Science.gov

Sample records for passive safety injection

  1. Passive safety injection system using borated water

    SciTech Connect

    Conway, Lawrence E.; Schulz, Terry L.

    1993-01-01

    A passive safety injection system relies on differences in water density to induce natural circulatory flow patterns which help maintain prescribed concentrations of boric acid in borated water, and prevents boron from accumulating in the reactor vessel and possibly preventing heat transfer.

  2. [Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Song, Nian-bin

    2015-12-01

    This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.

  3. Passive Safety Features in Advanced Nuclear Power Plant Design

    NASA Astrophysics Data System (ADS)

    Tahir, M.; Chughtai, I. R.; Aslam, M.

    2013-03-01

    For implementation of advance passive safety features in future nuclear power plant design, a passive safety system has been proposed and its response has been observed for Loss of Coolant Accident (LOCA) in the cold leg of a reactor coolant system. In a transient simulation the performance of proposed system is validated against existing safety injection system for a reference power plant of 325 MWe. The existing safety injection system is a huge system and consists of many active components including pumps, valves, piping and Instrumentation and Control (I&C). A good running of the active components of this system is necessary for its functionality as high head safety injection system under design basis accidents. Using reactor simulation technique, the proposed passive safety injection system and existing safety injection system are simulated and tested for their performance under large break LOCA for the same boundary conditions. Critical thermal hydraulic parameters of both the systems are presented graphically and discussed. The results obtained are approximately the same in both the cases. However, the proposed passive safety injection system is a better choice for such type of reactors due to reduction in components with improved safety.

  4. Passive injection control for microfluidic systems

    DOEpatents

    Paul, Phillip H.; Arnold, Don W.; Neyer, David W.

    2004-12-21

    Apparatus for eliminating siphoning, "dead" regions, and fluid concentration gradients in microscale analytical devices. In its most basic embodiment, the present invention affords passive injection control for both electric field-driven and pressure-driven systems by providing additional fluid flow channels or auxiliary channels disposed on either side of a sample separation column. The auxiliary channels are sized such that volumetric fluid flow rate through these channels, while sufficient to move the sample away from the sample injection region in a timely fashion, is less than that through the sample separation channel or chromatograph.

  5. An approach for assessing ALWR passive safety system reliability

    SciTech Connect

    Hake, T M

    1991-01-01

    Many advanced light water reactor designs incorporate passive rather than active safety features for front-line accident response. A method for evaluating the reliability of these passive systems in the context of probabilistic risk assessment has been developed at Sandia National Laboratories. This method addresses both the component (e.g. valve) failure aspect of passive system failure, and uncertainties in system success criteria arising from uncertainties in the system's underlying physical processes. These processes provide the system's driving force; examples are natural circulation and gravity-induced injection. This paper describes the method, and provides some preliminary results of application of the approach to the Westinghouse AP600 design.

  6. Passive Safety Features for Small Modular Reactors

    SciTech Connect

    Ingersoll, Daniel T

    2010-01-01

    The rapid growth in the size and complexity of commercial nuclear power plants in the 1970s spawned an interest in smaller, simpler designs that are inherently or intrinsically safe through the use of passive design features. Several designs were developed, but none were ever built, although some of their passive safety features were incorporated into large commercial plant designs that are being planned or built today. In recent years, several reactor vendors are actively redeveloping small modular reactor (SMR) designs with even greater use of passive features. Several designs incorporate the ultimate in passive safety they completely eliminate specific accident initiators from the design. Other design features help to reduce the likelihood of an accident or help to mitigate the accident s consequences, should one occur. While some passive safety features are common to most SMR designs, irrespective of the coolant technology, other features are specific to water, gas, or liquid-metal cooled SMR designs. The extensive use of passive safety features in SMRs promise to make these plants highly robust, protecting both the general public and the owner/investor. Once demonstrated, these plants should allow nuclear power to be used confidently for a broader range of customers and applications than will be possible with large plants alone.

  7. Vibration of safety injection pump motors

    SciTech Connect

    Wattrelos, D.

    1996-12-01

    This paper covers a fault encountered in the safety injection pump motors of the French 900 MWe unit nuclear power stations. This fault was not revealed either during the low pressure safety injection and containment spray system pump qualification tests under accident conditions or during the special tests on a test bench carried out to attempt to replicate the fault and to identify ways of remedying it. This constitutes a potential common mode of failure of the safety injection system and the containment spray system pumps. The vibration phenomena illustrate the importance of carrying out tests in the plants under conditions as close as possible to those of actual accident situations.

  8. A concept of JAERI passive safety light water reactor system (JPSR)

    SciTech Connect

    Murao, Y.; Araya, F.; Iwamura, T.

    1995-09-01

    The Japan Atomic Energy Research Institute (JAERI) proposed a passive safety reactor system concept, JPSR, which was developed for reducing manpower in operation and maintenance and influence of human errors on reactor safety. In the concept the system was extremely simplified. The inherent matching nature of core generation and heat removal rate within a small volume change of the primary coolant is introduced by eliminating chemical shim and adopting in-vessel control rod drive mechanism units, a low power density core and once-through steam generators. In order to simplify the system, a large pressurizer, canned pumps, passive engineered-safety-features-system (residual heat removal system and coolant injection system) are adopted and the total system can be significantly simplified. The residual heat removal system is completely passively actuated in non-LOCAs and is also used for depressurization of the primary coolant system to actuate accumulators in small break LOCAs and reactor shutdown cooling system in normal operation. All of systems for nuclear steam supply system are built in the containment except for the air coolers as a the final heat sink of the passive residual heat removal system. Accordingly the reliability of the safety system and the normal operation system is improved, since most of residual heat removal system is always working and a heat sink for normal operation system is {open_quotes}safety class{close_quotes}. In the passive coolant injection system, depressurization of the primary cooling system by residual heat removal system initiates injection from accumulators designed for the MS-600 in medium pressure and initiates injection from the gravity driven coolant injection pool at low pressure. Analysis with RETRAN-02/MOD3 code demonstrated the capability of passive load-following, self-power-controllability, cooling and depressurization.

  9. Issues affecting advanced passive light-water reactor safety analysis

    SciTech Connect

    Beelman, R.J.; Fletcher, C.D.; Modro, S.M.

    1992-08-01

    Next generation commercial reactor designs emphasize enhanced safety through improved safety system reliability and performance by means of system simplification and reliance on immutable natural forces for system operation. Simulating the performance of these safety systems will be central to analytical safety evaluation of advanced passive reactor designs. Yet the characteristically small driving forces of these safety systems pose challenging computational problems to current thermal-hydraulic systems analysis codes. Additionally, the safety systems generally interact closely with one another, requiring accurate, integrated simulation of the nuclear steam supply system, engineered safeguards and containment. Furthermore, numerical safety analysis of these advanced passive reactor designs wig necessitate simulation of long-duration, slowly-developing transients compared with current reactor designs. The composite effects of small computational inaccuracies on induced system interactions and perturbations over long periods may well lead to predicted results which are significantly different than would otherwise be expected or might actually occur. Comparisons between the engineered safety features of competing US advanced light water reactor designs and analogous present day reactor designs are examined relative to the adequacy of existing thermal-hydraulic safety codes in predicting the mechanisms of passive safety. Areas where existing codes might require modification, extension or assessment relative to passive safety designs are identified. Conclusions concerning the applicability of these codes to advanced passive light water reactor safety analysis are presented.

  10. Issues affecting advanced passive light-water reactor safety analysis

    SciTech Connect

    Beelman, R.J.; Fletcher, C.D.; Modro, S.M.

    1992-01-01

    Next generation commercial reactor designs emphasize enhanced safety through improved safety system reliability and performance by means of system simplification and reliance on immutable natural forces for system operation. Simulating the performance of these safety systems will be central to analytical safety evaluation of advanced passive reactor designs. Yet the characteristically small driving forces of these safety systems pose challenging computational problems to current thermal-hydraulic systems analysis codes. Additionally, the safety systems generally interact closely with one another, requiring accurate, integrated simulation of the nuclear steam supply system, engineered safeguards and containment. Furthermore, numerical safety analysis of these advanced passive reactor designs wig necessitate simulation of long-duration, slowly-developing transients compared with current reactor designs. The composite effects of small computational inaccuracies on induced system interactions and perturbations over long periods may well lead to predicted results which are significantly different than would otherwise be expected or might actually occur. Comparisons between the engineered safety features of competing US advanced light water reactor designs and analogous present day reactor designs are examined relative to the adequacy of existing thermal-hydraulic safety codes in predicting the mechanisms of passive safety. Areas where existing codes might require modification, extension or assessment relative to passive safety designs are identified. Conclusions concerning the applicability of these codes to advanced passive light water reactor safety analysis are presented.

  11. Transformational and passive leadership as cross-level moderators of the relationships between safety knowledge, safety motivation, and safety participation.

    PubMed

    Jiang, Lixin; Probst, Tahira M

    2016-06-01

    While safety knowledge and safety motivation are well-established predictors of safety participation, less is known about the impact of leadership styles on these relationships. The purpose of the current study was to examine whether the positive relationships between safety knowledge and motivation and safety participation are contingent on transformational and passive forms of safety leadership. Using multilevel modeling with a sample of 171 employees nested in 40 workgroups, we found that transformational safety leadership strengthened the safety knowledge-participation relationship, whereas passive leadership weakened the safety motivation-participation relationship. Under low transformational leadership, safety motivation was not related to safety participation; under high passive leadership, safety knowledge was not related to safety participation. These results are discussed in light of organizational efforts to increase safety-related citizenship behaviors. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

  12. Passive compact molten salt reactor (PCMSR), modular thermal breeder reactor with totally passive safety system

    NASA Astrophysics Data System (ADS)

    Harto, Andang Widi

    2012-06-01

    Design Study Passive Compact Molten Salt Reactor (PCMSR) with totally passive safety system has been performed. The term of Compact in the PCMSR name means that the reactor system is designed to have relatively small volume per unit power output by using modular and integral concept. In term of modular, the reactor system consists of three modules, i.e. reactor module, turbine module and fuel management module. The reactor module is an integral design that consists of reactor, primary and intermediate heat exchangers and passive post shutdown cooling system. The turbine module is an integral design of a multi heating, multi cooling, regenerative gas turbine. The fuel management module consists of all equipments related to fuel preparation, fuel reprocessing and radioactive handling. The preliminary calculations show that the PCMSR has negative temperature and void reactivity coefficient, passive shutdown characteristic related to fuel pump failure and possibility of using natural circulation for post shutdown cooling system.

  13. Passive compact molten salt reactor (PCMSR), modular thermal breeder reactor with totally passive safety system

    SciTech Connect

    Harto, Andang Widi

    2012-06-06

    Design Study Passive Compact Molten Salt Reactor (PCMSR) with totally passive safety system has been performed. The term of Compact in the PCMSR name means that the reactor system is designed to have relatively small volume per unit power output by using modular and integral concept. In term of modular, the reactor system consists of three modules, i.e. reactor module, turbine module and fuel management module. The reactor module is an integral design that consists of reactor, primary and intermediate heat exchangers and passive post shutdown cooling system. The turbine module is an integral design of a multi heating, multi cooling, regenerative gas turbine. The fuel management module consists of all equipments related to fuel preparation, fuel reprocessing and radioactive handling. The preliminary calculations show that the PCMSR has negative temperature and void reactivity coefficient, passive shutdown characteristic related to fuel pump failure and possibility of using natural circulation for post shutdown cooling system.

  14. Westinghouse Small Modular Reactor passive safety system response to postulated events

    SciTech Connect

    Smith, M. C.; Wright, R. F.

    2012-07-01

    The Westinghouse Small Modular Reactor (SMR) is an 800 MWt (>225 MWe) integral pressurized water reactor. This paper is part of a series of four describing the design and safety features of the Westinghouse SMR. This paper focuses in particular upon the passive safety features and the safety system response of the Westinghouse SMR. The Westinghouse SMR design incorporates many features to minimize the effects of, and in some cases eliminates the possibility of postulated accidents. The small size of the reactor and the low power density limits the potential consequences of an accident relative to a large plant. The integral design eliminates large loop piping, which significantly reduces the flow area of postulated loss of coolant accidents (LOCAs). The Westinghouse SMR containment is a high-pressure, compact design that normally operates at a partial vacuum. This facilitates heat removal from the containment during LOCA events. The containment is submerged in water which also aides the heat removal and provides an additional radionuclide filter. The Westinghouse SMR safety system design is passive, is based largely on the passive safety systems used in the AP1000{sup R} reactor, and provides mitigation of all design basis accidents without the need for AC electrical power for a period of seven days. Frequent faults, such as reactivity insertion events and loss of power events, are protected by first shutting down the nuclear reaction by inserting control rods, then providing cold, borated water through a passive, buoyancy-driven flow. Decay heat removal is provided using a layered approach that includes the passive removal of heat by the steam drum and independent passive heat removal system that transfers heat from the primary system to the environment. Less frequent faults such as loss of coolant accidents are mitigated by passive injection of a large quantity of water that is readily available inside containment. An automatic depressurization system is used to

  15. Use of DRACS to Enhance HTGRs Passive Safety and Economy

    SciTech Connect

    Haihua Zhao; Hongbin Zhang; Ling Zou

    2011-06-01

    This paper discusses the use of DRACS to Enhance HTGRs Passive Safety and Economy. One of the important requirements for Gen. IV High Temperature Gas Cooled Reactors (HTGR) is passive safety. Currently all the HTGR designs use Reactor Vessel Auxiliary Cooling System (RVACS) for passive decay heat removal. [1] The decay heat first is transferred to core barrel by conduction and radiation, and then to reactor vessel by thermal radiation and convection; finally the decay heat is transferred to natural circulated air or water systems. RVACS can be characterized as a surface based decay heat removal system. Similar concepts have been widely used in sodium cooled fast reactor (SFR) designs, advanced light water reactors like AP1000. The RVACS is especially suitable for smaller power reactors since small systems have relatively larger surface area. RVACS tends to be less expensive. However, it limits the largest achievable power level for modular HTGRs due to the mismatch between the reactor power (proportional to volume) and decay heat removal capability (proportional to surface). When the relative decay heat removal capability is reduced, the peak fuel temperature increases, even close to the design limit. Annual designs with internal reflector can mitigate this effect therefore further increase the power. Another way to increase power is to increase power density. However, it is also limited by the decay heat removal capability. Besides safety, HTGRs also need to be economical in order to compete with other reactor designs. The limit of decay heat removal capability set by using RVACS has affected the economy of HTGRs. Forsberg [2] pointed out other disadvantages of using RVACS such as conflicting functional requirements for the reactor vessel and scaling distortion for integral effect test of the system performance. A potential alternative solution is to use a volume based passive decay removal system, call Direct Reactor Auxiliary Cooling Systems (DRACS), to remove

  16. The Potential for Further Development of Passive Safety

    PubMed Central

    Frampton, Richard; Lenard, James

    2009-01-01

    In Europe, emphasis is being transferred from injury prevention to accident prevention to reduce road casualties. This study attempted to identify the current potential for serious casualty reduction using passive safety by examining the crash performance of new cars with seriously injured occupants. The Co-operative Crash Injury Study conducts in-depth investigations of around 1200 vehicles per year from seven sample regions around England. Attention was focussed on passenger cars manufactured from 2004 to 2008 with at least one occupant injured to AIS level 3 or more. 28% of MAIS 3+ occupants were unbelted and 40% were belted but involved in crashes with limited potential for passive protection. A further 32% of occupants were belted and involved in crashes with potential for improved crashworthiness design. For these occupants, five major functional requirements were identified for crashworthiness improvement: a reduction of seatbelt loads on the chest and abdomen in frontal crashes, particularly for seniors; reduction in femur and tibia loads in frontal crashes; provision of head and chest protection in near-side crashes; and reduction of occupant lateral excursion in far-side impacts. Together these functions accounted for 70% of the identified requirements. Other smaller requirements were identified, each contributing up to 5% of total. Overall, the case supporting further developments in passive safety still appears significant. PMID:20184832

  17. The evaluation of the safety benefits of combined passive and on-board active safety applications.

    PubMed

    Page, Yves; Cuny, Sophie; Zangmeister, Tobias; Kreiss, Jens-Peter; Hermitte, Thierry

    2009-10-01

    One of the objectives of the European TRACE project (TRaffic Accident Causation in Europe, 2006-2008) was to estimate the proportion of injury accidents that could be avoided and/or the proportion of injury accidents where the severity could be mitigated for on-the-market safety applications, if 100 % of the car fleet would be equipped with them. We have selected for evaluation the Electronic Stability Control (ESC) and the Emergency Brake Assist (EBA) applications. As for passive safety systems, recent cars are designed to offer overall safety protection. Car structure, load limiters, front airbags, side airbags, knee airbags, pretensioners, padding and non aggressive structures in the door panel, the dashboard, the windshield, the seats, and the head rest also contribute to applying more protection. The whole safety package is very difficult to evaluate separately, one element independently segmented from the others. We decided to consider evaluating the effectiveness of the whole passive safety package, This package,, for the sake of simplicity, was the number of stars awarded at the Euro NCAP testing. The challenges were to compare the effectiveness of some safety configuration SC I, with the effectiveness of a different safety configuration SC II. A safety configuration is understood as a package of safety functions. Ten comparisons have been carried out such as the evaluation of the safety benefit of a fifth star given that the car has four stars and an EBA. The main outcome of this analysis is that any addition of a passive or active safety function selected in this analysis is producing increased safety benefits. For example, if all cars were five stars fitted with EBA and ESC, instead of four stars without ESC and EBA, injury accidents would be reduced by 47.2% for severe injuries and 69.5% for fatal injuries.

  18. The Evaluation of the Safety Benefits of Combined Passive and On-Board Active Safety Applications

    PubMed Central

    Page, Yves; Cuny, Sophie; Zangmeister, Tobias; Kreiss, Jens-Peter; Hermitte, Thierry

    2009-01-01

    One of the objectives of the European TRACE project (TRaffic Accident Causation in Europe, 2006–2008) was to estimate the proportion of injury accidents that could be avoided and/or the proportion of injury accidents where the severity could be mitigated for on-the-market safety applications, if 100 % of the car fleet would be equipped with them. We have selected for evaluation the Electronic Stability Control (ESC) and the Emergency Brake Assist (EBA) applications. As for passive safety systems, recent cars are designed to offer overall safety protection. Car structure, load limiters, front airbags, side airbags, knee airbags, pretensioners, padding and non aggressive structures in the door panel, the dashboard, the windshield, the seats, and the head rest also contribute to applying more protection. The whole safety package is very difficult to evaluate separately, one element independently segmented from the others. We decided to consider evaluating the effectivenessof the whole passive safety package, This package,, for the sake of simplicity, was the number of stars awarded at the Euro NCAP testing. The challenges were to compare the effectiveness of some safety configuration SC I, with the effectiveness of a different safety configuration SC II. A safety configuration is understood as a package of safety functions. Ten comparisons have been carried out such as the evaluation of the safety benefit of a fifth star given that the car has four stars and an EBA. The main outcome of this analysis is that any addition of a passive or active safety function selected in this analysis is producing increased safety benefits. For example, if all cars were five stars fitted with EBA and ESC, instead of four stars without ESC and EBA, injury accidents would be reduced by 47.2% for severe injuries and 69.5% for fatal injuries. PMID:20184838

  19. Passive modular gas safety system for a reactor

    SciTech Connect

    Abalin, S.S.; Isaev, I.F.; Kulakov, A.A.; Sivokon, V.P.; Udovenko, A.N.; Ionaitis, R.R.

    1994-01-01

    Reactor safety systems have developed gradually. Today in particular, auxiliary systems are being developed which are based on nontraditional operational concepts, by using gaseous neutron absorbers. The Scientific-Research and Design Institute of Power Technology (NIKIET) and the Institute of Nuclear Reactors, Kurchatov Institute Reactor Science Center (RNTs), have done preliminary development and experimental verification of separate elements of this system, in which helium is used as the absorber. This article presents a rapid passive safety system based on gaseous absorber, which is made as autonomous modules as the final stage of reactor safety. Its effectiveness is discussed by using an RBMK reactor as an example. As opposed to traditional active, systems, it does not require a functioning power supply and information signals from outside the reactors system, which makes it stable against unsanctioned actions by personnel, the influence of other systems, and also outside actions (sabotage and natural calamities which could destroy the the nuclear power plant structure). Because the gas safety system can operate instantaneously (0.1-0.3 sec), in principle, it can shut down the reactor even with fast-neutron runaway, where traditional safety systems are ineffective.

  20. A survey of recent EBR-II passive safety testing

    SciTech Connect

    Planchon, H.P.; Golden, G.H.; Sackett, J.I.; Singer, R.M.; Mohr, D.; Chang, L.K.; Feldman, E.E.; Sevy, R.H.

    1987-01-01

    During the last two years, the testing program at EBR-II has investigated the capabilities of liquid metal reactors (LMRs) to perform vital safety functions passively. In particular the tests have examined post shutdown decay heat removal by natural circulation and passive shutdown of the reactor after accidents which lead to undercooling. The undercooling accidents have been divided into two categories - the loss of flow without scram (LOFWS) (a family of events involving a loss of forced flow through the reactor), and the loss of heat sink without scram (LOHSWS) (a family of events involving a loss of the ability to transfer reactor heat to down stream components which generate steam and electricity.) The type of ''passive shutdown'' that has been examined is caused by natural processes - principally thermal expansion of the reactor structures, fuel and coolant. As used in this paper the term excludes automatic control of power, operator intervention or negative reactivity generated by special in-core devices. 18 refs., 7 figs., 1 tab.

  1. New PANDA Tests to Investigate Effects of Light Gases on Passive Safety Systems

    SciTech Connect

    Paladino, D.; Auban, O.; Candreia, P.; Huggenberger, M.; Strassberger, H.J.

    2002-07-01

    The large- scale thermal-hydraulic PANDA facility (located at PSI in Switzerland), has been used over the last few years for investigating different passive decay- heat removal systems and containment phenomena for the next generation of light water reactors (Simplified Boiling Water Reactor: SBWR; European Simplified Boiling Water Reactor: ESBWR; Siedewasserreaktor: SWR-1000). Currently, as part of the European Commission 5. EURATOM Framework Programme project 'Testing and Enhanced Modelling of Passive Evolutionary Systems Technology for Containment Cooling' (TEMPEST), a new series of tests is being planned in the PANDA facility to experimentally investigate the distribution of non-condensable gases inside the containment and their effect on the performance of the 'Passive Containment Cooling System' (PCCS). Hydrogen release caused by the metal-water reaction in the case of a postulated severe accident will be simulated in PANDA by injecting helium into the reactor pressure vessel. In order to provide suitable data for Computational Fluid Dynamic (CFD) code assessment and improvement, the instrumentation in PANDA has been upgraded for the new tests. In the present paper, a detailed discussion is given of the new PANDA tests to be performed to investigate the effects of light gas on passive safety systems. The tests are scheduled for the first half of the year 2002. (authors)

  2. Identification and characterization of passive safety system and inherent safety feature building blocks for advanced light-water reactors

    SciTech Connect

    Forsberg, C.W.

    1989-01-01

    Oak Ridge National Laboratory (ORNL) is investigating passive and inherent safety options for Advanced Light-Water Reactors (ALWRs). A major activity in 1989 includes identification and characterization of passive safety system and inherent safety feature building blocks, both existing and proposed, for ALWRs. Preliminary results of this work are reported herein. This activity is part of a larger effort by the US Department of Energy, reactor vendors, utilities, and others in the United States to develop improved LWRs. The Advanced Boiling Water Reactor (ABWR) program and the Advanced Pressurized Water Reactor (APWR) program have as goals improved, commercially available LWRs in the early 1990s. The Advanced Simplified Boiling Water Reactor (ASBWR) program and the AP-600 program are developing more advanced reactors with increased use of passive safety systems. It is planned that these reactors will become commercially available in the mid 1990s. The ORNL program is an exploratory research program for LWRs beyond the year 2000. Desired long-term goals for such reactors include: (1) use of only passive and inherent safety, (2) foolproof against operator errors, (3) malevolence resistance against internal sabotage and external assault and (4) walkaway safety. The acronym ''PRIME'' (Passive safety, Resilient operation, Inherent safety, Malevolence resistance, and Extended (walkaway) safety) is used to summarize these desired characteristics. Existing passive and inherent safety options are discussed in this document.

  3. Passive Safety Features Evaluation of KIPT Neutron Source Facility

    SciTech Connect

    Zhong, Zhaopeng; Gohar, Yousry

    2016-06-01

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

  4. Injection safety for immunisation--Andhra Pradesh experience.

    PubMed

    Kaipilyawar, Satish B; Rao, R Gopal Krishna

    2005-04-01

    Injection safety is one component of a major immunisation project being implemented in partnership with Government of Andhra Pradesh and PATH, an international NGO. Prior to the project wrong and dangerous injection giving practices were present among the staff which needed immediate attention. It was decided to introduce auto disable syringes along with safety boxes with high quality training to staff and make all these available to all districts along with hepatitis B introduction in the routine immunisation. The State of Andhra Pradesh became the first to implement 'bundling' concept in the immunisation project. Implementation was planned to be done in a phased manner to cover all the 23 districts over a five-year period. For routine immunisation sessions, smaller locally produced boxes may be more acceptable. The Government of India made a decision on 21st July, 2004 on implementing injection safety. Injection safety and proper disposal of used needles and syringes can be successfully advocated if medical associations, paediatric associations, key governmental bodies and international agencies come together. PATH established a group and holds the secretariat for the India injection safety coalition on similar basis as the Safe Injection Global Network of WHO (SIGN). Description of AP system for safe disposal of needles and syringes using manual needle-cutters and plastics recycling has been depicted in this article.

  5. Deriving and Validating a Road Safety Performance Indicator for Vehicle Fleet Passive Safety

    PubMed Central

    Page, Marianne; Rackliff, Lucy

    2006-01-01

    Road safety performance indicators (RSPI) are policy tools which describe the extent of insecure operational safety conditions within traffic systems. This study describes the production of an RSPI which represents the presence within a country’s vehicle fleet, of vehicles that may not effectively protect an occupant in a collision. This work is highly original, as it uses the entire vehicle database of European Union Member States in order to estimate the average level of passive safety offered by the entire fleet in each country. The EuroNCAP safety ratings and vehicle age of each vehicle in each fleet have been obtained to calculate the RSPI. The methodology used could be adopted as an international standard. PMID:16968645

  6. 78 FR 41436 - Proposed Revision to Treatment of Non-Safety Systems for Passive Advanced Light Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ... COMMISSION Proposed Revision to Treatment of Non-Safety Systems for Passive Advanced Light Water Reactors... Treatment of Non-Safety Systems (RTNSS) for Passive Advanced Light Water Reactors.'' The NRC seeks public...- Safety Systems (RTNSS) for Passive Advanced Light Water Reactors.'' This area includes a revised...

  7. Testing of Passive Safety System Performance for Higher Power Advanced Reactors

    SciTech Connect

    brian G. Woods; Jose Reyes, Jr.; John Woods; John Groome; Richard Wright

    2004-12-31

    This report describes the results of NERI research on the testing of advanced passive safety performance for the Westinghouse AP1000 design. The objectives of this research were: (a) to assess the AP1000 passive safety system core cooling performance under high decay power conditions for a spectrum of breaks located at a variety of locations, (b) to compare advanced thermal hydraulic computer code predictions to the APEX high decay power test data and (c) to develop new passive safety system concepts that could be used for Generation IV higher power reactors.

  8. Functional Safety of Hybrid Laser Safety Systems - How can a Combination between Passive and Active Components Prevent Accidents?

    NASA Astrophysics Data System (ADS)

    Lugauer, F. P.; Stiehl, T. H.; Zaeh, M. F.

    Modern laser systems are widely used in industry due to their excellent flexibility and high beam intensities. This leads to an increased hazard potential, because conventional laser safety barriers only offer a short protection time when illuminated with high laser powers. For that reason active systems are used more and more to prevent accidents with laser machines. These systems must fulfil the requirements of functional safety, e.g. according to IEC 61508, which causes high costs. The safety provided by common passive barriers is usually unconsidered in this context. In the presented approach, active and passive systems are evaluated from a holistic perspective. To assess the functional safety of hybrid safety systems, the failure probability of passive barriers is analysed and added to the failure probability of the active system.

  9. No change in calf muscle passive stiffness after botulinum toxin injection in children with cerebral palsy.

    PubMed

    Alhusaini, Adel A A; Crosbie, Jack; Shepherd, Roberta B; Dean, Catherine M; Scheinberg, Adam

    2011-06-01

    Stiffness and shortening of the calf muscle due to neural or mechanical factors can profoundly affect motor function. The aim of this study was to investigate non-neurally mediated calf-muscle tightness in children with cerebral palsy (CP) before and after botulinum toxin type A (BoNT-A) injection. Sixteen children with spastic CP (seven females, nine males; eight at Gross Motor Function Classification System level I, eight at level II; age range 4-10 y) and calf muscle spasticity were tested before and during the pharmaceutically active phase after injection of BoNT-A. Measures of passive muscle compliance and viscoelastic responses, hysteresis, and the gradient of the torque-angle curve were computed and compared before and after injection. Although there was a slight, but significant increase in ankle range of motion after BoNT-A injection and a small, significant decrease in the torque required to achieve plantigrade and 5° of dorsiflexion, no significant difference in myotendinous stiffness or hysteresis were detected after BoNT-A injection. Despite any effect on neurally mediated responses, the compliance of the calf muscle was not changed and the muscle continued to offer significant resistance to passive motion of the ankle. These findings suggest that additional treatment approaches are required to supplement the effects of BoNT-A injections when managing children with calf muscle spasticity. © The Authors. Developmental Medicine & Child Neurology © 2011 Mac Keith Press.

  10. Passive cooling safety system for liquid metal cooled nuclear reactors

    DOEpatents

    Hunsbedt, Anstein; Boardman, Charles E.; Hui, Marvin M.; Berglund, Robert C.

    1991-01-01

    A liquid metal cooled nuclear reactor having a passive cooling system for removing residual heat resulting from fuel decay during reactor shutdown. The passive cooling system comprises a plurality of partitions surrounding the reactor vessel in spaced apart relation forming intermediate areas for circulating heat transferring fluid which remove and carry away heat from the reactor vessel. The passive cooling system includes a closed primary fluid circuit through the partitions surrounding the reactor vessel and a partially adjoining secondary open fluid circuit for carrying transferred heat out into the atmosphere.

  11. Passive mechanical properties and related proteins change with botulinum neurotoxin A injection of normal skeletal muscle.

    PubMed

    Thacker, Bryan E; Tomiya, Akihito; Hulst, Jonah B; Suzuki, Kentaro P; Bremner, Shannon N; Gastwirt, Randy F; Greaser, Marion L; Lieber, Richard L; Ward, Samuel R

    2012-03-01

    The effects of botulinum neurotoxin A on the passive mechanical properties of skeletal muscle have not been investigated, but may have significant impact in the treatment of neuromuscular disorders including spasticity. Single fiber and fiber bundle passive mechanical testing was performed on rat muscles treated with botulinum neurotoxin A. Myosin heavy chain and titin composition of single fibers was determined by gel electrophoresis. Muscle collagen content was determined using a hydroxyproline assay. Neurotoxin-treated single fiber passive elastic modulus was reduced compared to control fibers (53.00 kPa vs. 63.43 kPa). Fiber stiffness and slack sarcomere length were also reduced compared to control fibers and myosin heavy chain composition shifted from faster to slower isoforms. Average titin molecular weight increased 1.77% after treatment. Fiber bundle passive elastic modulus increased following treatment (168.83  kPa vs. 75.14 kPa). Bundle stiffness also increased while collagen content per mass of muscle tissue increased 38%. Injection of botulinum neurotoxin A produces an effect on the passive mechanical properties of normal muscle that is opposite to the changes observed in spastic muscles. Copyright © 2011 Orthopaedic Research Society.

  12. Health and safety risks associated with public injecting among people who inject drugs in Bangkok, Thailand.

    PubMed

    Leung, Leslie Tze Fung; Ti, Lianping; Hayashi, Kanna; Suwannawong, Paisan; Kaplan, Karyn; Wood, Evan; Kerr, Thomas

    2013-11-01

    The injection of illicit drugs in public spaces is known to pose significant health risks to people who inject drugs (IDU). However, to our knowledge this practice has not been explored in the Asian context. Therefore, we sought to characterise the prevalence of and factors associated with public injecting among a community-recruited sample of IDU in Bangkok, Thailand. Data were derived from the Mitsampan Community Research Project between July and October 2011. Using multivariate logistic regression, this cross-sectional study examined the prevalence and correlates of public injecting within the past six months among 437 IDU participants. In total, 121 (27.7%) participants reported injecting drugs in a public space within the past six months. In multivariate analyses, public drug injection was independently associated with male gender [adjusted odds ratio (AOR) 2.51, 95% confidence interval (CI)) 1.29-5.22], weekly heroin injection (AOR 2.19, 95% CI 1.27-3.77), assisted injection (AOR 1.93, 95% CI 1.06-3.49), rushed injection (AOR 4.36, 95% CI 2.65-7.24), incarceration (AOR 2.27, 95% CI 1.01-5.04) and noticing police presence where drugs are bought or used (AOR 1.83, 95% CI 1.06-3.19). A substantial proportion of Thai IDU in our sample reported recent public drug injection. This behaviour was independently associated with a wide range of individual and contextual factors that pose significant health and safety risks to the IDU. These findings highlight the importance of addressing the broader social and physical risk environment surrounding IDU as a means of preventing negative health outcomes among this population. © 2013 Australasian Professional Society on Alcohol and other Drugs.

  13. Passive Safety Features in Sodium Cooled Super-Safe,Small and Simple Reactor

    SciTech Connect

    Ueda, N.; Kinoshita, I.; Nishi, Y.; Minato, A.; Matsumiya, H.; Nishiguchi, Y.

    2002-07-01

    This paper describes the passive safety features utilized in the updated sodium cooled Super-Safe, Small and Simple fast reactor, which is the improved 4S reactor. This reactor can operate up to ten years without refueling and neutron reflector regulates the reactivity. One of the design requirements is to secure the core against all anticipated transients without reactor scram. Therefore, the reactor concept is to design to enhance the passive safety features. All temperature reactivity feedback coefficients including whole core sodium void worth are negative. Also, introducing of RVACS (Reactor Vessel Auxiliary Cooling System) can enhance the passive decay heat removal capability. Safety analyses are carried out to simulate various transient sequences, which are loss of flow events, transient overpower events and loss of heat sink events, in order to evaluate the passive safety capabilities. A calculation tool for plant dynamics analyses for fast reactors has been modified to model the 4S including the unique plant system, which are reflector control system, circulation pumps and RVACS. The analytical results predict that the designed passive features improve the safety in which temperature variation in transients are satisfied with the safety criteria for the fuel element and the structure of the primary coolant boundary. (authors)

  14. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

  15. Passive and inherent safety technologies for light-water nuclear reactors

    SciTech Connect

    Forsberg, C.W.

    1990-07-01

    Passive/inherent safety implies a technical revolution in our approach to nuclear power safety. This direction is discussed herein for light-water reactors (LWRs) -- the predominant type of power reactor used in the world today. At Oak Ridge National Laboratory (ORNL) the approach to the development of passive/inherent safety for LWRs consists of four steps: identify and quantify safety requirements and goals; identify and quantify the technical functional requirements needed for safety; identify, invent, develop, and quantify technical options that meet both of the above requirements; and integrate safety systems into designs of economic and reliable nuclear power plants. Significant progress has been achieved in the first three steps of this program. The last step involves primarily the reactor vendors. These activities, as well as related activities worldwide, are described here. 27 refs., 7 tabs.

  16. Safety and Efficacy of Permacol Injection in the Treatment of Fecal Incontinence

    PubMed Central

    Ayers, Jennifer; Ayantunde, Abraham; Praveen, Bandipalyam V

    2016-01-01

    Purpose Permacol has been gaining popularity in recent times for the treatment of fecal incontinence (FI). This study aims to evaluate the safety and efficacy of anal submucosal Permacol injection in the treatment of FI. Methods All consecutive patients who underwent Permacol injection for FI over a 3-year period were included. Patients' data relating to obstetric history, anorectal/pelvic operations, type of FI, preoperative anorectal physiology results and follow-up details for outcome measures were collected. Preoperative and postoperative Cleveland Clinic Florida Incontinence Scores (CCFISs) were noted. Patients were surveyed by using a telephone questionnaire to assess the quality of life and other outcome measures. Data were analysed using SPSS ver.19.0. Results Thirty patients (28 females and 2 males) with a median age of 67 years were included in the study. Of those patients, 37%, 50%, and 13% were noted to have passive, mixed and urge FI, respectively. Six of the patients (20%) had repeat Permacol injections, 5 of whom had sustained responses to the first Permacol injection for a mean of 11 months. There was a significant improvement in the CCFIS from a baseline median of 12.5, mean 12.8 interquartile range [IQR], 6–20), to a median of 3.5, mean 4.8 (IQR, 0–20), P < 0.001. Of the patients surveyed by telephone 89% were satisfied with their overall experience and the improvement in their symptoms following Permacol injections. Conclusion This study has demonstrated that Permacol injection for the treatment of FI is safe and effective and has no associated major complications. However, the results are not permanent; consequently, a significant proportion of the patients with an initial response may require repeat injections. PMID:27218098

  17. Injection locked Fabry-Perot laser diodes for WDM passive optical network spare function

    NASA Astrophysics Data System (ADS)

    Han, Wei; Zhu, Ning-Hua; Xie, Liang; Ren, Min; Sun, Ke; Zhang, Bang-Hong; Li, Liang; Zhang, Hong-Guang

    2009-09-01

    In this paper, a protection scheme for transmitters in wavelength-division-multiplexing passive optical network (WDM-PON) has been proposed and demonstrated. If any downstream transmitter encounters problems at the central office (CO), the interrupted communication can be restored immediately by injecting a Fabry-Perot laser diode (FP-LD) with the upstream lightwave corresponding to the failure transmitter. Compared with the conventional methods, this proposed architecture provides a cost-effective and reliable protection scheme employing a common FP-LD. In the experiment, a 1:36 protection capability was implemented with a 2.5 Gbit/s downstream transmission capability.

  18. Passive millimeter-wave imaging for security and safety applications

    NASA Astrophysics Data System (ADS)

    Sato, Hiroyasu; Sawaya, Kunio; Mizuno, Koji; Uemura, Jun; Takeda, Masamune; Takahashi, Junichi; Yamada, Kota; Morichika, Keiichi; Hasegawa, Tsuyoshi; Hirai, Haruyuki; Niikura, Hirotaka; Matsuzaki, Tomohiko; Kato, Shigeto; Nakada, Jun

    2010-04-01

    77 GHz passive millimeter wave (PMMW) imaging camera for the purpose of security is developed. In order to detect concealed objects in clothes without hindrance to flow of people at airport security checks, video rate imaging is realized using one-dimensional imaging sensor array of 25 elements and a flapping reflector. As receiving antennas, novel antipodal Fermi antenna (APFA) having required characteristics for passive imaging such as broad bandwidth to obtain enough power, axially symmetric directivity with 10dB beam width of 35 degrees to obtain optimum coupling with dielectric lens, narrow width geometry for high spatial resolution of imaging is used. Real-time calibration (RTC) technique is introduced to eliminate the drift of receiving circuits. Interpolation technique to improve the quality of image and marking software for screening of suspicious objects are also developed. High spatial resolution of 20 mm is obtained by using developed imaging camera.

  19. The REPAS Study: Reliability Evaluation of Passive Safety Systems

    SciTech Connect

    Ricotti, M.E.; Bianchi, F.; Burgazzi, L.; D'Auria, F.; Galassi, G.

    2002-07-01

    The strategy of approach to the problem moves from the consideration that a passive system should be theoretically more reliable than an active one. In fact it does not need any external input or energy to operate and it relies only upon natural physical laws (e.g. gravity, natural circulation, internally stored energy, etc.) and/or 'intelligent' use of the energy inherently available in the system (e.g. chemical reaction, decay heat, etc.). Nevertheless the passive system may fail its mission not only as a consequence of classical mechanical failure of components, but also for deviation from the expected behaviour, due to physical phenomena mainly related to thermal-hydraulics or due to different boundary and initial conditions. The main sources of physical failure are identified and a probability of occurrence is assigned. The reliability analysis is performed on a passive system which operates in two-phase, natural circulation. The selected system is a loop including a heat source and a heat sink where the condensation occurs. The system behavior under different configurations has been simulated via best-estimate code (Relap5 mod3.2). The results are shown and can be treated in such a way to give qualitative and quantitative information on the system reliability. Main routes of development of the methodology are also depicted. (authors)

  20. System Study: High-Pressure Safety Injection 1998–2013

    SciTech Connect

    Schroeder, John Alton

    2015-02-01

    This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2013 for selected components were obtained from the Institute of Nuclear Power Operations (INPO) Consolidated Events Database (ICES). The unreliability results are trended for the most recent 10-year period while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

  1. System Study: High-Pressure Safety Injection 1998-2014

    SciTech Connect

    Schroeder, John Alton

    2015-12-01

    This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2014 for selected components were obtained from the Institute of Nuclear Power Operations (INPO) Consolidated Events Database (ICES). The unreliability results are trended for the most recent 10 year period, while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

  2. System Study: High-Pressure Safety Injection 1998–2012

    SciTech Connect

    T. E. Wierman

    2013-10-01

    This report presents an unreliability evaluation of the high-pressure safety injection system (HPSI) at 69 U.S. commercial nuclear power plants. Demand, run hours, and failure data from fiscal year 1998 through 2012 for selected components were obtained from the Equipment Performance and Information Exchange (EPIX). The unreliability results are trended for the most recent 10 year period while yearly estimates for system unreliability are provided for the entire active period. No statistically significant increasing or decreasing trends were identified in the HPSI results.

  3. Study of Cost Effective Large Advanced Pressurized Water Reactors that Employ Passive Safety Features

    SciTech Connect

    Winters, J. W.; Corletti, M. M.; Hayashi, Y.

    2003-11-12

    A report of DOE sponsored portions of AP1000 Design Certification effort. On December 16, 1999, The United States Nuclear Regulatory Commission issued Design Certification of the AP600 standard nuclear reactor design. This culminated an 8-year review of the AP600 design, safety analysis and probabilistic risk assessment. The AP600 is a 600 MWe reactor that utilizes passive safety features that, once actuated, depend only on natural forces such as gravity and natural circulation to perform all required safety functions. These passive safety systems result in increased plant safety and have also significantly simplified plant systems and equipment, resulting in simplified plant operation and maintenance. The AP600 meets NRC deterministic safety criteria and probabilistic risk criteria with large margins. A summary comparison of key passive safety system design features is provided in Table 1. These key features are discussed due to their importance in affecting the key thermal-hydraulic phenomenon exhibited by the passive safety systems in critical areas. The scope of some of the design changes to the AP600 is described. These changes are the ones that are important in evaluating the passive plant design features embodied in the certified AP600 standard plant design. These design changes are incorporated into the AP1000 standard plant design that Westinghouse is certifying under 10 CFR Part 52. In conclusion, this report describes the results of the representative design certification activities that were partially supported by the Nuclear Energy Research Initiative. These activities are unique to AP1000, but are representative of research activities that must be driven to conclusion to realize successful licensing of the next generation of nuclear power plants in the United States.

  4. Passive fire protection--a vital safety role.

    PubMed

    MacInnes, Callum; Rankin, Richard

    2012-06-01

    Callum Maclnnes BSc (Hons), AIFireE, an engineer at WSP UK--part of a global design engineering and management consultancy group specialising in property, transport and infrastructure, industry and environment projects--and his colleague, senior engineer, Richard Rankin CEng MEng (Hons) MIFireE, discuss the importance of passive fire protection in healthcare premises at a time when, due particularly to the difficult financial climate, many hospitals are undergoing upgrading and refurbishment, potentially affording an ideal opportunity to ensure that proper fire compartmentation measures are in place.

  5. FFTF Passive Safety Test Data for Benchmarks for New LMR Designs

    SciTech Connect

    Wootan, David W.; Casella, Andrew M.

    2016-09-01

    Liquid Metal Reactors (LMRs) continue to be considered as an attractive concept for advanced reactor design. Software packages such as SASSYS are being used to im-prove new LMR designs and operating characteristics. Significant cost and safety im-provements can be realized in advanced liquid metal reactor designs by emphasizing inherent or passive safety through crediting the beneficial reactivity feedbacks associ-ated with core and structural movement. This passive safety approach was adopted for the Fast Flux Test Facility (FFTF), and an experimental program was conducted to characterize the structural reactivity feedback. The FFTF passive safety testing pro-gram was developed to examine how specific design elements influenced dynamic re-activity feedback in response to a reactivity input and to demonstrate the scalability of reactivity feedback results to reactors of current interest. The U.S. Department of En-ergy, Office of Nuclear Energy Advanced Reactor Technology program is in the pro-cess of preserving, protecting, securing, and placing in electronic format information and data from the FFTF, including the core configurations and data collected during the passive safety tests. Benchmarks based on empirical data gathered during operation of the Fast Flux Test Facility (FFTF) as well as design documents and post-irradiation examination will aid in the validation of these software packages and the models and calculations they produce. Evaluation of these actual test data could provide insight to improve analytical methods which may be used to support future licensing applications for LMRs

  6. 77 FR 62270 - Proposed Revision Treatment of Non-Safety Systems for Passive Advanced Light Water Reactors

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ... Non-Safety Systems for Passive Advanced Light Water Reactors AGENCY: Nuclear Regulatory Commission... Systems (RTNSS) for Passive Advanced Light Water Reactors.'' The current SRP does not contain guidance on the proposed RTNSS for Passive Advance Light Water Reactors. DATES: Submit comments by November...

  7. Impact of Passive Safety on FHR Instrumentation Systems Design and Classification

    SciTech Connect

    Holcomb, David Eugene

    2015-01-01

    Fluoride salt-cooled high-temperature reactors (FHRs) will rely more extensively on passive safety than earlier reactor classes. 10CFR50 Appendix A, General Design Criteria for Nuclear Power Plants, establishes minimum design requirements to provide reasonable assurance of adequate safety. 10CFR50.69, Risk-Informed Categorization and Treatment of Structures, Systems and Components for Nuclear Power Reactors, provides guidance on how the safety significance of systems, structures, and components (SSCs) should be reflected in their regulatory treatment. The Nuclear Energy Institute (NEI) has provided 10 CFR 50.69 SSC Categorization Guideline (NEI-00-04) that factors in probabilistic risk assessment (PRA) model insights, as well as deterministic insights, through an integrated decision-making panel. Employing the PRA to inform deterministic requirements enables an appropriately balanced, technically sound categorization to be established. No FHR currently has an adequate PRA or set of design basis accidents to enable establishing the safety classification of its SSCs. While all SSCs used to comply with the general design criteria (GDCs) will be safety related, the intent is to limit the instrumentation risk significance through effective design and reliance on inherent passive safety characteristics. For example, FHRs have no safety-significant temperature threshold phenomena, thus enabling the primary and reserve reactivity control systems required by GDC 26 to be passively, thermally triggered at temperatures well below those for which core or primary coolant boundary damage would occur. Moreover, the passive thermal triggering of the primary and reserve shutdown systems may relegate the control rod drive motors to the control system, substantially decreasing the amount of safety-significant wiring needed. Similarly, FHR decay heat removal systems are intended to be running continuously to minimize the amount of safety-significant instrumentation needed to initiate

  8. Passive Safety of the STAR-LM HLMC Natural Convection Reactor

    SciTech Connect

    Sienicki, James J.; Petkov, Plamen V.

    2002-07-01

    The STAR-LM 300 to 400 MWt class modular, factory fabricated, fully transportable, proliferation resistant, autonomous, reactor system achieves passive safety by taking advantage of the intrinsic benefits of inert lead-bismuth eutectic heavy liquid metal coolant, 100+% natural circulation heat transport, a fast neutron spectrum core utilizing high thermal conductivity transuranic nitride fuel, redundant passive air cooling of the outside of the guard/containment vessel driven by natural circulation, and seismic isolation where required by site conditions. Postulated loss-of-heat sink without scram, overcooling without scram, and unprotected transient overpower accidents are analyzed for the 300 MWt STAR-LM design using a coupled thermal hydraulics-neutron kinetics plant dynamics analysis computer code. In all cases, STAR-LM is calculated to exhibit passive safety with peak cladding and coolant temperatures remaining within the existing database for lead-bismuth eutectic coolant and ferritic steel core materials. (authors)

  9. Active and Passive Fatigue in Simulated Driving: Discriminating Styles of Workload Regulation and Their Safety Impacts

    PubMed Central

    Saxby, Dyani J.; Matthews, Gerald; Warm, Joel S.; Hitchcock, Edward M.; Neubauer, Catherine

    2015-01-01

    Despite the known dangers of driver fatigue, it is a difficult construct to study empirically. Different forms of task-induced fatigue may differ in their effects on driver performance and safety. Desmond and Hancock (2001) defined active and passive fatigue states that reflect different styles of workload regulation. In 2 driving simulator studies we investigated the multidimensional subjective states and safety outcomes associated with active and passive fatigue. Wind gusts were used to induce active fatigue, and full vehicle automation to induce passive fatigue. Drive duration was independently manipulated to track the development of fatigue states over time. Participants were undergraduate students. Study 1 (N = 108) focused on subjective response and associated cognitive stress processes, while Study 2 (N = 168) tested fatigue effects on vehicle control and alertness. In both studies the 2 fatigue manipulations produced different patterns of subjective response reflecting different styles of workload regulation, appraisal, and coping. Active fatigue was associated with distress, overload, and heightened coping efforts, whereas passive fatigue corresponded to large-magnitude declines in task engagement, cognitive underload, and reduced challenge appraisal. Study 2 showed that only passive fatigue reduced alertness, operationalized as speed of braking and steering responses to an emergency event. Passive fatigue also increased crash probability, but did not affect a measure of vehicle control. Findings support theories that see fatigue as an outcome of strategies for managing workload. The distinction between active and passive fatigue is important for assessment of fatigue and for evaluating automated driving systems which may induce dangerous levels of passive fatigue. PMID:24041288

  10. Scale Model Test and Transient Analysis of Steam Injector Driven Passive Core Injection System for Innovative-Simplified Nuclear Power Plant

    NASA Astrophysics Data System (ADS)

    Ohmori, Shuichi; Narabayashi, Tadashi; Mori, Michitsugu

    A steam injector (SI) is a simple, compact and passive pump and also acts as a high-performance direct-contact compact heater. This provides SI with capability to serve also as a direct-contact feed-water heater that heats up feed-water by using extracted steam from turbine. Our technology development aims to significantly simplify equipment and reduce physical quantities by applying "high-efficiency SI", which are applicable to a wide range of operation regimes beyond the performance and applicable range of existing SIs and enables unprecedented multistage and parallel operation, to the low-pressure feed-water heaters and emergency core cooling system of nuclear power plants, as well as achieve high inherent safety to prevent severe accidents by keeping the core covered with water (a severe accident-free concept). This paper describes the results of the scale model test, and the transient analysis of SI-driven passive core injection system (PCIS).

  11. Plant control impact on IFR power plant passive safety response

    SciTech Connect

    Vilim, R.B.

    1993-03-01

    A method is described for optimizing the closed-loop plant control strategy with respect to safety margins sustained in the unprotected upset response of a liquid metal reactor. The optimization is performed subject to the normal requirements for reactor startup, load change and compensation for reactivity changes over the cycle. The method provides a formal approach to the process of exploiting the innate self-regulating property of a metal fueled reactor to make it less dependent on operator action and less vulnerable to automatic control system fault and/or operator error.

  12. Plant control impact on IFR power plant passive safety response

    SciTech Connect

    Vilim, R.B.

    1993-01-01

    A method is described for optimizing the closed-loop plant control strategy with respect to safety margins sustained in the unprotected upset response of a liquid metal reactor. The optimization is performed subject to the normal requirements for reactor startup, load change and compensation for reactivity changes over the cycle. The method provides a formal approach to the process of exploiting the innate self-regulating property of a metal fueled reactor to make it less dependent on operator action and less vulnerable to automatic control system fault and/or operator error.

  13. Fabrication and modelling of injection moulded all-polymer capillary microvalves for passive microfluidic control

    NASA Astrophysics Data System (ADS)

    Kistrup, Kasper; Esben Poulsen, Carl; Østergaard, Peter Friis; Haugshøj, Kenneth Brian; Taboryski, Rafael; Wolff, Anders; Fougt Hansen, Mikkel

    2014-12-01

    Rapid prototyping is desirable when developing products. One example of such a product is all-polymer, passive flow controlled lab-on-a-chip systems that are preferential when developing low-cost disposable chips for point-of-care use. In this paper we investigate the following aspects of going from rapid prototyping to pilot (mass) production. (1) Fabrication of an all-polymer microfluidic system using a rapid prototyped master insert for injection moulding and ultrasonic welding, including a systematic experimental characterisation of chip featured geometric capillary microvalve test structures. (2) Numerical modelling of the microvalve burst pressures. Numerical modelling of burst pressures is challenging due to its non-equilibrium nature. We have implemented and tested the level-set method modified with a damped driving term and show that the introduction of the damping term leads to numerically robust results with limited computational demands and a low number of iterations. Numerical and simplified analytical results are validated against the experimental results. We find that injection moulding and ultrasonic welding are effective for chip production and that the experimental burst pressures could be estimated with an average accuracy of 5% using the presented numerical model.

  14. SRS supplemental safety system injection (gas pressurizer) test

    SciTech Connect

    Howarth, W.L.; Dimenna, R.A.

    1992-12-31

    An evaluation and validation of an existing version of the RELAP5 thermal hydraulics computer code was undertaken for the purpose of certification for use in the new production reactor - heavy water reactor (NPR-HWR) program. This version of the code was RELAP5/MOD3 Version 5q, designated for the purposes of the NPR-HWR program as RELAP5/NPR Version 0. As part of the evaluation and assessment, test data from theSRS Supplemental Safety System Injection (Gas Pressurizer) was used to verify and assess the ability of RELAP5/NPR Version 0 to perform thermal-hydraulic model analysis using the test data. Specifically, the assessment determines RELAP5/NPR Version 0 capability in modeling sudden depressurization phenomena. Two RELAP5/NPR Version 0 components (pipe and accumulator) were used to compare calculated pressure and temperature against test data. The code deficiencies are a temperature clamp in the accumulator component prevents the gas temperature from going below {minus}9{degrees}F, and RELAP5 accumulator and pipe components wall-to-fluid heat transfer correlation and interfacial vapor heat transfer correlation need substantial improvement. Only the code pipe component calculated pressures and temperatures within the specified 10 percent accuracy.

  15. SRS supplemental safety system injection (gas pressurizer) test

    SciTech Connect

    Howarth, W.L.; Dimenna, R.A.

    1992-01-01

    An evaluation and validation of an existing version of the RELAP5 thermal hydraulics computer code was undertaken for the purpose of certification for use in the new production reactor - heavy water reactor (NPR-HWR) program. This version of the code was RELAP5/MOD3 Version 5q, designated for the purposes of the NPR-HWR program as RELAP5/NPR Version 0. As part of the evaluation and assessment, test data from theSRS Supplemental Safety System Injection (Gas Pressurizer) was used to verify and assess the ability of RELAP5/NPR Version 0 to perform thermal-hydraulic model analysis using the test data. Specifically, the assessment determines RELAP5/NPR Version 0 capability in modeling sudden depressurization phenomena. Two RELAP5/NPR Version 0 components (pipe and accumulator) were used to compare calculated pressure and temperature against test data. The code deficiencies are a temperature clamp in the accumulator component prevents the gas temperature from going below [minus]9[degrees]F, and RELAP5 accumulator and pipe components wall-to-fluid heat transfer correlation and interfacial vapor heat transfer correlation need substantial improvement. Only the code pipe component calculated pressures and temperatures within the specified 10 percent accuracy.

  16. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    PubMed

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  17. Worldwide advanced nuclear power reactors with passive and inherent safety: What, why, how, and who

    SciTech Connect

    Forsberg, C.W.; Reich, W.J.

    1991-09-01

    The political controversy over nuclear power, the accidents at Three Mile Island (TMI) and Chernobyl, international competition, concerns about the carbon dioxide greenhouse effect and technical breakthroughs have resulted in a segment of the nuclear industry examining power reactor concepts with PRIME safety characteristics. PRIME is an acronym for Passive safety, Resilience, Inherent safety, Malevolence resistance, and Extended time after initiation of an accident for external help. The basic ideal of PRIME is to develop power reactors in which operator error, internal sabotage, or external assault do not cause a significant release of radioactivity to the environment. Several PRIME reactor concepts are being considered. In each case, an existing, proven power reactor technology is combined with radical innovations in selected plant components and in the safety philosophy. The Process Inherent Ultimate Safety (PIUS) reactor is a modified pressurized-water reactor, the Modular High Temperature Gas-Cooled Reactor (MHTGR) is a modified gas-cooled reactor, and the Advanced CANDU Project is a modified heavy-water reactor. In addition to the reactor concepts, there is parallel work on super containments. The objective is the development of a passive box'' that can contain radioactivity in the event of any type of accident. This report briefly examines: why a segment of the nuclear power community is taking this new direction, how it differs from earlier directions, and what technical options are being considered. A more detailed description of which countries and reactor vendors have undertaken activities follows. 41 refs.

  18. [Comparison of a safety evaluation between paclitaxel injection NK and Taxol®].

    PubMed

    Yamamoto, Daigo; Tsubota, Yu; Sueoka, Noriko; Yokoi, Takashi; Inoue, Kentaro; Ohira, Masumi; Muranaka, Tatsuya

    2013-07-01

    Paclitaxel injection NK(NK)is a generic product containing the same amount of ingredients as a Taxol®Injection. We examined the safety of NK in clinical practice compared to the original drug. Our results suggested that for the cancer patient, most safety profiles between NK and the original drug are similar. However, patients who received Taxol®Injection had significantly more grade 2 neuropathy compared to those who received NK(p<0. 01).

  19. Passive coherent beam combining of four Yb-doped fiber amplifier chains with injection-locked seed source.

    PubMed

    Yang, Yifeng; Hu, Man; He, Bing; Zhou, Jun; Liu, Houkang; Dai, Shoujun; Wei, Yunrong; Lou, Qihong

    2013-03-15

    An injection-locked fiber laser is introduced to the passive fiber laser coherent beam combination with all-optical feedback loop. A coherent beam combining system with two-dimensional four Yb-doped fiber amplifier chains is established, and the injection-locked fiber laser works as a switchable seed source. The 1064 nm output laser of the injection-locked fiber laser is extinguished automatically as the feedback injection power is high enough, and the injection-locked fiber laser acts as an amplifier for the feedback laser with 7.4 dB gains. We find that the phase-locked far-field interference pattern of our system with seed laser extinguished is stable, and the visibility is up to 91.5%, which is slightly higher than the prevalent method with auxiliary seed laser (88.2%).

  20. Design and Transient Analysis of Passive Safety Cooling Systems for Advanced Nuclear Reactors

    NASA Astrophysics Data System (ADS)

    Galvez, Cristhian

    2011-12-01

    The Pebble Bed Advanced High Temperature Reactor (PB-AHTR) is a pebble fueled, liquid salt cooled, high temperature nuclear reactor design that can be used for electricity generation or other applications requiring the availability of heat at elevated temperatures. A stage in the design evolution of this plant requires the analysis of the plant during a variety of potential transients to understand the primary and safety cooling system response. This study focuses on the performance of the passive safety cooling system with a dual purpose, to assess the capacity to maintain the core at safe temperatures and to assist the design process of this system to achieve this objective. The analysis requires the use of complex computational tools for simulation and verification using analytical solutions and comparisons with experimental data. This investigation builds upon previous detailed design work for the PB-AHTR components, including the core, reactivity control mechanisms and the intermediate heat exchanger, developed in 2008. In addition the study of this reference plant design employs a wealth of auxiliary information including thermal-hydraulic physical phenomena correlations for multiple geometries and thermophysical properties for the constituents of the plant. Finally, the set of performance requirements and limitations imposed from physical constrains and safety considerations provide with a criteria and metrics for acceptability of the design. The passive safety cooling system concept is turned into a detailed design as a result from this study. A methodology for the design of air-cooled passive safety systems was developed and a transient analysis of the plant, evaluating a scrammed loss of forced cooling event was performed. Furthermore, a design optimization study of the passive safety system and an approach for the validation and verification of the analysis is presented. This study demonstrates that the resulting point design responds properly to the

  1. Safety of immunization injections in Africa: not simply a problem of logistics.

    PubMed

    Dicko, M; Oni, A Q; Ganivet, S; Kone, S; Pierre, L; Jacquet, B

    2000-01-01

    In 1995, the WHO Regional Office for Africa launched a logistics project to address the four main areas of immunization logistics: the cold chain, transport, vaccine supply and quality, and the safety of injections in the countries of the region. The impact of this logistic approach on immunization injection safety was evaluated through surveys of injection procedures and an analysis of the injection materials (e.g. sterilizable or disposable syringes) chosen by the Expanded Programme on Immunization (EPI) and those actually seen to be used. Re-use of injection materials without sterilization, accidental needle-stick injuries among health care workers, and injection-related abscesses in patients were common in countries in the WHO African Region. Few health centres used time-steam saturation-temperature (TST) indicators to check the quality of sterilization and, in many centres, the injection equipment was boiled instead of being steam sterilized. Facilities for the proper disposal of used materials were rarely present. Although the official EPI choice was to use sterilizable equipment, use of a combination of sterilizable and disposable equipment was observed in the field. Unsafe injection practices in these countries were generally due to a failure to integrate nursing practices and public awareness with injection safety issues, and an absence of the influence of EPI managers on health care service delivery. Holistic rather than logistic approaches should be adopted to achieve safe injections in immunization, in the broader context of promoting safe vaccines and safety of all injections.

