic telangiectasia that is refractory to standard therapy. We recruited patients aged 17 years or older with hereditary haemorrhagic telangiectasia who had severe recurrent epistaxis refractory to minimally invasive surgical procedures into an open-label, phase 2, non-randomised, single-centre study at IRCCS Policlinico San Matteo Foundation (Pavia, Italy). We gave patients thalidomide at a starting dose of 50 mg/day orally. If they had no response, we increased the thalidomide dose by 50 mg/day increments every 4 weeks, until a response was seen, up to a maximum dose of 200 mg/day. After patients had achieved a response, they continued treatment for 8-16 additional weeks. The primary endpoint was the efficacy of thalidomide measured as the percentage of patients who had reductions of at least one grade in the frequency, intensity, or duration of epistaxis. We followed up patients each month to assess epistaxis severity score and transfusion need, and any adverse events were reported. We included all patients who received any study drug and who participated in at least one post-baseline assessment in the primary efficacy population. The safety population consisted of all patients who received any dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01485224. Between Dec 1, 2011, and May 12, 2014, we enrolled 31 patients. Median follow-up was 15·9 months (IQR 10·1-22·3). Three (10%, 95% CI 2-26) patients had a complete response, with bleeding stopped, 28 (90%, 95% CI 74-98) patients had partial responses

  5. Pressure relief protection in cryostats: CERN’s experience on LHC and HIE Isolde

    CERN Multimedia

    CERN. Geneva

    2016-01-01

    Cryostats contain large cold surfaces, cryogenic fluids, and sometimes large stored energy (e.g. energized magnets), with the potential risk of sudden liberation of energy through thermodynamic transformations of the fluids, which can be uncontrolled and lead to a dangerous increase of pressure inside the cryostat envelopes. The consequence, in the case of a rupture of the envelopes, may be serious for personnel (injuries from deflagration, burns, and oxygen deficiency hazard) as well as for the equipment. Performing a thorough risk analysis is an essential step to identify and understand risk hazards that may cause a pressure increase and in order to assess consequences, define mitigation actions, and design adequate safety relief devices to limit pressure accordingly. Lessons learnt from real cases are essential for improving safety awareness for future projects: LHC and HIE Isolde are amongst these examples.

  6. Seismic response of the Pickering pressure relief duct to the 1985 Nahanni earthquake

    International Nuclear Information System (INIS)

    Ghobarah, A.

    1995-05-01

    The objective of this study is to examine the structural response of the Pickering pressure relief duct when subjected to the ground motion records of the 1985 Nahanni earthquake (December 23, 05:16 GMT, Site 1 - Iverson, N.W.T.). It also includes an estimate of the possible impact on the nuclear safety function of the duct. The structural models developed in an earlier study were used in this analysis. The response to the earthquake ground motion was determined on the basis of the estimated capacities of various components of the duct. The ability of the structure to fulfill its nuclear safety function is discussed. (author). 6 refs., 1 tab., 17 figs

  7. Determination of Terrain Serviceability of Military Vehicles by GIS Relief Analysis

    Directory of Open Access Journals (Sweden)

    Mladen Pahernik

    2006-11-01

    Full Text Available This paper analyses capabilities of terrain serviceability ofvehicles in regards to the ground features. Two key relief attributesrelated to the slope inclination are defined, as well as reliefforms quantitatively defined as deviations of height above sea-level. As the secondary attribute, the topographic wetness indexis estimated, which, in correlation with the drainage coefficientyields the wetness value index as an essential factor of passablenessin the conditions of harder and more intensive precipitations,that is to say, sudden snow melting. By application ofGIS analysis, based on the digital model of space heights alongthe Kupa River from Pisarovina to SiSinec, the values of primaryand secondary relief attributes have been calculated, andthe analysis of Landsat satellite images has been used to definethe values of vegetation cover. Based on these values and dataon the soil type, the layer of ground wetness has been estimated.Cross Country Mobility Program of ESRI company, withinGIS program package Arc View 3.3. has been used to set themarginal values of the defined relief parameters and to estimatethe levels of mobility for single vehicles in different terrain conditions.The comparison of the obtained results clearly indicatesa possible application of the defined data in the analysisof terrain serviceability of military vehicles, with regard to therelief features of the terrain. For full applicability of the model itis also necessary to define other attributes of mobility related tohydrographical, vegetation, pedological, anthropogenic andother ground features.

  8. Interactive High-Relief Reconstruction for Organic and Double-Sided Objects from a Photo.

    Science.gov (United States)

    Yeh, Chih-Kuo; Huang, Shi-Yang; Jayaraman, Pradeep Kumar; Fu, Chi-Wing; Lee, Tong-Yee

    2017-07-01

    We introduce an interactive user-driven method to reconstruct high-relief 3D geometry from a single photo. Particularly, we consider two novel but challenging reconstruction issues: i) common non-rigid objects whose shapes are organic rather than polyhedral/symmetric, and ii) double-sided structures, where front and back sides of some curvy object parts are revealed simultaneously on image. To address these issues, we develop a three-stage computational pipeline. First, we construct a 2.5D model from the input image by user-driven segmentation, automatic layering, and region completion, handling three common types of occlusion. Second, users can interactively mark-up slope and curvature cues on the image to guide our constrained optimization model to inflate and lift up the image layers. We provide real-time preview of the inflated geometry to allow interactive editing. Third, we stitch and optimize the inflated layers to produce a high-relief 3D model. Compared to previous work, we can generate high-relief geometry with large viewing angles, handle complex organic objects with multiple occluded regions and varying shape profiles, and reconstruct objects with double-sided structures. Lastly, we demonstrate the applicability of our method on a wide variety of input images with human, animals, flowers, etc.

  9. Balancing of the air pollution relief through new technologies in the new Laender of Germany

    International Nuclear Information System (INIS)

    Kampet, T.; Broege, M.; Jappe, H.; Jones, E.; Koerner, T.; Lindner, H.

    1992-01-01

    The air pollution relief through the application of new technologies in the new Federal states is balanced. Content: objective and method, energy and environmental situation in the new Federal states in 1989, tendency development of the environmental impact due to energy in the new Federal states up to 2010, possible environmental relief through an increased utilization of renewable energy and new energy technologies (scenario), cost-benefit aspects of a stranger utilization of new energy technologies and renewable energy. The appendices contain indications on the energy situation and air pollution emissions due to energy (sulfur dioxide, nitrogen oxide, carbon dioxide, dust) in the GDR of 1989 as a whole and in the single new Federal states, results of expert discussions about the environmental effects of energy technologies and energy economic priorities in the five new Federal states and about measure priorities for the introduction of newest energy technologies and increased utilization of renewable energy in the new five Federal states up to 2010 as well as test calculation regarding environmental relief effects of alternative measure options. (BBR) [de

  10. Colored Height and Shaded Relief, Kamchatka Peninsula

    Science.gov (United States)

    2002-01-01

    Russia's Kamchatka Peninsula, lying between the Sea of Okhotsk to the west and the Bering Sea and Pacific Ocean to the east, is one of the most active volcanic regions along the Pacific Ring of Fire. It covers an area about the size of Colorado but contains more than 100 volcanoes stretching across the 1000-kilometer-long (620-mile-long) land mass. A dozen or more of these have active vents, with the youngest located along the eastern half of the peninsula. This color-coded shaded relief image, generated with data from the Shuttle Radar Topography Mission (SRTM), shows Kamchatka's volcanic nature to dramatic effect.Kliuchevskoi, one of the most active and renowned volcanoes in the world, dominates the main cluster of volcanoes called the Kliuchi group, visible as a circular feature in the center-right of the image. The two other main volcanic ranges lie along northeast-southwest lines, with the older, less active range occupying the center and western half of Kamchatka. The younger, more active belt begins at the southernmost point of the peninsula and continues upward along the Pacific coastline.Two visualization methods were combined to produce this image: shading and color coding of topographic height. The shade image was derived by computing topographic slope in the north-south direction, so northern slopes appear bright and southern slopes appear dark. Color coding is directly related to topographic height, with green at the lower elevations, rising through yellow and brown to white at the highest elevations.The Shuttle Radar Topography Mission flew aboard the Space Shuttle Endeavour, launched on February 11, 2000. The mission used the same radar instrument that comprised the Spaceborne Imaging Radar-C/X-Band Synthetic Aperture Radar that flew twice on the Space Shuttle Endeavour in 1994. The Shuttle Radar Topography Mission was designed to collect three-dimensional measurements of the Earth's surface. To collect the 3-D data, engineers added a 60-meter (200

  11. Sinai Peninsula, Shaded Relief and Colored Height

    Science.gov (United States)

    2004-01-01

    The Sinai Peninsula, located between Africa and Asia, is a result of those two continents pulling apart from each other. Earth's crust is cracking, stretching, and lowering along the two northern branches of the Red Sea, namely the Gulf of Suez, seen here on the west (left), and the Gulf of Aqaba, seen to the east (right). This color-coded shaded relief image shows the triangular nature of the peninsula, with the coast of the Mediterranean Sea forming the northern side of the triangle. The Suez Canal can be seen as the narrow vertical blue line in the upper left connecting the Red Sea to the Mediterranean. The peninsula is divided into three distinct parts; the northern region consisting chiefly of sandstone, plains and hills, the central area dominated by the Tih Plateau, and the mountainous southern region where towering peaks abound. Much of the Sinai is deeply dissected by river valleys, or wadis, that eroded during an earlier geologic period and break the surface of the plateau into a series of detached massifs with a few scattered oases. Two visualization methods were combined to produce the image: shading and color coding of topographic height. The shade image was derived by computing topographic slope in the northwest-southeast direction, so that northwest slopes appear bright and southeast slopes appear dark. Color coding is directly related to topographic height, with green at the lower elevations, rising through yellow and tan, to white at the highest elevations. Elevation data used in this image were acquired by the Shuttle Radar Topography Mission aboard the Space Shuttle Endeavour, launched on Feb. 11, 2000. SRTM used the same radar instrument that comprised the Spaceborne Imaging Radar-C/X-Band Synthetic Aperture Radar (SIR-C/X-SAR) that flew twice on the Space Shuttle Endeavour in 1994. SRTM was designed to collect 3-D measurements of the Earth's surface. To collect the 3-D data, engineers added a 60-meter (approximately 200-foot) mast, installed

  12. Bali, Shaded Relief and Colored Height

    Science.gov (United States)

    2004-01-01

    The volcanic nature of the island of Bali is evident in this shaded relief image generated with data from the Shuttle Radar Topography Mission (SRTM).Bali, along with several smaller islands, make up one of the 27 Provinces of Indonesia. It lies over a major subduction zone where the Indo-Australian tectonic plate collides with the Sunda plate, creating one of the most volcanically active regions on the planet.The most significant feature on Bali is Gunung Agung, the symmetric, conical mountain at the right-center of the image. This 'stratovolcano,' 3,148 meters (10,308 feet) high, is held sacred in Balinese culture, and last erupted in 1963 after being dormant and thought inactive for 120 years. This violent event resulted in over 1,000 deaths, and coincided with a purification ceremony called Eka Dasa Rudra, meant to restore the balance between nature and man. This most important Balinese rite is held only once per century, and the almost exact correspondence between the beginning of the ceremony and the eruption is though to have great religious significance.Two visualization methods were combined to produce the image: shading and color coding of topographic height. The shade image was derived by computing topographic slope in the northwest-southeast direction, so that northwest slopes appear bright and southeast slopes appear dark. Color coding is directly related to topographic height, with green at the lower elevations, rising through yellow and tan, to white at the highest elevations.Elevation data used in this image were acquired by the Shuttle Radar Topography Mission aboard the Space Shuttle Endeavour, launched on Feb. 11, 2000. SRTM used the same radar instrument that comprised the Spaceborne Imaging Radar-C/X-Band Synthetic Aperture Radar (SIR-C/X-SAR) that flew twice on the Space Shuttle Endeavour in 1994. SRTM was designed to collect 3-D measurements of the Earth's surface. To collect the 3-D data, engineers added a 60-meter (approximately 200-foot

  13. Ireland, Shaded Relief and Colored Height

    Science.gov (United States)

    2005-01-01

    The island of Ireland comprises a large central lowland of limestone with a relief of hills surrounded by a discontinuous border of coastal mountains which vary greatly in geological structure. The mountain ridges of the south are composed of old red sandstone separated by limestone river valleys. Granite predominates in the mountains of Galway, Mayo and Donegal in the west and north-west and in Counties Down and Wicklow on the east coast, while a basalt plateau covers much of the north-east of the country. The central plain, which is broken in places by low hills, is extensively covered with glacial deposits of clay and sand. It has considerable areas of bog and numerous lakes. The island has seen at least two general glaciations and everywhere ice-smoothed rock, mountain lakes, glacial valleys and deposits of glacial sand, gravel and clay mark the passage of the ice. Two visualization methods were combined to produce this image: shading and color coding of topographic height. The shade image was derived by computing topographic slope in the northwest-southeast direction, so that northwest slopes appear bright and southeast slopes appear dark. Color coding is directly related to topographic height, with green at the lower elevations, rising through yellow and tan, to white at the highest elevations. Elevation data used in this image were acquired by the Shuttle Radar Topography Mission aboard the Space Shuttle Endeavour, launched on Feb. 11, 2000. SRTM used the same radar instrument that comprised the Spaceborne Imaging Radar-C/X-Band Synthetic Aperture Radar (SIR-C/X-SAR) that flew twice on the Space Shuttle Endeavour in 1994. SRTM was designed to collect 3-D measurements of the Earth's surface. To collect the 3-D data, engineers added a 60-meter (approximately 200-foot) mast, installed additional C-band and X-band antennas, and improved tracking and navigation devices. The mission is a cooperative project between NASA, the National Geospatial-Intelligence Agency

  14. South America, Shaded Relief and Colored Height

    Science.gov (United States)

    2003-01-01

    This image of South America was generated with data from the Shuttle Radar Topography Mission (SRTM). For this broad view the resolution of the data was first reduced to 30 arcseconds (about 928 meters north-south but variable east-west), matching the best previously existing global digital topographic data set called GTOPO30. The data were then resampled to a Mercator projection with approximately square pixels (about one kilometer, or 0.6 miles, on each side). Even at this decreased resolution the variety of landforms comprising the South American continent is readily apparent.Topographic relief in South America is dominated by the Andes Mountains, which extend all along the Pacific Coast. These mountains are created primarily by the convergence of the Nazca and South American tectonic plates. The Nazca Plate, which underlies the eastern Pacific Ocean, slides under western South America resulting in crustal thickening, uplift, and volcanism. Another zone of plate convergence occurs along the northwestern coast of South America where the Caribbean Plate also slides under the South American Plate and forms the northeastern extension of the Andes Mountains.East of the Andes, much of northern South America drains into the Amazon River, the world's largest river in terms of both watershed area and flow volume. Topographic relief is very low in much of the Amazon Basin but SRTM data provide an excellent detailed look at the basin's three-dimensional drainage pattern, including the geologic structural trough (syncline) that hosts the eastern river channel.North of the Amazon, the Guiana Highlands commonly stand in sharp contrast to the surrounding lowlands, indeed hosting the world's tallest waterfall, Angel Falls (979 meters or 3212 feet). Folded and fractured bedrock structures are distinctive in the topographic pattern.South of the Amazon, the Brazilian Highlands show a mix of landforms, including some broad areas of consistent topographic patterns that indicate the

  15. Next Generation Public Safety and Emergency Technologies

    DEFF Research Database (Denmark)

    Bonde, Camilla; Tadayoni, Reza; Skouby, Knud Erik

    2014-01-01

    The paper researches the existing European standards for Public Safety and Emergency (PSE) services (also called Public Protection Disaster Relief “PPDR”), and identifies based on user studies in Denmark conflicts between the current deployments of the standards and the user requirements. The aim...

  16. Olduvai Gorge, Shaded Relief and Colored Height

    Science.gov (United States)

    2004-01-01

    Three striking and important areas of Tanzania in eastern Africa are shown in this color-coded shaded relief image from the Shuttle Radar Topography Mission. The largest circular feature in the center right is the caldera, or central crater, of the extinct volcano Ngorongoro. It is surrounded by a number of smaller volcanoes, all associated with the Great Rift Valley, a geologic fault system that extends for about 4,830 kilometers (2,995 miles) from Syria to central Mozambique. Ngorongoro's caldera is 22.5 kilometers (14 miles) across at its widest point and is 610 meters (2,000 feet) deep. Its floor is very level, holding a lake fed by streams running down the caldera wall. It is part of the Ngorongoro Conservation Area and is home to over 75,000 animals. The lakes south of the crater are Lake Eyasi and Lake Manyara, also part of the conservation area. The relatively smooth region in the upper left of the image is the Serengeti National Park, the largest in Tanzania. The park encompasses the main part of the Serengeti ecosystem, supporting the greatest remaining concentration of plains game in Africa including more than 3,000,000 large mammals. The animals roam the park freely and in the spectacular migrations, huge herds of wild animals move to other areas of the park in search of greener grazing grounds (requiring over 4,000 tons of grass each day) and water. The faint, nearly horizontal line near the center of the image is Olduvai Gorge, made famous by the discovery of remains of the earliest humans to exist. Between 1.9 and 1.2 million years ago a salt lake occupied this area, followed by the appearance of fresh water streams and small ponds. Exposed deposits show rich fossil fauna, many hominid remains and items belonging to one of the oldest stone tool technologies, called Olduwan. The time span of the objects recovered dates from 2,100,000 to 15,000 years ago. Two visualization methods were combined to produce the image: shading and color coding of

  17. 30 CFR 204.205 - How do I obtain accounting and auditing relief?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false How do I obtain accounting and auditing relief... MINERALS REVENUE MANAGEMENT ALTERNATIVES FOR MARGINAL PROPERTIES Accounting and Auditing Relief § 204.205 How do I obtain accounting and auditing relief? (a) To take cumulative reports and payments relief...

  18. 30 CFR 204.201 - Who may obtain accounting and auditing relief?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Who may obtain accounting and auditing relief... MINERALS REVENUE MANAGEMENT ALTERNATIVES FOR MARGINAL PROPERTIES Accounting and Auditing Relief § 204.201 Who may obtain accounting and auditing relief? (a) You may obtain accounting and auditing relief under...

  19. 30 CFR 204.203 - What is the other relief option?

    Science.gov (United States)

    2010-07-01

    ... MANAGEMENT ALTERNATIVES FOR MARGINAL PROPERTIES Accounting and Auditing Relief § 204.203 What is the other relief option? (a) Under this relief option, you may request any type of accounting and auditing relief that is appropriate for production from your marginal property, provided it is not prohibited under...

  20. 30 CFR 204.211 - When may MMS rescind relief for a property?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false When may MMS rescind relief for a property? 204... MMS rescind relief for a property? (a) MMS may retroactively rescind the relief for your property if MMS determines that your property was not eligible for the relief obtained under this subpart because...

  1. The role of hydromorphone and OPRM1 in postoperative pain relief with hydrocodone.

    Science.gov (United States)

    Boswell, Mark V; Stauble, M Elaine; Loyd, Gary E; Langman, Loralie; Ramey-Hartung, Bronwyn; Baumgartner, Richard N; Tucker, William W; Jortani, Saeed A

    2013-01-01

    Postoperative pain management remains a challenge for clinicians due to unpredictable patient responses to opioid therapy. Some of this variability may result from single nucleotide polymorphisms (SNPs) of the human opioid mu-1 receptor (OPRM1) that modify receptor binding or signal transduction. The OPRM1 variant with the highest frequency is the A118G SNP. However, previous studies have produced inconsistent results regarding the clinical effects of A118G on opioid response. We hypothesized that measurement of serum opioid concentrations, in addition to determining total opioid consumption, may provide a more precise method of assessing the effects of A118G on analgesic response. The current study evaluated the relationship of analgesia, side effects, total hydrocodone consumption, quantitative serum hydrocodone and hydromorphone concentrations, and A118G SNP in postoperative patients following Cesarean section. 158 women scheduled for Cesarean section were enrolled prospectively in the study. The patients had bupivacaine spinal anesthesia for surgery and received intrathcal morphine with the spinal anesthetic or parenteral morphine for the first 24 hours after surgery. Thereafter, patients received hydrocodone/acetaminophen for postoperative pain control. On postoperative day 3, venous blood samples were obtained for OPRM1 A118G genotyping and serum opioid concentrations. 131 (82.9%) of the subjects were homozygous for the 118A allele of OPRM1 (AA) and 27 (17.1%) carried the G allele (AG/GG). By regression analysis, pain relief was significantly associated with total hydrocodone dose in the AA group (P = 0.01), but not in the AG/GG group (P = 0.554). In contrast, there was no association between pain relief and serum hydrocodone concentration in either group. However, pain relief was significantly associated with serum hydromorphone concentration (a metabolite of hydrocodone) in the AA group (P = 0.004), but not in the AG/GG group (P = 0.724). Conversely, side

  2. Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects.

    Science.gov (United States)

    Lowe, Stephen L; Wong, Conrad J; Witcher, Jennifer; Gonzales, Celedon R; Dickinson, Gemma L; Bell, Robert L; Rorick-Kehn, Linda; Weller, MaryAnn; Stoltz, Randall R; Royalty, Jane; Tauscher-Wisniewski, Sitra

    2014-09-01

    Accumulating evidence indicates that selective antagonism of kappa opioid receptors may provide therapeutic benefit in the treatment of major depressive disorder, anxiety disorders, and substance use disorders. LY2456302 is a high-affinity, selective kappa opioid antagonist that demonstrates >30-fold functional selectivity over mu and delta opioid receptors. The safety, tolerability, and pharmacokinetics (PK) of LY2456302 were investigated following single oral doses (2-60 mg), multiple oral doses (2, 10, and 35 mg), and when co-administered with ethanol. Plasma concentrations of LY2456302 were measured by liquid chromatography-tandem mass spectrometry method. Safety analyses were conducted on all enrolled subjects. LY2456302 doses were well-tolerated with no clinically significant findings. No safety concerns were seen on co-administration with ethanol. No evidence for an interaction between LY2456302 and ethanol on cognitive-motor performance was detected. LY2456302 displayed rapid oral absorption and a terminal half-life of approximately 30-40 hours. Plasma exposure of LY2456302 increased proportionally with increasing doses and reached steady state after 6-8 days of once-daily dosing. Steady-state PK of LY2456302 were not affected by coadministration of a single dose of ethanol. No clinically important changes in maximum concentration (Cmax ) or AUC of ethanol (in the presence of LY2456302) were observed. © 2014, The American College of Clinical Pharmacology.

  3. Creative by Way of Adaption: Ramayana Relief of Prambanan Temple

    Directory of Open Access Journals (Sweden)

    Soeprapto Soedjono

    2015-10-01

    Full Text Available Artikel ini membahas tentang proses penciptaan karya seni berdasarkan teori adaptasi sebagaimana yang didiskusikan oleh Linda Hutcheon dalam bukunya yang berjudul: A Theory of Adaptation. Penekanan pembahasan lebih diletakkan pada aspek-aspek estetis visual yang terdapat pada karya seni relief naratif yang mengelilingi sepanjang dinding bagian dalam candi Prambanan di Kalasan, Yogyakarta. Sebagaimana tema relief yang diadaptasi dari ceritera legenda Ramayana yang ditulis oleh Walmiki pada waktu silam, maka proses penciptaan relief tersebut pada masa berikutnya diyakini mengikuti prosedur teori adaptasi tersebut.   This article aims to discuss the creation of arts based upon the theory of adaptation that had been laid on by Linda Hutcheon in her book called A Theory of Adaptation. The discussion has put emphasis on the elaboration of any visual aesthetics aspects embodied within the Ramayana sculptural program in the narrative relief which is encircling along Prambanan temple inner wall in Kalasan, Yogyakarta. Since the relief’s theme is derived from the ancient epic story of Ramayana legend (by Valmiki, it is plausible that the later creative process of the relief work was created through the adaptation theory procedure.

  4. A Randomized Clinical Trial to Measure Mouth Moisturization and Dry Mouth Relief in Dry Mouth Subjects Using Dry Mouth Products.

    Science.gov (United States)

    Jose, Anto; Atassi, Mounir; Shneyer, Lucy; Cronin, Matthew

    2017-06-01

    This study examined ratings of two subjective aspects (moisturization and dry mouth relief) that may be changed following the use of dry mouth relief products (an oral gel, an oral rinse, or a mouth spray), in comparison to water over a period of four hours following a single supervised use on two separate occasions. This was a single-center, two site, randomized, examiner blind, four treatment arm, stratified (by dry mouth screening score at baseline), parallel group study in healthy subjects with a self-reported feeling of dry mouth. Prior to product use, subjects rated their current subjective perception of moisturization and dry mouth on an 11-point scale. Subjects then rated the two questions immediately after product use and 30, 60, 90, 120, and 240 minutes later. At the 240-minute time point, subjects also rated global efficacy questions regarding "overall" and "long-lasting" moisturization and dry mouth relief, and overall product opinion. Subjects then used their assigned products at home for three days and the procedures were repeated on Day 4. In total, 300 subjects were randomized to treatment. Compared with water, all test products showed statistically significantly greater improvements over baseline on both Day 1 and Day 4 at most time points, on the area under the curve from baseline for the moisturization and dryness questions, and after 240 minutes for the global efficacy and overall opinion assessments (all p < 0.05). There was a statistically significant difference between the pre-dosing assessments on Day 1 versus Day 4 (p < 0.001) for both efficacy questions. Products were generally well-tolerated. Three different types of dry mouth relief products were shown to provide significant relief of dry mouth and increased feelings of moisturization compared to water using subjective questionnaires.

