WorldWideScience

Sample records for phase iii comparison

  1. Air quality and climate change, Topic 3 of the Model Inter-Comparison Study for Asia Phase III (MICS-Asia III) - Part 1: Overview and model evaluation

    Science.gov (United States)

    Gao, Meng; Han, Zhiwei; Liu, Zirui; Li, Meng; Xin, Jinyuan; Tao, Zhining; Li, Jiawei; Kang, Jeong-Eon; Huang, Kan; Dong, Xinyi; Zhuang, Bingliang; Li, Shu; Ge, Baozhu; Wu, Qizhong; Cheng, Yafang; Wang, Yuesi; Lee, Hyo-Jung; Kim, Cheol-Hee; Fu, Joshua S.; Wang, Tijian; Chin, Mian; Woo, Jung-Hun; Zhang, Qiang; Wang, Zifa; Carmichael, Gregory R.

    2018-04-01

    Topic 3 of the Model Inter-Comparison Study for Asia (MICS-Asia) Phase III examines how online coupled air quality models perform in simulating high aerosol pollution in the North China Plain region during wintertime haze events and evaluates the importance of aerosol radiative and microphysical feedbacks. A comprehensive overview of the MICS-Asia III Topic 3 study design, including descriptions of participating models and model inputs, the experimental designs, and results of model evaluation, are presented. Six modeling groups from China, Korea and the United States submitted results from seven applications of online coupled chemistry-meteorology models. Results are compared to meteorology and air quality measurements, including data from the Campaign on Atmospheric Aerosol Research Network of China (CARE-China) and the Acid Deposition Monitoring Network in East Asia (EANET). The correlation coefficients between the multi-model ensemble mean and the CARE-China observed near-surface air pollutants range from 0.51 to 0.94 (0.51 for ozone and 0.94 for PM2.5) for January 2010. However, large discrepancies exist between simulated aerosol chemical compositions from different models. The coefficient of variation (SD divided by the mean) can reach above 1.3 for sulfate in Beijing and above 1.6 for nitrate and organic aerosols in coastal regions, indicating that these compositions are less consistent from different models. During clean periods, simulated aerosol optical depths (AODs) from different models are similar, but peak values differ during severe haze events, which can be explained by the differences in simulated inorganic aerosol concentrations and the hygroscopic growth efficiency (affected by varied relative humidity). These differences in composition and AOD suggest that future models can be improved by including new heterogeneous or aqueous pathways for sulfate and nitrate formation under hazy conditions, a secondary organic aerosol (SOA) formation chemical

  2. The OPAL phase III microvertex detector

    International Nuclear Information System (INIS)

    De Jong, S.

    1997-01-01

    A description of the OPAL Phase III microvertex detector is given. Special emphasis is put on problems that have been encountered in the installation and operation of the different phases of the OPAL microvertex detector leading to the present Phase III detector and their cures. A short description of the new OPAL radiation monitoring and beam dump system is also given. (orig.)

  3. Bleeding and infection with external ventricular drainage: a systematic review in comparison with adjudicated adverse events in the ongoing Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR-III IHV) trial.

    Science.gov (United States)

    Dey, Mahua; Stadnik, Agnieszka; Riad, Fady; Zhang, Lingjiao; McBee, Nichol; Kase, Carlos; Carhuapoma, J Ricardo; Ram, Malathi; Lane, Karen; Ostapkovich, Noeleen; Aldrich, Francois; Aldrich, Charlene; Jallo, Jack; Butcher, Ken; Snider, Ryan; Hanley, Daniel; Ziai, Wendy; Awad, Issam A

    2015-03-01

    Retrospective series report varied rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions, or independent adjudication. To analyze the rate of complications in the ongoing Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial, providing a comparison with a systematic review of complications of EVD in the literature. Patients were prospectively enrolled in the CLEAR III trial after placement of an EVD for obstructive intraventricular hemorrhage and randomized to receive recombinant tissue-type plasminogen activator or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on computed tomography scan within 30 days from the randomization. Meta-analysis of published series of EVD placement was compiled with STATA software. Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 patients enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced ≥1 new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the present study, rates of new bleeds and bacterial meningitis/ventriculitis are very low despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to >60 trial sites.

  4. Violent flows in aqueous foams III: physical multi-phase model comparison with aqueous foam shock tube experiments

    Science.gov (United States)

    Redford, J. A.; Ghidaglia, J.-M.; Faure, S.

    2018-06-01

    Mitigation of blast waves in aqueous foams is a problem that has a strong dependence on multi-phase effects. Here, a simplified model is developed from the previous articles treating violent flows (D'Alesio et al. in Eur J Mech B Fluids 54:105-124, 2015; Faure and Ghidaglia in Eur J Mech B Fluids 30:341-359, 2011) to capture the essential phenomena. The key is to have two fluids with separate velocities to represent the liquid and gas phases. This allows for the interaction between the two phases, which may include terms for drag, heat transfer, mass transfer due to phase change, added mass effects, to be included explicitly in the model. A good test for the proposed model is provided by two experimental data sets that use a specially designed shock tube. The first experiment has a test section filled with spray droplets, and the second has a range of aqueous foams in the test section. A substantial attenuation of the shock wave is seen in both cases, but a large difference is observed in the sound speeds. The droplets cause no observable change from the air sound speed, while the foams have a reduced sound speed of approximately 50-75 m/s . In the model given here, an added mass term is introduced in the governing equations to capture the low sound speed. The match between simulation and experiment is found to be satisfactory for both droplets and the foam. This is especially good when considering the complexity of the physics and the effects that are unaccounted for, such as three-dimensionality and droplet atomisation. The resulting statistics illuminate the processes occurring in such flows.

  5. Design of a Laboratory Hall Thruster with Magnetically Shielded Channel Walls, Phase III: Comparison of Theory with Experiment

    Science.gov (United States)

    Mikellides, Ioannis G.; Katz, Ira; Hofer, Richard R.; Goebel, Dan M.

    2012-01-01

    A proof-of-principle effort to demonstrate a technique by which erosion of the acceleration channel in Hall thrusters of the magnetic-layer type can be eliminated has been completed. The first principles of the technique, now known as "magnetic shielding," were derived based on the findings of numerical simulations in 2-D axisymmetric geometry. The simulations, in turn, guided the modification of an existing 6-kW laboratory Hall thruster. This magnetically shielded (MS) thruster was then built and tested. Because neither theory nor experiment alone can validate fully the first principles of the technique, the objective of the 2-yr effort was twofold: (1) to demonstrate in the laboratory that the erosion rates can be reduced by >order of magnitude, and (2) to demonstrate that the near-wall plasma properties can be altered according to the theoretical predictions. This paper concludes the demonstration of magnetic shielding by reporting on a wide range of comparisons between results from numerical simulations and laboratory diagnostics. Collectively, we find that the comparisons validate the theory. Near the walls of the MS thruster, theory and experiment agree: (1) the plasma potential has been sustained at values near the discharge voltage, and (2) the electron temperature has been lowered by at least 2.5-3 times compared to the unshielded (US) thruster. Also, based on carbon deposition measurements, the erosion rates at the inner and outer walls of the MS thruster are found to be lower by at least 2300 and 1875 times, respectively. Erosion was so low along these walls that the rates were below the resolution of the profilometer. Using a sputtering yield model with an energy threshold of 25 V, the simulations predict a reduction of 600 at the MS inner wall. At the outer wall ion energies are computed to be below 25 V, for which case we set the erosion to zero in the simulations. When a 50-V threshold is used the computed ion energies are below the threshold at both

  6. Comparison of geochemical data obtained using four brine sampling methods at the SECARB Phase III Anthropogenic Test CO2 injection site, Citronelle Oil Field, Alabama

    Science.gov (United States)

    Conaway, Christopher; Thordsen, James J.; Manning, Michael A.; Cook, Paul J.; Trautz, Robert C.; Thomas, Burt; Kharaka, Yousif K.