  2. Safety of immunization injections in Africa: not simply a problem of logistics.

    PubMed Central

    Dicko, M.; Oni, A. Q.; Ganivet, S.; Kone, S.; Pierre, L.; Jacquet, B.

    2000-01-01

    In 1995, the WHO Regional Office for Africa launched a logistics project to address the four main areas of immunization logistics: the cold chain, transport, vaccine supply and quality, and the safety of injections in the countries of the region. The impact of this logistic approach on immunization injection safety was evaluated through surveys of injection procedures and an analysis of the injection materials (e.g. sterilizable or disposable syringes) chosen by the Expanded Programme on Immunization (EPI) and those actually seen to be used. Re-use of injection materials without sterilization, accidental needle-stick injuries among health care workers, and injection-related abscesses in patients were common in countries in the WHO African Region. Few health centres used time-steam saturation-temperature (TST) indicators to check the quality of sterilization and, in many centres, the injection equipment was boiled instead of being steam sterilized. Facilities for the proper disposal of used materials were rarely present. Although the official EPI choice was to use sterilizable equipment, use of a combination of sterilizable and disposable equipment was observed in the field. Unsafe injection practices in these countries were generally due to a failure to integrate nursing practices and public awareness with injection safety issues, and an absence of the influence of EPI managers on health care service delivery. Holistic rather than logistic approaches should be adopted to achieve safe injections in immunization, in the broader context of promoting safe vaccines and safety of all injections. PMID:10743280

  3. Projecting effects of improvements in passive safety of the New Zealand light vehicle fleet.

    PubMed

    Keall, Michael; Newstead, Stuart; Jones, Wayne

    2007-09-01

    In the year 2000, as part of the process for setting New Zealand road safety targets, a projection was made for a reduction in social cost of 15.5 percent associated with improvements in crashworthiness, which is a measure of the occupant protection of the light passenger vehicle fleet. Since that document was produced, new estimates of crashworthiness have become available, allowing for a more accurate projection. The objective of this paper is to describe a methodology for projecting changes in casualty rates associated with passive safety features and to apply this methodology to produce a new prediction. The shape of the age distribution of the New Zealand light passenger vehicle fleet was projected to 2010. Projected improvements in crashworthiness and associated reductions in social cost were also modeled based on historical trends. These projections of changes in the vehicle fleet age distribution and of improvements in crashworthiness together provided a basis for estimating the future performance of the fleet in terms of secondary safety. A large social cost reduction of about 22 percent for 2010 compared to the year 2000 was predicted due to the expected huge impact of improvements in passive vehicle features on road trauma in New Zealand. Countries experiencing improvements in their vehicle fleets can also expect significant reductions in road injury compared to a less crashworthy passenger fleet. Such road safety gains can be analyzed using some of the methodology described here.

  4. [Comparison of the pharmacokinetics and safety of a paclitaxel injection NK and Taxol injection in breast cancer patients].

    PubMed

    Sagara, Yoshiaki; Rai, Yoshiaki; Sagara, Yoshiatsu; Matsuyama, Yoshito; Baba, Shinichi; Tamada, Shugo; Sagara, Yasuaki; Ando, Mitsutake

    2009-02-01

    A paclitaxel injection NK (NK) is a generic product containing the same amount of ingredient as a Taxol Injection. We examined the pharmacokinetics and safety of NK compared to the original product in breast cancer patients. As a result, the transition of plasma paclitaxel concentration and pharmacokinetic parameter in NK and the original drug were almost equal, which suggested that these products were bioequivalent. In adjuvant therapy, there was no significant difference in adverse events reported, and these products were approximately equally safe.

  5. Integration of Active and Passive Safety Technologies--A Method to Study and Estimate Field Capability.

    PubMed

    Hu, Jingwen; Flannagan, Carol A; Bao, Shan; McCoy, Robert W; Siasoco, Kevin M; Barbat, Saeed

    2015-11-01

    The objective of this study is to develop a method that uses a combination of field data analysis, naturalistic driving data analysis, and computational simulations to explore the potential injury reduction capabilities of integrating passive and active safety systems in frontal impact conditions. For the purposes of this study, the active safety system is actually a driver assist (DA) feature that has the potential to reduce delta-V prior to a crash, in frontal or other crash scenarios. A field data analysis was first conducted to estimate the delta-V distribution change based on an assumption of 20% crash avoidance resulting from a pre-crash braking DA feature. Analysis of changes in driver head location during 470 hard braking events in a naturalistic driving study found that drivers' head positions were mostly in the center position before the braking onset, while the percentage of time drivers leaning forward or backward increased significantly after the braking onset. Parametric studies with a total of 4800 MADYMO simulations showed that both delta-V and occupant pre-crash posture had pronounced effects on occupant injury risks and on the optimal restraint designs. By combining the results for the delta-V and head position distribution changes, a weighted average of injury risk reduction of 17% and 48% was predicted by the 50th percentile Anthropomorphic Test Device (ATD) model and human body model, respectively, with the assumption that the restraint system can adapt to the specific delta-V and pre-crash posture. This study demonstrated the potential for further reducing occupant injury risk in frontal crashes by the integration of a passive safety system with a DA feature. Future analyses considering more vehicle models, various crash conditions, and variations of occupant characteristics, such as age, gender, weight, and height, are necessary to further investigate the potential capability of integrating passive and DA or active safety systems.

  6. [Construction and implementation of quality control index for clinical safety of Chinese medicine injection].

    PubMed

    Jiang, Jun-jie; Xie, Yan-ming

    2015-12-01

    In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.

  7. Probabilistic Analysis of Passive Safety System Reliability in Advanced Small Modular Reactors: Methodologies and Lessons Learned

    SciTech Connect

    Grabaskas, David; Bucknor, Matthew; Brunett, Acacia; Grelle, Austin

    2015-06-28

    Many advanced small modular reactor designs rely on passive systems to fulfill safety functions during accident sequences. These systems depend heavily on boundary conditions to induce a motive force, meaning the system can fail to operate as intended due to deviations in boundary conditions, rather than as the result of physical failures. Furthermore, passive systems may operate in intermediate or degraded modes. These factors make passive system operation difficult to characterize with a traditional probabilistic framework that only recognizes discrete operating modes and does not allow for the explicit consideration of time-dependent boundary conditions. Argonne National Laboratory has been examining various methodologies for assessing passive system reliability within a probabilistic risk assessment for a station blackout event at an advanced small modular reactor. This paper describes the most promising options: mechanistic techniques, which share qualities with conventional probabilistic methods, and simulation-based techniques, which explicitly account for time-dependent processes. The primary intention of this paper is to describe the strengths and weaknesses of each methodology and highlight the lessons learned while applying the two techniques while providing high-level results. This includes the global benefits and deficiencies of the methods and practical problems encountered during the implementation of each technique.

  8. Experimental and design experience with passive safety features of liquid metal reactors

    SciTech Connect

    Lucoff, D.M.; Waltar, A.E.; Sackett, J.I.; Salvatores, M.; Aizawa, K.

    1992-10-01

    Liquid metal cooled reactors (LMRs) have already been demonstrated to be robust machines. Many reactor designers now believe that it is possible to include in this technology sufficient passive safety that LMRs would be able to survive loss of flow, loss of heat sink, and transient overpower events, even if the plant protective system fails completely and do so without damage to the core. Early whole-core testing in Rapsodie, EBR-II. and FFTF indicate such designs may be possible. The operational safety testing program in EBR-II is demonstrating benign response of the reactor to a full range of controls failures. But additional testing is needed if transient core structural response under major accident conditions is to be properly understood. The proposed international Phase IIB passive safety tests in FFTF, being designed with a particular emphasis on providing, data to understand core bowing extremes, and further tests planned in EBR-II with processed IFR fuel should provide a substantial and unique database for validating the computer codes being used to simulate postulated accident conditions.

  9. Enhancing VHTR passive safety and economy with thermal radiation based direct reactor auxiliary cooling system

    SciTech Connect

    Zhao, H.; Zhang, H.; Zou, L.; Sun, X.

    2012-07-01

    One of the most important requirements for Gen. IV Very High Temperature Reactor (VHTR) is passive safety. Currently all the gas cooled version of VHTR designs use Reactor Vessel Auxiliary Cooling System (RVACS) for passive decay heat removal. The RVACS can be characterized as a surface-based decay heat removal system. It is especially suitable for smaller power reactors since small systems have relatively larger surface area to volume ratio. However, RVACS limits the maximum achievable power level for modular VHTRs due to the mismatch between the reactor power (proportional to the core volume) and decay heat removal capability (proportional to the vessel surface area). Besides the safety considerations, VHTRs also need to be economical in order to compete with other reactor concepts and other types of energy sources. The limit of decay heat removal capability set by using RVACS has affected the economy of VHTRs. A potential alternative solution is to use a volume-based passive decay heat removal system, called Direct Reactor Auxiliary Cooling Systems (DRACS), to remove or mitigate the limitation on decay heat removal capability. DRACS composes of natural circulation loops with two sets of heat exchangers, one on the reactor side and another on the environmental side. For the reactor side, cooling pipes will be inserted into holes made in the outer or inner graphite reflector blocks. There will be gaps or annular regions formed between these cooling pipes and their corresponding surrounding graphite surfaces. Graphite has an excellent heat conduction property. By taking advantage of this feature, we can have a volume-based method to remove decay heat. The scalability can be achieved, if needed, by employing more rows of cooling pipes to accommodate higher decay heat rates. Since heat can easily conduct through the graphite regions among the holes made for the cooling pipes, those cooling pipes located further away from the active core region can still be very

  10. Injection safety practices in a main referral hospital in Northeastern Nigeria.

    PubMed

    Gadzama, G B; Bawa, S B; Ajinoma, Z; Saidu, M M; Umar, A S

    2014-01-01

    No adherence of safe injection policies remains a major challenge, and, worldwide, annually, it leads to 21 million new hepatitis B cases and 260,000 HIV infection cases. This descriptive observational survey was conducted to determine the level of adherence to universal precaution for safe injection practices in the hospital. The study units were selected using a simple random sampling of injection services provider/phlebotomist in 27 units/wards of the hospital. The study instruments were observation checklist and interviewer administered questionnaires. EPI info (version 3.5.2) software was used for data entry and generation of descriptive statistics was done with units of analysis (units/wards) on injection safety practices of health workers, availability of logistics and supplies, and disposal methods. Only 33.3% of the units (95% CI, 16-54) had non-sharps infectious healthcare waste of any type inside containers specific for non-sharps infectious waste and 17 (77.3%) of the observed therapeutic injections were prepared on a clean, dedicated table or tray, where contamination of the equipment with blood, body fluids, or dirty swabs was unlikely. Absence of recapping of needles was observed in 11 (50.0%) units giving therapeutic injections. Only 7.4% of units surveyed had separate waste containers for infectious non-sharps. This study depicts poor knowledge and a practice of injection safety, inadequate injection safety supplies, and non-compliance to injection safety policy and guidelines.

  11. Improved methodology for integral analysis of advanced reactors employing passive safety

    NASA Astrophysics Data System (ADS)

    Muftuoglu, A. Kursad

    After four decades of experience with pressurized water reactors, a new generation of nuclear plants are emerging. These advanced designs employ passive safety which relies on natural forces, such as gravity and natural circulation. The new concept of passive safety also necessitates improvement in computational tools available for best-estimate analyses. The system codes originally designed for high pressure conditions in the presence of strong momentum sources such as pumps are challenged in many ways. Increased interaction of the primary system with the containment necessitates a tool for integral analysis. This study addresses some of these concerns. An improved tool for integral analysis coupling primary system with containment calculation is also presented. The code package is based on RELAP5 and CONTAIN programs, best-estimate thermal-hydraulics code for primary system analysis and containment code for containment analysis, respectively. The suitability is demonstrated with a postulated small break loss of coolant accident analysis of Westinghouse AP600 plant. The thesis explains the details of the analysis including the coupling model.

  12. Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

    PubMed

    Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

    2015-01-01

    Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently

  13. Availability of high-pressure safety injection system in PWRs

    SciTech Connect

    Sun, Y.H.; Fresco, A.; Papazoglou, I.A.

    1983-01-01

    This paper presents an evaluation of the impact of typical variations in configuration of the design of the High Pressure Injection (HPSI) System on system unavailability. The HPSI systems in seventeen nuclear power plants were reviewed for variations in design, systems operation, testing and maintenance policies, and possible sources for common cause failures. The power plants reviewed include PWRs with two, three and four loop Reactor Coolant Systems and cover all three PWR vendors. As a result of this effort, the following five representative configurations (along with some variations) were identified and their unavailability to initiate injection was estimated.

  14. Knowledge and Practice on Injection Safety among Primary Health Care Workers in Kaski District, Western Nepal

    PubMed Central

    Gyawali, Sudesh; Rathore, Devendra Singh; Shankar, P Ravi; Kc, Vikash Kumar; Jha, Nisha; Sharma, Damodar

    2016-01-01

    Background Unsafe injection practice can transmit various blood borne infections. The aim of this study was to assess the knowledge and practice of injection safety among injection providers, to obtain information about disposal of injectable devices, and to compare the knowledge and practices of urban and rural injection providers. Methods The study was conducted with injection providers working at primary health care facilities within Kaski district, Nepal. Ninety-six health care workers from 69 primary health care facilities were studied and 132 injection events observed. A semi-structured checklist was used for observing injection practice and a questionnaire for the survey. Respondents were interviewed to complete the questionnaire and obtain possible explanations for certain observed behaviors. Results All injection providers knew of at least one pathogen transmitted through use/re-use of unsterile syringes. Proportion of injection providers naming hepatitis/jaundice as one of the diseases transmitted by unsafe injection practice was significantly higher in urban (75.6%) than in rural (39.2%) area. However, compared to urban respondents (13.3%), a significantly higher proportion of rural respondents (37.3%) named Hepatitis B specifically as one of the diseases transmitted. Median (inter-quartile range) number of therapeutic injection and injectable vaccine administered per day by the injection providers were 2 (1) and 1 (1), respectively. Two handed recapping by injection providers was significantly higher in urban area (33.3%) than in rural areas (21.6%). Most providers were not aware of the post exposure prophylaxis guideline. Conclusion The knowledge of the injection providers about safe injection practice was acceptable. The use of safe injection practice by providers in urban and rural health care facilities was almost similar. The deficiencies noted in the practice must be addressed. PMID:27540325

  15. Knowledge and Practice on Injection Safety among Primary Health Care Workers in Kaski District, Western Nepal.

    PubMed

    Gyawali, Sudesh; Rathore, Devendra Singh; Shankar, P Ravi; Kc, Vikash Kumar; Jha, Nisha; Sharma, Damodar

    2016-01-01

    Unsafe injection practice can transmit various blood borne infections. The aim of this study was to assess the knowledge and practice of injection safety among injection providers, to obtain information about disposal of injectable devices, and to compare the knowledge and practices of urban and rural injection providers. The study was conducted with injection providers working at primary health care facilities within Kaski district, Nepal. Ninety-six health care workers from 69 primary health care facilities were studied and 132 injection events observed. A semi-structured checklist was used for observing injection practice and a questionnaire for the survey. Respondents were interviewed to complete the questionnaire and obtain possible explanations for certain observed behaviors. All injection providers knew of at least one pathogen transmitted through use/re-use of unsterile syringes. Proportion of injection providers naming hepatitis/jaundice as one of the diseases transmitted by unsafe injection practice was significantly higher in urban (75.6%) than in rural (39.2%) area. However, compared to urban respondents (13.3%), a significantly higher proportion of rural respondents (37.3%) named Hepatitis B specifically as one of the diseases transmitted. Median (inter-quartile range) number of therapeutic injection and injectable vaccine administered per day by the injection providers were 2 (1) and 1 (1), respectively. Two handed recapping by injection providers was significantly higher in urban area (33.3%) than in rural areas (21.6%). Most providers were not aware of the post exposure prophylaxis guideline. The knowledge of the injection providers about safe injection practice was acceptable. The use of safe injection practice by providers in urban and rural health care facilities was almost similar. The deficiencies noted in the practice must be addressed.

  16. Nuclear Safety Functions of ITER Gas Injection System Instrumentation and Control and the Concept Design

    NASA Astrophysics Data System (ADS)

    Yang, Yu; Maruyama, S.; Fossen, A.; Villers, F.; Kiss, G.; Zhang, Bo; Li, Bo; Jiang, Tao; Huang, Xiangmei

    2016-08-01

    The ITER Gas Injection System (GIS) plays an important role on fueling, wall conditioning and distribution for plasma operation. Besides that, to support the safety function of ITER, GIS needs to implement three nuclear safety Instrumentation and Control (I&C) functions. In this paper, these three functions are introduced with the emphasis on their latest safety classifications. The nuclear I&C design concept is briefly discussed at the end.

  17. Final report-passive safety optimization in liquid sodium-cooled reactors.

    SciTech Connect

    Cahalana, J. E.; Hahn, D.; Nuclear Engineering Division; Korea Atomic Energy Research Inst.

    2007-08-13

    This report summarizes the results of a three-year collaboration between Argonne National Laboratory (ANL) and the Korea Atomic Energy Research Institute (KAERI) to identify and quantify the performance of innovative design features in metallic-fueled, sodium-cooled fast reactor designs. The objective of the work was to establish the reliability and safety margin enhancements provided by design innovations offering significant potential for construction, maintenance, and operating cost reductions. The project goal was accomplished with a combination of advanced model development (Task 1), analysis of innovative design and safety features (Tasks 2 and 3), and planning of key safety experiments (Task 4). Task 1--Computational Methods for Analysis of Passive Safety Design Features: An advanced three-dimensional subassembly thermal-hydraulic model was developed jointly and implemented in ANL and KAERI computer codes. The objective of the model development effort was to provide a high-accuracy capability to predict fuel, cladding, coolant, and structural temperatures in reactor fuel subassemblies, and thereby reduce the uncertainties associated with lower fidelity models previously used for safety and design analysis. The project included model formulation, implementation, and verification by application to available reactor tests performed at EBR-II. Task 2--Comparative Analysis and Evaluation of Innovative Design Features: Integrated safety assessments of innovative liquid metal reactor designs were performed to quantify the performance of inherent safety features. The objective of the analysis effort was to identify the potential safety margin enhancements possible in a sodium-cooled, metal-fueled reactor design by use of passive safety mechanisms to mitigate low-probability accident consequences. The project included baseline analyses using state-of-the-art computational models and advanced analyses using the new model developed in Task 1. Task 3--Safety

  18. Passive injection: a CO2 sequestration strategy that mitigates the threat of induced seismicity and brine migration

    NASA Astrophysics Data System (ADS)

    Dempsey, D.; Pawar, R.; Kelkar, S.

    2013-12-01

    Large-scale deployment of carbon capture and storage (CCS) faces several challenges including the possibility of shear movement on faults leading to the creation of CO2 leakage pathways and induced seismicity, and the migration of the brine displaced by CO2 into shallow groundwater aquifers, either through leaky wells or faults. Both of these processes are caused by fluid overpressure in the reservoir that a result of large-scale CO2 injection. We detail a novel strategy for CCS, termed passive injection, capable of emplacing megaton quantities of CO2 with no increase, transient or long-term, in reservoir pressure. The strategy leverages negative pressure gradients created by the strategic placement of brine production wells so that CO2 leaves an injection well at ambient reservoir pressure. A multi-stage, square-ring well configuration is considered, in which brine production wells are repurposed for CO2 injection upon CO2 breakthrough, and a new battery of production wells installed at a greater distance. As proof of concept, numerical simulations of passive injection are presented using the coupled thermo-hydro-mechanical (THM), multi-fluid simulator FEHM. We consider CO2 injection into a 3km-deep, confined reservoir over a period of 50 years, with up to four stages of injection and production depending on well-spacing and production pressures. Injection rates as high as 3 Mt yr-1 are achieved, with 70% utilization of the reservoir volume and long-term mass production of brine approximately 1.7 times that of CO2 sequestered (including structural and solubility trapping). The model accounts for the geomechanical effects of reservoir drawdown including surface subsidence. The induced seismic threat is quantified in terms of the change in the Coulomb Failure Stress (ΔCFS) for the conservative scenario of an optimally-oriented fault in an extensional tectonic regime. This quantity is shown to be negative in both the caprock and reservoir, which indicates that the

  19. Enhancing VHTR Passive Safety and Economy with Thermal Radiation Based Direct Reactor Auxiliary Cooling System

    SciTech Connect

    Haihua Zhao; Hongbin Zhang; Ling Zou; Xiaodong Sun

    2012-06-01

    One of the most important requirements for Gen. IV Very High Temperature Reactor (VHTR) is passive safety. Currently all the gas cooled version of VHTR designs use Reactor Vessel Auxiliary Cooling System (RVACS) for passive decay heat removal. The decay heat first is transferred to the core barrel by conduction and radiation, and then to the reactor vessel by thermal radiation and convection; finally the decay heat is transferred to natural circulated air or water systems. RVACS can be characterized as a surface based decay heat removal system. The RVACS is especially suitable for smaller power reactors since small systems have relatively larger surface area to volume ratio. However, RVACS limits the maximum achievable power level for modular VHTRs due to the mismatch between the reactor power (proportional to volume) and decay heat removal capability (proportional to surface area). When the relative decay heat removal capability decreases, the peak fuel temperature increases, even close to the design limit. Annular core designs with inner graphite reflector can mitigate this effect; therefore can further increase the reactor power. Another way to increase the reactor power is to increase power density. However, the reactor power is also limited by the decay heat removal capability. Besides the safety considerations, VHTRs also need to be economical in order to compete with other reactor concepts and other types of energy sources. The limit of decay heat removal capability set by using RVACS has affected the economy of VHTRs. A potential alternative solution is to use a volume-based passive decay heat removal system, called Direct Reactor Auxiliary Cooling Systems (DRACS), to remove or mitigate the limitation on decay heat removal capability. DRACS composes of natural circulation loops with two sets of heat exchangers, one on the reactor side and another on the environment side. For the reactor side, cooling pipes will be inserted into holes made in the outer or

  20. Conceptual Design of Passive Safety System for Lead-Bismuth Cooled Fast Reactor

    NASA Astrophysics Data System (ADS)

    Abdullah, A. G.; Nandiyanto, A. B. D.

    2016-04-01

    This paper presents the results of the conceptual design of passive safety systems for reactor power 225 MWth using Pb-Bi coolant. Main purpose of this research is to design of heat removal system from the reactor wall. The heat from the reactor wall is removed by RVACS system using the natural circulation from the atmosphere around the reactor at steady state. The calculation is performed numerically using Newton-Raphson method. The analysis involves the heat transfer systems in a radiation, conduction and natural convection. Heat transfer calculations is performed on the elements of the reactor vessel, outer wall of guard vessel and the separator plate. The simulation results conclude that the conceptual design is able to remove heat 1.33% to 4.67% from the thermal reactor power. It’s can be hypothesized if the reactor had an accident, the system can still overcome the heat due to decay.

  1. MODULAR AND FULL SIZE SIMPLIFIED BOILING WATER REACTOR DESIGN WITH FULLY PASSIVE SAFETY SYSTEMS

    SciTech Connect

    M. Ishii; S. T. Revankar; T. Downar; Y. Xu, H. J. Yoon; D. Tinkler; U. S. Rohatgi

    2003-06-16

    OAK B204 The overall goal of this three-year research project was to develop a new scientific design of a compact modular 200 MWe and a full size 1200 MWe simplified boiling water reactors (SBWR). Specific objectives of this research were: (1) to perform scientific designs of the core neutronics and core thermal-hydraulics for a small capacity and full size simplified boiling water reactor, (2) to develop a passive safety system design, (3) improve and validate safety analysis code, (4) demonstrate experimentally and analytically all design functions of the safety systems for the design basis accidents (DBA) and (5) to develop the final scientific design of both SBWR systems, 200 MWe (SBWR-200) and 1200 MWe (SBWR-1200). The SBWR combines the advantages of design simplicity and completely passive safety systems. These advantages fit well within the objectives of NERI and the Department of Energy's focus on the development of Generation III and IV nuclear power. The 3-year research program was structured around seven tasks. Task 1 was to perform the preliminary thermal-hydraulic design. Task 2 was to perform the core neutronic design analysis. Task 3 was to perform a detailed scaling study and obtain corresponding PUMA conditions from an integral test. Task 4 was to perform integral tests and code evaluation for the DBA. Task 5 was to perform a safety analysis for the DBA. Task 6 was to perform a BWR stability analysis. Task 7 was to perform a final scientific design of the compact modular SBWR-200 and the full size SBWR-1200. A no cost extension for the third year was requested and the request was granted and all the project tasks were completed by April 2003. The design activities in tasks 1, 2, and 3 were completed as planned. The existing thermal-hydraulic information, core physics, and fuel lattice information was collected on the existing design of the simplified boiling water reactor. The thermal-hydraulic design were developed. Based on a detailed integral

  2. Safety of bilateral same-day intravitreal injections of anti-vascular endothelial growth factor agents

    PubMed Central

    Ruão, Miguel; Andreu-Fenoll, María; Dolz-Marco, Rosa; Gallego-Pinazo, Roberto

    2017-01-01

    Purpose The aim was to evaluate the safety of bilateral same-day injections with intravitreal antiangiogenic drugs for macular diseases. Methods Cross-sectional retrospective review of unilateral and bilateral same-day antiangiogenic injections was conducted between January 2011 and March 2016 in the Unit of Macula, University and Polytechnic Hospital La Fe (Valencia, Spain). A total of 8,172 injections were administered, among which 6,560 were unilateral and 1,612 were bilateral injections. Patients were included in the study regardless of the diagnosis. Ranibizumab and aflibercept were the antiangiogenic drugs used. The presence of endophthalmitis or retinal detachment was evaluated. Results A total of 1 (0.012%) culture-proven endophthalmitis and 19 (0.233%) acute intraocular inflammations were registered. In the unilateral injections group, there were 18 (0.274%) acute intraocular inflammations and 1 (0.015%) culture-proven endophthalmitis. One (0.062%) of the 1,612 bilateral same-day injections had a unilateral acute intraocular inflammation, and there were no culture-proven endophthalmitis in this group. Conclusion Bilateral same-day injections are more convenient for patients and their caregivers than the unilateral injections administered on different days. In our study, the prevalence of culture-proven endophthalmitis and acute intraocular inflammation was lower in the bilateral injections than in the unilateral group. These data support the idea that bilateral same-day injections are a safe and valid treatment to use in our clinical practice. PMID:28203056

  3. Providing the Basis for Innovative Improvements in Advanced LWR Reactor Passive Safety Systems Design: An Educational R&D Project

    SciTech Connect

    Brian G. Williams; Jim C. P. Liou; Hiral Kadakia; Bill Phoenix; Richard R. Schultz

    2007-02-27

    This project characterizes typical two-phase stratified flow conditions in advanced water reactor horizontal pipe sections, following activation of passive cooling systems. It provides (1) a means to educate nuclear engineering students regarding the importance of two-phase stratified flow in passive cooling systems to the safety of advanced reactor systems and (2) describes the experimental apparatus and process to measure key parameters essential to consider when designing passive emergency core cooling flow paths that may encounter this flow regime. Based on data collected, the state of analysis capabilities can be determined regarding stratified flow in advanced reactor systems and the best paths forward can be identified to ensure that the nuclear industry can properly characterize two-phase stratified flow in passive emergency core cooling systems.

  4. Influence of Steering Control Devices Mounted in Cars for the Disabled on Passive Safety

    NASA Astrophysics Data System (ADS)

    Masiá, J.; Eixerés, B.; Dols, J. F.; Colomina, F. J.

    2009-11-01

    The purpose of this research is to analyze the influence of steering control devices for disabled people on passive safety. It is based on the advances made in the modelling and simulation of the driver position and in the suit verification test. The influence of these devices is studied through airbag deployment and/or its influence on driver safety. We characterize the different adaptations that are used in adapted cars that can be found mounted in vehicles in order to generating models that are verified by experimental test. A three dimensional design software package was used to develop the model. The simulations were generated using a dynamic simulation program employing LSDYNA finite elements. This program plots the geometry and assigns materials. The airbag is shaped, meshed and folded just as it is mounted in current vehicles. The thermodynamic model of expansion of gases is assigned and the contact interfaces are defined. Static tests were carried out on deployment of the airbag to contrast with and to validate the computational models and to measure the behaviour of the airbag when there are steering adaptations mounted in the vehicle.

  5. Passive safety device and internal short tested method for energy storage cells and systems

    DOEpatents

    Keyser, Matthew; Darcy, Eric; Long, Dirk; Pesaran, Ahmad

    2015-09-22

    A passive safety device for an energy storage cell for positioning between two electrically conductive layers of the energy storage cell. The safety device also comprising a separator and a non-conductive layer. A first electrically conductive material is provided on the non-conductive layer. A first opening is formed through the separator between the first electrically conductive material and one of the electrically conductive layers of the energy storage device. A second electrically conductive material is provided adjacent the first electrically conductive material on the non-conductive layer, wherein a space is formed on the non-conductive layer between the first and second electrically conductive materials. A second opening is formed through the non-conductive layer between the second electrically conductive material and another of the electrically conductive layers of the energy storage device. The first and second electrically conductive materials combine and exit at least partially through the first and second openings to connect the two electrically conductive layers of the energy storage device at a predetermined temperature.

  6. Advanced Fuel Cycles for Fusion Reactors: Passive Safety and Zero-Waste Options

    NASA Astrophysics Data System (ADS)

    Zucchetti, Massimo; Sugiyama, Linda E.

    2006-05-01

    Nuclear fusion is seen as a much ''cleaner'' energy source than fission. Most of the studies and experiments on nuclear fusion are currently devoted to the Deuterium-Tritium (DT) fuel cycle, since it is the easiest way to reach ignition. The recent stress on safety by the world's community has stimulated the research on other fuel cycles than the DT one, based on 'advanced' reactions, such as the Deuterium-Helium-3 (DHe) one. These reactions pose problems, such as the availability of 3He and the attainment of the higher plasma parameters that are required for burning. However, they have many advantages, like for instance the very low neutron activation, while it is unnecessary to breed and fuel tritium. The extrapolation of Ignitor technologies towards a larger and more powerful experiment using advanced fuel cycles (Candor) has been studied. Results show that Candor does reach the passive safety and zero-waste option. A fusion power reactor based on the DHe cycle could be the ultimate response to the environmental requirements for future nuclear power plants.

  7. Apparatus with annulus safety valve for through tubing injection and method of use

    SciTech Connect

    Bowyer, M. L.

    1984-10-23

    An assembly including a tubing safety valve and annulus safety valve mounted within nipples incorporated within an inner conduit is disclosed for use in conjunction with the injection of material, such as gas, through the center of the inner conduit. The injected material can be used to stimulate production of fluids from the formation through the annulus between the inner conduit and an outer concentric conduit. This outer concentric conduit normally comprises an existing producting tubing string having existing safety valve nipple and external control fluid lines. Nipples incorporated within the inner conduit provide means for sealing the annulus between the inner and the outer conduit and for positioning the inner conduit relative to the outer conduit to provide communication between the tubing safety valve and the annulus safety valve and the external existing source of control fluid pressure. Bypass ports above and below on opposite sides of the annulus seals extend through the nipple members and an axially reciprocal annulus safety valve mandrel is moved from a position closing at least one of the bypass ports to an open position when subjected to control line pressure. Both the tubing safety valve and the annulus safety valve are activated when subjected to a common source of control line pressure.

  8. Safety of Repeated Injections of Sodium Hyaluronate (SUPARTZ) for Knee Osteoarthritis

    PubMed Central

    Bannuru, Raveendhara R.; Brodie, Christopher R.; Sullivan, Matthew C.; McAlindon, Timothy E.

    2016-01-01

    Objective Though there is no consensus on its efficacy, knee osteoarthritis is symptomatically managed with intra-articular hyaluronic acid (IAHA). Recent reports suggest that IAHA may delay the need for total knee replacement, with the magnitude of delay proportional to the number of injection series. However, the safety of repeated injection series is reported to vary between commercial products. This report describes a systematic review of safety data on repeated treatment courses of SUPARTZ. Design We performed a systematic search of MEDLINE, Cochrane database, EMBASE, Web of Science, Google Scholar, and unpublished data. We included all human randomized controlled trials or observational studies with adverse event (AE) data for SUPARTZ in knee osteoarthritis. Two independent reviewers extracted data and evaluated study quality. Data were analyzed separately for the first and subsequent series of injections. Results The primary sources for repeated-injection data on SUPARTZ were a postmarket registry (N = 7404), 4 prospective studies (N = 127 total), and a retrospective study (N = 220). None of the sources reported increased frequency or severity of AEs with repeated injections. In the registry, 95% of multiple-injection-series patients who reported an AE did so during the first series. None of the AEs was serious, and most resolved spontaneously without medical intervention. The overall adverse event rate after repeat courses of SUPARTZ was 0.008 (95% confidence interval: 0.001-0.055). Conclusions Multiple courses of SUPARTZ injections appear to be at least as safe, and probably safer, than the first course. This study supports the safety of repeat courses of SUPARTZ injections for knee osteoarthritis. PMID:27688841

  9. DNA-based small molecules for hole charge injection and channel passivation in organic heptazole field effect transistors

    NASA Astrophysics Data System (ADS)

    Cho, Youngsuk; Lee, Junyeong; Lim, June Yeong; Yu, Sanghyuck; Yi, Yeonjin; Im, Seongil

    2017-02-01

    DNA-based small molecules of guanine, cytosine, thymine and adenine are adopted for the charge injection layer between the Au electrodes and organic semiconductor, heptazole (C26H16N2). The heptazole-channel organic field effect transistors (OFETs) with a DNA-based small molecule charge injection layer showed higher hole mobility (maximum 0.12 cm2 V-1 s-1) than that of a pristine device (0.09 cm2 V-1 s-1). We characterized the contact resistance of each device by a transfer length method (TLM) and found that the guanine layer among all DNA-based materials performs best as a hole injection layer leading to the lowest contact resistance. Since the guanine layer is also known to be a proper channel passivation layer coupled with a thin conformal Al2O3 layer protecting the channel from bias stress and ambient molecules, we could realize ultra-stable OFETs utilizing guanine/Au contact and guanine/Al2O3 bilayer on the organic channel.

  10. Passive fiber alignment to single-mode plastic waveguides fabricated by injection molding

    NASA Astrophysics Data System (ADS)

    Pompe, Guido; Lehmacher, Stefan; Rudolph, Stefan; Kalveram, Stefan; Joenck, Matthias; Neyer, Andreas

    1998-04-01

    Passive fibre-waveguide coupling is a promising alternative to expensive active coupling in single-mode fibre-optics. The idea to utilize replication techniques in transparent polymeric materials for waveguide and alignment structure fabrication has led to the SIGA-process (Silizium, Galvanik und Abformung) which allows a cost effective production of low loss polymer waveguides in the near IR. Major difficulties in passive fibre coupling are caused by the high lateral alignment accuracy (of about 1 micrometer) in fibre positioning. In the SIGA process, the exact position of the V- grooves relative to the waveguide trenches is defined by the etch mask for the silicon master wafer. The width of the V- grooves is determined by the KOH etching time. It is controlled precisely at various stages in the etching process by means of a microscope based piezo driven measurement system with a resolution better than 0.5 micrometer, thus allowing a final vertical precision of fibre positioning of 350 nm. In order to specify the capability of our technology we have measured the position of dozens of fibres glued into V- grooves. The result was that an amount of 55% of the fibre cores was closer than 1.5 micrometer to the waveguide centre. As the experience has shown, a two-step process for the fabrication of passively fibre coupled waveguides is necessary. First, the waveguides are produced by filling the waveguide trenches with an IR-transparent monomer and by polymerizing it using UV curing. The waveguides are inspected with visible and IR light by clamping a fibre ribbon mechanically into the integrated plastic V-grooves. In a second step the fibre ribbon is fixed irreversibly in the V- grooves. By that way we have reached an insertion loss of 3.5 dB at 1300nm and 1550nm for passively coupled 22mm single mode waveguides. Most of the losses are attributed to waveguide imperfections. More details concerning the coupling losses and the device performances will be reported at the

  11. Innovation, diffusion and safety of a medical technology: a review of the literature on injection practices.

    PubMed

    Kotwal, Atul

    2005-03-01

    The rapid uptake of the hypodermic syringe as a medical technology by physicians in Europe and America since its introduction in the middle of the 19th century has led to a level of medical and public acceptance seldom reached by other therapeutic techniques. Presently, the developed world has clear guidelines regarding injection use and safety; in contrast, developing countries are facing the brunt of risks associated with the use of this technology, which was introduced into their societies during the early 20th century. There is now a popular demand for injections, and an alarming number of unnecessary and unsafe injections are being administered. The problem of unsafe injections is not restricted to curative injections, but includes immunizations too. The association of unsafe injections and infection transmission is quite clear, and there is an urgent need to reduce the number of required injections and make them safe. An understanding of the determinants of current injection practices in the socio-cultural-economic context is necessary in order to plan relevant and effective interventions.

  12. [Post-licensure passive safety surveillance of rotavirus vaccines: reporting sensitivity for intussusception].

    PubMed

    Pérez-Vilar, S; Díez-Domingo, J; Gomar-Fayos, J; Pastor-Villalba, E; Sastre-Cantón, M; Puig-Barberà, J

    2014-08-01

    The aims of this study were to describe the reports of suspected adverse events due to rotavirus vaccines, and assess the reporting sensitivity for intussusception. Descriptive study performed using the reports of suspected adverse events following rotavirus vaccination in infants aged less than 10 months, as registered in the Pharmacovigilance Centre of the Valencian Community during 2007-2011. The reporting rate for intussusception was compared to the intussusception rate in vaccinated infants obtained using the hospital discharge database (CMBD), and the regional vaccine registry. The adverse event reporting rate was 20 per 100,000 administered doses, with the majority (74%) of the reports being classified as non-serious. Fever, vomiting, and diarrhea were the adverse events reported more frequently. Two intussusception cases, which occurred within the first seven days post-vaccination, were reported as temporarily associated to vaccination. The reporting sensitivity for intussusception at the Pharmacovigilance Centre in the 1-7 day interval following rotavirus vaccination was 50%. Our results suggest that rotavirus vaccines have, in general, a good safety profile. Intussusception reporting to the Pharmacovigilance Centre shows sensitivity similar to other passive surveillance systems. The intussusception risk should be further investigated using well-designed epidemiological studies, and evaluated in comparison with the well-known benefits provided by these vaccines. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  13. Effects of injection position and transponder size on the performances of passive injectable transponders used for the electronic identification of cattle.

    PubMed

    Conill, C; Caja, G; Nehring, R; Ribó, O

    2000-12-01

    A total of 686 Tiris half-duplex passive injectable transponders (PIT) of two sizes (23 and 32 mm) were randomly injected s.c. in three positions, armpit, ear scutulum, and upper lip, in 343 fattening calves (1 to 3 mo old). Injections were performed by two trained and two untrained operators. Losses and breakages on the farm were recorded at wk 1, 3, 7, 11, and 15 in restrained animals using two types of hand-held transceivers with a stick antenna. Dynamic reading efficiency (DRE) in animals running through a raceway was also evaluated at wk 1 and 3 and monthly until slaughter, using a stationary transceiver working at 137 dB x microV x m(-1) at 3 m. The total number of PIT that fell or broke in the slaughtering line, the location method, and the recovery time were also recorded. Results on the farm showed low breakages on average (0.4%) and differences (P < 0.05) in losses according to position (armpit, 1.7%; ear, 5.2%; and lip, 14.0%). An interaction (P < 0.05) between position x size was observed, and losses were greatest using a 32-mm PIT in the lip. The DRE was affected (P < 0.05) by PIT position and size, and values were greater for the 32-mm PIT in all positions (armpit: 99.9 +/- 0.1 vs 95.8 +/- 4.9%; ear: 93.8 +/- 2.2 vs 81.9 +/- 4.6%; lip: 66.8 +/- 4.9 vs 53.4 +/- 4.7%, respectively, for 32 vs 23 mm). Recovery of PIT in the abattoir was on average 96.7, 96.7, and 99.2% for armpit, ear, and lip, respectively (P > 0.05). Most of the PIT injected in the armpit were recovered by sight or palpation, but 31.9% were recovered after cutting the muscles around the area and 10.7% were recovered on the internal side of the hide, which jeopardized carcass identification. Recovery of PIT injected in the ear was 23.4% in the hide and 76.6% in the auricular muscles of the head. The easiest recovery was in the lip, 8.9% of PIT were located in the hide and 91.1% in the head. Recovery time was affected (P < 0.05) by position: the quickest was lip (27 +/- 2 s), followed by

  14. Identification of the Permeability Field of Porous Medium from the Injection of Passive Tracer

    SciTech Connect

    Zhan, Lang; Yortsos, Y.C.

    1999-10-18

    In this paper, a method was proposed which focused on the question, namely on how to invert data on arrival times at various (and numerous) points in the porous medium to map the permeability field. The method, elements of which were briefly described in (9), is based on a direct inversion of the data, as will be described below , rather than on the optimization of initial random (or partly constrained) guesses of the permeability field, to match the available data, as typically done in the analogous problem of pressure transients. The direct inversion is based on two conditions, that Darcy's law for single-phase flow in porous media is valid, and that dispersion of the concentration of the injected tracer is negligible. While the former is a well-accepted premise, the latter depends on injection and field conditions, and may not necessarily apply in all cases. Based on these conditions, we formulate a nonlinear boundary value problem, the coefficients of which depend on the experimental arrival time data.

  15. New Concept of a Small Passive-Safety Reactor with UO{sub 2}-Graphite-Water Core

    SciTech Connect

    Tetsuo Matsumura; Takanori Kameyama; Yasushi Nauchi; Izumi Kinoshita

    2002-07-01

    New concept of a passive-safety reactor with I/O:-graphite-water core is proposed, which has negligible possibility of core melting and, flexibility of total reactor power. Present concept has simple plant system design without a reactor pressure vessel, ECCS, recirculation systems (of BWR) and others. Therefore construction cost per electric power generation is expected to be slightly low comparing with conventional large scale WRs. (authors)

  16. Safety and pharmacodynamics of suprachoroidal injection of triamcinolone acetonide as a controlled ocular drug release model.

    PubMed

    Chen, Mei; Li, Xiaoli; Liu, Jinkun; Han, Yin; Cheng, Lingyun

    2015-04-10

    Suprachoroidal injection is an emerging technique for drug delivery to the posterior segment, which is hard to reach by non-invasive approaches. However, the injection technique varies and the associated ocular safety is not well understood. In addition, it is not clear if drug formulation is a major factor in optimizing pharmacodynamics using this technique. The current study was designed to compare the suprachoroidal injection of different drug formulations and to characterize the safety and pharmacodynamics of triamcinolone acetonide (TA) delivered by this technique. Both indocyanine green (ICG) solution and TA suspension, at 50μL, 100μL, and 150μL, were suprachoroidally injected and intraocular pressure (IOP) tonometry, fundus photography, and electroretinography were performed over multiple time points up to eight weeks. After 50μL TA (Kenalog-40) suprachoroidal injection, 4-5 animals at 7 time points were sacrificed for aqueous, vitreous, retina, and plasma collections. TA was quantitated using ultra-performance liquid chromatography tandem mass spectrometry. For comparative efficacy study, 50μL (2mg) suprachoroidal TA versus 20mg subtenon TA were performed 4weeks before induction of experimental uveitis with 10ng of intravitreal lipopolysaccharide. After suprachoroidal injection, IOP had an acute elevation, higher volume caused higher IOP (p<0.0001). Equivalent volume of ICG solution led to a significantly smaller IOP elevation than after TA suprachoroidal injection. This finding suggests better distribution of ICG solution than TA suspension in the suprachoroidal space. Following a 50μL suprachoroidal injection, peak TA concentration in the aqueous was below 1ng/mL. In contrast, the posterior vitreous and retina had 1912ng/mL and 400,369ng/mL TA, respectively. Maximum TA in plasma was 11.6ng/mL. Drug exposure to the posterior retina was 523,910 times more than that to the aqueous and 29,516 times more than systemic TA exposure. In the treatment of

  17. Patient-Centered Robot-Aided Passive Neurorehabilitation Exercise Based on Safety-Motion Decision-Making Mechanism.

    PubMed

    Pan, Lizheng; Song, Aiguo; Duan, Suolin; Yu, Zhuqing

    2017-01-01

    Safety is one of the crucial issues for robot-aided neurorehabilitation exercise. When it comes to the passive rehabilitation training for stroke patients, the existing control strategies are usually just based on position control to carry out the training, and the patient is out of the controller. However, to some extent, the patient should be taken as a "cooperator" of the training activity, and the movement speed and range of the training movement should be dynamically regulated according to the internal or external state of the subject, just as what the therapist does in clinical therapy. This research presents a novel motion control strategy for patient-centered robot-aided passive neurorehabilitation exercise from the point of the safety. The safety-motion decision-making mechanism is developed to online observe and assess the physical state of training impaired-limb and motion performances and regulate the training parameters (motion speed and training rage), ensuring the safety of the supplied rehabilitation exercise. Meanwhile, position-based impedance control is employed to realize the trajectory tracking motion with interactive compliance. Functional experiments and clinical experiments are investigated with a healthy adult and four recruited stroke patients, respectively. The two types of experimental results demonstrate that the suggested control strategy not only serves with safety-motion training but also presents rehabilitation efficacy.

  18. Patient-Centered Robot-Aided Passive Neurorehabilitation Exercise Based on Safety-Motion Decision-Making Mechanism

    PubMed Central

    Duan, Suolin; Yu, Zhuqing

    2017-01-01

    Safety is one of the crucial issues for robot-aided neurorehabilitation exercise. When it comes to the passive rehabilitation training for stroke patients, the existing control strategies are usually just based on position control to carry out the training, and the patient is out of the controller. However, to some extent, the patient should be taken as a “cooperator” of the training activity, and the movement speed and range of the training movement should be dynamically regulated according to the internal or external state of the subject, just as what the therapist does in clinical therapy. This research presents a novel motion control strategy for patient-centered robot-aided passive neurorehabilitation exercise from the point of the safety. The safety-motion decision-making mechanism is developed to online observe and assess the physical state of training impaired-limb and motion performances and regulate the training parameters (motion speed and training rage), ensuring the safety of the supplied rehabilitation exercise. Meanwhile, position-based impedance control is employed to realize the trajectory tracking motion with interactive compliance. Functional experiments and clinical experiments are investigated with a healthy adult and four recruited stroke patients, respectively. The two types of experimental results demonstrate that the suggested control strategy not only serves with safety-motion training but also presents rehabilitation efficacy. PMID:28194413

  19. On demand nanoliter-scale microfluidic droplet generation, injection, and mixing using a passive microfluidic device

    PubMed Central

    Tangen, Uwe; Sharma, Abhishek

    2015-01-01

    We here present and characterize a programmable nanoliter scale droplet-on-demand device that can be used separately or readily integrated into low cost single layer rapid prototyping microfluidic systems for a wide range of user applications. The passive microfluidic device allows external (off-the-shelf) electronically controlled pinch valves to program the delivery of nanoliter scale aqueous droplets from up to 9 different inputs to a central outlet channel. The inputs can be either continuous aqueous fluid streams or microliter scale aqueous plugs embedded in a carrier fluid, in which case the number of effective input solutions that can be employed in an experiment is no longer strongly constrained (100 s–1000 s). Both nanoliter droplet sequencing output and nanoliter-scale droplet mixing are reported with this device. Optimization of the geometry and pressure relationships in the device was achieved in several hardware iterations with the support of open source microfluidic simulation software and equivalent circuit models. The requisite modular control of pressure relationships within the device is accomplished using hydrodynamic barriers and matched resistance channels with three different channel heights, custom parallel reversible microfluidic I/O connections, low dead-volume pinch valves, and a simply adjustable array of external screw valves. Programmable sequences of droplet mixes or chains of droplets can be achieved with the device at low Hz frequencies, limited by device elasticity, and could be further enhanced by valve integration. The chip has already found use in the characterization of droplet bunching during export and the synthesis of a DNA library. PMID:25759752

  20. A Single Neonatal Injection of Ethinyl Estradiol Impairs Passive Avoidance Learning and Reduces Expression of Estrogen Receptor α in the Hippocampus and Cortex of Adult Female Rats.

    PubMed

    Shiga, Tatsuomi; Nakamura, Takahiro J; Komine, Chiaki; Goto, Yoshikuni; Mizoguchi, Yasushi; Yoshida, Midori; Kondo, Yasuhiko; Kawaguchi, Maiko

    2016-01-01

    Although perinatal exposure of female rats to estrogenic compounds produces irreversible changes in brain function, it is still unclear how the amount and timing of exposure to those substances affect learning function, or if exposure alters estrogen receptor α (ERα) expression in the hippocampus and cortex. In adult female rats, we investigated the effects of neonatal exposure to a model estrogenic compound, ethinyl estradiol (EE), on passive avoidance learning and ERα expression. Female Wistar-Imamichi rats were subcutaneously injected with oil, 0.02 mg/kg EE, 2 mg/kg EE, or 20 mg/kg 17β-estradiol within 24 h after birth. All females were tested for passive avoidance learning at the age of 6 weeks. Neonatal 0.02 mg/kg EE administration significantly disrupted passive avoidance compared with oil treatment in gonadally intact females. In a second experiment, another set of experimental females, treated as described above, was ovariectomized under pentobarbital anesthesia at 10 weeks of age. At 15-17 weeks of age, half of each group received a subcutaneous injection of 5 μg estradiol benzoate a day before the passive avoidance learning test. Passive avoidance learning behavior was impaired by the 0.02 mg/kg EE dose, but notably only in the estradiol benzoate-injected group. At 17-19 weeks of age, hippocampal and cortical samples were collected from rats with or without the 5 μg estradiol benzoate injection, and western blots used to determine ERα expression. A significant decrease in ERα expression was observed in the hippocampus of the estradiol-injected, neonatal EE-treated females. The results demonstrated that exposure to EE immediately after birth decreased learning ability in adult female rats, and that this may be at least partly mediated by the decreased expression of ERα in the hippocampus.

  1. A Single Neonatal Injection of Ethinyl Estradiol Impairs Passive Avoidance Learning and Reduces Expression of Estrogen Receptor α in the Hippocampus and Cortex of Adult Female Rats

    PubMed Central

    Shiga, Tatsuomi; Nakamura, Takahiro J.; Komine, Chiaki; Goto, Yoshikuni; Mizoguchi, Yasushi; Yoshida, Midori; Kondo, Yasuhiko; Kawaguchi, Maiko

    2016-01-01

    Although perinatal exposure of female rats to estrogenic compounds produces irreversible changes in brain function, it is still unclear how the amount and timing of exposure to those substances affect learning function, or if exposure alters estrogen receptor α (ERα) expression in the hippocampus and cortex. In adult female rats, we investigated the effects of neonatal exposure to a model estrogenic compound, ethinyl estradiol (EE), on passive avoidance learning and ERα expression. Female Wistar-Imamichi rats were subcutaneously injected with oil, 0.02 mg/kg EE, 2 mg/kg EE, or 20 mg/kg 17β-estradiol within 24 h after birth. All females were tested for passive avoidance learning at the age of 6 weeks. Neonatal 0.02 mg/kg EE administration significantly disrupted passive avoidance compared with oil treatment in gonadally intact females. In a second experiment, another set of experimental females, treated as described above, was ovariectomized under pentobarbital anesthesia at 10 weeks of age. At 15–17 weeks of age, half of each group received a subcutaneous injection of 5 μg estradiol benzoate a day before the passive avoidance learning test. Passive avoidance learning behavior was impaired by the 0.02 mg/kg EE dose, but notably only in the estradiol benzoate-injected group. At 17–19 weeks of age, hippocampal and cortical samples were collected from rats with or without the 5 μg estradiol benzoate injection, and western blots used to determine ERα expression. A significant decrease in ERα expression was observed in the hippocampus of the estradiol-injected, neonatal EE-treated females. The results demonstrated that exposure to EE immediately after birth decreased learning ability in adult female rats, and that this may be at least partly mediated by the decreased expression of ERα in the hippocampus. PMID:26741502

  2. Passive range of motion exercise to enhance growth in infants following the Norwood procedure: a safety and feasibility trial.

    PubMed

    Lambert, Linda M; Trachtenberg, Felicia L; Pemberton, Victoria L; Wood, Janine; Andreas, Shelley; Schlosser, Robin; Barnard, Teresa; Daniels, Kaitlyn; Harrington, Ann T; Dagincourt, Nicholas; Miller, Thomas A

    2017-09-01

    The aim of this study was to evaluate the safety and feasibility of a passive range of motion exercise programme for infants with CHD. Study design This non-randomised pilot study enrolled 20 neonates following Stage I palliation for single-ventricle physiology. Trained physical therapists administered standardised 15-20-minute passive range of motion protocol, for up to 21 days or until hospital discharge. Safety assessments included vital signs measured before, during, and after the exercise as well as adverse events recorded through the pre-Stage II follow-up. Feasibility was determined by the percent of days that >75% of the passive range of motion protocol was completed. A total of 20 infants were enrolled (70% males) for the present study. The median age at enrolment was 8 days (with a range from 5 to 23), with a median start of intervention at postoperative day 4 (with a range from 2 to 12). The median hospital length of stay following surgery was 15 days (with a range from 9 to 131), with an average of 13.4 (with a range from 3 to 21) in-hospital days per patient. Completion of >75% of the protocol was achieved on 88% of eligible days. Of 11 adverse events reported in six patients, 10 were expected with one determined to be possibly related to the study intervention. There were no clinically significant changes in vital signs. At pre-Stage II follow-up, weight-for-age z-score (-0.84±1.20) and length-for-age z-score (-0.83±1.31) were higher compared with historical controls from two earlier trials. A passive range of motion exercise programme is safe and feasible in infants with single-ventricle physiology. Larger studies are needed to determine the optimal duration of passive range of motion and its effect on somatic growth.

  3. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis

    PubMed Central

    van Drumpt, Rogier A.M.; van der Weegen, Walter; King, William; Toler, Krista; Macenski, Mitchell M.

    2016-01-01

    Abstract Osteoarthritis (OA) is a common degenerative condition characterized by pain and loss of function. A pathological biochemical environment with excess inflammatory and catabolic proteins is a major contributor to OA. nSTRIDE® Autologous Protein Solution (APS) is a new therapy under development for the treatment of OA. This therapy is formed from a patient's blood and contains high concentrations of anti-inflammatory and anabolic proteins. This study assessed the safety and treatment effects of APS. Eleven subjects with early to moderate OA were injected with APS. Subjects were closely monitored for adverse events (AE) following the injection. Treatment outcome measures were obtained before injection. AE and clinical outcomes were assessed at 1 and 2 weeks postinjection and 1, 3, and 6 months postinjection. There were no serious AE or AE that were reported by the investigator as greater than mild in severity. There were no AE that were related to the device. There were minor AE related to the injection procedure, including injection site discomfort (1/11), injection site joint pain (1/11), and procedural nausea (1/11), which resolved quickly and did not require treatment. Mean Western Ontario and McMaster Universities Arthritis Index (WOMAC) composite scores and pain, stiffness, and function subscale scores all showed significant improvement compared to baseline by 2 weeks postinjection. The data presented here suggest that the treatment is safe and show a complication profile that is mild and consistent with similar treatments. A single injection of APS for treatment of early to moderate knee OA led to symptom improvement over the study course. Based on these results, an adequately powered, well-controlled, randomized multicenter study to establish clinical efficacy is warranted. PMID:27668131

  4. Power Injection Through Ultrasound-Guided Intravenous Lines: Safety and Efficacy Under an Institutional Protocol.

    PubMed

    Witting, Michael D; Moayedi, Siamak; Dunning, Kathy; Babin, Lisa S; Cogan, Brad M

    2017-01-01

    After an index case of contrast-associated compartment syndrome, an urban hospital instituted a protocol limiting high-speed injection to intravenous (IV) lines started proximal to the forearm and testing those lines before contrast injection. In this article, we estimate the safety and efficacy of high-speed injection using this protocol in patients with IV lines inserted under ultrasound guidance. In an ambispective study, we enrolled prospective cohorts of ED patients requiring high-speed radiographic contrast media injection (≥3.5 mL/sec) into two groups: those with IV lines placed under ultrasound guidance and those with IV lines placed using traditional inspection and palpation. We also performed a retrospective review involving those groups. In addition, we reviewed hospital records for all patients with compartment syndrome between January 2010 and December 2011. We calculated 95% confidence intervals using normal approximation or exact calculation. Between November 2013 and August 2014, the ED referred 32 patients to the Department of Radiology for computed tomography angiography involving high-speed contrast injection through ultrasound-guided IV lines. Of these, 25 of 32 (78%) had successful injection (7 failed in the Department of Radiology) vs. 26 of 27 (96%) with catheters inserted using traditional methods (risk difference 0.18 [95% confidence interval -0.01 to 0.38]). Based on retrospective records, we estimated 79 additional cases. We found no cases of compartment syndrome during either period, for an incidence estimate of 0 per 100 cases (95% confidence interval 0-3). A hospital policy for high-speed contrast injection through ultrasound-guided IV lines has a safe record. However, 22% of patients with ultrasound-guided IV lines were refused for CT. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Efficacy and safety of puerarin injection in curing acute ischemic stroke

    PubMed Central

    Zheng, Qing-Hua; Li, Xiao-Li; Mei, Zhi-Gang; Xiong, Li; Mei, Qing-Xian; Wang, Jin-Feng; Tan, Ling-Jing; Yang, Song-Bai; Feng, Zhi-Tao

    2017-01-01

    Abstract Background: Previous studies indicated that the puerarin injection has been widely employed in China for the treatment of acute ischemic stroke. We aim to evaluate the efficacy and safety of the puerarin injection for the treatment of acute ischemic stroke. Methods: A systematic literature search was performed in PUBMED, EMBASE, SPRINGER LINK, Scopus, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Journals Database, Wanfang database and the China Biological Medicine database before November 2016, randomized controlled clinical trials (RCTs) of puerarin injection treating acute ischemic stroke were included. In addition, we searched reference lists of relevant retrieved articles. Two authors extracted data independently. The effective rate, the neurologic deficit score, the blood rheology indexes, and fibrinogen were assessed and analyzed by the Review Manager 5.3 software. The continuous variables were expressed as MD with 95% CI and dichotomous data used RR or ORs. Adverse reactions related to the puerarin injection were also examined. Results: Thirty-five RCTs with a total of 3224 participants were identified in the meta-analysis. The combined results of 32 trials indicated that the puerarin injection was better than control drugs at the clinical effective rate (RR 1.22, 95% CI 1.17 to 1.28, P < 0.001) and 16 studies showed the neurological deficit was significantly improved (MD –3.69, 95% CI –4.67 to –2.71, P < 0.001); the hemorheology index and fibrinogen were much lower with the puerarin injection when compared with western conventional medicines (WCM) or other control drugs (the whole blood viscosity: MD –0.89, 95% CI –1.37 to –0.41, P < 0.001; the HCT: MD –0.04, 95% CI –0.06 to –0.02, P < 0.001; the fibrinogen: MD –0.64, 95% CI –0.96 to –0.31, P < 0.001). Eleven trials reported that the adverse reactions related to the puerarin injection included facial flushing, dizziness, vomiting

  6. Long-term efficacy and safety of botulinum toxin injections in dystonia.

    PubMed

    Ramirez-Castaneda, Juan; Jankovic, Joseph

    2013-02-04

    Local chemodenervation with botulinum toxin (BoNT) injections to relax abnormally contracting muscles has been shown to be an effective and well-tolerated treatment in a variety of movement disorders and other neurological and non-neurological disorders. Despite almost 30 years of therapeutic use, there are only few studies of patients treated with BoNT injections over long period of time. These published data clearly support the conclusion that BoNT not only provides safe and effective symptomatic relief of dystonia but also long-term benefit and possibly even favorably modifying the natural history of this disease. The adverse events associated with chronic, periodic exposure to BoNT injections are generally minor and self-limiting. With the chronic use of BoNT and an expanding list of therapeutic indications, there is a need to carefully examine the existing data on the long-term efficacy and safety of BoNT. In this review we will highlight some of the aspects of long-term effects of BoNT, including efficacy, safety, and immunogenicity.

  7. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    PubMed

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  8. [Efficacy and safety of Danhong injection for idiopathic pulmonary fibrosis:Meta-analysis].

    PubMed

    Xin, Li-Li; Jiang, Miao; Zhang, Geng; Gong, Jie-Ning

    2016-10-01

    To systematically review the efficacy and safety of Danhong injection for patients with idiopathic pulmonary fibrosis(IPF), two researchers electronically searched PubMed, EMbase, Web of Science, Cochrane Library, CNKI, CBM, WanFang Data and VIP databases from the date of establishment to May 2016 for all randomized controlled trials(RCTs) and quasi-RCTs on the use of Danhong injection in patients with IPF. Manual search in relevant journals and search of relevant literature on other websites were also performed. The data extraction and quality assessment of included RCTs and quasi-RCT were conducted by two reviewers independently. Then, Meta-analysis was conducted by using RevMan 5.3 software. A total of 12 RCTs involving 844 patients were included, 423 cases in experiment group and 421 cases in control group. The results of meta-analysis indicated that the Danhong injection group was superior than the control group in clinical effectiveness(RR=1.36, 95%CI 1.25 to 1.49, P<0.000 01), increased DLCO value(MD=4.25, 95%CI 3.32 to 5.18, P<0.000 01), and increased PaO2 value(MD=14.51, 95%CI 12.35 to 16.68, P<0.000 01). The analysis results showed that Danhong injection could significantly reduce the level of TGF-β1 in serum. There were no serious or frequently happened adverse effects in the Danhong injection group, indicating high safety and good tolerance of Danhong injection in treatment of IPF. The current evidences suggested that Danhong injection in short term use(<12 weeks) could increase clinical effectiveness, improve DLCO and PaO2, and decrease the level of TGF-β1 in serum of IPF patients, with less adverse effects. However, these results should be carefully interpreted due to the low methodology quality and small sample size of trials, and this conclusion had to be further verified by high quality, large scale and double blinded RCTs. Copyright© by the Chinese Pharmaceutical Association.