  5. Bridging the sanitation gap between disaster relief and development.

    Science.gov (United States)

    Lai, Ka-Man; Ramirez, Claudia; Liu, Weilong; Kirilova, Darina; Vick, David; Mari, Joe; Smith, Rachel; Lam, Ho-Yin; Ostovari, Afshin; Shibakawa, Akifumi; Liu, Yang; Samant, Sidharth; Osaro, Lucky

    2015-10-01

    By interpreting disasters as opportunities to initiate the fulfilment of development needs, realise the vulnerability of the affected community and environment, and extend the legacy of relief funds and effort, this paper builds upon the concept linking relief, rehabilitation and development (LRRD) in the sanitation sector. It aims to use a composite of case studies to devise a framework for a semi-hypothetical scenario to identify critical components and generic processes for a LRRD action plan. The scenario is based on a latrine wetland sanitation system in a Muslim community. Several sub-frameworks are developed: (i) latrine design; (ii) assessment of human waste treatment; (iii) connective sanitation promotion strategy; and (iv) ecological systems and environmental services for sanitation and development. This scenario illustrates the complex issues involved in LRRD in sanitation work and provides technical notes and references for a legacy plan for disaster relief and development. © 2015 The Author(s). Disasters © Overseas Development Institute, 2015.

  6. Epidural morphine for postoperative pain relief in children

    DEFF Research Database (Denmark)

    Henneberg, S W; Hole, P; Haas, Inge Madsen De

    1993-01-01

    Epidural morphine for postoperative pain relief is in general use, and has proved to be very efficient in adults. The epidural technique and the use of epidural morphine are much less frequent in children. For 2 years we have prospectively followed 76 children who had epidural morphine...... for postoperative pain relief after major abdominal surgery. The age distribution was from newborn to 13 years, with a median age of 12 months. It was estimated that 94% of the patients had good analgesia for the first 24 postoperative hours and no other opioids were given. The side effects were few, but one case...... the investigation. We observed a change in the sleeping pattern with an increased number of sleep-induced myoclonia during the administration of epidural morphine. In conclusion, the use of epidural morphine in children for postoperative pain relief is very efficient. The minimal effective dose has not been...

  7. Challenges and opportunities for humanitarian relief in Afghanistan.

    Science.gov (United States)

    Sharp, Trueman W; Burkle, Frederick M; Vaughn, Andrew F; Chotani, Rashid; Brennan, Richard J

    2002-06-15

    Afghanistan is in the midst of a profound humanitarian crisis resulting primarily from long-standing armed conflict, a devastating drought, and massive population migration. The economy, government, and health care system are in shambles. Currently, as many as 5 million Afghans are in camps either as refugees in neighboring countries or as internally displaced persons within Afghanistan. Much of the rest of the population is in dire need of basic essentials such as food, water, shelter, and basic medical care. Those attempting to carry out humanitarian relief face many daunting challenges, such as reaching remote locations, coping with a dangerous security situation, and working with limited resources. However, there are opportunities in the short run to save many lives and substantially improve the plight of Afghans by carrying out appropriate and effective emergency relief programs. Over the long term, effective medical and public health relief efforts will be an essential part of rehabilitating and rebuilding this devastated country.

  8. Experiences in disaster-related mental health relief work: An exploratory model for the interprofessional training of psychological relief workers.

    Science.gov (United States)

    Ren, ZhengJia; Wang, HongTao; Zhang, Wei

    2017-01-01

    The purpose of this study was to begin to generate an exploratory model of the disaster-related mental health education process associated with the training experiences of psychological relief workers active during the Sichuan earthquake in China. The data consisted of semi-structured interviews with 20 psychological relief workers from four different professions (social workers, psychiatric nurses, psychiatrists, and counsellors) regarding their experiences in training and ideas for improvement. The model explains the need to use a people-centred community interprofessional education approach, which focuses on role-modelling of the trainer, caring for relief workers, paying attention to the needs of the trainee, and building systematic interprofessional education strategies. The proposed model identifies areas for the comprehensive training of relief workers and aims to address the importance of people-centred mental health service provisions, ensure intentional and strategic training of relief workers using interprofessional concepts and strategies, and use culturally attuned and community-informed strategies in mental health training practices.

  9. Synapsin determines memory strength after punishment- and relief-learning.

    Science.gov (United States)

    Niewalda, Thomas; Michels, Birgit; Jungnickel, Roswitha; Diegelmann, Sören; Kleber, Jörg; Kähne, Thilo; Gerber, Bertram

    2015-05-13

    Adverse life events can induce two kinds of memory with opposite valence, dependent on timing: "negative" memories for stimuli preceding them and "positive" memories for stimuli experienced at the moment of "relief." Such punishment memory and relief memory are found in insects, rats, and man. For example, fruit flies (Drosophila melanogaster) avoid an odor after odor-shock training ("forward conditioning" of the odor), whereas after shock-odor training ("backward conditioning" of the odor) they approach it. Do these timing-dependent associative processes share molecular determinants? We focus on the role of Synapsin, a conserved presynaptic phosphoprotein regulating the balance between the reserve pool and the readily releasable pool of synaptic vesicles. We find that a lack of Synapsin leaves task-relevant sensory and motor faculties unaffected. In contrast, both punishment memory and relief memory scores are reduced. These defects reflect a true lessening of associative memory strength, as distortions in nonassociative processing (e.g., susceptibility to handling, adaptation, habituation, sensitization), discrimination ability, and changes in the time course of coincidence detection can be ruled out as alternative explanations. Reductions in punishment- and relief-memory strength are also observed upon an RNAi-mediated knock-down of Synapsin, and are rescued both by acutely restoring Synapsin and by locally restoring it in the mushroom bodies of mutant flies. Thus, both punishment memory and relief memory require the Synapsin protein and in this sense share genetic and molecular determinants. We note that corresponding molecular commonalities between punishment memory and relief memory in humans would constrain pharmacological attempts to selectively interfere with excessive associative punishment memories, e.g., after traumatic experiences. Copyright © 2015 Niewalda et al.

  10. Synapsin Determines Memory Strength after Punishment- and Relief-Learning

    Science.gov (United States)

    Niewalda, Thomas; Michels, Birgit; Jungnickel, Roswitha; Diegelmann, Sören; Kleber, Jörg; Kähne, Thilo

    2015-01-01

    Adverse life events can induce two kinds of memory with opposite valence, dependent on timing: “negative” memories for stimuli preceding them and “positive” memories for stimuli experienced at the moment of “relief.” Such punishment memory and relief memory are found in insects, rats, and man. For example, fruit flies (Drosophila melanogaster) avoid an odor after odor-shock training (“forward conditioning” of the odor), whereas after shock-odor training (“backward conditioning” of the odor) they approach it. Do these timing-dependent associative processes share molecular determinants? We focus on the role of Synapsin, a conserved presynaptic phosphoprotein regulating the balance between the reserve pool and the readily releasable pool of synaptic vesicles. We find that a lack of Synapsin leaves task-relevant sensory and motor faculties unaffected. In contrast, both punishment memory and relief memory scores are reduced. These defects reflect a true lessening of associative memory strength, as distortions in nonassociative processing (e.g., susceptibility to handling, adaptation, habituation, sensitization), discrimination ability, and changes in the time course of coincidence detection can be ruled out as alternative explanations. Reductions in punishment- and relief-memory strength are also observed upon an RNAi-mediated knock-down of Synapsin, and are rescued both by acutely restoring Synapsin and by locally restoring it in the mushroom bodies of mutant flies. Thus, both punishment memory and relief memory require the Synapsin protein and in this sense share genetic and molecular determinants. We note that corresponding molecular commonalities between punishment memory and relief memory in humans would constrain pharmacological attempts to selectively interfere with excessive associative punishment memories, e.g., after traumatic experiences. PMID:25972175

  11. Subducted oceanic relief locks the shallow megathrust in central Ecuador

    Science.gov (United States)

    Collot, Jean-Yves; Sanclemente, Eddy; Nocquet, Jean-Mathieu; Leprêtre, Angélique; Ribodetti, Alessandra; Jarrin, Paul; Chlieh, Mohamed; Graindorge, David; Charvis, Philippe

    2017-05-01

    Whether subducted oceanic reliefs such as seamounts promote seismic rupture or aseismic slip remains controversial. Here we use swath bathymetry, prestack depth-migrated multichannel seismic reflection lines, and wide-angle seismic data collected across the central Ecuador subduction segment to reveal a broad 55 km × 50 km, 1.5-2.0 km high, low height-to-width ratio, multipeaked, sediment-bare, shallow subducted oceanic relief. Owing to La Plata Island and the coastline being located, respectively, 35 km and 50-60 km from the trench, GPS measurements allow us to demonstrate that the subducted oceanic relief spatially correlates to a shallow, 80 km × 55 km locked interplate asperity within a dominantly creeping subduction segment. The oceanic relief geometrical anomaly together with its highly jagged topography, the absence of a subduction channel, and a stiff erosive oceanic margin are found to be long-term geological characteristics associated with the shallow locking of the megathrust. Although the size and level of locking observed at the subducted relief scale could produce an Mw >7+ event, no large earthquakes are known to have happened for several centuries. On the contrary, frequent slow slip events have been recorded since 2010 within the locked patch, and regular seismic swarms have occurred in this area during the last 40 years. These transient processes, together with the rough subducted oceanic topography, suggest that interplate friction might actually be heterogeneous within the locked patch. Additionally, we find that the subducted relief undergoes internal shearing and produces a permanent flexural bulge of the margin, which uplifted La Plata Island.

  12. Crash problem definition and safety benefits methodology for stability control for single-unit medium and heavy trucks and large-platform buses

    Science.gov (United States)

    2009-10-01

    This report presents the findings of a comprehensive engineering analysis of electronic stability control (ESC) and roll stability control (RSC) systems for single-unit medium and heavy trucks and large-platform buses. This report details the applica...

  13. Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study.

    Science.gov (United States)

    Seddighzadeh, Ali; Hung, Serena; Selmaj, Krzysztof; Cui, Yue; Liu, Shifang; Sperling, Bjoern; Calabresi, Peter A

    2014-11-01

    A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β1a (a pegylated interferon-β1a in clinical development) in a subset of relapsing-remitting multiple sclerosis (MS) patients participating in ATTAIN, a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study. Over 8 weeks, patients self-administered peginterferon-β1a 125 µg or placebo every 2 weeks (two injections via manual pre-filled syringe [PFS]; two injections via single-use autoinjector). Primary end points were incidence of adverse events (AEs), patient assessment of injection pain score (10-point Visual Analog Scale), and clinician assessment of injection site reactions (ISRs). Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials. In 39 patients, the safety profile of peginterferon-β1a was similar when delivered via autoinjector or PFS; AEs were mostly mild or moderate in severity. Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector, and pain scores were low (ISRs after administration with the autoinjector. Patients perceived the single-use autoinjector to be easy to use and convenient; overall patient satisfaction with the autoinjector and accompanying training materials was high. The safety and tolerability profile of peginterferon-β1a delivered via autoinjector was similar to delivery via PFS. Patients found the autoinjector easy to use and convenient; this device may simplify the injection process for MS patients who require long-term therapy, thereby potentially improving patient's quality of life and adherence.

  14. Pain relief and clinical outcome: from opioids to balanced analgesia

    DEFF Research Database (Denmark)

    Kehlet, H

    1996-01-01

    If it is generally accepted that adequate postoperative pain relief will improve outcome from surgery, several controlled trials demonstrated this only for lower body surgical procedures with epidural and spinal anesthetics. Important effects on outcome were not shown when postoperative opioids...... were administered with patient controlled (PCA) or epidural techniques. However, the most optimal pain relief seems to be best achieved with balanced analgesia techniques using combinations of epidural opioids and local anesthetics and systemic non-steroidal antiinflammatory drugs. Future efforts...... should aim at including physical rehabilitation programs in the pain treatment regimen....

  15. Percutaneous Relief of Tension Pneumomediastinum in a Child

    International Nuclear Information System (INIS)

    Chau, Helen Hoi-lun; Kwok, Philip Chong-hei; Lai, Albert Kwok-hung; Fan, Tsz Wo; Chan, Susan Chi-hum; Miu, Ting Yat; Chan, Grace Lai-har

    2003-01-01

    The purpose of this article was to describe the experience of relieving tension pneumomediastinum by a fluoroscopic-guided percutaneous method. We inserted a percutaneous drainage catheter with a Heimlich valve under fluoroscopic guidance to relieve the tension pneumomediastinum in a 2-year-old girl who suffered from dermatomyositis with lung involvement. This allowed immediate relief without the need for surgery. The procedure was repeated for relapsed tension pneumomediastinum. Good immediate results were achieved in each attempt. We conclude that percutaneous relief of pneumomediastinum under fluoroscopic guidance can be performed safely and rapidly in patients not fit for surgery

  16. Single-dose oral naproxen for acute postoperative pain: a quantitative systematic review

    Directory of Open Access Journals (Sweden)

    Moore R Andrew

    2003-09-01

    Full Text Available Abstract Background Naproxen and naproxen sodium are non-steroidal anti-inflammatory drugs used in a variety of painful conditions, including the treatment of postoperative pain. This review aims to assess the efficacy, safety and duration of action of a single oral dose of naproxen/naproxen sodium for moderate to severe acute postoperative pain in adults, compared with placebo. Methods The Cochrane Library (issue 4 2002, EMBASE, PubMed, MEDLINE and an in-house database were searched for randomised, double blind, placebo controlled trials of a single dose of orally administered naproxen or naproxen sodium in adults with acute postoperative pain. Pain relief or pain intensity data were extracted and converted into dichotomous information to give the number of patients with at least 50% pain relief over 4 to 6 hours. Relative benefit and number-needed-to-treat were then calculated. The percentage of patients with any adverse event, number-needed-to-harm, and time to remedication were also calculated. Results Ten trials with 996 patients in met the inclusion criteria. Six trials compared naproxen sodium 550 mg (252 patients with placebo (248 patients; the NNT for at least 50% pain relief over six hours was 2.6 (95% confidence interval 2.2 to 3.2. There was no significant difference between the number of patients experiencing any adverse event on treatment compared with placebo. Weighted mean time to remedication was 7.6 hours for naproxen sodium 550 mg (206 patients and 2.6 hours for placebo (205 patients. Four other trials used lower doses. Conclusion A single oral dose of naproxen sodium 550 mg is an effective analgesic in the treatment of acute postoperative pain. A low incidence of adverse events was found, although these were not reported consistently.

  17. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    OpenAIRE

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Herv?; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Kr?ger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 ho...

  18. Comparison of Efficacy and Safety between First and Second Generation Drug-eluting Stents in Patients with Stable Coronary Artery Disease: A Single-center Retrospective Study

    Directory of Open Access Journals (Sweden)

    Ru Liu

    2017-01-01

    Conclusions: G1-DES showed the same safety as G2-DES in this large Chinese cohort of real-world patients. However, G2-DES improved TLR-free survival of SCAD patients 2 years after PCI. The advantage was influenced by baseline clinical factors. G1-DES was associated with a trend of increase in revascularization risk and was not an independent predictor of worse medium-term prognosis compared with G2-DES.

  19. Sero-Surveillance to assess immunity to rubella and assessment of immunogenicity and safety of a single dose of rubella vaccine in school girls

    Directory of Open Access Journals (Sweden)

    Sharma Hitt

    2010-01-01

    Full Text Available Background: Rubella vaccination is not yet included in National Immunization Schedule in India. Serosurvey is frequently used to assess epidemiologic pattern of Rubella in a community. Serosurveys in different parts of India have found that 6-47% of women are susceptible for Rubella infection. The present serosurveillance was conducted in Jammu, India, in two public schools. Objective: To determine serological status of Rubella antibodies of school girls and assessment of immunogenicity and reactogenicity of Rubella immunization in seronegative girls. Materials and Methods: The current study was conducted to determine Rubella serostatus in peripubertal schoolgirls aged 11-18 years and also to assess immunogenicity and safety of Rubella vaccine (R-Vac of Serum Institute of India Ltd., Pune, in seronegative girls. For screening, pre-vaccination serum Rubella IgG antibodies were determined and to assess immunogenicity of the vaccine, post-vaccination IgG antibodies were compared with pre-vaccination levels. Safety assessment was done for a period of 8 weeks, post-vaccination. Results: A total of 90 (32.7% seronegative girls were vaccinated. All girls (100% became seropositive, post-vaccination. Clinically relevant and statistically significant increase in anti-Rubella IgG titres was observed. The adverse events were mild and self-limiting. Conclusions: R-Vac vaccine used in the study demonstrated an excellent safety and immunogenicity profile.

  20. Pressure Relief Devices for High-Pressure Gaseous Storage Systems: Applicability to Hydrogen Technology

    Energy Technology Data Exchange (ETDEWEB)

    Kostival, A.; Rivkin, C.; Buttner, W.; Burgess, R.

    2013-11-01

    Pressure relief devices (PRDs) are viewed as essential safety measures for high-pressure gas storage and distribution systems. These devices are used to prevent the over-pressurization of gas storage vessels and distribution equipment, except in the application of certain toxic gases. PRDs play a critical role in the implementation of most high-pressure gas storage systems and anyone working with these devices should understand their function so they can be designed, installed, and maintained properly to prevent any potentially dangerous or fatal incidents. As such, the intention of this report is to introduce the reader to the function of the common types of PRDs currently used in industry. Since high-pressure hydrogen gas storage systems are being developed to support the growing hydrogen energy infrastructure, several recent failure incidents, specifically involving hydrogen, will be examined to demonstrate the results and possible mechanisms of a device failure. The applicable codes and standards, developed to minimize the risk of failure for PRDs, will also be reviewed. Finally, because PRDs are a critical component for the development of a successful hydrogen energy infrastructure, important considerations for pressure relief devices applied in a hydrogen gas environment will be explored.

  1. Design of emergency relief system to flare; Projeto de sistemas de alivio de emergencia para tocha

    Energy Technology Data Exchange (ETDEWEB)

    Britto, Joelson de Carvalho [PETROBRAS, Rio de Janeiro, RJ (Brazil)

    2004-07-01

    The relief system has for objective to protect the unit equipment and piping system for high pressures developed during eventual operational upset. As examples of operational upset could mention: human failure (operational mistake - example: inadvertent closure of a block valve), heat exchange tube rupture, utility failure (cooling water, electric power, steam, instrument air) and fire. The relieved products are piping to flare system in order to burn the waste gas. The burned or unburned relieved stream shall be dispersed in order to not to cause damages to the people and the environment. That system should operate automatically without the need of interference of the personnel of the operation. The system is basically constituted of Pressure Safety and Relief Valves (PSVs), piping net, gas-liquid separation vessel, separation vessel residual liquid pump (if necessary) and flare for burning waste gas without liquid. They are necessary also some utilities as fuel gas (to be used as purge gas by flare tip and as fuel gas by pilots in order to guarantee the continuous operation of the flare pilots), electric power, instrument/service air and compressed air or steam (if necessary) to improve the quality of the burns. (author)

  2. Pharmacological interventions for pain relief during orthodontic treatment.

    Science.gov (United States)

    Monk, Aoife B; Harrison, Jayne E; Worthington, Helen V; Teague, Annabel

    2017-11-28

    rating scale (NRS) or categorical scale. Two review authors independently screened the search results, agreed the studies to be included and extracted information from the included studies regarding methods, participants, interventions, outcomes, harms and results. We planned to resolve any discrepancies or disagreements through discussion. We used the Cochrane 'Risk of bias' tool to assess the risk of bias in the studies. We identified 32 relevant RCTs, which included 3110 participants aged 9 to 34 years, 2348 of whom we were able to include in our analyses. Seventeen of the studies had more than two arms. We were able to use data from 12 trials in meta-analyses that compared analgesics versus control (no treatment or a placebo); nine that compared non-steroidal anti-inflammatories (NSAIDs) versus paracetamol; and two that compared pre-emptive versus post-treatment ibuprofen for pain control following orthodontic treatment. One study provided data for the comparison of NSAIDs versus local anaesthetic.We found moderate-quality evidence that analgesics effectively reduced pain following orthodontic treatment when compared to no treatment or a placebo at 2 hours (mean difference (MD) -11.66 mm on a 0 to 100 mm VAS, 95% confidence interval (CI) -16.15 to -7.17; 10 studies, 685 participants), 6 hours (MD -24.27 mm on a VAS, 95% CI -31.44 to -17.11; 9 studies, 535 participants) and 24 hours (MD -21.19 mm on a VAS, 95% CI -28.31 to -14.06; 12 studies, 1012 participants).We did not find any evidence of a difference in efficacy between NSAID and paracetamol at 2, 6 or 24 hours (at 24 hours: MD -0.51, 95% CI -8.93 to 7.92; 9 studies, 734 participants; low-quality evidence).Very low-quality evidence suggested pre-emptive ibuprofen gave better pain relief at 2 hours than ibuprofen taken post treatment (MD -11.30, 95% CI -16.27 to -6.33; one study, 41 participants), however, the difference was no longer significant at 6 or 24 hours.A single study of 48 participants compared topical

  3. Pain relief at the end of life: nurses' experiences regarding end-of-life pain relief in patients with dementia.

    Science.gov (United States)

    Brorson, Hanna; Plymoth, Henrietta; Örmon, Karin; Bolmsjö, Ingrid

    2014-03-01

    Patients with dementia receive suboptimal palliative care, and this patient group is at risk to have pain at the end of life. Because communicative impairments are common in this patient group, nurses play an important caregiver role in identifying, assessing, and relieving patients' pain. This study aimed to describe nurses' experiences regarding end-of-life pain relief in patients with dementia. This descriptive exploratory qualitative study was based on seven semistructured interviews. Burnard's content analysis inspired the data analysis. Two main categories were identified: (1) nurses' experience of difficulties concerning pain relief and (2) nurses' experience of resources concerning pain relief. Nurses experienced difficulties, such as feeling of powerlessness because of difficulties in obtaining adequate prescriptions for analgesics, ethical dilemmas, feeling of inadequacy because analgesia did not have the desired effect, and a feeling of not being able to connect with the patient. Factors, including knowledge about the patient, professional experience, utilization of pain assessment tools, interpersonal relationships, and interprofessional cooperation, served as resources and enabled end-of-life pain relief. The results of this study highlight the complexity of pain relief in patients with dementia at the end of life from a nursing perspective. The inability of patients with dementia to verbally communicate their pain makes them a vulnerable patient group, dependent on their caregivers. Knowing the life story of the patient, professional experience, teamwork based on good communication, and use of a pain assessment tool were reported by the nurses to improve pain relief at the end of life for patients with dementia. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  4. Nuclear safety in Slovak Republic. Status of safety improvements

    International Nuclear Information System (INIS)

    Toth, A.

    1999-01-01

    Status of the safety improvements at Bohunice V-1 units concerning WWER-440/V-230 design upgrading were as follows: supplementing of steam generator super-emergency feed water system; higher capacity of emergency core cooling system; supplementing of automatic links between primary and secondary circuit systems; higher level of secondary system automation. The goal of the modernization program for Bohunice V-1 units WWER-440/V-230 was to increase nuclear safety to the level of the proposals and IAEA recommendations and to reach probability goals of the reactor concerning active zone damage, leak of radioactive materials, failures of safety systems and damage shields. Upgrading program for Mochovce NPP - WWER-440/V-213 is concerned with improving the integrity of the reactor pressure vessel, steam generators 'leak before break' methods applied for the NPP, instrumentation and control of safety systems, diagnostic systems, replacement of in-core monitoring system, emergency analyses, pressurizers safety relief valves, hydrogen removal system, seismic evaluations, non-destructive testing, fire protection. Implementation of quality assurance has a special role in improvement of operational safety activities as well as safety management and safety culture, radiation protection, decommissioning and waste management and training. The Year 2000 problem is mentioned as well

  5. A Closer Look: The American Taxpayer Relief Act of 2012

    Science.gov (United States)

    Balmer, Mary

    2013-01-01

    School districts may be affected by the American Taxpayer Relief Act of 2012 with regard to fixed assets management and education entities. The act avoids the scheduled increases to individual income tax rates for most Americans and extends a host of expired and expiring tax provisions for both individuals and businesses. The provisions described…

  6. Topology-optimized broadband surface relief transmission grating

    DEFF Research Database (Denmark)

    Andkjær, Jacob; Ryder, Christian P.; Nielsen, Peter C.

    2014-01-01

    We propose a design methodology for systematic design of surface relief transmission gratings with optimized diffraction efficiency. The methodology is based on a gradient-based topology optimization formulation along with 2D frequency domain finite element simulations for TE and TM polarized plane...

  7. Pain Relief in Postabortion Care Practiced by Healthcare ...

    African Journals Online (AJOL)

    anxiolytics. The general anesthesia and paracervical block were offered only by the doctors. Table 3 shows the various sociodemographic variables and their association with the use of pain relief in PAC offered by the healthcare professionals. Only 115 (41.1%) and 55 (35.0%) of the health professionals in the rural and.

  8. Bas-relief generation using adaptive histogram equalization.

    Science.gov (United States)

    Sun, Xianfang; Rosin, Paul L; Martin, Ralph R; Langbein, Frank C

    2009-01-01

    An algorithm is presented to automatically generate bas-reliefs based on adaptive histogram equalization (AHE), starting from an input height field. A mesh model may alternatively be provided, in which case a height field is first created via orthogonal or perspective projection. The height field is regularly gridded and treated as an image, enabling a modified AHE method to be used to generate a bas-relief with a user-chosen height range. We modify the original image-contrast-enhancement AHE method to use gradient weights also to enhance the shape features of the bas-relief. To effectively compress the height field, we limit the height-dependent scaling factors used to compute relative height variations in the output from height variations in the input; this prevents any height differences from having too great effect. Results of AHE over different neighborhood sizes are averaged to preserve information at different scales in the resulting bas-relief. Compared to previous approaches, the proposed algorithm is simple and yet largely preserves original shape features. Experiments show that our results are, in general, comparable to and in some cases better than the best previously published methods.

  9. Optimization for sinusoidal profiles in surface relief gratings ...

    Indian Academy of Sciences (India)

    2014-02-07

    Feb 7, 2014 ... ometric pattern in photosensitive materials such as photoresists and many other types of photopolymers that are capable of generating surface relief structures. Indigenous devel- opment of such diffraction gratings has been taken up in our department for laser and spectroscopic applications. The purpose ...