    2016-01-01

    The chemical composition of formation water and associated gases from the lower Cretaceous Paluxy Formation was determined using four different sampling methods at a characterization well in the Citronelle Oil Field, Alabama, as part of the Southeast Regional Carbon Sequestration Partnership (SECARB) Phase III Anthropogenic Test, which is an integrated carbon capture and storage project. In this study, formation water and gas samples were obtained from well D-9-8 #2 at Citronelle using gas lift, electric submersible pump, U-tube, and a downhole vacuum sampler (VS) and subjected to both field and laboratory analyses. Field chemical analyses included electrical conductivity, dissolved sulfide concentration, alkalinity, and pH; laboratory analyses included major, minor and trace elements, dissolved carbon, volatile fatty acids, free and dissolved gas species. The formation water obtained from this well is a Na–Ca–Cl-type brine with a salinity of about 200,000 mg/L total dissolved solids. Differences were evident between sampling methodologies, particularly in pH, Fe and alkalinity. There was little gas in samples, and gas composition results were strongly influenced by sampling methods. The results of the comparison demonstrate the difficulty and importance of preserving volatile analytes in samples, with the VS and U-tube system performing most favorably in this aspect.

  7. Failures in Phase III: Causes and Consequences.

    Science.gov (United States)

    Seruga, Bostjan; Ocana, Alberto; Amir, Eitan; Tannock, Ian F

    2015-10-15

    Phase III randomized controlled trials (RCT) in oncology fail to lead to registration of new therapies more often than RCTs in other medical disciplines. Most RCTs are sponsored by the pharmaceutical industry, which reflects industry's increasing responsibility in cancer drug development. Many preclinical models are unreliable for evaluation of new anticancer agents, and stronger evidence of biologic effect should be required before a new agent enters the clinical development pathway. Whenever possible, early-phase clinical trials should include pharmacodynamic studies to demonstrate that new agents inhibit their molecular targets and demonstrate substantial antitumor activity at tolerated doses in an enriched population of patients. Here, we review recent RCTs and found that these conditions were not met for most of the targeted anticancer agents, which failed in recent RCTs. Many recent phase III RCTs were initiated without sufficient evidence of activity from early-phase clinical trials. Because patients treated within such trials can be harmed, they should not be undertaken. The bar should also be raised when making decisions to proceed from phase II to III and from phase III to marketing approval. Many approved agents showed only better progression-free survival than standard treatment in phase III trials and were not shown to improve survival or its quality. Introduction of value-based pricing of new anticancer agents would dissuade the continued development of agents with borderline activity in early-phase clinical trials. When collaborating with industry, oncologists should be more critical and better advocates for cancer patients. ©2015 American Association for Cancer Research.

  8. Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

    Science.gov (United States)

    Zhang, Sheng; Liang, Fei; Li, Wenfeng

    2017-11-01

    The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Air quality and climate change, Topic 3 of the Model Inter-Comparison Study for Asia Phase III (MICS-Asia III – Part 1: Overview and model evaluation

    Directory of Open Access Journals (Sweden)

    M. Gao

    2018-04-01

    Full Text Available Topic 3 of the Model Inter-Comparison Study for Asia (MICS-Asia Phase III examines how online coupled air quality models perform in simulating high aerosol pollution in the North China Plain region during wintertime haze events and evaluates the importance of aerosol radiative and microphysical feedbacks. A comprehensive overview of the MICS-Asia III Topic 3 study design, including descriptions of participating models and model inputs, the experimental designs, and results of model evaluation, are presented. Six modeling groups from China, Korea and the United States submitted results from seven applications of online coupled chemistry–meteorology models. Results are compared to meteorology and air quality measurements, including data from the Campaign on Atmospheric Aerosol Research Network of China (CARE-China and the Acid Deposition Monitoring Network in East Asia (EANET. The correlation coefficients between the multi-model ensemble mean and the CARE-China observed near-surface air pollutants range from 0.51 to 0.94 (0.51 for ozone and 0.94 for PM2.5 for January 2010. However, large discrepancies exist between simulated aerosol chemical compositions from different models. The coefficient of variation (SD divided by the mean can reach above 1.3 for sulfate in Beijing and above 1.6 for nitrate and organic aerosols in coastal regions, indicating that these compositions are less consistent from different models. During clean periods, simulated aerosol optical depths (AODs from different models are similar, but peak values differ during severe haze events, which can be explained by the differences in simulated inorganic aerosol concentrations and the hygroscopic growth efficiency (affected by varied relative humidity. These differences in composition and AOD suggest that future models can be improved by including new heterogeneous or aqueous pathways for sulfate and nitrate formation under hazy conditions, a secondary organic aerosol (SOA

  10. Objectives and methodology of BIOBADASER phase iii.

    Science.gov (United States)

    Sanchez-Piedra, Carlos; Hernández Miguel, M Victoria; Manero, Javier; Roselló, Rosa; Sánchez-Costa, Jesús Tomás; Rodríguez-Lozano, Carlos; Campos, Cristina; Cuende, Eduardo; Fernández-Lopez, Jesús Carlos; Bustabad, Sagrario; Martín Domenech, Raquel; Pérez-Pampín, Eva; Del Pino-Montes, Javier; Millan-Arcineas, Ana Milena; Díaz-González, Federico; Gómez-Reino, Juan Jesús

    2017-09-18

    Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III). Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015. During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations. BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  11. A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens.

    Science.gov (United States)

    Phillips, Patrick P J; Mendel, Carl M; Nunn, Andrew J; McHugh, Timothy D; Crook, Angela M; Hunt, Robert; Bateson, Anna; Gillespie, Stephen H

    2017-11-24

    Tuberculosis kills more people than any other infectious disease, and new regimens are essential. The primary endpoint for confirmatory phase III trials for new regimens is a composite outcome that includes bacteriological treatment failure and relapse. Culture methodology is critical to the primary trial outcome. Patients in clinical trials can have positive cultures after treatment ends that may not necessarily indicate relapse, which was ascribed previously to laboratory cross-contamination or breakdown of old lesions. Löwenstein-Jensen (LJ) medium was the previous standard in clinical trials, but almost all current and future trials will use the Mycobacteria Growth Indicator Tube (MGIT) system due to its simplicity and consistency of use, which will affect phase III trial results. LJ was used for the definition of the primary endpoint in the REMoxTB trial, but every culture was also inoculated in parallel into the MGIT system. The data from this trial, therefore, provide a unique opportunity to investigate and compare the incidence of false 'isolated positives' in liquid and solid media and their potential impact on the primary efficacy results. All post-treatment positive cultures were reviewed in the REMoxTB clinical trial. Logistic regression models were used to model the incidence of isolated positive cultures on MGIT and LJ. A total of 12,209 sputum samples were available from 1652 patients; cultures were more often positive on MGIT than LJ. In 1322 patients with a favourable trial outcome, 126 (9.5%) had cultures that were positive in MGIT compared to 34 (2.6%) patients with positive cultures on LJ. Among patients with a favourable outcome, the incidence of isolated positives on MGIT differed by study laboratory (p cultures in some patients even after adjusting for laboratory, p cultures, positive MGIT cultures were more likely to be associated with higher grade TB symptoms reported within 7 days either side of sputum collection in patients with an

  12. Los Angeles International Airport Runway Incursion Studies: Phase III--Center-Taxiway Simulation

    Science.gov (United States)

    Madson, Michael D.