  9. Efficacy and safety of percutaneous treatment of iatrogenic femoral artery pseudoaneurysm by biodegradable collagen injection.

    PubMed

    Hamraoui, Karim; Ernst, Sjef M P G; van Dessel, Pascal F H M; Kelder, Johannes C; ten Berg, Jurriën M; Suttorp, Maarten Jan; Jaarsma, Wybren; Plokker, Thijs H W

    2002-04-17

    OBJECTIVES; The goal of this study was to assess the safety and efficacy of femoral artery pseudoaneurysm (FAP) closure by collagen injection. BACKGROUND; The FAP is an infrequent but troublesome complication after percutaneous transfemoral catheter procedures. If ultrasound-guided compression repair (UGCR) fails, vascular surgery is indicated. We have developed a less invasive method to close FAPs percutaneously by injecting collagen and, thus, inducing clotting within the aneurysm. Via a 9F needle or 11F sheath, a biodegradable adhesive bovine collagen is injected percutaneously into the FAP, guided by angiography from the contralateral site. From 1993 to 2000, compression and UGCR had failed to obliterate 110 FAPs. These patients have been treated by collagen injection. Mean age of the patients was 65.6 +/- 10.2 years (range: 32 to 85 years), and 50% were women. Immediate closure of the FAP was achieved in 107/110 patients (97.3%) without any complication or adverse effect. In one patient the collagen could not be applied due to unfavorable anatomy. One patient needed a second session of collagen injection. In one patient too much collagen was inserted, which resulted in external compression of the artery, and surgical intervention was required. The overall success rate was 108/110 (98%, 95% confidence interval: 93.5% to 99.8%). Among the patients with successful procedures, there were no recurrences during six months follow-up. The percutaneous treatment of iatrogenic FAP, by injection with collagen, is an effective and safe strategy. This method provides an excellent therapeutic alternative to the traditional surgical management.

  10. Epidemiology of needlesticks and other sharps injuries and injection safety practices in the Dominican Republic.

    PubMed

    Moro, Pedro L; Moore, Arelis; Balcacer, Patricia; Montero, Alex; Diaz, Delissa; Gómez, Virgen; Garib, Zacarias; Weniger, Bruce G

    2007-10-01

    Contaminated sharps, such as needles, lancets, scalpels, broken glass, specimen tubes, and other instruments, can transmit bloodborne pathogens such as HIV, hepatitis B (HBV), and hepatitis C viruses (HCV). Observation of facilities and injections and questionnaire-guided interviews were conducted in 2005 among health care workers (HCWs) in 2 public hospitals in Santo Domingo and 136 public immunization clinics (IC) in the Dominican Republic. Injection practices and sharps injuries (SIs) in health care facilities in the Dominican Republic were assessed in cross-sectional surveys to identify areas in which preventive efforts might be directed to make injection practices safer. Of the 304 hospital HCWs and 136 ICs HCWs interviewed, 98 (22.3%) reported > or =1 SIs during the previous 12 months. ICs had a lower incidence (13 per 100 per person-years [p-y]) of SIs than hospitals (65 per 100 p-y) (P < .0001). Unsafe needle recapping was observed in 98% of all injections observed at hospitals but in only 12% of injections at ICs (P < .0001). Sharps were observed improperly disposed in regular waste containers in 24 (92%) of 26 areas at which injections are prepared at the hospitals but in only 11 (8%) of 136 ICs (P < .0001). Training in injection safety was received by 4% of HCWs in hospitals but by 77% in ICs (P < .001). Of 425 HCWs, 247 (58%) were fully immunized against hepatitis B. There was a higher risk of SIs among staff dentists (adjusted relative risks [aRR], 5.9; 95% confidence interval [CI]: 2.8-12.6), resident physicians (aRR, 3.5; 95% CI: 1.8-6.9), and those who gave > or =11 therapeutic injections per day (aRR, 1.6; 95% CI: 1.1-2.4). Injection practices at ICs were safer than those found at public hospitals. Preventive strategies to lower SIs in public hospitals should include regular training of hospital staff to minimize needle recapping and improper disposal, among other interventions to reduce the dangers of needles.

  11. Safety of intramyocardial injection of autologous bone marrow cells to treat myocardial ischemia in pigs.

    PubMed

    Goodchild, Traci; Pang, Wenxin; Tondato, Fernando; Cui, Jianhua; Otsuka, Yoritaka; Frowein, Steve; Ungs, Mark; Robinson, Keith; Poznansky, Mark; Chronos, Nicolas

    2006-01-01

    The purpose of this study is to determine the potential adverse consequences of intracardiac injections of bone marrow mononuclear cells (BMCs) to facilitate the revascularization of ischemic myocardium. Bone marrow mononuclear cells are used to treat heart failure, though there are few studies that evaluated the safety of BMC transplantation for chronic myocardial ischemia. The pigs received coronary ameroid constrictors to induce chronic myocardial ischemia and left ventricular dysfunction. At 4 weeks, autologous BMCs were injected intramyocardially by Boston Scientific Stiletto catheter with low-dose (10(7) cells) or high-dose BMC (10(8)). Control animals received saline. Blood samples were collected for hematological and chemical indices, including cardiac enzyme levels at regular time intervals postinfarction. At 7 weeks, animals underwent electrophysiological study to evaluate the arrhythmic potential of transplanted BMC, followed by necropsy and histopathology. No mortalities were associated with intramyocardial delivery of BMC or saline. At Day 0, the total creatine phosphokinase (CPK) was in the normal range in all groups. All groups had significant elevations in CPK after ameroid placement, with no significant differences between groups. At 7 weeks, CPK in all groups had returned to pretreatment levels. Electrophysiological assessment revealed that one control animal had an inducible arrhythmia. No arrhythmias were induced in low- or high-dose BMC-treated pigs. There were no histopathological changes associated with BMC injection. This study showed, in a clinically relevant large-animal model, that catheter-based intramyocardial injection of autologous BMC into ischemic myocardium is safe.

  12. Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers

    PubMed Central

    Berteau, Cecile; Schwarzenbach, Florence; Donazzolo, Yves; Latreille, Mathilde; Berube, Julie; Abry, Herve; Cotten, Joël; Feger, Celine; Laurent, Philippe E

    2010-01-01

    Objective: A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe. Methods: This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects’ preferred system for a final study injection or future treatment. Results: A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment. Conclusion: This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference. PMID:21049090

  13. Safety and Acceptability of Community-Based Distribution of Injectable Contraceptives: A Pilot Project in Mozambique

    PubMed Central

    Jacinto, Ana; Mobaracaly, Mahomed Riaz; Ustáb, Momade Bay; Bique, Cassimo; Blazer, Cassandra; Weidert, Karen; Prata, Ndola

    2016-01-01

    ABSTRACT Mozambique has witnessed a climbing total fertility rate in the last 20 years. Nearly one-third of married women have an unmet need for family planning, but the supply of family planning services is not meeting the demand. This study aimed to explore the safety and effectiveness of training 2 cadres of community health workers—traditional birth attendants (TBAs) and agentes polivalentes elementares (APEs) (polyvalent elementary health workers)—to administer the injectable contraceptive depot-medroxyprogesterone acetate (DMPA), and to provide evidence to policy makers on the feasibility of expanding community-based distribution of DMPA in areas where TBAs and APEs are present. A total of 1,432 women enrolled in the study between February 2014 and April 2015. The majority (63% to 66%) of women in the study started using contraception for the first time during the study period, and most women (over 66%) did not report side effects at the 3-month and 6-month follow-up visits. Very few (less than 0.5%) experienced morbidities at the injection site on the arm. Satisfaction with the performance of TBAs and APEs was high and improved over the study period. Overall, the project showed a high continuation rate (81.1%) after 3 injections, with TBA clients having significantly higher continuation rates than APE clients after 3 months and after 6 months. Clients’ reported willingness to pay for DMPA (64%) highlights the latent demand for modern contraceptives. Given Mozambique’s largely rural population and critical health care workforce shortage, community-based provision of family planning in general and of injectable contraceptives in particular, which has been shown to be safe, effective, and acceptable, is of crucial importance. This study demonstrates that community-based distribution of injectable contraceptives can provide access to family planning to a large group of women that previously had little or no access. PMID:27651076

  14. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia.

    PubMed

    Hough, David; Lindenmayer, Jean-Pierre; Gopal, Srihari; Melkote, Rama; Lim, Pilar; Herben, Virginie; Yuen, Eric; Eerdekens, Marielle

    2009-08-31

    Paliperidone palmitate is an investigational, injectable atypical antipsychotic. The safety and tolerability of initiating treatment with paliperidone palmitate via deltoid versus gluteal injections given once monthly, and of switching injection sites, in adults with stable schizophrenia were assessed. In this crossover trial, stable outpatients (N=252) were randomly assigned 1:1:1 to 3 dose groups (paliperidone palmitate 50, 75, or 100 mg eq.) and 2 treatment sequences (blinded to dose): deltoid muscle (period 1 [13 weeks]) followed by gluteal muscle (period 2 [12 weeks]) or the reverse. The intent-to-treat analysis set had 249 patients: mean age=43 (SD: 12.8) years; 57% men, 81% white, baseline mean Positive and Negative Syndrome Scale (PANSS) total score=56 (SD: 11.5). A total of 170 (68%) patients completed the study, with a similar proportion completing each treatment sequence. The incidence of systemic treatment-emergent adverse events (TEAEs) was similar between the 2 injection sites across doses during period 1 (deltoid [D]: 61% to 67%; gluteus [G]: 58% to 65%), and during the last 8 weeks of the 2 study periods (DG: 32% to 45% [period 1], 29% to 42% [period 2]; GD: 31% to 40% [period 1], 30% to 41% [period 2]). During the first treatment week, median plasma paliperidone concentrations were higher with treatment initiation in the deltoid muscle compared with the gluteal muscle. At apparent steady state, there was little difference in plasma paliperidone concentrations between the deltoid and gluteus sites for a given dose. Local tolerability was slightly better with gluteal injections. Patient preference for injection sites differed between geographical regions, e.g. patients from the US preferred deltoid to gluteal sites. The most common (>or=5% overall) TEAEs were: (period 1) insomnia, anxiety, headache, and agitation; and (period 2) insomnia, psychotic disorder, weight increased, and tachycardia. Paliperidone palmitate treatment was tolerated

  15. Intra-articular sodium hyaluronate injections in the osteoarthritic ankle joint: effects, safety and dose dependency.

    PubMed

    Witteveen, Angelique G H; Sierevelt, Inger N; Blankevoort, Leendert; Kerkhoffs, Gino M M J; van Dijk, C Niek

    2010-12-01

    To determine the efficacy, safety and dose dependency of intra-articular Orthovisc(®) hyaluronic acid injections in the ankle. A prospective single blinded study in patients with symptomatic ankle-osteoarthritis. Patients were randomly allocated to 1, 2, 3 ml, or 3 weekly injections of 1 ml (3 × 1 ml). Primary outcome was 'pain during walking' at 15 weeks measured on a 100mm VAS. Twenty-six patients (ITT) participated. The 3 × 1 ml dose group showed statistically significant decreases at week 7 for 'pain during walking' and 'pain at rest' (p=0.046). At week 15 decreases were significant for 'pain at rest' (p=0.046). There was no significant decrease of VAS-scores in any of the single dose groups. Seven patients experienced temporary local swelling and increased pain in the injected ankle. Orthovisc(®) viscosupplementation in the ankle joint is effective and well tolerated. The 3 × 1 ml dose regimen shows the best results. Copyright © 2009 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

  16. [Efficacy and safety of 3% mepivacaine hydrochloride injection for oral local anesthesia].

    PubMed

    Ding, Sheng; Zhu, Ya-Qin; Wu, Ying-Na; Cao, Dong

    2008-06-01

    To assess the efficacy and safety of 3% mepivacaine hydrochloride injection for oral local anesthesia. 68 non-hypertension patients and 36 hypertension patients were randomly divided into 2 groups for local anesthesia. 2% lidocaine with adrenaline in same cartridge was as control group and 3% mepivacaine was as the experimental group. The onset time,duration and pain-free time of 2 anaesthetics were examined. The blood pressure and heart rate change, neural reaction and side effect of 2 groups were observed. SAS software package was used for statistical analysis. In the mepivacaine group, the average onset time was 111s, the duration time was 212s and pain-free time was 134 min ,which was similar to those of 2% lidocaine. Immediately after injection, 5 minutes and 10 minutes after injection of anesthesia, and post-operation, there were no significant changes in the systolic blood pressures between 2% lidocaine group and 3% mepivacaine group (P>0.05), but there were significant changes in diastolic blood pressures and heart rate (P<0.05). 3% mepivacaine has quick onset, ideal anesthetic effect and little side effect on cardiovascular system.

  17. Pegvisomant bioavailability of single 30 mg/mL subcutaneous injection compared to two 15 mg/mL subcutaneous injections: a pharmacokinetic, safety and tolerability study.

    PubMed

    Jen, Juif; LaBadie, Robert R; Liang, Yali; Crownover, Penelope H; Gao, Xiang; Hey-Hadavi, Juliana H

    2013-08-01

    The study was conducted to evaluate the pharmacokinetics (PK), relative bioavailability (relBA), safety and tolerability of two single-dose pegvisomant subcutaneous (SC) administrations: one injection of 30 mg/mL (1 × 30 mg/mL) versus two injections of two 15 mg/mL (2 × 15 mg/mL). This was a 2-period, single-dose, crossover study in 14 healthy male and female subjects. All subjects received both administrations during the two treatment periods separated by a two-week washout. Serum samples were collected intensively up to 360 h post injection and were assayed by a validated enzyme linked immunosorbent assay (ELISA) for pegvisomant. PK parameters including AUC and Cmax were derived by noncompartmental analyses. Mixed effects model was used to obtain bioavailability estimates. Safety and tolerability were assessed by clinical monitoring, including adverse events, laboratory assessments and injection site reactions. All subjects completed the study. The relBA of 1 × 30 mg/mL relative to 2 × 15 mg/mL was 123.89% with a 90% CI (112.91-135.93%). Adjusted for the difference in actual pegvisomant amounts in both formulations the dose-adjusted relBA reduced to 112.97% with a 90% CI (103.09-123.80%). Single injection with a higher drug concentration in injection solution might have a role in this 13% higher bioavailability for 1 × 30 mg/mL administration. Other PK parameters for the two administrations were comparable. No laboratory abnormalities, vital signs, ECG, or injection site reactions of clinical concern were observed in either treatment. Comparable BA, safety and tolerability of the new 30 mg/mL strength to the currently marketed 15 mg/mL strength were established in this study. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. [Pharmacokinetics and safety of aripiprazole long-acting injection, following multiple deltoid administrations in schizophrenia patients in Japan].

    PubMed

    Ishigooka, Jun; Noda, Takamasa; Nishiyama, Kosuke; Tamaru, Noriko; Shima, Tomoko; Yamasaki, Yumiko; Tadori, Yoshihiro

    2016-06-01

    Aripiprazole once-monthly (AOM) was previously approved for treatment of schizophrenia as monthly injections in the gluteal muscle. The deltoid muscle provides a more accessible injection site. The present study was conducted in Japanese schizophrenia patients as a 24-week, open-label trial that assessed the pharmacokinetics and safety of 5 sequential doses of AOM 400 mg (AOM 400) once every 4 weeks administered in the deltoid muscle. Patients treated with an oral atypical antipsychotic (other than aripiprazole) continued to receive their pre-study medication up to 14 days after the first AOM 400 injection. The completion rate was 76.5% (n = 13/17). Mean aripiprazole plasma C(min) almost reached steady-state by the fourth AOM 400 injection. After the fifth AOM 400 injection, mean aripiprazole AUC(28d), C(max) and C(min) were 165 μg x h/ml, 331 ng/ml and 201 ng/ml, respectively, which were similar to previously published pharmacokinetic parameters after the fifth gluteal injection of AOM 400. The most common treatment-emergent adverse event (TEAE) was injection site pain (35.3%). Most TEAEs were classified as mild in intensity. In conclusion, the deltoid injection of AOM can be considered an alternative route of administration, as deltoid and gluteal injections are interchangeable in terms of aripiprazole plasma concentrations, with no additional safety issues.

  19. Efficacy and Safety of an Injectable Combination Hormonal Contraceptive for Men.

    PubMed

    Behre, Hermann M; Zitzmann, Michael; Anderson, Richard A; Handelsman, David J; Lestari, Silvia W; McLachlan, Robert I; Meriggiola, M Cristina; Misro, Man Mohan; Noe, Gabriela; Wu, Frederick C W; Festin, Mario Philip R; Habib, Ndema A; Vogelsong, Kirsten M; Callahan, Marianne M; Linton, Kim A; Colvard, Doug S

    2016-12-01

    The development of a safe and effective reversible method of male contraception is still an unmet need. Evaluation of suppression of spermatogenesis and contraceptive protection by coadministered im injections of progestogen and testosterone. Prospective multicentre study. Ten study centers. Healthy men, aged 18-45 years, and their 18- to 38-year-old female partners, both without known fertility problems. Intramuscular injections of 200-mg norethisterone enanthate combined with 1000-mg testosterone undecanoate, administered every 8 weeks. Suppression of spermatogenesis by ejaculate analysis, contraceptive protection by pregnancy rate. Of the 320 participants, 95.9 of 100 continuing users (95% confidence interval [CI], 92.8-97.9) suppressed to a sperm concentration less than or equal to 1 million/mL within 24 weeks (Kaplan-Meier method). During the efficacy phase of up to 56 weeks, 4 pregnancies occurred among the partners of the 266 male participants, with the rate of 1.57 per 100 continuing users (95% CI, 0.59-4.14). The cumulative reversibility of suppression of spermatogenesis after 52 weeks of recovery was 94.8 per 100 continuing users (95% CI, 91.5-97.1). The most common adverse events were acne, injection site pain, increased libido, and mood disorders. Following the recommendation of an external safety review committee the recruitment and hormone injections were terminated early. The study regimen led to near-complete and reversible suppression of spermatogenesis. The contraceptive efficacy was relatively good compared with other reversible methods available for men. The frequencies of mild to moderate mood disorders were relatively high.

  20. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren contracture: report of 40 cases.

    PubMed

    Alberton, F; Corain, M; Garofano, A; Pangallo, L; Valore, A; Zanella, V; Adani, R

    2014-12-01

    Dupuytren's disease (DD) is a fibroproliferative pathology that affects the palmar aponeurosis causing the development of nodules and collagen cords and the progressive flexion of the fingers. The standard procedure is surgical fasciectomy, followed by high recurrence rates. Collagenase Clostridium histolyticum (CCH) injection represents an innovative noninvasive approach to the treatment of DD. This prospective study was designed to examine the efficacy and safety of CCH injection performed in the outpatient, using local anesthesia. Forty patients [32 metacarpophalangeal (MP), 8 proximal interphalangeal (PIP)] with Dupuytren's contracture of at least 20° for MP joint and any degree for PIP joint were included. The mean age was 66. All joints were treated with a single vial of collagenase injection and manual breaking of the cord 24 h after. All adverse effects (AEs) were monitored. Patients were checked 7, 30, 90, and 180 days after the injection. Primary endpoint was a reduction in digit contracture within 0°-5° of normal extension. Secondary endpoints were the improvement of range of motion, the evaluation of AEs incidence, and cost-effectiveness of collagenase treatment. About 67.5 % of patients obtained a clinical success. At 6 months, a further 7.5% attained the same result. The mean contracture of treated joints was 5.3º for MP and 6.8° for PIP joints. Twenty-three patients had one or more mild-to-moderate side effects. The use of collagenase appears to be an effective and safe method for the treatment of Dupuytren's contracture. Therapeutic success was achieved in a significant percentage of patients. The incidence of side effects was higher, but they were local reactions of short duration. The use of a single collagenase vial in patients treated in day surgery appears more cost-effective than surgery.

  1. Treatment of Passive Component Reliability in Risk-Informed Safety Margin Characterization FY 2010 Report

    SciTech Connect

    Robert W Youngblood

    2010-09-01

    The Risk-Informed Safety Margin Characterization (RISMC) pathway is a set of activities defined under the U.S. Department of Energy (DOE) Light Water Reactor Sustainability Program. The overarching objective of RISMC is to support plant life-extension decision-making by providing a state-of-knowledge characterization of safety margins in key systems, structures, and components (SSCs). A technical challenge at the core of this effort is to establish the conceptual and technical feasibility of analyzing safety margin in a risk-informed way, which, unlike conventionally defined deterministic margin analysis, is founded on probabilistic characterizations of SSC performance.

  2. Safety of intra-articular hip injection of hyaluronic acid products by ultrasound guidance: an open study from ANTIAGE register.

    PubMed

    Migliore, A; Tormenta, S; Laganà, B; Piscitelli, P; Granata, M; Bizzi, E; Massafra, U; Giovannangeli, F; Maggi, C; De Chiara, R; Iannessi, F; Sanfilippo, A; Camminiti, M; Pagano, M G; Bagnato, G; Iolascon, G

    2013-07-01

    We developed a standardized technique for ultrasound guided intra-articular injection of the hip joint with the purpose of extending routine intra-articular injection of hyaluronans and steroids to the hip, as commonly used in the knee. In this article we report the safety of this technique in an extended series of patients. Patients were injected supine with an anterosuperior approach under ultrasound guidance. The Us probe is applied with a target device for biopsy. The standardised technique was used to inject 1906 patients with 4002 injections of hyaluronan products over a four-year period. The treatment was well tolerated with few, and exclusively local, side effects. The administration of hyaluronans under ultrasound-guided intra-articular injection is a safe technique for treatment of rheumatic diseases of the hip.

  3. Safety and efficacy of bi-annual intra-articular LBSA0103 injections in patients with knee osteoarthritis.

    PubMed

    Lee, Jin Kyu; Choi, Chong-Hyuk; Oh, Kwang-Jun; Kyung, Hee-Soo; Yoo, Ju-Hyung; Ha, Chul-Won; Bin, Seong-Il; Kang, Seung-Baik; Kim, Myung Ku; Lee, Ju-Hong; Lee, Myung Chul

    2017-08-22

    The objective of this study is to assess the safety and efficacy of repeated intra-articular injection of high molecular weight hyaluronic acid (LBSA0103) at a 26-week interval, in patients with osteoarthritis of the knee. The study was an open-label, single arm, multicentre prospective trial conducted in patients with symptomatic knee osteoarthritis. The intervention consisted of two intra-articular injections of LBSA0103, with the second injection performed 26 weeks after the first injection. The primary outcome was the incidence of adverse drug reactions related to each injection. Assessment of efficacy of repeated injections in terms of maintenance of pain relief was a secondary objective of this study. Of the 185 patients screened, 174 patients received the first injection and 153 patients received both injections of LBSA0103. Nine adverse drug reactions occurred in seven patients (4.02%) after the first injection, while only one adverse drug reaction occurred (0.65%) after the second injection. As a secondary outcome measure, the improvements in the efficacy parameters including total WOMAC score and weight-bearing pain were all significant at both week 13 and 39 compared to the baseline value (P < 0.001), and improvements after the second injection were consistent with those after the initial injection of LBSA0103 (between week 26 and week 39, P < 0.001). Repeated intra-articular injection of LBSA0103 at a 26-week interval is safe without increased risk of adverse drug reactions. Additionally, LBSA0103 is effective in reduction of osteoarthritis knee pain and in maintenance of pain reduction for a 39-week period when a second injection is administered.

  4. Safety, sterility and stability of direct-from-vial multiple dosing intravitreal injection of bevacizumab.

    PubMed

    Das, Taraprasad; Volety, Srinivas; Ahsan, Saad M; Thakur, Abhay K; Sharma, Savitri; Padhi, Tapas R; Basu, Soumyava; Rao, Ch Mohan

    2015-07-01

    This study aims to determine the stability, sterility and safety of bevacizumab multiple dosing from a single vial without prior aliquoting. In-vitro and human study. Six bevacizumab vials, used in multiple patients on a single day by direct withdrawal from the vial, and stored in 4°C up to a variable period, were tested for stability (high-performance liquid chromatography; [HPLC]), sterility (culture), conformational stability by circular dichroism and fluorescence spectroscopy and the rubber cork structural integrity (electron microscopy [EM]). HPLC of all six samples of used bevacizumab and the control bevacizumab sample were similar; culture was negative; and the EM of rubber corks did not show an open communication. Spectroscopic studies indicated drug conformational stability. Further, there was no infection or inflammation in 221 consecutive patients (973 injections) when bevacizumab was stored at 4°C and used for one week. Bevacizumab does not lose stability when stored at 4°C. It may be used for a week by direct withdrawal from the vial without fear of infection or inflammation if all standard precautions related to intravitreal injection are adhered to. © 2014 Royal Australian and New Zealand College of Ophthalmologists.

  5. The Safety of CT-Guided Epidural Steroid Injections in an Older Patient Cohort.

    PubMed

    Fenster, Andrew J; Fernandes, Kevin; Brook, Alan L; Miller, Todd

    2016-01-01

    Epidural steroid injections (ESIs) are a common method for treating lower back pain, which is one of the most prevalent health-related complaints in the adult US population. Although the safety of CT-guided ESIs has been extensively studied in adults, there is limited data concerning the procedure's safety profile in an older patient population. This retrospective study analyzed safety data among a single-center cohort of patients > 65 years-old who received one or more CT-guided interlaminar ESIs from 2012 to 2015. An Institutional Review Board (IRB)-approved retrospective chart review. University hospital center. A total of 688 CT-guided ESI procedures were evaluated and a linear regression analysis was conducted to examine the relationship between dose length product (DLP), body mass index (BMI), procedure duration, and kVp/mA settings. Further analysis was performed on a sample of long procedure time, average-DLP and high-DLP procedures. Average age was 75.77 years, with 44% having a BMI > 30. The mean DLP was 55.58 mGy x cm and the mean procedure duration was 5.94 minutes. All procedures were technically successful and no complications were observed during or after any of the procedures, including at one-month follow-up office visits. The kVp and mA settings were the strongest predictors of DLP, followed by procedure time. The high-DLP cases had a greater number of needle placement series, more intervertebral disc spaces included in each planning series and higher machine settings (kVp 120; mA 87.5) than the average-DLP cases (kVp 100; mA 49.9). This study is limited by its retrospective design. CT-guided interlaminar ESIs can be performed safely, with low procedure times, relatively low DLP's and without complications in an older patient population. Key words: Epidural steroid injection, interlaminar approach, CT-guidance, older adults, back pain, lumbar spine, thoracic spine, cervical spine, dose length product, radiation exposure.

  6. Mitigation of steam generator tube rupture in a pressurized water reactor with passive safety systems

    DOEpatents

    McDermott, Daniel J.; Schrader, Kenneth J.; Schulz, Terry L.

    1994-01-01

    The effects of steam generator tube ruptures in a pressurized water reactor are mitigated by reducing the pressure in the primary loop by diverting reactor coolant through the heat exchanger of a passive heat removal system immersed in the in containment refueling water storage tank in response to a high feed water level in the steam generator. Reactor coolant inventory is maintained by also in response to high steam generator level introducing coolant into the primary loop from core make-up tanks at the pressure in the reactor coolant system pressurizer. The high steam generator level is also used to isolate the start-up feed water system and the chemical and volume control system to prevent flooding into the steam header. 2 figures.

  7. Mitigation of steam generator tube rupture in a pressurized water reactor with passive safety systems

    DOEpatents

    McDermott, D.J.; Schrader, K.J.; Schulz, T.L.

    1994-05-03

    The effects of steam generator tube ruptures in a pressurized water reactor are mitigated by reducing the pressure in the primary loop by diverting reactor coolant through the heat exchanger of a passive heat removal system immersed in the in containment refueling water storage tank in response to a high feed water level in the steam generator. Reactor coolant inventory is maintained by also in response to high steam generator level introducing coolant into the primary loop from core make-up tanks at the pressure in the reactor coolant system pressurizer. The high steam generator level is also used to isolate the start-up feed water system and the chemical and volume control system to prevent flooding into the steam header. 2 figures.

  8. [Skin test: guide of post-marketed re-evaluation of clinical safety in traditional Chinese medicine injection].

    PubMed

    Wei, Xu; Xie, Yanming; Wang, Yongyan

    2011-10-01

    Anaphylaxis is the most common adverse reaction caused by traditional Chinese medicine (TCM) injection, the most serious of which is type I, so post-marketed safety re-evaluation is necessary. Skin test can be used to screen type I allergy reaction, which is of great significance for TCM injection safe use. Skin test is not only able to find the population sensitization situation of TCM injection, but also is a way of understanding the mechanism of allergy reaction. TCM injection varieties that often occur type I anaphylaxis are applicable to skin test, and study population include healthy volunteers and patients whose disease is listed in the drug specification, intracutaneous test and prick test are the alternative method. The concentration of skin-test solution may influence the positive rate of skin test, penicillin skin-test solution preparation method can be used as the reference in TCM injection. Different doses of TCM injection skin-test solution,glucose injection and normal saline, histamine hydrochloride are comprised in comparison. Given the characteristics of type I allergy reaction,we should be pay close attention to skin test reaction in half an hour, and observation index need be designed based on post-marketed re-evaluation of clinical safety.

  9. Intravitreal Injection of Bone Marrow Mesenchymal Stem Cells in Patients with Advanced Retinitis Pigmentosa; a Safety Study

    PubMed Central

    Satarian, Leila; Nourinia, Ramin; Safi, Sare; Kanavi, Mozhgan Rezaei; Jarughi, Neda; Daftarian, Narsis; Arab, Leila; Aghdami, Nasser; Ahmadieh, Hamid; Baharvand, Hossein

    2017-01-01

    Purpose: To examine the safety of a single intravitreal injection of autologous bone Marrow Mesenchymal stem cells (MSCs) in patients with advanced retinitis pigmentosa (RP). Methods: A prospective, phase I, nonrandomized, open-label study was conducted on 3 eyes of 3 volunteers with advanced RP. Visual acuity, slit-lamp examination, fundus examination, optical coherence tomography, fundus auto-fluorescence, fluorescein angiography and multifocal electroretinography were performed before and after an intravitreal injection of approximately one-million MSCs. The patients were followed for one year. Further evaluation of MSCs was performed by injection of these cells into the mouse vitreous cavity. Results: No, adverse events were observed in eyes of 2 out of 3 patients after transplantation of MSCs. These patients reported improvements in perception of the light after two weeks, which lasted for 3 months. However, severe fibrous tissue proliferation was observed in the vitreous cavity and retrolental space of the third patient's eye, which led to tractional retinal detachment (TRD), iris neovascularization and formation of mature cataract. Injection of this patient's MSCs into the vitreous cavity of mice also resulted in fibrosis; however, intravitreal injections of the two other patients' cells into the mouse vitreous did not generate any fibrous tissue. Conclusion: Intravitreal injection of autologous bone marrow MSCs into patients' eyes with advanced RP does not meet safety standards. Major side effects of this therapy can include fibrosis and TRD. We propose thorough evaluation of MSCs prior to transplantation by intravitreal injection in the laboratory animals.\\ PMID:28299008

  10. Intravitreal Injection of Bone Marrow Mesenchymal Stem Cells in Patients with Advanced Retinitis Pigmentosa; a Safety Study.

    PubMed

    Satarian, Leila; Nourinia, Ramin; Safi, Sare; Kanavi, Mozhgan Rezaei; Jarughi, Neda; Daftarian, Narsis; Arab, Leila; Aghdami, Nasser; Ahmadieh, Hamid; Baharvand, Hossein

    2017-01-01

    To examine the safety of a single intravitreal injection of autologous bone Marrow Mesenchymal stem cells (MSCs) in patients with advanced retinitis pigmentosa (RP). A prospective, phase I, nonrandomized, open-label study was conducted on 3 eyes of 3 volunteers with advanced RP. Visual acuity, slit-lamp examination, fundus examination, optical coherence tomography, fundus auto-fluorescence, fluorescein angiography and multifocal electroretinography were performed before and after an intravitreal injection of approximately one-million MSCs. The patients were followed for one year. Further evaluation of MSCs was performed by injection of these cells into the mouse vitreous cavity. No, adverse events were observed in eyes of 2 out of 3 patients after transplantation of MSCs. These patients reported improvements in perception of the light after two weeks, which lasted for 3 months. However, severe fibrous tissue proliferation was observed in the vitreous cavity and retrolental space of the third patient's eye, which led to tractional retinal detachment (TRD), iris neovascularization and formation of mature cataract. Injection of this patient's MSCs into the vitreous cavity of mice also resulted in fibrosis; however, intravitreal injections of the two other patients' cells into the mouse vitreous did not generate any fibrous tissue. Intravitreal injection of autologous bone marrow MSCs into patients' eyes with advanced RP does not meet safety standards. Major side effects of this therapy can include fibrosis and TRD. We propose thorough evaluation of MSCs prior to transplantation by intravitreal injection in the laboratory animals.\\.

  11. Safety of intracameral injection of gatifloxacin, levofloxacin on corneal endothelial structure and viability.

    PubMed

    Choi, Jin A; Chung, Sung Kun

    2009-10-01

    To investigate the safety of intracameral injection of gatifloxacin, levofloxacin in a rabbit model as prophylaxis against endophthalmitis. Twenty-four eyes of New Zealand white rabbits were randomly divided into 3 treatment groups: levofloxacin, gatifloxacin, and balanced salt solution (BSS) control groups. After 100 microL of each was injected into the anterior chamber, endothelial toxicity was evaluated by measuring the central corneal thicknesses and the clinical toxicity scores using a slit-lamp at post-procedure days 3 and 7. The percent of dead cells was determined by vital staining with alizarin red and trypan blue at 7 days after injection. Finally, in each group, scanning electron microscopy (SEM) and transmission electron microscopy (TEM) were performed for the evaluation of structural integrity. The toxicity scores were increased at post-procedure days 3 and 7, but the difference among the groups was not statistically significant (P = 0.661, 0.216, respectively). With regard to baseline corneal thickness, only the levofloxacin group exhibited a significant increase from baseline (P = 0.028), whereas the other treatment groups showed no difference from baseline (P = 0.128 in gatifloxacin, 0.161 in BSS group). The mean corneal endothelial damage was 0.81 +/- 0.31% in the levofloxacin group, 0.56 +/- 0.47% in the gatifloxacin group, and 0.53 +/- 0.52% in the BSS group, with no statistically significant difference noted among the groups (P = 0.582). SEM revealed a well-preserved hexagonal endothelial cell mosaic and normal microvilli on the endothelial cell surface in the gatifloxacin and control groups. However, the levofloxacin group showed slightly disintegrated cellular borders. TEM revealed that each group maintained normal intracellular organization, whereas the levofloxacin group exhibited slightly flat cell configuration with irregular folds on the apical cell surface. Intracameral injection of gatifloxacin and levofloxacin was nontoxic in terms of

  12. Efficacy and safety of concurrent collagenase clostridium histolyticum injections for multiple Dupuytren contractures.

    PubMed

    Coleman, Stephen; Gilpin, David; Kaplan, F Thomas D; Houston, Anthony; Kaufman, Gregory J; Cohen, Brian M; Jones, Nigel; Tursi, James P

    2014-01-01

    To assess the safety and efficacy of 2 concurrent injections of collagenase clostridium histolyticum (CCH) in the same hand to treat multiple Dupuytren flexion contractures. In a multicenter, open-label phase IIIb study, 60 patients received two 0.58-mg CCH doses injected into cords affecting 2 joints in the same hand during 1 visit, followed by finger extension approximately 24 hours later. Efficacy at postinjection day 30 (change in flexion contracture and active range of motion, patient satisfaction, physician-rated improvement, and rates of clinical success [flexion contracture 5° or less]) and adverse events were summarized. The concurrent injections were most commonly administered in cords affecting metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints on the same finger (47%) or 2 MCP joints on different fingers of the same hand (37%). Mean total (sum of the 2 treated joints) flexion contracture decreased 76%, from 87° to 24° (MCP joints: 86%; PIP joints: 66%). Mean total range of motion increased from 100° to 161°. Clinical success was 76% for MCP joints and 33% for PIP joints. Most patients were very satisfied (60%) or quite satisfied (28%) with treatment. Most investigators rated treated joints as very much improved (55%) or much improved (37%). The most common treatment-related adverse events (> 75% of patients) were contusion, pain in extremity, and edema peripheral (local edema). Most adverse events were mild to moderate in severity. Serious complications included 1 pulley rupture related to study medication and 1 flexor tendon rupture (following conclusion of the study). There were no systemic complications. Results suggest that 2 affected joints can be effectively and safely treated with concurrent CCH injections. There was an increased incidence of some adverse events with concurrent treatment (pruritus, lymphadenopathy, blood blister, and skin laceration) compared with treatment of a single joint. High degrees of patient

  13. An assessment of the ocular safety of inactive excipients following sub-tenon injection in rabbits.

    PubMed

    Younis, Husam S; Shawer, Mohannad; Palacio, Kimberly; Gukasyan, Hovhannes J; Stevens, Greg J; Evering, Winston

    2008-04-01

    This work characterized the safety and toleration of inactive excipients following sub-Tenon (ST) administration. Rabbits were anesthetized and eyes received an ST injection of the following test excipients: carboxy methylcellulose (CMC; low [90 kDa], mid [250 kDa], and high [700 kDa] molecular weight [MW], 0.25%-1.0% w/v), polysorbate 80 (0.02 and 0.2% w/v), polyethylene glycol 3350 (PEG; 0.2 and 1.0% w/v), poloxamer 188 (0.01 and 0.25% w/v), poloxamer 182 (2% w/v), benzyl alcohol (BA; 4% w/v), benzalkonium chloride (BAC; 0.02%, 0.04%, and 0.05% w/v), and methylcellulose (MC; 0.25% w/v). After a 1-week observation period for clinical signs of ocular tolerability, the animals were euthanized and eyes were collected for histologic examination. The ocular tolerability of the tested excipients were ranked as follows from the innocuous to most deleterious: saline approximately PEG (1% w/v) approximately polysorbate 80 (0.2% w/v) > CMC (0.25% w/v, 90 kDa) > MC (0.25% w/v) approximately poloxomer 188 (0.25% w/v) approximately sodium citrate (pH 9) BAC (0.05% w/v) > CMC (0.5% w/v, 700 kDa) > poloxomer 182 (2% w/v) > BA (4% w/v). Clinical signs of ocular irritation were limited to redness and chemosis observed with most test excipients. The BA excipient also produced corneal opacity. Microscopic findings included histiocytic infiltration (BAC, BA, CMC, MC, and poloxamer 188), heterophilic inflammation (BA, CMC, and poloxamer 182), and edema (BAC, BA, CMC, and poloxamer 182) in episcleral tissue. The severity of the clinical and hisopathologic effects increased with the concentration of the test excipients administered. This research has evaluated the safety profile of inactive excipients that may be used to formulate new chemical entities for the treatment of ocular disease following a ST injection.

  14. Efficacy and safety of penile girth enhancement by autologous fat injection for patients with thin penises.

    PubMed

    Kang, Dong Hyuk; Chung, Jae Hoon; Kim, Yong Jin; Lee, Haeng Nam; Cho, Seung Hoon; Chang, Taek Hee; Lee, Seung Wook

    2012-08-01

    This study aimed to investigate the efficacy and safety of autologous fat injection (AFI) for penile girth enhancement (PGE) in patients with thin penises. This study investigated 52 patients with a small penile circumference who underwent AFI for PGE and were followed up for more than 6 months. The patients whose proximal one third (G1) and distal one third of their penis (G2) had a mean thickness of 7.4 cm or less were selected as subjects. After fat suction using a liposuction device, fat was evenly injected into the superficial, middle, and deep layers of the Colles' fascia. Patient age and operative time were analyzed. The G1, G2, flaccid (L1), stretched length (L2), and five-item version of the International Index of Erectile Function-5 (IIEF-5) before and 6 months after the surgery were compared. Postoperative complications were surveyed. The patient mean age was 42.15 years (range, 22-56) years, and the operative time was 44.44 min (range, 37-49 min). The injected fat volume was 38.54 ml (range, 25-49 ml). Preoperatively, G1 was 7.01±0.39 cm, and G2 was 7.06±0.37 cm. Postoperatively, G1 was 9.29±0.82 cm (P<0.001), and G2 was 9.34±0.86 (P<0.001) cm 6 months after the surgery. The difference between L1 and L2 before and after the surgery was not significant. The IIEF-5 was 19.10±3.22 before the surgery and 19.90±3.05 after the surgery (P=0.001). The only complication was nodular fat observed in one case (1.92%). The use of AFI for PGE in men with thin penises was effective and safe without major complications. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

  15. Expanding pedestrian injury risk to the body region level: how to model passive safety systems in pedestrian injury risk functions.

    PubMed

    Niebuhr, Tobias; Junge, Mirko; Achmus, Stefanie

    2015-01-01

    decomposable into the 3 body regions and so are the risk functions as body region-specific risk functions. The risk functions for each body region are stated explicitly for different injury severity levels and compared to the real-world accident data. The body region-specific risk functions can then be used to model the effect of improved passive safety systems. These modified body region-specific injury risk functions are aggregated to a new pedestrian injury risk function. Passive safety systems can therefore be modeled in injury risk functions for the first time. A short example on how the results can be used for assessing the effectiveness of new driver assistance systems concludes the article.

  16. Safety and immunogenicity of CPG 7909 injection as an adjuvant to Fluarix influenza vaccine.

    PubMed

    Cooper, C L; Davis, H L; Morris, M L; Efler, S M; Krieg, A M; Li, Y; Laframboise, C; Al Adhami, M J; Khaliq, Y; Seguin, I; Cameron, D W

    2004-08-13

    CPG 7909, a 24-mer B-Class CpG oligodeoxynucleotide (ODN), was tested for safety, tolerability and its ability to augment the immunogenicity of a commercial trivalent killed split influenza vaccine (Fluarix containing A/Beijing/262/95, A/Sydney/5/97 and B/Harbin/7/94; SmithKline Beecham) in a phase Ib blinded, randomized, controlled clinical trial. Sixty healthy volunteers were recruited in two consecutive cohorts of 30 subjects, who were randomly assigned to receive Fluarix plus 1mg CPG 7909 or Fluarix plus saline control (15 subjects each). Vaccines were administered by intramuscular injection on a single occasion with subjects in the first cohort receiving a 1/10th dose of Fluarix and those in the second cohort receiving the full-dose. All safety measures including physical evaluation, laboratory blood assays, and assays for DNA autoimmunity were within normal values except for transient and clinically inconsequential decreases in total white blood cell counts in groups receiving CPG 7909. All vaccines were found to be generally well tolerated with similar frequency and intensity for most adverse reactions for groups receiving CPG 7909 as controls. Exceptions were injection site pain and headache, which were reduced in frequency in subjects receiving the 1/10th Fluarix dose without CpG, compared to the frequency in all other groups. There was a lack of pre-existing immunity, defined as hemagglutinin inhibition (HI) activity < or =20, for all subjects to the influenza strains A/Beijing/262/95 and B/Harbin/7/94 and for some subjects to A/Sydney/5/97. Post-vaccination humoral immune responses, as determined 2 and 4 weeks later by assay of HI activity and ELISA to detect antibodies against hemagglutinin (anti-HA) were similar for both full and reduced Fluarix doses but the cellular immune responses (measured as PBMC antigen-specific IFN-gamma secretion) were reduced in the 1/10th Fluarix dose group. Humoral responses were not significantly enhanced by the addition

  17. The impact of adverse reactions to injectable filler substances on quality of life: results from the Berlin Injectable Filler Safety (IFS) - study.

    PubMed

    Düker, D; Erdmann, R; Hartmann, V; Nast, A; Rzany, B; Bachmann, F

    2016-06-01

    Injectable filler substances are commonly used in aesthetic medicine. Adverse reactions are rare, but may cause severe impact on quality of life (QoL). To the best of our knowledge, data on the impact of adverse reactions caused by injectable filler substances on QoL is missing. To evaluate the impact of adverse filler reactions on the QoL. The Injectable Filler Safety (IFS) - study is a partially population-based registry for adverse reactions due to injectable filler substances. In 2008, the Dermatology Life Quality Index (DLQI) questionnaire was added to the questionnaires of the IFS study. For this analysis, only patients with a completed DLQI were included in the analysis. One hundred and four patients of the IFS study were analysed. A total of 88.5% were female with an average age of 49.2 years. Here, 50.0% were treated with biodegradable and 40.4% with permanent fillers. The most common adverse reactions were nodule formation and hardening. Most patients experienced mild to moderate adverse reactions. Impact on QoL was moderate with an average of 8.9 (±8.4 SD) in patients with adverse reactions to biodegradable and 10.5 (±9.4 SD) to permanent products. However, 24.0% and 13.4% showed a large or a very large impact on QoL. Adverse reactions to injectable filler products can have a considerable impact on the QoL, comparable to severe chronic inflammatory skin diseases such as psoriasis. © 2016 European Academy of Dermatology and Venereology.

  18. Peyronie's Disease and Injectable Collagenase Clostridium histolyticum: Safety, Efficacy, and Improvements in Subjective Symptoms.

    PubMed

    Yang, Kevin K; Bennett, Nelson

    2016-08-01

    To report on an early adopter series of collagenase Clostridium histolyticum (CCh) for Peyronie's disease (PD). Postapproval studies of CCh have been anticipated after recent Food and Drug Administration authorization of its use for men with PD as definitive and durable nonsurgical interventions have been long desired. From May 2014 to October 2015, a database consisting of PD patients with >30° of penile curvature received CCh from a single provider at a single institution. Objective penile curvature measurements and deformity directions were assessed pre- and posttreatment. Using the validated Peyronie's Disease Questionnaire (PDQ), changes in subjective symptoms of intercourse ability, penile pain, and bother were also noted. We followed 49 unique PD patients treated with CCh. Mean follow-up was 183 days with a median of 6 injections over 3 cycles performed per patient. The mean pretreatment penile curvature was 49.3 degrees. Curvature was reduced by 15.4 degrees (32.4%, P < .01) after therapy. There were 10 out of 22 patients who regained ability to perform vaginal intercourse. Subjectively, there was an improvement in the ability to perform intercourse (29.1% improvement, P < .01) and bother symptoms (mean decrease 43.2%, P < .01), but no significant changes in penile pain (P = .89). Five notable bleeding events (10.2%) were noted, including 1 penile fracture requiring operative exploration. CCh use for PD yielded improvements in penile curvature, subjective intercourse, and bother symptoms. Further postanalysis studies of greater follow-up are needed to assess long-term durability, efficacy, and safety. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. The safety of intracytoplasmic sperm injection in men with hepatitis B

    PubMed Central

    Zheng, Zhong; Hong, Yan; Xu, Bing; Tong, Jing; Xia, Lan

    2016-01-01

    Introduction In this study, we aimed to evaluate the safety of using different sources of sperm when male partners were infected with hepatitis B virus (HBV). Material and methods A total of 338 couples receiving their first intracytoplasmic sperm injection (ICSI) cycle at the Department of Reproduction, Ren Ji Hospital, between 2007 and 2012 were enrolled if the female partner tested negative for HBV DNA, HBsAg, HBeAg, HBeAb and HBcAb. Couples were divided into HBV active infection (group B), convalescent infection (group C) and controls (group A). Subgroups were divided by source of sperm: ejaculated sperm and testicular sperm aspiration/percutaneous epididymal sperm aspiration (TESA/PESA) sperm. Results When using ejaculated sperm for ICSI, two pronuclear (2PN) fertilization rate, implantation rate, clinical pregnant rate, early miscarriage rate and live birth rate showed no significant difference between the three groups. However, in the three TESA/PESA groups, the early miscarriage rate was highest in men with active HBV infection (B2) (23.1%, p = 0.035). The 2PN fertilization rate and CPR were also lower in the active infection group (76.7%, 26.3%) than the convalescent infection (82.9%, 36.2%) and control group (78.2%, 50%), but the difference was not statistically significant. No malformed infant was found in any of these groups. Conclusions When men have an active HBV infection, using TESA/PESA sperm may cause lower fertilization, a high miscarriage rate and a lower live birth rate, which indicates that HBV active infection may cause adverse effects on ICSI reproductive performance when using testicular or epididymal aspirated sperm. PMID:27279852

  20. Efficiency and safety of subconjunctival injection of anti-VEGF agent – bevacizumab – in treating dry eye

    PubMed Central

    Jiang, Xiaodan; Lv, Huibin; Qiu, Weiqiang; Liu, Ziyuan; Li, Xuemin; Wang, Wei

    2015-01-01

    Purpose Dry eye is a chronic inflammatory ocular surface disease with high prevalence. The current therapies for dry eye remain to be unspecific and notcomprehensive. This study aims to explore safety and efficacy of a novel treatment – subconjunctival injection of bevacizumab – in dry eye patients. Methods Sixty-four eyes of 32 dry eye patients received subconjunctival injection of 100 μL 25 mg/mL bevacizumab. Dry eye symptoms, signs (corrected visual acuity, intraocular pressure, conjunctival vascularity, corneal staining, tear break-up time, Marx line score, and blood pressure), and conjunctival impression cytology were evaluated 3 days before and 1 week, 1 month, and 3 months after injection. Results Significant improvements were observed in dry eye symptoms, tear break-up time, and conjunctival vascularization area at all the visits after injection compared to the baseline (P<0.05). The density of the goblet cell increased significantly at 1 month and 3 months after injection (P<0.05). There was no visual and systemic threat observed in any patient. Conclusion Subconjunctival injection of 100 μL 25 mg/mL bevacizumab is a safe and efficient treatment for ocular surface inflammation of dry eye disease. PMID:26109847

  1. Safety of Intracameral Injection of Minimal Bactericidal Concentration of Povidone Iodine on the Corneal Endothelium in a Rabbit Model.

    PubMed

    ElKitkat, Rania S; Ebeid, Weam M; Habib, Eman K; Shoukry, Youssef

    2016-01-01

    To investigate the safety of intracameral injection of minimum bactericidal concentration (MBC) of povidone iodine (PI) on the corneal endothelium in a rabbit model as a proposed method of prophylaxis against postoperative endophthalmitis. We included 32 New Zealand white rabbits in the study. Twenty-four rabbits received intracameral injections of 0.1 mL of 0.25% PI, and they were sequentially killed at intervals; first, seventh, and 14th day. The control group included 4 rabbits that received intracameral injections of 0.1 mL normal saline, and 4 rabbits that underwent the same intraocular procedure without injections (sham operated). Slit-lamp examination and ultrasonic corneal pachymetry were performed before and after injections for both eyes. The corneas were histopathologically examined by light and electron microscopy. MBC of PI (0.25%) was toxic to rabbits' corneal endothelium as evident by histopathological changes, corneal edema, and increased corneal thickness on day 1. Signs of healing were obvious on day 7 and were almost complete on day 14, as detected by histopathology, subsidence of corneal edema, and normalization of corneal thickness. MBC (0.25%) of PI was found toxic to the rabbits' corneal endothelium, with progressive regeneration and complete healing within 2 weeks. To our knowledge, we are the first to use MBC of PI in intracameral injection trials. Further studies on primates, which have more comparable regenerative capacity to humans' corneal endothelium, are encouraged to evaluate their endothelial healing response.

  2. Impact of Active Control on Passive Safety Response Characteristics of Sodium-Cooled Fast Reactors: II-Model Implementation and Simulations

    DOE PAGES

    Ponciroli, Roberto; Passerini, Stefano; Vilim, Richard B.

    2017-06-21

    Advanced reactors are often claimed to be passively safe against unprotected upset events. In common practice, these events are not considered in the context of the plant control system, i.e., the reactor is subjected to classes of unprotected upset events while the normally programmed response of the control system is assumed not to be present. However, this approach constitutes an oversimplification since, depending on the upset involving the control system, an actuator does not necessarily go in the same direction as needed for safety. In this work, dynamic simulations are performed to assess the degree to which the inherent self-regulatingmore » plant response is safe from active control system override. The simulations are meant to characterize the resilience of the plant to unprotected initiators. The initiators were represented and modeled as an actuator going to a hard limit. Consideration of failure is further limited to individual controllers as there is no cross-connect of signals between these controllers. The potential for passive safety override by the control system is then relegated to the single-input single-output controllers. Here, the results show that when the plant control system is designed by taking into account and quantifying the impact of the plant control system on accidental scenarios there is very limited opportunity for the preprogrammed response of the control system to override passive safety protection in the event of an unprotected initiator.« less

  3. [Literature review on premarketing and postmarketing evidence of xiyanping injection].

    PubMed

    Wang, Zhi-Fei; Chen, Xiao; Zhang, Wen; Xie, Yan-Ming

    2014-09-01

    This article systematically summarizes the non-clinical safety studies, pharmacological studies and postmarketing safety studies of Xiyanping injection based on literature. These studies include acute toxicity test, long-term toxicity test, reproductive toxicity test, active and passive anaphylaxis test, curative mechanism study, clinical trials of effectiveness, active surveillance, security analysis of passive monitoring data, the real world analysis of hospital information system (HIS) data, literature analysis, etcetera This article also analysis the relationship of the different evidence, summarizes the strategy of the researches, in order to make it to be a reference for making a systemic research program of traditional Chinese medicine injection.

  4. Intra-articular hip viscosupplementation with synthetic hyaluronic acid for osteoarthritis: efficacy, safety and relation to pre-injection radiographs.

    PubMed

    Gaston, M S; Tiemessen, C H; Philips, J E

    2007-12-01

    The aim of this study was to determine the efficacy and safety of viscosupplementation with synthetic hyaluronic acid to the hip joint and to determine if there was any relation to pre-injection radiographic changes of osteoarthritis (OA). Three Suplasyn injections were performed each to 15 hips with OA. Standing antero-posterior radiographs of the pelvis were performed prior to injection and scored according to Kelgren and Lawrence grades along with recordings of the minimum joint space width. Harris Hip Scores (HHS) which contain a component for pain, function, activities, absence of deformity and range of motion were recorded pre-injection and at 3 and 6 months. We established that at 3 months the HHS is significantly higher (P < 0.05). At 6 months, four hips had been excluded as they has went on to total hip arthroplasty (these hips showed a lower HHS at 3 months). For the remaining hips the HHS was highly significantly increased (P < 0.001). No side effects or complications were observed. Analysis of the pre-injection radiographs showed a trend towards a bigger increase in HHS with less radiographic OA changes. Viscosupplementation performed under fluoroscopic guidance is an effective and safe method of treating hip OA and appears to be more efficacious in those with less radiographic changes of OA.

  5. Effectiveness and safety of computer-controlled periodontal ligament injection system in endodontic access to the mandibular posterior teeth.

    PubMed

    Jing, Quan; Wan, Kuo; Wang, Xiao-jun; Ma, Lin

    2014-03-01

    To evaluate the effectiveness and safety of a computer-controlled periodontal ligament (PDL) injection system to the local soft tissues as the primary technique in endodontic access to mandibular posterior teeth in patients with irreversible pulpitis. A total of 162 Chinese patients who had been diagnosed with irreversible pulpitis in their mandibular posterior teeth without acute infection or inflammation in the periodontal tissues were enrolled in this clinical study. The patients were divided into 3 groups according to the position of the involved tooth: the premolar group (PM, n=38), first molar group (FM, n=66), and second molar group (SM, n=58). All the patients received computer-controlled PDL injection with 4% articaine and 1:100 000 epinephrine. Immediately after the injection, endodontic access was performed, and the degree of pain during the treatment was evaluated by the patients using Visual Analogue Scale for pain. The success rates were compared among the 3 groups. The responses of local soft tissues were evaluated 3-8 days and 3 weeks after the procedure. The overall success rate was 76.5%. There was a significant difference in success rates among the PM, FM, and SM groups (92.1%, 53.0%, 93.1%, respectively; χ² = 34.3, P<0.01). Both the PM and SM groups showed higher success rates than that of the FM group (v=1, χ² = 16.73, P<0.01; v=1, χ² = 24.5, P<0.01). No irreversible adverse effects on the periodontal soft tissues at the injection sites were observed in the follow-up visits in any of the groups. The computer-controlled PDL injection system demonstrates both satisfactory anesthetic effects and safety in local soft tissues as primary anesthetic technique in endodontic access to the mandibular posterior teeth in patients with irreversible pulpitis.

  6. Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16

    PubMed Central

    Bricout, Hélène; Chabanon, Anne Laure; Souverain, Audrey; Sadorge, Christine; Vesikari, Timo; Caroe, Timothy David

    2017-01-01

    Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 µg vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorities’ requirements; further fine tuning of the methodology is under discussion between all stakeholders. PMID:28494843

  7. The safety of intra-articular injections for the treatment of knee osteoarthritis: a critical narrative review.

    PubMed

    Nguyen, Christelle; Rannou, François

    2017-08-01

    International guidelines recommend that the management of knee osteoarthritis (OA) combine both nonpharmacological and pharmacological interventions. Intra-articular (IA) therapies are considered part of this multimodal approach and are well-established Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments. Areas covered: Safety data for knee OA, including IA corticosteroids, hyaluronic acid, platelet-rich plasma and botulinum toxin are critically reviewed, and evidence- and pratice-based measures to improve safety of IA therapies are discussed. Expert opinion: The incidence of AEs attributable to IA therapies across clinical trials in knee OA is very low, and barely reaches significance when compared to the incidence of AEs in the comparator group. These events are exceptionally serious. Mild differences between products have been inconsistently reported mainly for IA HA. One can distinguish self-limited AEs such as post-injection pain and swelling that are the most frequently reported AEs, from AEs that are not self-limited but rare such as septic arthritis. The safety of IA therapies can be improved by applying simple measures designed to prevent AEs. However, even though no specific safety concerns have been raised to date about IA therapies, the quality of evidence is low, and there is a need to improve the monitoring and reporting of safety data from clinical trials and post-marketing surveillance.

  8. Safety Design Strategy for the Advanced Test Reactor Emergency Firewater Injection System Replacement Project

    SciTech Connect

    Noel Duckwitz

    2011-06-01

    In accordance with the requirements of U.S. Department of Energy (DOE) Order 413.3B, “Program and Project Management for the Acquisition of Capital Assets,” safety must be integrated into the design process for new or major modifications to DOE Hazard Category 1, 2, and 3 nuclear facilities. The intended purpose of this requirement involves the handling of hazardous materials, both radiological and chemical, in a way that provides adequate protection to the public, workers, and the environment. Requirements provided in DOE Order 413.3B and DOE Order 420.1B, “Facility Safety,” and the expectations of DOE-STD-1189-2008, “Integration of Safety into the Design Process,” provide for identification of hazards early in the project and use of an integrated team approach to design safety into the facility. This safety design strategy provides the basic safety-in-design principles and concepts that will be used for the Advanced Test Reactor Reliability Sustainment Project. While this project does not introduce new hazards to the ATR, it has the potential for significant impacts to safety-related systems, structures, and components that are credited in the ATR safety basis and are being replaced. Thus the project has been determined to meet the definition of a major modification and is being managed accordingly.

  9. Safety of Ultrasound-Guided Botulinum Toxin Injections for Sialorrhea as Performed by Pediatric Otolaryngologists.

    PubMed

    Shariat-Madar, Bahbak; Chun, Robert H; Sulman, Cecille G; Conley, Stephen F

    2016-05-01

    To evaluate incidence of complications and hospital readmission as a result of ultrasound-guided botulinum toxin injections to manage sialorrhea. Case series with chart review. Children's Hospital of Wisconsin. A case series with chart review was performed of all cases of ultrasound-guided injection of botulinum toxin by pediatric otolaryngologists from March 5, 2010, to September 26, 2014,. Primary outcomes included complications such as dysphagia, aspiration pneumonia, and motor paralysis. Secondary outcomes included hospitalization, intubation, and nasogastric tube placement. There were 48 patients, 111 interventions, and 306 intraglandular injections identified. Botulinum toxin type A and type B were utilized in 4 and 107 operative interventions, respectively. Type A was injected into 4 parotid and 4 submandibular glands, utilizing doses of 20 U per parotid and 30 U per submandibular gland. Type B was injected into 98 parotid and 200 submandibular glands, with average dosing of 923 U per parotid and 1170 U per submandibular gland, respectively. There were 2 instances of subjectively worsening of baseline dysphagia that self-resolved. No cases were complicated by aspiration pneumonia or motor paralysis. No patients required hospital readmission, intubation, or nasogastric tube placement. Prior published data indicated 16% complication incidence with ultrasound-guided injection of botulinum toxin. Our study found a low complication rate (0.6%) with ultrasound-guided injections of botulinum toxin to manage sialorrhea, without cases of aspiration pneumonia or motor paralysis. Of 306 intraglandular injections, there were 2 cases of worsening baseline subjective dysphagia that self-resolved. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  10. Design of Complex Systems to Achieve Passive Safety: Natural Circulation Cooling of Liquid Salt Pebble Bed Reactors

    NASA Astrophysics Data System (ADS)

    Scarlat, Raluca Olga

    This dissertation treats system design, modeling of transient system response, and characterization of individual phenomena and demonstrates a framework for integration of these three activities early in the design process of a complex engineered system. A system analysis framework for prioritization of experiments, modeling, and development of detailed design is proposed. Two fundamental topics in thermal-hydraulics are discussed, which illustrate the integration of modeling and experimentation with nuclear reactor design and safety analysis: thermal-hydraulic modeling of heat generating pebble bed cores, and scaled experiments for natural circulation heat removal with Boussinesq liquids. The case studies used in this dissertation are derived from the design and safety analysis of a pebble bed fluoride salt cooled high temperature nuclear reactor (PB-FHR), currently under development in the United States at the university and national laboratories level. In the context of the phenomena identification and ranking table (PIRT) methodology, new tools and approaches are proposed and demonstrated here, which are specifically relevant to technology in the early stages of development, and to analysis of passive safety features. A system decomposition approach is proposed. Definition of system functional requirements complements identification and compilation of the current knowledge base for the behavior of the system. Two new graphical tools are developed for ranking of phenomena importance: a phenomena ranking map, and a phenomena identification and ranking matrix (PIRM). The functional requirements established through this methodology were used for the design and optimization of the reactor core, and for the transient analysis and design of the passive natural circulation driven decay heat removal system for the PB-FHR. A numerical modeling approach for heat-generating porous media, with multi-dimensional fluid flow is presented. The application of this modeling

  11. Efficacy and Safety of Intravesical OnabotulinumtoxinA Injection in Patients with Detrusor Hyperactivity and Impaired Contractility.