  10. Building relations with women's organisations in relief work.

    Science.gov (United States)

    Gell, F

    1997-02-01

    An Oxfam Emergency Team arrived in Ingushetia in the Northern Caucasus region of the former Soviet Union in August 1996 to set up a program of shelter, rehabilitation, and relief in response to the large influx of people displaced by conflicts in the neighboring republics of Chechnya and North Ossetia. The team was also tasked with contacting community organizations such as women's groups and developing a relationship with them through joint relief work. The Chechen population was comprised of mainly women, children, and the elderly. The internally displaced population of 100,000 people is now scattered throughout the republic in collective centers and host families. Small committees of women were formed to help identify the most vulnerable residents and to distribute winter clothing. It was found during the relief work that fledgling women's groups are establishing themselves as vehicles for change, increasingly open to work with and learn from international organizations such as Oxfam. The Chechen branch of the Union of North Caucasian Women and the Ingushetian ALMOS played leading roles in peacemaking, human rights observance, and humanitarian relief.

  11. Topical cryotherapy-use for relief of pain and spasticity.

    Science.gov (United States)

    Mead, S; Knott, M

    1966-09-01

    Cold applications are sometimes of pronounced symptomatic benefit in some rheumatic disorders such as acute myalgia; in the temporary relief of spasticity; in helping to release tight structures in poliomyelitis and allied diseases; and in temporary recovery of energy in multiple sclerosis.

  12. Topical Cryotherapy—Use for Relief of Pain and Spasticity

    Science.gov (United States)

    Mead, Sedgwick; Knott, Margaret

    1966-01-01

    Cold applications are sometimes of pronounced symptomatic benefit in some rheumatic disorders such as acute myalgia; in the temporary relief of spasticity; in helping to release tight structures in poliomyelitis and allied diseases; and in temporary recovery of energy in multiple sclerosis. PMID:18730022

  13. Trends in intraoperative pain relief in anesthesized Nigerian ...

    African Journals Online (AJOL)

    shobha

    Aim: The study aims at examining the current trend in intraoperative pain relief in patients of pediatric age at the. University of ... skills acquisition of physicians and other relevant health care personnel in the development ofpediatric acute pain service (PAPS) .... foreign body removal (13 i.e.1.9%), skin graft. (18 i.e. 2.7%) ...

  14. Careful: Acetaminophen in Pain Relief Medicines Can Cause Liver Damage

    Science.gov (United States)

    ... Pain Relievers and Fever Reducers Careful: Acetaminophen in pain relief medicines can cause liver damage Share Tweet Linkedin Pin it More sharing options Linkedin Pin ... ingredient in many over-the-counter and prescription medicines that help relieve pain and reduce fever. More than 600 over-the- ...

  15. 27 CFR 19.251 - Relief of surety from bond.

    Science.gov (United States)

    2010-04-01

    ... deposits wholly subsequent to the effective date of the new or superseding bond. Notwithstanding such relief, the surety shall remain liable for the tax on all distilled spirits or wines produced, or for... bond for all spirits or wines on hand or in transit to the bonded premises or bonded wine cellar, as...

  16. Poverty Relief or Poverty Eradication? | Kritzinger | Acta Theologica

    African Journals Online (AJOL)

    The author challenges the reader to make two mindshifts: from a focus on poverty relief to an emphasis on poverty eradication; and from viewing the poor as the objects of poverty alleviation to accepting them as the subjects of poverty eradication. The case is argued and a practical approach towards poverty eradication is ...

  17. Civil-military relations in disaster rescue and relief activities ...

    African Journals Online (AJOL)

    This article examines engagements between civilian actors, the Philippine security forces and the US military during disaster response operations. The Philippine disaster framework recognises the military's role in disaster relief and has existing mechanisms for accepting international assistance and procedures for ...

  18. 19 CFR 210.68 - Complainant's temporary relief bond.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Complainant's temporary relief bond. 210.68 Section 210.68 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR... individual, a trust, an estate, or a partnership, or a corporation, whose solvency and financial...

  19. Pain relief using paraceevical block in patients undergoing manual ...

    African Journals Online (AJOL)

    Objective: To evaluate pain relief using paracervical nerve block with 1% lignocaine injection in patients undergoing uterine evacuation by Manual Vacuum Aspiration (MVA) for the treatment of incomplete abortion. Design: A randomized double blind clinical trial. Setting: Marie Stopes Health Centre, Nairobi. Methods: One ...

  20. Japanese women's experiences of pharmacological pain relief in New Zealand.

    Science.gov (United States)

    Doering, Keiko; Patterson, Jean; Griffiths, Christine R

    2014-06-01

    In Japan, most women manage labour pain without pharmacological interventions. However, New Zealand statistics show a high percentage of epidural use amongst Asian women. Entonox (a gas mixture of nitrous oxide and oxygen) and pethidine are also available to women in New Zealand. This article investigates how Japanese women in New Zealand respond to the use of pharmacological pain relief in labour. The study was guided by two research questions: (1) How do Japanese women experience and manage labour pain in New Zealand? (2) How do they feel about the use of pharmacological pain relief? Thirteen Japanese women who had given birth in New Zealand were interviewed individually or in a focus group. The conversations were analysed using thematic analysis. Although in Japan very few women use pain relief, nine women received epidural and/or Entonox out of 11 women who experienced labour pain. The contrast between their Japanese cultural expectations and their birth experiences caused some of the women subsequent personal conflict. Japanese women's cultural perspectives and passive attitudes were demonstrated to influence the decision-making process concerning pain relief. It was concluded that understanding Japanese cultural worldviews and approaches to the role of pain in labour would help maternity providers in their provision of appropriate care for Japanese women. Copyright © 2013 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  1. Diffraction from relief gratings on a biomimetic elastomer cast

    International Nuclear Information System (INIS)

    Guerrero, Raphael A.; Aranas, Erika B.

    2010-01-01

    Biomimetic optical elements combine the optimized designs of nature with the versatility of materials engineering. We employ a beetle carapace as the template for fabricating relief gratings on an elastomer substrate. Biological surface features are successfully replicated by a direct casting procedure. Far-field diffraction effects are discussed in terms of the Fraunhofer approximation in Fourier space.

  2. Knowledge of and attitude towards pain relief during labour of ...

    African Journals Online (AJOL)

    Objective: This study determined women's knowledge of and attitudes to pain relief during labour. Methods: This descriptive study included 151 women, 18 years or older, attending the antenatal clinic of Cecilia Makiwane Hospital. Women were interviewed using a questionnaire that determined their knowledge of and ...

  3. civil-military relations in disaster rescue and relief activities

    African Journals Online (AJOL)

    Abel

    and Natural Resources (DENR) and Public Works and Highways (DPWH) and the. Tacloban City chapter of the ... focus group discussions were conducted with 18 officers and enlisted men from the. 8th Regional .... rescue and disaster relief teams, and their accompanying equipment and supplies. Assistance by way of ...

  4. 2-minute Gridded Global Relief Data (ETOPO2) v2

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Two-minute gridded global relief for both ocean and land areas are available in the ETOPO2v2 (2006) database. ETOPO2v2 replaced ETOPO2 (2001). The historic 2-minute...

  5. Pain Relief in Labor: A Randomized Controlled Trial Comparing ...

    African Journals Online (AJOL)

    Conclusions: This study showed that 600 mg intramuscular paracetamol provides similar and modest pain relief in labor when compared to 100 mg intramuscular tramadol. It also has fewer maternal adverse effects and favorable neonatal outcome such as tramadol. It is concluded that intramuscular paracetamol is simple, ...

  6. A Surface Relief Meter Based on Trinocular Vision

    NARCIS (Netherlands)

    Ernst, V.G.S.; Sablik, P.W.; Balendonck, J.; Houkes, Z.; Regtien, Paulus P.L.

    1995-01-01

    The concept for the relief meter being developed, appears to function well, when used with the artificial images. The described matching criterion leads to high matching percentages, and accurate results. The percentage of mismatches is reduced to practically zero for the tested scenes. Future work

  7. Bivalent oral cholera vaccine in participants aged 1 year and older in the Dominican Republic: A phase III, single-arm, safety and immunogenicity trial.

    Science.gov (United States)

    Cordero De Los Santos, Lina; Feris-Iglesias, Jesús; Aloysia D'Cor, Naveena; Midde, Venkata Jayanth; Patnaik, Badri Narayan; Thollot, Yaël; Rasuli, Anvar; Desauziers, Eric

    2018-02-22

    The Dominican Republic, historically non-endemic for cholera, is experiencing an ongoing cholera epidemic. We assessed the safety and immunogenicity of two doses of the killed bivalent (O1 and O139) whole-cell oral cholera vaccine (OCV) on day (D)0 and D14 in healthy participants aged ≥1 year. Immediate unsolicited systemic adverse events (AEs) were monitored up to 30 minutes and solicited systemic reactions, up to 7 days after each vaccination. Unsolicited AEs were recorded up to D14 (post-dose 1) and 30 days post-dose 2. A vibriocidal antibody assay with microtiter technique was used to measure serum antibodies to V. cholerae strains (O1 El Tor Inaba, O1 El Tor Ogawa, O139) on D0, D14 and D28. Geometric mean titers (GMTs) and seroconversion (≥4-fold increase from D0) rates were calculated. We recruited 336 participants; 112 in three age groups (1-4, 5-14 and ≥15 years). No safety concerns were observed. GMTs increased from baseline for all serotypes, with marked increases for O1 Inaba and Ogawa post-dose 1. Post-dose 2 GMTs tended to be equal or slightly lower, with ranges: O1 Inaba, 283 (95% confidence interval 191-419) to 612 (426-880); O1 Ogawa, 346 (223-536) to 754 (553-1028); and O139, 20.3 (13.5-30.6) to 43.8 (30.1-63.7). Seroconversion rates post-dose 2 for O1 Inaba and Ogawa were high (≥87%) for all age groups. OCV demonstrated an acceptable safety profile and robust immunogenicity in these participants, in-line with previous observations in epidemic and endemic settings.This study is registered on www.clinicaltrials.gov (NCT02434822).

  8. A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain.

    Science.gov (United States)

    Wen, Warren; Sitar, Steve; Lynch, Shau Yu; He, Ellie; Ripa, Steven R

    2015-01-01

    This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP). The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) using a mixed effect model with repeated measures incorporating a pattern mixture model framework. Responder analysis was a secondary endpoint. Safety was assessed. Out of 905 patients who were treated with HYD during the open-label titration period, 588 (65%) were randomized to continue to receive HYD (n = 296, 20 - 120 mg taken once daily, average daily dose 57 mg) or a matching placebo (n = 292). HYD demonstrated superior pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain from screening to week 12 also favored HYD (p = 0.0033 and 0.0225, respectively). HYD was generally well tolerated. HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.

  9. Barriers to spousal contribution to childbirth pain relief in Nigeria.

    Science.gov (United States)

    Emelonye, A U; Pitkäaho, T; Aregbesola, A; Vehviläinen-Julkunen, K

    2017-12-01

    The aim of this study was to investigate the barriers inhibiting the use of spousal presence for childbirth pain relief in health facilities and recommendations from three perspectives: the midwife, the woman, and the spouse. Spousal presence is a non-invasive, participatory and inexpensive technique used in pain management during childbirth. Although it contributes to a large extent in relieving childbirth pain, it is underutilized in Nigerian hospitals. Overcoming the challenges impeding spousal presence and participation during childbirth will improve maternal outcome, satisfaction and midwifery care practices. A cross-sectional survey conducted in four hospitals in Nigeria involving midwives (n = 100), women (n = 142) and their spouses (n = 142) from June to December 2014 using pretested questionnaires. Five themes were identified: poor infrastructural facility, lack of adequate pain management policy, lack of midwife pain management practices, midwives' attitudes towards spousal presence during childbirth and feelings about spousal presence during childbirth pain relief. Infrastructural defects in the health facilities resulting in the lack of privacy in maternity units for both spouses and partners negatively influence the presence of a spouse during childbirth and pain relief. Adopting effective strategies such as good infrastructural facilities, staff training and spouse-friendly hospital policies will encourage spouses to fully participate in and contribute to childbirth pain relief. This study identified poor staff attitudes towards pain relief and spousal presence during childbirth as barriers. Providing adequate policies on pain management, continuous staff education and orientation on spousal relationship will improve active spousal participation and maternal satisfaction during childbirth. © 2016 International Council of Nurses.

  10. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study.

    Science.gov (United States)

    Huang, Li-Min; Chiu, Nan-Chang; Yeh, Shu-Jen; Bhusal, Chiranjiwi; Arora, Ashwani Kumar

    2014-09-08

    MenACWY-CRM (Menveo®, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is approved within the European Union in persons >2 years of age and in persons from 2 months to 55 years of age in the United States, among other countries. Little is known about the immunogenicity and safety of this vaccine in Taiwanese children >2 years and adolescents. This study assessed the immunogenicity and safety of a single injection of MenACWY-CRM vaccine in Taiwanese subjects aged 2-18 years old. In this phase III, multicentre, open-label study 341 subjects received one dose of MenACWY-CRM. Immunogenicity measures were rates of seroresponse (defined as the proportion of subjects with a postvaccination hSBA ≥1:8 if the prevaccination (baseline) titre was CRM vaccination at Day 29 for the serogroups A, C, W, and Y were 83%, 93%, 50%, and 65%, respectively. At Day 29 the percentages of subjects with hSBA ≥1:8 against all four serogroups A, C, W and Y were: 83%, 96%, 96% and 82%, respectively. GMTs against all serogroups rose by ≥7-fold from baseline to Day 29. The vaccine was well tolerated. A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese children and adolescents. Copyright © 2014 Elsevier Ltd. All rights reserved.

  11. Reparative therapy for acute ischemic stroke with allogeneic mesenchymal stem cells from adipose tissue: a safety assessment: a phase II randomized, double-blind, placebo-controlled, single-center, pilot clinical trial.

    Science.gov (United States)

    Díez-Tejedor, Exuperio; Gutiérrez-Fernández, María; Martínez-Sánchez, Patricia; Rodríguez-Frutos, Berta; Ruiz-Ares, Gerardo; Lara, Manuel Lara; Gimeno, Blanca Fuentes

    2014-01-01

    Few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke. Intravenous administration of allogeneic mesenchymal stem cells (MSCs) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair, consequently supporting better functional recovery. We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair. A Phase IIa, prospective, randomized, double-blind, placebo-controlled, single-center, pilot clinical trial. Twenty patients presenting acute ischemic stroke will be randomized in a 1:1 proportion to treatment with allogeneic MSCs from adipose tissue or to placebo (or vehicle) administered as a single intravenous dose within the first 2 weeks after the onset of stroke symptoms. The patients will be followed up for 2 years. Primary outcomes for safety analysis: adverse events (AEs) and serious AEs; neurologic and systemic complications, and tumor development. Secondary outcomes for efficacy analysis: modified Rankin Scale; NIHSS; infarct size; and biochemical markers of brain repair (vascular endothelial growth factor, brain-derived neurotrophic factor, and matrix metalloproteinases 9). To our knowledge, this is the first, phase II, pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first 2 weeks of stroke. In addition, its results will help us define the best criteria for a future phase III study. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  12. Single and Multiple Dose Pharmacokinetics, Pharmacodynamics and Safety of the Novel Lipoprotein-Associated Phospholipase A2 Enzyme Inhibitor Darapladib in Healthy Chinese Subjects: An Open Label Phase-1 Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Chaoying Hu

    Full Text Available Darapladib is a lipoprotein-associated phospholipase A2 (Lp-PLA2 inhibitor. This study evaluated the pharmacokinetics, pharmacodynamics and safety of darapladib in healthy Chinese subjects.Twenty-four subjects received darapladib 160 mg orally, approximately 1 hour after a standard breakfast, as a single dose and once daily for 28 days. Non-compartmental methods were used to determine the single and multiple dose pharmacokinetics of darapladib and its metabolite SB-553253. Repeat dose Lp-PLA2 activity and safety were evaluated.Systemic exposure (AUC(0-T, Cmax geometric mean (CVb% of darapladib was higher after multiple-dosing (519 ng.h/mL (33.3%, 34.4 ng/mL (49.9% compared to single-dose administration (153 ng.h/mL (69.0%, 17.9 ng/mL (55.2%. The steady-state accumulation ratio was less than unity (Rs = 0.80, indicating time-dependent pharmacokinetics of darapladib. Darapladib steady-state was reached by Day 14 of once daily dosing. Systemic exposure to SB-553253 was lower than darapladib with median (SB-553253: darapladib ratios for AUC(0-τ of 0.0786 for single dose and 0.0532 for multiple dose administration. On Day 28, pre-dose and maximum inhibition of Lp-PLA2 activity was approximately 70% and 75% relative to the baseline value, respectively and was dependent of darapladib concentration. The most common adverse events (≥ 21% subjects were abnormal faeces, abnormal urine odour, diarrhoea and nasopharyngitis.Darapladib 160 mg single and repeat doses were profiled in healthy Chinese subjects. Single dose systemic exposure to darapladib in healthy Chinese subjects was consistent with that observed previously in Western subjects whereas steady-state systemic exposure was approximately 65% higher in Chinese than Western subjects. The Lp-PLA2 activity and adverse event profile were similar in healthy Chinese and previous reports in Western subjects. Ethnic-specific dose adjustment of darapladib is not considered necessary for the Chinese

  13. Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study.

    Science.gov (United States)

    Schiopu, Elena; Chatterjee, Soumya; Hsu, Vivien; Flor, Armando; Cimbora, Daniel; Patra, Kaushik; Yao, Wenliang; Li, Jing; Streicher, Katie; McKeever, Kathleen; White, Barbara; Katz, Eliezer; Drappa, Jorn; Sweeny, Sarah; Herbst, Ronald

    2016-06-07

    Systemic sclerosis (SSc) is a clinically heterogeneous, life-threatening disease characterized by fibrosis, microvasculopathy, and autoimmunity. Extensive nonclinical and clinical data implicate B cells in the pathogenesis of SSc. MEDI-551 is an investigational humanized monoclonal antibody that targets the B cell surface antigen CD19 and mediates antibody-dependent, cell-mediated cytotoxicity of B cells. This clinical study evaluated the safety and tolerability, pharmacokinetics, and pharmacodynamics of MEDI-551 in subjects with SSc. This phase I multicenter, randomized, double-blind, placebo-controlled, single escalating dose study enrolled adult subjects with either limited or diffuse cutaneous SSc. A single intravenous dose of MEDI-551 was administered, and safety and tolerability were evaluated. MEDI-551 pharmacokinetics (PK), pharmacodynamics, and immunogenicity were also assessed. Safety assessments included the incidence of adverse events and changes in clinical and laboratory results. MEDI-551 serum concentrations, effects on circulating and tissue B cells and plasma cells (PCs), and antidrug antibodies were analyzed. Modified Rodnan skin score (MRSS) and pulmonary function tests were used to explore the clinical effect of MEDI-551. The study enrolled 28 subjects with SSc (mean age, 47.3 years; 67.9 % female). Twenty-four received a single dose of MEDI-551 (0.1-10.0 mg/kg) and four received placebo. Treatment-emergent adverse events (TEAEs) occurred in 95.8 % of subjects in the MEDI-551 group and in 75.0 % of subjects in the placebo group; the majority of TEAEs were mild or moderate in severity. Two serious adverse events were considered possibly related to the study drug. One death, deemed not related to the study drug, occurred in a MEDI-551-treated subject. MEDI-551 exhibited linear PK in the dose range of 1.0 to 10.0 mg/kg, and more rapid clearance at lower doses. Dose-dependent depletion of circulating B cells and plasma cells was observed. MRSS

  14. Single dose oral tenoxicam for acute postoperative pain in adults.

    Science.gov (United States)

    Moore, Owen A; McIntyre, Mairead; Moore, R Andrew; Derry, Sheena; McQuay, Henry J

    2009-07-08

    Tenoxicam is a non-steroidal anti-inflammatory drug (NSAID) licensed for use in rheumatic disease and other musculoskeletal disorders in the UK, and is widely available in other countries worldwide. This review sought to evaluate the efficacy and safety of oral tenoxicam in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 hours using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties. To assess the efficacy of single dose oral tenoxicam in acute postoperative pain, and any associated adverse events. We searched The Cochrane Library (Issue 1, 2009), MEDLINE (March 2009); EMBASE via Ovid (March 2009); the Oxford Pain Relief Database. Randomised, double-blind, placebo-controlled clinical trials of oral tenoxicam for relief of acute postoperative pain in adults. Two review authors independently assessed trial quality and extracted data. The area under the "pain relief versus time" curve was used to derive the proportion of participants with tenoxicam experiencing least 50% pain relief over 4 to 6 hours, using validated equations. The number needed to treat to benefit (NNT) was calculated using 95% confidence intervals (CI). The proportion of participants using rescue analgesia over a specified time period, and time to use of rescue analgesia, were sought as additional measures of efficacy. Information on adverse events and withdrawals was also collected. Not one of sixteen studies identified by the searches and examined in detail studied oral tenoxicam in patients with established postoperative pain and therefore no results are available. In the absence of evidence of efficacy for oral tenoxicam in acute postoperative pain, its use in this indication is not justified at present. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be

  15. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    Science.gov (United States)

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

  16. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing phase IV study

    Directory of Open Access Journals (Sweden)

    Bashaireh K

    2015-04-01

    Full Text Available Khaldoon Bashaireh,1 Ziad Naser,2 Khaled Al Hawadya,2 Sorour Sorour,2 Rami Nabeel Al-Khateeb3 1Department of Orthopedics Surgery, King Abdullah University Hospital, Jordan University of Science and Technology, Irbid, Jordan; 2Private Clinic, 3Elaf Medical Supplies Company, Amman, Jordan Purpose: The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period.Materials and methods: The study was a post-marketing phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4 in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection.Main outcome measure(s: An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated.Main results: The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3

  17. Percutaneous vertebroplasty in vertebral metastases from breast cancer: interest in terms of pain relief and quality of life.

    Science.gov (United States)

    Barragán-Campos, Héctor Manuel; Le Faou, Anne-Laurence; Rose, Michèle; Livartowski, Alain; Doz, Marianne; Astagneau, Pascal; Cormier, Evelyne; Chiras, Jacques

    2014-10-31

    Percutaneous vertebroplasty (PV) is a therapeutic option in patients with vertebral metastases (VM). However its efficacy in pain relief, improvement in quality of life and safety in patients with VM from breast cancer has not been reported. We present a longitudinal retrospective study of 31 consecutively treated female patients with VM from breast cancer where 88 vertebrae were treated in 44 sessions of PV, in which osteolytic, osteoblastic and mixed lesions were recorded. The visual analogue pain scale (VAS) was used to evaluate pain pre-PV, at one, three, six and 12 months post-PV. The Eastern Cooperative Group (ECOG) performance status scale was used at the same time intervals to measure quality of life: 90.3% pain relief was identified with a VAS reduction from 5.7 ± 2.0 pre-PV to 2.9 ± 2.2 post-PV at one-month follow-up (ppain relief, and improvement of quality of life in patients with diverse types of VM from breast cancer.

  18. Shoulder motion assistance using a single-joint Hybrid Assistive Limb®robot: Evaluation of its safety and validity in healthy adults.

    Science.gov (United States)

    Makihara, Takeshi; Kadone, Hideki; Onishi, Shinzo; Kubota, Shigeki; Hada, Yasushi; Shimizu, Yukiyo; Kawamoto, Hiroaki; Sankai, Yoshiyuki; Yamazaki, Masashi

    2017-01-01

    To evaluate the feasibility of using the single-joint Hybrid Assistive Limb ® robot (HAL) to assist with shoulder flexion-extension in healthy adults, and to assess the capacity of the HAL to analyze the bioelectrical signals of muscle activity for shoulder flexion-extension. This cross-sectional feasibility study included six healthy adult men with no impairment in shoulder motion. The single-joint HAL was fixed to a custom-designed platform and upper arm attachment, and aligned 3 cm below the acromion process. Vital signs, shoulder fatigue, and shoulder pain were evaluated before and after the shoulder elevation exercise performed with and without the HAL. Activity of selected muscles of the shoulder was recorded using a wireless superficial electromyography device. Shoulder movement was captured using a three-dimensional motion analysis system. The HAL supported smooth flexion-extension of the arm at the shoulder joint, with no negative effects on vital signs, shoulder fatigue, and shoulder pain. The HAL decreased muscle activity levels, with a 55% decrease in trapezius muscle activity. The upward rotation angle of the scapula was significantly lower with the HAL at 120° of shoulder flexion. The single-joint HAL provided safe and effective assistance to scapular plane shoulder flexion-extension among healthy adults.

  19. Safety and Efficacy of Using a Single Transradial MAC Guiding Catheter for Coronary Angiography and Intervention in Patients with ST Elevation Myocardial Infarction.

    Science.gov (United States)

    Guo, Jincheng; Chen, Wenming; Wang, Guozhong; Liu, Zijing; Hao, Minghui; Xu, Min; Zhu, Fuli

    2017-02-01

    There are limited data on the impact of using a single dedicated radial guiding catheter in primary percutaneous coronary intervention (PCI) via radial access. To investigate the effect of using a single guiding catheter (MAC 3.5) for left and right coronary angiography and intervention on catheterization laboratory door to balloon (C2B) time in patients with ST elevation myocardial infarction (STEMI). Three hundred and sixty patients were randomized (1:1) to using a single MAC3.5 guiding catheter (MAC group) or diagnostic Tiger catheter first for coronary angiography followed by guiding catheter selection (control group) for intervention. The primary outcomes were C2B. The secondary outcomes were major adverse cardiac events (MACE) at 30 days and 6 months. Median C2B time (16.6 min, interquartile range [IQR] 14.3-20.2 min vs 19.0 min, IQR 14.3-23.1 min; P guiding catheter for coronary angiography and intervention can shorten C2B time, procedure time, and fluoroscopy time. (RAPID study; NCT01759043). © 2016, Wiley Periodicals, Inc.