    2004-01-01

    Phase III of the Los Angeles International Airport Runway Incursion Studies was conducted, under an agreement with HNTB Corporation, at the NASA Ames FutureFlight Central (FFC) facility in June 2003. The objective of the study was the evaluation of a new center-taxiway concept at LAX. This study is an extension of the Phase I and Phase II studies previously conducted at FFC. This report presents results from Phase III of the study, in which a center-taxiway concept between runways 25L and 25R was simulated and evaluated. Phase III data were compared objectively against the Baseline data. Subjective evaluations by participating LAX controllers were obtained with regard to workload, efficiency, and safety criteria. To facilitate a valid comparison between Baseline and Phase III data, the same scenarios were used for Phase III that were tested during Phases I and II. This required briefing participating controllers on differences in airport and airline operations between 2001 and today.

  13. MAQARIN natural analogue study: phase III

    Energy Technology Data Exchange (ETDEWEB)

    Alexander, W R; Mazurek, M; Waber, H N [Univ. of Berne (Switzerland). Institutes of Geology, Mineralogy and Petrology, Rock-Water Interaction Group (GGWW); Arlinger, J; Erlandson, A C; Hallbeck, L; Pedersen, K [Goeteborg University (Sweden). Dept. of General and Marine Microbiology; Boehlmann, W; Fritz, P; Geyer, S; Geyer, W; Hanschman, G; Kopinke, F D; Poerschmann, J [Umweltforschungszentrum Leipzig-Halle (Germany); Chambers, A V; Haworth, A; Ilett, D; Linklater, C M; Tweed, C J [AEA Technology plc, Harwell (United Kingdom); Chenery, S R.N.; Kemp, S J; Milodowski, A E; Pearce, J M; Reeder, S; Rochelle, C A; Smith, B; Wetton, P D; Wragg, J [British Geological Survey, Keyworth (United Kingdom); Clark, I D [Univ. of Ottawa (Canada). Dept. of Geology; Hodginson, E; Hughes, C R [Univ. of Manchester (United Kingdom). Dept. of Earth Sciences; Hyslop, E K [British Geological Survey, Edinburgh (United Kingdom); Karlsson, F [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Khoury, H N; Salameh, E [Univ. of Jordan, Amman (Jordan); Lagerblad, B [Cement Institute, Stockholm (Sweden); Longworth, G [Univ. of Manchester (United Kingdom). Dept. of Geology; Pitty, A F [Private consultant, Norwich (United Kingdom); Savage, D [QuantiSci Ltd, Melton Mowbray (United Kingdom); Smellie, J A.T. [ed.; Conterra AB, Uppsala (Sweden)

    1998-12-01

    This report represents the conclusion to Phase III of the Maqarin Natural Analogue Study. The main thrust was to establish the origin and chemistry of the Western Springs hyper alkaline groundwaters (Na/K enriched Ca(OH){sub 2} type) and to study their interaction with rocks of different compositions, as natural analogues to key processes that might occur at an early stage within the `alkali disturbed zone` of cementitious repositories in different host rocks. Whilst earlier studies at Maqarin were very much site-specific and process-oriented, Phase III provided a regional perspective to the geological evolution of the Maqarin region. This was made possible by greater field access which allowed a more systematic structural and geomorphological study of the area. This has resulted in a greater understanding of the age and spatial relationships concerning formation of the cement zones through spontaneous combustion of the Bituminous Marls, and the subsequent formation of high pH groundwaters at the Eastern and Western Springs locations. At the Western Springs locality, hydrochemical and hydrogeological evaluation of new and published data (plus access to unpublished data), together with detailed mineralogical and geochemical studies, helped to clarify the very earliest stage of cement leachate/host rock interaction. The data were used also to test coupled flow/transport codes developed to assess the long-term evolution of a cementitious repository. Additional objectives addressed include: a) rock matrix diffusion, b) the occurrence and chemical controls on zeolite composition, e) the occurrence and chemical controls on clay stability, and d) the role of microbes, organics and colloids in trace element transport. The Maqarin site now provides a consistent picture explaining the origin of the hyperalkaline groundwaters, and is therefore a unique location for the examination of the mechanisms and processes associated with cementitious repositories. Application of these

  14. MAQARIN natural analogue study: phase III

    International Nuclear Information System (INIS)

    Alexander, W.R.; Mazurek, M.; Waber, H.N.; Arlinger, J.; Erlandson, A.C.; Hallbeck, L.; Pedersen, K.; Chambers, A.V.; Haworth, A.; Ilett, D.; Linklater, C.M.; Tweed, C.J.; Chenery, S.R.N.; Kemp, S.J.; Milodowski, A.E.; Pearce, J.M.; Reeder, S.; Rochelle, C.A.; Smith, B.; Wetton, P.D.; Wragg, J.; Clark, I.D.; Karlsson, F.; Khoury, H.N.; Salameh, E.; Lagerblad, B.; Longworth, G.; Savage, D.; Smellie, J.A.T.

    1998-12-01

    This report represents the conclusion to Phase III of the Maqarin Natural Analogue Study. The main thrust was to establish the origin and chemistry of the Western Springs hyper alkaline groundwaters (Na/K enriched Ca(OH) 2 type) and to study their interaction with rocks of different compositions, as natural analogues to key processes that might occur at an early stage within the 'alkali disturbed zone' of cementitious repositories in different host rocks. Whilst earlier studies at Maqarin were very much site-specific and process-oriented, Phase III provided a regional perspective to the geological evolution of the Maqarin region. This was made possible by greater field access which allowed a more systematic structural and geomorphological study of the area. This has resulted in a greater understanding of the age and spatial relationships concerning formation of the cement zones through spontaneous combustion of the Bituminous Marls, and the subsequent formation of high pH groundwaters at the Eastern and Western Springs locations. At the Western Springs locality, hydrochemical and hydrogeological evaluation of new and published data (plus access to unpublished data), together with detailed mineralogical and geochemical studies, helped to clarify the very earliest stage of cement leachate/host rock interaction. The data were used also to test coupled flow/transport codes developed to assess the long-term evolution of a cementitious repository. Additional objectives addressed include: a) rock matrix diffusion, b) the occurrence and chemical controls on zeolite composition, e) the occurrence and chemical controls on clay stability, and d) the role of microbes, organics and colloids in trace element transport. The Maqarin site now provides a consistent picture explaining the origin of the hyperalkaline groundwaters, and is therefore a unique location for the examination of the mechanisms and processes associated with cementitious repositories. Application of these

  15. MAQARIN natural analogue study: phase III

    Energy Technology Data Exchange (ETDEWEB)

    Alexander, W R; Mazurek, M; Waber, H N [Univ. of Berne (Switzerland). Institutes of Geology, Mineralogy and Petrology, Rock-Water Interaction Group (GGWW); Arlinger, J; Erlandson, A C; Hallbeck, L; Pedersen, K [Goeteborg Univ. (Sweden). Dept. of General and Marine Microbiology; Boehlmann, W; Fritz, P; Geyer, S; Geyer, W; Hanschman, G; Kopinke, F D; Poerschmann, J [Umweltforschungszentrum Leipzig-Halle (Germany); Chambers, A V; Haworth, A; Ilett, D; Linklater, C M; Tweed, C J [AEA Technology plc, Harwell (United Kingdom); Chenery, S R.N.; Kemp, S J; Milodowski, A E; Pearce, J M; Reeder, S; Rochelle, C A; Smith, B; Wetton, P D; Wragg, J [British Geological Survey, Keyworth (United Kingdom); Clark, I D [Univ. of Ottawa (Canada). Dept. of Geology; Hodginson, E; Hughes, C R [Univ. of Manchester (United Kingdom). Dept. of Earth Sciences; Hyslop, E K [British Geological Survey, Edinburgh (United Kingdom); Karlsson, F [Swedish Nuclear Fuel and Waste Management Co., Stockholm (Sweden); Khoury, H N; Salameh, E [Univ. of Jordan, Amman (Jordan); Lagerblad, B [Cement Inst., Stockholm (Sweden); Longworth, G [Univ. of Manchester (United Kingdom). Dept. of Geology; Pitty, A F [Private consultant, Norwich (United Kingdom); Savage, D [QuantiSci Ltd, Melton Mowbray (United Kingdom); Smellie, J A.T. [ed.; Conterra AB, Uppsala (Sweden)