    PubMed

    Wang, Chung-Cheng; Lee, Cheng-Ling; Kuo, Hann-Chorng

    2016-03-18

    We investigated the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with detrusor hyperactivity and impaired contractility (DHIC). Twenty-one patients with urodynamically proven DHIC and 21 age-matched patients with overactive bladder (OAB) with urodynamic detrusor overactivity were treated with intravesical injections of 100 U of onabotulinumtoxinA. The overactive bladder symptom score, urgency severity score, patient perception of bladder condition, global response assessment, voiding diary, and procedure-related adverse events (AE) at baseline, two weeks, one, three, and six months after treatment were assessed. The results showed that the subjective symptom scores improved significantly in both groups, and the scores did not differ between the groups. The decrease in urgency episodes and urgency urinary incontinence were noted in OAB patients but not in DHIC patients. Although the incidence of AEs was comparable between the groups, the therapeutic efficacy lasted for a mean of 4.9 ± 4.8 months in DHIC patients and 7.2 ± 3.3 months in OAB patients (p = 0.03). We concluded that the efficacy of intravesical onabotulinumtoxinA injection for DHIC patients was limited and short-term. Nevertheless, AEs did not increase in DHIC. Intravesical onabotulinumtoxinA might not be a good indication in patients with DHIC and high post-voiding residual urine. Physicians should inform patients of the potential benefits and risks of onabotulinumtoxinA injection for treatment of DHIC.

  12. Efficacy and Safety of Intravesical OnabotulinumtoxinA Injection in Patients with Detrusor Hyperactivity and Impaired Contractility

    PubMed Central

    Wang, Chung-Cheng; Lee, Cheng-Ling; Kuo, Hann-Chorng

    2016-01-01

    We investigated the efficacy and safety of intravesical onabotulinumtoxinA injection in patients with detrusor hyperactivity and impaired contractility (DHIC). Twenty-one patients with urodynamically proven DHIC and 21 age-matched patients with overactive bladder (OAB) with urodynamic detrusor overactivity were treated with intravesical injections of 100 U of onabotulinumtoxinA. The overactive bladder symptom score, urgency severity score, patient perception of bladder condition, global response assessment, voiding diary, and procedure-related adverse events (AE) at baseline, two weeks, one, three, and six months after treatment were assessed. The results showed that the subjective symptom scores improved significantly in both groups, and the scores did not differ between the groups. The decrease in urgency episodes and urgency urinary incontinence were noted in OAB patients but not in DHIC patients. Although the incidence of AEs was comparable between the groups, the therapeutic efficacy lasted for a mean of 4.9 ± 4.8 months in DHIC patients and 7.2 ± 3.3 months in OAB patients (p = 0.03). We concluded that the efficacy of intravesical onabotulinumtoxinA injection for DHIC patients was limited and short-term. Nevertheless, AEs did not increase in DHIC. Intravesical onabotulinumtoxinA might not be a good indication in patients with DHIC and high post-voiding residual urine. Physicians should inform patients of the potential benefits and risks of onabotulinumtoxinA injection for treatment of DHIC. PMID:26999209

  13. Safety evaluation of poly(lactic-co-glycolic acid)/poly(lactic-acid) microspheres through intravitreal injection in rabbits.

    PubMed

    Rong, Xianfang; Yuan, Weien; Lu, Yi; Mo, Xiaofen

    2014-01-01

    Poly(lactic-co-glycolic acid) (PLGA) and/or poly(lactic-acid) (PLA) microspheres are important drug delivery systems. This study investigated eye biocompatibility and safety of PLGA/PLA microspheres through intravitreal injection in rabbits. Normal New Zealand rabbits were randomly selected and received intravitreal administration of different doses (low, medium, or high) of PLGA/PLA microspheres and erythropoietin-loaded PLGA/PLA microspheres. The animals were clinically examined and sacrificed at 1, 2, 4, 8, and 12 weeks postadministration, and retinal tissues were prepared for analysis. Retinal reactions to the microspheres were evaluated by terminal deoxynucleotidyl transferase-mediated dUTP nick end staining and glial fibrillary acidic protein immunohistochemistry. Retinal structure changes were assessed by hematoxylin and eosin staining and transmission electron microscopy. Finally, retinal function influences were explored by the electroretinography test. Terminal deoxynucleotidyl transferase-mediated dUTP nick end staining revealed no apoptotic cells in the injected retinas; immunohistochemistry did not detect any increased glial fibrillary acidic protein expression. Hematoxylin and eosin staining and transmission electron microscopy revealed no micro- or ultrastructure changes in the retinas at different time points postintravitreal injection. The electroretinography test showed no significant influence of scotopic or photopic amplitudes. The results demonstrated that PLGA/PLA microspheres did not cause retinal histological changes or functional damage and were biocompatible and safe enough for intravitreal injection in rabbits for controlled drug delivery.

  14. Poly(ortho ester) nanoparticles targeted for chronic intraocular diseases: ocular safety and localization after intravitreal injection.

    PubMed

    Li, Huiling; Palamoor, Mallika; Jablonski, Monica M

    2016-10-01

    Treatment of posterior eye diseases is more challenging than the anterior segment ailments due to a series of anatomical barriers and physiological constraints confronted by drug delivery to the back of the eye. In recent years, concerted efforts in drug delivery have been made to prolong the residence time of drugs injected in the vitreous humor of the eye. Our previous studies demonstrated that poly(ortho ester) (POE) nanoparticles were biodegradable/biocompatible and were capable of long-term sustained release. The objective of the present study was to investigate the safety and localization of POE nanoparticles in New Zealand white rabbits and C57BL/6 mice after intravitreal administration for the treatment of chronic posterior ocular diseases. Two concentration levels of POE nanoparticles solution were chosen for intravitreal injection: 1.5 mg/ml and 10 mg/ml. Our results demonstrate that POE nanoparticles were distributed throughout the vitreous cavity by optical coherence tomography (OCT) examination 14 days post-intravitreal injection. Intraocular pressure was not changed from baseline. Inflammatory or adverse effects were undetectable by slit lamp biomicroscopy. Furthermore, we demonstrate that POE nanoparticles have negligible toxicity assessed at the cellular level evidenced by a lack of glia activation or apoptosis estimation after intravitreal injection. Collectively, POE nanoparticles are a novel and nontoxic as an ocular drug delivery system for the treatment of posterior ocular diseases.

  15. Safety evaluation of poly(lactic-co-glycolic acid)/poly(lactic-acid) microspheres through intravitreal injection in rabbits

    PubMed Central

    Rong, Xianfang; Yuan, Weien; Lu, Yi; Mo, Xiaofen

    2014-01-01

    Poly(lactic-co-glycolic acid) (PLGA) and/or poly(lactic-acid) (PLA) microspheres are important drug delivery systems. This study investigated eye biocompatibility and safety of PLGA/PLA microspheres through intravitreal injection in rabbits. Normal New Zealand rabbits were randomly selected and received intravitreal administration of different doses (low, medium, or high) of PLGA/PLA microspheres and erythropoietin-loaded PLGA/PLA microspheres. The animals were clinically examined and sacrificed at 1, 2, 4, 8, and 12 weeks postadministration, and retinal tissues were prepared for analysis. Retinal reactions to the microspheres were evaluated by terminal deoxynucleotidyl transferase-mediated dUTP nick end staining and glial fibrillary acidic protein immunohistochemistry. Retinal structure changes were assessed by hematoxylin and eosin staining and transmission electron microscopy. Finally, retinal function influences were explored by the electroretinography test. Terminal deoxynucleotidyl transferase-mediated dUTP nick end staining revealed no apoptotic cells in the injected retinas; immunohistochemistry did not detect any increased glial fibrillary acidic protein expression. Hematoxylin and eosin staining and transmission electron microscopy revealed no micro- or ultrastructure changes in the retinas at different time points postintravitreal injection. The electroretinography test showed no significant influence of scotopic or photopic amplitudes. The results demonstrated that PLGA/PLA microspheres did not cause retinal histological changes or functional damage and were biocompatible and safe enough for intravitreal injection in rabbits for controlled drug delivery. PMID:25028546

  16. Industrial-grade silicone injections causing intermittent bilateral malar swelling: review of safety and efficacy of techniques and products available.

    PubMed

    Seward, Austin C; Meara, Daniel J

    2013-07-01

    Silicone and other fillers have become a popular aid to increase soft tissue density, decrease static skin rhytids, and treat muscle wasting, particularly in the face. As a result, injectable silicone has become popular in patients with the human immunodeficiency virus (HIV). It has been postulated that highly active antiretroviral therapy detrimentally induces the physiologic process of fat atrophy of the temporal and buccal fat pads of the face and regional fat wasting of the arms, legs, and buttocks and that HIV protease inhibitors may induce fat atrophy by binding and inhibiting homologous human proteins that are involved in fat metabolism. The classic hollowed-out facial appearance linked to HIV positivity can have detrimental social implications in infected patients who are otherwise very functional. In consequence, facial implantation, fat transplantation, and dermal and subcutaneous fillers have been used to aid in the restoration of facial appearance. This report describes the case of a patient who underwent multiple rounds of silicone injections and complained of intermittent facial swelling and pain long after the injections. The authors report on the safety of specific medical-grade injectable fillers and techniques found to be safely effective, especially in the HIV-positive population.

  17. Safety engineered injection devices for intramuscular, subcutaneous and intradermal injections in healthcare delivery settings: a systematic review and meta-analysis.

    PubMed

    Harb, Alain C; Tarabay, Rami; Diab, Batoul; Ballout, Rami A; Khamassi, Selma; Akl, Elie A

    2015-01-01

    Occupational sharps injuries are associated with transmission of bloodborne viruses to healthcare workers, including hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Similarly reuse of syringes in healthcare settings might transmit these infections between patients. The objective of this study was to systematically review the evidence about the effects of the use by health care workers of two types of safety engineered injection devices, when delivering intramuscular, subcutaneous, or intradermal injectable medications: sharps injury protection syringes and reuse prevention syringes. We included both randomized and non-randomized studies comparing safety syringes to syringes without safety features. Outcomes of interest included needlestick injuries, and HIV, HBV and HCV infections amongst HCWs (for sharps injury prevention syringes) and patients (for reuse prevention syringes). When possible, we conducted meta-analyses using a random-effects model. We tested results for heterogeneity across studies using the I statistic. We assessed the quality of evidence by outcome using the GRADE methodology. We included nine eligible studies: six assessed devices that qualify as sharps injury prevention devices, and three assessed devices that qualify as both injury prevention devices and reuse prevention devices. Eight studies were observational while one was randomized. All studies assessed a single outcome: needle stick injuries among healthcare workers. For sharp injury prevention syringes, the meta-analysis of five studies resulted in a pooled relative risk of 0.54 [0.41, 0.71] for the effect on needlestick injuries per healthcare worker. The associated quality of evidence was rated as moderate. For reuse prevention syringes, data from one study provided a relative risk of 0.40 [0.27, 0.59] for the effect on needlestick injuries per healthcare worker. The associated quality of evidence was rated as moderate. We identified no

  18. A study of passive safety features by utilizing intra-subassembly-equipped self-actuated shutdown mechanism for future large fast breeder reactors

    SciTech Connect

    Uto, N.; Niwa, H.; Ieda, Y.; Satoh, K.

    1996-08-01

    Passive prevention of core disruptive accidents (CDAs) is desired in terms of enhancement of safety for future fast breeder reactors. In addition, mitigation of CDA`s consequences should be required because mitigation measures have a potential of applying to all accidents, while prevention measures are prepared for specific accident initiators. In this paper, the Intra-Subassembly-equipped Self-Actuated Shutdown System (IS-SASS) , which is considered effective on passive prevention and mitigation of CDAs, is described. The IS-SASS is introduced in a fuel subassembly and consists of absorber materials at the top of the active core and an inner duct through which molten fuel can be excluded out of the core. The determination of the appropriate number of the IS-SASS units, their arrangement in the core and their suitable structure are found to be suited to prevention and mitigation of CDAs for liquid metal-cooled large fast breeder reactors.

  19. Performance of a Fuel-Injection Spark-Ignition Engine Using a Hydrogenated Safety Fuel

    NASA Technical Reports Server (NTRS)

    Schey, Oscar W; Young, Alfred W

    1934-01-01

    This report presents the performance of a single-cylinder test engine using a hydrogenated safety fuel. The safety fuel has a flash point of 125 degrees f. (Cleveland open-dup method), which is high enough to remove most of the fire hazard, and an octane number of 95, which permits higher compression ratios to be used than are permissible with most undoped gasolines.

  20. Effectiveness and safety of prolotherapy injections for management of lower limb tendinopathy and fasciopathy: a systematic review.

    PubMed

    Sanderson, Lane M; Bryant, Alan

    2015-01-01

    The aim of this review was to identify and evaluate existing research to determine the clinical effectiveness and safety of prolotherapy injections for treatment of lower limb tendinopathy and fasciopathy. Nine databases were searched (Medline, Science Direct, AMED, Australian Medical Index, APAIS-Health, ATSIhealth, EMBASE, Web of Science, OneSearch) without language, publication or data restrictions for all relevant articles between January 1960 and September 2014. All prospective randomised and non-randomised trials, cohort studies, case-series, cross-sectional studies and controlled trials assessing the effectiveness of one or more prolotherapy injections for tendinopathy or fasciopathy at or below the superior aspect of the tibia/fibula were included. Methodological quality of studies was determined using a modified evaluation tool developed by the Cochrane Musculoskeletal Injuries Group. Data analysis was carried out to determine the mean change of outcome measure scores from baseline to final follow-up for trials with no comparative group, and for randomised controlled trials, standardised mean differences between intervention groups were calculated. Pooled SMD data were calculated where possible to determine the statistical heterogeneity and overall effect for short-, intermediate- and long-term data. Adverse events were also reported. Two hundred and three studies were identified, eight of which met the inclusion criteria. These were then grouped according to tendinopathy or fasciopathy being treated with prolotherapy injections: Achilles tendinopathy, plantar fasciopathy and Osgood-Schlatter disease. The methodological quality of the eight included studies was generally poor, particularly in regards to allocation concealment, intention to treat analysis and blinding procedures. Results of the analysis provide limited support for the hypothesis that prolotherapy is effective in both reducing pain and improving function for lower limb tendinopathy and

  1. Comparative Study of Efficacy and Safety of Botulinum Toxin a Injections and Subcutaneous Curettage in the Treatment of Axillary Hyperhidrosis

    PubMed Central

    Budamakuntla, Leelavathy; Loganathan, Eswari; George, Anju; Revanth, BN; Sankeerth, V; Sarvjnamurthy, Sacchidananda Aradhya

    2017-01-01

    Background: Primary focal axillary hyperhidrosis is a chronic distressing disorder affecting both the sexes. When the condition is refractory to conservative management, we should go for more promising therapies like intradermal botulinum toxin A (BtxA) injections in the axilla, and surgical therapies like subcutaneous curettage of sweat glands. Aims and Objectives: The aim of this study is to compare the efficacy, safety and duration of action of intradermal BtxA injections in one axilla and subcutaneous curettage of sweat glands in the other axilla of the same patient with axillary hyperhidrosis. Materials and Methods: Twenty patients (40 axillae) received intradermal BtxA injections on the right side (20 axillae) and underwent tumescent subcutaneous curettage of sweat glands on the left side (20 axillae). Sweat production rate was measured using gravimetry analyses at baseline and at 3 months after the procedure. Subjective analyses were done using hyperhidrosis disease severity scale (HDSS) score at baseline, at 3rd and 6th month after the procedure. Results: At 3 months post-treatment, the resting sweat rate in the toxin group improved by 80.32% versus 79.79% in the subcutaneous curettage method (P = 0.21). Exercise-induced sweat rate in the toxin group improved by 88.76% versus 88.8% in the subcutaneous curettage group (P = 0.9). There was a significant difference in the HDSS score after treatment with both the modalities. There were no adverse events with BtxA treatment compared to very minor adverse events with the surgical method. Conclusion: Both intradermal BtxA injections and tumescent subcutaneous curettage of sweat glands had a significant decrease in the sweat rates with no significant difference between the two modalities. Hence, in resource poor settings where affordability of BtxA injection is a constraint, subcutaneous curettage of sweat glands can be preferred which has been found equally effective with no or minimal adverse events. PMID

  2. Comparative Study of Efficacy and Safety of Botulinum Toxin a Injections and Subcutaneous Curettage in the Treatment of Axillary Hyperhidrosis.

    PubMed

    Budamakuntla, Leelavathy; Loganathan, Eswari; George, Anju; Revanth, B N; Sankeerth, V; Sarvjnamurthy, Sacchidananda Aradhya

    2017-01-01

    Primary focal axillary hyperhidrosis is a chronic distressing disorder affecting both the sexes. When the condition is refractory to conservative management, we should go for more promising therapies like intradermal botulinum toxin A (BtxA) injections in the axilla, and surgical therapies like subcutaneous curettage of sweat glands. The aim of this study is to compare the efficacy, safety and duration of action of intradermal BtxA injections in one axilla and subcutaneous curettage of sweat glands in the other axilla of the same patient with axillary hyperhidrosis. Twenty patients (40 axillae) received intradermal BtxA injections on the right side (20 axillae) and underwent tumescent subcutaneous curettage of sweat glands on the left side (20 axillae). Sweat production rate was measured using gravimetry analyses at baseline and at 3 months after the procedure. Subjective analyses were done using hyperhidrosis disease severity scale (HDSS) score at baseline, at 3(rd) and 6(th) month after the procedure. At 3 months post-treatment, the resting sweat rate in the toxin group improved by 80.32% versus 79.79% in the subcutaneous curettage method (P = 0.21). Exercise-induced sweat rate in the toxin group improved by 88.76% versus 88.8% in the subcutaneous curettage group (P = 0.9). There was a significant difference in the HDSS score after treatment with both the modalities. There were no adverse events with BtxA treatment compared to very minor adverse events with the surgical method. Both intradermal BtxA injections and tumescent subcutaneous curettage of sweat glands had a significant decrease in the sweat rates with no significant difference between the two modalities. Hence, in resource poor settings where affordability of BtxA injection is a constraint, subcutaneous curettage of sweat glands can be preferred which has been found equally effective with no or minimal adverse events.

  3. Safety and efficacy of botulinum toxin injection therapy for esophageal achalasia in Japan.

    PubMed

    Yamaguchi, Daisuke; Tsuruoka, Nanae; Sakata, Yasuhisa; Shimoda, Ryo; Fujimoto, Kazuma; Iwakiri, Ryuichi

    2015-11-01

    Botulinum toxin injection is an accepted treatment modality for esophageal achalasia in western countries. This pilot study aimed to clarify the effectiveness of botulinum toxin injection for esophageal achalasia in Japanese patients. We enrolled 10 patients diagnosed with esophageal achalasia between 2008 and 2014. A total of 100 U botulinum toxin A was divided into eight aliquots and injected around the esophagogastric junction. We compared the lower esophageal sphincter pressure before and 1 week after treatment. Scores of subjective symptoms for esophageal achalasia were assessed using a visual analog scale (VAS) before and after 1 week of follow-up of treatment. Barium passage was improved in barium esophagography and passage of contrast agent was also improved. Mean Eckardt score was reduced from 5.5 to 1.6 after treatment (p<0.001). By esophageal manometric study, mean lower esophageal sphincter pressure was reduced from 46.9 to 29.1 mmHg after treatment (p = 0.002). One week after treatment, mean VAS score was reduced from 10 to 3.9 (p<0.001). There were no side effects in any cases. Botulinum toxin injection for esophageal achalasia was safe and effective with few complications. Therefore, botulinum toxin could be used as minimally invasive therapy for esophageal achalasia in Japan.

  4. Effectiveness and safety of CEUS-guided haemostatic injection for blunt splenic trauma: an animal experiment.

    PubMed

    Li, W; Tang, J; Lv, F; Zhang, H; Zhang, S; An, L

    2010-10-01

    The aim of this study was to investigate whether complications occur after haemostatic agents are injected into blunt splenic injuries. After undergoing ultrasound (US), contrast-enhanced US (CEUS) and contrast-enhanced computed tomography (CECT) examinations, dogs with grade III-IV injury received the minimally invasive therapy. After treatment, CEUS was performed to observe changes in the regions treated. In the immediate group, dogs underwent laparotomy 30 min after treatment to observe the haemostatic effect. In the survival group, animals underwent CEUS and CECT examinations to observe the short-term healing outcome and complications at 3, 7, 14, and 21 days after the injection. After undergoing CEUS and CECT examinations, 12 dogs with grade III-IV injury received the minimally invasive therapy. Before injection, CEUS examinations showed anechoic and/or hypoechoic perfusion defects and active bleeding at the injury sites, and CECT showed traumatic lesions as low-density regions without enhancement. After treatment, CEUS demonstrated the disappearance of active bleeding, and hyperechoic spots emerged at the injury sites. Uneven density regions were displayed on CECT. Treated areas were covered by blood clots and glue membrane in the immediate-group animals. Three weeks later, CEUS showed a decrease of hyperechoic spots in the survival group, and the splenic parenchyma enhanced uniformly on CECT. Laparotomy showed that the greater omentum had moved upwards and partly covered the wound in four animals, and the injury sites had completely healed. Histopathological examination showed that fibrous connective tissue covered the splenic capsule and that the haemostatic glue had degraded. No complication occurred, such as delayed splenic haemorrhage, splenic abscesses, splenic pseudoaneurysms, intestinal obstruction or intestinal adhesions. CEUS-guided haemostatic injection is not only effective in stopping active bleeding immediately, but it is also safe in that no

  5. Intrathecal injection of CD133-positive enriched bone marrow progenitor cells in children with cerebral palsy: feasibility and safety.

    PubMed

    Zali, Alireza; Arab, Leila; Ashrafi, Farzad; Mardpour, Soura; Niknejhadi, Maryam; Hedayati-Asl, Amir Abbas; Halimi-Asl, Aliasghar; Ommi, Davood; Hosseini, Seyyedeh-Esmat; Baharvand, Hossein; Aghdami, Nasser

    2015-02-01

    Recent studies have proposed that cellular transplantation may have some regenerative and functional efficacy in the treatment of cerebral palsy (CP); however, much remains to be understood regarding its safety, feasibility and efficacy. This study was initiated to evaluate the safety of autologous bone marrow-derived CD133(+) cell intrathecal injection. Children (n = 12), aged 4 to 12 years, who were diagnosed with different types of CP underwent BM aspiration. CD133(+) cells were enriched from the BM samples and intrathecally injected. The Gross Motor Function Measure (GMFM-66), Gross Motor Function Classification System (GMFCS), UK FIM+FAM, Functional Independence Measure (FIM) and Functional Assessment Measure (FAM) were assessed at baseline and 6 months after the procedure. Patients' ability to balance was measured by the Berg Balance Scale (BBS), and severity of spasticity was evaluated by the Modified Ashworth Scale. Magnetic resonance imaging was done at baseline and 6 months after therapy. This study was registered in ClinicalTrials.gov (NCT01404663). There were no adverse events detected by clinical and laboratory tests or imaging studies, with the exception of a seizure in 1 patient. A significant improvement was observed 6 months after cell transplantation versus baseline according to GMFM, GMFCS, FIM+FAM, Ashworth Scale, and BBS outcomes. Subarachnoid injection of CD133-positive enriched bone marrow progenitor cells in children with CP is a safe approach. The results suggest a possible short-term improvement in neurological function. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  6. Safety of the reuse of needles for subcutaneous insulin injection: A systematic review and meta-analysis.

    PubMed

    Zabaleta-Del-Olmo, Edurne; Vlacho, Bogdan; Jodar-Fernández, Lina; Urpí-Fernández, Ana-María; Lumillo-Gutiérrez, Iris; Agudo-Ugena, Josep; Morros-Pedrós, Rosa; Violán, Concepción

    2016-08-01

    Many people with diabetes often reuse disposable needles for subcutaneous insulin injection. We aimed to identify, critically appraise and summarize the available evidence about the safety of this practice. Systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. MEDLINE (via PubMed), CINALH (via EBSCO), SCOPUS, Web of Science, Cochrane Central Register of Controlled Trials and Open Grey were searched from their inception to December 2015, with no language restrictions. Epidemiologic and experimental studies assessing adverse effects of reusing needles in people of any age or sex, with or without diabetes, were included. Two reviewers independently assessed the methodological quality of included studies using a multi-design tool. In total, 25 studies were included. All studies had a high risk of bias and data from only nine studies could be pooled. Five studies showed no association between infection at site of injection and reuse of needles (risk difference=-0.00; 95% confidence interval=-0.12-0.11; P=0.99); heterogeneity between these studies was substantial (I(2)=66%; P=0.02). Five cross-sectional studies showed an association between lipohypertrophy and needle reuse (risk difference=0.16, 95% confidence interval=0.05-0.28, P=0.006); there was strong evidence of heterogeneity between these studies (I(2)=87%; P<0.001). Pooled data of two studies with no evidence of heterogeneity between them showed more perceived pain among reusers (risk difference=0.24; 95% confidence interval=0.06-0.43; P=0.006). Reusing a pen needle or disposable syringe-needle was not associated with worse glycaemic control. There is currently no clear scientific evidence to suggest for or against the reuse of needles for subcutaneous insulin injection. This practice is very common among people with diabetes; consequently, further research is necessary to establish its safety. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. The Safety of Aircraft Exposed to Electromagnetic Fields: HIRF Testing of Aircraft Using Direct Current Injection

    DTIC Science & Technology

    2007-06-01

    divides the current modes into two types; a capacitive type which flows between charge concentrations and an inductive type which flows in closed loops...Airframe resonances will be clearly shown to exist in the capacitive type modes and circulating type modes will be shown to occur at low and uniform...variety of DCI topologies. • Section 6 takes a promising DCI topology, and the capacitive mode currents are used to control the direct injected

  8. Safety of 1000 CT-guided steroid injections with air used to localize the epidural space.

    PubMed

    Chang, A; Pochert, S; Romano, C; Brook, A; Miller, T

    2011-10-01

    Historically, ESIs were performed without any imaging guidance, resulting in erroneous placement in up to 30% of injections. Fluoroscopic imaging is now used to guide most procedures. Recently, several reports have described the use of CT to guide ESIs instead of fluoroscopy. CT provides the ability to use air as contrast to localize the epidural space. This retrospective review will discuss findings in 1000 CT-guided ESIs with air localization.

  9. Long-acting injectable risperidone: safety and efficacy in stable patients switched from conventional depot antipsychotics.

    PubMed

    Turner, Martin; Eerdekens, Els; Jacko, Mary; Eerdekens, Mariëlle

    2004-07-01

    Long-acting injectable risperidone was assessed in schizophrenia patients who were symptomatically stable on conventional depot antipsychotics and who were then switched to long-acting risperidone. Participants in this open-label, multicentre, 12-week trial had received flupenthixol decanoate, fluphenazine decanoate, haloperidol decanoate, or zuclopenthixol decanoate for 4 months or longer. Each was considered symptomatically stable by investigators. After receiving two cycles of their conventional depot antipsychotic during the run-in period, patients were switched to receive long-acting risperidone every 2 weeks for 12 weeks at an initial dose of 25 mg. This dose could be increased in 12.5-mg increments at 4-week intervals. Ninety-two percent of the patients received all six injections; 62% received the 25-mg dose throughout the treatment period. Adverse events related to movement disorders were reported in 3%. Severity of movement disorders decreased during long-acting risperidone treatment. Positive and Negative Syndrome Scale (PANSS) total and factor scores and scores on the Clinical Global Impressions severity scale were significantly reduced during treatment; 48% of these stable patients showed further symptom improvement (> or =20% decrease in PANSS score at endpoint). The results indicate that patients with schizophrenia who are symptomatically stable during treatment with a conventional depot antipsychotic can be safely and effectively switched to long-acting injectable risperidone without a prior transition to oral risperidone.

  10. Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome

    PubMed Central

    Lee, Cheng-Ling; Kuo, Hann-Chorng

    2015-01-01

    Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks sustainability. Repeated injections have been shown to provide a superior outcome to a single injection, but data on long-term efficacy and safety is limited. In this prospective study, we enrolled patients with refractory IC/BPS, and treated them with 100 U of BoNT-A injection plus hydrodistention followed by repeated injections every six months for up to two years or until the patient wished to discontinue. A “top-up” dose was offered after the fourth injection. Of these 104 participants, 56.7% completed four BoNT-A injections and 34% voluntarily received the fifth injection due to exacerbated IC symptoms. With a follow-up period of up to 79 months, O’Leary-Sant symptom and problem indexes (ICSI, ICPI, OSS), pain visual analogue scale (VAS) functional bladder capacity, frequency episodes, and global response assessment (GRA) all showed significant improvement (p < 0.0001). Those who received repeated injections had a better success rate during the long-term follow-up period. The incidence of adverse events did not rise with the increasing number of BoNT-A injections. A higher pre-treatment ICSI and ICPI score was predictive for successful response to repeated intravesical BoNT-A injections plus hydrodistention. PMID:26506388

  11. Long-Term Efficacy and Safety of Repeated Intravescial OnabotulinumtoxinA Injections Plus Hydrodistention in the Treatment of Interstitial Cystitis/Bladder Pain Syndrome.

    PubMed

    Lee, Cheng-Ling; Kuo, Hann-Chorng

    2015-10-22

    Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS), but lacks sustainability. Repeated injections have been shown to provide a superior outcome to a single injection, but data on long-term efficacy and safety is limited. In this prospective study, we enrolled patients with refractory IC/BPS, and treated them with 100 U of BoNT-A injection plus hydrodistention followed by repeated injections every six months for up to two years or until the patient wished to discontinue. A "top-up" dose was offered after the fourth injection. Of these 104 participants, 56.7% completed four BoNT-A injections and 34% voluntarily received the fifth injection due to exacerbated IC symptoms. With a follow-up period of up to 79 months, O'Leary-Sant symptom and problem indexes (ICSI, ICPI, OSS), pain visual analogue scale (VAS) functional bladder capacity, frequency episodes, and global response assessment (GRA) all showed significant improvement (p < 0.0001). Those who received repeated injections had a better success rate during the long-term follow-up period. The incidence of adverse events did not rise with the increasing number of BoNT-A injections. A higher pre-treatment ICSI and ICPI score was predictive for successful response to repeated intravesical BoNT-A injections plus hydrodistention.

  12. Fault Injection Software Tools and Robust Design Principles for Reliability and Safety in Measurement Science Education

    NASA Astrophysics Data System (ADS)

    Faller, Lisa-Marie; Zangl, Hubert; Leitzke, Juliana P.

    2016-11-01

    In the design of measurement systems we face the fact that parameters are subject to (measurement-) uncertainties. Additionally, components may behave entirely different from what is specified, which is then considered a fault. Consequently, both uncertainty as well as probability of failure should be considered in education on robust design and reliability. In this paper we present a teaching concept based on hardware fault injection using a simple level sensor system as an example. Learning objectives are faults, errors, failures, false alarms versus misses as well as advantages and disadvantages of redundancy.

  13. Analytical prediction and experimental verification of reactor safety system injection transient

    SciTech Connect

    Roy, B.N.; Nomm, E.

    1991-12-31

    This paper describes the computer code that was developed for thermal hydraulic transient analysis of mixed phase fluid system and the flow tests that were carried out to validate the Code. A full scale test facility was designed to duplicate the Supplementary Shutdown System (SSS) of Savannah River Production Reactors. Several steady state and dynamic flow tests were conducted simulating the actual reactor injection transients. A dynamic multiphase fluid flow code was developed and validated with experimental results and utilized for system performance predictions and development of technical specifications for reactors. 3 refs.

  14. Analytical prediction and experimental verification of reactor safety system injection transient

    SciTech Connect

    Roy, B.N.; Nomm, E.

    1991-01-01

    This paper describes the computer code that was developed for thermal hydraulic transient analysis of mixed phase fluid system and the flow tests that were carried out to validate the Code. A full scale test facility was designed to duplicate the Supplementary Shutdown System (SSS) of Savannah River Production Reactors. Several steady state and dynamic flow tests were conducted simulating the actual reactor injection transients. A dynamic multiphase fluid flow code was developed and validated with experimental results and utilized for system performance predictions and development of technical specifications for reactors. 3 refs.

  15. The clinical safety, biodistribution and internal radiation dosimetry of flutemetamol (¹⁸F) injection in healthy Japanese adult volunteers.

    PubMed

    Senda, Michio; Brooks, David J; Farrar, Gill; Somer, Edward J; Paterson, Carolyn L; Sasaki, Masahiro; McParland, Brian J

    2015-08-01

    The Phase I safety, biodistribution and internal radiation dosimetry study in adult healthy Japanese males of flutemetamol ((18)F) injection, an in vivo β-amyloid imaging agent, is reported and compared with previously obtained Caucasian data. Whole-body PET scans of 6 healthy volunteers (age 51.8-61.7 years) were acquired approximately 4 h post-injection (administered activity 102-160 MBq). Venous blood sampling determined (18)F activity concentrations in whole blood and plasma and high-performance liquid chromatography (HPLC) established the percentages of parent [(18)F]flutemetamol and its metabolites. Voided urine activity was recorded. The decay-corrected and normalised (18)F activity of 14 source organ regions as a function of time was entered into the OLINDA/EXM software to calculate the internal radiation dosimetry and effective dose of each subject following the MIRD schema. The pharmacokinetics, biodistribution and dosimetry profiles were compared to data obtained from a cohort of healthy Caucasian adult volunteers from a previous Phase I study of [(18)F]flutemetamol. Flutemetamol ((18)F) injection was well tolerated. The highest mean initial uptakes were measured in the liver (15.2%), lungs (10.2%) and brain (6.6%). The highest mean radiation absorbed doses were received by the gallbladder wall (366 μGy/MBq), upper large intestine (138 μGy/MBq) and small intestine (121 μGy/MBq). The mean effective dose was 34.9 μSv/MBq. HPLC analysis demonstrated that at 5-min post-injection about 75% of plasma (18)F radioactivity was in the form of parent [(18)F]flutemetamol, reducing to 8 and 2% at 25 and 90 min, respectively, giving rise to less lipophilic (18)F-labelled metabolites. Comparisons with the Caucasian cohort showed no differences that could be regarded as clinically significant. The clinical safety of [(18)F]flutemetamol demonstrated no differences of clinical significance in the pharmacokinetics, biodistribution and internal radiation dosimetry

  16. Analysis of the clinical safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for adults with Peyronie's disease (PD).

    PubMed

    Carson, Culley C; Sadeghi-Nejad, Hossein; Tursi, James P; Smith, Ted M; Kaufman, Gregory J; Gilbert, Kimberly; Honig, Stanton C

    2015-11-01

    To examine the safety of intralesional injection of collagenase Clostridium histolyticum (CCH) for the treatment of Peyronie's disease (PD), using a pooled safety analysis of patients who received at least one dose of CCH in any of six clinical studies. Patients from six clinical studies, including three randomised, double-blind, placebo-controlled studies and three open-label safety and efficacy studies, were included if they had received at least one dose of 0.58 mg CCH. Adverse events (AEs), including treatment-emergent AEs, treatment-related AEs, and serious AEs (SAEs), were characterised. Potential immunogenicity-related AEs were evaluated through examination of increased anti-AUX-I and anti-AUX-II antibody levels, AEs, and reported terms possibly associated with immunological or hypersensitivity events. Overall, 85.8% of 1 044 pooled patients reported at least one treatment-related AE. The most frequently reported (≥25.0% of patients) treatment-related AEs included penile haematoma (82.7% had the verbatim 'penile bruising'), penile pain, and penile swelling. Most patients (75.2%) had mild- or moderate-severity treatment-related AEs, and 14.2% had no treatment-related AEs. Nine patients (0.9%) had treatment-related SAEs: five with penile haematoma and four with corporal rupture. There was no association between AEs and anti-AUX-I or anti-AUX-II antibody levels across treatment cycles, and no systemic hypersensitivity reactions occurred. This pooled safety analysis shows that although non-serious and serious treatment-related AEs can occur after CCH treatment for PD, most were non-serious and the SAEs were manageable. Providers should be prepared to manage possible SAEs. © 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.

  17. Percutaneous Ethanol Injection of Unresectable Medium-to-Large-Sized Hepatomas Using a Multipronged Needle: Efficacy and Safety

    SciTech Connect

    Ho, C.S. Kachura, J.R.; Gallinger, S.; Grant, D.; Greig, P.; McGilvray, I.; Knox, J.; Sherman, M.; Wong, F.; Wong, D.

    2007-04-15

    Fine needles with an end hole or multiple side holes have traditionally been used for percutaneous ethanol injection (PEI) of hepatomas. This study retrospectively evaluates the safety and efficacy of PEI of unresectable medium-to-large (3.5-9 cm) hepatomas using a multipronged needle and with conscious sedation. Twelve patients, eight men and four women (age 51-77 years; mean: 69) received PEI for hepatomas, mostly subcapsular or exophytic in location with average tumor size of 5.6 cm (range: 3.5-9.0 cm). Patients were consciously sedated and an 18G retractable multipronged needle (Quadrafuse needle; Rex Medical, Philadelphia, PA) was used for injection under real-time ultrasound guidance. By varying the length of the prongs and rotating the needle, the alcohol was widely distributed within the tumor. The progress of ablation was monitored by contrast-enhanced ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) after each weekly injection and within a month after the final (third) injection and 3 months thereafter. An average total of 63 mL (range: 20-154 ml) of alcohol was injected per patient in an average of 2.3 sessions. Contrast-enhanced CT, ultrasound, or MRI was used to determine the degree of necrosis. Complete necrosis was noted in eight patients (67%), near-complete necrosis (90-99%) in two (16.7%), and partial success (50-89%) in two (16.7%). Follow-up in the first 9 months showed local recurrence in two patients and new lesions in another. There was no mortality. One patient developed renal failure, liver failure, and localized perforation of the stomach. He responded to medical treatment and surgery was not required for the perforation. One patient had severe postprocedural abdominal pain and fever, and another had transient hyperbilirubinemia; both recovered with conservative treatment. PEI with a multipronged needle is a new, safe, and efficacious method in treating medium-to-large-sized hepatocellular carcinoma under conscious

  18. Using medical student observers of infection prevention, hand hygiene, and injection safety in outpatient settings: A cross-sectional survey.

    PubMed

    Thompson, Deborah; Bowdey, Lisa; Brett, Meghan; Cheek, James

    2016-04-01

    Health care-associated infection outbreaks have occurred in outpatient settings due to lapses in infection prevention. However, little is known about the overall infection prevention status in outpatient environments. A cross-sectional design was employed to assess infection prevention policies and practices at 15 outpatient sites across New Mexico in 2014 during a medical student outpatient rotation. A standardized infection prevention checklist was completed via staff interview; observations of injection safety practices and hand hygiene behavior were conducted. Aggregate data were analyzed using Excel (Microsoft, Redmond, WA) and Stata (version 12.1, Stata Corp, College Station, TX) statistical software. Medical practice staff interviews reported a mean of 92.8% (median, 96.7%; range, 75.0%-98.9%) presence of recommended policies and practices. One hundred sixty-three injection safety observations were performed that revealed medication vial rubber septums were disinfected with alcohol 78.4% (95% confidence interval [CI], 71.1%-84.7%) of the time before piercing. Three hundred thirty hand hygiene observations revealed 33.9% (95% CI, 28.8%-39.1%) use of alcohol-based handrub, 29.1% (95% CI, 24.2%-34.0%) use of soap and water, and 37.0% (95% CI, 31.8%-42.4%) use of no hand hygiene. These findings support the need for ongoing infection prevention quality improvement initiatives in outpatient settings and underscore the importance of assessing both self-report and observed behavior of infection prevention compliance. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  19. Biodistribution and safety assessment of AAV2-GAD following intrasubthalamic injection in the rat

    PubMed Central

    Fitzsimons, Helen L.; Riban, Veronique; Bland, Ross J.; Wendelken, Jennifer L.; Sapan, Christine V.; During, Matthew J.

    2010-01-01

    Background The steps necessary to translate promising new biological therapies to the clinic are poorly documented. For gene therapy there are unique aspects that need to be addressed in biodistribution studies. Notably, spread of the vector beyond the intended target cells or tissue may result in persistent unwanted biological activity or unpredictable biological events, thus it is critical to evaluate risks associated with viral vector-mediated gene transfer prior to embarking on human clinical trials. Methods Here we present a rodent study comprising of a comprehensive assessment of vector biodistribution through the brain, blood and major organs of rats injected into the subthalamic nucleus with recombinant adeno-associated virus (AAV) expressing glutamic acid decarboxylase (GAD). In addition, behavioral and histological analyses were also performed. Results AAV genomes were not detected in blood or CSF, and did not disseminate to organs outside of the brain in the majority of animals. In the brain, an average 97.3% of AAV2-GAD genomes were restricted to the area of the ipsilateral STN. There were no discernable effects of AAV2-GAD on general health and behavioral assessment of the animals did not reveal any alteration in general behavior, exploration, locomotion or motor symmetry. Conclusions This study met FDA requirements, in addition to efficacy and toxicity studies in rodents and non-human primates, to support and supplement a Phase II clinical trial for gene transfer of AAV2-GAD to the human STN for the potential therapy of Parkinson’s disease. PMID:20352617

  20. Effectiveness and safety of local adalimumab injection in patients with fistulizing perianal Crohn's disease: a pilot study.

    PubMed

    Tonelli, Francesco; Giudici, Francesco; Asteria, Corrado Rosario

    2012-08-01

    Various blockers of tumor necrosis factor-α are available for treatment of Crohn's disease. Randomized controlled trials have demonstrated the effects of systemic therapy with adalimumab, a fully humanized monoclonal antibody against tumor necrosis factor-α. The aim of this study was to investigate the effectiveness and safety of local injection of adalimumab along the fistula in the treatment of perianal Crohn's disease. This was a prospective, uncontrolled, open-label observational study performed at a university tertiary care center. A total of 12 outpatients (9 women, 3 men) treated for fistulizing perianal Crohn's disease between 2009 and 2010 were enrolled. The mean age was 43.5 (range, 27-59) years. The fistula was classified as anovaginal in 3 patients, transsphincteric in 7 patients (low in 2, high in 5), and complex (multiple tracts) in 2 patients. Pikarsky's Perianal Crohn's Disease Activity Index was used to evaluate severity of the perianal disease. Adalimumab was injected locally along the fistula tract and around the internal orifice every 2 weeks. The primary end point of the study was the proportion of patients in whom complete or improved healing of fistulas was observed at follow-up, with improvement based on the number of daily changes of sanitary pads. The median number of injections per patient was 7 (range, 4-16). The mean length of follow-up was 17.5 (range, 5-30) months; 75% of patients (9 of 12) reached complete cessation of fistula drainage, and 3 patients (25%), all with transsphincteric fistula, showed improvement. Comparison of overall follow-up scores on the Perianal Crohn's Disease Activity Index with baseline showed significant improvement (p = 0.002). No adverse side effects were noted. The study was limited by its small sample size and by the absence of a control group. This pilot study suggests that a high local concentration of adalimumab favors prompt and definitive healing of the fistulous tract in patients with perianal

  1. The efficacy and safety of urethral injection therapy for urinary incontinence in women: a systematic review

    PubMed Central

    Matsuoka, Priscila Katsumi; Locali, Rafael Fagionato; Pacetta, Aparecida Maria; Baracat, Edmund Chada; Haddad, Jorge Milhem

    2016-01-01

    To evaluate the efficacy and safety of different bulking agents for treating urinary incontinence in women, a systematic review including only randomized controlled trials was performed. The subjects were women with urinary incontinence. The primary outcomes were clinical and urodynamic parameters. The results were presented as a weighted mean difference for non-continuous variables and as relative risk for continuous variables, both with 95% confidence intervals. Initially, 942 studies were identified. However, only fourteen eligible trials fulfilled the prerequisites. Altogether, the review included 1814 patients in trials of eight different types of bulking agents, and all studies were described and analyzed. The measured outcomes were evaluated using a large variety of instruments. The most common complications of the bulking agents were urinary retention and urinary tract infection. Additionally, there were certain major complications, such as one case of death after use of autologous fat. However, the lack of adequate studies, the heterogeneous populations studied, the wide variety of materials used and the lack of long-term follow-up limit guidance of practice. To determine which substance is the most suitable, there is a need for more randomized clinical trials that compare existing bulking agents based on standardized clinical outcomes. PMID:26934239

  2. Proposed and existing passive and inherent safety-related structures, systems, and components (building blocks) for advanced light-water reactors

    SciTech Connect

    Forsberg, C.W.; Moses, D.L.; Lewis, E.B.; Gibson, R.; Pearson, R.; Reich, W.J.; Murphy, G.A.; Staunton, R.H.; Kohn, W.E.

    1989-10-01

    A nuclear power plant is composed of many structures, systems, and components (SSCs). Examples include emergency core cooling systems, feedwater systems, and electrical systems. The design of a reactor consists of combining various SSCs (building blocks) into an integrated plant design. A new reactor design is the result of combining old SSCs in new ways or use of new SSCs. This report identifies, describes, and characterizes SSCs with passive and inherent features that can be used to assure safety in light-water reactors. Existing, proposed, and speculative technologies are described. The following approaches were used to identify the technologies: world technical literature searches, world patent searches, and discussions with universities, national laboratories and industrial vendors. 214 refs., 105 figs., 26 tabs.

  3. Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

    PubMed

    Ai, Qinghua; Zhang, Wen; Xie, Yanming; Huang, Wenhua; Liang, Hong; Cao, Hui

    2014-08-01

    To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. This study introduces "get full access" to the flow of information on

  4. A global health partnership's use of time-limited support to catalyze health practice change: the case of GAVI's Injection Safety Support.

    PubMed

    Levin, Ann; Fang, Arnold; Hansen, Peter M; Pyle, David; Dia, Ousmane; Schwalbe, Nina

    2010-09-27

    This paper presents the findings of a study to assess the effectiveness and sustainability of a GAVI (Global Alliance of Vaccines and Immunization) sponsored, time-limited Injection Safety (INS) support. The support came in two forms: 1) in-kind, in the form of AD syringes and safety boxes, and 2) in cash, for those countries that already had a secure, multi-year source of AD syringes and safety boxes, but proposed to use INS support to strengthen their injection safety activities. In total, GAVI gave INS support for a three-year period to 58 countries: 46 with commodities and 12 with cash support. To identify variables that might be associated with financial sustainability, frequencies and cross-tabulations were run against various programmatic and socio-economic variables in the 58 countries. All but two of the 46 commodity-recipient countries were able to replace and sustain the use of AD syringes and safety boxes after the end of their GAVI INS support despite the fact that standard disposable syringes are less costly than ADs (10-15 percent differential). In addition, all 12 cash-recipient countries continued to use AD syringes and safety boxes in their immunization programs in the years following GAVI INS assistance. At the same time, countries were often not prepared for the increased waste management requirements associated with the use of the syringes, suggesting the importance of anticipating challenges with the introduction of new technologies. The sustained use of AD syringes in countries receiving injection safety support from GAVI, in a majority of cases through government financing, following the completion of three years of time-limited support, represents an early indication of how GHPs can contribute to improved health outcomes in immunization safety in the world's poorest countries in a sustainable way.

  5. Assessment of safety, accuracy, and human CD34+ cell retention after intramyocardial injections with a helical needle catheter in a porcine model.

    PubMed

    Kumar, Arun; Haralampus, Chris A; Hughes, Micah; Rouy, Didier; Cresswell, Nate; Braun, Ryan; Turner, David; Amrani, David; Motlagh, Delara; Schaer, Gary L

    2013-05-01

    Assess accuracy of Helix injections via fluoroscopic-mapping and evaluate delivery safety. Percutaneous intramyocardial-delivery of agents must be safe and accurate; retention is also important. A delivery system (Helical Infusion/Morph Guide-Catheter, Biocardia Inc) has been developed to improve maneuverability and stability of catheter-needle-myocardium intersection. Accuracy and safety: 12 swine underwent LV and coronary angiography via 8F sheath. Targeted delivery was assigned into LAD, LCX, or RCA. System was advanced into LV and 6 targeted intramyocardial dye injections (5 mm apart) delivered using fluoroscopy. After euthanization, hearts underwent gross and histologic evaluation. Retention was assessed by iron-oxide and fluorochrome labeled CD34+ cells. Cells were injected into 6 swine using same techniques. Delivery system was advanced into LV, and injections delivered using fluoroscopy. Euthanization was performed at 2 hr and hearts formalin fixed. MRI was performed on 6 treated hearts and 4 untreated controls. Blinded analysis performed by 2 radiologists. Two treated hearts underwent immunohistological analysis. Accuracy and safety evaluation: 71/72 injections (98.6%) were within prespecified zone; 7/72 (9.7%) less than 5 mm apart. No adverse events occurred. MRI-presence of iron-oxide labeled CD34+ cells were correctly identified in 95% (19/20) of imaged injections. Anti-CD34+ antibody staining and fluorescence microscopy confirmed CD34+ cells in myocardium. Histology confirmed cell viability at fixation. Helix system was accurate and safe. Retention of CD34+ cells was confirmed by MRI and immunohistology. Further preclinical studies are needed to characterize retention over time and quantify efficiency. Studies are needed to confirm accuracy, safety, and retention in humans. Copyright © 2012 Wiley Periodicals, Inc.

  6. Assessment of a large break loss of coolant accident scenario requiring operator action to initiate safety injection

    SciTech Connect

    Grendys, R.C.; Nissley, M.E.; Baker, D.C.

    1996-11-01

    As part of the licensing basis for a nuclear power plant, the acceptability of the Emergency Core Cooling Systems (ECCS) following a postulated Loss-of-Coolant Accident (LOCA) as described in the Code of Federal Regulations (CFR), Title 10, Chapter 1, Part 50.46, must be verified. The LOCA analysis is performed with an acceptable ECCS Evaluation Model and results must show compliance with the 10 CFR 50.46 acceptance criteria. Westinghouse Electric Corporation performs Large and Small Break LOCA and LOCA-related analyses to support the licensing basis of various nuclear power plants and also performs evaluations against the licensing basis analyses as required. Occasionally, the need arises for the holder of an operating license of a nuclear power plant to submit a Licensee Event Report (LER) to the US Nuclear Regulatory Commission (USNRC) for any event of the type described in the Code of Federal Regulations, Title 10, Chapter 1, Part 50.73. To support the LER, a Justification for Past Operation (JPO) may be performed to assess the safety consequences and implications of the event based on previous operating conditions. This paper describes the work performed for the Large Break LOCA to assess the impact of an event discovered by Florida Power and Light and reported in LER-94-005-02. For this event, it was determined that under certain circumstances, operator action would have been required to initiate safety injection (SI), thus challenging the acceptability of the ECCS. This event was specifically addressed for the Large Break LOCA by using an advanced thermal hydraulic analysis methodology with realistic input assumptions.

  7. Evaluation of the safety and efficiency of novel metallic implant scaler tips manufactured by the powder injection molding technique.

    PubMed

    Chun, Kyung A; Kum, Kee-Yeon; Lee, Woo-Cheol; Baek, Seung-Ho; Choi, Hae-Won; Shon, Won-Jun

    2017-07-11

    Although many studies have compared the properties of ultrasonic scaling instruments, it remains controversial as to which is most suitable for implant scaling. This study evaluated the safety and efficiency of novel metallic ultrasonic scaler tips made by the powder injection molding (PIM) technique on titanium surfaces. Mechanical instrumentation was carried out using four types of metal scaler tips consisting of copper (CU), bronze (BR), 316 L stainless steel (316 L), and conventional stainless steel (SS) tips. The instrumented surface alteration image of samples was viewed with scanning electron microscope (SEM) and surface profile of the each sample was investigated with confocal laser scanning microscopy (CLSM). Arithmetic mean roughness (Ra) and maximum height roughness (Rmax) of titanium samples were measured and dissipated power of the scaler tip was estimated for scaling efficiency. The average Ra values caused by the 316 L and SS tip were about two times higher than those of the CU and BR tips (p < 0.05). The Rmax value showed similar results. The efficiency of the SS tip was about 3 times higher than that of CU tip, the 316 L tip is about 2.7 times higher than that of CU tip, and the BR tip is about 1.2 times higher than that of CU tip. Novel metallic bronze alloy ultrasonic scaler tip minimally damages titanium surfaces, similar to copper alloy tip. Therefore, this bronze alloy scaler tip may be promising instrument for implant maintenance therapy.

  8. Assessment of Knowledge and Practices regarding Injection Safety and Related Biomedical Waste Management amongst Interns in a Tertiary Care Teaching Hospital, Delhi.

    PubMed

    Acharya, Anita Shankar; Priyanka; Khandekar, Jyoti; Bachani, Damodar

    2014-01-01

    Injuries caused by needle sticks and sharps due to unsafe injection practices are the most common occupational hazard amongst health care personnel. The objectives of our study were to determine the existing knowledge and practices of interns and change in their level following an information education and communication (IEC) package regarding safe injection practices and related biomedical waste management and to determine the status of hepatitis B vaccination. We conducted a follow-up study among all (106) interns in a tertiary care teaching hospital, Delhi. A predesigned semistructured questionnaire was used. IEC package in the form of hands-on workshop and power point presentation was used. A highly significant (P < 0.001) improvement in the knowledge of interns was observed after intervention with respect to the "three criteria of a safe injection" and cleaning of injection site. Thus, the baseline knowledge of interns was good in certain aspects of injection safety, namely, diseases transmitted by unsafe injections and their prevention. We conclude that IEC intervention package was effective in significantly improving the interns' knowledge regarding safe injection practices and biomedical waste management. Almost two-thirds of interns were immunised against hepatitis B before the intervention and this proportion rose significantly after the intervention.

  9. [Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Xu, Wen-fu

    2015-12-01

    This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.

  10. Solitary pulse-on-demand production by optical injection locking of passively Q-switched InGaN diode laser near lasing threshold

    SciTech Connect

    Zeng, X. E-mail: dmitri.boiko@csem.ch; Stadelmann, T.; Grossmann, S.; Hoogerwerf, A. C.; Boïko, D. L. E-mail: dmitri.boiko@csem.ch; Sulmoni, L.; Lamy, J.-M.; Grandjean, N.

    2015-02-16

    In this letter, we investigate the behavior of a Q-switched InGaN multi-section laser diode (MSLD) under optical injection from a continuous wave external cavity diode laser. We obtain solitary optical pulse generation when the slave MSLD is driven near free running threshold, and the peak output power is significantly enhanced with respect to free running configuration. When the slave laser is driven well above threshold, optical injection reduces the peak power. Using standard semiconductor laser rate equation model, we find that both power enhancement and suppression effects are the result of partial bleaching of the saturable absorber by externally injected photons.

  11. Comparison of safety and efficacy of the early injection of atropine during dobutamine stress echocardiography with the conventional protocol.

    PubMed

    Tsutsui, Jeane M; Osório, Altamiro F F; Lario, F Abio C; Fernandes, Daniela R A; Sodre, Gustavo; Andrade, José L; Ramires, José A F; Mathias, Wilson

    2004-12-01

    Although dobutamine-atropine stress echocardiography (DASE) is an established method for evaluating patients who have coronary artery disease (CAD), it can increase test duration and a patient's exposure to large doses of dobutamine. New protocols, including the early injection of atropine during dobutamine stress echocardiography (EA-DSE), have been proposed to decrease test duration. This study compared the safety, efficacy, and accuracy of EA-DSE with those of DASE. We retrospectively evaluated 3,163 patients who underwent DASE and 1,664 patients who underwent EA-DSE over a period of 12 years. In EA-DSE, atropine at a dose 50% stenosis) was assessed in patients who underwent quantitative angiography

  12. Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects.

    PubMed

    Li, Dong; Xie, Yun; Li, Qin; Sun, Jiaming; Jiang, Ping; Jia, Yi; Murphy, Diane K; Li, Qingfeng

    2017-01-01

    Hyaluronic acid dermal fillers are effective in correcting severe nasolabial folds (NLFs) in non-Asian populations. We assessed safety and effectiveness of Juvéderm Ultra Plus in a Chinese population. This double-blind study randomized Chinese subjects with severe NLFs to Juvéderm Ultra Plus (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (0 is "no wrinkle" and 4 is "very deep wrinkle"). Investigator-assessed responder rates (primary outcome at 6 months), NLF mean improvements, and subject-assessed responder rates and preference were assessed. Of 124 subjects randomized, 122 completed the 6-month visit. NLFs treated with Juvéderm Ultra Plus required less volume than those treated with Restylane (median [range]: 0.80 [0.3-2.0] vs 1.00 [0.3-1.9]; P<0.001). Investigator-assessed responder rates were 90.4% for Juvéderm Ultra Plus and 89.6% for Restylane, establishing noninferiority of Juvéderm Ultra Plus. Mean (SD) improvements in NLF Severity Scale scores from baseline at 6 months were 1.5 (0.75) for Juvéderm Ultra Plus and 1.6 (0.73) for Restylane. Subject-assessed responder rates were similar to investigator-assessed rates (87.3%, Juvéderm Ultra Plus; 83.9%, Restylane). Of subjects reporting a preference, 62.1% preferred Juvéderm Ultra Plus. The most common treatment site responses were swelling and tenderness; most were mild or moderate in severity and resolved without intervention. Juvéderm Ultra Plus had fewer severe treatment site responses than Restylane. In this study in Chinese subjects, Juvéderm Ultra Plus was safe and effective for correcting severe NLFs.

  13. Safety Evaluation of Chinese Medicine Injections with a Cell Imaging-Based Multiparametric Assay Revealed a Critical Involvement of Mitochondrial Function in Hepatotoxicity

    PubMed Central

    Wang, Meng; Liu, Chen-Xiang; Dong, Ran-Ran; He, Shuang; Liu, Ting-Ting; Zhao, Tie-Chan; Wang, Zhi-Long; Shen, Xi-Ya; Zhang, Bo-Li; Gao, Xiu-Mei; Zhu, Yan

    2015-01-01

    The safety of herbal medicine products has been a widespread concern due to their complex chemical nature and lack of proper evaluation methods. We have adapted a sensitive and reproducible multiparametric cell-based high-content analysis assay to evaluate the hepatic-safety of four Chinese medicine injections and validated it with classical animal-based toxicity assays. Our results suggested that the reported hepatotoxicity by one of the drugs, Fufangkushen injection, could be attributed at least in part to the interference of mitochondrial function in human HepG2 cells by some of its constituents. This method should be useful for both preclinical screen in a drug discovery program and postclinical evaluation of herbal medicine preparations. PMID:25792997

  14. Safety and efficacy of a novel injectable filler in the treatment of nasolabial folds: polymethylmethacrylate and cross-linked dextran in hydroxypropyl methylcellulose.

    PubMed

    Lee, Young Bok; Song, Eun Jong; Kim, Sang Seok; Kim, Jin Wou; Yu, Dong Soo

    2014-08-01

    Nasolabial folds are a sign of aging and increasing number of people want filler injections in their nasolabial folds to look younger. Various dermal fillers are used for the correction of nasolabial folds. Recently, a novel injectible filler, polymethylmethacrylate (PMMA) and cross-linked dextran in hydroxypropyl methylcellulose, was introduced for facial contouring. This study was designed as a six-month, prospective, single-blinded, and open-label study in two centers located in Korea. Nineteen Korean patients received the novel filler injections on both nasolabial folds. At Weeks 4, 12, and 24, the efficacy and safety of the dermal filler were evaluated by blinded-investigators using clinical photographs. The mean Wrinkle Severity Rating Scale revealed significant decrease after dermal filler injections at each study visit. The decreased Wrinkle Severity Rating Scale was maintained for 6 months (p < 0.0001). The Global Aesthetic Improvement score showed an improvement greater than 2 in 95% of the per-proto col population 24 weeks after the injections. All patients (100%) experienced an improvement of their nasolabial folds at Week 24. There were no complications related to the novel filler injection. The novel dermal filler, PMMA, and cross-linked dextran in hydroxylpropyl methylcellulose, can be another safe and effective treatment option in the treatment of nasolabial folds.

  15. Assessment of Knowledge and Practices regarding Injection Safety and Related Biomedical Waste Management amongst Interns in a Tertiary Care Teaching Hospital, Delhi

    PubMed Central

    Acharya, Anita Shankar; Priyanka; Khandekar, Jyoti; Bachani, Damodar

    2014-01-01

    Injuries caused by needle sticks and sharps due to unsafe injection practices are the most common occupational hazard amongst health care personnel. The objectives of our study were to determine the existing knowledge and practices of interns and change in their level following an information education and communication (IEC) package regarding safe injection practices and related biomedical waste management and to determine the status of hepatitis B vaccination. We conducted a follow-up study among all (106) interns in a tertiary care teaching hospital, Delhi. A predesigned semistructured questionnaire was used. IEC package in the form of hands-on workshop and power point presentation was used. A highly significant (P < 0.001) improvement in the knowledge of interns was observed after intervention with respect to the “three criteria of a safe injection” and cleaning of injection site. Thus, the baseline knowledge of interns was good in certain aspects of injection safety, namely, diseases transmitted by unsafe injections and their prevention. We conclude that IEC intervention package was effective in significantly improving the interns' knowledge regarding safe injection practices and biomedical waste management. Almost two-thirds of interns were immunised against hepatitis B before the intervention and this proportion rose significantly after the intervention. PMID:27433489

  16. Safety Study: Intraventricular Injection of a Modified Oncolytic Measles Virus into Measles-Immune, hCD46-Transgenic, IFNαRko Mice.