  20. Randomized Crossover Comparison of the Short-Term Efficacy and Safety of Single Half-Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

    Science.gov (United States)

    Takeshita, Hideki; Moriyama, Shingo; Arai, Yoshiaki; Washino, Satoshi; Saito, Kimitoshi; Chiba, Koji; Horiuchi, Susumu; Noro, Akira

    2016-01-01

    To compare the efficacy and safety of single half-dose silodosin and single full-dose tamsulosin in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). Japanese men aged ≥50 years with LUTS/BPH and an International Prostate Symptom Score (IPSS) of ≥8 were enrolled in the randomized crossover study and divided into silodosin-preceding (S-T) and tamsulosin-preceding (T-S) groups. The S-T group received 4 mg silodosin once daily for 4 weeks followed by 0.2 mg tamsulosin once daily for 4 weeks. The T-S group received the reverse treatment sequence. A washout period prior to drug crossover was not included. Subjective and objective efficacy parameters including IPSS, quality of life (QOL) index, uroflowmetry, and safety were compared between the two groups. Thirty of 34 men (S-T group n = 16; T-S group n = 14) completed the study. Both drugs significantly improved all IPSS items and QOL index in the first treatment period. Subjective improvement in nocturia by silodosin was observed in both the first and crossover treatment periods. Objective improvement in maximum flow rate by silodosin was only observed in the first treatment period. Adverse events occurred more frequently with silodosin than with tamsulosin; however, none of the adverse events required treatment discontinuation. Ejaculation disorders occurred in three participants (10%) and were associated with silodosin use. Single half-dose silodosin has a similar efficacy to full-dose tamsulosin in Japanese men with LUTS/BPH and thus, may represent an effective, safe, and affordable treatment option. © 2015 Wiley Publishing Asia Pty Ltd.

  1. Feasibility of the Atlas Unicompartmental Knee System Load Absorber in Improving Pain Relief and Function in Patients Needing Unloading of the Medial Compartment of the Knee: 1-Year Follow-Up of a Prospective, Multicenter, Single-Arm Pilot Study (PHANTOM High Flex Trial).

    Science.gov (United States)

    Slynarski, Konrad; Walawski, Jacek; Smigielski, Robert; van der Merwe, Willem

    2017-01-01

    In young patients with medial knee osteoarthritis (OA), surgical intervention may not be desirable due to preferences to avoid bone cutting procedures, return to high activity levels, and prolong implant survival. The Atlas Knee System was designed to fill the gap between ineffective conservative treatments and invasive surgery. This single-arm study included 26 patients, aged 25 to 65 years, who completed 12 months of follow-up. All dimensions of the Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Knee Society Score significantly improved from baseline to 12 months. About 96.2% and 92.3% of patients experienced a ⩾20% improvement in their KOOS pain and WOMAC pain scores, respectively, at 12 months. This study highlights the potential benefit of a joint unloading device in the management of young patients with medial knee OA. The trial is still ongoing and another analysis is planned at 24 months.

  2. Feasibility of the Atlas Unicompartmental Knee System Load Absorber in Improving Pain Relief and Function in Patients Needing Unloading of the Medial Compartment of the Knee: 1-Year Follow-Up of a Prospective, Multicenter, Single-Arm Pilot Study (PHANTOM High Flex Trial

    Directory of Open Access Journals (Sweden)

    Konrad Slynarski

    2017-09-01

    Full Text Available In young patients with medial knee osteoarthritis (OA, surgical intervention may not be desirable due to preferences to avoid bone cutting procedures, return to high activity levels, and prolong implant survival. The Atlas Knee System was designed to fill the gap between ineffective conservative treatments and invasive surgery. This single-arm study included 26 patients, aged 25 to 65 years, who completed 12 months of follow-up. All dimensions of the Knee injury and Osteoarthritis Outcome Score (KOOS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, and Knee Society Score significantly improved from baseline to 12 months. About 96.2% and 92.3% of patients experienced a ⩾20% improvement in their KOOS pain and WOMAC pain scores, respectively, at 12 months. This study highlights the potential benefit of a joint unloading device in the management of young patients with medial knee OA. The trial is still ongoing and another analysis is planned at 24 months.

  3. Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Mufuta Tshimanga

    Full Text Available We aimed to determine if the adverse event (AE rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision.Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46; 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459; 337 (85% on anti-retroviral therapy. Among 385 (96% observed completely healed, median days to complete healing was 42 (IQR: 35-49. There was no association between time to healing and CD4 (p = 0.66. Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5. This was non-inferior to 2% AEs (p = 0.0003. All AEs were device displacements resulting in surgical MC and, subsequently, complete healing.Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.

  4. Efficacy, Reliability, and Safety of Completely Autologous Fibrin Glue in Neurosurgical Procedures: Single-Center Retrospective Large-Number Case Study.

    Science.gov (United States)

    Nakayama, Noriyuki; Yano, Hirohito; Egashira, Yusuke; Enomoto, Yukiko; Ohe, Naoyuki; Kanemura, Nobuhiro; Kitagawa, Junichi; Iwama, Toru

    2018-01-01

    Commercially available fibrin glue (Com-FG), which is used commonly worldwide, is produced with pooled human plasma from multiple donors. However, it has added bovine aprotinin, which involves the risk of infection, allogenic immunity, and allergic reactions. We evaluate the efficacy, reliability, and safety of completely autologous fibrin glue (CAFG). From August 2014 to February 2016, prospective data were collected and analyzed from 153 patients. CAFG was prepared with the CryoSeal System using autologous blood and was applied during neurosurgical procedures. Using CAFG-soaked oxidized regenerated cellulose and/or polyglycolic acid sheets, we performed a pinpoint hemostasis, transposed the offending vessels in a microvascular decompression, and covered the dural incision to prevent cerebrospinal fluid leakage. The CryoSeal System had generated up to a mean of 4.51 mL (range, 3.0-8.4 mL) of CAFG from 400 mL autologous blood. Com-FG products were not used in our procedures. Only 6 patients required an additional allogeneic blood transfusion. The hemostatic effective rate was 96.1% (147 of 153 patients). Only 1 patient who received transsphenoidal surgery for a pituitary adenoma presented with the complication of delayed postoperative cerebrospinal fluid leakage (0.65%). No patient developed allergic reactions or systemic complications associated with the use of CAFG. CAFG effectively provides hemostatic, adhesive, and safety performance. The timing and three-dimensional shape of CAFG-soaked oxidized regenerated cellulose and/or polyglycolic acid sheets solidification can be controlled with slow fibrin formation. The cost to prepare CAFG is similar compared with Com-FG products, and it can therefore be easily used at most institutions. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Integration of real-time mapping technology in disaster relief distribution.

    Science.gov (United States)

    2013-02-01

    Vehicle routing for disaster relief distribution involves many challenges that distinguish this problem from those in commercial settings, given the time sensitive and resource constrained nature of relief activities. While operations research approa...

  6. Beyond Pain Relief: Total Knee Replacement Surgery | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... Relief: Total Knee Replacement Surgery Follow us Beyond Pain Relief: Total Knee Replacement Surgery Photo: AdobeStock With total knee replacement surgery, researchers are looking beyond simply reducing pain. The hope is to return patients to the ...

  7. Nuclear safety

    International Nuclear Information System (INIS)

    1991-02-01

    This book reviews the accomplishments, operations, and problems faced by the defense Nuclear Facilities Safety Board. Specifically, it discusses the recommendations that the Safety Board made to improve safety and health conditions at the Department of Energy's defense nuclear facilities, problems the Safety Board has encountered in hiring technical staff, and management problems that could affect the Safety Board's independence and credibility

  8. Imaging pain relief in osteoarthritis (IPRO): protocol of a double-blind randomised controlled mechanistic study assessing pain relief and prediction of duloxetine treatment outcome.

    Science.gov (United States)

    Reckziegel, Diane; Bailey, Helen; Cottam, William J; Tench, Christopher R; Mahajan, Ravi P; Walsh, David A; Knaggs, Roger D; Auer, Dorothee P

    2017-06-26

    Osteoarthritis (OA) pain is a major cause of long-term disability and chronic pain in the adult population. One in five patients does not receive satisfactory pain relief, which reflects the complexity of chronic pain and the current lack of understanding of mechanisms of chronic pain. Recently, duloxetine has demonstrated clinically relevant pain relief, but only in half of treated patients with OA. Here, the aim is to investigate the neural mechanisms of pain relief and neural signatures that may predict treatment response to duloxetine in chronic knee OA pain. This is an ongoing single-centre randomised placebo-controlled mechanistic study (2:1 (placebo) allocation), using a multimodal neuroimaging approach, together with psychophysiological (quantitative sensory testing), genetics and questionnaire assessments. Eighty-one subjects with chronic knee OA pain are planned to power for between-group comparisons (placebo, duloxetine responder and duloxetine non-responder). Participants have a baseline assessment and, following 6 weeks of duloxetine (30 mg for 2 weeks, then 60 mg for 4 weeks), a follow-up evaluation. Brain imaging is performed at 3T with blood-oxygen-level dependent functional MRI at rest and during pin-prick nociceptive stimulation for main outcome assessment; arterial spin labelling and structural imaging (T1-weighted) for secondary outcome assessment. Questionnaires evaluate pain, negative affect, quality of sleep and cognition. The study has been approved by the East Midlands, Nottingham and is being carried out under the principles of the Declaration of Helsinki (64th, 2013) and Good Clinical Practice standards. Results will be disseminated in peer-reviewed journals and at scientific conferences. This trial is registered at ClinicalTrials.gov (NCT02208778).This work was supported by Arthritis Research UK (Grant 18769). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  9. Safety and efficacy of staged retrograde intrarenal surgery for large stone burden of renal stones in selected patients: A single-center experience

    Directory of Open Access Journals (Sweden)

    Cheng-Feng Lin

    2017-06-01

    Conclusion: To the best of our knowledge, RIRS for large renal stone manipulation is an effective and safe treatment modality currently. In our study, the single RIRS SFR was superior to PNL or SWL even when the stone burden was between 2.0 cm and 3.0 cm (80.2%. For those patients whose stone burden was over 3.0 cm or for those with comorbidities, staged RIRS resulted in a lower complication rate, reduced hospital stay, and better SFR (76.5%.

  10. knowledge, attitude and use of pain relief in labour among women ...

    African Journals Online (AJOL)

    2014-07-01

    Jul 1, 2014 ... benefits in terms of pain relief are well-recognised. In some cases like in cardiac diseases in pregnancy, pain relief is an important component of labour management. Pain relief by epidural analgesia in labour is however not a common practice in Kenya. Two surveys done in Hong Kong public hospitals.

  11. 21 CFR 882.5880 - Implanted spinal cord stimulator for pain relief.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Implanted spinal cord stimulator for pain relief... Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve...

  12. 21 CFR 882.5890 - Transcutaneous electrical nerve stimulator for pain relief.

    Science.gov (United States)

    2010-04-01

    ... pain relief. 882.5890 Section 882.5890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5890 Transcutaneous electrical nerve stimulator for pain relief. (a) Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to...

  13. 21 CFR 882.5840 - Implanted intracerebral/subcortical stimulator for pain relief.

    Science.gov (United States)

    2010-04-01

    ... pain relief. 882.5840 Section 882.5840 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Devices § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current...

  14. 30 CFR 204.204 - What accounting and auditing relief will MMS not allow?

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What accounting and auditing relief will MMS... INTERIOR MINERALS REVENUE MANAGEMENT ALTERNATIVES FOR MARGINAL PROPERTIES Accounting and Auditing Relief § 204.204 What accounting and auditing relief will MMS not allow? MMS will not approve your request for...

  15. 46 CFR 64.69 - Location of the pressure relief device.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Location of the pressure relief device. 64.69 Section 64.69 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING MARINE PORTABLE TANKS AND CARGO HANDLING SYSTEMS Pressure Relief Devices and Vacuum Relief Devices for MPTs § 64...

  16. 30 CFR 204.202 - What is the cumulative royalty reports and payments relief option?

    Science.gov (United States)

    2010-07-01

    ... Auditing Relief § 204.202 What is the cumulative royalty reports and payments relief option? (a) The... information on Form MMS-2014 for the calendar year, the same as if it were a monthly report; and (5) Report... section until the date MMS receives it. (d) If you take relief you are not qualified for, you may be...

  17. Humanitarian relief supply chain: a multi-objective model and solution

    Indian Academy of Sciences (India)

    This paper models a humanitarian relief chain that includes a relief goods supply chain and an evacuation chain in case of a natural disaster. Optimum network flow is studied for both the chains by considering three conflicting objectives, namely demand satisfaction in relief chain, demand satisfaction in evacuation chain ...

  18. Nuclear safety

    International Nuclear Information System (INIS)

    Tarride, Bruno

    2015-10-01

    The author proposes an overview of methods and concepts used in the nuclear industry, at the design level as well as at the exploitation level, to ensure an acceptable safety level, notably in the case of nuclear reactors. He first addresses the general objectives of nuclear safety and the notion of acceptable risk: definition and organisation of nuclear safety (relationships between safety authorities and operators), notion of acceptable risk, deterministic safety approach and main safety principles (safety functions and confinement barriers, concept of defence in depth). Then, the author addresses the safety approach at the design level: studies of operational situations, studies of internal and external aggressions, safety report, design principles for important-for-safety systems (failure criterion, redundancy, failure prevention, safety classification). The next part addresses safety during exploitation and general exploitation rules: definition of the operation domain and of its limits, periodic controls and tests, management in case of incidents, accidents or aggressions

  19. Drug Safety

    Science.gov (United States)

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  20. Safety and efficacy of allogeneic umbilical cord red blood cell transfusion for children with severe anaemia in a Kenyan hospital: an open-label single-arm trial

    Science.gov (United States)

    Hassall, Oliver W; Thitiri, Johnstone; Fegan, Greg; Hamid, Fauzat; Mwarumba, Salim; Denje, Douglas; Wambua, Kongo; Mandaliya, Kishor; Maitland, Kathryn; Bates, Imelda

    2015-01-01

    Summary Background In sub-Saharan Africa, children are frequently admitted with severe anaemia needing an urgent blood transfusion, but blood is often unavailable. When conventional blood supplies are inadequate, allogeneic umbilical cord blood could be a feasible alternative. The aim of this study was to assess the safety and efficacy of cord blood transfusion in children with severe anaemia. Methods Between June 26, 2007, and May 20, 2008, 413 children needing an urgent blood transfusion were admitted to Kilifi District Hospital in Kenya. Of these, 87 children were eligible for our study—ie, younger than 12 years, no signs of critical illness, and haemoglobin 100 g/L or lower (if aged 3 months or younger) or 40 g/L or lower (if older than 3 months). Cord blood was donated at Coast Provincial General Hospital, Mombasa, and screened for transfusion-transmitted infections and bacterial contamination. Red blood cells were stored vertically at 2–6°C to enable sedimentation. After transfusion, children were monitored closely for adverse events and followed up for 28 days. The primary outcome measure was the frequency and nature of adverse reactions associated with the transfusion. Secondary outcomes were the changes in haemoglobin concentrations 24 h and 28 days after transfusion, compared with pretransfusion levels. This trial is registered on ISRCTN.com, number ISRCTN66687527. Findings Of the 87 children eligible for the study, cord blood was unavailable for 24, six caregivers declined consent, and two children were withdrawn before transfusion. Therefore, 55 children received umbilical cord red blood cells from 74 donations. Ten (18%) children had ten serious adverse events and 43 (78%) had 94 adverse events; the most frequent adverse events were anaemia (n=14), weight loss (n=12), and vomiting (n=10). An independent expert panel judged none of these adverse events to be probably or certainly caused by the cord blood transfusion (one-sided 97·5% CI 0–6·5

  1. Comparison of Efficacy and Safety between First and Second Generation Drug-eluting Stents in Patients with Stable Coronary Artery Disease: A Single-center Retrospective Study.

    Science.gov (United States)

    Liu, Ru; Xiong, Fei; Wen, Yuan; Ma, Yuan-Liang; Yao, Yi; Gao, Zhan; Xu, Bo; Yang, Yue-Jin; Qiao, Shu-Bin; Gao, Run-Lin; Yuan, Jin-Qing

    2017-07-20

    Lots of trials demonstrate that second-generation drug-eluting stents (G2-DES), with their improved properties, offer significantly superior efficacy and safety profiles compared to first generation DES (G1-DES) for patients with coronary artery disease (CAD) receiving percutaneous coronary intervention (PCI). This study aimed to verify the advantage of G2-DES over G1-DES in Chinese patients with stable CAD (SCAD). For this retrospective observational analysis, 2709 SCAD patients with either G1-DES (n = 863) or G2-DES (n = 1846) were enrolled consecutively throughout 2013. Propensity score matching (PSM) was applied to control differing baseline factors. Two-year outcomes, including major adverse coronary events as well as individual events, including target vessel-related myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, and cardiogenic death were evaluated. The incidence of revascularization between G1- and G2-DES showed a trend of significant difference with a threshold P - value (8.6% vs. 6.7%, χ2 = 2.995, P = 0.084). G2-DES significantly improved TLR-free survival compared to G1-DES (96.6% vs. 97.9%, P = 0.049) and revascularization-free survival curve showed a trend of improvement of G2-DES (92.0% vs. 93.8%, P = 0.082). These differences diminished after PSM. Multivariate Cox proportional hazard regression analysis showed a trend for G1-associated increase in revascularization (hazard ratio: 1.28, 95% confidence interval: 0.95-1.72, P = 0.099) while no significance was found after PSM. Other endpoints showed no significant differences after multivariate adjustment regardless of PSM. G1-DES showed the same safety as G2-DES in this large Chinese cohort of real-world patients. However, G2-DES improved TLR-free survival of SCAD patients 2 years after PCI. The advantage was influenced by baseline clinical factors. G1-DES was associated with a trend of increase in revascularization risk and was not an independent

  2. Reward and motivation in pain and pain relief

    Science.gov (United States)

    Navratilova, Edita; Porreca, Frank

    2015-01-01

    Pain is fundamentally unpleasant, a feature that protects the organism by promoting motivation and learning. Relief of aversive states, including pain, is rewarding. The aversiveness of pain, as well as the reward from relief of pain, is encoded by brain reward/motivational mesocorticolimbic circuitry. In this Review, we describe current knowledge of the impact of acute and chronic pain on reward/motivation circuits gained from preclinical models and from human neuroimaging. We highlight emerging clinical evidence suggesting that anatomical and functional changes in these circuits contribute to the transition from acute to chronic pain. We propose that assessing activity in these conserved circuits can offer new outcome measures for preclinical evaluation of analgesic efficacy to improve translation and speed drug discovery. We further suggest that targeting reward/motivation circuits may provide a path for normalizing the consequences of chronic pain to the brain, surpassing symptomatic management to promote recovery from chronic pain. PMID:25254980

  3. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers.

    Science.gov (United States)

    Hirawat, Samit; Welch, Ellen M; Elfring, Gary L; Northcutt, Valerie J; Paushkin, Sergey; Hwang, Seongwoo; Leonard, Eileen M; Almstead, Neil G; Ju, William; Peltz, Stuart W; Miller, Langdon L

    2007-04-01

    Nonsense (premature stop codon) mutations are causative in 5% to 15% of patients with monogenetic inherited disorders. PTC124, a 284-Dalton 1,2,4-oxadiazole, promotes ribosomal readthrough of premature stop codons in mRNA and offers therapeutic potential for multiple genetic diseases. The authors conducted 2 phase I studies of PTC124 in 62 healthy adult volunteers. The initial, single-dose study evaluated doses of 3 to 200 mg/kg and assessed fed-fasting status on pharmacokinetics following a dose of 50 mg/kg. The subsequent multiple-dose study evaluated doses from 10 to 50 mg/kg/dose twice per day (bid) for up to 14 days. PTC124 administered orally as a liquid suspension was palatable and well tolerated through single doses of 100 mg/kg. At 150 and 200 mg/kg, PTC124 induced mild headache, dizziness, and gastrointestinal events. With repeated doses through 50 mg/kg/dose bid, reversible transaminase elevations Duchenne muscular dystrophy.

  4. Trends in intraoperative pain relief in anesthesized Nigerian ...

    African Journals Online (AJOL)

    Keywords: Intraoperative period, pain relief, trends. Arrière-plan: De nouveaux médicaments et nouvelles modalités pour soulager la douleur peropératoire est la tendance actuelle dans la gestion de la douleur. L'étude vise à examiner la tendance actuelle dans le soulagement de la douleur peropératoire chez les patients ...

  5. Exploring Heat Stress Relief Measures among the Australian Labour Force.

    Science.gov (United States)

    Zander, Kerstin K; Mathew, Supriya; Garnett, Stephen T

    2018-02-26

    Australia experiences frequent heat waves and generally high average temperatures throughout the continent with substantial impacts on human health and the economy. People adapt to heat by adopting various relief measures in their daily lives including changing their behaviour. Many labour intensive outdoor industries implement standards for heat stress management for their workforce. However, little is known about how people cope with heat at their workplaces apart from studies targeting some specific industries where labourers are exposed to extreme heat. Here, we analysed responses from 1719 people in the Australian labour force to self-reported heat stress and associated coping mechanisms. Three quarters of respondents experienced heat stress at their workplace with fatigue and headache being the two most frequently stated symptoms. Almost all of those who were affected by heat would hydrate (88%), 67% would cool, and 44% would rest as a strategy for coping with heat. About 10% intended to change their jobs because of heat stress in the workplace. We found differences in heat relief measures across gender, education, health, level of physical intensity of job, and time spent working outside. People working in jobs that were not very demanding physically were more likely to choose cooling down as a relief measure, while those in labour intensive jobs and jobs that required considerable time outside were more likely to rest. This has potential consequences for their productivity and work schedules. Heat affects work in Australia in many types of industry with impact dependent on workforce acclimatisation, yet public awareness and work relief plans are often limited to outdoor and labour intensive industries. Industries and various levels of government in all sectors need to implement standards for heat management specific to climate zones to help people cope better with high temperatures as well as plan strategies in anticipation of projected temperature

  6. Neural correlates of mindfulness meditation-related anxiety relief

    OpenAIRE

    Zeidan, Fadel; Martucci, Katherine T.; Kraft, Robert A.; McHaffie, John G.; Coghill, Robert C.

    2013-01-01

    Anxiety is the cognitive state related to the inability to control emotional responses to perceived threats. Anxiety is inversely related to brain activity associated with the cognitive regulation of emotions. Mindfulness meditation has been found to regulate anxiety. However, the brain mechanisms involved in meditation-related anxiety relief are largely unknown. We employed pulsed arterial spin labeling MRI to compare the effects of distraction in the form of attending to the breath (ATB; be...

  7. Mechanisms of pain relief by vibration and movement.

    OpenAIRE

    Kakigi, R; Shibasaki, H

    1992-01-01

    Mechanisms of pain relief induced by vibration and movement were investigated. A CO2 laser beam, which is useful for pure nociceptive stimulation, was used for recording pain-related somatosensory evoked potentials (pain SEPs) and for measuring pain threshold and reaction time (RT). Concurrently applied vibratory stimuli to and active movements of the fingers significantly reduced and prolonged pain SEPs, increased pain threshold, and prolonged RT, indicating that an increase in the inhibitor...

  8. Exploring Heat Stress Relief Measures among the Australian Labour Force

    Directory of Open Access Journals (Sweden)

    Kerstin K. Zander

    2018-02-01

    Full Text Available Australia experiences frequent heat waves and generally high average temperatures throughout the continent with substantial impacts on human health and the economy. People adapt to heat by adopting various relief measures in their daily lives including changing their behaviour. Many labour intensive outdoor industries implement standards for heat stress management for their workforce. However, little is known about how people cope with heat at their workplaces apart from studies targeting some specific industries where labourers are exposed to extreme heat. Here, we analysed responses from 1719 people in the Australian labour force to self-reported heat stress and associated coping mechanisms. Three quarters of respondents experienced heat stress at their workplace with fatigue and headache being the two most frequently stated symptoms. Almost all of those who were affected by heat would hydrate (88%, 67% would cool, and 44% would rest as a strategy for coping with heat. About 10% intended to change their jobs because of heat stress in the workplace. We found differences in heat relief measures across gender, education, health, level of physical intensity of job, and time spent working outside. People working in jobs that were not very demanding physically were more likely to choose cooling down as a relief measure, while those in labour intensive jobs and jobs that required considerable time outside were more likely to rest. This has potential consequences for their productivity and work schedules. Heat affects work in Australia in many types of industry with impact dependent on workforce acclimatisation, yet public awareness and work relief plans are often limited to outdoor and labour intensive industries. Industries and various levels of government in all sectors need to implement standards for heat management specific to climate zones to help people cope better with high temperatures as well as plan strategies in anticipation of projected

  9. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.

    Science.gov (United States)

    Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, Hervé; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

    2015-01-01

    This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4 ± 6.3°; p SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  10. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF of traumatic origin. We enrolled 103 patients (median age: 61.6 years with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS. Secondary outcomes were Oswestry Disability Index (ODI, EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score and in quality of life (increase 21.1% of EQ-VAS score were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°; p<0.001, remained at 12 months (-4.4±6.0°, p=0.002. No adverse events were implant-related and none required device removal. Three patients (2.9% experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  11. Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth.