    1998-12-01

    This report represents the conclusion to Phase III of the Maqarin Natural Analogue Study. The main thrust was to establish the origin and chemistry of the Western Springs hyper alkaline groundwaters (Na/K enriched Ca(OH){sub 2} type) and to study their interaction with rocks of different compositions, as natural analogues to key processes that might occur at an early stage within the `alkali disturbed zone` of cementitious repositories in different host rocks. Whilst earlier studies at Maqarin were very much site-specific and process-oriented, Phase III provided a regional perspective to the geological evolution of the Maqarin region. This was made possible by greater field access which allowed a more systematic structural and geomorphological study of the area. This has resulted in a greater understanding of the age and spatial relationships concerning formation of the cement zones through spontaneous combustion of the Bituminous Marls, and the subsequent formation of high pH groundwaters at the Eastern and Western Springs locations. At the Western Springs locality, hydrochemical and hydrogeological evaluation of new and published data (plus access to unpublished data), together with detailed mineralogical and geochemical studies, helped to clarify the very earliest stage of cement leachate/host rock interaction. The data were used also to test coupled flow/transport codes developed to assess the long-term evolution of a cementitious repository. Additional objectives addressed include: a) rock matrix diffusion, b) the occurrence and chemical controls on zeolite composition, e) the occurrence and chemical controls on clay stability, and d) the role of microbes, organics and colloids in trace element transport. The Maqarin site now provides a consistent picture explaining the origin of the hyperalkaline groundwaters, and is therefore a unique location for the examination of the mechanisms and processes associated with cementitious repositories. Application of these

  16. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra.

    Science.gov (United States)

    Reisinger, Keith S; Baxter, Roger; Block, Stanley L; Shah, Jina; Bedell, Lisa; Dull, Peter M

    2009-12-01

    Neisseria meningitidis is a leading cause of bacterial meningitis in the United States, with the highest case fatality rates reported for individuals > or = 15 years of age. This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, to those of the licensed meningococcal conjugate vaccine, Menactra, when administered to healthy adults. In this phase III multicenter study, 1,359 adults 19 to 55 years of age were randomly assigned to one of four groups (1:1:1:1 ratio) to receive a single dose of one of three lots of MenACWY-CRM or a single dose of Menactra. Serum samples obtained at baseline and 1 month postvaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA). The hSBA titers following vaccination with MenACWY-CRM and Menactra were compared in noninferiority and prespecified superiority analyses. Reactogenicity was similar in the MenACWY-CRM and Menactra groups, and neither vaccine was associated with a serious adverse event. When compared with Menactra, MenACWY-CRM met the superiority criteria for the proportions of recipients achieving a seroresponse against serogroups C, W-135, and Y and the proportion of subjects achieving postvaccination titers of > or = 1:8 for serogroups C and Y. MenACWY-CRM's immunogenicity was statistically noninferior (the lower limit of the two-sided 95% confidence interval was more than -10%) to that of Menactra for all four serogroups, with the postvaccination hSBA geometric mean titers being consistently higher for MenACWY-CRM than for Menactra. MenACWY-CRM is well tolerated in adults 19 to 55 years of age, with immune responses to each of the serogroups noninferior and, in some cases, statistically superior to those to Menactra.

  17. Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients With Advanced Carcinoid Tumors: SWOG S0518.

    Science.gov (United States)

    Yao, James C; Guthrie, Katherine A; Moran, Cesar; Strosberg, Jonathan R; Kulke, Matthew H; Chan, Jennifer A; LoConte, Noelle; McWilliams, Robert R; Wolin, Edward M; Mattar, Bassam; McDonough, Shannon; Chen, Helen; Blanke, Charles D; Hochster, Howard S

    2017-05-20

    Purpose Treatment options for neuroendocrine tumors (NETs) remain limited. This trial assessed the progression-free survival (PFS) of bevacizumab or interferon alfa-2b (IFN-α-2b) added to octreotide among patients with advanced NETs. Patients and Methods Southwest Oncology Group (SWOG) S0518, a phase III study conducted in a US cooperative group system, enrolled patients with advanced grades 1 and 2 NETs with progressive disease or other poor prognostic features. Patients were randomly assigned to treatment with octreotide LAR 20 mg every 21 days with either bevacizumab 15 mg/kg every 21 days or 5 million units of IFN-α-2b three times per week. The primary end point was centrally assessed PFS. This trial is registered with ClinicalTrials.gov as NCT00569127. Results A total of 427 patients was enrolled, of whom 214 were allocated to bevacizumab and 213 to IFN-α-2b. The median PFS by central review was 16.6 months (95% CI, 12.9 to 19.6 months) in the bevacizumab arm and was 15.4 months (95% CI, 9.6 to 18.6 months) in the IFN arm (hazard ratio [HR], 0.93; 95% CI, 0.73 to 1.18; P = .55). By site review, the median PFS times were 15.4 months (95% CI, 12.6 to 17.2 months) for bevacizumab and 10.6 months (95% CI, 8.5 to 14.4 months) for interferon (HR, 0.90; 95% CI, 0.72 to 1.12; P = .33). Time to treatment failure was longer with bevacizumab than with IFN (HR, 0.72; 95% CI, 0.58 to 0.89; P = .003). Confirmed radiologic response rates were 12% (95% CI, 8% to 18%) for bevacizumab and 4% (95% CI, 2% to 8%) for IFN. Common adverse events with bevacizumab and octreotide included hypertension (32%), proteinuria (9%), and fatigue (7%); with IFN and octreotide, they included fatigue (27%), neutropenia (12%), and nausea (6%). Conclusion No significant differences in PFS were observed between the bevacizumab and IFN arms, which suggests that these agents have similar antitumor activity among patients with advanced NETs.

  18. CONVERSION EXTRACTION DESULFURIZATION (CED) PHASE III

    Energy Technology Data Exchange (ETDEWEB)

    James Boltz

    2005-03-01

    This project was undertaken to refine the Conversion Extraction Desulfurization (CED) technology to efficiently and economically remove sulfur from diesel fuel to levels below 15-ppm. CED is considered a generic term covering all desulfurization processes that involve oxidation and extraction. The CED process first extracts a fraction of the sulfur from the diesel, then selectively oxidizes the remaining sulfur compounds, and finally extracts these oxidized materials. The Department of Energy (DOE) awarded Petro Star Inc. a contract to fund Phase III of the CED process development. Phase III consisted of testing a continuous-flow process, optimization of the process steps, design of a pilot plant, and completion of a market study for licensing the process. Petro Star and the Degussa Corporation in coordination with Koch Modular Process Systems (KMPS) tested six key process steps in a 7.6-centimeter (cm) (3.0-inch) inside diameter (ID) column at gas oil feed rates of 7.8 to 93.3 liters per hour (l/h) (2.1 to 24.6 gallons per hour). The team verified the technical feasibility with respect to hydraulics for each unit operation tested and successfully demonstrated pre-extraction and solvent recovery distillation. Test operations conducted at KMPS demonstrated that the oxidation reaction converted a maximum of 97% of the thiophenes. The CED Process Development Team demonstrated that CED technology is capable of reducing the sulfur content of light atmospheric gas oil from 5,000-ppm to less than 15-ppm within the laboratory scale. In continuous flow trials, the CED process consistently produced fuel with approximately 20-ppm of sulfur. The process economics study calculated an estimated process cost of $5.70 per product barrel. The Kline Company performed a marketing study to evaluate the possibility of licensing the CED technology. Kline concluded that only 13 refineries harbored opportunity for the CED process. The Kline study and the research team's discussions