    PubMed

    Lal, Sangeet; Peng, Kah-Whye; Steele, Michael B; Jenks, Nathan; Ma, Hong; Kohanbash, Gary; Phillips, Joanna J; Raffel, Corey

    2016-12-01

    The modified Edmonston vaccine strain of measles virus (MV) has shown potent oncolytic efficacy against various tumor types and is being investigated in clinical trials. Our laboratory showed that MV effectively kills medulloblastoma tumor cells in both localized disease and when tumor cells are disseminated through cerebrospinal fluid (CSF). Although the safety of repeated intracerebral injection of modified MV in rhesus macaques has been established, the safety of administering MV into CSF has not been adequately investigated. In this study, we assessed the safety of MV-NIS (MV modified to express the human sodium iodide symporter protein) injected into the CSF of measles-immunized and measles virus-susceptible transgenic (CD46, IFNαRko) mice. Treated animals were administered a single intraventricular injection of 1 × 10(5) or 1 × 10(6) TCID50 (50% tissue culture infective dose) of MV-NIS. Detailed clinical observation was performed over a 90-day period. Clinically, we did not observe any measles-related toxic effects or behavioral abnormality in animals of any treated cohort. The complete blood count and blood chemistry analysis results were found to be within normal range for all the cohorts. Histologic examination of brains and spinal cords revealed inflammatory changes, mostly related to the needle track; these resolved by day 21 postinjection. To assess viral biodistribution, quantitative RT-PCR to detect the measles virus N-protein was performed on blood and brain samples. Viral RNA was not detectable in the blood as soon as 2 days after injection, and virus cleared from the brain by 45 days postadministration in all treatment cohorts. In conclusion, our data suggest that a single injection of modified MV into the CSF is safe and can be used in future therapeutic applications.

  17. [Efficacy and safety of a single intra-articular injection of 2% hyaluronic acid plus mannitol in knee osteoarthritis over a 6-month period].

    PubMed

    Borrás-Verdera, A; Calcedo-Bernal, V; Ojeda-Levenfeld, J; Clavel-Sainz, C

    2012-01-01

    To evaluate the safety and efficacy of a single intra-articular injection of 2% hyaluronic acid (HA)+mannitol in symptomatic knee osteoarthritis (KOA). Pilot, multicentre, open, non-comparative study performed in eighty patients with painful KOA, of whom 79 completed the study. They received one injection of 2ml of 2% HA+0.5% mannitol (Day 0) and were followed-up for 6 months. On Days 0, 15, 30, 60, 90, 120, 150 and 180, pain and joint function were assessed using a visual analogue scale (VAS) and WOMAC index. Efficacy and safety by investigator and patient, and rescue medication, as an indirect measure of pain, were also recorded. A significant reduction in joint pain, stiffness and functional disability compared with baseline was observed at every follow-up visit (P<.001). Joint function improved by 38.7% on Day 30, reaching 47.5% on Day 180. Rescue medication use decreased from 58.2% at baseline to 2.5% on Day 90, increasing in the last visits. Efficacy and safety were positively evaluated by investigators and patients. No serious adverse events were observed. Mild side effects were reported in 4 patients (local pain and swelling in the infiltration area). There is evidence that repeated intra-articular injections of HA improve symptoms in KOA. However, studies with a single injection of HA have shown mixed results. This study demonstrates that one single intra-articular injection of non-cross-linked HA reduces joint pain and increases function in patients with KOA over a period of at least 6 months. Copyright © 2011 SECOT. Published by Elsevier España, S.L. All rights reserved.

  18. Development and validation of THUMS version 5 with 1D muscle models for active and passive automotive safety research.

    PubMed

    Kimpara, Hideyuki; Nakahira, Yuko; Iwamoto, Masami

    2016-08-01

    Accurately predicting the occupant kinematics is critical to better understand the injury mechanisms during an automotive crash event. The objectives of this study were to develop and validate a finite element (FE) model of the human body integrated with an active muscle model called Total HUman Model for Safety (THUMS) version 5, which has the body size of the 50th percentile American adult male (AM50). This model is characterized by being able to generate a force owing to muscle tone and to predict the occupant response during an automotive crash event. Deformable materials were assigned to all body parts of THUMS model in order to evaluate the injury probabilities. Each muscle was modeled as a Hill-type muscle model with 800 muscle-tendon compartments of 1D truss and seatbelt elements covering whole joints in the neck, thorax, lumbar region, and upper and lower extremities. THUMS was validated against 36 series of post-mortem human surrogate (PMHS) and volunteer tests on frontal, lateral, and rear impacts. The muscle architectural and kinetic properties for the hip, knee, shoulder, and elbow joints were validated in terms of the moment arms and maximum isometric joint torques over a wide range of joint angles. The muscular moment arms and maximum joint torques estimated from THUMS occupant model with 1D muscles agreed with the experimental data for a wide range of joint angles. Therefore, this model has the potential to predict the occupant kinematics and injury outcomes considering appropriate human body motions associated with various human body postures, such as sitting or standing.

  19. Reducing risk of overdose with midazolam injection in adults: an evaluation of change in clinical practice to improve patient safety in England.

    PubMed

    Flood, Chris; Matthew, Linda; Marsh, Rachel; Patel, Bhavesh; Mansaray, Mariama; Lamont, Tara

    2015-02-01

    This study sought to evaluate potential reductions in risk associated with midazolam injection, a sedating medication, following a UK National Patient Safety Alert. This alert, 'Reducing risk of overdose with midazolam injection in adults', was sent to all National Health Service organizations as a Rapid Response Report detailing actions services should take to minimize risks. To evaluate any potential changes arising from this alert, a number of data sources were explored including reported incidents to a national reporting system for health care error, clinician survey and audit data, pharmaceutical purchasing patterns and feedback from National Health Service managers. Prior to the Rapid Response Report, 498 incidents were received by the National Patient Safety Agency including three deaths. Post-implementation of the Rapid Response Report (June 2009), no incidents resulting in death or severe harm had been received. All organizations reported having completed the Rapid Response Report actions. Purchase and use of risk-prone, high-strength sedating midazolam by health care organizations decreased significantly as did the increased use of safer, lower strength doses (as recommended in the Rapid Response Report). Organizations can achieve safer medication practices, better knowledge, awareness and implementation of national safer practice recommendations. Risks from inadvertent overdose of midazolam injection were reduced post-implementation of national recommendations. Ongoing monitoring of this particular adverse event will be required with a sustained patient safety message to health services to maintain awareness of the issue and reduction in the number of midazolam-related errors. © 2014 John Wiley & Sons, Ltd.

  20. Efficacy and safety of point-of-care ultrasound-guided intra-articular corticosteroid joint injections in patients with haemophilic arthropathy.

    PubMed

    Martin, E J; Cooke, E J; Ceponis, A; Barnes, R F W; Moran, C M; Holle, S; Hughes, T H; Moore, R E; von Drygalski, A

    2017-01-01

    Intra-articular corticosteroid injections are standard of care for managing joint pain secondary to osteoarthritis or rheumatoid arthritis but are rarely used in haemophilic arthropathy. We have introduced and evaluated the efficacy and safety of ultrasound-guided corticosteroid injections for pain relief in patients with haemophilic arthropathy. Ultrasound-guided intra-articular injections performed on haemophilia patients at UCSD between March 2012 and January 2016 were analysed. Needle placement and injection (40 mg triamcinolone; 3-5 mL lidocaine) were performed with musculoskeletal ultrasound and Power Doppler. Analysis included patient demographics, joint-specific parameters such as tissue hypervascularity and effusions, pain relief, and procedure-associated complications. Forty-five injections (14 ankles, 13 elbows, 18 knees) were administered in 25 patients. Advanced arthropathy with hypervascularity and/or effusions was present in 91% and 61% of joints, respectively. Ninety-one per cent of injections resulted in pain relief which was significant in 84% (>30% reduction). Median pain score was reduced from 7 of 10 to 1 of 10 (P < 0.001), usually within 24 h. Median duration of pain relief was 8 weeks (range 1-16 weeks). Haemophilia B patients experienced longer periods of relief, and high Pettersson scores were associated with shorter duration of relief. There were no procedure-associated complications. Repeat ultrasound of eight joints within 4 weeks of injection demonstrated nearly complete resolution of hypervascularity. Point-of-care ultrasound enabled intra-articular corticosteroid injections that provided highly effective, safe, and relatively long-lasting pain relief in haemophilic arthropathy. This approach should be used to improve pain management in haemophilic arthropathy. © 2016 John Wiley & Sons Ltd.

  1. Citrus/Cydonia Compositum Subcutaneous Injections versus Nasal Spray for Seasonal Allergic Rhinitis: A Randomized Controlled Trial on Efficacy and Safety

    PubMed Central

    Baars, Erik W.; Jong, Miek; Nierop, Andreas F. M.; Boers, Inge; Savelkoul, Huub F. J.

    2011-01-01

    Background. Clinical experiences in vitro and clinical studies have demonstrated the curative potency and safety of Citrus/Cydonia compositum in seasonal allergic rhinitis treatment. Objectives. To compare the efficacy and safety of two routes of administration (nasal spray versus subcutaneous injections). Methodology: Design. a national, randomised, comparative clinical trial with two parallel groups. Participants. 23 patients fulfilled the study requirements. Intervention. after a one- or two-week wash-out period, 23 patients were randomized, to a 6-week treatment period. Outcomes. immunological and symptom severity changes and safety. Immunologic outcome assessments were blinded to group assignment. 23 patients were randomized and from 22/23 patients (11 in each group) blood samples were analyzed before and after treatment. Conclusion. Both routes of administration demonstrate immunological and clinical effects, with larger inflammatory and innate immunological effects of the nasal spray route and larger allergen-specific clinical effects of the subcutaneous route, and are safe. PMID:23724234

  2. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study

    PubMed Central

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    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 3.36, 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. Conclusion Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce

  3. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    PubMed

    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.

  4. Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects

    PubMed Central

    Li, Dong; Xie, Yun; Li, Qin; Sun, Jiaming; Jiang, Ping; Jia, Yi; Murphy, Diane K.

    2017-01-01

    Background: Hyaluronic acid dermal fillers are effective in correcting severe nasolabial folds (NLFs) in non-Asian populations. We assessed safety and effectiveness of Juvéderm Ultra Plus in a Chinese population. Methods: This double-blind study randomized Chinese subjects with severe NLFs to Juvéderm Ultra Plus (24 mg/mL) in 1 NLF and Restylane injectable gel (20 mg/mL) in the other NLF. NLFs were evaluated using the validated 5-point photonumeric Allergan NLF Severity Scale (0 is “no wrinkle” and 4 is “very deep wrinkle”). Investigator-assessed responder rates (primary outcome at 6 months), NLF mean improvements, and subject-assessed responder rates and preference were assessed. Results: Of 124 subjects randomized, 122 completed the 6-month visit. NLFs treated with Juvéderm Ultra Plus required less volume than those treated with Restylane (median [range]: 0.80 [0.3–2.0] vs 1.00 [0.3–1.9]; P<0.001). Investigator-assessed responder rates were 90.4% for Juvéderm Ultra Plus and 89.6% for Restylane, establishing noninferiority of Juvéderm Ultra Plus. Mean (SD) improvements in NLF Severity Scale scores from baseline at 6 months were 1.5 (0.75) for Juvéderm Ultra Plus and 1.6 (0.73) for Restylane. Subject-assessed responder rates were similar to investigator-assessed rates (87.3%, Juvéderm Ultra Plus; 83.9%, Restylane). Of subjects reporting a preference, 62.1% preferred Juvéderm Ultra Plus. The most common treatment site responses were swelling and tenderness; most were mild or moderate in severity and resolved without intervention. Juvéderm Ultra Plus had fewer severe treatment site responses than Restylane. Conclusion: In this study in Chinese subjects, Juvéderm Ultra Plus was safe and effective for correcting severe NLFs. PMID:28203492

  5. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  6. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  7. A study on the safety evaluation of buphrenorphine administered through an autoinjector compared with manual injection using haematological and biochemical variables in rats.

    PubMed

    Sheela, D; Vijayaraghavan, R; Senthilkumar, S

    2017-09-01

    Buprenorphine drug cartridge was made for autoinjector device for use in emergency and critical situations to reduce the morbidity and mortality. Water-filled cartridges were prepared and buprenorphine was injected aseptically in the cartridge, to make 0.05 and 0.10 mg/mL. Rats were injected intraperitoneally, buprenorphine (0.3 and 0.6 mg/kg), repeatedly with the autoinjector and compared with manual injection (7 days and 14 days) using various haematological and biochemical parameters. No significant change was observed in the body weight, organ to body weight ratio and haematological variables in any of the experimental groups compared with the control group. Except serum urea and aspartate aminotransferase, no significant change was observed in glucose, cholesterol, triglycerides, bilirubin, protein, albumin, creatinine, uric acid, alanine aminotransferase, gamma glutamyltransferase and alkaline phosphatase. The autoinjectors deliver the drugs with spray effect and force for faster absorption. In the present study, the autoinjector meant for intramuscular injection was injected intraperitoneally in rats, and the drug was delivered with force on the vital organs. No significant difference was observed in the autoinjector group compared to the manual group showing tolerability and safety of the buphrenorphine autoinjector. This study shows that buprenorphine autoinjector can be considered for further research work.

  8. Appraisal of efficacy and safety of intralesional injection of high concentration of bleomycin A5 for treatment of huge macrocystic lymphatic malformations in cervical region.

    PubMed

    Xu, Da-Peng; Zhai, Qin-Kai; Cheng, Chen; Gong, He; Wang, Hong-Wei; Wang, Xu-Kai

    2014-09-01

    The objective of this study was to investigate the therapeutic effects and safety of intralesional injection of high concentration of bleomycin A5 for huge (more than 5 cm in diameter) macrocystic lymphatic malformations (LMs) in the cervical region. Thirty-two patients with huge macrocystic LMs were treated with percutaneous injection of bleomycin A5 in our department between 2006 and 2011. Among them, 13 patients had unilateral submandibular lesions, and 19 patients had lesions in anterior cervical regions. The age of patients ranged from 10 months to 29 years (mean age, 11.4 y). The concentration of the drug was as high as 2.7 mg/mL (8 mg/3 mL) with an addition of dexamethasone. The mean sessions of injection were 1.6 (1-3 sessions). Repeated injection interval was 4 to 6 weeks. The follow-up period was 6 months to 4 years after the last treatment, and the mean follow-up time was 18 months. The results were evaluated based on clinical examination and Doppler ultrasonography scan. The clinical follow-up showed excellent response in 28 of the 32 patients, whereas 4 of the 32 patients also had a satisfactory response. No serious complications were encountered. Intralesional injection of high concentration of bleomycin A5 was an effective and safe treatment of huge macrocystic LMs in the cervical region and can obtain satisfactory results esthetically and functionally without surgery.

  9. Safety study of 38,503 intravitreal ranibizumab injections performed mainly by physicians in training and nurses in a hospital setting.

    PubMed

    Hasler, Pascal W; Bloch, Sara Brandi; Villumsen, Jørgen; Fuchs, Josefine; Lund-Andersen, Henrik; Larsen, Michael

    2015-03-01

    To evaluate and to compare the safety of intravitreal ranibizumab injections performed by physicians and nurses at a single large hospital clinic in Denmark during 5 years. Retrospective, interventional, non-comparative study. All eyes that underwent a protocolized ranibizumab injection procedure performed in an operating room mainly by nurses and physicians in their first year of ophthalmology training. A total of 4623 eyes in 3679 patients with subretinal neovascularization secondary to a variety of retinal diseases, mainly neovascular AMD treated with intravitreal therapy (IVT) at the Glostrup Hospital from January 1, 2007 to December 31, 2011 with a mean follow-up of 12.2 months (95% confidence interval: 11.9-12.6). Frequency of endophthalmitis, traumatic cataract, intraocular haemorrhage and retinal detachment from 2007 to 2012. Overall, 38,503 intravitreal ranibizumab injections were performed in 4623 eyes. Injections were performed by nurses (32.5%), ophthalmology residents (61.3%) and vitreoretinal surgeons (6.2%). Severe complications to treatment were observed in 17 eyes: Endophthalmitis (14 eyes, 0.36 ‰ of injections whereof seven cases were culture-positive), anterior uveitis (one eye, 0.026 ‰), traumatic cataract (one eye, 0.026 ‰) and rhegmatogenous retinal detachment (one eye, 0.026 ‰). Retinal pigment epithelial tears were registered in 14 eyes in 14 subjects within the first year of treatment with ranibizumab. Of the 14 cases of endophthalmitis, seven occurred within a period of 5 weeks in 2010 when occasionally abnormal needle outflow resistance prompted the needle replacement in the operating room. No drug-related adverse events were recorded. Intravitreal ranibizumab injection performed by nurses and physicians without preinjection topical antibiotics was associated with a rate of injection-related adverse events of 0.44 ‰. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  10. The effect and safety of intravitreal injection of ranibizumab and bevacizumab on the corneal endothelium in the treatment of diabetic macular edema.

    PubMed

    Guzel, Huseyin; Bakbak, Berker; Koylu, Mehmet Talay; Gonul, Saban; Ozturk, Banu; Gedik, Sansal

    2017-03-01

    To investigate the effect and safety of intravitreal injection (IVI) of bevacizumab and ranibizumab on corneal endothelial cell count and morphology in patients with diabetic macular edema. A total of 60 eyes from 60 consecutive patients who received 0.5 mg/0.05 ml IVIs of bevacizumab (n = 30, IVB group) or 1.25 mg/0.05 ml ranibizumab (n = 30, IVR group) for three consecutive months were investigated prospectively. Specular microscopy was performed to evaluate endothelial cell count, the percentage of hexagonal cells (pleomorphism), and the coefficient of variation of the cell size (polymegathism); optical biometry was performed to evaluate central corneal thickness. Results before injection and 1 month after the first and third injections were compared. The groups were matched for age (p = 0.11) and gender (p = 0.32). There was no significant difference in endothelial cell count (IVB group, p = 0.66; IVR group, p = 0.74), pleomorphism (IVB group, p = 0.44; IVR group, p = 0.88) and polymegathism (IVB group, p = 0.21; IVR group, p = 0.24) before injection or 1 month after the first and third injections. There was also no difference in central corneal thickness (IVB group, p = 0.15; IVR group, p = 0.58) before injection or 1 month after the first and third injections. Monthly 1.25 mg/0.05 ml IVIs of bevacizumab or 0.5 mg/0.05 ml of ranibizumab for three consecutive months in the treatment of diabetic macular edema does not affect corneal morphology and has no harmful effects on the endothelium.

  11. Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe.

    PubMed

    Yang, Bing-Bing; Morrow, Phuong Khanh; Wu, Xikun; Moxness, Michael; Padhi, Desmond

    2015-06-01

    For patients with clinically significant risk of febrile neutropenia, pegfilgrastim administration should occur the day after myelosuppressive chemotherapy; however, a variety of factors may preclude patients from returning to the clinic the next day for pegfilgrastim administration, necessitating other strategies. This study compared the pharmacokinetics and safety of pegfilgrastim administered via an on-body injector applied to the subject's skin versus manual injection using a prefilled syringe. Healthy subjects aged 18-50 years were randomized 1:1 to receive a single 6-mg subcutaneous pegfilgrastim dose from an on-body injector or a prefilled syringe. Blood for pharmacokinetic measurements was collected at baseline and prespecified time points after pegfilgrastim administration; safety was assessed throughout the 6-week study. Primary endpoints were maximum concentration (C max) and area under the concentration curve from time 0 to infinity (AUC0-inf). Secondary endpoints included safety, tolerability, and immunogenicity. Pegfilgrastim mean AUC0-inf values for the on-body injector (n = 125) and manual injection (n = 128) were 10,900 and 11,100 h ng/mL, respectively; mean C max values were 248 and 262 ng/mL, respectively. The least squares geometric mean ratios were 0.97 for C max and 1.00 for AUC0-inf; the corresponding 90 % CIs were within the prespecified range (0.80-1.25), indicating comparable pegfilgrastim pharmacokinetics between delivery methods. Treatment-emergent adverse events (AEs) were similar between groups (injector, 86 %; manual, 85 %). Injector- or syringe-related AEs were more prevalent with the injector (13 %; manual, 4 %); none were serious. No pegfilgrastim-neutralizing antibodies were detected. Pegfilgrastim pharmacokinetics and safety were comparable between the on-body injector and manual injection groups.

  12. The reporting completeness of a passive safety surveillance system for pandemic (H1N1) 2009 vaccines: a capture-recapture analysis.

    PubMed

    Huang, Wan-Ting; Huang, Wei-I; Huang, Yu-Wen; Hsu, Chien-Wen; Chuang, Jen-Hsiang

    2012-03-09

    Adverse events following pandemic (H1N1) 2009 vaccines ("2009 H1N1 vaccines") in Taiwan were passively reported to the National Adverse Drug Reaction Reporting System. To evaluate the completeness of spontaneous reporting, cases of death, Guillain-Barré syndrome (GBS), convulsion, Bell's palsy, and idiopathic thrombocytopenic purpura (ITP) after 2009 H1N1 vaccination that occurred between November 1, 2009 and August 31, 2010 were selected from the National Adverse Drug Reaction Reporting System (NADRRS) database and an additionally constructed nationwide large-linked database (LLDB), and matched on a unique personal identifier, date of vaccination (within ±7 days), and date of diagnosis (within ±7 days). Overall, matches occurred between the two data sources included 21 for death, 5 for GBS, 19 for convulsion, 22 for Bell's palsy, and 5 for ITP. The Chapman capture-recapture estimated spontaneous reporting completeness within 0-42 days of vaccination was 4% for death, 71% for GBS, 3% for convulsion, 9% for Bell's palsy, and 15% for ITP. For the interval ≥43 days after vaccination, reporting completeness was 0.1% for death, 14% for GBS, 0.1% for convulsion, <0.1% for Bell's palsy, and 0% for ITP. The estimated-to-expected ratio for Bell's palsy in the interval 0-42 days after vaccination was 1.48 (95% CI 1.11-1.98). Reporting completeness was higher for GBS than other adverse events after 2009 H1N1 vaccination. Linking the NADRRS to existing data sources in a capture-recapture analysis can be considered as an alternative to enhance Taiwan's postlicensure safety assessment of other routine vaccines. Nevertheless, the possibility of an increased risk for Bell's palsy detected by capture-recapture analyses needs further evaluation by controlled studies.

  13. Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

    PubMed

    Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

    2015-03-01

    Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

  14. Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction.

    PubMed

    Austeng, Dordi; Morken, Tora Sund; Bolme, Stine; Follestad, Turid; Halsteinli, Vidar

    2016-10-01

    Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) now improve or stabilize visual acuity in a number of previously untreatable eye diseases, of which the main are age-related macular degeneration, retinal vein occlusion and diabetic macular edema. Most patients require multiple injections over lengthy periods of time and the prevalence of treatable conditions is increasing. Anti-VEGF IVI normally administered by physicians, therefore represent a considerable workload on ophthalmologic clinics and will continue to do so in the near future. Nurse-administered IVI may relieve this workload, but the safety, cost and patient satisfaction of such an extended role for nurses in ophthalmologic clinics has not earlier been investigated. To investigate these outcomes following independent anti-VEGF IVI by trained nurses, a noninferiority randomized controlled trial is being conducted. Patients eligible for anti-VEGF treatment, minimum 304, are recruited and randomized to IVI administration by either trained nurses or physicians. The primary outcome is safety, measured by difference in mean change in visual acuity between the two groups during an observation period of 12 months. Secondary outcomes are incidence of ocular adverse events, cost per patient and patient satisfaction. This study protocol describes the design of the first randomized controlled trial of nurse-administered IVI of anti-VEGF. The study is designed to examine safety, cost and patient satisfaction during 12 months follow-up. ClinicalTrials.gov NCT02359149 . Registered February 4, 2015.

  15. The Efficacy and Safety of Concurrent Collagenase Clostridium Histolyticum Injections for 2 Dupuytren Contractures in the Same Hand: A Prospective, Multicenter Study.

    PubMed

    Gaston, R Glenn; Larsen, Søren Erik; Pess, Gary M; Coleman, Stephen; Dean, Brian; Cohen, Brian M; Kaufman, Gregory J; Tursi, James P; Hurst, Lawrence C

    2015-10-01

    To evaluate efficacy and safety of concurrent administration of 2 collagenase clostridium histolyticum (CCH) injections to treat 2 joints in the same hand with Dupuytren fixed flexion contractures (FFCs). Patients with 2 or more contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same hand (1 injection per affected joint) during the same visit. Finger extension was performed approximately 24, 48, or 72 or more hours later. Changes in FFC and range of motion, incidence of clinical success (FFC ≤ 5°), and adverse events (AEs) were summarized. The study enrolled 715 patients (725 treated joint pairs), and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean total FFC (sum of 2 treated joints) decreased 74%, from 98° to 27°. Mean total range of motion increased from 90° to 156°. The incidence of clinical success was 65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. Most treatment-related AEs were mild to moderate, resolving without intervention; the most common were swelling of treated extremity, contusion, and pain in extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and safety were similar regardless of time to finger extension. Collagenase clostridium histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint, with the exception of skin laceration. The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint. Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints, and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment. Copyright © 2015 American

  16. Efficacy and safety of collagenase clostridium histolyticum injection for Dupuytren contracture: short-term results from 2 open-label studies.

    PubMed

    Witthaut, Jörg; Jones, Graeme; Skrepnik, Nebojsa; Kushner, Harvey; Houston, Anthony; Lindau, Tommy R

    2013-01-01

    The JOINT I (United States) and JOINT II (Australia and Europe) studies evaluated the efficacy and safety of collagenase clostridium histolyticum (CCH) injection for the treatment of Dupuytren contracture. Both studies used identical open-label protocols. Patients with fixed-flexion contractures of metacarpophalangeal (MCP) (20° to 100°) or proximal interphalangeal (PIP) joints (20° to 80°) could receive up to three 0.58-mg CCH injections per cord (up to 5 total injections per patient). We performed standardized finger extension procedures to disrupt injected cords the next day, with follow-up 1, 2, 6, and 9 months thereafter. The primary end point (clinical success) was reduction in contracture to within 0° to 5° of full extension 30 days after the last injection. Clinical improvement was defined as 50% or more reduction from baseline contracture. Dupuytren cords affecting 879 joints (531 MCP and 348 PIP) in 587 patients were administered CCH injections at 14 U.S. and 20 Australian/European sites, with similar outcomes in both studies. Clinical success was achieved in 497 (57%) of treated joints using 1.2 ± 0.5 (mean ± SD) CCH injections per cord. More MCP than PIP joints achieved clinical success (70% and 37%, respectively) or clinical improvement (89% and 58%, respectively). Less severely contracted joints responded better than those more severely contracted. Mean change in contracture was 55° for MCP joints and 25° for PIP joints. With average contracture reductions of 73% and improvements in range of motion by 30°, most patients (92%) were "very satisfied" (71%) or "quite satisfied" (21%) with treatment. Physicians rated change from baseline as "very much improved" (47%) or "much improved" (35%). The CCH injections were well tolerated, causing no tendon ruptures or systemic reactions. Collagenase clostridium histolyticum was an effective, minimally invasive option for the treatment of Dupuytren contracture of a broad range of severities. Most

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

    PubMed

    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.

  18. Thermal-hydraulic modeling needs for passive reactors

    SciTech Connect

    Kelly, J.M.

    1997-07-01

    The U.S. Nuclear Regulatory Commission has received an application for design certification from the Westinghouse Electric Corporation for an Advanced Light Water Reactor design known as the AP600. As part of the design certification process, the USNRC uses its thermal-hydraulic system analysis codes to independently audit the vendor calculations. The focus of this effort has been the small break LOCA transients that rely upon the passive safety features of the design to depressurize the primary system sufficiently so that gravity driven injection can provide a stable source for long term cooling. Of course, large break LOCAs have also been considered, but as the involved phenomena do not appear to be appreciably different from those of current plants, they were not discussed in this paper. Although the SBLOCA scenario does not appear to threaten core coolability - indeed, heatup is not even expected to occur - there have been concerns as to the performance of the passive safety systems. For example, the passive systems drive flows with small heads, consequently requiring more precision in the analysis compared to active systems methods for passive plants as compared to current plants with active systems. For the analysis of SBLOCAs and operating transients, the USNRC uses the RELAP5 thermal-hydraulic system analysis code. To assure the applicability of RELAP5 to the analysis of these transients for the AP600 design, a four year long program of code development and assessment has been undertaken.

  19. Report on bioventing of petroleum contaminated soils at 108-3C: Active extraction and passive injection (barometric pumping) of a gaseous nutrient

    SciTech Connect

    Kastner, J.R.; Lombard, K.; Radway, J.

    1997-05-01

    A bioventing system was constructed with horizontal extraction wells and vertical injection wells in an area which had previously been excavated and then backfilled. Initial in-situ respiration rates (air addition only) suggest that hydrocarbon degradation may be nutrient limited. The rate of TPH degradation was maximum (0.8-1.2 mg/kg/day) between 10-15 ft (bgs), but dropped to essentially zero 30 ft (bgs) within the contaminated zone (even though previous analysis at this depth indicated a TPH concentration of 3800 ppm). Analysis of the soil at 17 ft showed that NO{sub 3} and PO{sub 4} were below detection limits (0.5 ppm), indicating that nutrient limitation may be occurring. Nitrate levels were highest at 10 ft (bgs), correlating with the highest respiration rates. However, phosphate levels were at/or below detection levels throughout tile site (indicating possible PO{sub 4} limitation). Viable cells increased from 3 x 10{sup 6} cfu/g at 3 ft (bgs) to 1 x 10{sup 7} cfu/g at 10 ft (bgs) and remained relatively constant down to 17 ft. Cell numbers in the control area were significantly lower than in the contaminated zone (4.5 x 10{sup 3}). Gas phase nutrients (triethlyphosphate and nitrous oxide) will be injected to see if the hydrocarbon degradation rate can be increased.

  20. Efficacy and safety of hylan G-F 20 injection in treatment of knee osteoarthritis in Chinese patients: results of a prospective, multicentre, longitudinal study.

    PubMed

    Yan, C H; Chan, W L; Yuen, W H; Yung, Patrick S H; Ip, K Y; Fan, Jason C H; Chiu, K Y

    2015-08-01

    To study the efficacy and safety of single intra-articular injection of 6-mL hylan G-F 20 in Chinese patients with symptomatic knee osteoarthritis. Prospective case series. Six government hospitals in Hong Kong. Patients with primary knee osteoarthritis were recruited from six government hospitals from 1 October 2010 to 31 May 2012. All patients received 6-mL intra-articular injection of hylan G-F 20. Pain visual analogue scale, functional visual analogue scale, and 5-point Likert scale on change of pain and function were assessed. Adverse events were checked. Radiographs were taken pre-injection and at 3 months and 1 year. A total of 110 knees of 95 patients with primary knee osteoarthritis were treated. The mean age of the patients was 62 (standard deviation, 9.8) years. All patients completed 1 year of follow-up. The mean pain visual analogue scale, functional visual analogue scale, and Likert value for pain and function showed statistically significant improvements at 6 weeks, 3 months, 6 months, and 1 year compared with the pre-injection values. No significant correlations were found between changes in visual analogue scale and age, body mass index, pre-injection radiological osteoarthritis severity, serum erythrocyte sedimentation rate, or C-reactive protein. Serial radiographs did not show any changes in the radiological severity of knee osteoarthritis. Overall, 16.4% of the patients experienced mild and self-limiting adverse events. Hylan G-F 20 is a safe and effective therapy to relieve pain and improve function for up to 1 year in Chinese patients with knee osteoarthritis.

  1. Efficacy and safety of adalimumab by intra-articular injection for moderate to severe knee osteoarthritis: An open-label randomized controlled trial.

    PubMed

    Wang, Jianping

    2017-01-01

    Objective To evaluate the efficacy and safety of adalimumab (ADA) versus hyaluronic acid (HA) by intra-articular injection for moderate to severe knee osteoarthritis. Methods Fifty-six consecutive patients with moderate to severe knee osteoarthritis were randomly allocated to either the ADA group or HA group. On day 0, patients in the ADA group received 10 mg of ADA by intra-articular injection, while those in the HA group received 25 mg of HA. All patients received celecoxib at 200 mg/day for 4 weeks. The pain visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Patient Global Assessment (PGA), and Physician Global Assessment (PhGA) scores were assessed. Results At baseline, the pain VAS, WOMAC, PGA, and PhGA scores were similar between the two groups. The decrease in the pain VAS score, WOMAC pain score, WOMAC physical function score, and WOMAC total score from baseline to week 4 were greater in the ADA than HA group. A greater decrease in the PGA and PhGA scores from baseline to week 4 was noted in the ADA than HA group. No difference in adverse events was observed between the two groups. Conclusion ADA by intra-articular injection was effective and tolerated for moderate to severe knee osteoarthritis.

  2. Novel electric power-driven hydrodynamic injection system for gene delivery: safety and efficacy of human factor IX delivery in rats.

    PubMed

    Yokoo, T; Kamimura, K; Suda, T; Kanefuji, T; Oda, M; Zhang, G; Liu, D; Aoyagi, Y

    2013-08-01

    The development of a safe and reproducible gene delivery system is an essential step toward the clinical application of the hydrodynamic gene delivery (HGD) method. For this purpose, we have developed a novel electric power-driven injection system called the HydroJector-EM, which can replicate various time-pressure curves preloaded into the computer program before injection. The assessment of the reproducibility and safety of gene delivery system in vitro and in vivo demonstrated the precise replication of intravascular time-pressure curves and the reproducibility of gene delivery efficiency. The highest level of luciferase expression (272 pg luciferase per mg of proteins) was achieved safely using the time-pressure curve, which reaches 30 mm Hg in 10 s among various curves tested. Using this curve, the sustained expression of a therapeutic level of human factor IX protein (>500 ng ml(-1)) was maintained for 2 months after the HGD of the pBS-HCRHP-FIXIA plasmid. Other than a transient increase in liver enzymes that recovered in a few days, no adverse events were seen in rats. These results confirm the effectiveness of the HydroJector-EM for reproducible gene delivery and demonstrate that long-term therapeutic gene expression can be achieved by automatic computer-controlled hydrodynamic injection that can be performed by anyone.

  3. [Development of new mixing method of Busulfex injection for the purpose of improvement of medical safety method: the prefilled syringe method].

    PubMed

    Senoo, Makoto; Tajika, Kenji; Shimizu, Hisanori; Hamada, Masaki; Dobashi, Yasuo; Dobashi, Akira; Dan, Kazuo; Katayama, Shiro

    2009-06-01

    Busulfex is a new type of busulfan which can be administered intravenously. Usually it is administered over 2 hours every 6 hours. Its injection should be finished within 8 hours after mixture with a saline, which may bring some troublesome in clinical practice. We, here, introduce the prefilled-syringe method; Busulfex is filled into an injection syringe made of polypropylene beforehand under a sterile condition, and mixed with a saline just before the administration at the bed side. To evaluate the safety of this method we studied the stability of busulfan solution in the syringe physically and chemically. The drug solution was made with the same ingredients as Busulfex, filled into a syringe, and stored at 4 degrees C until use. Then, the transparency of this solution was studied with spectroscopy and the concentration of busulfan was analyzed directly by HPLC. Busulfan solution stored in non-colored injection syringe at 4 degrees C was stable for up to 96 hours both physically and chemically. We concluded that prefilled-syringe method is ease and safe way to administer Busulfex on scheduled time.

  4. The effectiveness and safety of intra-articular injection of sodium hyaluronate (500-730 kDa) in the treatment of patients with painful knee osteoarthritis.

    PubMed

    Phiphobmongkol, Vajara; Sudhasaneya, Vudhipong

    2009-10-01

    Sodium Hyaluronate (500-730 kilodalton (kDa); Hyalgan) is recommended to administer intra-articularly once a week for 3-5 weeks in patients with osteoarthritis of the knee which its efficacy has been shown, from many clinical studies, to persist for at least 6 months. However only a few studies were done in Thai patients. To assess the efficacy and safety of intra-articular Sodium Hyaluronate, administered once a week for four weeks (four injections) in Thai patients with painful Tibio-Femoral osteoarthritis of the knee over a six-month period. Thirty-one patients with painful knee osteoarthritis in grade I (32.3%) and grade II (67.7%) severity on Ahlback radiological criteria from Orthopedic Clinic in Bhumibol Adulyadej Hospital were included in this study. All patients were administered with 4-weekly injections of intra-articular Sodium Hyaluronate (500-730 kDa; Hyalgan; 20mg/2ml). Only paracetamol was permitted for escape analgesia. The efficacy parameters were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain, stiffness and physical function, intake of paracetamol, and overall efficacy judgment by investigators and patients. The occurrence of adverse event was recorded at each visit. After the second injection of Sodium Hyaluronate, all WOMAC index revealed the significant improvement from baseline (p < 0.05). The WOMAC-VAS for pain at baseline, Day 14, 28, 84, and 168 were 50.3, 33.3, 29.1, 23.1, and 21.4 mm respectively. At the end of study, most patients and investigators evaluated treatment efficacy as moderate to very effective. There was a decrease in paracetamol consumption from baseline until the last follow-up. Nine adverse events were recorded, which were transient events; most of them consisted of pain at injection site. No systemic or serious adverse event was reported. The results of this study showed the efficacy and safety of 4-weekly injections of Sodium Hyaluronate in the treatment of knee osteoarthritis in

  5. Efficacy and safety of alcohol sclerotherapy involving single-session multiple injections to treat simple renal cysts: a multicenter, prospective, randomized, controlled trial.

    PubMed

    Li, Yong-zhong; Li, Ming-xing; Wang, Tao; Yang, Li-chuan; Feng, Ping; Gou, Zhong-ping; Yuan, Jia-ying; Zhang, Wei

    2013-03-01

    Alcohol has been used for treating simple renal cysts since 1981. Since then, various observational studies have examined the technique, but they differ significantly in the details of the procedures and efficacy measures used. This has made it difficult to assess the safety and efficacy of this technique. We carried out a randomized controlled trial to evaluate the efficacy and safety of ultrasound-guided alcohol sclerotherapy involving single-session multiple injections to treat simple renal cysts. A total of 144 patients with simple renal cysts were randomly allocated to either the treatment group (ultrasound-guided percutaneous drainage and alcohol sclerotherapy with single-session multiple injections) or control group (ultrasound-guided simple percutaneous drainage). Follow-up CT scans of ablated cysts were collected 3 and 6 months after the procedure. The outcome was considered successful if cyst volume between baseline and 6 months decreased by at least 87.5%. Intention-to-treat analysis revealed an average volume reduction of 94.2% in the treatment group and 50.8% in the control group (P < 0.0001). The percentage of patients achieving successful outcomes was 88.9% (95%CI 77.0% - 100.0%) in the treatment group and 22.2% (95%CI 6.54% - 37.9%) in the control group (P < 0.0001). The corresponding results in the per-protocol analysis were an average volume reduction of 96.4% in the treatment group and 50.8% in the control group (P < 0.0001). The percentage of patients achieving a successful outcome was 94.3% (95%CI 85.6% - 100.0%) in the treatment group and 22.2% (95%CI 6.54% - 37.9%) in the control group (P < 0.0001). Alcohol sclerotherapy involving single-session multiple injections is safe and efficacious in the treatment of renal cysts.

  6. Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (Shasta study).

    PubMed

    Capone, Antonio; Singer, Michael A; Dodwell, David G; Dreyer, Richard F; Oh, Kean T; Roth, Daniel B; Walt, John G; Scott, Lanita C; Hollander, David A

    2014-02-01

    To evaluate the efficacy, safety, and reinjection interval of dexamethasone intravitreal implant (DEX implant) in branch retinal vein occlusion and central retinal vein occlusion patients receiving ≥ 2 DEX implant treatments. Multicenter (26-site), retrospective chart review study. Data were collected from baseline (at first DEX implant) through 3 months to 6 months after last DEX implant. Patients (n = 289) received 2 to 9 (mean, 3.2) DEX implants as monotherapy (29.1% of patients) or with adjunctive treatments/procedures. Mean duration of macular edema before first DEX implant was 18.4 months. Mean reinjection interval was 5.6 months. Mean peak change in best-corrected visual acuity from baseline through 4 weeks to 20 weeks after final DEX implant was +1.0 line (P < 0.001). Best-corrected visual acuity and central retinal thickness improved significantly from baseline after each of the first 6 DEX implant injections (P ≤ 0.037); 59.7% of branch retinal vein occlusion and 66.7% of central retinal vein occlusion patients achieved ≥ 2-line best-corrected visual acuity improvement. Intraocular pressure increase (≥ 10 mmHg) occurred in 32.6% of patients; 29.1% used intraocular pressure-lowering medication to treat increases associated with DEX implant. Only 1.7% of patients required incisional glaucoma surgery. Retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

  7. Safety of recombinant adeno-associated virus type 2-RPE65 vector delivered by ocular subretinal injection.

    PubMed

    Jacobson, Samuel G; Acland, Gregory M; Aguirre, Gustavo D; Aleman, Tomas S; Schwartz, Sharon B; Cideciyan, Artur V; Zeiss, Caroline J; Komaromy, Andras M; Kaushal, Shalesh; Roman, Alejandro J; Windsor, Elizabeth A M; Sumaroka, Alexander; Pearce-Kelling, Susan E; Conlon, Thomas J; Chiodo, Vincent A; Boye, Sanford L; Flotte, Terence R; Maguire, Albert M; Bennett, Jean; Hauswirth, William W

    2006-06-01

    AAV2 delivery of the RPE65 gene to the retina of blind RPE65-deficient animals restores vision. This strategy is being considered for human trials in RPE65-associated Leber congenital amaurosis (LCA), but toxicity and dose efficacy have not been defined. We studied ocular delivery of AAV-2/2.RPE65 in RPE65-mutant dogs. There was no systemic toxicity. Ocular examinations showed mild or moderate inflammation that resolved over 3 months. Retinal histopathology indicated that traumatic lesions from the injection were common, but thinning within the injection region occurred only at the two highest vector doses. Biodistribution studies at 3 months postinjection showed no vector in optic nerve or visual centers in the brain and only isolated non-dose-related detection in other organs. We also performed biodistribution studies in normal rats at about 2 weeks and 2 months postinjection and vector was not widespread outside the injected eye. Dose-response results in RPE65-mutant dogs indicated that the highest 1.5-log unit range of vector doses proved efficacious. The efficacy and toxicity limits defined in this study lead to suggestions for the design of a subretinal AAV-2/2.RPE65 human trial of RPE65-associated LCA.

  8. Passive euthanasia

    PubMed Central

    Garrard, E; Wilkinson, S

    2005-01-01

    The idea of passive euthanasia has recently been attacked in a particularly clear and explicit way by an "Ethics Task Force" established by the European Association of Palliative Care (EAPC) in February 2001. It claims that the expression "passive euthanasia" is a contradiction in terms and hence that there can be no such thing. This paper critically assesses the main arguments for the Task Force's view. Three arguments are considered. Firstly, an argument based on the (supposed) wrongness of euthanasia and the (supposed) permissibility of what is often called passive euthanasia. Secondly, the claim that passive euthanasia (so-called) cannot really be euthanasia because it does not cause death. And finally, a consequence based argument which appeals to the (alleged) bad consequences of accepting the category of passive euthanasia. We conclude that although healthcare professionals' nervousness about the concept of passive euthanasia is understandable, there is really no reason to abandon the category provided that it is properly and narrowly understand and provided that "euthanasia reasons" for withdrawing or withholding life-prolonging treatment are carefully distinguished from other reasons. PMID:15681666

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

    PubMed

    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.

  10. Recombinant human angiostatin by twice-daily subcutaneous injection in advanced cancer: a pharmacokinetic and long-term safety study.

    PubMed

    Beerepoot, Laurens V; Witteveen, Els O; Groenewegen, Gerard; Fogler, William E; Sim, B Kim Leel; Sidor, Carolyn; Zonnenberg, Bernard A; Schramel, Franz; Gebbink, Martijn F B G; Voest, Emile E

    2003-09-15

    A clinical study was performed to evaluate the pharmacokinetics (PK) and toxicity of three dose levels of the angiogenesis inhibitor recombinant human (rh) angiostatin when administered twice daily by s.c. injection. Eligible patients had cancer not amenable to standard treatments. Three groups of 8 patients received 7.5, 15, or 30 mg/m(2)/day divided in two s.c. injections for 28 consecutive days followed by a 7-day washout period. PK assessment was done at days 1 and 28. Thereafter, in absence of toxicity or a 100% increase in tumor size, treatment was continued without interruption. Median age was 53 years (range, 43-75), male:female ratio 10:14, Eastern Cooperative Oncology Group performance 0-1. At the range of doses evaluated, serum PK of all 24 of the patients showed linear relation between dose and area under the curve (0- infinity) and C(max) (reached after 2 h). Thirteen of 24 patients developed erythema at injection sites (11 patients, CTC grade 1; 2 patients, CTC grade 2) without pain or itching, spontaneously resolving within 2-3 weeks of treatment. Two patients went off study after developing hemorrhage in brain metastases, and 2 patients developed deep venous thrombosis. No other relevant treatment-related toxicities were seen, even during prolonged treatment. A panel of coagulation parameters was not influenced by rhAngiostatin treatment. Long-term (>6 months) stable disease (<25% growth of measurable uni- or bidimensional tumor size) was observed in 6 of 24 patients. Five patients received rhAngiostatin treatment for >1 year (overall median time on treatment 99 days). Long-term twice-daily s.c. treatment with rhAngiostatin is well tolerated and feasible at the selected doses, and merits additional evaluation. Systemic exposure to rhAngiostatin is within the range of drug exposure that has biological activity in preclinical models.

  11. Clinical effects and safety of treating diabetic macular edema with intravitreal injection of ranibizumab combined with retinal photocoagulation

    PubMed Central

    Yan, Panshi; Qian, Cheng; Wang, Wenzhan; Dong, Yi; Wan, Guangming; Chen, Yue

    2016-01-01

    Background This study was designed to examine the clinical effects of treating diabetic macular edema with an intravitreal injection of ranibizumab in combination with retinal photocoagulation. Methods Sixty-two cases (75 eyes) with confirmed severe proliferative diabetic retinopathy or proliferative diabetic retinopathy in combination with macular edema were randomly divided into the observation group (37 eyes were given an intravitreal injection of ranibizumab combined with retinal photocoagulation) and the control group (38 eyes received retinal photocoagulation only). Vision, fundus condition, central macular thickness, and the macular leakage area were recorded before and after treatment. Results The best-corrected visual acuity and macular leakage area were similar between the observation and control groups (P>0.05). The best-corrected visual acuity in the observation group was higher than that in the control group 3 and 6 months after treatment (P<0.05) and showed a rising tendency. The macular leakage area in the observation group was significantly lower than that in the control group 1 and 3 months after treatment (P<0.05). However, the macular leakage area was similar 6 months after treatment (P>0.05). The central macular thickness of the observation group was lower than that in the control group 1, 3, and 6 months after treatment (P<0.05). The laser energy used in the observation group was also smaller than that in the control group (P<0.05). The intraocular pressure was not significantly different between the groups (P<0.05). No patients in the two groups developed eye or systemic complications, such as glaucoma, cataract, or vitreous hemorrhage during treatment. Conclusion Intravitreal injection of ranibizumab combined with retinal photocoagulation was proven to be effective in treating diabetic macular edema as it improved vision and resulted in fewer complications. PMID:27103811

  12. Identification of UV-absorbing extractables from rubber closures used in containers of injectable powder and safety assessment of leachables in the drug.

    PubMed

    Wei, Yulei; Wu, Ying; Zhu, Tingli; Li, Zhiyan; Zhang, Yilan

    2017-05-10

    Rubber closures have been of great concern to regulatory authorities on account of their potential safety risks to patients. The aim of our work is to provide part of data about the compatibility of the injectable powder and its packaging materials for the drug registration. In this report, methodologies were established to study the system of the preparation. Firstly, three major extractables were isolated by semi-preparative HPLC method combined with silica gel-based chromatographic methods. NMR spectra including 1D NMR ((1)H, (13)C, DEPT135) and 2D NMR (COSY, HSQC, HMBC) were introduced to identify the extractables, besides HPLC, GC-MS, ESI-MS/MS and HRMS. The extractables were determined to be N-(2-(2,2,4,4-tetramethylcyclohexyl)allyl) benzo[d]thiazol-2-amine (1), 2,6-Di-tert-butyl-4-methylphenol (2) and sulfur (3) respectively. Then, to address safety concerns, approaches including QSAR analysis, the TTC and comprehensive literature evaluation methods to toxicological safety evaluation of the target compounds were established, where the safety threshold such as TTC and PDE values were developed. Finally, the migration testing of the extractables were performed to assess the leaching behavior of the rubber closures. An optimized analysis method was proposed using SPE and HPLC with an ultraviolet detector, which demonstrated good linearity, acceptable accuracy and precision. The levels of the target compounds in the powder were measured and the calculated worst case exposure of extractable 2 exceeded the TTC limit of 1.5μg/day, indicating that the products may possess potential health risks to patients. In contrast to previous studies, various NMR techniques, which were rarely applied to identify unknown extractables from rubber closures in the literature, were discussed for the structural elucidation of rubber closures extractables. Among the target compounds, extractable 1 was a new compound, whose isolation and structural elucidation were first reported here

  13. Preparation of doxorubicin-hydrochloride nanoliposomes by ethanol injection-pH gradient method and their safety evaluation.

    PubMed

    Xie, Ming; Chen, Yuxiang; Wu, Lixiang

    2013-01-01

    A new type of ethanol injection-pH gradient method was established to produce Doxorubicin-Hydrochloride Nanoliposome (DHNP). The characteristics of DHNP were examined by Zetasizer. The acute toxicity and chronic toxicity trials were conducted in Kuming mice with different doses of DHNP. The results showed that the DHNP had the uniform distribution size, diameter ranged in 140-170 nm, its entrapment rate could reach as high as 99.85%, and it was relatively stable in low temperature. The LD50 of the DHNP is 31.69 mg/kg. In the chronic toxicity study, body weight, hematocrit, the mean red blood cell volume, platelets counts and percentage of eosinophil at the dose of 6 mg/kg and 9 mg/kg groups were significantly different (p < 0.05) compared with control group, while the other parameters had no significantly difference. In the tissue analysis, pathological change was found in the lung at the treated group, and its pathological degree increased as the dose increased, while there were no other pathological changes detected in other tissues. This study demonstrates that the DHNP prepared by ethanol injection-pH gradient method possesses the advantage of uniform distribution size, high encapsulation efficiency, big drug loading rate, and its toxicity is lower than free doxorubicin.

  14. The Safety of EXPAREL ® (Bupivacaine Liposome Injectable Suspension) Administered by Peripheral Nerve Block in Rabbits and Dogs

    PubMed Central

    Richard, Brigitte M.; Newton, Paul; Ott, Laura R.; Haan, Dean; Brubaker, Abram N.; Cole, Phaedra I.; Ross, Paul E.; Rebelatto, Marlon C.; Nelson, Keith G.

    2012-01-01

    A sustained-release DepoFoam injection formulation of bupivacaine (EXPAREL, 15 mg/mL) is currently being investigated for postsurgical analgesia via peripheral nerve block (PNB). Single-dose toxicology studies of EXPAREL (9, 18, and 30 mg/kg), bupivacaine solution (Bsol, 9 mg/kg), and saline injected around the brachial plexus nerve bundle were performed in rabbits and dogs. The endpoints included clinical pathology, pharmacokinetics, and histopathology evaluation on Day 3 and Day 15 (2/sex/group/period). EXPAREL resulted in a nearly 4-fold lower C max versus Bsol at the same dose. EXPAREL was well tolerated at doses up to 30 mg/kg. The only EXPAREL-related effect seen was minimal to mild granulomatous inflammation of adipose tissue around nerve roots (8 of 24 rabbits and 7 of 24 dogs) in the brachial plexus sites. The results indicate that EXPAREL was well tolerated in these models and did not produce nerve damage after PNB in rabbits and dogs. PMID:22363842

  15. Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study.

    PubMed

    Levine, Laurence A; Cuzin, Beatrice; Mark, Stephen; Gelbard, Martin K; Jones, Nigel A; Liu, Genzhou; Kaufman, Gregory J; Tursi, James P; Ralph, David J

    2015-01-01

    Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration-approved, intralesional treatment for Peyronie's disease (PD). The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD. This phase 3, open-label study enrolled subjects who were CCH-naïve, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 CCH study. Each treatment cycle included two intralesional injections of CCH 0.58 mg, approximately 24-72 hours apart, and plaque modeling 24-72 hours after the second injection of each cycle. The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles. The co-primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score (range 0-16) from baseline to week 36. Of the 347 subjects treated with ≥1 injection, 238 had both a penile curvature measurement and a Peyronie's Disease Questionnaire response at baseline and ≥1 subsequent time point. Mean baseline penile curvature deformity was 53.0° and mean PD symptom bother was 7.3. Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity (34.4% [95% confidence interval {CI}, 31.2%, 37.6%]) and PD symptom bother score (3.3 [95% CI, 2.8, 3.7]). Most adverse events (AEs) were mild or moderate in severity and local to the penis. There were three serious treatment-related AEs, two penile hematomas and one corporal rupture; all resolved with treatment. Potentially clinically meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD. CCH was generally well tolerated, with AEs primarily transient and local to injection site. In conjunction with previous studies, the results of this open

  16. Profile of paliperidone palmitate once-monthly long-acting injectable in the management of schizophrenia: long-term safety, efficacy, and patient acceptability – a review

    PubMed Central

    González-Rodríguez, Alexandre; Catalán, Rosa; Penadés, Rafael; Garcia-Rizo, Clemente; Bioque, Miquel; Parellada, Eduard; Bernardo, Miquel

    2015-01-01

    Background and objectives Short-term studies focused on once-monthly paliperidone palmitate (PP) at doses of 25 mg eq, 50 mg eq, 75 mg eq, 100 mg eq, or 150 mg eq have shown its efficacy and tolerability in the treatment of schizophrenia patients. However, few open-label and long-term studies are available regarding this new pharmacological formulation. Thus, our main aim was to review the scientific evidence on efficacy, safety, tolerability, and preference of PP in these populations. Method Electronic searches were conducted by using PubMed and ISI Web of Knowledge databases. All relevant studies published from 2009 until January 2015 were included without any language restriction if patients met diagnostic criteria for schizophrenia, and adequate information on efficacy, safety, and tolerability of once-monthly PP was available. Results Nineteen studies were identified irrespective of the study design and duration of the follow-up period. Randomized, double-blind, placebo-controlled trials found that schizophrenia patients receiving PP showed a significant improvement in psychotic symptoms and similar adverse events compared to placebo and suggested that all doses of PP were efficacious and well tolerated. Other studies demonstrated noninferiority of PP compared to risperidone long-acting injectable in recently diagnosed schizophrenia patients, chronically ill patients, as well as in acute and nonacute symptomatic schizophrenia patients, and a similar proportion of treatment-emergent adverse events between both groups were also noted. Conclusion Several studies have demonstrated that schizophrenia patients treated with PP show higher rates of improvement of psychotic symptoms compared to placebo, and similar efficacy and tolerability outcomes were noted when comparing PP to risperidone long-acting injectable or oral, paliperidone extended release. PMID:26082620

  17. Safety assessment and therapeutic efficacy of percutaneous microwave ablation therapy combined with percutaneous ethanol injection for hepatocellular carcinoma adjacent to the gallbladder.

    PubMed

    Huang, Hui; Liang, Ping; Yu, Xiao-ling; Cheng, Zhi-gang; Han, Zhi-yu; Yu, Jie; Liu, Fang-yi

    2015-02-01

    This study sought to evaluate the safety and efficacy of ultrasound-guided (US-guided) percutaneous microwave (MW) ablation combined with percutaneous ethanol injection (PEI) to treat liver tumours adjacent to the gallbladder. A total of 136 patients with hepatocellular carcinoma (HCC) adjacent to the gallbladder, who underwent ultra-sonographically-guided percutaneous MW ablation, which was combined with PEI in 132 patients, were retrospectively assessed. The patient population characteristics, tumour features, local tumour progression and treatment were compared and analysed. The safety and efficacy of the therapy were assessed by clinical data and imaging in follow-up examinations. All patients were completely treated with two sessions; 120 patients underwent one session, 16 patients underwent two sessions. The primary technique was effective in 95.6% of the cases, according to the computed tomography (CT) or magnetic resonance imaging (MRI) in the one-month follow-up (132 of 138 sessions). PEI and other therapies were performed in the patients who had been incompletely treated (all six patients underwent PEI, and some underwent other therapies, including one transcatheter arterial chemoembolisation (TACE), one liver transplantation and two liver resections). There was a median follow-up period of 30.1 months and a range of 4 to 68 months. None of the patients had major complications. There were no treatment-related deaths. Twenty-six patients died of primary disease progression that was not directly attributable to MW ablation (19.1%, 26/136). Local tumour progression was noted in five patients (3.7%, 5/136), who had completely ablated tumours at follow-up. The patients with locally progressing tumours underwent additional therapy (three patients underwent PEI, one patient TACE, and one liver resection). Ultrasound-guided percutaneous MW ablation, in combination with percutaneous ethanol injection and thermal monitoring, is a safe and effective treatment for

  18. Assessment of Well Safety from Pressure and Temperature-Induced Damage during CO2 Injection in Deep Saline Aquifers

    NASA Astrophysics Data System (ADS)

    Singh, A. K.; Delfs, J.; Goerke, U.; Kolditz, O.

    2013-12-01

    Carbon dioxide Capture and Storage (CCS) technology is known for disposing a specific amount of CO2 from industrial release of flue gases into a suitable storage where it stays for a defined period of time in a safe way. Types of storage sites for CO2 are depleted hydrocarbon reservoirs, unmineable coal seams and saline aquifers. In this poster, we address the problem of CO2 sequestration into deep saline aquifers. The main advantage of this kind of site for the CO2 sequestration is its widespread geographic distribution. However, saline aquifers are very poorly characterized and typically located at one kilometer depth below the earth's surface. To demonstrate that supercritical CO2 injection into deep saline aquifers is technically and environmentally safe, it is required to perform thermo-hydro-mechanical analysis of failure moods with numerical models. In the poster, we present simple process-catching benchmark for testing the scenario of compressed CO2 injection into a multi- layered saline aquifer.The pores of the deformable matrix are initially filled with saline water at hydrostatic pressure and geothermal temperature conditions. This benchmark investigates (i) how the mechanical and thermal stresses enhance the permeability for CO2 migration; and (ii) subsequent failures mode, i.e., tensile, and shear failures. The tensile failure occurs when pore fluid pressure exceeds the principle stress whereas the Mohr-Coulomb failure criterion defines the shear failure mode. The thermo-hydro-mechanical (THM) model is based on a ';multi-componential flow' module . The coupled system of balance equations is solvedin the monolithic way. The Galerkin finite element approach is used for spatial discretization, whereas temporal discretization is performed with a generalized single step scheme. This numerical module has been implemented in the open-source scientific software OpenGeoSys.

  19. Effectiveness and safety of cefovecin sodium, an extended-spectrum injectable cephalosporin, in the treatment of cats with abscesses and infected wounds.

    PubMed

    Six, Robert; Cleaver, Dawn M; Lindeman, Cindy J; Cherni, Judith; Chesebrough, Robert; Papp, Georg; Skogerboe, Terry L; Weigel, Dan J; Boucher, Joseph F; Stegemann, Michael R

    2009-01-01

    To evaluate the effectiveness and safety of cefovecin sodium in the treatment of cats with naturally occurring skin infections (abscesses and infected wounds). Multicenter (26 sites), randomized, double-blind, controlled clinical trial. Client-owned cats of any breed with naturally occurring skin infections with associated clinical signs and confirmatory bacteriologic culture results. Cats with clinical signs of skin and soft tissue infection were randomly allocated to receive a single dose of cefovecin (8 mg/kg [3.6 mg/lb], SC) followed by placebo drops administered orally once daily for 14 days or 1 SC placebo injection followed by cefadroxil (22 mg/kg [10 mg/lb], PO, once daily for 14 days). Only one 14-day treatment course was permitted. Effectiveness of cefovecin in the treatment of cats with abscesses and infected wounds was similar to that of cefadroxil. At the final assessment on day 28, 97% (86/89) of cefovecin-treated cats and 91% (80/88) of cefadroxil-treated cats were considered treatment successes. There were no serious adverse events or deaths related to treatment. 1 SC injection of 8 mg of cefovecin/kg for the treatment of cats with naturally occurring skin infections (wounds and abscesses) was safe and as effective as cefadroxil administered orally at 22 mg/kg, once daily for 14 days.

  20. Efficacy and Safety of Intravesical OnabotulinumtoxinA Injection on Elderly Patients with Chronic Central Nervous System Lesions and Overactive Bladder

    PubMed Central

    Jiang, Yuan-Hong; Liao, Chun-Hou; Tang, Dong-Ling; Kuo, Hann-Chorng

    2014-01-01

    Purpose Intravesical injection of onabotulinumtoxinA is an effective treatment for overactive bladder (OAB). Nonetheless, the treatment outcome is unclear in OAB patients with central nervous system (CNS) lesions. This study evaluated the efficacy and safety of intravesical onabotulinumtoxinA treatment in elderly patients with chronic cerebrovascular accidents (CVAs), Parkinson’s disease (PD) and dementia. Materials and Methods Patients with CVA, PD, dementia, and OAB refractory to antimuscarinic therapy were consecutively enrolled in the study group. Age-matched OAB patients without CNS lesions were selected to serve as a control group. OnabotulinumtoxinA (100 U) was injected into the bladder suburothelium at 20 sites. The clinical effects, adverse events, and urodynamic parameters were assessed at baseline and 3 months post-treatment. The Kaplan-Meier method was used to compare long-term success rates between groups. Results A total of 40 patients with OAB due to CVA (23), PD (9), dementia (8) and 160 control patients were included in this retrospetive analysis. Improvement of urgency severity scale, increased bladder capacity and increased post-void residual volume were comparable between the groups at 3 months. Patients with CNS lesions did not experience increased risks of acute urinary retention and urinary tract infection; nonetheless, patients with CVA experienced a higher rate of straining to void. Long-term success rates did not differ between the patients with and without CNS lesions. Conclusion Intravesical injection of 100 U of onabotulinumtoxinA effectively decreased urgency symptoms in elderly OAB patients with CNS lesions. The adverse events were acceptable, and long-term effects were comparable to OAB patients in general. Nonetheless, the possibility of longstanding urinary retention and chronic catheterization need careful evaluation for this very vulnerable population before choosing intravesical onabotulinumtoxinA treatment. PMID:25148378

  1. Comparison of the safety and efficacy of single injection of subtenon triamcinolone and topical dexamethasone in reducing postoperative inflammation after phacoemulsification and intraocular lens implantation.