    Science.gov (United States)

    Bailey, Edmund; Worthington, Helen V; van Wijk, Arjen; Yates, Julian M; Coulthard, Paul; Afzal, Zahid

    2013-12-12

    Both paracetamol and ibuprofen are commonly used analgesics for the relief of pain following the surgical removal of lower wisdom teeth (third molars). In 2010, a novel analgesic (marketed as Nuromol) containing both paracetamol and ibuprofen in the same tablet was launched in the United Kingdom, this drug has shown promising results to date and we have chosen to also compare the combined drug with the single drugs using this model. In this review we investigated the optimal doses of both paracetamol and ibuprofen via comparison of both and via comparison with the novel combined drug. We have taken into account the side effect profile of the study drugs. This review will help oral surgeons to decide on which analgesic to prescribe following wisdom tooth removal. To compare the beneficial and harmful effects of paracetamol, ibuprofen and the novel combination of both in a single tablet for pain relief following the surgical removal of lower wisdom teeth, at different doses and administered postoperatively. We searched the Cochrane Oral Health Group'sTrials Register (to 20 May 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 4); MEDLINE via OVID (1946 to 20 May 2013); EMBASE via OVID (1980 to 20 May 2013) and the metaRegister of Controlled Trials (to 20 May 2013). We checked the bibliographies of relevant clinical trials and review articles for further studies. We wrote to authors of the identified randomised controlled trials (RCTs), and searched personal references in an attempt to identify unpublished or ongoing RCTs. No language restriction was applied to the searches of the electronic databases. Only randomised controlled double-blinded clinical trials were included. Cross-over studies were included provided there was a wash out period of at least 14 days. There had to be a direct comparison in the trial of two or more of the trial drugs at any dosage. All trials used the third molar pain model. All trials

  12. What helps when it hurts: children's views on pain relief.

    Science.gov (United States)

    Franck, L S; Sheikh, A; Oulton, K

    2008-07-01

    Previous studies have focused on children's views of sources of pain and only secondarily explored their views on pain-relief strategies. An exploratory cross-sectional descriptive design and 'draw and write' technique were used to investigate what children think helps them when they have pain. The sample (n = 71) was comprised of 33% boys and 67% girls, with an age range of 4-16 years (mean +/- SD: 9.25 +/- 3.04). Four overarching themes were derived that were common to both the texts and drawings: 'People who help', 'What I do that helps', 'What other people do that helps' and 'Things that help'. Children also described their emotional reactions to pain or pain relief. Multiple themes were represented in most of the texts and drawings. There were few differences in the themes present in the children's texts and drawings based on developmental age and no differences based on gender. Children across the three developmental age groups view themselves as active agents in pain relief. Although less than half of the children described specific behaviours they had taken, almost all children indicated their active role as the central figure in relation to use of objects or the actions of others.

  13. A nondimensional framework for exploring the relief structure of landscapes

    Science.gov (United States)

    Grieve, Stuart W. D.; Mudd, Simon M.; Hurst, Martin D.; Milodowski, David T.

    2016-04-01

    Considering the relationship between erosion rate and the relief structure of a landscape within a nondimensional framework facilitates the comparison of landscapes undergoing forcing at a range of scales, and allows broad-scale patterns of landscape evolution to be observed. We present software which automates the extraction and processing of relevant topographic parameters to rapidly generate nondimensional erosion rate and relief data for any landscape where high-resolution topographic data are available. Individual hillslopes are identified using a connected-components technique which allows spatial averaging to be performed over geomorphologically meaningful spatial units, without the need for manual identification of hillslopes. The software is evaluated on four landscapes across the continental United States, three of which have been studied previously using this technique. We show that it is possible to identify whether landscapes are in topographic steady state. In locations such as Cascade Ridge, CA, a clear signal of an erosional gradient can be observed. In the southern Appalachians, nondimensional erosion rate and relief data are interpreted as evidence for a landscape decaying following uplift during the Miocene. An analysis of the sensitivity of this method to free parameters used in the data smoothing routines is presented which allows users to make an informed choice of parameters when interrogating new topographic data using this method. A method to constrain the critical gradient of the nonlinear sediment flux law is also presented which provides an independent constraint on this parameter for three of the four study landscapes.

  14. Neural mechanisms underlying the induction and relief of perceptual curiosity

    Directory of Open Access Journals (Sweden)

    Marieke eJepma

    2012-02-01

    Full Text Available Curiosity is one of the most basic biological drives in both animals and humans, and has been identified as a key motive for learning and discovery. Despite the importance of curiosity and related behaviors, the topic has been largely neglected in human neuroscience; hence little is known about the neurobiological mechanisms underlying curiosity. We used functional magnetic resonance imaging (fMRI to investigate what happens in our brain during the induction and subsequent relief of perceptual curiosity. Our core findings were that (i the induction of perceptual curiosity, through the presentation of ambiguous visual input, activated the anterior insula and anterior cingulate cortex, brain regions sensitive to conflict and arousal; (ii the relief of perceptual curiosity, through visual disambiguation, activated regions of the striatum that have been related to reward processing; and (iii the relief of perceptual curiosity was associated with hippocampal activation and enhanced incidental memory. These findings provide the first demonstration of the neural basis of human perceptual curiosity. Our results provide neurobiological support for a classic psychological theory of curiosity, which holds that curiosity is an aversive condition of increased arousal whose termination is rewarding and facilitates memory.

  15. Acupuncture as pain relief during delivery: a randomized controlled trial.

    Science.gov (United States)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten; Kesmodel, Ulrik S; Hvidman, Lone

    2009-03-01

    Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery with respect to pain intensity, birth experience, and obstetric outcome. A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain assessed by a visual analogue scale, birth experience and satisfaction with delivery, and pain relief evaluated at 2 months postpartum. Secondary obstetric outcomes were duration of labor, use of oxytocin, mode of delivery, postpartum hemorrhage, Apgar score, and umbilical cord pH value. Analysis complied with the intention-to-treat principle. Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin. Mean Apgar score at 5 minutes and umbilical cord pH value were significantly higher among infants in the acupuncture group compared with infants in the other groups. Acupuncture reduced the need for pharmacological and invasive methods during delivery. Acupuncture is a good supplement to existing pain relief methods.

  16. Fertility and Symptom Relief following Robot-Assisted Laparoscopic Myomectomy

    Directory of Open Access Journals (Sweden)

    Michael C. Pitter

    2015-01-01

    Full Text Available Objective. To examine success of robot-assisted laparoscopic myomectomy (RALM measured by sustained symptom relief and fertility. Methods. This is a retrospective survey of 426 women who underwent RALM for fibroids, symptom relief, or infertility at three practice sites across the US. We examined rates of symptom recurrence and pregnancy and factors associated with these outcomes. Results. Overall, 70% of women reported being symptom-free, with 62.9% free of symptoms after three years. At >3 years, 66.7% of women who underwent surgery to treat infertility and 80% who were also symptom-free reported achieving pregnancy. Factors independently associated with symptom recurrence included greater time after surgery, preoperative dyspareunia, multiple fibroid surgeries, smoking after surgery, and preexisting diabetes. Factors positively correlated with achieving pregnancy included desiring pregnancy, prior pregnancy, greater time since surgery, and Caucasian race. Factors negatively correlated with pregnancy were advanced age and symptom recurrence. Conclusions. This paper, the first to examine symptom recurrence after RALM, demonstrates both short- and long-term effectiveness in providing symptom relief. Furthermore, RALM may have the potential to improve the chance of conception, even in a population at high risk of subfertility, with greater benefits among those who remain symptom-free. These findings require prospective validation.

  17. Neural correlates of mindfulness meditation-related anxiety relief

    Science.gov (United States)

    Martucci, Katherine T.; Kraft, Robert A.; McHaffie, John G.; Coghill, Robert C.

    2014-01-01

    Anxiety is the cognitive state related to the inability to control emotional responses to perceived threats. Anxiety is inversely related to brain activity associated with the cognitive regulation of emotions. Mindfulness meditation has been found to regulate anxiety. However, the brain mechanisms involved in meditation-related anxiety relief are largely unknown. We employed pulsed arterial spin labeling MRI to compare the effects of distraction in the form of attending to the breath (ATB; before meditation training) to mindfulness meditation (after meditation training) on state anxiety across the same subjects. Fifteen healthy subjects, with no prior meditation experience, participated in 4 d of mindfulness meditation training. ATB did not reduce state anxiety, but state anxiety was significantly reduced in every session that subjects meditated. Meditation-related anxiety relief was associated with activation of the anterior cingulate cortex, ventromedial prefrontal cortex and anterior insula. Meditation-related activation in these regions exhibited a strong relationship to anxiety relief when compared to ATB. During meditation, those who exhibited greater default-related activity (i.e. posterior cingulate cortex) reported greater anxiety, possibly reflecting an inability to control self-referential thoughts. These findings provide evidence that mindfulness meditation attenuates anxiety through mechanisms involved in the regulation of self-referential thought processes. PMID:23615765

  18. Neural correlates of mindfulness meditation-related anxiety relief.

    Science.gov (United States)

    Zeidan, Fadel; Martucci, Katherine T; Kraft, Robert A; McHaffie, John G; Coghill, Robert C

    2014-06-01

    Anxiety is the cognitive state related to the inability to control emotional responses to perceived threats. Anxiety is inversely related to brain activity associated with the cognitive regulation of emotions. Mindfulness meditation has been found to regulate anxiety. However, the brain mechanisms involved in meditation-related anxiety relief are largely unknown. We employed pulsed arterial spin labeling MRI to compare the effects of distraction in the form of attending to the breath (ATB; before meditation training) to mindfulness meditation (after meditation training) on state anxiety across the same subjects. Fifteen healthy subjects, with no prior meditation experience, participated in 4 d of mindfulness meditation training. ATB did not reduce state anxiety, but state anxiety was significantly reduced in every session that subjects meditated. Meditation-related anxiety relief was associated with activation of the anterior cingulate cortex, ventromedial prefrontal cortex and anterior insula. Meditation-related activation in these regions exhibited a strong relationship to anxiety relief when compared to ATB. During meditation, those who exhibited greater default-related activity (i.e. posterior cingulate cortex) reported greater anxiety, possibly reflecting an inability to control self-referential thoughts. These findings provide evidence that mindfulness meditation attenuates anxiety through mechanisms involved in the regulation of self-referential thought processes. © The Author (2013). Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

  19. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy

    DEFF Research Database (Denmark)

    Haahr, Martha Kirstine; Jensen, Charlotte Harken; Toyserkani, Navid Mohamadpour

    2016-01-01

    is registered with ClinicalTrials.gov, NCT02240823. FINDINGS: Intracavernous injection of ADRCs was well-tolerated and only minor events related to the liposuction and cell injections were reported at the one-month evaluation, but none at later time points. Overall during the study period, 8 of 17 men recovered...... to a mean difference of 0.57 (0.38-0.85; p = 0.0069), versus inclusion. In contrast, incontinent men did not regain erectile function (median IIEF1/3/6 months = 5 (95% CI 5-6); mean difference 1 (95% CI 0.85-1.18), p > 0.9999). INTERPRETATION: In this phase I trial a single intracavernosal injection...

  20. Comparison of the single dose pharmacokinetics, pharmacodynamics, and safety of two novel oral formulations of dimethandrolone undecanoate (DMAU): a potential oral, male contraceptive.

    Science.gov (United States)

    Ayoub, R; Page, S T; Swerdloff, R S; Liu, P Y; Amory, J K; Leung, A; Hull, L; Blithe, D; Christy, A; Chao, J H; Bremner, W J; Wang, C

    2017-03-01

    Dimethandrolone (DMA, 7α,11β-dimethyl-19-nortestosterone) has both androgenic and progestational activities, ideal properties for a male hormonal contraceptive. In vivo, dimethandrolone undecanoate (DMAU) is hydrolyzed to DMA. We showed previously that single oral doses of DMAU powder in capsule taken with food are well tolerated and effective at suppressing both LH and testosterone (T), but absorption was low. We compared the pharmacokinetics and pharmacodynamics of two new formulations of DMAU, in castor oil and in self-emulsifying drug delivery systems (SEDDS), with the previously tested powder formulation. DMAU was dosed orally in healthy adult male volunteers at two academic medical centers. For each formulation tested in this double-blind, placebo-controlled study, 10 men received single, escalating, oral doses of DMAU (100, 200, and 400 mg) and two subjects received placebo. All doses were evaluated for both fasting and with a high fat meal. All three formulations were well tolerated without clinically significant changes in vital signs, blood counts, or serum chemistries. For all formulations, DMA and DMAU showed higher maximum (p food, but only the SEDDS formulation was effectively suppressed serum T when given fasting. We conclude that while all three formulations of oral DMAU are effective and well tolerated when administered with food, DMAU in oil and SEDDS increased conversion to DMA, and SEDDS may have some effectiveness when given fasting. These properties might be advantageous for the application of DMAU as a male contraceptive. © 2016 American Society of Andrology and European Academy of Andrology.

  1. Feasibility and safety of augmented-reality glass for computed tomography-assisted percutaneous revascularization of coronary chronic total occlusion: A single center prospective pilot study.

    Science.gov (United States)

    Opolski, Maksymilian P; Debski, Artur; Borucki, Bartosz A; Staruch, Adam D; Kepka, Cezary; Rokicki, Jakub K; Sieradzki, Bartosz; Witkowski, Adam

    2017-11-01

    Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) may be facilitated by projection of coronary computed tomography angiography (CTA) datasets in the catheterization laboratory. There is no data on the feasibility and safety outcomes of CTA-assisted CTO PCI using a wearable augmented-reality glass. A total of 15 patients scheduled for elective antegrade CTO intervention were prospectively enrolled and underwent preprocedural coronary CTA. Three-dimensional and curved multiplanar CT reconstructions were transmitted to a head-mounted hands-free computer worn by interventional cardiologists during CTO PCI to provide additional information on CTO tortuosity and calcification. The results of CTO PCI using a wearable computer were compared with a time-matched prospective angiographic registry of 59 patients undergoing antegrade CTO PCI without a wearable computer. Operators' satisfaction was assessed by a 5-point Likert scale. Mean age was 64 ± 8 years and the mean J-CTO score was 2.1 ± 0.9 in the CTA-assisted group. The voice-activated co-registration and review of CTA images in a wearable computer during CTO PCI were feasible and highly rated by PCI operators (4.7/5 points). There were no major adverse cardiovascular events. Compared with standard CTO PCI, CTA-assisted recanalization of CTO using a wearable computer showed more frequent selection of the first-choice stiff wire (0% vs 40%, p augmented-reality glass is feasible and safe, and might reduce the resources required for the interventional treatment of CTO. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  2. The safety issues and hardware-related complications of deep brain stimulation therapy: a single-center retrospective analysis of 478 patients with Parkinson’s disease

    Directory of Open Access Journals (Sweden)

    Zhang J

    2017-06-01

    Full Text Available Jing Zhang,1,* Tao Wang,1,* Chen-cheng Zhang,1 Kristina Zeljic,2 Shikun Zhan,1 Bo-min Sun,1 Dian-you Li1 1Department of Functional Neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 2Institute of Neuroscience, Chinese Academy of Sciences, Shanghai, China *These authors contributed equally to this work Introduction: Deep brain stimulation (DBS is a well-established therapy for the treatment of advanced Parkinson’s disease (PD in patients experiencing motor fluctuations and medication-refractory tremor. Despite the relative tolerability and safety of this procedure, associated complications and unnatural deaths are still unavoidable.Methods: In this study, hardware-related complications and the causes of unnatural death were retrospectively analyzed in 478 patients with PD who were treated with DBS.Results: The results showed a 3-year survival rate of 98.6% and a 5-year survival rate of 96.4% for patients with PD who underwent DBS treatment at the study center. Pneumonia was the cause of death with the highest frequency. Prophylactic antibiotics and steroids or antihistamine drugs were adopted to reduce the risk of infection. Twenty-two patients (4.6% experienced hardware-related complications.Conclusion: Deaths of PD patients who receive DBS are typically unrelated to the disease itself or complications associated with the surgery. Pneumonia, malignant tumors, asphyxia, and multiple-organ failure are the common causes of death. Swallowing-related problems may be the most important clinical symptom in late-stage PD, as they cannot be stabilized or improved by DBS alone, and are potentially lethal. Although prophylactic antibiotics and steroids or antihistamine drugs may reduce the risk of infection, it is imperative to identify high-risk patients for whom a therapeutic approach not requiring an implantable device is more suitable, for example, pallidotomy and potentially transcranial ultrasound. Keywords: motor

  3. The safety and efficacy of the Angio-Seal closure device in diagnostic and interventional neuroangiography setting: a single-center experience with 1,443 closures

    International Nuclear Information System (INIS)

    Geyik, Serdar; Yavuz, Kivilcim; Akgoz, Ayca; Koc, Osman; Peynircioglu, Bora; Cil, Barbaros; Cekirge, Saruhan; Saatci, Isil

    2007-01-01

    We evaluated the safety and efficacy of the Angio-Seal closure device used to close arterial puncture sites in patients who had undergone diagnostic cerebral angiography and neurointerventional procedures. A total of 1,443 Angio-Seal devices were placed in 1,099 patients in the Interventional Neuroradiology Unit between May 2005 and August 2006. Of these, 670 were interventional and 745 were diagnostic cerebral angiographic procedures. In 28 patients bilateral puncture of the femoral arteries was performed for endovascular treatment. In 167 patients 286 repeat diagnostic procedures were performed and 30 interventional procedures were followed by re-closure with an Angio-Seal device at the time of repeat puncture. The procedural success rate for antegrade closures was 99.7% for all procedures. The device failed in 5 of 745 diagnostic procedures (0.7%). Major complication occurred in one patient only (0.13%) in the diagnostic group. No minor complications were observed in this group. In the interventional group, the major complication rate was 1.4% (10 of 698 closures) and the minor complication rate was 2.4% (17 of 698 closures). However, in the subgroup of patients with cerebral aneurysms who received heparin in combination with antiplatelet agents after the procedure, the major complication rate was 5.3%, but in the carotid/vertebral stenting group it was 0.8%. Our experience in a relatively large series of patients shows that the use of the Angio-Seal STS vascular closure device is safe and effective in patients undergoing cerebral diagnostic angiography and neurointerventional procedures with an acceptable rate of complications, although the complication rate was higher in the group of patients who received heparin and/or antiplatelet medication. (orig.)

  4. Evaluation of the Safety of Imatinib Mesylate in 200 Iraqi Patients with Chronic Myeloid Leukemia in the Chronic Phase: Single-Center Study

    Directory of Open Access Journals (Sweden)

    Bassam Francis Matti

    2013-12-01

    Full Text Available OBJECTIVE: Imatinib mesylate, a tyrosine kinase inhibitor, is presently the drug of choice for chronic myeloid leukemia (CML. During therapy, a few patients may develop hematological and non-hematological adverse effects. METHODS: The aim of this study was to evaluate the safety of imatinib therapy in patients with CML. Between December 2007 and October 2009 two hundred patients with CML in chronic phase were included in the study. Written informed consent was obtained from all patients prior to the start of the study. Imatinib was started at 400 mg orally daily. Patients were monitored carefully for any adverse effects. Complete blood count, liver, and renal function tests were done once in 2 weeks during the first month and on a monthly basis during follow-up. Toxicities that encountered were graded as per the National Cancer Institute common toxicity criteria version 2. Both hematologic and non-hematologic toxicities were managed with short interruptions of treatment and supportive measures, but the daily dose of imatinib was not reduced below 300 mg/day. RESULTS: Two hundred CML patients in chronic phase were included in this study; the male: female ratio was 0.7: 1 with mean age 39.06±13.21 years (ranged from 15-81 years. The study showed that the commonest hematological side effects were grade 2 anemia (12.5% followed by leukopenia (8% and thrombocytopenia (4%, while the most common non-hematological adverse effects were superficial edema and weight gain (51.5%, followed by musculoskeletal pain (35.5%, then gastro-intestinal symptoms (vomiting, diarrhea (19%. Fluid retention was the commonest side effect, which responded to low-dose diuretics. The drug was safe and well tolerated. There were no deaths due to toxicity. CONCLUSION: Imatinib mesylate a well-tolerated drug, and all undesirable effects could be ameliorated easily. The most common hematological and non-hematological side effects were anemia and fluid retention, respectively.

  5. 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.)

  6. Evaluation of an International Disaster Relief Team After Participation in an ASEAN Regional Forum Disaster Relief Exercise.

    Science.gov (United States)

    Lee, Jeong Il; Lee, Kang Hyun; Kim, Oh Hyun; Cha, Yong Sung; Hwang, Sung Oh; Kim, Hyun; Cha, Kyung Chul

    2016-10-01

    Devastating disasters around the world directly contribute to significant increases in human mortality and economic costs. The objective of this study was to examine the current state of the Korea Disaster Relief Team that participated in an international training module. The whole training period was videotaped in order to observe and evaluate the respondents. The survey was carried out after completion of the 3-day training, and the scores were reported by use of a 5-point Likert scale. A total of 43 respondents were interviewed for the survey, and the results showed that the overall preparedness score for international disasters was 3.4±1.6 (mean±SD). The awareness of the Incident Command System for international disasters was shown to be low (3.5±1.1). Higher scores were given to personnel who took on leadership roles in the team and who answered "I knew my duty" (4.4±0.6) in the survey, as well as to the training participants who answered "I clearly knew my duty" (4.5±0.5). The preparedness level of the Korea Disaster Relief Team was shown to be insufficient, whereas understanding of the roles of leaders and training participants in the rescue team was found to be high. It is assumed that the preparedness level for disaster relief must be improved through continued training. (Disaster Med Public Health Preparedness. 2016;1-5).

  7. Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER.

    Science.gov (United States)

    Rosenberg, Jason; Fabi, Alain; Candido, Kenneth; Knezevic, Nick; Creamer, Michael; Carayannopoulos, Alexios; Ghodsi, Abdi; Nelson, Christopher; Bennett, Matthew

    2016-12-01

    The EMP 3 OWER™ study evaluated spinal cord stimulation (SCS) safety and efficacy and the associated changes in psychosocial and functional outcomes. Upon informed consent and IRB approval, 620 eligible subjects were enrolled prior to SCS trial evaluation and were assessed at baseline, 3, 6 and 12 months post-implant. Patient-reported pain relief (PRP), numerical rating scale (NRS), satisfaction, quality of life (QOL), and pain disability index (PDI) were assessed at all follow-up visits while the pain catastrophizing scale (PCS), short form-36 (SF-36), short form-McGill pain questionnaire version 2 (SF-MPQ-2), and the state-trait anxiety inventory (STAI) were assessed at the 6- and 12-month follow-up visits. Device and/or procedure-related adverse events were also recorded and reported. Subjects reporting a PRP ≥ 50% were considered responders. Repeated measures analysis of variance (RMANOVA) examined the changes across time for all continuous measures. A total of 401 (71%) subjects received a permanent implant. Mean (±SD) patient-reported pain relief was 59.3% (±26.2), 59.2% (±28.9), and 58.2% (±32.0) at 3, 6, and 12 months, respectively. A majority of enrolled subjects were responders at 3 (75.5%), 6 (74.7%), and 12 months (69.7%). RMANOVA revealed a statistically significant change for NRS, PCS, PDI, SF-36, SF-MPQ-2, and STAI scores. At 3 months, the majority of subjects (85.7%) were either very satisfied or satisfied with their device, with similar results at 6 and 12 months. At 3 months, the majority of subjects (73.3%) reported greatly improved or improved QOL with similar results at 6 and 12 months. Spinal cord stimulation provided pain relief and significant improvement of patient psychological and functional outcome measures. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  8. Analysis of preservice inspection relief requests and recommendations for ASME code changes

    International Nuclear Information System (INIS)

    Cook, J.F.

    1985-05-01

    NRC regulations require that preservice inspection (PSI) of nuclear plants be performed in accordance with referenced editions and addenda of Division 1 rules of Section XI, ''Rules for Inservice Inspection of Nuclear Power Plant Components'', of the ASME Boiler and Pressure Vessel Code (ASME Code). The regulations permit applicants to request and obtain relief from the NRC from specific ASME Code requirements that are determined to be impractical. Applicant requests for relief from preservice inspection (PSI) requirements were compiled and analyzed. From this data, covering a total of 178 relief requests, common problems with examination requirements were identified. Changes to examination requirements to solve selected problems are proposed. By following later ASME Code requirements, 46 out of the 178 relief requests can be eliminated. Implementing proposed Code changes would eliminate another 25 relief requests, leaving 107 relief requests out of the original 178 relief requests covered by this survey

  9. Effect of tip relief on endurance characteristics of super nitralloy and AISI M-50 spur gears

    Science.gov (United States)

    Townsend, D. P.; Zaretsky, E. V.

    1974-01-01

    Tests were conducted with two groups of 8.89-centimeter (3.5-in.) pitch diameter spur gears with standard 20 deg involute profile with tip relief made of CVM Super-Nitralloy (5Ni-2Al) and CVM AISI M-50 at a temperature of 350 K (170 F). Super-Nitralloy gears with tip relief had a life 150 percent that of gears without tip relief. An increased scoring phenomenon was noted with the Super-Nitralloy gears with tip relief. Through-hardened AISI M-50 gears with tip relief failed due to tooth fracture. AISI M-50 gears without tip relief had a life approximately 40 times greater than the AISI M-50 gears with tip relief.

  10. [Comparison of the efficacy and safety of praziquantel administered in single dose of 40 versus 60 mg/kg for treating urinary schistosomiasis in Mauritania].

    Science.gov (United States)

    Ouldabdallahi, M; Ousmane, B; Ouldbezeid, M; Mamadou, D; Konaté, L; Chitsulo, L

    2013-08-01

    During the last twenty years, praziquantel (PZQ) was the drug of choice for the treatment of schistosomiasis in the majority of national programs. However, a lower rate of cure had been significantly noted on the left bank of the Senegal River. To explain this unusual rate of cure, the assumption of a possible resistance to the drug as well as under-dosing was considered. With an aim of testing this hypothesis of underdosing, we compared the amount of a single dose of 60 mg/kg of PZQ versus the standardized dose of 40 mg/kg used in curing urinary schistosomiasis in Mauritania. One hundred and fifty-one children aged from 10 to 19 years, including 77 in the group of 60 mg/kg and 74 in the group of 40 mg/ kg, were included in the study. The rates of cure were respectively 64.8% for 60 mg/kg and 67.5% for 40 mg/kg three weeks after the administration of the treatment without statistically significant difference. For the majority of the patients, the drug was well tolerated and no serious adverse events were noted; however, clinical signs in the form of abdominal pain associated or not with diarrhea and vomiting were noted. Praziquantel remains an effective and well-tolerated drug: the amount of 40 mg/kg of body weight can still be maintained for the treatment of schistosomiasis in Mauritania.