  19. Probability of success for phase III after exploratory biomarker analysis in phase II.

    Science.gov (United States)

    Götte, Heiko; Kirchner, Marietta; Sailer, Martin Oliver

    2017-05-01

    The probability of success or average power describes the potential of a future trial by weighting the power with a probability distribution of the treatment effect. The treatment effect estimate from a previous trial can be used to define such a distribution. During the development of targeted therapies, it is common practice to look for predictive biomarkers. The consequence is that the trial population for phase III is often selected on the basis of the most extreme result from phase II biomarker subgroup analyses. In such a case, there is a tendency to overestimate the treatment effect. We investigate whether the overestimation of the treatment effect estimate from phase II is transformed into a positive bias for the probability of success for phase III. We simulate a phase II/III development program for targeted therapies. This simulation allows to investigate selection probabilities and allows to compare the estimated with the true probability of success. We consider the estimated probability of success with and without subgroup selection. Depending on the true treatment effects, there is a negative bias without selection because of the weighting by the phase II distribution. In comparison, selection increases the estimated probability of success. Thus, selection does not lead to a bias in probability of success if underestimation due to the phase II distribution and overestimation due to selection cancel each other out. We recommend to perform similar simulations in practice to get the necessary information about the risk and chances associated with such subgroup selection designs. Copyright © 2017 John Wiley & Sons, Ltd.

  20. Comparison of incidences of normal tissue complications with tumor response in a phase III trial comparing heat plus radiation to radiation alone

    International Nuclear Information System (INIS)

    Dewhirst, M.W.; Sim, D.A.; Grochowski, K.J.

    1984-01-01

    The success of hyperthermia (/sup Δ/) as an adjuvant to radiation (XRT) will depend on whether the increase in tumor control is greater than that for normal tissue reactions. One hundred and thirty dogs and cats were stratified by histology and randomized to receive XRT (460 rads per fraction, two fractions per week, for eight fractions) or /sup Δ/ + XRT (30 min. at 44 +-2 0 C; one fraction per week, four fractions; immediately prior to XRT). Heat induced changes in tumor and normal tissue responses were made by comparing ratios of incidence for /sup Δ/ + XRT and XRT alone (TRR; Thermal Relative Risk). Change in tumor response duration was calculated from statistical analysis of response duration curves (RRR; Relative Relapse Rate). Heat increased early normal tissue reactions (moist desquamation and mucositis by a factor of 1.08. Tumor complete response, by comparison, was significantly improved (TRR = 2.12, p < .001). Late skin fibrosis was also increased (TRR = 1.51), but the prolongation in tumor response was greater (RRR 1.85). The degree of thermal enhancement for all tissues was dependent on the minimum temperature achieved on the first treatment, but the values for tumor were consistently greater than those achieved for normal tissues

  1. Qinshan Phase III (CANDU) nuclear power project quality assurance

    International Nuclear Information System (INIS)

    Wang Lingen; Du Jinxiang

    2001-01-01

    The completion and implementation of quality assurance system of Qinshan Phase III (CANDU) nuclear power project are presented. Some comments and understanding with consideration of the project characteristics are put forward

  2. Sample exchange/evaluation (SEE) report - Phase III

    International Nuclear Information System (INIS)

    Winters, W.I.

    1996-01-01

    This report describes the results from Phase III of the Sample Exchange Evaluation (SEE) program. The SEE program is used to compare analytical laboratory performance on samples from the Hanford Site's high level waste tanks

  3. Electronic construction collaboration system : phase III.

    Science.gov (United States)

    2011-12-01

    This phase of the electronic collaboration project involved two major efforts: 1) implementation of AEC Sync (formerly known as Attolist), a web-based project management system (WPMS), on the Broadway Viaduct Bridge Project and the Iowa Falls Arch Br...

  4. Social Analysis Systems (SAS2) - Phase III

    International Development Research Centre (IDRC) Digital Library (Canada)

    Scaling Up the International Impact of Action Research : Social Analysis ... up the international impact of action research : SAS phase 3; final technical report ... 000 Canadians abroad to work at the local level on various development issues.

  5. Two-phase titration of cerium(III) by permanganate

    International Nuclear Information System (INIS)

    Lazarev, A.I.; Lazareva, V.I.; Gerko, V.V.

    1987-01-01

    This paper presents a method for the two-phase titrimetric determination of cerium(III) with permanganate which does not require an expenditure of sugar and preliminary removal of chlorides and nitrates. The interaction of cerium(III) with permanganate at room temperature was studied as a function of the pH, the concentration of pyrophosphate, tetraphenylphosphonium (TPP), permanganate, and extraneous compounds, the rate of titration, and the time of stay of the solution in air before titration. The investigations were conducted according to the following methodology: water, solution of cerium(III) pyrophosphate, and TPP were introduced into an Erlenmeyer flask with a side branch near the bottom for clearer observation of the color of the chloroform phase. The authors established the given pH value, poured the water into a volume of 50 ml, and added chloroform. The result was titrated with permanganate solutions of various concentrations until a violet color appeared in the chloroform phase

  6. Joint probability of statistical success of multiple phase III trials.

    Science.gov (United States)

    Zhang, Jianliang; Zhang, Jenny J

    2013-01-01

    In drug development, after completion of phase II proof-of-concept trials, the sponsor needs to make a go/no-go decision to start expensive phase III trials. The probability of statistical success (PoSS) of the phase III trials based on data from earlier studies is an important factor in that decision-making process. Instead of statistical power, the predictive power of a phase III trial, which takes into account the uncertainty in the estimation of treatment effect from earlier studies, has been proposed to evaluate the PoSS of a single trial. However, regulatory authorities generally require statistical significance in two (or more) trials for marketing licensure. We show that the predictive statistics of two future trials are statistically correlated through use of the common observed data from earlier studies. Thus, the joint predictive power should not be evaluated as a simplistic product of the predictive powers of the individual trials. We develop the relevant formulae for the appropriate evaluation of the joint predictive power and provide numerical examples. Our methodology is further extended to the more complex phase III development scenario comprising more than two (K > 2) trials, that is, the evaluation of the PoSS of at least k₀ (k₀≤ K) trials from a program of K total trials. Copyright © 2013 John Wiley & Sons, Ltd.

  7. Research ICT Africa (RIA!) - phase III | CRDI - Centre de recherches ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Research ICT Africa (RIA!) - phase III. Depuis la création du réseau RIA! en 2003, ses responsables ont mené avec succès des études portant tant sur l'offre que sur la demande afin de permettre de mieux comprendre l'accès aux TIC et leur utilisation en Afrique. Au cours des deux premières phases du projet (nos 101584 ...

  8. Public Policy and Protection from Exclusion - Phase III | IDRC ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Public Policy and Protection from Exclusion - Phase III ... and decision-makers active in the promotion of equitable health policies, with a view to promoting the emergence of an observatory of health systems in the ... Policy in Focus publishes a special issue profiling evidence to empower women in the labour market.

  9. Palestinian Adolescents Coping with Trauma (PACT) - Phase III ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Palestinian Adolescents Coping with Trauma (PACT) - Phase III. Violent conflict has been repeatedly shown to result in severe, long-term social and mental health problems for exposed children and adolescents. While in the developed world, it is generally accepted that individuals seek professional one-on-one ...