    PubMed

    Khan, Habibullah; Alam, Mumtaz; Khan, Akbar

    2016-09-01

    To compare the safety and efficacy of single injection of sub-tenon triamcinolone and topical dexamethasone in reducing post-operative inflammation after phacoemulsification and intraocular lens implantation. The randomised controlled study was conducted at Khyber Teaching Hospital, Peshawar, Pakistan, from September 2013 to February 2014. Patients who had undergone uneventful phacoemulsification with intraocular lens implantation by the same surgeon were included. Patients in Group A received 0.1% dexamethasone eye drops and those in Group B received sub-tenon triamcinolone injection (40mg/1ml). Follow-up was at 1st day, 14th day and 6 weeks post-operatively. At follow-up visit, grades of anterior chamber cells and aqueous flare were examined with slit lamp, and intraocular pressure was recorded. Of the 108 patients, each group had 54(50%) subjects. The mean age was 58.87±9.69 years (range: 33 to 84 years) in Group A and 57.77±8.93 years (range: 30 to 78 years) in Group B (p=0.544). On the first post-operative day, all the patients in both groups had some degree of inflammation in the anterior chamber. On the 14th post-operative day, anterior chamber cells were present in 4(7.4%) eyes in Group A and in 3(5.55%) eyes in Group B (p>0.999), while aqueous flare was present in 5(9.25%) eyes in Group A and 9(16.66%) eyes in Group B (p=0.391). Six weeks after the operation, no anterior chamber cells or aqueous flare was seen in any eye in either group. Sub-tenon triamcinolone injection was found to be a safe and effective alternative to topical dexamethasone for control of post-operative inflammation after phacoemulsification.

  2. Comparison of Peritendinous Hyaluronan Injections Versus Extracorporeal Shock Wave Therapy in the Treatment of Painful Achilles' Tendinopathy: A Randomized Clinical Efficacy and Safety Study.

    PubMed

    Lynen, Nils; De Vroey, Thierry; Spiegel, Imke; Van Ongeval, Frederik; Hendrickx, Niels-Jan; Stassijns, Gaëtane

    2017-01-01

    To compare the safety and efficacy of hyaluronan (HA) injections with standard extracorporeal shock wave therapy (ESWT) in the treatment of painful midportion Achilles' tendinopathy. Multinational, prospective, randomized controlled, blinded-observer trial. Ambulatory care. Adults (N=62) with Achilles' midportion tendinopathy for ≥6 weeks and a pain score of at least 40mm (Huskisson visual analog scale [VAS], 100mm) were randomized, and 59 were analyzed in the intention-to-treat data set. There were no withdrawals because of adverse effects. Two peritendinous HA injections versus 3 ESWT applications at weekly intervals. Primary efficacy criterion was changed from the Victorian Institute of Sports Assessment-Achilles' questionnaire (VISA-A) score to the percent change in pain (VAS) at 3 months posttreatment, compared with baseline values. Main secondary parameters were VISA-A, Clinical Global Impression (CGI), and clinical parameters. HA treatment provided a clinically relevant improvement in Achilles' midportion tendinopathy. A large superiority of the HA group, compared with ESWT application, was observed for percent change in pain (VAS), and this superiority was proven to be statistically significant (Mann-Whitney statistic [MW]=.7507 with P=.0030 lower than required α=.025 significance level 1-sided; Mann-Whitney U test) at 3 months posttreatment. Similar findings for HA were also observed at 4 weeks (MW=.6425, P=.0304) and 6 months (MW=.7172, P=.0018). Advantage of HA treatment was confirmed by VISA-A questionnaire, CGI, and clinical parameters. Ten adverse events, 4 in the HA group and 6 in the ESWT group, were reported, but none were classified as serious. Two peritendinous HA injections showed greater treatment success in Achilles' midportion tendinopathy compared with standard ESWT. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  3. Efficacy and safety of metronidazole injection for the treatment of infectious peritonitis, abdominal abscess and pelvic inflammatory diseases in Japan.

    PubMed

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

    2015-02-01

    Although metronidazole (MNZ) has been used worldwide for more than 4 decades as a standard therapy for trichomoniasis, anaerobic and amebic infections, resistance to MNZ is still low. MNZ is available as oral, intravenous, and vaginal formulations, but the intravenous formulation of MNZ has not been approved in Japan. We conducted a phase 3 study to evaluate the efficacy and safety of intravenous MNZ combined with ceftriaxone (CTRX) in Japanese subjects with infectious peritonitis, abdominal abscess or pelvic inflammatory diseases (PIDs) to obtain regulatory approval. A combination of MNZ/CTRX at doses of 500 mg 3 or 4 times a day/1 or 2 g twice a day was administered intravenously to a total of 38 hospitalized subjects. MNZ/CTRX was well tolerated and exhibited excellent clinical and bacteriological efficacy with clinical efficacy rates of 100% (20/20) in infectious peritonitis or abdominal abscess subjects and 90.0% (9/10) in PID subjects, and the eradication rates in infectious peritonitis or abdominal abscess subjects and PID subjects were 100% (16/16) and 100% (4/4), respectively, at the test of cure. MNZ/CTRX was effective in 1 subject in whom a metallo-β-lactamase-producing Bacteroides fragilis strain (MIC of MNZ, 2 μg/ml) was identified. The most common treatment-related adverse event was diarrhea (23.7%), followed by nausea (5.3%). No new safety signals were identified. MNZ/CTRX demonstrated excellent efficacy and was well tolerated in Japanese infectious peritonitis, abdominal abscess and PID subjects. This treatment regimen can be useful for anaerobic infections. Clinical registration number: NCT01473836. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  4. Passive emergency heat rejection concepts for CANDU reactors

    SciTech Connect

    Spinks, N.J.; Rabbat, R.M.

    1994-12-31

    A study is in progress at AECL to assess the safety and capital cost implications of a more extensive use of passive design features in CANDU reactors. The study is focussed on emergency heat rejection and applies passive design principles to enhance the independence of core cooling via the moderator, as distinct from core cooling via the emergency coolant injection system. Emergency heat rejection from the moderator and from containment is integrated via a water jacket formed in part by the cylindrical wall of a steel containment vessel. The water jacket acts as an interim heat sink and ultimately transfers its heat to the outside air. The design as described here uses an advance in fuel channel design that enables the moderator to act as a heat sink even at zero subcooling. This provides the option of passive moderator heat rejection during normal operation, and facilitates the design of passive moderator heat rejection during accidents. With two diverse and redundant emergency core cooling systems, core melt frequency is reduced to an insignificant level.

  5. Usability, Participant Acceptance, and Safety of a Prefilled Insulin Injection Device in a 3-Month Observational Survey in Everyday Clinical Practice in Australia

    PubMed Central

    Carter, John; Beilin, Jonathan; Morton, Adam; De Luise, Mario

    2009-01-01

    Background SoloSTAR® (SOL; sanofi-aventis, Paris, France) is a prefilled insulin pen device for the injection of insulin glargine and insulin glulisine. This is the first Australian survey to determine its usability, participant acceptance, and safety in clinical practice. Methods A 3-month, nonrandomized, noncomparative, observational survey in Australia was conducted in individuals with diabetes. Participants were given SOL pens containing glargine, the instruction leaflet, and a toll-free helpline number. Training was offered to all participants. Safety data, including product technical complaints (PTCs), were gathered from ongoing feedback given by the participant or health care professional (HCP) and by independent interviews conducted 6–10 weeks after study start. Results Some 2674 people consented to take part across 93 sites (150 HCPs), and 2029 participated in interviews. Of these, 52.6% had type 1 diabetes, 16.3% had manual dexterity problems, and 15.5% had poor eyesight not corrected by glasses. At the time of interview, 96.8% of participants were still using SOL. None of the eight PTCs reported were due to technical defects; most were related to handling errors. Some 62 participants reported 77 adverse events; none were related to a PTC. The vast majority of participants (95.4%) were “very satisfied” or “satisfied” with using SOL, and 89.7% of the participants had no questions or concerns using SOL on a daily basis. Similar positive findings were reported by participants with manual or dexterity impairments. Conclusions In this survey of everyday clinical practice, SOL had a good safety profile and was very well accepted by participants. PMID:20144398

  6. Baseline characteristics and hospitalizations in patients with schizophrenia receiving olanzapine long-acting injection: an interim analysis from a non-interventional, prospective observational safety study.

    PubMed

    Jones, Meghan E; Andrews, Jeffrey S; Faries, Douglas E; Landry, John; Xu, Jenny; Detke, Holland C; Chhabra-Khanna, Rashna; McDonnell, David P

    2015-11-13

    Depot antipsychotics are a treatment option for medication nonadherence in patients with schizophrenia. Nonadherence can lead to increased relapse and hospitalization rates. This article reports hospitalization data before and after initiation of olanzapine long-acting injection (LAI), a depot antipsychotic. Data were assessed from an ongoing, multinational, prospective, observational post-authorisation safety study being conducted to evaluate post-injection delirium/sedation syndrome (PDSS), an adverse reaction that can occur following injection of olanzapine LAI. Eligible patients were aged ≥18 years, diagnosed with schizophrenia, were prescribed olanzapine LAI, and lived outside the United States. Psychiatric hospitalization and medication data were collected retrospectively for the 6-month period before study entry and prospectively throughout the study. Paired t-tests and McNemar's tests were used to assess changes in hospitalization incidence and duration. Stepwise Cox proportional hazards models assessed factors associated with hospitalizations. Analyses were based on data from the first 3 years of the continuously enrolling study (N = 668). The average duration of olanzapine LAI exposure for all patients was 0.768 years. Of the 529 patients who received at least 1 injection of olanzapine LAI and were not hospitalized at study entry, 8.1% had at least 1 subsequent psychiatric hospitalization with a mean duration of 2.0 days. Of the 288 patients who had a >6-month follow-up, 8.3% had at least 1 post-baseline psychiatric hospitalization with a mean duration of 2.3 days. The incidence of hospitalizations in the 6-month period after treatment was significantly lower than that in the 6-month period prior to treatment (8.3 vs 32.6%, respectively; P < 0.001). Furthermore, mean hospitalization duration decreased from 11.5 days in the 6-month period before treatment to 2.3 days in the 6-month period after treatment (P < 0.001). Psychiatric

  7. Measurements of waste tank passive ventilation rates using tracer gases

    SciTech Connect

    Huckaby, J.L.; Olsen, K.B.; Sklarew, D.S.; Evans, J.C.; Remund, K.M.

    1997-09-01

    This report presents the results of ventilation rate studies of eight passively ventilated high-level radioactive waste tanks using tracer gases. Head space ventilation rates were determined for Tanks A-101, AX-102, AX-103, BY-105, C-107, S-102, U-103, and U-105 using sulfur hexafluoride (SF{sub 6}) and/or helium (He) as tracer gases. Passive ventilation rates are needed for the resolution of several key safety issues. These safety issues are associated with the rates of flammable gas production and ventilation, the rates at which organic salt-nitrate salt mixtures dry out, and the estimation of organic solvent waste surface areas. This tracer gas study involves injecting a tracer gas into the tank headspace and measuring its concentration at different times to establish the rate at which the tracer is removed by ventilation. Tracer gas injection and sample collection were performed by SGN Eurisys Service Corporation and/or Lockheed Martin Hanford Corporation, Characterization Project Operations. Headspace samples were analyzed for He and SF{sub 6} by Pacific Northwest National Laboratory (PNNL). The tracer gas method was first demonstrated on Tank S-102. Tests were conducted on Tank S-102 to verify that the tracer gas was uniformly distributed throughout the tank headspace before baseline samples were collected, and that mixing was sufficiently vigorous to maintain an approximately uniform distribution of tracer gas in the headspace during the course of the study. Headspace samples, collected from a location about 4 in away from the injection point and 15, 30, and 60 minutes after the injection of He and SF{sub 6}, indicated that both tracer gases were rapidly mixed. The samples were found to have the same concentration of tracer gases after 1 hour as after 24 hours, suggesting that mixing of the tracer gas was essentially complete within 1 hour.

  8. Critical appraisal of the efficacy, safety, and patient acceptability of hydroxyprogesterone caproate injection to reduce the risk of preterm birth

    PubMed Central

    Vidaeff, Alex C; Belfort, Michael A

    2013-01-01

    Prevention of preterm delivery is a major desiderate in contemporary obstetrics and a societal necessity. The means to achieve this goal remain elusive. Progesterone has been used in an attempt to prevent preterm delivery since the 1970s, but the evidence initially accumulated was fraught by mixed results and was based on mostly underpowered studies with variable eligibility criteria, including history of spontaneous abortion as an indication for treatment. More recent randomized controlled clinical trials restimulated the interest in progesterone supplementation, suggesting that progesterone may favorably influence the rate of preterm delivery. Preterm delivery is a complex disorder and consequently it is unlikely that one generalized prevention strategy will be effective in all patients. Further, an additional impediment in accepting progesterone as the “magic bullet” in the prevention of preterm delivery is that its mechanism of action is not fully understood and the optimal formulations, route of administration, and dose have yet to be established. We have concerned ourselves in this review with the most recent status of 17 alpha-hydroxyprogesterone caproate (17OH-PC) supplementation for prevention of preterm delivery. Our intention is to emphasize the efficacy, safety, and patient acceptability of this intervention, based on a comprehensive and unbiased review of the available literature. Currently there are insufficient data to suggest that 17OH-PC is superior or inferior to natural progesterone. Based on available evidence, we suggest a differential approach giving preferential consideration to either 17OH-PC or other progestins based on obstetric history and cervical surveillance. Progestin therapy for risk factors other than a history of preterm birth and/or a short cervix in the current pregnancy is not currently supported by the published evidence. The experience to date with 17OH-PC indicates that there are population subgroups that may be harmed by

  9. A Study on the Conceptual Design of a 1,500 MWe Passive PWR with Annular Fuel

    SciTech Connect

    Kwi Lim Lee; Soon Heung Chang

    2004-07-01

    In this study, the preliminary conceptual design of a 1500 MWe pressurized water reactor (PWR) with annular fuel has been performed. This design is derived from the AP1000 which is a 1000 MWe PWR with two-loop. However, the present design is a 1500 MWe PWR with three-loop, passive safety features and extensive plant simplifications to enhance the construction, operation, and maintenance. The preliminary design parameters of this reactor have been determined through simple relation to those of AP1000 for reactor, reactor coolant system, and passive safety injection system. Using the MATRA code, we analyze the core designs for two alternatives on fuel assembly types: solid fuel and annular fuel. The performance of reactor cooling systems is evaluated through the accident of the cold leg break in the core makeup tank loop by using MARS2.1 code. This study presents the developmental strategy, preliminary design parameters and safety analysis results. (authors)

  10. Efficacy, Safety, and Predictors of Intradiscal Methylene Blue Injection for Discogenic Low Back Pain: Results of a Multicenter Prospective Clinical Series.

    PubMed

    Kallewaard, Jan Willem; Geurts, José W; Kessels, Alphons; Willems, Paul; van Santbrink, Henk; van Kleef, Maarten

    2016-04-01

    Prospective clinical study of intradiscal methylene blue injection for the treatment of lumbar discogenic pain. The objective of this study was to collect information about efficacy, safety, and acceptability of the intervention, gain and burden of outcome measures, and sample size assumptions for a potential following randomized controlled trial (RCT). If the pilot study demonstrates that this treatment is potentially effective and safe, and the methods and procedures used in this study are feasible, a RCT follows. Low back pain (LBP) is a highly common problem with a lifetime prevalence of more than 70%. A substantial part of chronic LBP is attributable to degenerative changes in the intervertebral disc. A recently published RCT assessing the treatment intradiscal injection of methylene blue for chronic discogenic LBP, showed exceptionally good results. Patients were selected on clinical criteria, magnetic resonance imaging, and a positive provocative discogram. The primary outcome measure was mean pain reduction at 6 months. Fifteen consecutive patients with chronic lumbar discogenic pain enrolled in a multicenter prospective case series in two interventional pain treatment centers in the Netherlands. Six months after the intervention, 40% of the patients claimed at least 30% pain relief. In patients who responded, physical function improved and medication use diminished. We observed no procedural complications or adverse events. Predictors for success were Pfirrmann grading of 2 or less and higher quality of life mental component scores. Our findings of 40% positive respondents, and no complications, give reason to set up a randomized, double-blind, placebo-controlled, trial. © 2015 World Institute of Pain.

  11. A randomized, controlled, blinded study of the safety and immunogenicity of Haemophilus influenzae type b conjugate vaccine injected at different intramuscular sites in Chinese infants

    PubMed Central

    Shi, Nianmin; Luo, Feng-Ji; Li, Li; Zheng, Dongyi; Zhang, Zheng; Wang, Zhao-Yun; Yang, Liqing; Liu, Zhaoqiu; Ai, Xing; Bai, Yunhua; Lu, Qiang

    2013-01-01

    To compare the safety and immunogenicity of Haemophilus influenzae type b (Hib) conjugate vaccine administered via the vastus lateralis and deltoid muscles, 320 healthy Chinese infants <12 mo of age were enrolled in a randomized, controlled, blinded study and divided into 2 age groups: 2–5 mo and 6–12 mo. Each age group was then randomized (1:1) to either the vastus lateralis (experimental) group who received Hib vaccination into this muscle 2 or 3 times at monthly intervals, or the deltoid (control) group who received Hib vaccination into this muscle either 3 times (2–5 mo group) or twice (6–12 mo group) at monthly intervals. Local and systemic adverse reactions after each vaccine dose were recorded, and Hib-PRP antibody concentrations were determined by ELISA at 28 d after completion of the immunization schedule. There were no significant differences in the proportions of subjects with post-immunization Hib-PRP antibody concentrations ≥1.0 μg/mL or ≥0.15 μg/mL with the two injection sites for either age group, or in the post-immunization Hib-PRP antibody concentrations achieved (P > 0.05). In addition, there were no significant differences in the rates of local and systemic reactions after the first and second vaccinations between the 2 injection sites for either age group (P > 0.05), but the rate of systemic reactions in the 2–5 mo group after the third vaccination via the vastus lateralis muscle was significantly lower than after deltoid vaccination (0% vs 8.57%; P < 0.05). Thus, administration via the vastus lateralis muscle is worth considering for Hib vaccination. PMID:23842003

  12. Safety, Tolerability, and Pharmacokinetic Characteristics of a Novel Nonopioid Analgesic, VVZ-149 Injections in Healthy Volunteers: A First-in-Class, First-in-Human Study.

    PubMed

    Oh, Jaeseong; Lee, SeungHwan; Kim, Anhye; Yoon, Jangsoo; Jang, Kyungho; Lee, Doo H; Cho, Sunyoung; Lee, Sang Rim; Yu, Kyung-Sang; Chung, Jae-Yong

    2017-08-16

    VVZ-149, a dual antagonist of GlyT2 and 5HT2 A receptors, is an investigational analgesic with a novel mechanism of action that is currently under early-stage clinical development as an injectable agent for the treatment of postoperative pain. Here, the safety, tolerability, and pharmacokinetics of VVZ-149 injections in healthy male volunteers were explored in a randomized, double-blind, single- and multiple-ascending-dose (SAD and MAD, respectively), placebo-controlled clinical study. Subjects randomly received a 4-hour intravenous infusion of 0.25-8 mg/kg VVZ-149 or placebo in the SAD study (n = 46) or a 4-hour intravenous infusion of 4-7 mg/kg VVZ-149 or placebo twice daily for 3 days in the MAD study (n = 20). Serial blood and urine samples were collected for the pharmacokinetic analysis of VVZ-149 and its active metabolite (VVZ-368). Noncompartmental and compartmental pharmacokinetic analyses were performed. Various dosing scenarios were simulated to identify the adequate dosing regimen for the subsequent trials. Plasma exposure to VVZ-149 and VVZ-368 showed a dose-proportional increase. VVZ-149 did not accumulate in the plasma, whereas the plasma concentration of VVZ-368 increased by 1.23- to 2.49-fold after the fifth and sixth doses, respectively, in the MAD trial. Among the simulated dosing regimens, a loading dose followed by a maintenance dose was found to be an optimal dosing regimen, yielding the effective concentration estimated from animal studies in rat models of neuropathic or inflammatory pain. Single- or multiple-dose administration of VVZ-149 was generally well tolerated. These results showed that 0.5-8 mg/kg VVZ-149 exhibited linear pharmacokinetic characteristics and can be safely administered in further clinical studies. © 2017, The American College of Clinical Pharmacology.

  13. Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia

    PubMed Central

    2011-01-01

    Background In a recently published 24-week maintenance study of olanzapine long-acting injection (LAI) in schizophrenia (Kane et al., 2010), apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI, we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to "low" (150 mg/2 weeks; N = 140), "medium" (405 mg/4 weeks; N = 318), or "high" (300 mg/2 weeks; N = 141) dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis, the Jonckheere-Terpstra test (continuous data), or the Cochran-Armitage test (categorical data). Results Safety parameters statistically significantly related to dose were mean weight change (low: +0.67 [SD = 4.38], medium: +0.89 [SD = 3.87], high: +1.70 [SD = 4.14] kg, p = .024; effect size [ES] = 0.264 high vs. low dose), mean change in prolactin (low: -5.61 [SD = 12.49], medium: -2.76 [SD = 19.02]), high: +3.58 [SD = 33.78] μg/L, p = .001; ES = 0.410 high vs. low dose), fasting triglycerides change from normal at baseline to high (low: 3.2%, medium: 6.0%, high: 18.9%, p = .001; NNT = 7 high vs. low dose) and fasting high-density lipoprotein cholesterol change from normal at baseline to low (low: 13.8%, medium: 19.6%, high: 30.7%, p = .019; NNT = 6 high vs. low dose). Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change (low: +2.66 [SD = 14.95], medium: -0.09 [SD = 13.47], high: -2.19 [SD = 13.11], p <.01; ES = 0.356 high vs. low dose), relapse rate (low: 16%, medium: 10%, high: 5%, p = .003; NNT = 9 high vs. low dose), all-cause discontinuation rate (low: 36%, medium: 30%, high: 24%, p = .037; NNT = 9 high vs. low dose), and rate of discontinuation due to efficacy

  14. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials.

    PubMed

    Strand, Vibeke; Lim, Sooyeol; Takamura, Junko

    2016-06-01

    Gel-200 is a cross-linked hyaluronate single-injection device for treatment of osteoarthritis pain in the knee. This report summarizes new analyses of the safety of retreatment with Gel-200 from the 13-week, pivotal, multicenter, randomized controlled trial (RCT) followed by an open-label extension trial (OLE). 379 patients were enrolled in the RCT [Gel-200; phosphate-buffered saline (PBS)]. Safety of retreatment with Gel-200 was assessed by comparing adverse events (AEs) and device-related AEs reported through Week 4 following retreatment with Gel-200 to those reported in patients receiving their first injection in the OLE. 350 patients completed the initial RCT (231 Gel-200; 119 PBS); 258 patients enrolled in the OLE (162 Gel-200; 96 PBS). In total, 202 patients (125 Gel-200; 77 PBS) qualified for retreatment, while 56 (37 Gel-200; 19 PBS) did not. There were no significant demographic or disease characteristic differences between Gel-200 patients who were and were not retreated; those who were not eligible for retreatment experienced greater pain relief from Gel-200 in the RCT by all effectiveness endpoints (all p < 0.001), without differences in their safety profile. In the OLE, the safety of Gel-200, including percentages of patients who experienced any AEs (p = 0.547) and device-related AEs (p = 0.521), did not significantly differ between those receiving a second versus a first injection of Gel-200 following PBS in the RCT. In the OLE, the safety of a second injection of Gel-200 was comparable to that of a first injection and effectiveness was similar, as previously reported. ClinicalTrials.gov identification numbers NTC 00449696 and NTC 00450112.

  15. Safety profile of incobotulinum toxin A [Xeomin(®)] in gastrocnemious muscles injections in children with cerebral palsy: Randomized double-blind clinical trial.

    PubMed

    Carraro, Elena; Trevisi, Enrico; Martinuzzi, Andrea

    2016-07-01

    The only two preparations of botulinum toxin A for which there are published evidences of efficacy in children with cerebral palsy are onabotulinum toxin A (Botox(®)) and abobotulinum toxin A (Dyport(®)); these toxins should be considered generally safe and appropriate in the treatment for localized upper and lower limb spasticity. To establish the safety profile of incobotulinum toxin A (Xeomin(®)) in children with cerebral palsy and muscle spasticity. Randomized double-blind controlled trial that involved the recruitment of children of both sexes with spastic hemiplegia or diplegia in cerebral palsy, aged between 3 and 18 years. Children were randomized to either the study group (SG, incobotulinum toxin A) or the control group (CG, onabotulinum toxin A) both to be injected with 5units/kg on gastrocnemius (medialis and lateralis) muscles. The occurrence of adverse events at baseline, after 48 h, 10 days and 3 months was recorded by the caregivers in a checklist that listed both common and uncommon side effects. 35 patients were treated (CG = 18; SG = 17); the 2 groups were well balanced regarding demographics and anthropometry characteristics. At least 1 adverse event occurred in 49% of patients within first 2 days, 46% between 2 and 10 days, and 12% between 10 and 90 days. All the reported events were minor; no serious adverse event was recorded. Fatigue was the most frequent complaint. There was no significant difference in frequency and type of events between the 2 groups. Incobotulinum toxin A and onabotulinum toxin A share similar profile of safety in the treatment of lower limb spasticity in CP children. Copyright © 2016 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

  16. A randomized, double-blind, multicenter, placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure.

    PubMed

    Xian, Shaoxiang; Yang, Zhongqi; Lee, Jun; Jiang, Zhiping; Ye, Xiaohan; Luo, Luyi; Jin, Lili; Yang, Tianlun; Ye, Suilin; Lu, Dongfeng

    2016-06-20

    Shenmai injection (SMI) is a traditional Chinese herbal medicine extracted from Panax ginseng (Panax ginseng C.A. Mey, steamed and dry) and Ophiopogon japonicus (Ophiopogon japonicus (L.f.) Ker-Gawl, root). It has been widely used for the treatment of chronic heart failure (CHF) in China. However, the evidence supporting its effects remains unclear due to lack of high quality trials. The aim of this study was to investigate the efficacy and safety of SMI in CHF patients with coronary artery disease (CAD). This double-blind, multicenter study randomized 240 eligible patients equally to receive SMI or placebo (100ml/day) in addition to standard medicines for the treatment of CHF. The primary endpoint was the New York Heart Association (NYHA) functional classification. The secondary endpoints were 6-min walking distance (6MWD), short-form 36 (SF-36) hearth survey score, traditional Chinese medicines (TCM) syndrome score, left ventricular ejection fractions (LVEF) and B-type natriuretic peptide (BNP) level. During treatment of 1 week, the NYHA functional classification was gradually improved in both groups, but the SMI group demonstrated a significantly greater improvement compared with the placebo group (p=0.001). Moreover, the improvement in patients received SMI was superior to those in control group with respect to 6MWD, SF-36 score and TCM syndrome score. Treatment with SMI within 1 week was well tolerated with no apparent safety concerns. The integrative treatment with standard medicines plus SMI can further improve NYHA functional classification for patients with CHF and CAD. Therefore, SMI could be recommended in the combination therapy for CHF accompanied with CAD. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery.

    PubMed

    Sinatra, Raymond S; Jahr, Jonathan S; Reynolds, Lowell W; Viscusi, Eugene R; Groudine, Scott B; Payen-Champenois, Catherine

    2005-04-01

    Intravenous acetaminophen injection (paracetamol) is marketed in Europe for the management of acute pain. A repeated-dose, randomized, double-blind, placebo-controlled, three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug (propacetamol) and placebo. Propacetamol has been available in many European countries for more than 20 yr. After orthopedic surgery, patients reporting moderate to severe pain received either 1 g intravenous acetaminophen, 2 g propacetamol, or placebo at 6-h intervals over 24 h. Patients were allowed "rescue" intravenous patient-controlled analgesia morphine. Pain intensity, pain relief, and morphine use were measured at selected intervals. Safety was monitored through adverse event reporting, clinical examination, and laboratory testing. One hundred fifty-one patients (intravenous acetaminophen: 49; propacetamol: 50; placebo: 52) received at least one dose of study medication. The intravenous acetaminophen and propacetamol groups differed significantly from the placebo group regarding pain relief from 15 min to 6 h (P < 0.05) and median time to morphine rescue (intravenous acetaminophen: 3 h; propacetamol: 2.6 h; placebo: 0.8 h). Intravenous acetaminophen and propacetamol significantly reduced morphine consumption over the 24-h period: The total morphine doses received over 24 h were 38.3 +/- 35.1 mg for intravenous acetaminophen, 40.8 +/- 30.2 mg for propacetamol, and 57. 4 +/- 52.3 mg for placebo, corresponding to decreases of -33% (19 mg) and -29% (17 mg) for intravenous acetaminophen and propacetamol, respectively. Drug-related adverse events were reported in 8.2%, 50% (most of them local), and 17.3% of patients treated with intravenous acetaminophen, propacetamol, and placebo, respectively. Intravenous acetaminophen, 1 g, administered over a 24-h period in patients with moderate to severe pain after orthopedic surgery provided rapid and effective

  18. Strategies for safe injections.

    PubMed Central

    Battersby, A.; Feilden, R.; Stoeckel, P.; Da Silva, A.; Nelson, C.; Bass, A.

    1999-01-01

    In 1998, faced with growing international concern, WHO set out an approach for achieving injection safety that encompassed all elements from patients' expectations and doctors' prescribing habits to waste disposal. This article follows that lead and describes the implications of the approach for two injection technologies: sterilizable and disposable. It argues that focusing on any single technology diverts attention from the more fundamental need for health services to develop their own comprehensive strategies for safe injections. National health authorities will only be able to ensure that injections are administered safely if they take an approach that encompasses the whole system, and choose injection technologies that fit their circumstances. PMID:10680247

  19. Twenty-second water reactor safety information meeting. Volume 2: Severe accident research, thermal hydraulic research for advanced passive LWRs, high-burnup fuel behavior

    SciTech Connect

    Monteleone, S.

    1995-04-01

    This three-volume report contains papers presented at the Twenty-Second Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, during the week of October 24-26, 1994. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from Finland, France, Italy, Japan, Russia, and United Kingdom. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting.

  20. Safety and efficacy of repeated injections of botulinum toxin A in peripheral neuropathic pain (BOTNEP): a randomised, double-blind, placebo-controlled trial.

    PubMed

    Attal, Nadine; de Andrade, Daniel C; Adam, Frédéric; Ranoux, Danièle; Teixeira, Manoel J; Galhardoni, Ricardo; Raicher, Irina; Üçeyler, Nurcan; Sommer, Claudia; Bouhassira, Didier

    2016-05-01

    Data from previous studies suggest that botulinum toxin A has analgesic effects against peripheral neuropathic pain, but the quality of the evidence is low. We aimed to assess the safety and efficacy of repeated administrations of botulinum toxin A in patients with neuropathic pain. We did a randomised, double-blind, placebo-controlled trial at two outpatient clinics in France (Clinical Pain Centre, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, and Neurological Centre, Hôpital Dupuytren, Limoges) and one in Brazil (Neurological Department, Hospital das Clínicas da FMUSP, São Paulo). Patients aged 18-85 years with peripheral neuropathic pain were randomly assigned (1:1) by block randomisation, according to a centralised schedule, to receive two subcutaneous administrations of botulinum toxin A (up to 300 units) or placebo, 12 weeks apart. All patients and investigators were masked to treatment assignment. The primary outcome was the efficacy of botulinum toxin A versus placebo, measured as the change from baseline in self-reported mean weekly pain intensity over the course of 24 weeks from the first administration. The primary efficacy analysis was a mixed-model repeated-measures analysis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01251211. Between Oct 2, 2010, and Aug 2, 2013, 152 patients were enrolled, of whom 68 were randomly assigned (34 per group), and 66 (37 [56%] men) were included in the primary analysis (34 in the botulinum toxin A group and 32 in the placebo group). Botulinum toxin A reduced pain intensity over 24 weeks compared with placebo (adjusted effect estimate -0·77, 95% CI -0·95 to -0·59; p<0·0001). Pain on injection was the only adverse effect reported, and occurred in 19 (56%) participants in the botulinum toxin A group and 17 (53%) of those in the placebo group (p=1·0). Severe pain was experienced by ten (29%) participants in the botulinum toxin A group and 11 (34%) in the placebo

  1. Evaluation of efficacy, safety, pain perception and health-related quality of life of percutaneous ethanol injection as first-line treatment in symptomatic thyroid cysts.

    PubMed

    Reverter, Jordi L; Alonso, Núria; Avila, Marta; Lucas, Anna; Mauricio, Dídac; Puig-Domingo, Manel

    2015-11-26

    To evaluate the efficacy, safety, pain perception and health-related quality of life (QoL) of percutaneous ethanol injection treatment (PEIT) as an alternative to thyroid surgery in symptomatic thyroid cysts. Thirty consecutive patients (46 ± 10 years; 82% women) with symptomatic benign thyroid cysts relapsed after drainage were included. In all cases, cytology prior to treatment, maximum cyst diameter and volume were determined. PEIT was conducted using the established procedure, and the volume of fluid removed and pain perceived by the patient were assessed. In each procedure, the volume of alcohol instilled was <2 ml. After follow-up, final cyst diameter and volume were determined and the persistence of symptoms and QoL were assessed by a questionnaire (SF-36). Mean symptom duration was 10 ± 20 months. A single session of PEIT was required to complete the procedure in 45% of patients, two in 31% and three in 13%. Mean initial maximum cyst diameter was 3.5 ± 1.0 cm and mean extracted liquid volume 61 ± 36 ml. During PEIT, 39% of patients experienced virtually no pain, 43% mild pain and 17% moderate pain. No complications of PEIT were observed. After 12.1 ± 1.4 months of follow-up, cysts were reduced more than 70% in volume in 86.3% of patients, more than 80% in 61.9% and more than 90% in 42%. On the health-related QoL SF-36 questionnaire, patient scores 6 months post-PEIT did not differ significantly from those of the healthy Spanish population. With respect to cosmetic complaints or local symptoms of compression, PEIT-treated patients presented an initial score of 22 ± 8 and 13 ± 5 after treatment (p < 0.05). In our experience, percutaneous ethanol injection has prove to be an effective, safe and well-tolerated first-line treatment of symptomatic thyroid cysts.

  2. Etanercept Injection

    MedlinePlus

    ... injection comes as a solution (liquid) in a prefilled syringe and an automatic injection device, and as a ... etanercept injection.If your medication comes in a prefilled syringe or automatic injection device, use each syringe or ...

  3. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study.

    PubMed

    McDonnell, David P; Landry, John; Detke, Holland C

    2014-11-01

    The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18-76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2-4 weeks. The mean duration of exposure was ∼3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (P<0.001), with 40.6% of patients experiencing 7% or higher weight gain. Treatment-emergent categorical changes occurred in fasting glucose, total cholesterol, and triglyceride levels. Pharmacokinetic analyses revealed no systemic accumulation of olanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome).

  4. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study

    PubMed Central

    Landry, John; Detke, Holland C.

    2014-01-01

    The objective of this study was to assess the long-term safety and efficacy of olanzapine long-acting injection (LAI). A 6-year, single-arm, open-label extension study of olanzapine LAI was conducted at 127 sites in 25 countries. Patients were 18–76 years of age, were diagnosed with schizophrenia or schizoaffective disorder (N=931), and had been previously enrolled in one of three clinical trials of olanzapine LAI. Patients received flexibly dosed (45-405 mg) olanzapine LAI every 2–4 weeks. The mean duration of exposure was ∼3 years. A total of 393 (42.2%) patients completed the study. The mean weight change was +2.1 kg (P<0.001), with 40.6% of patients experiencing 7% or higher weight gain. Treatment-emergent categorical changes occurred in fasting glucose, total cholesterol, and triglyceride levels. Pharmacokinetic analyses revealed no systemic accumulation of olanzapine after long-term treatment. There were 36 occurrences of post-injection delirium/sedation syndrome, all resolving within 72 h. The mean Positive and Negative Syndrome Scale total and subscale scores did not change significantly over the course of the study, indicating clinical stability. Olanzapine LAI appeared effective as a long-term maintenance treatment, with a safety profile generally consistent with the known profile of oral olanzapine, except for injection-related events (including post-injection delirium/sedation syndrome). PMID:24850228

  5. [Passive euthanasia].

    PubMed

    Trube-Becker, E

    1977-01-01

    After having been acquainted with the historical development of euthanasia, the following steps for assitance in dying, called passive euthanasia are being discussed. a) Assistance during dying without speeding up death is the self-evident duty of a doctor. b) Assistance during death and speeding up the same as an unavoidable result of therapeutical treatment, more or less desired or more or less unavoidable. c) Assistance through letting the patient die by abandoning all therapeutical means, when these would only lead to a short extension of life time. No doctor is compelled to take measures to extend life if it is against the will of the patient. He is not even entitled to do so. A special problem is the abandoning of extended operative treatment, this borders on the so called active enthanasia. The dying patient always has the same right of treatment by a docter as well as nursing like all other suffering human beings. The decision to let a patient die should not result in leaving him by himself and to abandon all nursing as well. Such steps would include letting him lie in dirty linen, not sucking off the mucous secretion from the trachea, refusal to assist during mealtimes, non-assistance during cathetering, and the removal of the dying person to the bathroom, or any other remote orner of the hospital. No dying person should stay without help Loneliness especially is the greatest pain of a dying patient.

  6. Alternative to Nitric Acid Passivation

    NASA Technical Reports Server (NTRS)

    Kessel, Kurt R.

    2016-01-01

    Corrosion is an extensive problem that affects the National Aeronautics and Space Administration (NASA) and European Space Agency (ESA). The deleterious effects of corrosion result in steep costs, asset downtime affecting mission readiness, and safety risks to personnel. It is vital to reduce corrosion costs and risks in a sustainable manner. The primary objective of this effort is to qualify citric acid as an environmentally-preferable alternative to nitric acid for passivation of stainless steel alloys.

  7. A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus.

    PubMed

    Korytkowski, Mary; Bell, David; Jacobsen, Carol; Suwannasari, Rudee

    2003-11-01

    The accuracy and convenience of pen devices for insulin injection have improved quality of life for patients with insulin-treated diabetes mellitus (DM). Prefilled, disposable pens have the advantage of simplicity, with minimal training and attention required and no installation of new cartridges necessary. The aim of this study was to assess patient preference, efficacy, and safety profiles of a prefilled, disposable pen (FlexPen) and conventional vial/syringe injection method for insulin injection therapy among patients with DM. In a multicenter, randomized, open-label, crossover study, patients with type 1 or 2 DM were transferred from previous QD or BID conventional insulin therapy to a mixture of 70% insulin aspart protamine suspension and 30% insulin aspart injection (NovoLog Mix 7030) for 4 weeks of dose optimization using their usual type of syringe. Patients were then randomly assigned to use either vial/syringe or a prefilled, disposable pen to inject the biphasic insulin aspart 7030 mixture for the next 4 weeks, followed by 4 weeks of use of the other injection device. Efficacy, safety profiles, and patient preference for the delivery systems were compared. A total of 121 patients (mean [SD] age, 57.0 [12.4] years; age range, 28-81 years; mean [SD] body mass index, 31 [5.5] kg/m(2)) were enrolled. One hundred three patients completed the study. Seventy-four percent of patients (78105) indicated a preference for the pen over the vial/syringe method (95% CI, 71%-87%), compared with 20% (21105) who preferred the vial/syringe. Eighty-five percent (88104) considered the pen more discreet for use in public (compared with 9% [9104] for the vial/syringe), 74% (77104) considered it easier to use overall (compared with 21% [22104] for the vial/syringe), and 85% (89105) found the insulin dose scale on the pen easier to read (compared with 10% [10105] for the vial/syringe). Patients had statistically significant improvement in glycosylated hemoglobin values during

  8. The Therapeutic Efficacy and Safety of Compound Kushen Injection Combined with Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma: An Update Systematic Review and Meta-Analysis

    PubMed Central

    Ma, Xiao; Li, Rui-Sheng; Wang, Jian; Huang, Yin-Qiu; Li, Peng-Yan; Wang, Ji; Su, Hai-Bin; Wang, Rui-Lin; Zhang, Ya-Ming; Liu, Hong-Hong; Zhang, Cong-En; Ma, Zhi-Jie; Wang, Jia-Bo; Zhao, Yan-Ling; Xiao, Xiao-He

    2016-01-01

    Background: Compound Kushen Injection (CKI) is a Chinese patent medicine approved by the China Food and Drug Administration for the treatment of various types of solid tumors. CKI, combined with transarterial chemoembolization (TACE), is believed to increase the therapeutic efficacy of unresectable hepatocellular carcinoma (HCC). We report an updated and extended meta-analysis with detailed outcomes of both the efficacy and adverse events (AEs) of CKI combined with TACE therapy. Materials and methods: Electronic databases, including PubMed, Embase, the Cochrane Library, the Chinese Biomedical Database (CBM), Wanfang, the VIP medicine information system (VMIS) and the China National Knowledge Infrastructure (CNKI), were examined for relevant articles before November 13, 2015. An odds ratio (OR) was used to estimate tumor response (TR), Karnofsky Performance Scale (KPS) improvement, Child-Pugh (CP) improvement, survival rate (SR) and AEs. A publication bias and a subgroup analysis were also assessed. Results: Eighteen studies, with a total of 1,338 HCC patients who met the criteria for the meta-analysis, were included. TR, KPS improvement and CP improvement were significantly enhanced for the combination therapy compared to TACE alone (OR = 1.84, 95% CI: [1.46, 2.33], P < 0.00001; OR = 2.37, 95% CI: [1.76, 3.18], P < 0.00001; OR = 1.81, 95% CI: [1.08, 3.03], P = 0.02, respectively). The combination therapy was associated with an improvement in 1-year and 2-year SRs but not an improved 3-year SR (OR = 2.40; 95% CI: [1.59, 3.62], P < 0.0001; OR = 2.49, 95% CI: [1.24, 5.00], P = 0.01; OR = 2.49, 95% CI: [0.94, 6.61], P = 0.07, respectively). A safety analysis indicated that AEs (including nausea/vomiting, fever, hepatalgia, increased transaminase, increased bilirubin and leukopenia) were reduced for the combination treatment compared to TACE alone. Conclusion: The combination treatment of TACE and CKI was associated with improved TR, KPS and CP improvement and improved

  9. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects.

    PubMed

    Lunven, Catherine; Paehler, Tobias; Poitiers, Franck; Brunet, Aurélie; Rey, Jacques; Hanotin, Corinne; Sasiela, William J

    2014-12-01

    We investigated the relative pharmacokinetics, pharmacodynamics, and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab following injection at three different sites. Sixty healthy subjects (39 male, 21 female; age 20-45 years) were randomized to receive a single subcutaneous injection of alirocumab 75 mg via 1-mL prefilled pen into the abdomen, upper arm, or thigh (NCT01785329). Subjects were followed for 85 days ± 2 days following study drug administration. Pharmacokinetic (PK) parameters for the systemic exposure of alirocumab were calculated, and levels of free PCSK9 were assessed. Percentage changes from baseline in LDL-C were compared between injection site groups using linear mixed-effects models. Alirocumab concentration-time profiles were similar, and free PCSK9 levels were reduced to approximately zero between Day 3 and Day 4 postinjection in all groups. LDL-C levels reached nadir on Day 15 postinjection in all groups with mean percentage reductions of 48.4% (abdomen), 39.5% (upper arm), and 45.6% (thigh) at this time point. A similar effect on LDL-C levels was seen across the entire time course of the study at all three injection sites. Treatment-emergent adverse events were experienced by 8/20 (abdomen), 11/20 (upper arm), and 13/20 (thigh) subjects. There were 2 mild/transient injection site reactions. There were no serious adverse events. A single subcutaneous administration of alirocumab 75 mg via prefilled pen was well tolerated with similar pharmacokinetics and pharmacodynamics when injected into the abdomen, upper arm, or thigh. These results suggest that alirocumab can be interchangeably injected in the abdomen, upper arm, or thigh. © 2014 Sanofi and Regeneron Pharmaceuticals Inc. Cardiovascular Therapeutics published by John Wiley & Sons Ltd.

  10. Passive solar technology

    SciTech Connect

    Watson, D

    1981-04-01

    The present status of passive solar technology is summarized, including passive solar heating, cooling and daylighting. The key roles of the passive solar system designer and of innovation in the building industry are described. After definitions of passive design and a summary of passive design principles are given, performance and costs of passive solar technology are discussed. Passive energy design concepts or methods are then considered in the context of the overall process by which building decisions are made to achieve the integration of new techniques into conventional design. (LEW).

  11. Pegfilgrastim Injection

    MedlinePlus

    Pegfilgrastim comes as a solution (liquid) in prefilled injection syringes and in a pre-filled automatic injection device (On-body Injector) to inject subcutaneously (under the skin). If you are using pegfilgrastim to ...

  12. Cabazitaxel Injection

    MedlinePlus

    ... injection is used along with prednisone to treat prostate cancer (cancer of a male reproductive organ) that has ... cabazitaxel injection is usually used in men with prostate cancer. If used by pregnant women, cabazitaxel injection can ...

  13. Ondansetron Injection

    MedlinePlus

    Zofran® Injection ... Ondansetron injection is used to prevent nausea and vomiting caused by cancer chemotherapy and surgery. Ondansetron is in a ... medications: or any of the ingredients in ondansetron injection. Ask your pharmacist for a list of the ...

  14. Does Reduction of Number of Intradetrusor Injection Sites of aboBoNTA (Dysport®) Impact Efficacy and Safety in a Rat Model of Neurogenic Detrusor Overactivity?

    PubMed Central

    Huynh Le Maux, Amélie; Pignol, Bernadette; Behr-Roussel, Delphine; Blachon, Jean-Luc; Chabrier, Pierre-Etienne; Compagnie, Sandrine; Picaut, Philippe; Bernabé, Jacques; Giuliano, François; Denys, Pierre

    2015-01-01

    Intradetrusor injections of Botulinum toxin A—currently onabotulinumtoxinA—is registered as a second-line treatment to treat neurogenic detrusor overactivity (NDO). The common clinical practice is 30 × 1 mL injections in the detrusor; however, protocols remain variable and standardization is warranted. The effect of reducing the number of injection sites of Dysport® abobotulinumtoxinA (aboBoNTA) was assessed in the spinal cord-injured rat (SCI). Nineteen days post-spinalization, female rats received intradetrusor injections of saline or aboBoNTA 22.5 U distributed among four or eight sites. Two days after injection, continuous cystometry was performed in conscious rats. Efficacy of aboBoNTA 22.5 U was assessed versus aggregated saline groups on clinically-relevant parameters: maximal pressure, bladder capacity, compliance, voiding efficiency, as well as amplitude, frequency, and volume threshold for nonvoiding contractions (NVC). AboBoNTA 22.5 U significantly decreased maximal pressure, without affecting voiding efficiency. Injected in four sites, aboBoNTA significantly increased bladder capacity and compliance while only the latter when in eight sites. AboBoNTA significantly reduced NVC frequency and amplitude. This preclinical investigation showed similar inhibiting effects of aboBoNTA despite the number of sites reduction. Further studies are warranted to optimize dosing schemes to improve the risk-benefit ratio of BoNTA-based treatment modalities for NDO and further idiopathic overactive bladder. PMID:26694464

  15. A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety data.

    PubMed

    Gidudu, Jane; Kohl, Katrin S; Halperin, Scott; Hammer, Sandra Jo; Heath, Paul T; Hennig, Renald; Hoet, Bernard; Rothstein, Edward; Schuind, Anne; Varricchio, Frederick; Walop, Wikke

    2008-12-09

    The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.

  16. Passivation of fluorinated activated charcoal

    SciTech Connect

    Del Cul, G.D.; Trowbridge, L.D.; Simmons, D.W.; Williams, D.F.; Toth, L.M.

    1997-10-01

    The Molten Salt Reactor Experiment (MSRE), at the Oak Ridge National Laboratory has been shut down since 1969 when the fuel salt was drained from the core into two Hastelloy N tanks at the reactor site. In 1995, a multiyear project was launched to remediate the potentially hazardous conditions generated by the movement of fissile material and reactive gases from the storage tanks into the piping system and an auxiliary charcoal bed (ACB). The top 12 in. of the ACB is known by gamma scan and thermal analysis to contain about 2.6 kg U-233. According to the laboratory tests, a few feet of fluorinated charcoal are believed to extend beyond the uranium front. The remainder of the ACB should consist of unreacted charcoal. Fluorinated charcoal, when subjected to rapid heating, can decompose generating gaseous products. Under confined conditions, the sudden exothermic decomposition can produce high temperatures and pressures of near-explosive characteristics. Since it will be necessary to drill and tap the ACB to allow installation of piping and instrumentation for remediation and recovery activities, it is necessary to chemically convert the reactive fluorinated charcoal into a more stable material. Ammonia can be administered to the ACB as a volatile denaturing agent that results in the conversion of the C{sub x}F to carbon and ammonium fluoride, NH{sub 4}F. The charcoal laden with NH{sub 4}F can then be heated without risking any sudden decomposition. The only consequence of heating the treated material will be the volatilization of NH{sub 4}F as a mixture of NH{sub 3} and HF, which would primarily recombine as NH{sub 4}F on surfaces below 200 C. The planned scheme for the ACB denaturing is to flow diluted ammonia gas in steps of increasing NH{sub 3} concentration, 2% to 50%, followed by the injection of pure ammonia. This report summarizes the planned passivation treatment scheme to stabilize the ACB and remove the potential hazards. It also includes basic information

  17. Ibandronate Injection

    MedlinePlus

    Boniva® Injection ... Ibandronate injection is used to treat osteoporosis (a condition in which the bones become thin and weak and break ... Ibandronate injection comes as a solution (liquid) to be injected into a vein by a doctor or nurse in ...

  18. Leuprolide Injection

    MedlinePlus

    Leuprolide injection comes as a long-acting suspension (Lupron) that is injected intramuscularly (into a muscle) by a doctor or nurse in a medical ... Depot-4 month, Lupron Depot-6 Month). Leuprolide injection also comes as a long-acting suspension (Eligard) that is injected subcutaneously (just under ...

  19. The efficacy and safety of sodium hyaluronate injection (Adant®) in treating degenerative osteoarthritis: a multi-center, randomized, double-blind, positive-drug parallel-controlled and non-inferiority clinical study.

    PubMed

    Xin, Yang; Jianhao, Lin; Tiansheng, Sun; Yongqiang, Hao; Weimin, Fan; Ming, Chen; Tiezheng, Sun; Jianhua, Yao; Liang, Xuan; Xiaoyuan, Gu; Yongping, Cao

    2016-03-01

    To compare the efficacy and safety of two different sodium hyaluronate drugs in treating degenerative osteoarthritis (OA) of the knee. This randomized, multi-center, double-blind, positive-drug, parallel-controlled study included 229 patients aged ≥ 45 years who were clinically diagnosed with degenerative OA of the knee. The patients were randomly assigned to receive for 5 consecutive weeks a once-weekly intra-articular injection of the investigational drug Adant®, which is manufactured by fermentation, or the control drug Artz®, which is manufactured by extraction of cockscomb. The follow-up examinations were conducted 1, 2, 3, 4 and 6 weeks after the first injection. The primary efficacy parameter was the decrease in the visual analog scale (VAS) scores of pain on movement caused by load-bearing, and the secondary efficacy parameter was the decrease in the Lequesne index. The intra-articular injections of Adant® and Artz® produced a significant reduction in the VAS scores for pain on movement (50.4 and 50.3 mm, respectively) and in the Lequesne index. There were no significant differences in efficacy and safety between the two drugs and non-inferiority in VAS score decreases was confirmed. The results of this study show that both Adant® and Artz® are effective for the treatment of OA and that there were no statistical differences between them in the VAS scores of pain on movement, Lequesne index or safety during the observation period with short-time follow up. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

  20. Fundamental studies on passivity and passivity breakdown

    SciTech Connect

    Macdonald, D.D.; Urquidi-Macdonald, M.

    1993-06-01

    Using photoelectrochemical impedance and admittance spectroscopies, a fundamental and quantitative understanding of the mechanisms for the growth and breakdown of passive films on metal and alloy surfaces in contact with aqueous environments is being developed. A point defect model has been extended to explain the breakdown of passive films, leading to pitting and crack growth and thus development of damage due to localized corrosion.

  1. A Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HPβCD-Diclofenac in Subjects with Acute Postoperative Pain.

    PubMed

    Daniels, Stephen E; Gan, Tong J Tj; Hamilton, Douglas A; Singla, Neil; Lacouture, Peter G; Johnson, Olufunmibi; Min, Lauren H; Reyes, Christian R D; Carr, Daniel B

    2016-12-01

    OBJECTIVE : While injectable nonsteroidal anti-inflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HPβCD-diclofenac when given for ≤ 5 days following orthopedic or abdominal/pelvic surgery. METHODS : Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. RESULTS : There were three renal AEs each in the HPβCD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HPβCD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HPβCD-diclofenac) was treatment-related. One incidence of postoperative shift to high (> upper limit of normal) serum creatinine occurred in the HPβCD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HPβCD-diclofenac and placebo. CONCLUSIONS : While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HPβCD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population.

  2. A Pooled Analysis Evaluating Renal Safety in Placebo- and Active Comparator-Controlled Phase III Trials of Multiple-Dose Injectable HPβCD-Diclofenac in Subjects with Acute Postoperative Pain.

    PubMed

    Daniels, Stephen E; Gan, Tong J Tj; Hamilton, Douglas A; Singla, Neil; Lacouture, Peter G; Johnson, Olufunmibi; Min, Lauren H; Reyes, Christian R D; Carr, Daniel B

    2016-07-17

    OBJECTIVE : While injectable nonsteroidal anti-inflammatory drugs (NSAIDs) are a key component of postoperative multimodal analgesia, renal safety concerns may limit use in some patients. This study examined the renal safety of injectable HPβCD-diclofenac when given for ≤ 5 days following orthopedic or abdominal/pelvic surgery. METHODS : Pooled analysis of data from two randomized, placebo- and active comparator-controlled phase III trials in 608 total patients was conducted. Renal safety was assessed by examining treatment-emergent adverse events (AEs) and postoperative blood urea nitrogen (BUN) and serum creatinine shifts. RESULTS : There were three renal AEs each in the HPβCD-diclofenac (n = 318 patients) and placebo (n = 148 patients) groups, and two renal AEs in the ketorolac group (n = 142 patients). No significant difference in renal AE risk was detected for patients receiving HPβCD-diclofenac (RR: 1.40 [0.15,13.3]; P = 0.75) or ketorolac (RR: 2.08 [0.19,22.7]; P = 0.56) versus placebo. All renal AEs were mild or moderate in severity, and a single renal AE (acute renal failure in a patient receiving HPβCD-diclofenac) was treatment-related. One incidence of postoperative shift to high (> upper limit of normal) serum creatinine occurred in the HPβCD-diclofenac group (n = 2 in the ketorolac group). Mean changes in serum creatinine or BUN did not differ significantly between patients receiving HPβCD-diclofenac and placebo. CONCLUSIONS : While this analysis examined relatively brief exposure typical for parenterally administered analgesics in the postoperative setting in patients with largely normal renal function, the results suggest that HPβCD-diclofenac use for acute postoperative pain may not be associated with added renal safety risks over placebo in this patient population.

  3. Passive storage technologies

    NASA Technical Reports Server (NTRS)

    Kittel, P.

    1984-01-01

    Advances in storage technology and how passive techniques could be applied to the storage of propellants at the space station are described. The devices considered are passive orbital disconnect struts, cooled shield optimization, liftweight shields and catalytic converters.

  4. Tropospheric Passive Remote Sensing

    NASA Technical Reports Server (NTRS)

    Keafer, L. S., Jr. (Editor)

    1982-01-01

    The long term role of airborne/spaceborne passive remote sensing systems for tropospheric air quality research and the identification of technology advances required to improve the performance of passive remote sensing systems were discussed.

  5. Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: a randomized trial.

    PubMed

    Wright, Jennifer G; Plikaytis, Brian D; Rose, Charles E; Parker, Scott D; Babcock, Janiine; Keitel, Wendy; El Sahly, Hana; Poland, Gregory A; Jacobson, Robert M; Keyserling, Harry L; Semenova, Vera A; Li, Han; Schiffer, Jarad; Dababneh, Hanan; Martin, Sandra K; Martin, Stacey W; Marano, Nina; Messonnier, Nancy E; Quinn, Conrad P

    2014-02-12

    We evaluated an alternative administration route, reduced schedule priming series, and increased intervals between booster doses for anthrax vaccine adsorbed (AVA). AVA's originally licensed schedule was 6 subcutaneous (SQ) priming injections administered at months (m) 0, 0.5, 1, 6, 12 and 18 with annual boosters; a simpler schedule is desired. Through a multicenter randomized, double blind, non-inferiority Phase IV human clinical trial, the originally licensed schedule was compared to four alternative and two placebo schedules. 8-SQ group participants received 6 SQ injections with m30 and m42 "annual" boosters; participants in the 8-IM group received intramuscular (IM) injections according to the same schedule. Reduced schedule groups (7-IM, 5-IM, 4-IM) received IM injections at m0, m1, m6; at least one of the m0.5, m12, m18, m30 vaccine doses were replaced with saline. All reduced schedule groups received a m42 booster. Post-injection blood draws were taken two to four weeks following injection. Non-inferiority of the alternative schedules was compared to the 8-SQ group at m2, m7, and m43. Reactogenicity outcomes were proportions of injection site and systemic adverse events (AEs). The 8-IM group's m2 response was non-inferior to the 8-SQ group for the three primary endpoints of anti-protective antigen IgG geometric mean concentration (GMC), geometric mean titer, and proportion of responders with a 4-fold rise in titer. At m7 anti-PA IgG GMCs for the three reduced dosage groups were non-inferior to the 8-SQ group GMCs. At m43, 8-IM, 5-IM, and 4-IM group GMCs were superior to the 8-SQ group. Solicited injection site AEs occurred at lower proportions in the IM group compared to SQ. Route of administration did not influence the occurrence of systemic AEs. A 3 dose IM priming schedule with doses administered at m0, m1, and m6 elicited long term immunological responses and robust immunological memory that was efficiently stimulated by a single booster vaccination at

  6. A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease.

    PubMed

    Fuchs, Shmuel; Dib, Nabil; Cohen, Barry M; Okubagzi, Petros; Diethrich, Edward B; Campbell, Ann; Macko, Jennifer; Kessler, Paul D; Rasmussen, Henrik S; Epstein, Stephen E; Kornowski, Ran

    2006-09-01

    The experience with direct myocardial injection of adenovirus encoding angiogenic growth factor is limited to invasive surgical approach. Accordingly, we sought to evaluate, for the first time, in a randomized, double-blind, placebo-controlled, phase I pilot study the safety and feasibility of percutaneous catheter-based intramyocardial delivery of a replication-deficient adenovector encoding the 121-amino-acid isoform of vascular endothelial growth factor (AdVEGF121). Ten "no-option" patients with severe coronary artery disease were randomized (2:1) to receive AdVEGF121 (4 x 10(10) pu) or placebo as fifteen 100 microL, evenly distributed, endomyocardial injections using a nonflouroscopic, 3-dimensional mapping and injection (NOGA) catheter-based system. Injection procedure was successfully completed in all cases and was associated with no major adverse events. AdVEGF121 was considered potentially associated with a single serious adverse event of transient moderate fever. Elevated postprocedure CK and CK-MB fraction levels were recorded in two placebo-treated and three AdVEGF121-treated patients; all CK measured values were <1.5 times upper limit of normal. All adenoviral cultures (urine and throat swab) were negative 24-hr after dosing, and no significant changes in serial plasma VEGF levels were noted over time. At 12 months follow-up, no cancers, proliferative retinal changes, or significant abnormalities in hepatic, renal or hematological indices were observed. Percutaneous, catheter-based AdVEGF121 intramyocardial injection is a practical, feasible, and potentially safe approach for intramyocardial gene transfer. A larger randomized, phase II efficacy study is warranted.

  7. Alternative to Nitric Acid Passivation Project Overview

    NASA Technical Reports Server (NTRS)

    Lewis, Pattie L.

    2013-01-01

    The standard practice for protection of stainless steel is a process called passivation. This procedure results in the formation of a metal oxide layer to prevent corrosion. Typical passivation procedures call for the use of nitric acid which exhibits excellent corrosion performance; however, there are a number of environmental, worker safety, and operational issues associated with its use. The longtime military specification for the passivation of stainless steel was cancelled in favor of newer specifications which allow for the use of citric acid in place of nitric acid. Citric acid offers a variety of benefits that include increased safety for personnel, reduced environmental impact, and reduced operational costs. There have been few studies, however, to determine whether citric acid is an acceptable alternative for NASA and DoD. This paper details activities to date including development of the joint test plan, on-going and planned testing, and preliminary results.