  11. An open-label, single-arm study assessing the efficacy and safety of L: -menthol sprayed onto the gastric mucosa during upper gastrointestinal endoscopy.

    Science.gov (United States)

    Hiki, Naoki; Kaminishi, Michio; Tanabe, Satoshi; Fujisaki, Junko; Yoshino, Junji; Iguchi, Mikitaka; Kobayashi, Hiroyuki; Ashida, Kiyoshi; Kawabe, Takao; Kawano, Tatsuyuki; Nomura, Sachiyo; Yahagi, Naohisa; Tajiri, Hisao; Suzuki, Hiroaki

    2011-07-01

    The results of a phase III, placebo-controlled study demonstrated that endoscopic direct spraying of L: -menthol onto the gastric mucosa effectively suppressed gastric peristalsis in the study patients. The aim of the study reported here was to determine whether the anti-peristaltic effect of an L: -menthol preparation facilitates endoscopic examinations in a clinical setting. This was a multicenter, open-label, single-arm trial in which the study cohort comprised patients in whom L: -menthol was likely to be used to facilitate endoscopic examination in clinical settings. The primary outcome was the proportion of subjects with no peristalsis (Grade 1) after treatment and at the end of endoscopy (defined as the complete suppression of gastric peristalsis). This variable was assessed according to the level of anti-Helicobacter pylori immunoglobulin G (IgG) antibody, pepsinogen test results, whether sedation was performed, and whether subjects were considered unsuitable for the use of conventional antispasmodics. Of the 119 enrolled subjects, data from 112 were included in the primary efficacy analysis. Gastric peristalsis was completely suppressed in 37.5% of the patients [42/112 patients; 95% confidence interval (CI) 28.5-47.1]. Subgroup analyses revealed that the rate of peristalsis suppression was significantly higher in patients with elevated levels of anti-H. pylori IgG antibody (26/44, 59.1%; 95% CI 43.2-73.7); P peristalsis during upper gastrointestinal endoscopy.

  12. Randomized, comparative study of the efficacy and safety of artesunate plus amodiaquine, administered as a single daily intake versus two daily intakes in the treatment of uncomplicated falciparum malaria

    Directory of Open Access Journals (Sweden)

    Brasseur Phillipe

    2008-01-01

    Full Text Available Abstract Background Artesunate plus amodiaquine is a coblistered ACT, given as a single daily intake. It has been suggested that, in view of the number of tablets to be taken (particularly in adults, it may be possible to improve compliance by allowing patients to divide the daily dose. The objectives of this randomized, comparative, open-label, multicentre study, conducted in Senegal and in Cameroon in 2005, was to demonstrate the non-inferiority and to compare the safety of artesunate plus amodiaquine, as a single daily intake versus two daily intakes. Methods A three-day treatment period and 14-day follow-up period was performed in any subject weighting more than 10 kg, presenting with a malaria paroxysm confirmed by parasitaemia ≥ 1,000/μl, after informed consent. Patients were randomly allocated into one of the two regimens, with dosage according to bodyweight range. All products were administered by an authorized person, blinded to both the investigating physician and the biologist. The primary endpoint was an adequate response to treatment on D14 (WHO definition. The two-sided 90% confidence interval of the difference was calculated on intent to treat (ITT population; the acceptance limit for non-inferiority was 3%. The safety was evaluated by incidence of adverse events. Results Three-hundred and sixteen patients were included in the study. The two patient groups were strictly comparable on D0. The adequate responses to treatment were similar for the two treatment regimens on D14, PCR-corrected (99,4% in the one-daily intake group versus 99,3% in the comparative group. The statistical analyses demonstrated the non-inferiority of administering artesunate/amodiaquine as two intakes. The drug was well tolerated. The main adverse events were gastrointestinal disorders (2.5% and pruritus (2.5%; safety profiles were similar in the two groups. Conclusion This pilot study confirms the efficacy and good tolerability of artesunate plus

  13. Development of a pharmacovigilance safety monitoring tool for the rollout of single low-dose primaquine and artemether-lumefantrine to treat Plasmodium falciparum infections in Swaziland: a pilot study.

    Science.gov (United States)

    Poirot, Eugenie; Soble, Adam; Ntshalintshali, Nyasatu; Mwandemele, Asen; Mkhonta, Nomcebo; Malambe, Calisile; Vilakati, Sibonakaliso; Pan, Sisi; Darteh, Sarah; Maphalala, Gugu; Brown, Joelle; Hwang, Jimee; Pace, Cheryl; Stergachis, Andy; Vittinghoff, Eric; Kunene, Simon; Gosling, Roland

    2016-07-22

    Countries remain reluctant to adopt the 2012 World Health Organization recommendation for single low-dose (0.25 mg/kg) primaquine (SLD PQ) for Plasmodium falciparum transmission-blocking due to concerns over drug-related haemolysis risk, especially among glucose-6-phosphate dehydrogenase-deficient (G6PDd) people, without evidence demonstrating that it can be safely deployed in their settings. Pharmacovigilance methods provide a systematic way of collecting safety data and supporting the rollout of SLD PQ. The Primaquine Roll Out Monitoring Pharmacovigilance Tool (PROMPT), comprising: (1) a standardized form to support the surveillance of possible adverse events following SLD PQ treatment; (2) a patient information card to enhance awareness of known adverse drug reactions of SLD PQ use; and (3) a database compiling recorded information, was developed and piloted. Data on patient characteristics, malaria diagnosis and treatment are collected. Blood samples are taken to measure haemoglobin (Hb) and test for G6PD deficiency. Active follow-up includes a repeat Hb measurement and adverse event monitoring on or near day 7. A 13-month prospective pilot study in two hospital facilities in Swaziland alongside the introduction of SLD PQ generated preliminary evidence on the feasibility and acceptability of PROMPT. PROMPT was well received by nurses as a simple, pragmatic approach to active surveillance of SLD PQ safety data. Of the 102 patients enrolled and administered SLD PQ, none were G6PDd. 93 (91.2 %) returned on or near day 7 for follow-up. Four (4.6 %) patients had falls in Hb ≥25 % from baseline, none of whom presented with signs or symptoms of anaemia. No patient's Hb fell below 7 g/dL and none required a blood transfusion. Of the 11 (11 %) patients who reported an adverse event over the study period, three were considered serious and included two deaths and one hospitalization; none were causally related to SLD PQ. Four non-serious adverse events were

  14. Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial.

    Directory of Open Access Journals (Sweden)

    Emma-Jo Hayton

    Full Text Available HIV-1 vaccine development has advanced slowly due to viral antigenic diversity, poor immunogenicity and recently, safety concerns associated with human adenovirus serotype-5 vectors. To tackle HIV-1 variation, we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-1 proteome, which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA, a non-replicating simian (chimpanzee adenovirus ChAdV-63 and a non-replicating poxvirus, modified vaccinia virus Ankara. A block-randomized, single-blind, placebo-controlled phase I trial HIV-CORE 002 administered for the first time candidate HIV-1- vaccines or placebo to 32 healthy HIV-1/2-uninfected adults in Oxford, UK and elicited high frequencies of HIV-1-specific T cells capable of inhibiting HIV-1 replication in vitro. Here, detail safety and tolerability of these vaccines are reported.Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards. Data on all other adverse events were collected using open questions. Serum neutralizing antibody titres to ChAdV-63 were determined before and after vaccination.Two volunteers withdrew for vaccine-unrelated reasons. No vaccine-related serious adverse events or reactions occurred during 190 person-months of follow-up. Local and systemic events after vaccination occurred in 27/32 individuals and most were mild (severity grade 1 and predominantly transient (<48 hours. Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV63 or DNA vectors and more common in vaccine recipients than in placebo. There were no intercurrent HIV-1 infections during follow-up. 2/24 volunteers had low ChAdV-63-neutralizing titres at baseline and 7 increased their titres to over 200 with a median (range of 633 (231-1533 post-vaccination, which is of no safety concern.These data demonstrate safety and good tolerability of the pSG2

  15. Preclinical Study of Single-Dose Moxidectin, a New Oral Treatment for Scabies: Efficacy, Safety, and Pharmacokinetics Compared to Two-Dose Ivermectin in a Porcine Model.

    Science.gov (United States)

    Bernigaud, Charlotte; Fang, Fang; Fischer, Katja; Lespine, Anne; Aho, Ludwig Serge; Dreau, Dominique; Kelly, Andrew; Sutra, Jean-François; Moreau, Francis; Lilin, Thomas; Botterel, Françoise; Guillot, Jacques; Chosidow, Olivier

    2016-10-01

    Scabies is one of the commonest dermatological conditions globally; however it is a largely underexplored and truly neglected infectious disease. Foremost, improvement in the management of this public health burden is imperative. Current treatments with topical agents and/or oral ivermectin (IVM) are insufficient and drug resistance is emerging. Moxidectin (MOX), with more advantageous pharmacological profiles may be a promising alternative. Using a porcine scabies model, 12 pigs were randomly assigned to receive orally either MOX (0.3 mg/kg once), IVM (0.2 mg/kg twice) or no treatment. We evaluated treatment efficacies by assessing mite count, clinical lesions, pruritus and ELISA-determined anti-S. scabiei IgG antibodies reductions. Plasma and skin pharmacokinetic profiles were determined. At day 14 post-treatment, all four MOX-treated but only two IVM-treated pigs were mite-free. MOX efficacy was 100% and remained unchanged until study-end (D47), compared to 62% (range 26-100%) for IVM, with one IVM-treated pig remaining infected until D47. Clinical scabies lesions, pruritus and anti-S. scabiei IgG antibodies had completely disappeared in all MOX-treated but only 75% of IVM-treated pigs. MOX persisted ~9 times longer than IVM in plasma and skin, thereby covering the mite's entire life cycle and enabling long-lasting efficacy. Our data demonstrate that oral single-dose MOX was more effective than two consecutive IVM-doses, supporting MOX as potential therapeutic approach for scabies.

  16. Pharmacokinetics, pharmacodynamics and safety of CEP-26401, a high-affinity histamine-3 receptor antagonist, following single and multiple dosing in healthy subjects.

    Science.gov (United States)

    Spiegelstein, Ofer; Stevens, Jasper; Van Gerven, Joop; Nathan, Pradeep J; Maynard, James P; Mayleben, David W; Hellriegel, Edward; Yang, Ronghua

    2016-10-01

    CEP-26401 is a novel orally active, brain-penetrant, high-affinity histamine H3 receptor (H3R) antagonist, with potential therapeutic utility in cognition enhancement. Two randomized, double-blind, placebo-controlled dose escalation studies with single (0.02 to 5 mg) or multiple administration (0.02 to 0.5 mg once daily) of CEP-26401 were conducted in healthy subjects. Plasma and urine samples were collected to investigate CEP-26401 pharmacokinetics. Pharmacodynamic endpoints included a subset of tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB) and nocturnal polysomnography. Population pharmacokinetic-pharmacodynamic modeling was conducted on one CANTAB and one polysomnography parameter of interest. CEP-26401 was slowly absorbed (median tmax range 3-6 hours) and the mean terminal elimination half-life ranged from 24-60 hours. Steady-state plasma concentrations were achieved within six days of dosing. CEP-26401 exhibits dose- and time-independent pharmacokinetics, and renal excretion is a major elimination pathway. CEP-26401 had a dose-dependent negative effect on sleep, with some positive effects on certain CANTAB cognitive parameters seen at lower concentrations. The derived three compartment population pharmacokinetic model, with first-order absorption and elimination, accurately described the available pharmacokinetic data. CEP-26401 was generally well tolerated up to 0.5 mg/day with most common treatment related adverse events being headache and insomnia. Further clinical studies are required to establish the potential of low-dose CEP-26401 in cognition enhancement. © The Author(s) 2016.

  17. Preclinical Study of Single-Dose Moxidectin, a New Oral Treatment for Scabies: Efficacy, Safety, and Pharmacokinetics Compared to Two-Dose Ivermectin in a Porcine Model

    Science.gov (United States)

    Bernigaud, Charlotte; Aho, Ludwig Serge; Dreau, Dominique; Kelly, Andrew; Sutra, Jean-François; Moreau, Francis; Lilin, Thomas; Botterel, Françoise; Guillot, Jacques; Chosidow, Olivier

    2016-01-01

    Background Scabies is one of the commonest dermatological conditions globally; however it is a largely underexplored and truly neglected infectious disease. Foremost, improvement in the management of this public health burden is imperative. Current treatments with topical agents and/or oral ivermectin (IVM) are insufficient and drug resistance is emerging. Moxidectin (MOX), with more advantageous pharmacological profiles may be a promising alternative. Methodology/Principal Findings Using a porcine scabies model, 12 pigs were randomly assigned to receive orally either MOX (0.3 mg/kg once), IVM (0.2 mg/kg twice) or no treatment. We evaluated treatment efficacies by assessing mite count, clinical lesions, pruritus and ELISA-determined anti-S. scabiei IgG antibodies reductions. Plasma and skin pharmacokinetic profiles were determined. At day 14 post-treatment, all four MOX-treated but only two IVM-treated pigs were mite-free. MOX efficacy was 100% and remained unchanged until study-end (D47), compared to 62% (range 26–100%) for IVM, with one IVM-treated pig remaining infected until D47. Clinical scabies lesions, pruritus and anti-S. scabiei IgG antibodies had completely disappeared in all MOX-treated but only 75% of IVM-treated pigs. MOX persisted ~9 times longer than IVM in plasma and skin, thereby covering the mite’s entire life cycle and enabling long-lasting efficacy. Conclusions/Significance Our data demonstrate that oral single-dose MOX was more effective than two consecutive IVM-doses, supporting MOX as potential therapeutic approach for scabies. PMID:27732588

  18. Stereotactic biopsy of brainstem lesions: Techniques, efficacy, safety, and disease variation between adults and children: A single institutional series and review

    Directory of Open Access Journals (Sweden)

    N Manoj

    2014-01-01

    Full Text Available Background: Stereotactic biopsy of brainstem lesions have been performed with varying indications, with most of the literature reporting on children. Materials and Methods: The present study retrospectively analyzed all cases that underwent stereotactic biopsy for brainstem lesion in both adult and pediatric population between 1994 and 2009 in a single tertiary neurosurgical center. The clinical and radiological features, technique of the procedure, morbidity, diagnostic accuracy, spectrum of diagnosis, and variations in adult and pediatric population were analyzed. Results: Eighty-two patients were included in the study. Computed tomography (CT was used as guidance in 73 (38 children and 35 adults patients and magnetic resonance imaging (MRI in 9 (3 children and 6 adults. The biopsy was performed in a procedure room under local anesthesia in most adults, while children required sedation. Glioblastoma comprised 29.3% of all pathologies in children, compared with only 4.9% of the pathologies in adult population (P = 0.007. Tuberculosis was the next major diagnosis (9.8%. In 12 patients, initial biopsy was inconclusive. Following a repeat biopsy in 5 of these patients, a diagnosis was possible for 75/82 (91.5% patients by STB. The location of the target, the choice of entry, the radiological characteristic of the lesion, enhancement pattern, and age group did not significantly correlate with the occurrence of inconclusive biopsy. Permanent complications occurred in two patients (2.4%. There was no mortality in this series. Conclusion: Stereotactic biopsy has an important role in brainstem lesions, more significantly in adults, due to wider pathological spectrum. It can be performed safely under local anesthesia through a twist drill craniostomy in most of the adults.

  19. Safety Aspects of Big Cryogenic Systems Design

    Science.gov (United States)

    Chorowski, M.; Fydrych, J.; Poliński, J.

    2010-04-01

    Superconductivity and helium cryogenics are key technologies in the construction of large scientific instruments, like accelerators, fusion reactors or free electron lasers. Such cryogenic systems may contain more than hundred tons of helium, mostly in cold and high-density phases. In spite of the high reliability of the systems, accidental loss of the insulation vacuum, pipe rupture or rapid energy dissipation in the cold helium can not be overlooked. To avoid the danger of over-design pressure rise in the cryostats, they need to be equipped with a helium relief system. Such a system is comprised of safety valves, bursting disks and optionally cold or warm quench lines, collectors and storage tanks. Proper design of the helium safety relief system requires a good understanding of worst case scenarios. Such scenarios will be discussed, taking into account different possible failures of the cryogenic system. In any case it is necessary to estimate heat transfer through degraded vacuum superinsulation and mass flow through the valves and safety disks. Even if the design of the helium relief system does not foresee direct helium venting into the environment, an occasional emergency helium spill may happen. Helium propagation in the atmosphere and the origins of oxygen-deficiency hazards will be discussed.

  20. 75 FR 35516 - Pipeline Safety: Request for Special Permit

    Science.gov (United States)

    2010-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION... the Federal pipeline safety laws, PHMSA is publishing this notice of special permit request we have... seeking relief from compliance with certain plastic pipe design requirements in the Federal pipeline...

  1. Heart Rate Variability Biofeedback Stress Relief Program for Depression A Replicated Single-Subject Design

    NARCIS (Netherlands)

    Hartogs, Bregje M. A.; Bartels-Velthuis, Agna A.; Van der Ploeg, Karen; Bos, Elske H.

    2017-01-01

    Background: Depressive disorders often have a chronic course and the efficacy of evidence-based treatments may be overestimated. Objective: To examine the effectiveness of the Heart Rate Variability Stress Reduction Program (SRP) as a supplement to standard treatment in patients with depressive

  2. Effect of adding celecoxib to a single dose of gabapentin on postoperative pain relief

    Directory of Open Access Journals (Sweden)

    Mansour Choubsaz

    2015-01-01

    Full Text Available Background: In recent years, several studies with conflicting results have been done on the role of gabapentin and non-steroidal anti-inflammatory drugs in pre-emptive analgesia to control postoperative pain. The purpose of this study was to evaluate the effect of adding low doses of celecoxib to gabapentin on increasing the analgesic effect and patients’ satisfaction. Methods: In this double-blind randomized clinical trial, 130 patients with ASA I, II class were divided in two groups as they were the candidates for elective inguinal hernia surgery with spinal anesthesia. Before the surgery, the control group (G received 300 mg oral dose of gabapentin and the study group (GC received 100 mg celecoxib in addition to the above dose. Severity of patients’ pain was measured using the visual analogue scale (VAS. By the same token, the amount of painkillers usedwas measured and statistically analyzed. Results: The results suggested a statistically significant difference between the two groups in terms of pain level 4, 6 and 24 hours after surgery (P<0.05. Adding low-dose of celeoxib to gabapentin before the surgery and the combination of these two drugs caused further reduction of pain 4, 6 and 24 h after the surgery in comparison to the administration of gabapentin alone. Conclusion: Adding 100 mg celecoxib to 300 mg gabapentin resulted in a reduction of pain level 24 h after elective surgery of inguinal hernia in patients of control group (P<0.05. However, in terms of using painkillers (analgesics, there was no statistically significant difference between the two groups.

  3. Immediate pain relief by microvascular decompression for idiopathic trigeminal neuralagia

    International Nuclear Information System (INIS)

    Haq, N.U.; Ali, M.; Khan, H.M.; Ishaq, M.; Khattak, M.I.

    2016-01-01

    Background: Trigeminal neuralgia is a common entity which is managed by neurosurgeons in day to day practice. Up-till now many treatment options have been adopted for it but micro-vascular decompression is much impressive in terms of pain control and recurrence rate in all of them. The objective of study was known the efficacy of micro vascular decompression for idiopathic trigeminal neuralgia by using muscle patch in terms of immediate pain relief. Methods: This descriptive study was carried out in Neurosurgery Department lady reading hospital, Peshawar from January 2010 to December 2012. All patients who underwent micro vascular decompression for idiopathic trigeminal neuralgia were included in the study. Patients were assessed 72 hours after the surgery by borrow neurological institute pain scale (BNIP scale) for pain relief and findings were documented on predesigned proforma. Data was analysed by SPSS-17. Results: Total 52 patients were included in this study. Among these 32 (61.53 percentage) were female and 20 (38.46 percentage) were males having age from 22-76 years (mean 49 years). Right side was involved in 36 (69.23 percentage) and left side in 16 (30.76 percentage) patients. Duration of symptoms ranged from 6 months to 16 years (mean 8 years). History of dental extraction and peripheral neurectomy was present in 20 (38 percentage) and 3(5.76 percentage) patients while V3 was most commonly involved branch with 28(57.69 percentage) frequency and combined V2,V3 involvement was 1 (11.53 percentage). Superior cerebellar artery was most common offending vessel in 46(88.46 percentage) while arachnoid adhesions were in 2(3.84 percentage) patients. We assessed patient immediate postoperatively using BNIP pain scale. Conclusion: Micro-vascular decompression is most effective mode of treatment for trigeminal neuralgia in terms of immediate pain relief. (author)

  4. Inadequate pain relief among patients with primary knee osteoarthritis.

    Science.gov (United States)

    Laires, Pedro A; Laíns, Jorge; Miranda, Luís C; Cernadas, Rui; Rajagopalan, Srini; Taylor, Stephanie D; Silva, José C

    Despite the widespread treatments for osteoarthritis (OA), data on treatment patterns, adequacy of pain relief, and quality of life are limited. The prospective multinational Survey of Osteoarthritis Real World Therapies (SORT) was designed to investigate these aspects. To analyze the characteristics and the patient reported outcomes of the Portuguese dataset of SORT at the start of observation. Patients ≥50 years with primary knee OA who were receiving oral or topical analgesics were eligible. Patients were enrolled from seven healthcare centers in Portugal between January and December 2011. Pain and function were evaluated using the Brief Pain Inventory (BPI) and WOMAC. Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). Inadequate pain relief (IPR) was defined as a score >4/10 on item 5 of the BPI. Overall, 197 patients were analyzed. The median age was 67.0 years and 78.2% were female. Mean duration of knee OA was 6.2 years. IPR was reported by 51.3% of patients. Female gender (adjusted odds ratio - OR 2.15 [95%CI 1.1, 4.5]), diabetes (OR 3.1 [95%CI 1.3, 7.7]) and depression (OR 2.24 [95%CI 1.2, 4.3]) were associated with higher risk of IPR. Patients with IPR reported worst outcomes in all dimensions of WOMAC (p<0.001) and in all eight domains and summary components of SF-12 (p<0.001). Our findings indicate that improvements are needed in the management of pain in knee OA in order to achieve better outcomes in terms of pain relief, function and quality of life. Copyright © 2016 Elsevier Editora Ltda. All rights reserved.

  5. Innovative qPCR using interfacial effects to enable low threshold cycle detection and inhibition relief

    Science.gov (United States)

    Harshman, Dustin K.; Rao, Brianna M.; McLain, Jean E.; Watts, George S.; Yoon, Jeong-Yeol

    2015-01-01

    Molecular diagnostics offers quick access to information but fails to operate at a speed required for clinical decision-making. Our novel methodology, droplet-on-thermocouple silhouette real-time polymerase chain reaction (DOTS qPCR), uses interfacial effects for droplet actuation, inhibition relief, and amplification sensing. DOTS qPCR has sample-to-answer times as short as 3 min 30 s. In infective endocarditis diagnosis, DOTS qPCR demonstrates reproducibility, differentiation of antibiotic susceptibility, subpicogram limit of detection, and thermocycling speeds of up to 28 s/cycle in the presence of tissue contaminants. Langmuir and Gibbs adsorption isotherms are used to describe the decreasing interfacial tension upon amplification. Moreover, a log-linear relationship with low threshold cycles is presented for real-time quantification by imaging the droplet-on-thermocouple silhouette with a smartphone. DOTS qPCR resolves several limitations of commercially available real-time PCR systems, which rely on fluorescence detection, have substantially higher threshold cycles, and require expensive optical components and extensive sample preparation. Due to the advantages of low threshold cycle detection, we anticipate extending this technology to biological research applications such as single cell, single nucleus, and single DNA molecule analyses. Our work is the first demonstrated use of interfacial effects for sensing reaction progress, and it will enable point-of-care molecular diagnosis of infections. PMID:26601245

  6. Epidural morphine for postoperative pain relief in children

    DEFF Research Database (Denmark)

    Henneberg, S W; Hole, P; Haas, Inge Madsen De

    1993-01-01

    for postoperative pain relief after major abdominal surgery. The age distribution was from newborn to 13 years, with a median age of 12 months. It was estimated that 94% of the patients had good analgesia for the first 24 postoperative hours and no other opioids were given. The side effects were few, but one case...... of respiratory depression was seen and 20% of the children had pruritus. There were four dural punctures and three catheters slipped out accidentally, but otherwise the treatment was continued as long as it was considered necessary (1-11 days). The use of postoperative ventilatory support decreased during...

  7. Optically induced surface relief phenomena in azobenzene polymers

    DEFF Research Database (Denmark)

    Holme, NCR; Nikolova, Ludmila; Hvilsted, Søren

    1999-01-01

    Azobenzene polymers and oligomers show intriguing surface relief features when irradiated with polarized laser light. We show through atomic force microscopic investigation of side-chain azobenzene polymers after irradiation through an amplitude mask that large peaks or trenches result depending...... on the architecture of the polymer. Extensive mass transport over long distances has been observed, paving the way for easy replication of nanostructures. We also show that it is possible to store microscopic images as topographic features in the polymers just through polarized light irradiation. (C) 1999 American...

  8. Vibration stress relief of DH 36 rectangle welded plates

    Science.gov (United States)

    Li, Shuqi; Fang, Hongyuan

    2018-03-01

    Vibration stress relief (VSR) is widely used in reducing residual stress in welded structures. However, the effectiveness of this method is still instable in some circumstance. In this study, a covert negative treatment phenomenon was investigated, i.e. natural frequency of welded structures decreased after VSR but residual stress in one direction increased. When the alteration of natural frequency after VSR is significant, the residual stresses in both the longitudinal and transversal directions shall decrease. Otherwise, residual stresses may increase on one direction. Thus, sufficient power shall be applied to the welded structures to avoid negative results.