  10. CHAOS. III. GAS-PHASE ABUNDANCES IN NGC 5457

    Energy Technology Data Exchange (ETDEWEB)

    Croxall, Kevin V.; Pogge, Richard W. [Department of Astronomy, The Ohio State University, 140 West 18th Avenue, Columbus, OH 43210 (United States); Berg, Danielle A. [Center for Gravitation, Cosmology and Astrophysics, Department of Physics, University of Wisconsin Milwaukee, 1900 East Kenwood Boulevard, Milwaukee, WI 53211 (United States); Skillman, Evan D. [Minnesota Institute for Astrophysics, University of Minnesota, 116 Church Street SE, Minneapolis, MN 55455 (United States); Moustakas, John [Department of Physics and Astronomy, Siena College, 515 Loudon Road, Loudonville, NY 12211 (United States)

    2016-10-10

    We present Large Binocular Telescope observations of 109 H ii regions in NGC 5457 (M101) obtained with the Multi-Object Double Spectrograph. We have robust measurements of one or more temperature-sensitive auroral emission lines for 74 H ii regions, permitting the measurement of “direct” gas-phase abundances. Comparing the temperatures derived from the different ionic species, we find: (1) strong correlations of T [N ii] with T [S iii] and T [O iii], consistent with little or no intrinsic scatter; (2) a correlation of T [S iii] with T [O iii], but with significant intrinsic dispersion; (3) overall agreement between T [N ii], T [S ii], and T [O ii], as expected, but with significant outliers; (4) the correlations of T [N ii] with T [S iii] and T [O iii] match the predictions of photoionization modeling while the correlation of T [S iii] with T [O iii] is offset from the prediction of photoionization modeling. Based on these observations, which include significantly more observations of lower excitation H ii regions, missing in many analyses, we inspect the commonly used ionization correction factors (ICFs) for unobserved ionic species and propose new empirical ICFs for S and Ar. We have discovered an unexpected population of H ii regions with a significant offset to low values in Ne/O, which defies explanation. We derive radial gradients in O/H and N/O which agree with previous studies. Our large observational database allows us to examine the dispersion in abundances, and we find intrinsic dispersions of 0.074 ± 0.009 in O/H and 0.095 ± 0.009 in N/O (at a given radius). We stress that this measurement of the intrinsic dispersion comes exclusively from direct abundance measurements of H ii regions in NGC 5457.

  11. Superconductivity in the unconventional high pressure phase bismuth-III

    Energy Technology Data Exchange (ETDEWEB)

    Semeniuk, Konstantin; Brown, Philip; Vasiljkovic, Aleksandar; Grosche, Malte [University of Cambridge (United Kingdom)

    2015-07-01

    One of the most surprising developments in high pressure research was the realisation that many elements assume very unexpected high pressure structures, described in terms of extremely large or even infinite unit cells. Elemental bismuth, which has been known to undergo a series of pressure induced structural transitions between 25 kbar and 80 kbar, is an interesting example: the intermediate pressure Bi-III phase has a complex 'host-guest' structure consisting of two incommensurate sublattices. Since the unit cell is infinitely large, the description of electronic and lattice excitations is problematic. Apart from its metallic character and the observation of superconductivity at low temperature, little is known about the electronic structure in this phase. We investigate the electrical resistivity within the metallic Bi-III phase under high hydrostatic pressure and in applied magnetic field using a piston cylinder cell. Superconductivity is observed below 7.1 K, and we extract the temperature dependence of the upper critical field, which exceeds 2 T at low temperature. The normal state resistivity exhibits an approximately linear temperature dependence. This could be attributed to strong scattering from low-lying excitations, as caused by an unusually soft phonon spectrum. The results suggest that strong coupling superconductivity arises within the host-guest structure of Bi-III out of an unusual electronic state.

  12. Aqueous phase complexation of Cm(III) and Cf(III) with ionizable macrocyclic ligands

    International Nuclear Information System (INIS)

    Manchanda, V.K.; Mohapatra, P.K.

    1995-01-01

    Complexation behaviour of Cm(III) and Cf(III) with 1,7-diaza-4,10,13-trioxacyclopentadecane-N,N'-diacetic acid (K21DA), 1,10-diaza-4,7,13,16-tetraoxacyclooctadecane-N,N'-diacetic acid (K22DA) and ethylene diamine N,N'- diacetic acid (EDDA) has been investigated using dinonyl naphthalene sulphonic acid (DNNS), in tetramethyl ammonium form as liquid cation exchanger. The aqueous phase complex formation constants are computed from the distribution data. Though larger complex formation constants are observed with K21DA as well as K22DA compared to those with the acyclic analog EDDA, no size correlation is observed. (author). 5 refs., 1 tab

  13. Solar neutrino oscillation parameters after SNO Phase-III and SAGE Part-III

    International Nuclear Information System (INIS)

    Yang Ping; Liu Qiuyu

    2009-01-01

    We analyse the recently published results from solar neutrino experiments SNO Phase-III and SAGE Part-III and show their constraints on solar neutrino oscillation parameters, especially for the mixing angle θ 12 . Through a global analysis using all existing data from SK, SNO, Ga and Cl radiochemical experiments and long base line reactor experiment KamLAND , we obtain the parameters Δm 12 2 =7.684 -0.208 +0.212 x 10 -5 eV 2 , tan 2 θ 12 =0.440 -0.057 +0.059 . We also find that the discrepancy between the KamLAND and solar neutrino results can be reduced by choosing a small non-zero value for the mixing angle θ 13 . (authors)

  14. Extraction of Am (III) and Nd (III): comparison of TODGA and TEHDGA

    International Nuclear Information System (INIS)

    Gujar, R.B.; Murali, M.S.; Ansari, S.A.; Manchanda, V.K.

    2009-01-01

    Belonging to the class of extractants, diglycolamides which are recently explored and promising for actinide partitioning, two reagents (N, N, N', N'-tetraoctyl diglycolamide) TODGA and its isomerically substituted counterpart, (N, N, N', N'- tetraethylhexyl diglycolamide) TEHDGA after addition of suitable phase modifiers, Dihexyoctanamide and isodecanol respectively in dodecane have been compared in their extraction abilities for Am (III) and Nd (III) from nitric acid as well as simulated high-level waste solutions (SHLW) equivalent to HLW arising from PHWR fuel reprocessing. Both 0.1M TODGA + 0.5M DHOA and 0.2M TEHDGA + 30% isodecanol in dodecane display high distribution ratios for the trivalent metal ions of f-elements. Similarities and differences in their extraction are discussed. (author)

  15. A phase III comparison of radiation therapy with or without recombinant β-interferon for poor-risk patients with locally advanced non-small-cell lung cancer (RTOG 93-04)

    International Nuclear Information System (INIS)

    Bradley, Jeffrey D.; Scott, Charles B.; Paris, Kristie J.; Demas, William F.; Machtay, Mitchell; Komaki, Ritsuko; Movsas, Benjamin; Rubin, Philip; Sause, William T.