  8. Golimumab Injection

    MedlinePlus

    ... body and causes pain, swelling, and damage) including: rheumatoid arthritis (condition in which the body attacks its own ... doctor.If golimumab injection is used to treat rheumatoid arthritis, it may also be injected intravenously (into a ...

  9. Adalimumab Injection

    MedlinePlus

    ... causes pain, swelling, and damage) including the following: rheumatoid arthritis (a condition in which the body attacks its ... If you are using adalimumab injection to treat rheumatoid arthritis, your doctor may tell you to inject the ...

  10. Ipilimumab Injection

    MedlinePlus

    ... are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving ipilimumab injection, call your doctor. Ipilimumab injection may cause your baby to be born too early or to die before birth.

  11. Teniposide Injection

    MedlinePlus

    ... in men. You should not become pregnant or breast-feed while you are receiving teniposide injection. If you or your partner become pregnant while receiving teniposide injection, call your doctor. Teniposide may harm the fetus.

  12. Dexrazoxane Injection

    MedlinePlus

    ... Dexrazoxane injection (Zinecard) is used to prevent or decrease heart damage caused by doxorubicin in women who ... with doxorubicin. Dexrazoxane injection (Totect) is used to decrease damage to the skin and tissues that may ...

  13. Colistimethate Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.Antibiotics such as colistimethate injection will not work ...

  14. Chloramphenicol Injection

    MedlinePlus

    ... treat certain types of serious infections caused by bacteria when other antibiotics cannot be used. Chloramphenicol injection ... antibiotics. It works by stopping the growth of bacteria..Antibiotics such as chloramphenicol injection will not work ...

  15. Natalizumab Injection

    MedlinePlus

    ... your condition. Keep all appointments to receive natalizumab injection even if you feel well. ... tests to check your body's response to natalizumab injection.It is important ... you are taking, as well as any products such as vitamins, minerals, or ...

  16. Methylnaltrexone Injection

    MedlinePlus

    ... taking opioid medications, you should stop using methylnaltrexone injection as well.You should stop taking other laxative medications when you start using methylnaltrexone injection. However, be sure to let your doctor know ...

  17. Triptorelin Injection

    MedlinePlus

    ... used to treat the symptoms associated with advanced prostate cancer. Triptorelin injection (Triptodur) is used to treat central ... a medical office or clinic. When used for prostate cancer, an injection of 3.75 mg of triptorelin ( ...

  18. Degarelix Injection

    MedlinePlus

    Degarelix injection is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]). Degarelix injection is in a class of medications called gonadotropin-releasing hormone (GnRH) ...

  19. Medroxyprogesterone Injection

    MedlinePlus

    ... Medroxyprogesterone injection is a very effective method of birth control but does not prevent the spread of human ... you have been using a different method of birth control and are switching to medroxyprogesterone injection, your doctor ...

  20. Dolasetron Injection

    MedlinePlus

    ... treat nausea and vomiting that may occur after surgery. Dolasetron injection should not be used to prevent ... a single injection just before the end of surgery or as soon as nausea or vomiting occurs. ...

  1. Levoleucovorin Injection

    MedlinePlus

    Levoleucovorin injection is used to prevent harmful effects of methotrexate (Rheumatrex, Trexall) when methotrexate is used to to treat certain types of cancer. Levoleucovorin injection is also used to treat people ...

  2. Etelcalcetide Injection

    MedlinePlus

    Etelcalcetide injection is used to treat secondary hyperparathyroidism (condition in which the body produces too much parathyroid ... blood when the kidneys are not working properly.) Etelcalcetide injection is in a class of medications called ...

  3. Dupilumab Injection

    MedlinePlus

    ... injection is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the ... use other medications for their condition or whose eczema has not responded to other medications. Dupilumab injection ...

  4. Methylprednisolone Injection

    MedlinePlus

    ... allergic reactions. Methylprednisolone injection is used in the management of multiple sclerosis (a disease in which the ... laboratory test, tell your doctor and the laboratory personnel that you are using methylprednisolone injection.If you ...

  5. Clindamycin Injection

    MedlinePlus

    ... your treatment with clindamycin injection or during the first several months after your treatment is finished: watery or bloody stools, diarrhea, stomach cramps, or fever.Talk to your doctor about the risks of receiving clindamycin injection.

  6. Obinutuzumab Injection

    MedlinePlus

    Obinutuzumab injection is used with chlorambucil (Leukeran) to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Obinutuzumab injection is in a class of medications called ...

  7. Ferumoxytol Injection

    MedlinePlus

    Ferumoxytol injection is used to treat iron-deficiency anemia (a lower than normal number of red blood ... and may cause the kidneys to stop working). Ferumoxytol injection is in a class of medications called ...

  8. Pralatrexate Injection

    MedlinePlus

    Pralatrexate injection is used to treat peripheral T-cell lymphoma (PTCL; a form of cancer that begins in a ... come back after treatment with other medications. Pralatrexate injection has not been shown to help people who ...

  9. Cyanocobalamin Injection

    MedlinePlus

    Cyanocobalamin injection is used to treat and prevent a lack of vitamin B12 that may be caused by any ... organs) and permanent damage to the nerves. Cyanocobalamin injection also may be given as a test to ...

  10. Paclitaxel Injection

    MedlinePlus

    Paclitaxel injection manufactured with human albumin is used to treat breast cancer that has not improved or that has come back after treatment with other medications. Paclitaxel injection manufactured with polyoxyethylated castor oil is used to ...

  11. Peramivir Injection

    MedlinePlus

    Peramivir injection is used to treat some types of influenza infection ('flu') in people who have had symptoms of ... flu for no longer than 2 days. Peramivir injection is in a class of medications called neuraminidase ...

  12. Cefotetan Injection

    MedlinePlus

    Cefotetan injection is used to treat infections of the lungs, skin, bones, joints, stomach area, blood, female reproductive organs, and urinary tract. Cefotetan injection is also used before surgery to prevent infections. ...

  13. Mipomersen Injection

    MedlinePlus

    Mipomersen injection is used to decrease levels of cholesterol and other fatty substances in the blood in people who ... that removes LDL from the blood), but mipomersen injection should not be used along with this treatment. ...

  14. Romiplostim Injection

    MedlinePlus

    Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order ... low number of platelets in the blood). Romiplostim injection should only be used in people who cannot ...

  15. Hydrocortisone Injection

    MedlinePlus

    Hydrocortisone injection is used to treat symptoms of low corticosteroid levels (lack of certain substances that are usually produced ... also used to treat severe allergic reactions. Hydrocortisone injection is used in the management of multiple sclerosis ( ...

  16. Palivizumab Injection

    MedlinePlus

    Palivizumab injection is used to help prevent respiratory syncytial virus (RSV; common virus that can cause serious lung infections) ... or have certain heart or lung diseases. Palivizumab injection is not used to treat the symptoms of ...

  17. Naltrexone Injection

    MedlinePlus

    Naltrexone injection is used along with counseling and social support to help people who have stopped drinking large amounts of alcohol to avoid drinking again. Naltrexone injection is also used along with counseling and social ...

  18. Tesamorelin Injection

    MedlinePlus

    Tesamorelin injection is used to decrease the amount of extra fat in the stomach area in adults with human ... fat in certain areas of the body). Tesamorelin injection is not used to help with weight loss. ...

  19. Tigecycline Injection

    MedlinePlus

    Tigecycline injection used to treat certain serious infections including community acquired pneumonia (a lung infection that developed in a ... area between the chest and the waist). Tigecycline injection should not be used to treat pneumonia that ...

  20. Eculizumab Injection

    MedlinePlus

    Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH: a type of anemia in which too many red ... oxygen to all parts of the body). Eculizumab injection is also used to treat atypical hemolytic uremic ...

  1. Pembrolizumab Injection

    MedlinePlus

    Pembrolizumab injection is used to treat melanoma (a type of skin cancer) that cannot be treated with surgery or ... spread to other parts of the body. Pembrolizumab injection is also used to treat a certain type ...

  2. Oxacillin Injection

    MedlinePlus

    ... is used to treat infections caused by certain bacteria. Oxacillin injection is in a class of medications called penicillins. It works by killing bacteria.Antibiotics such as oxacillin injection will not work ...

  3. Cefoxitin Injection

    MedlinePlus

    ... injection is used to treat infections caused by bacteria including pneumonia and other lower respiratory tract (lung) ... medications called cephamycin antibiotics. It works by killing bacteria.Antibiotics such as cefoxitin injection will not work ...

  4. Nafcillin Injection

    MedlinePlus

    ... to treat infections caused by certain types of bacteria. Nafcillin injection is in a class of medications called penicillins. It works by killing bacteria.Antibiotics such as nafcillin injection will not work ...

  5. Doripenem Injection

    MedlinePlus

    ... tract, kidney, and abdomen that are caused by bacteria. Doripenem injection is not approved by the Food ... medications called carbapenem antibiotics. It works by killing bacteria.Antibiotics such as doripenem injection will not work ...

  6. Citric Acid Passivation of Stainless Steel

    NASA Technical Reports Server (NTRS)

    Yasensky, David; Reali, John; Larson, Chris; Carl, Chad

    2009-01-01

    Passivation is a process for cleaning and providing corrosion protection for stainless steel. Currently, on Kennedy Space Center (KSC), only parts passivated with nitric acid are acceptable for use. KSC disposes of approximately 125gal of concentrated nitric acid per year, and receives many parts from vendors who must also dispose of used nitric acid. Unfortunately, nitric acid presents health and environmental hazards. As a result, several recent industry studies have examined citric acid as an alternative. Implementing a citric acid-based passivation procedure would improve the health and environmental safety aspects of passivation process. However although there is a lack of published studies that conclusively prove citric acid is a technically sound passivation agent. In 2007, NASA's KSC Materials Advisory Working Group requested the evaluation of citric acid in place of nitric acid for passivation of parts at KSC. United Space Alliance Materials & Processes engineers have developed a three-phase test plan to evaluate citric acid as an alternative to nitric acid on three stainless steels commonly used at KSC: UNS S30400, S41000, and S17400. Phases 1 and 2 will produce an optimized citric acid treatment based on results from atmospheric exposure at NASA's Beach Corrosion Facility. Phase 3 will compare the optimized solution(s) with nitric acid treatments. If the results indicate that citric acid passivates as well or better than nitric acid, NASA intends to approve this method for parts used at the Kennedy Space Center.

  7. 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.

    PubMed

    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

  8. Recent innovations in IFR safety research

    SciTech Connect

    Wade, D.C.

    1994-03-01

    Recent progress in IFR safety research suggests potential for two extensions of passive features to improve the robustness of safety response. This report provides a discussion of these recent innovations.

  9. Ionic transport in passivation layered on the lithium electrode

    NASA Astrophysics Data System (ADS)

    Nimon, Eugeny S.; Churikov, Alexei V.; Shirokov, Alexander V.; Lvov, Arlen L.; Chuvashkin, Anatoly N.

    1993-04-01

    The processes of ionic transport in passivating layers on the surface of the lithium electrode in solutions based on thionyl chloride, propylene carbonate and gamma -butyrolactone have been studied by means of pulse electrochemical methods. The data obtained are quantitatively described by a model which takes into account transport of both the intrinsic mobile lithium ions of the passivating layer and lithium ions injected into the passivating layer from the electrode or from the electrolyte solution under anodic or cathodic current directions, respectively. The values of mobility and concentration of mobile lithium ions in passivating layers formed on lithium in various solutions under open-circuit conditions have been determined.

  10. Efficacy and safety of collagenase Clostridium histolyticum injection for Dupuytren's contracture in non-Caucasian Japanese patients (CORD-J Study): the first clinical trial in a non-Caucasian population.

    PubMed

    Hirata, H; Tanaka, K; Sakai, A; Kakinoki, R; Ikegami, H; Tateishi, N

    2016-06-16

    To assess the efficacy, safety and pharmacokinetics of 0.58 mg collagenase Clostridium histolyticum injections for the treatment of Dupuytren's contracture in Japanese patients, we conducted a phase III, multicentre, uncontrolled, open-label clinical study in patients with Dupuytren's contracture. Of the 77 patients, 66 achieved clinical success in the primary treated joint (86%; 95% confidence interval: 76% to 93%), confirming the efficacy of collagenase Clostridium histolyticum injections. More improvement was seen in the metacarpophalangeal joints than in the proximal interphalangeal joints (94% versus 73%). The main adverse reaction was a local reaction in the injected hand. No tendon rupture or anaphylactic reactions were seen. The concentrations of collagenase Clostridium histolyticum were below the lower limit of quantification in plasma samples at all time points. As seen in global studies in Caucasian patients, a corrective effect on Dupuytren's contracture and good tolerance were observed in most non-Caucasian (Asian) Japanese patients. Level 3. © The Author(s) 2016.

  11. Long-Term Real-Life Efficacy and Safety of Repeated Ozurdex® Injections and Factors Associated with Macular Edema Resolution after Retinal Vein Occlusion: The REMIDO 2 Study.

    PubMed

    Pommier, Stéphan; Meyer, Franck; Guigou, Sébastien; Barthelemy, Tony; Gobert, Fréderic; Hajjar, Christian; Merite, Pierre-Yves; Parrat, Eric; Rouhette, Hervé; Matonti, Fréderic

    2016-01-01

    The objective was to study long-term real-life efficacy and safety of repeated Ozurdex® injections and factors associated with macular edema (ME) resolution after retinal vein occlusion. Patients with ME after retinal vein occlusion, receiving Ozurdex®, were included to assess the following endpoints: visual acuity and central retinal thickness, retreatment, number of injections, side effects and ME resolution. ME resolution was defined as permanent discontinuation of intravitreal injections (IVTs) for at least 6 months after the last IVT. A total of 94 eyes were included with an average of 2.6 IVTs (max 6 IVTs). 58.6% of patients gained ≥15 letters and 51.1% of patients showed ME resolution. Among the resolved patients, 64.6% were treatment-naïve, 60.4% had branch retinal vein occlusion, and 78.1% gained ≥15 letters. Ozurdex® seemed to be a valuable treatment which may allow to achieve long-term anatomical and functional improvements and ME resolution with a minimum number of IVTs. © 2016 S. Karger AG, Basel.

  12. A randomized, double-blind, placebo-controlled study to determine the safety and efficacy of cultured and expanded autologous fibroblast injections for the treatment of interdental papillary insufficiency associated with the papilla priming procedure.

    PubMed

    McGuire, Michael K; Scheyer, E Todd

    2007-01-01

    The aim of this study was to assess the efficacy and safety of using autologous fibroblast injections following a minimally invasive papilla priming procedure to augment open interproximal spaces. Twenty-one patients with open interproximal spaces were enrolled in this study, with 20 patients retained to study completion. Two primary sites were selected and randomized to receive autologous fibroblast injections or placebo injections beginning 1 week following the papilla priming procedure; two additional injections were performed 7 to 14 days following the initial injections. Up to seven additional sites could be treated per patient, and the analyses were conducted for the primary and secondary sites. The primary efficacy parameter was the percentage change in papillary height of the primary treatment areas from baseline to the 4-month visit, as measured by a periodontal probe from the base of the contact area to the tip of the interproximal papilla. Digital image analysis and diagnostic models were used to confirm clinical measurements. A visual analog scale (VAS) was used by the examiner and subject to assess the defect change from baseline to 2, 3, and 4 months. Tissue texture also was assessed by the examiner. The primary efficacy analysis failed to show a significant treatment effect at 4 months, but the treatment areas showed a statistically significant mean percentage increase from baseline in papillary height (P = 0.0067; signed-rank test) at 2 months. The difference between test and placebo sites in papillary height at 2 months approached statistical significance (P = 0.0730), suggesting that the test treatment was superior to the placebo treatment. The examiner and subject VASs were statistically significantly different from baseline for both treatment groups, and the VAS was superior for the test sites over the placebo. Based on safety data, the test treatment was deemed safe. This early-phase study using cell transplantation of autologous cultured and

  13. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.

    PubMed

    Granel, Brigitte; Daumas, Aurélie; Jouve, Elisabeth; Harlé, Jean-Robert; Nguyen, Pierre-Sébastien; Chabannon, Christian; Colavolpe, Nathalie; Reynier, Jean-Charles; Truillet, Romain; Mallet, Stéphanie; Baiada, Antoine; Casanova, Dominique; Giraudo, Laurent; Arnaud, Laurent; Veran, Julie; Sabatier, Florence; Magalon, Guy

    2015-12-01

    In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability. We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy. All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed. This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population. GFRS (Groupe Francophone de Recherche sur la Sclérodermie). NCT01813279. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  14. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial

    PubMed Central

    Granel, Brigitte; Daumas, Aurélie; Jouve, Elisabeth; Harlé, Jean-Robert; Nguyen, Pierre-Sébastien; Chabannon, Christian; Colavolpe, Nathalie; Reynier, Jean-Charles; Truillet, Romain; Mallet, Stéphanie; Baiada, Antoine; Casanova, Dominique; Giraudo, Laurent; Arnaud, Laurent; Veran, Julie; Sabatier, Florence; Magalon, Guy

    2015-01-01

    Background In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability. Methods We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy. Findings All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed. Interpretation This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population. Funding GFRS (Groupe Francophone de Recherche sur la Sclérodermie). Clinical Trials number NCT01813279. PMID:25114060

  15. Safety and biodistribution assessment of sc-rAAV2.5IL-1Ra administered via intra-articular injection in a mono-iodoacetate-induced osteoarthritis rat model

    PubMed Central

    Wang, Gensheng; Evans, Christopher H; Benson, Janet M; Hutt, Julie A; Seagrave, JeanClare; Wilder, Julie A; Grieger, Joshua C; Samulski, R Jude; Terse, Pramod S

    2016-01-01

    Interleukin-1 (IL-1) plays an important role in the pathophysiology of osteoarthritis (OA), and gene transfer of IL-1 receptor antagonist (IL-1Ra) holds promise for OA treatment. A preclinical safety and biodistribution study evaluated a self-complementary adeno-associated viral vector carrying rat IL-1Ra transgene (sc-rAAV2.5rIL-1Ra) at 5 × 108, 5 × 109, or 5 × 1010 vg/knee, or human IL-1Ra transgene (sc-rAAV2.5hIL-1Ra) at 5 × 1010 vg/knee, in Wistar rats with mono-iodoacetate (MIA)–induced OA at days 7, 26, 91, 180, and 364 following intra-articular injection. The MIA-induced OA lesions were consistent with the published data on this model. The vector genomes persisted in the injected knees for up to a year with only limited vector leakage to systemic circulation and uptake in tissues outside the knee. Low levels of IL-1Ra expression and mitigation of OA lesions were observed in the vector-injected knees, albeit inconsistently. Neutralizing antibodies against the vector capsid developed in a dose-dependent manner, but only the human vector induced a small splenic T-cell immune response to the vector capsid. No local or systemic toxicity attributable to vector administration was identified in the rats as indicated by clinical signs, body weight, feed consumption, clinical pathology, and gross and microscopic pathology through day 364. Taken together, the gene therapy vector demonstrated a favorable safety profile. PMID:26817025

  16. Cidofovir Injection

    MedlinePlus

    ... in babies whose mothers received cidofovir injection during pregnancy. You should not use cidofovir injection while you are pregnant or plan to become pregnant unless your doctor decides that this is the best treatment for your condition.Cidofovir injection has caused tumors ...

  17. Albiglutide Injection

    MedlinePlus

    ... blood) when other medications did not control levels well enough. Albiglutide injection is not used to treat type 1 diabetes ( ... does not cure it. Continue to use albiglutide injection even if you feel well. Do not stop using albiglutide injection without talking ...

  18. Nalbuphine Injection

    MedlinePlus

    ... Your doctor may adjust your dose of nalbuphine injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling ... nalbuphine injection.You may receive nalbuphine injection in a hospital, ...

  19. Liraglutide Injection

    MedlinePlus

    ... blood) when other medications did not control levels well enough. Liraglutide injection (Victoza) is not used to treat type 1 ... does not cure it. Continue to use liraglutide injection even if you feel well. Do not stop using liraglutide injection without talking ...

  20. Meperidine Injection

    MedlinePlus

    ... Your doctor may adjust your dose of meperidine injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling ... meperidine injection.If you have used meperidine injection for longer ...

  1. Dulaglutide Injection

    MedlinePlus

    ... blood) when other medications did not control levels well enough. Dulaglutide injection is not used to treat type 1 diabetes ( ... does not cure it. Continue to use dulaglutide injection even if you feel well. Do not stop using dulaglutide injection without talking ...

  2. Morphine Injection

    MedlinePlus

    ... Your doctor may adjust your dose of morphine injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling ... with morphine injection.If you have used morphine injection for longer ...

  3. Busulfan Injection

    MedlinePlus

    Busulfex® Injection ... Busulfan injection is used to treat a certain type of chronic myelogenous leukemia (CML; a type of cancer of ... of 16 doses) before bone marrow transplant.Busulfan injection may cause seizures during therapy with the medication. ...

  4. Relative bioavailability and safety of aripiprazole lauroxil, a novel once-monthly, long-acting injectable atypical antipsychotic, following deltoid and gluteal administration in adult subjects with schizophrenia.

    PubMed

    Turncliff, Ryan; Hard, Marjie; Du, Yangchun; Risinger, Robert; Ehrich, Elliot W

    2014-11-01

    Aripiprazole lauroxil is a linker lipid ester of aripiprazole for extended-release intramuscular (IM) injection. This multicenter, randomized, open-label study evaluated the pharmacokinetics (PK), relative bioavailability, and tolerability of a single IM deltoid or gluteal injection of aripiprazole lauroxil in adult subjects with chronic stable schizophrenia or schizoaffective disorder. Forty-six subjects were randomized 1:1 to aripiprazole lauroxil 441 mg IM in the deltoid or gluteal muscle. Samples were collected through 89 days post-dose to measure levels of aripiprazole lauroxil, N-hydroxymethyl aripiprazole, aripiprazole, and dehydro-aripiprazole. Forty-three (93.5%) subjects completed all study assessments; most were CYP2D6 extensive or immediate metabolizers (96%); two (4%) were poor metabolizers. The PK of aripiprazole following aripiprazole lauroxil was characterized by a steady rise in plasma concentrations (Tmax 44-50 days), a broad peak, and prolonged exposure attributable to the dissolution of aripiprazole lauroxil and formation rate-limited elimination of aripiprazole (t1/2=15.4-19.2 days). Deltoid vs. gluteal administration resulted in slightly higher Cmax aripiprazole concentrations [1.31 (1.02, 1.67); GMR 90% CI]; total exposure (AUCinf) was similar between sites of administration [0.84 (0.57, 1.24)]. N-hydroxymethyl-aripiprazole and dehydro-aripiprazole exposures were 10% and 33-36%, respectively, of aripiprazole exposure following aripiprazole lauroxil. The most common adverse events were injection site pain in 20 subjects (43.5%) and headache in 6 subjects (13.0%) of mild intensity occurring at a similar rate with deltoid and gluteal administration. Exposure ranges with deltoid and gluteal administration overlapped, suggesting that these sites may be used interchangeably. Despite a higher incidence of adverse events, deltoid muscle provides a more accessible injection site and could facilitate patient acceptance.

  5. Rationale and design of the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis in Dilated Cardiomyopathy (the POSEIDON-DCM study): a phase I/II, randomized pilot study of the comparative safety and efficacy of transendocardial injection of autologous mesenchymal stem cell vs. allogeneic mesenchymal stem cells in patients with non-ischemic dilated cardiomyopathy.

    PubMed

    Mushtaq, Muzammil; DiFede, Darcy L; Golpanian, Samuel; Khan, Aisha; Gomes, Samirah A; Mendizabal, Adam; Heldman, Alan W; Hare, Joshua M

    2014-12-01

    While accumulating clinical trials have focused on the impact of cell therapy in patients with acute myocardial infarction (MI) and ischemic cardiomyopathy, there are fewer efforts to examine cell-based therapy in patients with non-ischemic cardiomyopathy (NICM). We hypothesized that cell therapy could have a similar impact in NICM. The POSEIDON-DCM trial is a phase I/II trial designed to address autologous vs. allogeneic bone marrow-derived mesenchymal stem cells (MSCs) in patients with NICM. In this study, cells will be administered transendocardially with the NOGA injection-catheter system to patients (n = 36) randomly allocated to two treatment groups: group 1 (n = 18 auto-human mesenchymal stem cells (hMSC)) and group 2 (n = 18 allo-hMSCs). The primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCS vs. auto-hMSCs in patients with NICM. This study will establish safety of transendocardial injection of stem cells (TESI), compare phenotypic outcomes, and offer promising advances in the field of cell-based therapy in patients with NICM.

  6. Safety Studies on Intrahepatic or Intratumoral Injection of Oncolytic Vesicular Stomatitis Virus Expressing Interferon-β in Rodents and Nonhuman Primates

    PubMed Central

    Jenks, Nathan; Myers, Rae; Greiner, Suzanne M.; Thompson, Jill; Mader, Emily K.; Greenslade, Andrew; Griesmann, Guy E.; Federspiel, Mark J.; Rakela, Jorge; Borad, Mitesh J.; Vile, Richard G.; Barber, Glen N.; Meier, Thomas R.; Blanco, Michael C.; Carlson, Stephanie K.; Russell, Stephen J.

    2010-01-01

    Abstract Toxicology studies were performed in rats and rhesus macaques to establish a safe starting dose for intratumoral injection of an oncolytic vesicular stomatitis virus expressing human interferon-β (VSV-hIFNβ) in patients with hepatocellular carcinoma (HCC). No adverse events were observed after administration of 7.59 × 109 TCID50 (50% tissue culture infective dose) of VSV-hIFNβ into the left lateral hepatic lobe of Harlan Sprague Dawley rats. Plasma alanine aminotransferase and alkaline phosphatase levels increased and platelet counts decreased in the virus-treated animals on days 1 and 2 but returned to pretreatment levels by day 4. VSV-hIFNβ was also injected into normal livers or an intrahepatic McA-RH7777 HCC xenograft established in Buffalo rats. Buffalo rats were more sensitive to neurotoxic effects of VSV; the no observable adverse event level (NOAEL) of VSV-hIFNβ in Buffalo rats was 107 TCID50. Higher doses were associated with fatal neurotoxicity and infectious virus was recovered from tumor and brain. Compared with VSV-hIFNβ, toxicity of VSV-rIFNβ (recombinant VSV expressing rat IFN-β) was greatly diminished in Buffalo rats (NOAEL, >1010 TCID50). Two groups of two adult male rhesus macaques received 109 or 1010 TCID50 of VSV-hIFNβ injected directly into the left hepatic lobe under computed tomographic guidance. No neurological signs were observed at any time point. No abnormalities (hematology, clinical chemistry, body weights, behavior) were seen and all macaques developed neutralizing anti-VSV antibodies. Plasma interleukin-6, tumor necrosis factor-α, and hIFN-β remained below detection levels by ELISA. On the basis of these studies, we will be proposing a cautious approach to dose escalation in a phase I clinical trial among patients with HCC. PMID:19911974

  7. A randomized, double-blind, placebo-controlled clinical study to assess safety and clinical activity of OTO-104 given as a single intratympanic injection in patients with unilateral Ménière's disease.

    PubMed

    Lambert, Paul R; Nguyen, Shaun; Maxwell, Kenneth S; Tucci, Debara L; Lustig, Lawrence R; Fletcher, Malcolm; Bear, Moraye; Lebel, Carl

    2012-09-01

    To evaluate the safety, tolerability, and clinical activity of a single intratympanic injection of OTO-104, sustained-release dexamethasone formulation, in patients with unilateral Ménière's disease. Prospective, double-blind, randomized, placebo-controlled, dose-escalation study of 16 weeks' (4-wk lead-in before dosing; 12-wk follow-up after dosing) duration for each patient. Fifteen centers (physician offices and academic or tertiary referral centers). Forty-four patients aged 22 to 75 years. Single intratympanic injection of OTO-104 (3 or 12 mg) or placebo. Safety and tolerability were assessed via adverse event reports, otoscopy, audiometry, and tympanometry. Clinical activity was assessed primarily as changes in vertigo frequency. OTO-104 was well tolerated, with no impact on hearing function. Plasma levels were observed in a few patients and were barely quantifiable. The most frequently reported adverse event considered related to investigational product was tympanic membrane perforation; no clinical sequelae were associated with these perforations and all were graded mild or moderate. At Month 3, the observed mean ± standard deviation (SD) change from baseline in vertigo frequency was -0.124 ± 0.153, -0.147 ± 0.166, and -0.211 ± 0.153 for the placebo, 3-mg OTO-104, and 12-mg OTO-104 groups, respectively; corresponding to 42%, 56% and 73% reductions in vertigo frequency, respectively. Similar results were observed for tinnitus, measured by the Tinnitus Handicap Inventory (THI-25). OTO-104 was safe and well tolerated. Although the sample size was small, the data suggest 12 mg of OTO-104 was associated with a clinically meaningful reduction in vertigo frequency compared to placebo 3 months after treatment.

  8. NRC review of passive reactor design certification testing programs: Overview, progress, and regulatory perspective

    SciTech Connect

    Levin, A.E.

    1995-09-01

    New reactor designs, employing passive safety systems, are currently under development by reactor vendors for certification under the U.S. Nuclear Regulatory Commission`s (NRC`s) design certification rule. The vendors have established testing programs to support the certification of the passive designs, to meet regulatory requirements for demonstration of passive safety system performance. The NRC has, therefore, developed a process for the review of the vendors` testing programs and for incorporation of the results of those reviews into the safety evaluations for the passive plants. This paper discusses progress in the test program reviews, and also addresses unique regulatory aspects of those reviews.

  9. Efficacy and safety of a single intra-articular injection of non-animal stabilized hyaluronic acid (NASHA) in patients with osteoarthritis of the knee.

    PubMed

    Altman, Roy D; Akermark, Christian; Beaulieu, André D; Schnitzer, Thomas

    2004-08-01

    Non-animal stabilized hyaluronic acid (NASHA) is a novel hyaluronan (HA) preparation with a 4-week intra-articular half-life. This study compared the efficacy of a single injection of NASHA with placebo in patients with osteoarthritis (OA) of the knee. This was a 26-week randomized, double-blind, multicenter study of a single intra-articular knee injection with either NASHA or placebo (saline). Assessments included the Western Ontario McMasters Universities osteoarthritis index (WOMAC, Likert Scale) and patients' overall global disease status. A positive response was defined as a reduction in WOMAC pain score for the study knee of 40% from baseline with a minimum improvement of > or =5 points. A total of 346 (NASHA 172; placebo 174) patients were treated. WOMAC scores and quality of life were improved in both the NASHA and placebo groups. For the overall population, there were no statistically significant between-group differences in response rates for any efficacy parameters. In patients with OA confined to the knee (N=216), a greater response to NASHA than placebo was observed at week 6 (P=0.025). There were few treatment-related events. NASHA was not superior to placebo for the primary efficacy analysis. However, these data may be confounded by the inclusion of patients with OA at other sites, as significant benefits over placebo were found among patients with OA confined to the knee. Future trials of OA that examine a local therapy might need to consider restricting the study population to those patients having OA of only the signal joint.

  10. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety.

    PubMed

    Sun, Shu-Fen; Hsu, Chien-Wei; Lin, Huey-Shyan; Liou, I-Hsiu; Chen, Yin-Han; Hung, Chia-Ling

    2017-03-15

    Viscosupplementation has been widely used for the treatment of knee osteoarthritis. Because we found no well-controlled trial comparing single-injection regimens of hyaluronan for knee osteoarthritis, we compared the efficacy and safety of a single intra-articular injection of a novel cross-linked hyaluronan (HYA-JOINT Plus) with a single injection of Synvisc-One in patients with knee osteoarthritis. In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 132 patients with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) were randomized to receive 1 intra-articular injection of 3 mL of HYA-JOINT Plus (20 mg/mL) (n = 66) or 6 mL of Synvisc-One (8 mg/mL) (n = 66). The primary outcome was the change from baseline in the visual analog scale (VAS) (0 to 100 mm) pain score at 6 months. Secondary outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert scale), Lequesne index, timed "Up & Go" (TUG) test, single-limb stance (SLS) test, use of rescue analgesics, and patient satisfaction. A total of 121 patients were available for the intention-to-treat analysis at 6 months. Both groups had a significant improvement in the VAS, WOMAC, and Lequesne index scores at each follow-up visit (p < 0.001). Patients who received HYA-JOINT Plus experienced a significantly greater improvement in the VAS pain score at 1, 3, and 6 months compared with those treated with Synvisc-One (adjusted mean difference: -12.0, -8.5, and -6.6; p = 0.001, 0.033, and 0.045, respectively). There were no significant between-group differences in any of the secondary outcomes except the WOMAC stiffness scores at 6 months, which favored HYA-JOINT Plus treatment (p = 0.043). The TUG time did not change significantly in either group during the study (p > 0.05), but the SLS time improved significantly in both the HYA-JOINT Plus and the Synvisc-One group (p = 0.004 and p = 0.022, respectively). No significant between

  11. Hydromorphone Injection

    MedlinePlus

    ... Your doctor may adjust your dose of hydromorphone injection during your treatment, depending on how well your pain is controlled and on the side ... to have pain after you finish the hydromorphone injection, call your doctor.It ... you are taking, as well as any products such as vitamins, minerals, or ...

  12. Ixabepilone Injection

    MedlinePlus

    ... doctor will order laboratory tests to see how well your liver is working before and during your treatment. If the tests show that you have liver problems, your doctor will probably not give you ixabepilone injection and capecitabine (Xeloda). Treatment with both ixabepilone injection ...

  13. Romidepsin Injection

    MedlinePlus

    ... group of cancers of the immune system that first appear as skin rashes) in people who have already been treated with at least one other medication given by mouth or by injection. Romidepsin injection is in a class of medications called histone deacetylase (HDAC) inhibitors. It ...

  14. Nusinersen Injection

    MedlinePlus

    Nusinersen injection is used for the treatment of spinal muscular atrophy (an inherited condition that reduces muscle strength and movement). Nusinersen injection is in a class of medications called antisense ... a certain protein necessary for the muscles and nerves to work normally.

  15. Passive magnetic bearing configurations

    DOEpatents

    Post, Richard F [Walnut Creek, CA

    2011-01-25

    A journal bearing provides vertical and radial stability to a rotor of a passive magnetic bearing system when the rotor is not rotating and when it is rotating. In the passive magnetic bearing system, the rotor has a vertical axis of rotation. Without the journal bearing, the rotor is vertically and radially unstable when stationary, and is vertically stable and radially unstable when rotating.

  16. LASL passive program

    SciTech Connect

    Neeper, D.A.

    1980-01-01

    Recent accomplishments are outlined on the following tasks: (1) solar load ratio for sunspaces; (2) thermal performance of components and buildings; (3) convective loop test; (4) similarity study of interzone convection; (5) evaluation of phase-change thermal storage; (6) off-peak electrical auxiliary heating; (7) passive solar design handbook; (8) program support to DOE; and (9) passive cooling for residences. (WHK)

  17. Musculoskeletal Injection

    PubMed Central

    Wittich, Christopher M.; Ficalora, Robert D.; Mason, Thomas G.; Beckman, Thomas J.

    2009-01-01

    Patients commonly present to primary care physicians with musculoskeletal symptoms. Clinicians certified in internal medicine must be knowledgeable about the diagnosis and management of musculoskeletal diseases, yet they often receive inadequate postgraduate training on this topic. The musculoskeletal problems most frequently encountered in our busy injection practice involve, in decreasing order, the knees, trochanteric bursae, and glenohumeral joints. This article reviews the clinical presentations of these problems. It also discusses musculoskeletal injections for these problems in terms of medications, indications, injection technique, and supporting evidence from the literature. Experience with joint injection and the pharmacological principles described in this article should allow primary care physicians to become comfortable and proficient with musculoskeletal injections. PMID:19720781

  18. Passive cooling system for liquid metal cooled nuclear reactors with backup coolant flow path

    DOEpatents

    Hunsbedt, Anstein; Boardman, Charles E.

    1993-01-01

    A liquid metal cooled nuclear fission reactor plant having a passive auxiliary safety cooling system for removing residual heat resulting from fuel decay during reactor shutdown, or heat produced during a mishap. This reactor plant is enhanced by a backup or secondary passive safety cooling system which augments the primary passive auxiliary cooling system when in operation, and replaces the primary system when rendered inoperable.

  19. Passive cooling system for top entry liquid metal cooled nuclear reactors

    DOEpatents

    Boardman, Charles E.; Hunsbedt, Anstein; Hui, Marvin M.

    1992-01-01

    A liquid metal cooled nuclear fission reactor plant having a top entry loop joined satellite assembly with a passive auxiliary safety cooling system for removing residual heat resulting from fuel decay during shutdown, or heat produced during a mishap. This satellite type reactor plant is enhanced by a backup or secondary passive safety cooling system which augments the primary passive auxiliary cooling system when in operation, and replaces the primary cooling system when rendered inoperative.

  20. Passive solar construction handbook

    SciTech Connect

    Levy, E.; Evans, D.; Gardstein, C.

    1981-08-01

    Many of the basic elements of passive solar design are reviewed. The unique design constraints presented in passive homes are introduced and many of the salient issues influencing design decisions are described briefly. Passive solar construction is described for each passive system type: direct gain, thermal storage wall, attached sunspace, thermal storage roof, and convective loop. For each system type, important design and construction issues are discussed and case studies illustrating designed and built examples of the system type are presented. Construction details are given and construction and thermal performance information is given for the materials used in collector components, storage components, and control components. Included are glazing materials, framing systems, caulking and sealants, concrete masonry, concrete, brick, shading, reflectors, and insulators. The Load Collector Ratio method for estimating passive system performance is appended, and other analysis methods are briefly summarized. (LEW)

  1. Efficacy, tolerability, and safety of aripiprazole once-monthly versus other long-acting injectable antipsychotic therapies in the maintenance treatment of schizophrenia: a mixed treatment comparison of double-blind randomized clinical trials

    PubMed Central

    Majer, Istvan M.; Gaughran, Fiona; Sapin, Christophe; Beillat, Maud; Treur, Maarten

    2015-01-01

    Background Treatment with long-acting injectable (LAI) antipsychotic medication is an important element of relapse prevention in schizophrenia. Recently, the intramuscular once-monthly formulation of aripiprazole received marketing approval in Europe and the United States for schizophrenia. Objective This study aimed to compare aripiprazole once-monthly with other LAI antipsychotics in terms of efficacy, tolerability, and safety. Data sources A systematic literature review was conducted to identify relevant double-blind randomized clinical trials of LAIs conducted in the maintenance treatment of schizophrenia. MEDLINE, MEDLINE In-Process, Embase, the Cochrane Library, PsycINFO, conference proceedings, clinical trial registries, and the reference lists of key review articles were searched. The literature search covered studies dating from January 2002 to May 2013. Study selection Studies were required to have ≥24 weeks of follow-up. Patients had to be stable at randomization. Studies were not eligible for inclusion if efficacy of acute and maintenance phase treatment was not reported separately. Six trials were identified (0.5% of initially identified studies), allowing comparisons of aripiprazole once-monthly, risperidone LAI, paliperidone palmitate, olanzapine pamoate, haloperidol depot, and placebo. Data extraction Data extracted included study details, study duration, the total number of patients in each treatment arm, efficacy, tolerability, and safety outcomes. The efficacy outcome contained the number of patients that experienced a relapse, tolerability outcomes included the number of patients that discontinued treatment due to treatment-related adverse events (AEs), and that discontinued treatment due to reasons other than AEs (e.g., loss to follow-up). Safety outcomes included the incidence of clinically relevant weight gain and extrapyramidal symptoms. Data synthesis Data were analyzed by applying a mixed treatment comparison competing risks model

  2. Safety and efficacy of intra-articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis: Results of a double-blind, controlled, multicenter, randomized trial.

    PubMed

    Conrozier, Thierry; Eymard, Florent; Afif, Naji; Balblanc, Jean-Charles; Legré-Boyer, Virginie; Chevalier, Xavier

    2016-10-01

    To compare both safety and efficacy of a novel intra-articular viscosupplement made of intermediate molecular weight (MW) hyaluronic acid (HA) mixed with high concentration of mannitol with a marketed high MW HA, in patients with knee osteoarthritis (OA). Patients with symptomatic knee OA, with radiological OARSI grades 1 to 3, were enrolled in a controlled, double-blind, parallel-group, non-inferiority trial. They were randomized to receive three intra-articular injections, at weekly intervals, of either HAnOX-M made of a combination of HA (MW one to 1.5MDa, 31mg/2ml) and mannitol (70mg/2ml) or Bio-HA (MW 2.3 to 3.6MDa, 20mg/2ml). The primary outcome was six-month change in the WOMAC pain subscale (0 to 20). Sample size was calculated according to a non-inferiority margin of 1.35. Secondary endpoints included six-month change in function and walking pain, analgesic consumption and safety. The intention-to-treat (ITT) and per-protocol (PP) populations consisted of 205 and 171 patients. HAnOX-M and Bio-Ha groups did not differ statistically at baseline. The primary analysis was conducted in the PP population, then in the ITT population. The average WOMAC pain score at baseline was 9.5 in both groups. Mean (SD) variations in WOMAC pain score were -4.4 (3.8) and -4.5 (4.3) mm, for HAnOX and Bio-HA respectively, satisfying the claim for non-inferiority. Similar results were obtained for all other secondary endpoints. Treatment with of HAnOX-M is effective to alleviate knee OA symptoms and to improve joint function over six months, with similar safety than conventional HA viscosupplement. Copyright © 2016. Published by Elsevier B.V.

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

    PubMed

    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.

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

    PubMed Central

    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

    2015-01-01

    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. PMID:25524052

  5. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction

    PubMed Central

    Hamdy, Reggie C; Montpetit, Kathleen; Ruck-Gibis, Joanne; Thorstad, Kelly; Raney, Ellen; Aiona, Michael; Platt, Robert; Finley, Allen; Mackenzie, William; McCarthy, James; Narayanan, Unni

    2007-01-01

    Background Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A), which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. Methods/Design The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5–21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont). Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group) intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. Discussion BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the

  6. Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction.

    PubMed

    Hamdy, Reggie C; Montpetit, Kathleen; Ruck-Gibis, Joanne; Thorstad, Kelly; Raney, Ellen; Aiona, Michael; Platt, Robert; Finley, Allen; Mackenzie, William; McCarthy, James; Narayanan, Unni

    2007-09-28

    Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A), which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5-21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont). Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group) intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the context of limb lengthening and

  7. Abaloparatide Injection

    MedlinePlus

    ... of a natural human hormone called parathyroid hormone (PTH). It works by causing the body to build ... container.You should know that abaloparatide injection may cause dizziness, lightheadedness, and fainting when you get up ...

  8. Sumatriptan Injection

    MedlinePlus

    ... accompanied by nausea and sensitivity to sound and light). Sumatriptan injection is also used to treat the ... children. Store it at room temperature, away from light, excess heat, and moisture (not in the bathroom). ...

  9. Certolizumab Injection

    MedlinePlus

    ... has not improved when treated with other medications, rheumatoid arthritis (a condition in which the body attacks its ... continues. When certolizumab injection is used to treat rheumatoid arthritis, it is usually given every other week and ...

  10. Acyclovir Injection

    MedlinePlus

    ... chickenpox in the past) in people with weak immune systems. It is also used to treat first-time ... from time to time) in people with normal immune systems. Acyclovir injection is used to treat herpes simplex ...

  11. Doxercalciferol Injection

    MedlinePlus

    Doxercalciferol injection is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in ...

  12. Evolocumab Injection

    MedlinePlus

    ... how to inject this medication.Remove the prefilled syringe or prefilled autoinjector from the refrigerator and allow it to ... before using it. Do not warm the prefilled syringe or prefilled autoinjector in hot water, microwave, or place in ...

  13. Ixekizumab Injection

    MedlinePlus

    ... as a as a solution (liquid) in a prefilled syringe, and as a prefilled autoinjector to inject subcutaneously ( ... dispose of the puncture-resistant container.Remove the prefilled syringe or autoinjector from the refrigerator. Place it on ...

  14. Alirocumab Injection

    MedlinePlus

    ... how to inject this medication.Remove the prefilled syringe or prefilled dosing pen from the refrigerator and allow it ... hours or longer. Do not put the prefilled syringe or prefilled dosing pen back in the refrigerator after it ...

  15. Daclizumab Injection

    MedlinePlus

    Daclizumab comes as a solution (liquid) in a prefilled syringe to inject subcutaneously (under the skin). It is ... or tattooed.Never reuse or share needles or prefilled syringes of medication. Throw away used syringes in a ...

  16. Sarilumab Injection

    MedlinePlus

    ... receive any vaccines. You should not receive any vaccinations while you are using sarilumab injection without talking ... pregnant, tellyour doctor before the baby receives any vaccinations.if you are having surgery, including dental surgery, ...

  17. Zidovudine Injection

    MedlinePlus

    ... zidovudine injection does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) ... sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus ...

  18. Rasburicase Injection

    MedlinePlus

    ... as tumors break down) in people with certain types of cancer who are being treated with chemotherapy medications. Rasburicase injection is in a class of medications called enzymes. It works by breaking down uric acid so ...

  19. Haloperidol Injection

    MedlinePlus

    ... release injection are used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of ... medications); medications for anxiety, depression, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary ...

  20. Risperidone Injection

    MedlinePlus

    ... acting) injection is used to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of ... ropinirole (Requip); medications for anxiety, blood pressure, or mental illness; medications for seizures such as carbamazepine (Carbatrol, Epitol, ...

  1. Thiotepa Injection

    MedlinePlus

    ... that begins in the female reproductive organs where eggs are formed), breast, and bladder cancer. It is ... comes as a powder to be mixed with liquid to be injected intravenously (into a vein) by ...

  2. Methotrexate Injection

    MedlinePlus

    ... Methotrexate injection is also used to treat severe psoriasis (a skin disease in which red, scaly patches ... slowing the growth of cancer cells. Methotrexate treats psoriasis by slowing the growth of skin cells to ...

  3. Cefazolin Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria including skin, bone, joint, genital, blood, heart valve, ... medications called cephalosporin antibiotics. It works by killing bacteria.Antibiotics such as cefazolin injection will not work ...

  4. Trastuzumab Injection

    MedlinePlus

    ... completed for up to 52 weeks. When trastuzumab injection is used to treat stomach cancer, it is usually given once every 3 weeks. The length of your treatment depends on how well your body responds to the medication and the ...

  5. Bendamustine Injection

    MedlinePlus

    ... leukemia (CLL; a type of cancer of the white blood cells). Bendamustine injection is also used to treat a ... NHL: cancer that begins in a type of white blood cell that normally fights infection) that is slow spreading, ...

  6. Palonosetron Injection

    MedlinePlus

    ... that may occur several days after receiving certain chemotherapy medications. Palonosetron injection is in a class of medications called 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural ...

  7. Doxycycline Injection

    MedlinePlus

    ... injection is in a class of medications called tetracycline antibiotics. It works by killing bacteria that cause ... are allergic to doxycycline, minocycline (Dynacin, Minocin, Solodyn), tetracycline (Achromycin V), any other medications, or any of ...

  8. Dexamethasone Injection

    MedlinePlus

    ... severe allergic reactions. It is used in the management of certain types of edema (fluid retention and ... needed for normal body functioning) and in the management of certain types of shock. Dexamethasone injection is ...

  9. Levofloxacin Injection

    MedlinePlus

    ... infections. Levofloxacin injection is also used to prevent anthrax (a serious infection that may be spread on ... in people who may have been exposed to anthrax germs in the air and treat and prevent ...

  10. Omalizumab Injection

    MedlinePlus

    ... steroids. Omalizumab is also used to treat chronic hives without a known cause that cannot successfully be ... is not used to treat other forms of hives or allergic conditions. Omalizumab injection is in a ...

  11. Plerixafor Injection

    MedlinePlus

    ... used along with a granulocyte-colony stimulating factor (G-CSF) medication such as filgrastim (Neupogen) or pegfilgrastim ( ... injection will begin after you have received a G-CSF medication once a day for 4 days, ...

  12. Avelumab Injection

    MedlinePlus

    ... doctor or nurse in a medical facility or infusion center. It is usually given once every 2 ... Avelumab injection may cause serious reactions during the infusion of the medication. You may be given other ...

  13. Alemtuzumab Injection

    MedlinePlus

    ... injection, the medication is usually given three times weekly on alternate days (usually Monday, Wednesday, and Friday) ... that you eat foods that are rich in iron such as meats, leafy green vegetables, and fortified ...

  14. Dinutuximab Injection

    MedlinePlus

    ... treat neuroblastoma (a cancer that begins in nerve cells) in children who have responded to other treatments. Dinutuximab injection is in a class of medications called monoclonal antibodies. It works by killing cancer cells.

  15. Cyclosporine Injection

    MedlinePlus

    ... transplanted organ by the immune system of the person receiving the organ) in people who have received kidney, liver, and heart transplants. Cyclosporine injection should only be used to treat people who are unable to take cyclosporine by mouth. ...

  16. Denosumab Injection

    MedlinePlus

    ... menstrual periods), who have an increased risk for fractures (broken bones) or who cannot take or did ... receiving certain treatments that increase their risk for fractures. Denosumab injection (Xgeva) is used to reduce fractures ...

  17. Epinephrine Injection

    MedlinePlus

    ... emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, ... at the first sign of a serious allergic reaction. Use epinephrine injection exactly as directed; do not ...

  18. Aflibercept Injection

    MedlinePlus

    ... injection is used to treat wet age-related macular degeneration (AMD; an ongoing disease of the eye that ... that leads to blurry vision and vision loss), diabetic macular edema (an eye disease caused by diabetes that can ...

  19. Fondaparinux Injection

    MedlinePlus

    ... the leg), which can lead to pulmonary embolism (PE; a blood clot in the lung), in people ... with warfarin (Coumadin, Jantoven) to treat DVT or PE. Fondaparinux injection is in a class of medications ...

  20. Panitumumab Injection

    MedlinePlus

    ... as a solution (liquid) to be given by infusion (injected into a vein). It is usually given ... doctor or nurse in a doctor's office or infusion center. Panitumumab is usually given once every 2 ...

  1. Topotecan Injection

    MedlinePlus

    ... organs where eggs are formed) and small cell lung cancer (a type of cancer that begins in the ... topotecan injection is used to treat ovarian or lung cancer, it is usually given once a day for ...

  2. Gemcitabine Injection

    MedlinePlus

    ... with surgery. Gemcitabine is also used to treat cancer of the pancreas that has spread to other parts of the ... 4 weeks. When gemcitabine is used to treat cancer of pancreas it may be injected once every week. The ...

  3. Lacosamide Injection

    MedlinePlus

    ... with other medications to control certain types of seizures in people who cannot take oral medications. Lacosamide ... If you suddenly stop using lacosamide injection, your seizures may happen more often. Your doctor will probably ...

  4. Pegloticase Injection

    MedlinePlus

    ... doctor if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency (an inherited blood disease). Your doctor may test you for G6PD deficiency before you start to receive pegloticase injection. If ...

  5. Ibritumomab Injection

    MedlinePlus

    ... is in a class of medications called monoclonal antibodies with radioisotopes. It works by attaching to cancer ... you receive ibritumomab injection, your body may develop antibodies (substances in the blood that help the immune ...

  6. Oxytocin Injection

    MedlinePlus

    Oxytocin injection is used to begin or improve contractions during labor. Oxytocin also is used to reduce bleeding after childbirth. ... other medications or procedures to end a pregnancy. Oxytocin is in a class of medications called oxytocic ...

  7. Edaravone Injection

    MedlinePlus

    Edaravone injection is used to treat amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and ...

  8. Pentamidine Injection

    MedlinePlus

    Pentamidine injection is used to treat pneumonia caused by a fungus called Pneumocystis carinii. It is in a class of medications called antiprotozoals. It works by stopping the growth of protozoa that can cause pneumonia.

  9. Diphenhydramine Injection

    MedlinePlus

    ... or along with other medications to control abnormal movements in people who have Parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Diphenhydramine injection should not ...

  10. Docetaxel Injection

    MedlinePlus

    ... allergic to docetaxel injection or drugs made with polysorbate 80, an ingredient found in some medications. Ask ... if a medication you are allergic to contains polysorbate 80. If you experience any of the following ...

  11. Octreotide Injection

    MedlinePlus

    ... hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much ... Octreotide long-acting injection is used to control acromegaly, carcinoid tumors, and VIP-omas in people who ...

  12. Vedolizumab Injection

    MedlinePlus

    ... injection may cause serious allergic reactions during an infusion and for several hours afterward. A doctor or ... of the following symptoms during or after your infusion: rash; itching; swelling of the face, eyes, mouth, ...

  13. Granisetron Injection

    MedlinePlus

    ... that may occur after surgery. Granisetron extended-release (long-acting) injection is used with other medications to prevent nausea and vomiting caused by cancer chemotherapy that may occur immediately ...

  14. Fluconazole Injection

    MedlinePlus

    ... injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading ... by fungus. Fluconazole is also used to prevent yeast infections in patients who are likely to become ...

  15. Intravitreal injection

    MedlinePlus

    ... You may have this procedure if you have: Macular degeneration : An eye disorder that slowly destroys sharp, central ... injection References American Academy of Ophthalmology. Age-related macular degeneration PPP - updated 2015. Aao.org web site. Updated ...

  16. Ciprofloxacin Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria such as pneumonia; and infections of the skin, ... of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections.Antibiotics such as ciprofloxacin injection ...

  17. Tobramycin Injection

    MedlinePlus

    ... treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that ... medications called aminoglycoside antibiotics. It works by killing bacteria.Antibiotics such as tobramycin injection will not work ...

  18. Ceftriaxone Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria such as gonorrhea (a sexually transmitted disease), pelvic ... medications called cephalosporin antibiotics. It works by killing bacteria.Antibiotics such as ceftriaxone injection will not work ...

  19. Moxifloxacin Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria such as pneumonia; ; and , skin, and abdominal (stomach ... antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections.Antibiotics such as moxifloxacin injection ...

  20. Daptomycin Injection

    MedlinePlus

    ... in adults or serious skin infections caused by bacteria in adults and children 1 year of age ... called cyclic lipopeptide antibiotics. It works by killing bacteria.Antibiotics such as daptomycin injection will not work ...

  1. Amikacin Injection

    MedlinePlus

    ... treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that ... medications called aminoglycoside antibiotics. It works by killing bacteria.Antibiotics such as amikacin injection will not work ...

  2. Meropenem Injection

    MedlinePlus

    ... skin and abdominal (stomach area) infections caused by bacteria and meningitis (infection of the membranes that surround ... of medications called antibiotics. It works by killing bacteria that cause infection.Antibiotics such as meropenem injection ...

  3. Cefepime Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria including pneumonia, and skin, urinary tract, and kidney ... medications called cephalosporin antibiotics. It works by killing bacteria.Antibiotics such as cefepime injection will not work ...

  4. Ertapenem Injection

    MedlinePlus

    ... abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of ... medications called carbapenem antibiotics. It works by killing bacteria.Antibiotics such as ertapenem injection will not work ...

  5. Aztreonam Injection

    MedlinePlus

    ... to treat certain infections that are caused by bacteria, including respiratory tract (including pneumonia and bronchitis), urinary ... abdominal (stomach area) infections, that are caused by bacteria. Aztreonam injection also may be used before, during, ...

  6. Ceftaroline Injection

    MedlinePlus

    ... infections and pneumonia (lung infection) caused by certain bacteria. Ceftaroline is in a class of medications called cephalosporin antibiotics. It works by killing bacteria.Antibiotics such as ceftaroline injection will not work ...

  7. Cefotaxime Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria including pneumonia and other lower respiratory tract (lung) ... medications called cephalosporin antibiotics. It works by killing bacteria.Antibiotics such as cefotaxime injection will not work ...

  8. Cefuroxime Injection

    MedlinePlus

    ... is used to treat certain infections caused by bacteria including pneumonia and other lower respiratory tract (lung) ... medications called cephalosporin antibiotics. It works by killing bacteria.Antibiotics such as cefuroxime injection will not work ...

  9. Ampicillin Injection

    MedlinePlus

    ... to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that ... of medications called penicillins. It works by killing bacteria.Antibiotics such as ampicillin injection will not work ...

  10. Gentamicin Injection

    MedlinePlus

    ... treat certain serious infections that are caused by bacteria such as meningitis (infection of the membranes that ... medications called aminoglycoside antibiotics. It works by killing bacteria.Antibiotics such as gentamicin injection will not work ...

  11. MEDICAL INJECTION

    NASA Image and Video Library

    1963-06-10

    S62-08371 (1962) --- The automatic medical injectors carried on the Mercury-Atlas 9 flight. The injectors provide the astronaut with injection tubes of Tigan, for preventing motion sickness and Demerol, for relieving pain. The tubes encased in the block are stowed in the astronauts survival kit. The single injection tubes are placed in a pocket of the astronauts spacesuit. Photo credit: NASA

  12. Injection overview

    SciTech Connect

    Prestwich, S.

    1983-12-01

    The test program was initiated at the Raft River Geothermal Field in southern Idaho in September 1982. A series of eight short-term injection and backflow tests, followed by a long-term injection test, were conducted on one well in the field. Tracers were added during injection and monitored during backflow as well. The principal objective was to determine if tracers could be effectively used as a means to assess reservoir characteristics in a one-well test. The test program resulted in a unique data set which shows promise as a means to improve understanding of the reservoir characteristics. In December 1982, an RFP was issued to obtain an industrial partner to obtain follow-on data on the injection/backflow technique in a second field, and to study any alternate advanced concepts for injection testing which the industrial community might recommend. The East Mesa Geothermal Field was selected for the second test series. Two wells were utilized for testing, and a series of ten tests were conducted in July and August 1983, aimed principally at further evaluation of the injection/backflow technique.

  13. Randomised, double-blind, parallel group, placebo-controlled study to evaluate the analgesic efficacy and safety of VVZ-149 injections for postoperative pain following laparoscopic colorectal surgery

    PubMed Central

    Nedeljkovic, Srdjan S; Correll, Darin J; Bao, Xiaodong; Zamor, Natacha; Zeballos, Jose L; Zhang, Yi; Young, Mark J; Ledley, Johanna; Sorace, Jessica; Eng, Kristen; Hamsher, Carlyle P; Maniam, Rajivan; Chin, Jonathan W; Tsui, Becky; Cho, Sunyoung; Lee, Doo H

    2017-01-01

    Introduction In spite of advances in understanding and technology, postoperative pain remains poorly treated for a significant number of patients. In colorectal surgery, the need for developing novel analgesics is especially important. Patients after bowel surgery are assessed for rapid return of bowel function and opioids worsen ileus, nausea and constipation. We describe a prospective, double-blind, parallel group, placebo-controlled randomised controlled trial testing the hypothesis that a novel analgesic drug, VVZ -149, is safe and effective in improving pain compared with providing opioid analgesia alone among adults undergoing laparoscopic colorectal surgery. Methods and analysis Based on sample size calculations for primary outcome, we plan to enrol 120 participants. Adult patients without significant medical comorbidities or ongoing opioid use and who are undergoing laparoscopic colorectal surgery will be enrolled. Participants are randomly assigned to receive either VVZ-149 with intravenous (IV) hydromorphone patient-controlled analgesia (PCA) or the control intervention (IV PCA alone) in the postoperative period. The primary outcome is the Sum of Pain Intensity Difference over 8 hours (SPID-8 postdose). Participants receive VVZ-149 for 8 hours postoperatively to the primary study end point, after which they continue to be assessed for up to 24 hours. We measure opioid consumption, record pain intensity and pain relief, and evaluate the number of rescue doses and requests for opioid. To assess safety, we record sedation, nausea and vomiting, respiratory depression, laboratory tests and ECG readings after study drug administration. We evaluate for possible confounders of analgesic response, such as anxiety, depression and catastrophising behaviours. The study will also collect blood sample data and evaluate for pharmacokinetic and pharmacodynamic relationships. Ethics and dissemination Ethical approval of the study protocol has been obtained from

  14. Results of a Demonstration Assessment of Passive System Reliability Utilizing the Reliability Method for Passive Systems (RMPS)

    SciTech Connect

    Bucknor, Matthew; Grabaskas, David; Brunett, Acacia; Grelle, Austin

    2015-04-26

    Advanced small modular reactor designs include many advantageous design features such as passively driven safety systems that are arguably more reliable and cost effective relative to conventional active systems. Despite their attractiveness, a reliability assessment of passive systems can be difficult using conventional reliability methods due to the nature of passive systems. Simple deviations in boundary conditions can induce functional failures in a passive system, and intermediate or unexpected operating modes can also occur. As part of an ongoing project, Argonne National Laboratory is investigating various methodologies to address passive system reliability. The Reliability Method for Passive Systems (RMPS), a systematic approach for examining reliability, is one technique chosen for this analysis. This methodology is combined with the Risk-Informed Safety Margin Characterization (RISMC) approach to assess the reliability of a passive system and the impact of its associated uncertainties. For this demonstration problem, an integrated plant model of an advanced small modular pool-type sodium fast reactor with a passive reactor cavity cooling system is subjected to a station blackout using RELAP5-3D. This paper discusses important aspects of the reliability assessment, including deployment of the methodology, the uncertainty identification and quantification process, and identification of key risk metrics.

  15. Techniques for active passivation

    SciTech Connect

    Roscioli, Joseph R.; Herndon, Scott C.; Nelson, Jr., David D.

    2016-12-20

    In one embodiment, active (continuous or intermittent) passivation may be employed to prevent interaction of sticky molecules with interfaces inside of an instrument (e.g., an infrared absorption spectrometer) and thereby improve response time. A passivation species may be continuously or intermittently applied to an inlet of the instrument while a sample gas stream is being applied. The passivation species may have a highly polar functional group that strongly binds to either water or polar groups of the interfaces, and once bound presents a non-polar group to the gas phase in order to prevent further binding of polar molecules. The instrument may be actively used to detect the sticky molecules while the passivation species is being applied.