  9. Evaluation of Congestion Relief Proposals in a Capital City

    Directory of Open Access Journals (Sweden)

    Sudhir C. Fowdur

    2012-01-01

    Full Text Available This paper aims at analyzing three different solutions suggested for traffic congestion relief in Port Louis, the busiest city of Mauritius. It evaluates the impact of the three alternatives which are the use of Light Rail Transit (LRT as an alternative mode of transport, the construction of a Ring road around Port Louis, and the upgrading of the current bus network into a Bus Rapid Transit (BRT system. The impact of these three solutions has been evaluated by performing Traffic Cellular Automata (TCA simulations. Our studies reveal that the Ring road will lead to more congestion while introducing the LRT or upgrading the current bus network will reduce congestion significantly.

  10. Pakistan Earthquake Relief Operations: Leveraging Humanitarian Missions for Strategic Success

    Science.gov (United States)

    2010-12-01

    pilots, relief missions had not previously been flown at night . But a little girl’s life was at stake, so Crocker authorized one of the State...with the Pakistani military, to Ambassador Crocker’s decision to launch a dangerous night mission to save the life of a 5-year-old girl, to Lance...PRISM 2, no. 1 leSSoNS leaRNed | 131 On Christmas morning 2005, at Saint Patrick’s Catholic Church in Auckland , New Zealand, a priest stepped up to

  11. Report on nuclear and radiological safety in 1995

    International Nuclear Information System (INIS)

    Lovincic, D.

    1996-07-01

    The Slovenian Nuclear Safety Administration (SNSA) in cooperation with the Health Inspectorate of the Republic of Slovenia and the Administration for Rescue and Disaster Relief (URSZR) has prepared a Report on Nuclear and Radiological Safety in the Republic of Slovenia for 1995. The report is presenting: the activities of the SNSA; the operation of nuclear facilities; monitoring of radioactivity; control of ionizing radiation and nuclear electricity generation.

  12. Study on high reliability safety valve for railway vehicle

    Science.gov (United States)

    Zhang, Xuan; Chen, Ruikun; Zhang, Shixi; Xu, BuDu

    2017-09-01

    Now, the realization of most of the functions of the railway vehicles rely on compressed air, so the demand for compressed air is growing higher and higher. This safety valve is a protection device for pressure limitation and pressure relief in an air supply system of railway vehicles. I am going to introduce the structure, operating principle, research and development process of the safety valve designed by our company in this document.

  13. Nuclear and radiation safety in Slovenia. Annual report 2000

    International Nuclear Information System (INIS)

    Lovincic, D.

    2001-09-01

    The Slovenian Nuclear Safety Administration (SNSA), in co-operation with the Health Inspectorate of the Republic of Slovenia, the Administration for Civil Protection and Disaster Relief and the Ministry of the Interior, has prepared a Report on Nuclear and Radiation Safety in the Republic of Slovenia for 2000. This is one of the regular forms of reporting on the work of the Administration to the Government and National Assembly of the Republic of Slovenia. (author)

  14. Nuclear and radiological safety in Slovenia in 1995

    International Nuclear Information System (INIS)

    Lovincic, D.

    1996-01-01

    The Slovenian Nuclear Safety Administration (SNSA) in cooperation with the Health Inspectorate of the Republic of Slovenia and the Administration for Rescue and Disaster Relief (URSZR) has prepared a Report on Nuclear and Radiological Safety in the Republic of Slovenia for 1995. The report is presenting: the activities of the SNSA; the operation of nuclear facilities; monitoring of radioactivity; control of ionizing radiation and nuclear electricity generation. (author)

  15. 77 FR 71131 - Implementation of the Middle Class Tax Relief and Job Creation Act of 2012; Establishment of a...

    Science.gov (United States)

    2012-11-29

    ... Contact Registered PSAP Numbers 10. Section 6507(b)(5) of the Tax Relief Act directs the Commission to... underlying section 6507 of the Tax Relief Act. In addition, section 6003 of the Tax Relief Act directs the.... Definitions. As noted above, the Tax Relief Act does not define ``automatic dialing'' or ``robocall...

  16. Safety, pharmacokinetics and efficacy findings in an open-label, single-arm study of weekly paclitaxel plus lapatinib as first-line therapy for Japanese women with HER2-positive metastatic breast cancer.

    Science.gov (United States)

    Inoue, Kenichi; Kuroi, Katsumasa; Shimizu, Satoru; Rai, Yoshiaki; Aogi, Kenjiro; Masuda, Norikazu; Nakayama, Takahiro; Iwata, Hiroji; Nishimura, Yuichiro; Armour, Alison; Sasaki, Yasutsuna

    2015-12-01

    Lapatinib is the human epidermal growth factor receptor 2 (HER2) targeting agent approved globally for HER2-positive metastatic breast cancer (MBC). The efficacy, safety and pharmacokinetics (PK) of lapatinib combined with paclitaxel (L+P) were investigated in this study, to establish clear evidence regarding the combination in Japanese patients. In this two-part, single-arm, open-label study, the tolerability of L+P as first-line treatment in Japanese patients with HER2-positive MBC was evaluated in six patients in the first part, and the safety, efficacy and PK were evaluated in a further six patients (making a total of twelve patients) in the second part. Eligible women were enrolled and received lapatinib 1500 mg once daily and paclitaxel 80 mg/m(2) weekly for at least 6 cycles. The only dose-limiting toxicity reported was Grade 3 diarrhea in one patient. The systemic exposure to maximum plasma concentration and area under the plasma concentration curve (AUC) for lapatinib, as well as the AUC of paclitaxel, were increased when combined. The most common adverse events (AEs) related to the study treatment were alopecia, diarrhea and decreased hemoglobin. The majority of drug-related AEs were Grade 1 or 2. The median overall survival was 35.6 months (95 % confidence interval 23.9, not reached). The response rate and clinical benefit rate were both 83 % (95 % confidence interval 51.6, 97.9). The L+P treatment was well tolerated in Japanese patients with HER2-positive MBC. Although the PK profiles of lapatinib and paclitaxel influenced each other, the magnitudes were not greatly different from those in non-Japanese patients.

  17. Criticality safety evaluation in Tokai Reprocessing Plant

    International Nuclear Information System (INIS)

    Shirai, Nobutoshi; Nakajima, Masayoshi; Takaya, Akikazu; Ohnuma, Hideyuki; Shirouzu, Hidetomo; Hayashi, Shinichiro; Yoshikawa, Koji; Suto, Toshiyuki

    2000-04-01

    Criticality limits for equipments in Tokai Reprocessing Plant which handle fissile material solution and are under shape and dimension control were reevaluated based on the guideline No.10 'Criticality safety of single unit' in the regulatory guide for reprocessing plant safety. This report presents criticality safety evaluation of each equipment as single unit. Criticality safety of multiple units in a cell or a room was also evaluated. The evaluated equipments were ones in dissolution, separation, purification, denitration, Pu product storage, and Pu conversion processes. As a result, it was reconfirmed that the equipments were safe enough from a view point of criticality safety of single unit and multiple units. (author)

  18. Humanitarian power : Canadian electrical techies help hurricane relief in Honduras

    Energy Technology Data Exchange (ETDEWEB)

    Mallett, N.

    1999-04-01

    A review of the emergency assistance provided to Honduras by Canada following Hurricane Mitch that struck the country with a ferocity not seen in 200 years, was described. Thousands of Hondurans were killed and three million were left homeless as vast regions of the country were literally washed away. The secondary effects of the storm - famine and disease - set in to claim even more lives. The Canadian Forces` Disaster Response Team (DART) was dispatched to conduct emergency relief operations for up to 40 days in order to bridge the gap until members of the international community arrive to provide long-term help. DART focused on providing medical care, clean drinking water, an engineering capability, and reliable communications. The medical team consisting of a small field hospital with a staff of 45 provided care for up to 500 outpatients and 30 inpatients daily, depending on the severity of injuries. The engineering team of about 40 provided a wide range of services, such as water purification, using a reverse osmosis water purification unit, fresh water distribution and power generation. The communications unit provided contact with headquarters in Honduras, and communicated with bases back in Canada. The operation was a great success, and well received by the Honduran people. This was the first deployment of DART, a team initially conceived after the Canadian Forces participated in relief efforts in Rwanda in 1994 and 1995.

  19. Humanitarian power : Canadian electrical techies help hurricane relief in Honduras

    International Nuclear Information System (INIS)

    Mallett, N.

    1999-01-01

    A review of the emergency assistance provided to Honduras by Canada following Hurricane Mitch that struck the country with a ferocity not seen in 200 years, was described. Thousands of Hondurans were killed and three million were left homeless as vast regions of the country were literally washed away. The secondary effects of the storm - famine and disease - set in to claim even more lives. The Canadian Forces' Disaster Response Team (DART) was dispatched to conduct emergency relief operations for up to 40 days in order to bridge the gap until members of the international community arrive to provide long-term help. DART focused on providing medical care, clean drinking water, an engineering capability, and reliable communications. The medical team consisting of a small field hospital with a staff of 45 provided care for up to 500 outpatients and 30 inpatients daily, depending on the severity of injuries. The engineering team of about 40 provided a wide range of services, such as water purification, using a reverse osmosis water purification unit, fresh water distribution and power generation. The communications unit provided contact with headquarters in Honduras, and communicated with bases back in Canada. The operation was a great success, and well received by the Honduran people. This was the first deployment of DART, a team initially conceived after the Canadian Forces participated in relief efforts in Rwanda in 1994 and 1995

  20. Relief-oriented use of marijuana by teens

    Science.gov (United States)

    Bottorff, Joan L; Johnson, Joy L; Moffat, Barbara M; Mulvogue, Tamsin

    2009-01-01

    Background There are indications that marijuana is increasingly used to alleviate symptoms and for the treatment of a variety of medical conditions both physical and psychological. The purpose of this study was to describe the health concerns and problems that prompt some adolescents to use marijuana for therapeutic reasons, and their beliefs about the risks and benefits of the therapeutic use of marijuana. Methods As part of a larger ethnographic study of 63 adolescents who were regular marijuana users, we analyzed interviews conducted with 20 youth who self-identified as using marijuana to relieve or manage health problems. Results Thematic analysis revealed that these teens differentiated themselves from recreational users and positioned their use of marijuana for relief by emphasizing their inability to find other ways to deal with their health problems, the sophisticated ways in which they titrated their intake, and the benefits that they experienced. These teens used marijuana to gain relief from difficult feelings (including depression, anxiety and stress), sleep difficulties, problems with concentration and physical pain. Most were not overly concerned about the risks associated with using marijuana, maintaining that their use of marijuana was not 'in excess' and that their use fit into the realm of 'normal.' Conclusion Marijuana is perceived by some teens to be the only available alternative for teens experiencing difficult health problems when medical treatments have failed or when they lack access to appropriate health care. PMID:19389223

  1. Relief-oriented use of marijuana by teens

    Directory of Open Access Journals (Sweden)

    Johnson Joy L

    2009-04-01

    Full Text Available Abstract Background There are indications that marijuana is increasingly used to alleviate symptoms and for the treatment of a variety of medical conditions both physical and psychological. The purpose of this study was to describe the health concerns and problems that prompt some adolescents to use marijuana for therapeutic reasons, and their beliefs about the risks and benefits of the therapeutic use of marijuana. Methods As part of a larger ethnographic study of 63 adolescents who were regular marijuana users, we analyzed interviews conducted with 20 youth who self-identified as using marijuana to relieve or manage health problems. Results Thematic analysis revealed that these teens differentiated themselves from recreational users and positioned their use of marijuana for relief by emphasizing their inability to find other ways to deal with their health problems, the sophisticated ways in which they titrated their intake, and the benefits that they experienced. These teens used marijuana to gain relief from difficult feelings (including depression, anxiety and stress, sleep difficulties, problems with concentration and physical pain. Most were not overly concerned about the risks associated with using marijuana, maintaining that their use of marijuana was not 'in excess' and that their use fit into the realm of 'normal.' Conclusion Marijuana is perceived by some teens to be the only available alternative for teens experiencing difficult health problems when medical treatments have failed or when they lack access to appropriate health care.

  2. Putting Qumran, Jesus and his movement into relief

    Directory of Open Access Journals (Sweden)

    Eben Scheffler

    2016-11-01

    Full Text Available After referring briefly to the fantasies regarding the origins of Christianity as elicited by the discovery of the Dead Sea Scrolls in 1947 (Dupont-Sommer, Allegro, Thiering, the purpose of the contribution is to put the Jesus movement into relief in the context of first-century Judaism. The identity of the Qumranites is argued to be Essene scribes. The identity, ideology and practices of the latter are compared with those of Jesus of Nazareth and the movement he elicited using the following rubrics: (1 Jesus, the teacher of righteousness and the powers that be; (2 asceticism versus itinerary charismaticism; (3 caring versus lack of caring for the sick, poor and marginalised; (4 elitist priests and scribes versus lower-class peasants; (5 the interpretation of the law; (6 religious and daily practices (baptism, ritual meal, sacrifice, prayer, community of possessions, scribal activity; (7 religious views or ideology (kingdom of God, the new covenant, light and darkness, politics. The result is a picture of Jesus (with his focus on human suffering in sharp relief versus Qumran and facets of the early church.

  3. Corruption in cyclone preparedness and relief efforts in coastal Bangladesh

    DEFF Research Database (Denmark)

    Mahmud, Tanvir; Prowse, Martin

    2012-01-01

    This article seeks to draw possible lessons for adaptation programmes in Bangladesh by examining whether cyclone preparedness and relief interventions are subject to corrupt practices. Based on a random sample survey of 278 households, three focus-group discussions and seven key-informant intervi......This article seeks to draw possible lessons for adaptation programmes in Bangladesh by examining whether cyclone preparedness and relief interventions are subject to corrupt practices. Based on a random sample survey of 278 households, three focus-group discussions and seven key......-informant interviews, the article investigates the nature and extent of corruption in pre- and post-disaster interventions in Khulna before and after Cyclone Aila in May 2009. Ninety nine percent of households reported losses from corrupt practices. Post-disaster interventions (such as food aid and public works...... schemes) suffered from greater levels, and worse types, of corruption than pre-disaster interventions (such as cyclone warning systems and disaster-preparedness training). Using an asset index created using principal component analysis, the article assesses how corruption affected wealth quartiles. Ultra...

  4. Water Safety

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Water Safety KidsHealth / For Teens / Water Safety What's in ... drownings are tied to alcohol use. At the Water Park OK, so you do more splashing than ...

  5. Water Safety

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Water Safety KidsHealth / For Parents / Water Safety What's in ... remains your best measure of protection. Making Kids Water Wise It's important to teach your kids proper ...

  6. Home Safety

    Science.gov (United States)

    ... Safety Sponsors Recalls Media Center Blog Videos Newsletter facebook twitter instagram pinterest gplus youtube Search Menu Why It Matters ... Safety Sponsors Recalls Media Center Blog Videos Newsletter facebook twitter instagram pinterest gplus youtube Sign up for quick tips ...

  7. Reactive Safety

    Directory of Open Access Journals (Sweden)

    Rüdiger Ehlers

    2011-06-01

    Full Text Available The distinction between safety and liveness properties is a fundamental classification with immediate implications on the feasibility and complexity of various monitoring, model checking, and synthesis problems. In this paper, we revisit the notion of safety for reactive systems, i.e., for systems whose behavior is characterized by the interplay of uncontrolled environment inputs and controlled system outputs. We show that reactive safety is a strictly larger class of properties than standard safety. We provide algorithms for checking if a property, given as a temporal formula or as a word or tree automaton, is a reactive safety property and for translating such properties into safety automata. Based on this construction, the standard verification and synthesis algorithms for safety properties immediately extend to the larger class of reactive safety.

  8. Safety Checklists

    National Research Council Canada - National Science Library

    1985-01-01

    The purpose of this checklist is to provide commanders, directors, safety officers, and supervisors with a ready safety reference that encompasses most functions and tasks common to operations within...

  9. ITER safety

    International Nuclear Information System (INIS)

    Raeder, J.; Piet, S.; Buende, R.

    1991-01-01

    As part of the series of publications by the IAEA that summarize the results of the Conceptual Design Activities for the ITER project, this document describes the ITER safety analyses. It contains an assessment of normal operation effluents, accident scenarios, plasma chamber safety, tritium system safety, magnet system safety, external loss of coolant and coolant flow problems, and a waste management assessment, while it describes the implementation of the safety approach for ITER. The document ends with a list of major conclusions, a set of topical remarks on technical safety issues, and recommendations for the Engineering Design Activities, safety considerations for siting ITER, and recommendations with regard to the safety issues for the R and D for ITER. Refs, figs and tabs

  10. Safety and effectiveness of the Genous™ endothelial progenitor cell-capture stent in the first year following ST-elevation acute myocardial infarction: A single center experience and review of the literature

    Energy Technology Data Exchange (ETDEWEB)

    Pereira-da-Silva, Tiago, E-mail: tiagopsilva@sapo.pt; Bernardes, Luís; Cacela, Duarte; Fiarresga, António; Sousa, Lídia; Patrício, Lino; Ferreira, Rui Cruz

    2013-11-15

    Purpose: The Genous™ stent (GS) is designed to accelerate endothelization, which is potentially useful in the pro-thrombotic environment of ST-elevation acute myocardial infarction (STEMI). We aimed to evaluate the safety and effectiveness of the GS in the first year following primary percutaneous coronary intervention (PCI) and to compare our results with the few previously published studies. Methods and Materials: All patients admitted to a single center due to STEMI that underwent primary PCI using exclusively GS, between May 2006 and January 2012, were enrolled. The primary study endpoints were major adverse cardiac events (MACEs), defined as the composite of cardiac death, acute myocardial infarction and target vessel revascularization, at one and 12 months. Results: In the cohort of 109 patients (73.4% male, 59 ± 12 years), 24.8% were diabetic. PCI was performed in 116 lesions with angiographic success in 99.1%, using 148 GS with median diameter of 3.00 mm (2.50–4.00) and median length of 15 mm (9–33). Cumulative MACEs were 2.8% at one month and 6.4% at 12 months. Three stent thromboses (2.8%), all subacute, and one stent restenosis (0.9%) occurred. These accounted for the four target vessel revascularizations (3.7%). At 12 months, 33.9% of patients were not on dual antiplatelet therapy. Conclusions: GS was safe and effective in the first year following primary PCI in STEMI, with an apparently safer profile comparing with the previously published data. Summary: We report the safety and effectiveness of the Genous™ stent (GS) in the first year following primary percutaneous coronary intervention in ST-elevation acute myocardial infarction. A comprehensive review of the few studies that have been published on this subject was included and some suggest a less safe profile of the GS. Our results and the critical review included may add information and reinforce the safety and effectiveness of the GS in ST-elevation in acute myocardial infarction.

  11. Radiation therapy in the management of symptomatic bone metastases: the effect of total dose and histology on pain relief and response duration

    International Nuclear Information System (INIS)

    Arcangeli, Giorgio; Giovinazzo, Giuseppe; Saracino, Biancamaria; D'Angelo, Luciano; Giannarelli, Diana; Arcangeli, Giancarlo; Micheli, Adriana

    1998-01-01

    the several ranges of total dose delivered to the painful metastases, with 81%, 65%, and 46% complete relief rates in the 40-46 Gy, 30-36 Gy (p 0.03), and 8-28 Gy (p = 0.0001) dose ranges respectively. A straight correlation between total dose and complete pain relief was confirmed by the curve calculated by the logistic model which shows that doses of 30 Gy or more are necessary to achieve complete pain relief in 70% or more of bone metastases. This correlation holds also for the duration of pain control, as shown by the actuarial analysis of time to pain progression. Multivariate analyses, with complete pain relief and time to pain progression as endpoints show a highly significant effect of radiation dose (p = 0.0007) and performance status (p = 0.003), with lower rates of complete pain relief and shorter time to pain progression observed after smaller radiation total doses or higher Eastern Cooperative Oncology Group (ECOG) scores. Conclusion: Although single-dose or short course irradiation is an attractive treatment in reducing the number of multiple visits to radiotherapy departments for patients with painful bone metastases, it is nevertheless clear that aggressive protracted treatments seem to offer significant advantages especially for patients in whom the expected life span is not short

  12. Occupational Trauma and Mental Illness: Combat, Peacekeeping or Relief Work and the NCS-R

    Science.gov (United States)

    Connorton, Ellen; Perry, Melissa J.; Hemenway, David; Miller, Matthew

    2011-01-01

    Objective Peacekeepers, relief workers and military members experience multiple traumas, and trauma is believed to increase risk for psychiatric distress. We examined whether combat and/or peacekeeping or relief work was associated with subsequent mental illness. Methods Using data from the US National Co-morbidity Survey Replication (NCS-R) (n = 2,383), we estimated whether combat, peacekeeping or relief work were associated with increased prevalence of mental illness through bivariate cross-tabulations and multivariate logistic regression. Results Combat was associated with increased subsequent post-traumatic stress disorder (PTSD), alcohol or drug issues more than peacekeeping or relief work. Conclusions Combat, alone or combined with peacekeeping/relief work, appears to be a risk factor for subsequent PTSD and issues with drugs and alcohol. Peacekeeping/relief work without combat does not appear to be associated with these diagnoses. PMID:22173283

  13. Navy Heat Source Safety Tests

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, C. G.; Cartmill, W. B.

    1975-06-18

    The purpose of these tests was to validate the integrity of the Navy Heat Source after imposing conditions which might, in the extreme, be encountered singly or serially so that safety would be assured.

  14. Pressure Relief Behaviors and Weight Shifting Activities to Prevent Pressure Ulcers in Persons with SCI

    Science.gov (United States)

    2016-10-01

    pressure relief maneuvers on ischial interface pressure and blood flow in people with spinal cord injury”, Archives of Physical Medicine and Rehabilitation, Vol. 95 no.7, pp. 1350-1357, July 2014. ...0 AWARD NUMBER: W81XWH-13-1-0387 TITLE: Pressure Relief Behaviors and Weight-Shifting Activities to Prevent Pressure Ulcers in Persons with...Annual Report 3. DATES COVERED 30 Sep 2015 - 29 Sep 2016 4. TITLE AND SUBTITLE Pressure Relief Behaviors and Weight-Shifting

  15. Intra-articular hip injection: does pain relief correlate with radiographic severity of osteoarthritis?

    International Nuclear Information System (INIS)

    Deshmukh, Ajit J.; Rodriguez, Jose A.; Panagopoulos, Georgia; Alizadeh, Ahmadreza; Klein, Devon A.

    2011-01-01

    Intra-articular injection is being used widely for both diagnostic and therapeutic purposes in the hip. However, its efficacy is not always predictable in patients with hip osteoarthritis (OA). The purpose of this study was to determine whether the degree of radiographic severity of OA was predictive of the response to intra-articular injection of local anesthetic with corticosteroid and to determine the relationship between immediate pain relief resulting from the anesthetic and delayed pain relief resulting from corticosteroid administration. This retrospective study included 217 patients (220 injections) with diagnosis of hip OA who underwent a fluoroscopically guided therapeutic hip injection of local anesthetic and corticosteroid. Hip radiographs were scored using the Kellgren-Lawrence scale. Immediate and delayed pain relief was documented using a visual analog scale. Logistic regression analysis was performed to investigate whether age, gender or radiographic severity of OA were independent predictors of pain relief. Degree of agreement between immediate and delayed response was assessed with the kappa coefficient. Immediate pain relief was reported in 68.2% of hips and delayed relief in 71.4% of hips. A high level of agreement was observed between immediate and delayed pain relief (kappa = 0.80, p < 0.001). 94% of patients reporting immediate relief also reported relief 2 weeks later. Univariate and multivariate analysis revealed that neither gender nor age was related to immediate or delayed pain relief. Only severity of OA (based on radiographic analysis) was observed to be predictive of pain relief. Pain relief following intra-articular hip injection correlated with radiographic severity of OA. This intervention may be of therapeutic and prognostic value in patients awaiting hip arthroplasty. (orig.)

  16. Nuclear power and safety

    International Nuclear Information System (INIS)

    Saunders, P.; Tasker, A.

    1991-01-01

    Nuclear power currently provides about a fifth of both Britain's and the world's electricity. It is the largest single source of electricity in Western Europe; in France three quarters of electricity is generated by nuclear power stations. This booklet is about the safety of those plants. It approaches the subject by outlining the basic principles and approaches behind nuclear safety, describing the protective barriers and safety systems that are designed to prevent the escape of radioactive material, and summarising the regulations that govern the construction and operation of nuclear power stations. The aim is to provide a general understanding of the subject by explaining the general principles of the Advanced Gas Cooled Reactor and setting out the UKAEA strategy for nuclear safety, the objective being always to minimize risk. (author)

  17. Assessment of Safety Culture

    International Nuclear Information System (INIS)

    Bilic Zabric, T.; Kavsek, D.