    2002-01-01

    Purpose: The results of Phase I/II data testing β-interferon with radiation therapy in a non-small-cell lung cancer population were promising. Based on these data, the Radiation Therapy Oncology Group (RTOG) initiated a Phase III trial to test the efficacy of β-interferon in poor-risk patients with Stages IIIA and IIIB non-small-cell lung carcinoma. Methods: Between September 1994 and March 1998, 123 patients were accrued to this trial. Enrolled patients were not eligible for other chemoradiation studies within the RTOG. Eligibility criteria included histologically confirmed Stage IIIA or IIIB non-small-cell lung cancer (according to American Joint Committee on Cancer) considered clinically inoperable or unresectable at the time of surgery. Patients were required to have a Karnofsky performance status 50-70 or >70 and at least 5% weight loss over the preceding 3 months. Betaseron (recombinant human interferon beta ser , rHuIFN-β ser ,) was the chosen preparation of β-interferon. The patients randomized to the investigational arm received 16x10 6 IU of Betaseron by i.v. bolus given 3 days a week (Monday-Wednesday) on Weeks 1, 3, and 5. The Betaseron was given 30 minutes before radiation therapy for a total of nine doses. Irradiation was delivered at 2 Gy per fraction, 5 days a week, for a total of 60 Gy over 6 weeks and was identical for both arms. The primary end point of the trial was overall survival with local control as a secondary end point. Toxicities occurring within 90 days of therapy completion were defined as acute. Results: The median follow-up was 4 years (range: 2.5-6 years) for surviving patients. Seventy-six percent of all patients completed β-interferon. Toxicity was the primary reason for noncompliance. Radiotherapy (RT) compliance was excellent in the RT-alone arm, with 94% completing therapy, compared to 82% in the β-interferon arm (p=0.0475). Grade 3 and 4 acute toxicities were higher on the β-interferon arm (p=0.0249). Grade 3 and 4

  16. Prevalência de rinite alérgica em adolescentes do Distrito Federal: comparação entre as fases I e III do ISAAC Prevalence of allergic rhinitis among adolescents from Distrito Federal, Brazil: comparison between ISAAC phases I and III

    Directory of Open Access Journals (Sweden)

    Wellington G. Borges

    2006-04-01

    (phases I and III written questionnaire. Thirty-nine schools were chosen at random from eight administrative regions in Brasilia, and were classified into three groups according to the socioeconomic conditions of the population. RESULTS: A total of 3,009 questionnaires were collected. Of these 53.5% related to female children and 80% to students from public schools. Prevalence rates for diagnosed rhinitis, recent rhinitis and allergic rhinitis were 20, 29.3 and 12.2%, respectively. Rhinitis was more prevalent in private schools than in public ones (17.8 versus 14.1% and sufferers were predominantly female. Prevalence rates were also higher among populations with higher socioeconomic status (23.5 versus 12.2%. Comparison with the 1996 data revealed significant increases in the prevalence of diagnosed rhinitis (12.7 versus 20%, p = 0.001. These increases were observed at all socioeconomic levels. CONCLUSION: A large number of 13 and 14-year-old children resident in the Distrito Federal exhibit symptoms indicative of rhinitis and the majority of them have allergic rhinitis. Over a six-year period the prevalence of allergic rhinitis increased significantly, predominantly affecting females and with greater prevalence among students at private school and from families with higher socioeconomic status.

  17. Comparison of Provider-Assessed and Patient-Reported Outcome Measures of Acute Skin Toxicity During a Phase III Trial of Mometasone Cream Versus Placebo During Breast Radiotherapy: The North Central Cancer Treatment Group (N06C4)

    International Nuclear Information System (INIS)

    Neben-Wittich, Michelle A.; Atherton, Pamela J.; Schwartz, David J.; Sloan, Jeff A.; Griffin, Patricia C.; Deming, Richard L.; Anders, Jon C.; Loprinzi, Charles L.; Burger, Kelli N.; Martenson, James A.; Miller, Robert C.

    2011-01-01

    Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider-assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: 0.7, strong. Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity.

  18. Pipe Overpack Container Fire Testing: Phase I II & III.

    Energy Technology Data Exchange (ETDEWEB)

    Figueroa, Victor G. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Ammerman, Douglas J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Lopez, Carlos [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Gill, Walter [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2018-02-01

    The Pipe Overpack Container (POC) was developed at Rocky Flats to transport plutonium residues with higher levels of plutonium than standard transuranic (TRU) waste to the Waste Isolation Pilot Plant (WIPP) for disposal. In 1996 Sandia National Laboratories (SNL) conducted a series of tests to determine the degree of protection POCs provided during storage accident events. One of these tests exposed four of the POCs to a 30-minute engulfing pool fire, resulting in one of the 7A drum overpacks generating sufficient internal pressure to pop off its lid and expose the top of the pipe container (PC) to the fire environment. The initial contents of the POCs were inert materials, which would not generate large internal pressure within the PC if heated. POCs are now being used to store combustible TRU waste at Department of Energy (DOE) sites. At the request of DOE’s Office of Environmental Management (EM) and National Nuclear Security Administration (NNSA), starting in 2015 SNL conducted a series of fire tests to examine whether PCs with combustibles would reach a temperature that would result in (1) decomposition of inner contents and (2) subsequent generation of sufficient gas to cause the PC to over-pressurize and release its inner content. Tests conducted during 2015 and 2016 were done in three phases. The goal of the first phase was to see if the PC would reach high enough temperatures to decompose typical combustible materials inside the PC. The goal of the second test phase was to determine under what heating loads (i.e., incident heat fluxes) the 7A drum lid pops off from the POC drum. The goal of the third phase was to see if surrogate aerosol gets released from the PC when the drum lid is off. This report will describe the various tests conducted in phase I, II, and III, present preliminary results from these tests, and discuss implications for the POCs.

  19. Thermal dewatering of lignite: Phase III - final report

    Energy Technology Data Exchange (ETDEWEB)

    Champagne, P J; Szladow, A J; Kybett, B D

    1981-01-01

    Phase III of this project extended the investigation of thermal dewatering on several lignite and peat samples at the temperature range up to 400 degrees C and investigated variables such as retention time, increased rates of heating and cooling, extent of trace element removal, effect of particle size and effect of dewatering under heavy and light oils. Lignites from three areas of Canada (Estevan and Coronach, Saskatchewan, and Onakawana, Ontario) and one peat sample (Garrick, Saskatchewan) were thermally dewatered. The equilibrium moisture values obtained for the dewatered products were as low as, or lower than those obtained in Phases I and II of this project (350 degrees C). However, the measured moisture contents of the thermally dewatered Saskatchewan lignites were somewhat higher than those measured in Phases I and II. The equilibrium moisture values and the moisture contents decreased with increasing temperature. An optimum balance between extent of dewatering and resulting steam pressures is obtained for a dewatering temperature between 300 and 350 degrees C. At these temperatures, residence times in the order of 15 minutes are required. (35 refs.)

  20. SIMMER-III code-verification. Phase 1

    International Nuclear Information System (INIS)

    Maschek, W.

    1996-05-01

    SIMMER-III is a computer code to investigate core disruptive accidents in liquid metal fast reactors but should also be used to investigate safety related problems in other types of advanced reactors. The code is developed by PNC with cooperation of the European partners FZK, CEA and AEA-T. SIMMER-III is a two-dimensional, three-velocity-field, multiphase, multicomponent, Eulerian, fluid-dynamics code coupled with a space-, time-, and energy-dependent neutron dynamics model. In order to model complex flow situations in a postulated disrupting core, mass and energy conservation equations are solved for 27 density components and 16 energy components, respectively. Three velocity fields (two liquid and one vapor) are modeled to simulate the relative motion of different fluid components. An additional static field takes into account the structures available in a reactor (pins, hexans, vessel structures, internal structures etc.). The neutronics is based on the discrete ordinate method (S N method) coupled into a quasistatic dynamic model. The code assessment and verification of the fluid dynamic/thermohydraulic parts of the code is performed in several steps in a joint effort of all partners. The results of the FZK contributions to the first assessment and verification phase is reported. (orig.) [de

  1. Radiotherapy in carcinoma of the uterine cervix phase III

    Energy Technology Data Exchange (ETDEWEB)

    Alvarez Villa, O; Reinerio, A; Felipe Castillo, A; Alonso Pantiga, R; Roig, M

    1985-01-01

    Between April 1968 and December 1980, 61 patients with phase III cancer of the cervix were treated. Fifty-six of them were squamous-cell carcinomas and five adenocarcinomas. The treatment consisted of a combination of external irradiation at doses varying between 4,000 and 7,000 rads and intracavitary radiotherapy with doses of 4.000 to 6.000 MHz, according to the schemes of the D.M. Anderson of Houston. The results obtained as far as survival is concerned and calculated by the actuarial method were 40% after five and ten years. The local control rate reached was 74%. The severe complications caused by the treatment reached 8.1%.