  16. Hood River Passive House

    SciTech Connect

    Hales, D.

    2013-03-01

    The Hood River Passive Project was developed by Root Design Build of Hood River Oregon using the Passive House Planning Package (PHPP) to meet all of the requirements for certification under the European Passive House standards. The Passive House design approach has been gaining momentum among residential designers for custom homes and BEopt modeling indicates that these designs may actually exceed the goal of the U.S. Department of Energy's (DOE) Building America program to reduce home energy use by 30%-50% (compared to 2009 energy codes for new homes). This report documents the short term test results of the Shift House and compares the results of PHPP and BEopt modeling of the project.

  17. Randomised, double-blind, parallel group, placebo-controlled study to evaluate the analgesic efficacy and safety of VVZ-149 injections for postoperative pain following laparoscopic colorectal surgery.

    PubMed

    Nedeljkovic, Srdjan S; Correll, Darin J; Bao, Xiaodong; Zamor, Natacha; Zeballos, Jose L; Zhang, Yi; Young, Mark J; Ledley, Johanna; Sorace, Jessica; Eng, Kristen; Hamsher, Carlyle P; Maniam, Rajivan; Chin, Jonathan W; Tsui, Becky; Cho, Sunyoung; Lee, Doo H

    2017-02-17

    In spite of advances in understanding and technology, postoperative pain remains poorly treated for a significant number of patients. In colorectal surgery, the need for developing novel analgesics is especially important. Patients after bowel surgery are assessed for rapid return of bowel function and opioids worsen ileus, nausea and constipation. We describe a prospective, double-blind, parallel group, placebo-controlled randomised controlled trial testing the hypothesis that a novel analgesic drug, VVZ -149, is safe and effective in improving pain compared with providing opioid analgesia alone among adults undergoing laparoscopic colorectal surgery. Based on sample size calculations for primary outcome, we plan to enrol 120 participants. Adult patients without significant medical comorbidities or ongoing opioid use and who are undergoing laparoscopic colorectal surgery will be enrolled. Participants are randomly assigned to receive either VVZ-149 with intravenous (IV) hydromorphone patient-controlled analgesia (PCA) or the control intervention (IV PCA alone) in the postoperative period. The primary outcome is the Sum of Pain Intensity Difference over 8 hours (SPID-8 postdose). Participants receive VVZ-149 for 8 hours postoperatively to the primary study end point, after which they continue to be assessed for up to 24 hours. We measure opioid consumption, record pain intensity and pain relief, and evaluate the number of rescue doses and requests for opioid. To assess safety, we record sedation, nausea and vomiting, respiratory depression, laboratory tests and ECG readings after study drug administration. We evaluate for possible confounders of analgesic response, such as anxiety, depression and catastrophising behaviours. The study will also collect blood sample data and evaluate for pharmacokinetic and pharmacodynamic relationships. Ethical approval of the study protocol has been obtained from Institutional Review Boards at the participating institutions

  18. An integrated analysis of five double-blind, randomized controlled trials evaluating the safety and efficacy of a hyaluronan product for intra-articular injection in osteoarthritis of the knee.

    PubMed

    Strand, V; Conaghan, P G; Lohmander, L S; Koutsoukos, A D; Hurley, F L; Bird, H; Brooks, P; Day, R; Puhl, W; Band, P A

    2006-09-01

    Five double-blind, randomized, saline-controlled trials (RCTs) were included in the United States marketing application for an intra-articular hyaluronan (IA-HA) product for the treatment of osteoarthritis (OA) of the knee. We report an integrated analysis of the primary Case Report Form (CRF) data from these trials. Trials were similar in design, patient population and outcome measures - all included the Lequèsne Algofunctional Index (LI), a validated composite index of pain and function, evaluating treatment over 3 months. Individual patient data were pooled; a repeated measures analysis of covariance was performed in the intent-to-treat (ITT) population. Analyses utilized both fixed and random effects models. Safety data from the five RCTs were summarized. A total of 1155 patients with radiologically confirmed knee OA were enrolled: 619 received three or five IA-HA injections; 536 received "placebo" saline injections. In the active and control groups, mean ages were 61.8 and 61.4 years; 62.4% and 58.8% were women; baseline total Lequèsne scores 11.03 and 11.30, respectively. Integrated analysis of the pooled data set found a statistically significant reduction (P < 0.001) in total Lequèsne score with hyaluronan (HA) (-2.68) vs placebo (-2.00); estimated difference -0.68 (95% CI: -0.56 to -0.79), effect size 0.20. Additional modeling approaches confirmed robustness of the analyses. This integrated analysis demonstrates that multiple design factors influence the results of RCTs assessing efficacy of intra-articular (IA) therapies, and that integrated analyses based on primary data differ from meta-analyses using transformed data.

  19. Ramucirumab Injection

    MedlinePlus

    ... effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

  20. Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study.

    PubMed

    Elabd, Christian; Centeno, Christopher J; Schultz, John R; Lutz, Gregory; Ichim, Thomas; Silva, Francisco J

    2016-09-01

    Chronic low back pain due to disc degeneration represents a major social and economic burden worldwide. The current standard of care is limited to symptomatic relief and no current approved therapy promotes disc regeneration. Bone marrow-derived mesenchymal stem cells (MSCs) are easily accessible and well characterized. These MSCs are multipotent and exhibit great tissue regenerative potential including bone, cartilage, and fibrous tissue regeneration. The use of this cell-based biologic for treating protruding disc herniation and/or intervertebral disc degeneration is a promising therapeutic strategy, due to their known regenerative, immuno-modulatory and anti-inflammatory properties. Five patients diagnosed with degenerative disc disease received an intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells (15.1-51.6 million cells) as part of a previous study. These patients were re-consented to participate in this study in order to assess long-term safety and feasibility of intra-discal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells 4-6 years post mesenchymal stem cell infusion. The follow-up study consisted of a physical examination, a low back MRI, and a quality of life questionnaire. Patients' lower back MRI showed absence of neoplasms or abnormalities surrounding the treated region. Based on the physical examination and the quality of life questionnaire, no adverse events were reported due to the procedure or to the stem cell treatment 4-6 years post autologous, hypoxic cultured mesenchymal stem cell infusion. All patients self-reported overall improvement, as well as improvement in strength, post stem cell treatment, and four out of five patients reported improvement in mobility. This early human clinical data suggests the safety and feasibility of the clinical use of hypoxic cultured bone marrow-derived mesenchymal stem cells for the treatment of lower back pain due to

  1. Efficacy and safety of second-generation antipsychotic long-acting injections (SGA LAIs) in maintenance treatment of bipolar disorder: protocol for a systematic review and meta-analysis

    PubMed Central

    Prajapati, Asta R; Wilson, Jonathan

    2016-01-01

    Introduction Bipolar disorder requires long-term treatment but non-adherence is a common problem. Antipsychotic long-acting injections (LAIs) have been suggested to improve adherence but none are licensed in the UK for bipolar. However, the use of second-generation antipsychotics (SGA) LAIs in bipolar is not uncommon albeit there is a lack of systematic review in this area. This study aims to systematically review safety and efficacy of SGA LAIs in the maintenance treatment of bipolar disorder. Methods and analysis The protocol is based on Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and will include only randomised controlled trials comparing SGA LAIs in bipolar. PubMed, EMBASE, CINAHL, Cochrane Library (CENTRAL), PsychINFO, LiLACS, http://www.clinicaltrials.gov will be searched, with no language restriction, from 2000 to January 2016 as first SGA LAIs came to the market after 2000. Manufacturers of SGA LAIs will also be contacted. Primary efficacy outcome is relapse rate or delayed time to relapse or reduction in hospitalisation and primary safety outcomes are drop-out rates, all-cause discontinuation and discontinuation due to adverse events. Qualitative reporting of evidence will be based on 21 items listed on standards for reporting qualitative research (SRQR) focusing on study quality (assessed using the Jadad score, allocation concealment and data analysis), risk of bias and effect size. Publication bias will be assessed using funnel plots. If sufficient data are available meta-analysis will be performed with primary effect size as relative risk presented with 95% CI. Sensitivity analysis, conditional on number of studies and sample size, will be carried out on manic versus depressive symptoms and monotherapy versus adjunctive therapy. Ethics and dissemination Ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, conference presentation and

  2. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial.

    PubMed

    Haahr, Martha Kirstine; Jensen, Charlotte Harken; Toyserkani, Navid Mohamadpour; Andersen, Ditte Caroline; Damkier, Per; Sørensen, Jens Ahm; Lund, Lars; Sheikh, Søren Paludan

    2016-03-01

    Prostate cancer is the most common cancer in men, and radical prostatectomy (RP) often results in erectile dysfunction (ED) and a substantially reduced quality of life. The efficacy of current interventions, principal treatment with PDE-5 inhibitors, is not satisfactory and this condition presents an unmet medical need. Preclinical studies using adipose-derived stem cells to treat ED have shown promising results. Herein, we report the results of a human phase 1 trial with autologous adipose-derived regenerative cells (ADRCs) freshly isolated after a liposuction. Seventeen men suffering from post RP ED, with no recovery using conventional therapy, were enrolled in a prospective phase 1 open-label and single-arm study. All subjects had RP performed 5-18 months before enrolment, and were followed for 6 months after intracavernosal transplantation. ADRCs were analyzed for the presence of stem cell surface markers, viability and ability to differentiate. Primary endpoint was the safety and tolerance of the cell therapy while the secondary outcome was improvement of erectile function. Any adverse events were reported and erectile function was assessed by IIEF-5 scores. The study is registered with ClinicalTrials.gov, NCT02240823. 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 their erectile function and were able to accomplish sexual intercourse. Post-hoc stratification according to urinary continence status was performed. Accordingly, for continent men (median IIEFinclusion = 7 (95% CI 5-12), 8 out of 11 men recovered erectile function (IIEF6months = 17 (6-23)), corresponding 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

  3. Design process of the nanofluid injection mechanism in nuclear power plants

    PubMed Central

    2011-01-01

    Nanofluids, which are engineered suspensions of nanoparticles in a solvent such as water, have been found to show enhanced coolant properties such as higher critical heat flux and surface wettability at modest concentrations, which is a useful characteristic in nuclear power plants (NPPs). This study attempted to provide an example of engineering applications in NPPs using nanofluid technology. From these motivations, the conceptual designs of the emergency core cooling systems (ECCSs) assisted by nanofluid injection mechanism were proposed after following a design framework to develop complex engineering systems. We focused on the analysis of functional requirements for integrating the conventional ECCSs and nanofluid injection mechanism without loss of performance and reliability. Three candidates of nanofluid-engineered ECCS proposed in previous researches were investigated by applying axiomatic design (AD) in the manner of reverse engineering and it enabled to identify the compatibility of functional requirements and potential design vulnerabilities. The methods to enhance such vulnerabilities were referred from TRIZ and concretized for the ECCS of the Korean nuclear power plant. The results show a method to decouple the ECCS designs with the installation of a separate nanofluids injection tank adjacent to the safety injection tanks such that a low pH environment for nanofluids can be maintained at atmospheric pressure which is favorable for their injection in passive manner. PMID:21711896

  4. Design process of the nanofluid injection mechanism in nuclear power plants

    NASA Astrophysics Data System (ADS)

    Kang, Myoung-Suk; Jee, Changhyun; Park, Sangjun; Bang, In Choel; Heo, Gyunyoung

    2011-04-01

    Nanofluids, which are engineered suspensions of nanoparticles in a solvent such as water, have been found to show enhanced coolant properties such as higher critical heat flux and surface wettability at modest concentrations, which is a useful characteristic in nuclear power plants (NPPs). This study attempted to provide an example of engineering applications in NPPs using nanofluid technology. From these motivations, the conceptual designs of the emergency core cooling systems (ECCSs) assisted by nanofluid injection mechanism were proposed after following a design framework to develop complex engineering systems. We focused on the analysis of functional requirements for integrating the conventional ECCSs and nanofluid injection mechanism without loss of performance and reliability. Three candidates of nanofluid-engineered ECCS proposed in previous researches were investigated by applying axiomatic design (AD) in the manner of reverse engineering and it enabled to identify the compatibility of functional requirements and potential design vulnerabilities. The methods to enhance such vulnerabilities were referred from TRIZ and concretized for the ECCS of the Korean nuclear power plant. The results show a method to decouple the ECCS designs with the installation of a separate nanofluids injection tank adjacent to the safety injection tanks such that a low pH environment for nanofluids can be maintained at atmospheric pressure which is favorable for their injection in passive manner.

  5. Design process of the nanofluid injection mechanism in nuclear power plants.

    PubMed

    Kang, Myoung-Suk; Jee, Changhyun; Park, Sangjun; Bang, In Choel; Heo, Gyunyoung

    2011-04-27

    Nanofluids, which are engineered suspensions of nanoparticles in a solvent such as water, have been found to show enhanced coolant properties such as higher critical heat flux and surface wettability at modest concentrations, which is a useful characteristic in nuclear power plants (NPPs). This study attempted to provide an example of engineering applications in NPPs using nanofluid technology. From these motivations, the conceptual designs of the emergency core cooling systems (ECCSs) assisted by nanofluid injection mechanism were proposed after following a design framework to develop complex engineering systems. We focused on the analysis of functional requirements for integrating the conventional ECCSs and nanofluid injection mechanism without loss of performance and reliability. Three candidates of nanofluid-engineered ECCS proposed in previous researches were investigated by applying axiomatic design (AD) in the manner of reverse engineering and it enabled to identify the compatibility of functional requirements and potential design vulnerabilities. The methods to enhance such vulnerabilities were referred from TRIZ and concretized for the ECCS of the Korean nuclear power plant. The results show a method to decouple the ECCS designs with the installation of a separate nanofluids injection tank adjacent to the safety injection tanks such that a low pH environment for nanofluids can be maintained at atmospheric pressure which is favorable for their injection in passive manner.

  6. Ganciclovir Injection

    MedlinePlus

    ... tests to check your body's response to ganciclovir injection.It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or ...

  7. Pertuzumab Injection

    MedlinePlus

    ... tests to check your body's response to pertuzumab injection.It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or ...

  8. Mitoxantrone Injection

    MedlinePlus

    ... to the treatment.If you are using mitoxantrone injection for MS, you should know that it controls MS but does not cure it. Continue to receive treatments even if you feel well. Talk to your doctor if you no longer ...

  9. Olaratumab Injection

    MedlinePlus

    ... your pharmacist any questions you have about olaratumab injection.It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or ...

  10. Reslizumab Injection

    MedlinePlus

    ... the infusion or for a short period of time after the infusion has finished.You will receive each injection of reslizumab in a doctor's office or medical facility. You will stay in the office for some time after you receive the medication so your doctor ...

  11. Teduglutide Injection

    MedlinePlus

    ... syndrome in people who need additional nutrition or fluids from intravenous (IV) therapy. Teduglutide injection is in a class of medications called glucagon-like peptide-2 (GLP-2) analogs. It works by improving the absorption of fluids and nutrients in the intestines.

  12. Pegaptanib Injection

    MedlinePlus

    ... if you have or have ever had diabetes, high blood pressure, a heart attack, or a stroke.tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using pegaptanib injection, ...

  13. Measure Guideline: Passive Vents

    SciTech Connect

    Berger, David; Neri, Robin

    2016-02-05

    This document addresses the use of passive vents as a source of outdoor air in multifamily buildings. The challenges associated with implementing passive vents and the factors affecting performance are outlined. A comprehensive design methodology and quantified performance metrics are provided. Two hypothetical design examples are provided to illustrate the process. This document is intended to be useful to designers, decision-makers, and contractors implementing passive ventilation strategies. It is also intended to be a resource for those responsible for setting high-performance building program requirements, especially pertaining to ventilation and outdoor air. To ensure good indoor air quality, a dedicated source of outdoor air is an integral part of high-performance buildings. Presently, there is a lack of guidance pertaining to the design and installation of passive vents, resulting in poor system performance. This report details the criteria necessary for designing, constructing, and testing passive vent systems to enable them to provide consistent and reliable levels of ventilation air from outdoors.

  14. Recent Advances in the Remote Sensing of Radiological Materials by Passive FTIR Radiometry. 2005-2006 Summary Report for the Canadian Safeguards Support Program of the Canadian Nuclear Safety Commission

    DTIC Science & Technology

    2006-05-01

    that some materials such as UO2 , UO3, U3O8 , CoO, Co2O3, ThO2, CsI, SrO, I2O5 and La2O3 have absorption features in the thermal infrared region, and...and strontium oxide (SrO). Initially it was planned to include two uranium oxides ( UO2 and U3O8 ); however, high wind conditions precluded their use...at DRDC Ottawa that will involve the use of ground-based passive standoff FTIR radiometry for detecting and identifying UO2 and U3O8 radioactive

  15. Integration of Passive System Reliability in PSA Studies

    SciTech Connect

    Burgazzi, Luciano; Marques, Michel

    2006-07-01

    The treatment of passive safety systems within the probabilistic safety assessment models is a difficult and challenging task. The main concern arises from the nature of the passive systems whose predominant operating principles are based on physical phenomena rather than on active components. The present study provides a consistent approach for the integration of passive safety systems into fault tree and event tree based Probabilistic Safety Assessment (PSA) model of accident sequences, in the fashion of and in combination with a front line system or a human action. With reference to the thermal-hydraulic passive systems (e.g. natural circulation systems), in addition to the component failures (i.e. mechanical and electrical faults), the impairment of the physical principle upon which the system relies, deserves special consideration. This makes the relative assessment process different as regards the system model commonly adopted in the fault tree approach (i.e. exponential failure model). For the thermal-hydraulic passive system, since the failure process is driven mainly by the occurrence of the phenomenological failure modes, each pertinent basic event will be characterized by defined critical parameters (e.g. non-condensable fraction) that are expected to drive the failure mechanisms. An application of this approach is presented, with reference to a system designed for decay heat removal of advanced Light Water Reactors, relying on natural circulation and provided with a heat exchanger immersed in a cooling pool, acting as heat sink, and connected to the pressure vessel via steam and condensate lines. (authors)

  16. Fully Passive Wireless Acquisition of Neuropotentials

    NASA Astrophysics Data System (ADS)

    Schwerdt, Helen N.

    The ability to monitor electrophysiological signals from the sentient brain is requisite to decipher its enormously complex workings and initiate remedial solutions for the vast amount of neurologically-based disorders. Despite immense advancements in creating a variety of instruments to record signals from the brain, the translation of such neurorecording instrumentation to real clinical domains places heavy demands on their safety and reliability, both of which are not entirely portrayed by presently existing implantable recording solutions. In an attempt to lower these barriers, alternative wireless radar backscattering techniques are proposed to render the technical burdens of the implant chip to entirely passive neurorecording processes that transpire in the absence of formal integrated power sources or powering schemes along with any active circuitry. These radar-like wireless backscattering mechanisms are used to conceive of fully passive neurorecording operations of an implantable microsystem. The fully passive device potentially manifests inherent advantages over current wireless implantable and wired recording systems: negligible heat dissipation to reduce risks of brain tissue damage and minimal circuitry for long term reliability as a chronic implant. Fully passive neurorecording operations are realized via intrinsic nonlinear mixing properties of the varactor diode. These mixing and recording operations are directly activated by wirelessly interrogating the fully passive device with a microwave carrier signal. This fundamental carrier signal, acquired by the implant antenna, mixes through the varactor diode along with the internal targeted neuropotential brain signals to produce higher frequency harmonics containing the targeted neuropotential signals. These harmonics are backscattered wirelessly to the external interrogator that retrieves and recovers the original neuropotential brain signal. The passive approach removes the need for internal power

  17. Wireless passive radiation sensor

    DOEpatents

    Pfeifer, Kent B; Rumpf, Arthur N; Yelton, William G; Limmer, Steven J

    2013-12-03

    A novel measurement technique is employed using surface acoustic wave (SAW) devices, passive RF, and radiation-sensitive films to provide a wireless passive radiation sensor that requires no batteries, outside wiring, or regular maintenance. The sensor is small (<1 cm.sup.2), physically robust, and will operate unattended for decades. In addition, the sensor can be insensitive to measurement position and read distance due to a novel self-referencing technique eliminating the need to measure absolute responses that are dependent on RF transmitter location and power.

  18. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  19. Subcutaneous (SQ) injections

    MedlinePlus

    SQ injections; Sub-Q injections; Diabetes subcutaneous injection; Insulin subcutaneous injection ... NIH. Giving a subcutaneous injection . Rockville, MD. National ... of Health and Human Services NIH publications; 2015. Available ...

  20. Method of passivating semiconductor surfaces

    DOEpatents

    Wanlass, Mark W.

    1990-01-01

    A method of passivating Group III-V or II-VI semiconductor compound surfaces. The method includes selecting a passivating material having a lattice constant substantially mismatched to the lattice constant of the semiconductor compound. The passivating material is then grown as an ultrathin layer of passivating material on the surface of the Group III-V or II-VI semiconductor compound. The passivating material is grown to a thickness sufficient to maintain a coherent interface between the ultrathin passivating material and the semiconductor compound. In addition, a device formed from such method is also disclosed.

  1. Method of passivating semiconductor surfaces

    DOEpatents

    Wanlass, M.W.

    1990-06-19

    A method is described for passivating Group III-V or II-VI semiconductor compound surfaces. The method includes selecting a passivating material having a lattice constant substantially mismatched to the lattice constant of the semiconductor compound. The passivating material is then grown as an ultrathin layer of passivating material on the surface of the Group III-V or II-VI semiconductor compound. The passivating material is grown to a thickness sufficient to maintain a coherent interface between the ultrathin passivating material and the semiconductor compound. In addition, a device formed from such method is also disclosed.

  2. Vaccine safety.

    PubMed

    Jacobson, Robert M

    2003-11-01

    Rates of reported adverse events are remarkably low. VAERS identifies an adverse event rate approximating 11.4 reports per 100,000 vaccine doses. Approximately 15% of these reports represent SAEs, but less than 2% involve death; in most cases, reviews have shown no causal relation between the events and the vaccine. Across the spectrum of vaccines in use (including those directed against influenza and hepatitis B virus), many claims of adverse events regarding vaccines represent typical reactions to vaccinations. These reactions can be thought of as foreign-body reactions and predominate among the inactivated vaccines. In controlled studies, the adverse event rates that occur with vaccination resemble those that occur with placebo injections. Typical reactions associated with live viral and bacterial vaccines, such as MMR and varicella vaccines, may resemble attenuated forms of the disease for which the vaccine is directed. Other claims against vaccines represent chance-coincidence or misunderstood data; further studies of claims have vindicated the overall safety of the vaccines in most cases. Two documented safety concerns with vaccines, however, have demonstrated that vaccines (like other biologics and pharmacologic) can result in harm (eg, rotavirus and OPV vaccines). The denouement with these vaccines indicates the broad postmarketing data collection and evaluation that extends efforts made with prelicensure study to balance the benefits from vaccination with the risk for harm. Overall, measures including prelicensure study and postlicensure surveillance, such as VAERS, the Vaccine Safety Datalink Project, and the Clinical Immunization Safety Assessment Centers, have resulted in an exceptional safety profile for the vaccines in use.

  3. Hood River Passive House

    SciTech Connect

    Hales, David

    2014-01-01

    The Hood River Passive Project was developed by Root Design Build of Hood River Oregon using the Passive House Planning Package (PHPP) to meet all of the requirements for certification under the European Passive House standards. The Passive House design approach has been gaining momentum among residential designers for custom homes and BEopt modeling indicates that these designs may actually exceed the goal of the U.S. Department of Energy's (DOE) Building America program to "reduce home energy use by 30%-50% (compared to 2009 energy codes for new homes). This report documents the short term test results of the Shift House and compares the results of PHPP and BEopt modeling of the project. The design includes high R-Value assemblies, extremely tight construction, high performance doors and windows, solar thermal DHW, heat recovery ventilation, moveable external shutters and a high performance ductless mini-split heat pump. Cost analysis indicates that many of the measures implemented in this project did not meet the BA standard for cost neutrality. The ductless mini-split heat pump, lighting and advanced air leakage control were the most cost effective measures. The future challenge will be to value engineer the performance levels indicated here in modeling using production based practices at a significantly lower cost.

  4. Hood River Passive House

    SciTech Connect

    Hales, D.

    2014-01-01

    The Hood River Passive Project was developed by Root Design Build of Hood River Oregon using the Passive House Planning Package (PHPP) to meet all of the requirements for certification under the European Passive House standards. The Passive House design approach has been gaining momentum among residential designers for custom homes and BEopt modeling indicates that these designs may actually exceed the goal of the U.S. Department of Energy's (DOE) Building America program to reduce home energy use by 30%-50% (compared to 2009 energy codes for new homes). This report documents the short term test results of the Shift House and compares the results of PHPP and BEopt modeling of the project. The design includes high R-Value assemblies, extremely tight construction, high performance doors and windows, solar thermal DHW, heat recovery ventilation, moveable external shutters and a high performance ductless mini-split heat pump. Cost analysis indicates that many of the measures implemented in this project did not meet the BA standard for cost neutrality. The ductless mini-split heat pump, lighting and advanced air leakage control were the most cost effective measures. The future challenge will be to value engineer the performance levels indicated here in modeling using production based practices at a significantly lower cost.

  5. Passives and Their Meaning

    ERIC Educational Resources Information Center

    Langacker, Ronald W.; Munro, Pamela

    1975-01-01

    An underlying representation for passive sentences in Mojave and Uto-Aztecan is proposed, and the broader issues that arise in extending the analysis to other languages and incorporating it in linguistic theory as a substantive language universal are explored. (Author/RM)

  6. Passive hydrogel fuel generator

    SciTech Connect

    Neefe, Ch. W.

    1985-04-16

    A passive hydrogen oxygen generator in which the long wavelength infrared portion of the sun's spectrum heats water to provide circulation of the water within the generator. The shorter wavelength portion of the spectrum to which water is transparent is used in splitting water into hydrogen and oxygen by photoelectrolysis.

  7. Passive Magnetic Bearing

    NASA Technical Reports Server (NTRS)

    Studer, P. A.

    1983-01-01

    Magnetic bearing for limited rotation devices requires no feedback control system to sense and correct shaft position. Passive Magnetic Torsion Bearing requires no power supply and has no rubbing parts. Torsion wire restrains against axial instability. Magnetic flux geometry chosen to assure lateral stability with radial restoring force that maintains alignment.

  8. A Phase IIb, Multicenter, Open-Label, Safety, and Efficacy Study of High-Dose, Propylene Glycol-Free Melphalan Hydrochloride for Injection (EVOMELA) for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Transplantation.

    PubMed

    Hari, Parameswaran; Aljitawi, Omar S; Arce-Lara, Carlos; Nath, Rajneesh; Callander, Natalie; Bhat, Gajanan; Allen, Lee F; Stockerl-Goldstein, Keith

    2015-12-01

    Autologous stem cell transplantation (ASCT) after high-dose melphalan conditioning is considered a standard of care procedure for patients with multiple myeloma (MM). Current formulations of melphalan (eg, Alkeran for Injection [melphalan hydrochloride]; GlaxoSmithKline, Research Triangle Park, NC, USA) have marginal solubility and limited chemical stability upon reconstitution. Alkeran requires the use of propylene glycol as a co-solvent, which itself has been reported to cause such complications as metabolic/renal dysfunction and arrhythmias. EVOMELA (propylene glycol-free melphalan HCl; Spectrum Pharmaceuticals, Inc., Irvine, CA, USA) is a new i.v. melphalan formulation that incorporates Captisol (Ligand Pharmaceuticals, Inc., La Jolla, CA, USA), a specially modified cyclodextrin that improves the solubility and stability of melphalan and eliminates the need for propylene glycol. This new formulation has been shown to be bioequivalent to Alkeran. EVOMELA (200 mg/m(2)) was administered as 2 doses of 100 mg/m(2) each in a phase IIb, open-label, multicenter study to confirm its safety and efficacy as a high-dose conditioning regimen for patients with MM undergoing ASCT. At 5 centers, 61 patients (26 women) with a median age of 62 years (range, 32-73) were enrolled. All patients achieved myeloablation with a median time of 5 days post-ASCT, and all successfully achieved neutrophil and platelet engraftment with median times of 12 days post-ASCT and 13 days post-ASCT, respectively; treatment-related mortality on day 100 was 0%. Overall response rate (according to independent, blinded review) was high (100%), with an overall complete response rate of 21% (13% stringent complete response; 8% complete response) and overall partial response rate of 79% (61% very good partial response; 18% partial response). The incidence of grade 3 mucositis and stomatitis was low (10% and 5%, respectively) with no grade 4 mucositis or stomatitis reported (graded according to National

  9. Phase 1 and 2 studies demonstrate the safety and efficacy of intraprostatic injection of PRX302 for the targeted treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.

    PubMed

    Denmeade, Samuel R; Egerdie, Blair; Steinhoff, Gary; Merchant, Rosemina; Abi-Habib, Ralph; Pommerville, Peter

    2011-05-01

    PRX302 is a prostate specific antigen (PSA)-activated pore-forming protein toxin under development as a targeted approach for improving lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) without affecting sexual function. To evaluate the safety and efficacy of PRX302 in men with moderate to severe BPH. Eligible subjects were refractory, intolerant, or unwilling to undergo medical therapies for BPH and had International Prostate Symptom Score (IPSS) ≥12, a quality of life (QoL) score ≥3, and prostate volumes between 30 and 80 g. Fifteen patients were enrolled in phase 1 studies, and 18 patients entered phase 2 studies. Subjects received intraprostatic injection of PRX302 into the right and left transition zone via a transperineal approach in an office-based setting. Phase 1 subjects received increasing concentrations of PRX302 at a fixed volume; phase 2 subjects received increasing volumes per deposit at a fixed concentration. IPSS, QoL, prostate volume, maximum flow rate (Q(max)), International Index of Erectile Function, serum PSA levels, pharmacokinetics, and adverse events were recorded at 30, 60, 90, 180, 270, and 360 d after treatment with PRX302. Sixty percent of men in the phase 1 study and 64% of men in the phase 2 study treated with PRX302 had ≥30% improvement compared to baseline in IPSS out to day 360. Patients also experienced improvement in QoL and reduction in prostate volume out to day 360. Patients receiving ≥1 ml of PRX302 per deposit had the best response overall. PRX302 had no deleterious effect on erectile function. Adverse events were mild to moderate and transient in nature. The major study limitation was the small sample size. The promising safety profile and evidence of efficacy in the majority of treated subjects in these phase 1 and 2 studies supports further development of PRX302 as a minimally invasive, targeted treatment for BPH. Copyright © 2010 European Association of Urology. Published by

  10. A novel, minimally-invasive technique of cartilage repair in the human knee using arthroscopic microfracture and injections of mesenchymal stem cells and hyaluronic acid--a prospective comparative study on safety and short-term efficacy.

    PubMed

    Lee, Kevin B L; Wang, Victor T Z; Chan, Yiong Huak; Hui, James H P

    2012-11-01

    Most current cell-based cartilage repair techniques require some form of scaffolds and 2 separate surgical procedures. We propose a novel, scaffold-less technique of cartilage repair in the human knee that combines arthroscopic microfracture and outpatient intra-articular injections of autologous bone marrow-derived mesenchymal stem cells (MSCs) and hyaluronic acid (HA). Seventy matched (age, sex, lesion size) knees with symptomatic cartilage defects underwent cartilage repair with the proposed technique (n = 35) or an open technique (n = 35) in which the MSCs were implanted beneath a sutured periosteal patch over the defect. Prospective evaluation of both groups were performed using the International Cartilage Repair Society (ICRS) Cartilage Injury Evaluation Package, which included questions from the Short-Form (SF-36) Health Survey, International Knee Documentation Committee (IKDC) subjective knee evaluation form, Lysholm knee scale, and Tegner activity level scale. Postoperative magnetic resonance imaging (MRI) evaluation was also performed at 1 year for most patients. There were no clinically significant adverse events reported through the course of our study. At the fi nal follow-up (mean = 24.5 months), there was significant improvement in mean IKDC, Lysholm, SF-36 physical component score and visual analogue pain scores in both treatment groups. In the short term, the results of this novel technique are comparable to the open procedure with the added advantages of being minimally invasive and requiring only a single operation under general anaesthesia. Its safety has been validated and its efficacy is currently being evaluated in an ongoing randomised controlled trial.

  11. Analgesic efficacy and safety of a novel injectable formulation of diclofenac compared with intravenous ketorolac and placebo after orthopedic surgery: a multicenter, randomized, double-blinded, multiple-dose trial.

    PubMed

    Daniels, Stephen; Melson, Timothy; Hamilton, Douglas A; Lang, Eric; Carr, Daniel B

    2013-08-01

    A novel injectable formulation of diclofenac, Dyloject, utilizes hydroxypropyl-β-cyclodextrin (HPβCD) as a solubilizing agent, allowing dosing as a small-volume intravenous bolus for postoperative pain. In this test of the efficacy and safety of HPβCD diclofenac, we hypothesized that HPβCD diclofenac would relieve moderate and severe pain after orthopedic surgery. Adults 18 to 85 years old with moderate and severe pain within 6 hours after surgery were randomized to HPβCD diclofenac, ketorolac tromethamine, or placebo, and stratified by risk cohort. The HPβCD diclofenac non-high-risk cohort dose was 37.5 mg, the high-risk cohort received 18.75 mg, and patients ≥95 kg received 50 mg. The ketorolac dose was 30 mg in the non-high-risk and high-weight cohorts and 15 mg in the high-risk cohort. Rescue intravenous morphine was given for pain as needed. Efficacy was measured by the sum of pain intensity differences (SPID). Mean SPID scores of 277 patients were significantly better with HPβCD diclofenac and ketorolac than with placebo (P<0.0001), across all risk cohorts (P<0.05). HPβCD diclofenac was associated with better SPID scores, faster onset of analgesia, and significantly lower opioid requirement (P<0.008) than ketorolac. In patients more than or equal to 65 years, HPβCD diclofenac was associated with significantly better analgesic efficacy (P=0.05), and lower opioid requirement versus ketorolac. The incidence of treatment-related adverse events was similar across groups. HPβCD diclofenac is safe and efficacious for acute moderate and severe pain after orthopedic surgery and significantly spares morphine use.

  12. The effect of intra-articular hyaluronate and tramadol injection on patients with adhesive capsulitis of the shoulder.

    PubMed

    Kim, Kyung-Hee; Suh, Jung-Woo; Oh, Ki Young

    2017-08-03

    Local administration of opioids causes effective analgesia without adverse effects related to the central nervous system. After the beneficial demonstration of peripheral opioid receptors in joint synovia, intra-articular opioid injections were used for pain treatment. Clinical studies have reported the safety and efficacy of hyaluronate injection in the shoulder joint of patients with osteoarthritis, periarthritis, rotator cuff tears, and adhesive capsulitis. To estimate the efficacy of intra-articular hyaluronate and tramadol injection for adhesive capsulitis of the shoulder compared with that of intra-articular hyaluronate injection alone. Thirty patients with adhesive capsulitis of the shoulder were randomized to the hyaluronate group (n= 16) or the tramadol group (n= 14). Hyaluronate group members were administered five weekly intra-articular hyaluronate injections; tramadol group members were administered three weekly intra-articular hyaluronate and tramadol injections and then two weekly intra-articular injections of hyaluronate. Visual Analog Scale (VAS), passive range of motion (PROM) of the shoulder joint, and Shoulder Pain and Disability Index (SPADI) scores were assessed at baseline and weeks 1, 2, 3, 4, and 6 after the initial injection. A significant improvement was observed in VAS, PROM, and SPADI scores between time points in both groups. In comparison in both groups at weeks 1 and 2 after the initial injection the VAS scores of the tramadol group were significantly lower than those of the hyaluronate group. Intra-articular hyaluronate with tramadol showed more rapid and strong analgesic effects than intra-articular hyaluronate alone and did not induce any adverse effects.

  13. "Get"-Passives in English.

    ERIC Educational Resources Information Center

    Collins, Peter C.

    1996-01-01

    Tests claims regarding "get"-passives in English via interrogation of a set of written and spoken corpora. The data suggest that "get"-passives are often associated with two types of pragmatic implicature. Finally, the corpus provides evidence of three types of variation with 'get'-passives: regional, stylistic, and diachronic.…

  14. Proceedings of the Twenty-First Water Reactor Safety Information Meeting: Volume 1, Plenary session; Advanced reactor research; advanced control system technology; advanced instrumentation and control hardware; human factors research; probabilistic risk assessment topics; thermal hydraulics; thermal hydraulic research for advanced passive LWRs

    SciTech Connect

    Monteleone, S.

    1994-04-01

    This three-volume report contains 90 papers out of the 102 that were presented at the Twenty-First Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, during the week of October 25--27, 1993. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Germany, Japan, Russia, Switzerland, Taiwan, and United Kingdom. The titles of the papers and the names of the authors have been updated and may differ from those that appeared in the final program of the meeting. Individual papers have been cataloged separately. This document, Volume 1 covers the following topics: Advanced Reactor Research; Advanced Instrumentation and Control Hardware; Advanced Control System Technology; Human Factors Research; Probabilistic Risk Assessment Topics; Thermal Hydraulics; and Thermal Hydraulic Research for Advanced Passive Light Water Reactors.

  15. Risk of needlestick injuries by injection pens.

    PubMed

    Pellissier, G; Miguéres, B; Tarantola, A; Abiteboul, D; Lolom, I; Bouvet, E

    2006-05-01

    Injection pens are used by patients when auto-administering medication (insulin, interferon, apokinon etc.) by the subcutaneous route. The objective of this study was to evaluate the rate of injection pen use by healthcare workers (HCWs) and the associated risk of needlestick injuries to document and compare injury rates between injection pens and subcutaneous syringes. A one-year retrospective study was conducted in 24 sentinel French public hospitals. All needlestick injuries linked to subcutaneous injection procedures, which were voluntarily reported to occupational medicine departments by HCWs between October 1999 and September 2000, were documented using a standardized questionnaire. Additional data (total number of needlestick injuries reported, number of subcutaneous injection devices purchased) were collected over the same period. A total of 144 needlestick injuries associated with subcutaneous injection were reported. The needlestick injury rate for injection pens was six times the rate for disposable syringes. Needlestick injuries with injection pens accounted for 39% of needlestick injuries linked with subcutaneous injection. In all, 60% of needlestick injuries with injection pens were related to disassembly. Injection pens are associated with needlestick injuries six times more often than syringes. Nevertheless, injection pens have been shown to improve the quality of treatment for patients and may improve treatment observance. This study points to the need for safety-engineered injection pens.

  16. Deltoid Injections of Risperidone Long-acting Injectable in Patients with Schizophrenia

    PubMed Central

    Quiroz, Jorge A.; Rusch, Sarah; Thyssen, An; Kushner, Stuart

    2011-01-01

    Background Risperidone long-acting injectable was previously approved for treatment of schizophrenia as biweekly injections in the gluteal muscle only. We present data on local injection-site tolerability and safety of risperidone long-acting injectable and comparability of systemic exposure of deltoid versus gluteal injections. Methods Risperidone long-acting injectable was administered in an open-label, single-dose, two-way crossover study, with patients randomized to receive either 25mg gluteal/37.5mg deltoid crossover in two treatment periods or 50mg gluteal/50mg deltoid injections crossover; each treatment period was separated by an 85-day observation period (Study 1) and an open-label, multiple-dose study (4 sequential 37.5mg or 50mg deltoid injections every 2 weeks) (Study 2). The pharmacokinetic results from both the studies have already been published. Results In Study 1 (n=170), the majority of patients had no local injection-site findings, based on investigator and patient-rated evaluations. In Study 2 (n=53), seven of the 51 patients who received at least two deltoid injections discontinued (primary endpoint). However, none of the discontinuations were due to injection-site related reasons. The 90-percent upper confidence limit of the true proportion of injection-site issue withdrawals was 5.7 percent. No moderate or severe injection-site reactions were reported. Conclusion Intramuscular injections via the deltoid and gluteal sites are equivalent routes of administration of risperidone long-acting injectable with respect to local injection-site tolerability. The overall safety and tolerability profile of risperidone long-acting injectable was comparable when administered as an intramuscular injection in the deltoid (37.5mg and 50mg) and gluteal (25mg and 50mg) sites. PMID:21779538

  17. Deltoid injections of risperidone long-acting injectable in patients with schizophrenia.

    PubMed

    Quiroz, Jorge A; Rusch, Sarah; Thyssen, An; Palumbo, Joseph M; Kushner, Stuart

    2011-06-01

    Risperidone long-acting injectable was previously approved for treatment of schizophrenia as biweekly injections in the gluteal muscle only. We present data on local injection-site tolerability and safety of risperidone long-acting injectable and comparability of systemic exposure of deltoid versus gluteal injections. Risperidone long-acting injectable was administered in an open-label, single-dose, two-way crossover study, with patients randomized to receive either 25mg gluteal/37.5mg deltoid crossover in two treatment periods or 50mg gluteal/50mg deltoid injections crossover; each treatment period was separated by an 85-day observation period (Study 1) and an open-label, multiple-dose study (4 sequential 37.5mg or 50mg deltoid injections every 2 weeks) (Study 2). The pharmacokinetic results from both the studies have already been published. In Study 1 (n=170), the majority of patients had no local injection-site findings, based on investigator and patient-rated evaluations. In Study 2 (n=53), seven of the 51 patients who received at least two deltoid injections discontinued (primary endpoint). However, none of the discontinuations were due to injection-site related reasons. The 90-percent upper confidence limit of the true proportion of injection-site issue withdrawals was 5.7 percent. No moderate or severe injection-site reactions were reported. Intramuscular injections via the deltoid and gluteal sites are equivalent routes of administration of risperidone long-acting injectable with respect to local injection-site tolerability. The overall safety and tolerability profile of risperidone long-acting injectable was comparable when administered as an intramuscular injection in the deltoid (37.5mg and 50mg) and gluteal (25mg and 50mg) sites.

  18. Passive broadband acoustic thermometry

    NASA Astrophysics Data System (ADS)

    Anosov, A. A.; Belyaev, R. V.; Klin'shov, V. V.; Mansfel'd, A. D.; Subochev, P. V.

    2016-04-01

    The 1D internal (core) temperature profiles for the model object (plasticine) and the human hand are reconstructed using the passive acoustothermometric broadband probing data. Thermal acoustic radiation is detected by a broadband (0.8-3.5 MHz) acoustic radiometer. The temperature distribution is reconstructed using a priori information corresponding to the experimental conditions. The temperature distribution for the heated model object is assumed to be monotonic. For the hand, we assume that the temperature distribution satisfies the heat-conduction equation taking into account the blood flow. The average error of reconstruction determined for plasticine from the results of independent temperature measurements is 0.6 K for a measuring time of 25 s. The reconstructed value of the core temperature of the hand (36°C) generally corresponds to physiological data. The obtained results make it possible to use passive broadband acoustic probing for measuring the core temperatures in medical procedures associated with heating of human organism tissues.

  19. Active and passive euthanasia.

    PubMed

    Rachels, J

    1975-01-09

    The traditional distinction between active and passive euthanasia requires critical analysis. The conventional doctrine is that there is such an important moral difference between the two that, although the latter is sometimes permissible, the former is always forbidden. This doctrine may be challenged for several reasons. First of all, active euthanasia is in many cases more humane than passive euthanasia, Secondly, the conventional doctrine leads to decisions concerning life and death on irrelevant grounds. Thirdly, the doctrine rests on a distinction between killing and letting die that itself has no moral importance. Fourthly, the most common arguments in favor of the doctrine are invalid. I therefore suggest that the American Medical Association policy statement that endorses this doctrine is unsound.

  20. Passivated niobium cavities

    DOEpatents

    Myneni, Ganapati Rao [Yorktown, VA; Hjorvarsson, Bjorgvin [Lagga Arby, SE; Ciovati, Gianluigi [Newport News, VA

    2006-12-19

    A niobium cavity exhibiting high quality factors at high gradients is provided by treating a niobium cavity through a process comprising: 1) removing surface oxides by plasma etching or a similar process; 2) removing hydrogen or other gases absorbed in the bulk niobium by high temperature treatment of the cavity under ultra high vacuum to achieve hydrogen outgassing; and 3) assuring the long term chemical stability of the niobium cavity by applying a passivating layer of a superconducting material having a superconducting transition temperature higher than niobium thereby reducing losses from electron (cooper pair) scattering in the near surface region of the interior of the niobium cavity. According to a preferred embodiment, the passivating layer comprises niobium nitride (NbN) applied by reactive sputtering.

  1. Passively actuated valve

    SciTech Connect

    Modro, S. Michael; Ougouag, Abderrafi M.

    2005-09-20

    A passively actuated valve for isolating a high pressure zone from a low pressure zone and discontinuing the isolation when the pressure in the high pressure zone drops below a preset threshold. If the pressure in the high pressure zone drops below the preset threshold, the valve opens and allows flow from the high pressure zone to the low pressure zone. The valve remains open allowing pressure equalization and back-flow should a pressure inversion between the two pressure zone occur.

  2. Passive fetal monitoring sensor

    NASA Technical Reports Server (NTRS)

    Zuckerwar, Allan J. (Inventor); Hall, Earl T. (Inventor); Baker, Donald A. (Inventor); Bryant, Timothy D. (Inventor)

    1992-01-01

    An ambulatory, passive sensor for use in a fetal monitoring system is discussed. The invention is comprised of a piezoelectric polymer film, combined with a metallic mounting plate fastened to a belt, and electrically connected to a signal processing unit by means of a shielded cable. The purpose of the sensor is to receive pressure pulses emitted by a fetus inside an expectant mother. Additionally, the monitor will filter out pressure pulses arising from other sources, such as the maternal heart.

  3. Passive fetal monitoring sensor

    NASA Astrophysics Data System (ADS)

    Zuckerwar, Allan J.; Hall, Earl T.; Baker, Donald A.; Bryant, Timothy D.

    1992-08-01

    An ambulatory, passive sensor for use in a fetal monitoring system is discussed. The invention is comprised of a piezoelectric polymer film, combined with a metallic mounting plate fastened to a belt, and electrically connected to a signal processing unit by means of a shielded cable. The purpose of the sensor is to receive pressure pulses emitted by a fetus inside an expectant mother. Additionally, the monitor will filter out pressure pulses arising from other sources, such as the maternal heart.

  4. Passive fetal monitoring sensor

    NASA Astrophysics Data System (ADS)

    1990-07-01

    The invention is an ambulatory, passive sensor for use in a fetal monitoring system. The invention incorporates piezoelectric polymer film combined with a metallic mounting plate fastened to a belt and electrically connected to a signal processing unit by means of a shielded cable. The purpose of the sensor is to receive pressure pulses emitted from a fetus inside an expectant mother and to provide means for filtering out pressure pulses arising from other sources, such as the maternal heart.

  5. Passive Wireless SAW Sensors for IVHM

    NASA Technical Reports Server (NTRS)

    Wilson, William C.; Perey, Daniel F.; Atkinson, Gary M.; Barclay, Rebecca O.

    2008-01-01

    NASA aeronautical programs require integrated vehicle health monitoring (IVHM) to ensure the safety of the crew and the vehicles. Future IVHM sensors need to be small, light weight, inexpensive, and wireless. Surface acoustic wave (SAW) technology meets all of these constraints. In addition it operates in harsh environments and over wide temperature ranges, and it is inherently radiation hardened. This paper presents a survey of research opportunities for universities and industry to develop new sensors that address anticipated IVHM needs for aerospace vehicles. Potential applications of passive wireless SAW sensors from ground testing to high altitude aircraft operations are presented, along with some of the challenges and issues of the technology.

  6. Correction of magnetization sextupole and decapole in a 5 centimeter bore SSC dipole using passive superconductor

    SciTech Connect

    Green, M.A.

    1991-05-01

    Higher multipoles due to magnetization of the superconductor in four and five centimeter bore Superconducting Super Collider (SSC) superconducting dipole magnets have been observed. The use of passive superconductor to correct out the magnetization sextupole has been demonstrated on two dipoles built by the Lawrence Berkeley Laboratory (LBL). This reports shows how passive correction can be applied to the five centimeter SSC dipoles to remove sextupole and decapole caused by magnetization of the dipole superconductor. Two passive superconductor corrector options will be presented. The change in magnetization sextupole and decapole due to flux creep decay of the superconductor during injection can be partially compensated for using the passive superconductor. 9 refs; 5 figs.

  7. Passive bioventing driven by natural air exchange

    SciTech Connect

    Foor, D.C.; Zwick, T.C.; Hinchee, R.E.; Hoeppel, R.E.; Kyburg, C.; Bowling, L.

    1995-12-31

    Bioventing wells installed in the vadose zone of petroleum-contaminated sites at the Marine Corps Air Ground Combat Center (MCAGCC) in Twentynine Palms, California, naturally inhale and exhale air. This natural air exchange appears to be driven primarily by barometric pressure changes. The natural air exchange was utilized to engineer a passive bioventing system in which a valve allows only air injection and prevents soil gas extraction. The system is effective in aerating petroleum-contaminated, oxygen-limited subsurface soils. This aeration resulted in enhanced biological activity and site remediation. The bioventing wells (vent wells) were fitted with a passive valve mechanism that opens when the atmospheric pressure overcomes the internal vent well pressure. When the valve is open it permits atmospheric air to enter the vent well and infiltrate into the soil, thereby stimulating bioremediation. When the vent well pressure overcomes atmospheric pressure, the valve is closed and inhibits soil gas extraction. The vent wells are installed in a coarse sand where the depth to groundwater is approximately 220 ft (67 m). Generally, deeper vent wells produce greater flowrates. Passive airflow rates of up to 7 cfm (12 m{sup 3}/h) have been achieved at the bioventing wells.

  8. Passive Endwall Treatments for Enhancing Stability

    NASA Technical Reports Server (NTRS)

    Hathaway, Michael D.

    2007-01-01

    These lecture notes were presented at the von Karman Institutes lecture series on Advances in Axial Compressor Aerodynamics, May 2006. They provide a fairly extensive overview of what's been learned from numerous investigations of various passive casing endwall technologies that have been proposed for alleviating the stall limiting physics associated with the compressor endwall flow field. The lecture notes are organized to give an appreciation for the inventiveness and understanding of the earliest compressor technologists and to provide a coherent thread of understanding that has arisen out of the early investigations. As such the lecture notes begin with a historical overview of casing treatments from their infancy through the earliest proposed concepts involving blowing, suction and flow recirculation. A summary of lessons learned from these early investigations is provided at the end of this section. The lecture notes then provide a somewhat more in-depth overview of recent advancements in the development of passive casing treatments from the late 1990's through 2006, including advancements in understanding the flow mechanism of circumferential groove casing treatments, and the development of discrete tip injection and self-recirculating casing treatments. At the conclusion of the lecture notes a final summary of lessons learned throughout the history of the development of passive casing treatments is provided. Finally, a list of future needs is given. It is hoped that these lecture notes will be a useful reference for future research endeavors to improve our understanding of the fluid physics of passive casing treatments and how they act to enhance compressor stability, and that they will perhaps provide a springboard for future research activities in this area of interest

  9. Is Passive Diagnosis Enough?

    PubMed Central

    Basu, Sanjay; Andrews, Jason R.

    2013-01-01

    Rationale: Tuberculosis (TB) is characterized by a subclinical phase (symptoms absent or not considered abnormal); prediagnostic phase (symptoms noticed but diagnosis not pursued); and clinical phase (care actively sought). Diagnostic capacity during these phases is limited. Objectives: To estimate the population-level impact of TB case-finding strategies in the presence of subclinical and prediagnostic disease. Methods: We created a mathematical epidemic model of TB, calibrated to global incidence. We then introduced three prototypical diagnostic interventions: increased sensitivity of diagnosis in the clinical phase by 20% (“passive”); early diagnosis during the prediagnostic phase at a rate of 10% per year (“enhanced”); and population-based diagnosis of 5% of undiagnosed prevalent cases per year (“active”). Measurements and Main Results: If the subclinical phase was ignored, as in most models, the passive strategy was projected to reduce TB incidence by 18% (90% uncertainty range [UR], 11–32%) by year 10, compared with 23% (90% UR, 14–35%) for the enhanced strategy and 18% (90% UR, 11–28%) for the active strategy. After incorporating a subclinical phase into the model, consistent with population-based prevalence surveys, the active strategy still reduced 10-year TB incidence by 16% (90% UR, 11–28%), but the passive and enhanced strategies’ impact was attenuated to 11% (90% UR, 8–25%) and 6% (90% UR, 4–13%), respectively. The degree of attenuation depended strongly on the transmission rate during the subclinical phase. Conclusions: Subclinical disease may limit the impact of current diagnostic strategies for TB. Active detection of undiagnosed prevalent cases may achieve greater population-level TB control than increasing passive case detection. PMID:23262515

  10. Passive millimeter wave imaging

    NASA Astrophysics Data System (ADS)

    Pergande, Al; Dean, Donald D.; O'Donnell, Daniel J.

    1996-05-01

    Passive millimeter wave (MMW) imaging provides a breakthrough capability for driver vision enhancement to counter the blinding effects of inclement weather. This type of sensor images in a manner analogous to an infrared or visible camera, but receives its energy from the MMW portion of the electromagnetic spectrum. Technology has progressed to the point where MMW radiometric systems offer advantages to a number of vision applications. We report on our developmental 94 GHz radiometric testbed, and the eventual technological evolutions that will help MMW radiometers and radars meet military and commercial market needs.

  11. Optimizing passive quantum clocks

    NASA Astrophysics Data System (ADS)

    Mullan, Michael; Knill, Emanuel

    2014-10-01

    We describe protocols for passive atomic clocks based on quantum interrogation of the atoms. Unlike previous techniques, our protocols are adaptive and take advantage of prior information about the clock's state. To reduce deviations from an ideal clock, each interrogation is optimized by means of a semidefinite program for atomic state preparation and measurement whose objective function depends on the prior information. Our knowledge of the clock's state is maintained according to a Bayesian model that accounts for noise and measurement results. We implement a full simulation of a running clock with power-law noise models and find significant improvements by applying our techniques.

  12. Passive propellant system

    NASA Technical Reports Server (NTRS)

    Hess, D. A.; Regnier, W. W.; Jacobs, V. L. (Inventor)

    1979-01-01

    A passive propellant acquisition and feed system is disclosed which acquires and feeds gas-free propellant in low or zero-g environments during orbital maneuvers and retains this propellant under high axially directed acceleration such as may be experienced during launch of a space vehicle and orbit-to-orbit transfer is described. The propellant system includes a dual compartment propellant tank with independent surface tension acquisition channels in each compartment to provide gas-free flow of pressurized liquid propellant from one compartment to the other in one direction only.

  13. Passive orbital disconnect strut

    NASA Technical Reports Server (NTRS)

    Parmley, R. T.; Kittel, P.

    1984-01-01

    The design and test results with a third generation passive orbital disconnect strut (PODS) for space-based cryogenic He dewars are presented. Three pairs of PODS struts support a tank and change lengths in response to gas and temperature changes. A thin wall fiberglass tube is used on the cold disconnect end, which can be operated on the ground or in space. Tests were performed to characterize heat flows across the cold end to a liquid He sink and subsequent vacuum pressure within the He tank. Heat transfer was lower than predicted, suggesting that longer dewar in-orbit lifetimes can be expected with the new PODS.

  14. Home Safety

    MedlinePlus

    ... Swimming and Water Apply Swimming and Water filter Toy Safety Apply Toy Safety filter TV and Furniture Tip-Overs Apply ... Laundry Packets Medication Poison Sleep Safety and Suffocation Toy Safety TV and Furniture Tip-Overs Water and ...

  15. Injection Locking Techniques for Spectrum Analysis

    NASA Astrophysics Data System (ADS)

    Gathma, Timothy D.; Buckwalter, James F.

    2011-04-01

    Wideband spectrum analysis supports future communication systems that reconfigure and adapt to the capacity of the spectral environment. While test equipment manufacturers offer wideband spectrum analyzers with excellent sensitivity and resolution, these spectrum analyzers typically cannot offer acceptable size, weight, and power (SWAP). CMOS integrated circuits offer the potential to fully integrate spectrum analysis capability with analog front-end circuitry and digital signal processing on a single chip. Unfortunately, CMOS lacks high-Q passives and wideband resonator tunability that is necessary for heterodyne implementations of spectrum analyzers. As an alternative to the heterodyne receiver architectures, two nonlinear methods for performing wideband, low-power spectrum analysis are presented. The first method involves injecting the spectrum of interest into an array of injection-locked oscillators. The second method employs the closed loop dynamics of both injection locking and phase locking to independently estimate the injected frequency and power.

  16. Injection Locking Techniques for Spectrum Analysis

    SciTech Connect

    Gathma, Timothy D.; Buckwalter, James F.

    2011-04-19

    Wideband spectrum analysis supports future communication systems that reconfigure and adapt to the capacity of the spectral environment. While test equipment manufacturers offer wideband spectrum analyzers with excellent sensitivity and resolution, these spectrum analyzers typically cannot offer acceptable size, weight, and power (SWAP). CMOS integrated circuits offer the potential to fully integrate spectrum analysis capability with analog front-end circuitry and digital signal processing on a single chip. Unfortunately, CMOS lacks high-Q passives and wideband resonator tunability that is necessary for heterodyne implementations of spectrum analyzers. As an alternative to the heterodyne receiver architectures, two nonlinear methods for performing wideband, low-power spectrum analysis are presented. The first method involves injecting the spectrum of interest into an array of injection-locked oscillators. The second method employs the closed loop dynamics of both injection locking and phase locking to independently estimate the injected frequency and power.

  17. Passive and Hybrid PFC Rectifiers

    NASA Astrophysics Data System (ADS)

    Nishida, Yasuyuki

    The diode rectifier offers several desirable features such as a unity displacement-factor and a high efficiency with low complexity and high reliability, but the utility line-current is significantly distorted. The traditional multi-pulse (e.g., 12-pulse, 18-pulse and so on) PAM concept by means of multiple rectifier units and phase-shifting isolation-transformers is a well-known scheme to improve the input line-current waveform and reduce dc-current/voltage ripple. Though, the necessity of the isolation-transformer is a great weak point especially for applications in low to medium power range. To mitigate the problem, several investigations have been done. The PWM rectifier is a modern and effective alternative, although it results in a higher initial cost, lower efficiency and EMI noise problems due to high frequency switching. To solve the problem, we have two alternatives without PWM and are so called “Passive” schemes. One is the multi-pulse/multi-phase scheme without the isolation transformer but with an autotransformer. This scheme results in a simplified multi-pulse PAM rectifier. The other is the Third-Harmonic-Current Injection and the expanded schemes. Although these two schemes have been studied independently in most cases, new types of diode PFC rectifier obtained by combining the two schemes have been studied recently. Additionally, further new topologies, so called “Hybrid” type, have been proposed very recently. The rectifiers with the new concept consist of an autotransformer-connected double 3-phase bridge 12-pulse rectifier and a PWM dc-dc converter on the dc-side to perform the current injection. The Hybrid rectifiers offer output voltage controllability and sinusoidal input currents similarly to the PWM rectifiers. To show the current trends and remaining possibilities of the Passive and Hybrid rectifiers, this paper gives a survey and historical review of the rectifiers. Then, some new topologies in the category are investigated

  18. Fly ash carbon passivation

    DOEpatents

    La Count, Robert B; Baltrus, John P; Kern, Douglas G

    2013-05-14

    A thermal method to passivate the carbon and/or other components in fly ash significantly decreases adsorption. The passivated carbon remains in the fly ash. Heating the fly ash to about 500 and 800 degrees C. under inert gas conditions sharply decreases the amount of surfactant adsorbed by the fly ash recovered after thermal treatment despite the fact that the carbon content remains in the fly ash. Using oxygen and inert gas mixtures, the present invention shows that a thermal treatment to about 500 degrees C. also sharply decreases the surfactant adsorption of the recovered fly ash even though most of the carbon remains intact. Also, thermal treatment to about 800 degrees C. under these same oxidative conditions shows a sharp decrease in surfactant adsorption of the recovered fly ash due to the fact that the carbon has been removed. This experiment simulates the various "carbon burnout" methods and is not a claim in this method. The present invention provides a thermal method of deactivating high carbon fly ash toward adsorption of AEAs while retaining the fly ash carbon. The fly ash can be used, for example, as a partial Portland cement replacement in air-entrained concrete, in conductive and other concretes, and for other applications.

  19. Passive bistatic radar analysis

    NASA Astrophysics Data System (ADS)

    O'Hagan, Daniel W.; Kuschel, H.; Schiller, Joachim

    2009-06-01

    Passive Bistatic Radar (PBR) research is at its zenith with several notable PBR systems currently operational, or available for deployment. Such PBRs include the Manastash Ridge Radar (MRR) developed for and by academia; Silent Sentry developed as a commercial concern by Lockheed Martin; and Homeland Alerter (HA100) also a commercial system developed by Thales. However at present, despite the existence of numerous PBR prototypes, take up of commercial passive radar technology remains slow. This is due in part to technology immaturity, in part to politics, and particularly due to the fact that monostatic radars perform so well. If PBRs are to enjoy longevity as a viable technology then it is imperative that they address certain niche application areas, with the aforementioned MRR being one prime example of this. The focus of this paper will be an analysis of a PBR system that utilised FM radio signals of opportunity to detect aircraft targets with an RCS generally not lower than 20 m2. The paper will demonstrate the theoretical detection coverage of an FM based PBR operating in a severe interference environment.

  20. Photometric Passive Range Sensor

    NASA Astrophysics Data System (ADS)

    Argueta-Diaz, Victor; García-Valenzuela, Augusto

    2008-04-01

    In this paper we present a passive optical ranging method that consists of taking several photometric measurements from the light radiated by an object and deriving the range from these measurements. This passive ranging device uses an iris of radius a, a lens of radius larger than a, and a photodetector of radius p