    2006-01-01

    A strong safety culture leads to more effective conduct of work and a sense of accountability among managers and employees, who should be given the opportunity to expand skills by training. The resources expended would thus result in tangible improvements in working practices and skills, which encourage further improvement of safety culture. In promoting an improved safety culture, NEK has emphasized both national and organizational culture with an appropriate balance of behavioural sciences and quality management systems approaches. In recent years there has been particular emphasis put on an increasing awareness of the contribution that human behavioural sciences can make to develop good safety practices. The purpose of an assessment of safety culture is to increase the awareness of the present culture, to serve as a basis for improvement and to keep track of the effects of change or improvement over a longer period of time. There is, however, no single approach that is suitable for all purposes and which can measure, simultaneously, all the intangible aspects of safety culture, i.e. the norms, values, beliefs, attitudes or the behaviours reflecting the culture. Various methods have their strengths and weaknesses. To prevent significant performance problems, self-assessment is used. Self-assessment is the process of identifying opportunities for improvement actively or, in some cases, weaknesses that could cause more serious errors or events. Self-assessments are an important input to the corrective action programme. NEK has developed questionnaires for safety culture self-assessment to obtain information that is representative of the whole organization. Questionnaires ensure a greater degree of anonymity, and create a less stressful situation for the respondent. Answers to questions represent the more apparent and conscious values and attitudes of the respondent. NEK proactively co-operates with WANO, INPO, IAEA in the areas of Safety Culture and Human

  18. Safety handbook

    International Nuclear Information System (INIS)

    1990-01-01

    The purpose of the Australian Nuclear Science and Technology Organization's Safety Handbook is to outline simply the fundamental procedures and safety precautions which provide an appropriate framework for safe working with any potential hazards, such as fire and explosion, welding, cutting, brazing and soldering, compressed gases, cryogenic liquids, chemicals, ionizing radiations, non-ionising radiations, sound and vibration, as well as safety in the office. It also specifies the organisation for safety at the Lucas Heights Research Laboratories and the responsibilities of individuals and committees. It also defines the procedures for the scrutiny and review of all operations and the resultant setting of safety rules for them. ills

  19. How Absent Negativity Relates to Affect and Motivation: An Integrative Relief Model

    Directory of Open Access Journals (Sweden)

    Roland eDeutsch

    2015-03-01

    Full Text Available The present paper concerns the motivational underpinnings and behavioral correlates of the prevention or stopping of negative stimulation – a situation referred to as relief. Relief is of great theoretical and applied interest. Theoretically, it is tied to theories linking affect, emotion and motivational systems (Carver & Scheier, 1990; Gray & McNaughton, 2000; Higgins, 1997; Lang, Bradley, & Cuthbert, 1990. Importantly, these theories make different predictions regarding the association between relief and motivational systems. Moreover, relief is a prototypical antecedent of counterfactual emotions, which involve specific cognitive processes compared to factual or mere anticipatory emotions. Practically, relief may be an important motivator of addictive and phobic behaviors (Mowrer, 1951; Ostafin & Brooks, 2011, self destructive behaviors (Favazza, 1998; Franklin, Lee, Hanna, & Prinstein, 2013, and social influence (Dolinski & Nawrat, 1998. In the present paper, we will first provide a review of conflicting conceptualizations of relief. We will then present an integrative relief model (IRMO that aims at resolving existing theoretical conflicts. We then review evidence relevant to distinctive predictions regarding the moderating role of various procedural features of relief situations. We conclude that our integrated model results in a better understanding of existing evidence on the affective and motivational underpinnings of relief, but that further evidence is needed to come to a more comprehensive evaluation of the viability of IRMO.

  20. Quantitative studies of the morphology of the south Poland using Relief Index (RI

    Directory of Open Access Journals (Sweden)

    Szypuła Bartłomiej

    2017-10-01

    Full Text Available The aim of this study was to introduce a new morphometric index named Relief Index (RI. RI is the ratio of the total length of the contour lines and the surface area at which they occur. This easily calculated index provides an objective quantitative measure of relief variability as an important feature in geomorphological studies. To achieve this goal, a highly detailed morphometric analysis was carried out using a high-resolution (1m×1m DEM. Twenty one sample areas in southern Poland were examined. These analyses showed RI, as a good tool for rapidly evaluating topography heterogeneity in division into relief classes. I distinguished 4 classes of the Relief Index that classify earth surface considering the variability of the relief. Results of the calculations demonstrated that there is a significant correlation between RI and the local relief and slopes, but there is no correlation between RI and planar curvatures and TWI. The relief of the sample areas were analysed using geomorphometric parameters (slopes, local relief, planar curvatures. Moreover the influence of the DEM resolution on Relief Index values was examined.

  1. Doubling Your Payoff: Winning Pain Relief Engages Endogenous Pain Inhibition1,2,3

    Science.gov (United States)

    Kwan, Saskia; Schweinhardt, Petra

    2015-01-01

    Abstract When in pain, pain relief is much sought after, particularly for individuals with chronic pain. In analogy to augmentation of the hedonic experience (“liking”) of a reward by the motivation to obtain a reward (“wanting”), the seeking of pain relief in a motivated state might increase the experience of pain relief when obtained. We tested this hypothesis in a psychophysical experiment in healthy human subjects, by assessing potential pain-inhibitory effects of pain relief “won” in a wheel of fortune game compared with pain relief without winning, exploiting the fact that the mere chance of winning induces a motivated state. The results show pain-inhibitory effects of pain relief obtained by winning in behaviorally assessed pain perception and ratings of pain intensity. Further, the higher participants scored on the personality trait novelty seeking, the more pain inhibition was induced. These results provide evidence that pain relief, when obtained in a motivated state, engages endogenous pain-inhibitory systems beyond the pain reduction that underlies the relief in the first place. Consequently, such pain relief might be used to improve behavioral pain therapy, inducing a positive, perhaps self-amplifying feedback loop of reduced pain and improved functionality. PMID:26464995

  2. Safety design

    International Nuclear Information System (INIS)

    Kunitomi, Kazuhiko; Shiozawa, Shusaku

    2004-01-01

    JAERI established the safety design philosophy of the HTTR based on that of current reactors such as LWR in Japan, considering inherent safety features of the HTTR. The strategy of defense in depth was implemented so that the safety engineering functions such as control of reactivity, removal of residual heat and confinement of fission products shall be well performed to ensure safety. However, unlike the LWR, the inherent design features of the high-temperature gas-cooled reactor (HTGR) enables the HTTR meet stringent regulatory criteria without much dependence on active safety systems. On the other hand, the safety in an accident typical to the HTGR such as the depressurization accident initiated by a primary pipe rupture shall be ensured. The safety design philosophy of the HTTR considers these unique features appropriately and is expected to be the basis for future Japanese HTGRs. This paper describes the safety design philosophy and safety evaluation procedure of the HTTR especially focusing on unique considerations to the HTTR. Also, experiences obtained from an HTTR safety review and R and D needs for establishing the safety philosophy for the future HTGRs are reported

  3. Nuclear Safety

    International Nuclear Information System (INIS)

    1978-09-01

    In this short paper it has only been possible to deal in a rather general way with the standards of safety used in the UK nuclear industry. The record of the industry extending over at least twenty years is impressive and, indeed, unique. No other industry has been so painstaking in protection of its workers and in its avoidance of damage to the environment. Headings are: introduction; how a nuclear power station works; radiation and its effects (including reference to ICRP, the UK National Radiological Protection Board, and safety standards); typical radiation doses (natural radiation, therapy, nuclear power programme and other sources); safety of nuclear reactors - design; key questions (matters of concern which arise in the public mind); safety of operators; safety of people in the vicinity of a nuclear power station; safety of the general public; safety bodies. (U.K.)

  4. Leadership and Safety Culture: Leadership for Safety

    International Nuclear Information System (INIS)

    Fischer, E.

    2016-01-01

    Following the challenge to operate Nuclear Power Plants towards operational excellence, a highly skilled and motivated organization is needed. Therefore, leadership is a valuable success factor. On the other hand a well-engineered safety orientated design of NPP’s is necessary. Once built, an NPP constantly requires maintenance, ageing management and lifetime modifications. E.ON tries to keep the nuclear units as close as possible to the state of the art of science and technology. Not at least a requirement followed by our German regulation. As a consequence of this we are continuously challenged to improve our units and the working processes using national and international operational experiences too. A lot of modifications are driven by our self and by regulators. That why these institutions — authorities and independent examiners—contribute significantly to the safety success. Not that it is easy all the day. The relationship between the regulatory body, examiners and the utilities should be challenging but also cooperative and trustful within a permanent dialog. To reach the common goal of highest standards regarding nuclear safety all parties have to secure a living safety culture. Without this attitude there is a higher risk that safety relevant aspects may stay undetected and room for improvement is not used. Nuclear operators should always be sensitized and follow each single deviation. Leaders in an NPP-organization are challenged to create a safety-, working-, and performance culture based on clear common values and behaviours, repeated and lived along all of our days to create a least a strong identity in the staffs mind to the value of safety, common culture and overall performance. (author)

  5. Corticosteroid Injections Accelerate Pain Relief and Recovery of Function Compared With Oral NSAIDs in Patients With Adhesive Capsulitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Ranalletta, Maximiliano; Rossi, Luciano A; Bongiovanni, Santiago L; Tanoira, Ignacio; Elizondo, Cristina M; Maignon, Gastón D

    2016-02-01

    Intra-articular corticosteroid injection is a common therapy for adhesive capsulitis, but there is a lack of prospective randomized controlled studies analyzing the efficacy of single injections applied blindly to accelerate improvement in pain and function. In patients with adhesive capsulitis, a single intra-articular corticosteroid injection without image control applied before the beginning of a physical therapy program will accelerate pain relief and recovery of function compared with oral nonsteroidal anti-inflammatory drugs (NSAIDs) and physical therapy. Randomized controlled trial; Level of evidence, 1. A total of 74 patients with primary adhesive capsulitis in the freezing stage were randomized to receive either intra-articular injections with betamethasone or oral NSAIDs. Clinical outcome was documented at baseline and after 2, 4, 8, and 12 weeks and comprised a visual analog scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) Shoulder Score, the abbreviated Constant-Murley score, and the abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH) score for function. Passive range of motion was measured with a goniometer. Patients treated with corticosteroid injections achieved faster pain relief compared with control patients during the first 8 weeks after treatment (P adhesive capsulitis, a single corticosteroid injection applied without image control provides faster pain relief and earlier improvement of shoulder function and motion compared with oral NSAIDs. © 2015 The Author(s).

  6. Safety studies on vacuum insulated liquid helium cryostats

    Science.gov (United States)

    Weber, C.; Henriques, A.; Zoller, C.; Grohmann, S.

    2017-12-01

    The loss of insulating vacuum is often considered as a reasonable foreseeable accident for the dimensioning of cryogenic safety relief devices (SRD). The cryogenic safety test facility PICARD was designed at KIT to investigate such events. In the course of first experiments, discharge instabilities of the spring loaded safety relief valve (SRV) occurred, the so-called chattering and pumping effects. These instabilities reduce the relief flow capacity, which leads to impermissible over-pressures in the system. The analysis of the process dynamics showed first indications for a smaller heat flux than the commonly assumed 4W/cm2. This results in an oversized discharge area for the reduced relief flow rate, which corresponds to the lower heat flux. This paper presents further experimental investigations on the venting of the insulating vacuum with atmospheric air under variation of the set pressure (p set) of the SRV. Based on dynamic process analysis, the results are discussed with focus on effective heat fluxes and operating characteristics of the spring-loaded SRV.

  7. [Human milk for neonatal pain relief during ophthalmoscopy].

    Science.gov (United States)

    Ribeiro, Laiane Medeiros; Castral, Thaíla Corrêa; Montanholi, Liciane Langona; Daré, Mariana Firmino; Silva, Aline Carolina de Araújo; Antonini, Sonir Roberto Rauber; Scochi, Carmen Gracinda Silvan

    2013-10-01

    Ophthalmoscopy performed for the early diagnosis of retinopathy of prematurity (ROP) is painful for preterm infants, thus necessitating interventions for minimizing pain. The present study aimed to establish the effectiveness of human milk, compared with sucrose, for pain relief in premature infants subjected to ophthalmoscopy for the early diagnosis of ROP. This investigation was a pilot, quasi-experimental study conducted with 14 premature infants admitted to the neonatal intensive care unit (NICU) of a university hospital. Comparison between the groups did not yield a statistically significant difference relative to the crying time, salivary cortisol, or heart rate (HR). Human milk appears to be as effective as sucrose in relieving acute pain associated with ophthalmoscopy. The study's limitations included its small sample size and lack of randomization. Experimental investigations with greater sample power should be performed to reinforce the evidence found in the present study.

  8. Western Tibet relief evolution, insight from sedimentary record and thermochronology

    Science.gov (United States)

    Mahéo, Gweltaz; Gourbet, Loraine; Hervé Leloup, Philippe; Sorrel, Philippe; Shuster, David L.; Paquette, Jean-Louis; Quillévéré, Frédéric

    2014-05-01

    The Tibetan plateau is defined as a low relief high elevation zone, resulting from India-Asia convergence. However, its morphology is relatively heterogeneous. Especially the western Tibetan plateau is characterized by a strong relief, numerous peaks higher than 6000 m.a.s.l. and large (up to 10 km), deep (1-2 km) valleys. We investigate the origin of this particular morphology, coupling geomorphologic studies with sedimentary records and (U-Th)/He thermochronometry. The western Tibet Tertiary sedimentation is mostly characterized by conglomerates, red sandstone and siltstones related with alluvial fan deposits. Zircon U-Pb dating of interbedded trachyte flows implies that deposition started before 25 Ma and was still ongoing at 20 Ma. These continental, detrital deposits are filling wide open valleys during probable arid climatic conditions. Such valleys are thus interpreted as inherited basins, paleovalleys, formed before detrital sedimentation i.e. at ~25 Ma. Moreover, rare marine sediments were observed below the detrital deposits. Foraminifera suggest an Oligocene age, which implies that the paleovalleys already existed during the Oligocene, and that the emersion of the Western Tibetan Plateau occurred between the Oligocene and 25 Ma. This emersion thus occurred much later than the India-Asia collision (~50-45Ma) but is compatible with the onset of the main thickening phase of the Indian plate. The orientation of the inherited valley axis appears to be that of active strike slip faults that induced eastward extrusion of Western Tibet. This suggests that such extrusion was already active at the time of sedimentation (both marine and continental). Thus extrusion was also active during the plateau emersion at Oligocene time. The morphology of the valleys, and their sedimentary infilling, suggest that a significant relief, similar to present-day one (about 1000-2000m between valleys floor and surrounding peaks) already existed at the time of sedimentation. This

  9. Numerical study of emergency cryogenics gas relief into confined spaces

    CERN Multimedia

    CERN. Geneva

    2016-01-01

    The presented work focuses on the risk analysis and the consequences of the unexpected leak to the tunnel of cryogenics gases. Formation of the gas mixture and its propagation along tunnels is an important issue for the safe operation of cryogenic machines, including superconducting accelerators or free electron lasers. As the cryogenics gas the helium and argon will be considered. A minimal numerical model will be presented and discussed. Series of numerical results related to emergency helium relief to the CERN tunnel and related to unexpected leak of the argon to an underground tunnel, will be shown. The numerical results will show temperature distribution, oxygen deficiency and gas cloud propagation in function of intensity of the leak and intensity of the ventilation.

  10. Interferometric Surface Relief Measurements with Subnano/Picometer Height Resolution

    Science.gov (United States)

    Sysoev, Evgeny; Kosolobov, Sergey; Kulikov, Rodion; Latyshev, Alexander; Sitnikov, Sergey; Vykhristyuk, Ignat

    2017-10-01

    We present an optical interference system nanoprofiler MNP-1 designed for high-precision noncontact measurement of surface relief with subnanometer resolution (root mean square of measured values), based on partial scanning of interference signal. The paper describes the construction of the measurement system with Linnik interferometer and the algorithm for nanorelief surface reconstruction. Experimental measurement results of silicon sample with profile height of surface structure of one interatomic distance obtained by MNP-1 are shown. It was proposed to use an atomically smooth surface as the reference mirror in the interferometer MNP-1 that allowed us to measure monatomic steps of the presented silicon sample. Monatomic steps of 0.31 nm in height on silicon (111) surface were measured with resolution up to 5 pm.

  11. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...... with the intention-to-treat principle. Results: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin...

  12. Gain-Based Relief for Invasion of Privacy

    Directory of Open Access Journals (Sweden)

    Sirko Harder

    2013-11-01

    Full Text Available In many common law jurisdictions, some or all instances of invasion of privacy constitute a privacy-specific wrong either at common law (including equity or under statute. A remedy invariably available for such a wrong is compensation for loss. However, the plaintiff may instead seek to claim the profit the defendant has made from the invasion. This article examines when a plaintiff is, and should be, entitled to claim that profit, provided that invasion of privacy is actionable as such. After a brief overview of the relevant law in major common law jurisdictions, the article investigates how invasion of privacy fits into a general concept of what is called ‘restitution for wrongs’. It will be argued that the right to privacy is a right against the whole world and as such forms a proper basis of awarding gain-based relief for the unauthorised use of that right.

  13. Human milk for neonatal pain relief during ophthalmoscopy

    Directory of Open Access Journals (Sweden)

    Laiane Medeiros Ribeiro

    2013-10-01

    Full Text Available Ophthalmoscopy performed for the early diagnosis of retinopathy of prematurity (ROP is painful for preterm infants, thus necessitating interventions for minimizing pain. The present study aimed to establish the effectiveness of human milk, compared with sucrose, for pain relief in premature infants subjected to ophthalmoscopy for the early diagnosis of ROP. This investigation was a pilot, quasi-experimental study conducted with 14 premature infants admitted to the neonatal intensive care unit (NICU of a university hospital. Comparison between the groups did not yield a statistically significant difference relative to the crying time, salivary cortisol, or heart rate (HR. Human milk appears to be as effective as sucrose in relieving acute pain associated with ophthalmoscopy. The study’s limitations included its small sample size and lack of randomization. Experimental investigations with greater sample power should be performed to reinforce the evidence found in the present study.

  14. Ensuring Pain Relief for Children at the End of Life

    Directory of Open Access Journals (Sweden)

    Marie-Claude Grégoire

    2006-01-01

    Full Text Available Pain management in the context of pediatric palliative care can be challenging. The present article reviews, through a case-based presentation, the nonpharmacological and pharmacological methods used to ensure adequate pain control in children facing end of life. Details on the impressive range of opioid dosages required and routes of administration are highlighted from published literature and clinical experience. Where available, evidence-based recommendations are provided. Potential side effects of pain medication and barriers to good pain control are discussed. Novel analgesics and innovative delivery methods are presented as future tools enhancing pain relief at the end of life. Some challenges to ethically grounded research in this important context of care are reviewed.

  15. Pemanfaatan Frekuensi Untuk Public Protection and Disaster Relief (PPDR

    Directory of Open Access Journals (Sweden)

    Diah Yuniarti

    2014-03-01

    Full Text Available Penanganan kejadian yang terkait dengan Public Protection and Disaster Relief (PPDR di Indonesia yang merupakan negara yang rawan terhadap bencana dan permasalahan sosial membutuhkan komunikasi yang intensif. Penelitian ini mengkaji mengenai kondisi pemanfaatan frekuensi PPDR di Indonesia dan strategi pengembangan ke depannya dengan menggunakan analisis SWOT. Hasil penelitian menunjukkan bahwa sistem komunikasi pada instansi PPDR di Indonesia tidak mendukung interoperabilitas dalam penanganan kejadian PPDR yang terkoordinasi. Selain itu, pita frekuensi yang digunakan merupakan pita sempit yang tidak mendukung aplikasi video dan data kecepatan tinggi yang dibutuhkan dalam penanganan kejadian PPDR yang lebih efektif. Oleh karena itu, dalam perencanaan alokasi frekuensi ke depannya, pemerintah perlu mengintegrasikan pita lebar ke dalam perencanaan sistem Government Radio Network (GRN.

  16. Seeking relief: Bankruptcy and health outcomes of adult women.

    Science.gov (United States)

    Addo, Fenaba R

    2017-12-01

    This study examined the impact of declaring consumer bankruptcy on the physical and mental health of adult women and if outcomes differed depending on whether the filer received automatic debt discharge under Chapter 7 compared to a debt repayment plan with Chapter 13. Sample data consisted of women from the NLSY79 cohort who completed the age 40 and 50 health modules as of the most recent wave. Results indicated a negative effect of bankruptcy on self-assessed health, whereas prior health history explained its negative relationship with depressive symptoms. Debt liquidation under Chapter 7 was associated with poor physical health relative to those who did not file and with depressive symptoms relative to Chapter 13 repayment plan filers. Poor health is an unintended consequence for women who seek financial relief through bankruptcy.

  17. On the capacity-formula for pressure relief devices of tanks for dangerous goods; Die Kapazitaetsformel fuer Druckentlastungsvorrichtungen von Gefahrguttanks

    Energy Technology Data Exchange (ETDEWEB)

    Ludwig, J. [Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin (Germany)

    2000-09-01

    Each tank-container respectively portable tank for multimodal purposes has to be closed and fitted with safety devices (pressure relief devices). Pressure relief devices have to meet essential requirements concerning their total delivery capacity in condition of complete engulfment of the tank in fire. The total capacity of these devices should be sufficient to limit the pressure in the tank in each case to its test pressure, maximally. The total delivery capacity has to be determined by applying a formula which had been developed in the USA and taken over later on into international and national regulations on the transport of dangerous goods. The derivation of this formula will be described and evaluated with regard to given facts related to general thermodynamics and fire test results. (orig.) [German] Wesentliche Anforderung an Sicherheitseinrichtungen (Druckentlastungsvorrichtungen) fuer Tanks und Tankcontainer im multimodalen Verkehr ist, dass diese Einrichtungen im Feuerfall eine Gesamtdurchflussmenge aufweisen muessen, die zumindest einen Druckanstieg ueber den Pruefdruck hinaus verhindert. Die Ermittlung der Gesamtdurchflussmenge erfolgt nach einer in den USA entwickelten, in internationale und nationale Verkehrsvorschriften uebernommenen Zahlenwertgleichung (Kapazitaetsformel). Die Herleitung dieser Zahlenwertgleichung sowohl aus allgemein thermodynamischen als auch empirischen Gegebenheiten wird beschrieben und bewertet. (orig.)

  18. The importance of context: when relative relief renders pain pleasant.

    Science.gov (United States)

    Leknes, Siri; Berna, Chantal; Lee, Michael C; Snyder, Gregory D; Biele, Guido; Tracey, Irene

    2013-03-01

    Context can influence the experience of any event. For instance, the thought that "it could be worse" can improve feelings towards a present misfortune. In this study we measured hedonic feelings, skin conductance, and brain activation patterns in 16 healthy volunteers who experienced moderate pain in two different contexts. In the "relative relief context," moderate pain represented the best outcome, since the alternative outcome was intense pain. However, in the control context, moderate pain represented the worst outcome and elicited negative hedonic feelings. The context manipulation resulted in a "hedonic flip," such that moderate pain elicited positive hedonics in the relative relief context. Somewhat surprisingly, moderate pain was even rated as pleasant in this context, despite being reported as painful in the control context. This "hedonic flip" was corroborated by physiological and functional neuroimaging data. When moderate pain was perceived as pleasant, skin conductance and activity in insula and dorsal anterior cingulate were significantly attenuated relative to the control moderate stimulus. "Pleasant pain" also increased activity in reward and valuation circuitry, including the medial orbitofrontal and ventromedial prefrontal cortices. Furthermore, the change in outcome hedonics correlated with activity in the periacqueductal grey (PAG) of the descending pain modulatory system (DPMS). The context manipulation also significantly increased functional connectivity between reward circuitry and the PAG, consistent with a functional change of the DPMS due to the altered motivational state. The findings of this study point to a role for brainstem and reward circuitry in a context-induced "hedonic flip" of pain. Copyright © 2012 International Association for the Study of Pain. All rights reserved.

  19. The importance of context: When relative relief renders pain pleasant

    Science.gov (United States)

    Leknes, Siri; Berna, Chantal; Lee, Michael C.; Snyder, Gregory D.; Biele, Guido; Tracey, Irene

    2013-01-01

    Context can influence the experience of any event. For instance, the thought that “it could be worse” can improve feelings towards a present misfortune. In this study we measured hedonic feelings, skin conductance, and brain activation patterns in 16 healthy volunteers who experienced moderate pain in two different contexts. In the “relative relief context,” moderate pain represented the best outcome, since the alternative outcome was intense pain. However, in the control context, moderate pain represented the worst outcome and elicited negative hedonic feelings. The context manipulation resulted in a “hedonic flip,” such that moderate pain elicited positive hedonics in the relative relief context. Somewhat surprisingly, moderate pain was even rated as pleasant in this context, despite being reported as painful in the control context. This “hedonic flip” was corroborated by physiological and functional neuroimaging data. When moderate pain was perceived as pleasant, skin conductance and activity in insula and dorsal anterior cingulate were significantly attenuated relative to the control moderate stimulus. “Pleasant pain” also increased activity in reward and valuation circuitry, including the medial orbitofrontal and ventromedial prefrontal cortices. Furthermore, the change in outcome hedonics correlated with activity in the periacqueductal grey (PAG) of the descending pain modulatory system (DPMS). The context manipulation also significantly increased functional connectivity between reward circuitry and the PAG, consistent with a functional change of the DPMS due to the altered motivational state. The findings of this study point to a role for brainstem and reward circuitry in a context-induced “hedonic flip” of pain. PMID:23352758

  20. Bilateral CT-guided percutaneous cordotomy for cancer pain relief

    International Nuclear Information System (INIS)

    Yegul, I.; Erhan, E.

    2003-01-01

    AIM: CT-guided percutaneous cordotomy is a useful procedure for treating unilateral cancer pain, however, bilateral cordotomy can be required on some occasions. We evaluated the effectiveness and complications of bilateral cordotomy. MATERIALS AND METHODS: Two hundred and thirty-four patients who suffered from unilateral cancer pain underwent CT-guided percutaneous cordotomy. The procedure was repeated in 22 patients, and nine patients had bilateral cordotomy. Effectiveness and complications were recorded after each procedure. RESULTS: Of nine patents (three women and six men) having bilateral percutaneous cordotomy in our study, four patients had mirror pain after the first procedure. In the remaining five patients the contralateral pain was due to new pain sites. The pain scores before and after the first procedure were 9.3 (range 7-10) and 1.2 (range 0-3), respectively. After the first procedure complete or satisfactory pain relief was achieved in all patients. The duration between the two procedures ranged from 7-243 days (mean 59.8 days). The pain scores before and after the second procedure were 8.4 (range 5-10) and 1.6 (range 0-4), respectively. After the second procedure complete or satisfactory pain relief was reported in all patients. There were no complications in four patients. One patient developed transient motor deficit after the first procedure. Other complications (nausea/vomiting, headache, ipsilateral neck pain, postcordotomy dysesthesia) were mild and transient. CONCLUSION: CT-guided percutaneous cordotomy is a useful procedure for the treatment of severe unilateral cancer pain syndromes. The procedure can be repeated on the other side at least 1 week later. These results show that the success on the second side appears to be similar to the first side with low complication rate for both procedures