  2. [EUROASPIRE III: a comparison between Turkey and Europe].

    Science.gov (United States)

    Tokgözoğlu, Lale; Kaya, Ergün Bariş; Erol, Cetin; Ergene, Oktay

    2010-04-01

    The EUROASPIRE III survey was conducted in 2006-2007 in 22 countries in Europe (76 centers) to describe risk factors, lifestyle and therapeutic management of patients with coronary heart disease (CHD), compliance with current guidelines, and to document changes over time. This study aimed to assess the results of the EUROASPIRE III survey in terms of differences between Turkey and other European countries. The results of the EUROASPIRE III survey were compared with those of 17 centers from Turkey. Consecutive patients with a diagnosis of CHD (669 medical records, 23.8% women) were identified retrospectively, of which 338 patients (50.5%) were followed-up, interviewed, and examined at least six months after the index event (acute coronary syndrome or interventional procedure). Compared to the EUROASPIRE III data, recordings from Turkey's centers at discharge on classical risk factors did not exhibit remarkable differences; however, data on weight, height, waist circumference, lipid profile, glucose, and HbA1c measurements were more incomplete. In comparison to Europe population, the most important differences were observed in the higher rates of the following: young patients with myocardial infarction (>50 years, 20% vs. 12.7%), persistence in smoking (23.1% vs. 17.2%), immobility, low HDL-cholesterol (50.2% vs. 36.7%), insufficient follow-up by physicians after the index event (12% vs. 2.2%-except Turkey), and insufficient patient education. The data from the Turkey arm of the survey show that efforts for cardiovascular disease prevention fall short of the targets, similar to Europe.

  3. 129I Interlaboratory comparison: phase I and phase II

    International Nuclear Information System (INIS)

    Caffee, M. W.; Roberts, M. L.

    1999-01-01

    An interlaboratory comparison exercise for 129 I was organized and conducted. Nine laboratories participated in the exercise to either a full or limited extent. In Phase I of the comparison, 11 samples were measured. The suite of samples contained both synthetic ''standard type'' materials (i.e., AgI) and environmental materials. The isotopic 129 I/ 127 I ratios of the samples varied from 10 -8 to 10 -14 . In this phase, each laboratory was responsible for its own chemical preparation of the samples. In Phase I, the 129 I AMS measurements for prepared AgI were in good agreement. However, large discrepancies were seen in 129 I AMS measurements of environmental samples. Because of the large discrepancies seen in the Phase I 129 I intercomparison, a subsequent study was conducted. In Phase II of the 129 I intercomparison, three separate laboratories prepared AgI from two environmental samples (IAEA 375 soil and maples leaves). Each laboratory used its own chemical preparation method with each of the methods being distinctly different. The resulting six samples (two sets of three) were then re-distributed to the participating 129 I AMS facilities and 129 I/ 127 I ratios measured. Results and discussion of both the Phase I and Phase II interlaboratory comparison are presented

  4. 78 FR 73555 - Deepwater Horizon Oil Spill; Draft Programmatic and Phase III Early Restoration Plan and Draft...

    Science.gov (United States)

    2013-12-06

    ... Environmental Impact Statement (Draft Phase III ERP/PEIS). The Draft Phase III ERP/PEIS considers programmatic... programmatic restoration alternatives. The Draft Phase III ERP/PEIS evaluates these restoration alternatives... the Framework Agreement. The Draft Phase III ERP/PEIS also evaluates the environmental consequences of...

  5. An Application of Graphical Approach to Construct Multiple Testing Procedure in a Hypothetical Phase III Design

    Directory of Open Access Journals (Sweden)

    Naitee eTing

    2014-01-01

    Full Text Available Many multiple testing procedures (MTP have been developed in recent years. Among these new procedures, the graphical approach is flexible and easy to communicate with non-statisticians. A hypothetical Phase III clinical trial design is introduced in this manuscript to demonstrate how graphical approach can be applied in clinical product development. In this design, an active comparator is used. It is thought that this test drug under development could potentially be superior to this comparator. For comparison of efficacy, the primary endpoint is well established and widely accepted by regulatory agencies. However, an important secondary endpoint based on Phase II findings looks very promising. The target dose may have a good opportunity to deliver superiority to the comparator. Furthermore, a lower dose is included in case the target dose may demonstrate potential safety concerns. This Phase III study is designed as a non-inferiority trial with two doses, and two endpoints. This manuscript will illustrate how graphical approach is applied to this design in handling multiple testing issues.

  6. Cyprus natural analogue project (CNAP). Phase III final report

    International Nuclear Information System (INIS)

    Alexander, W.R.; Milodowski, A.E.; Pitty, A.F.

    2012-01-01

    The CNAP Phase III project was carried out following identification of the requirement to support ongoing laboratory and modelling efforts on the potential reaction of the bentonite buffer with cementitious leachates in the repository EBS. Although it is known that the higher pH (12.5 to 13) leachates from OPC cement will degrade bentonite, it is unclear if this will also be the case for the lower pH (10 to 11) leachates typical of low alkali cements. Ongoing laboratory and URL programmes which are currently investigating this face the obstacle of slow kinetics and the production of short-lived metastable phases, meaning obtaining unambiguous results may take decades. This is exacerbated by the limitations of the thermodynamic databases for minerals of interest to models of bentonite/low alkali cement leachate reaction. It was therefore decided to implement a focussed NA study on bentonite/low alkali cement leachate reaction to provide indications of likely long-term reaction products and reaction pathways to provide feedback on the existing short-term investigations noted above and to ascertain if any critical path R and D needs to be instigated now. The results of the analyses presented here suggest that there has been very limited alkaline groundwater reaction with the bentonite. This is generally supported by both the geomorphological evidence and the natural decay series data which imply groundwater groundwater/rock interaction in the last 10 5 a. When integrated with the novel data currently being produced in the BIGRAD project, the CNAP data tend to indicate that any long-term bentonite reaction in low alkali cement leachates is minimal. (orig.)

  7. Cyprus natural analogue project (CNAP). Phase III final report

    Energy Technology Data Exchange (ETDEWEB)

    Alexander, W R [Bedrock Geosciences, Auenstein (Switzerland); Milodowski, A E [British Geological Survey, Keyworth (United Kingdom); Pitty, A F [Pitty (EIA) Consulting, Norwich (United Kingdom)

    2012-01-15

    The CNAP Phase III project was carried out following identification of the requirement to support ongoing laboratory and modelling efforts on the potential reaction of the bentonite buffer with cementitious leachates in the repository EBS. Although it is known that the higher pH (12.5 to 13) leachates from OPC cement will degrade bentonite, it is unclear if this will also be the case for the lower pH (10 to 11) leachates typical of low alkali cements. Ongoing laboratory and URL programmes which are currently investigating this face the obstacle of slow kinetics and the production of short-lived metastable phases, meaning obtaining unambiguous results may take decades. This is exacerbated by the limitations of the thermodynamic databases for minerals of interest to models of bentonite/low alkali cement leachate reaction. It was therefore decided to implement a focussed NA study on bentonite/low alkali cement leachate reaction to provide indications of likely long-term reaction products and reaction pathways to provide feedback on the existing short-term investigations noted above and to ascertain if any critical path R and D needs to be instigated now. The results of the analyses presented here suggest that there has been very limited alkaline groundwater reaction with the bentonite. This is generally supported by both the geomorphological evidence and the natural decay series data which imply groundwater groundwater/rock interaction in the last 10{sup 5} a. When integrated with the novel data currently being produced in the BIGRAD project, the CNAP data tend to indicate that any long-term bentonite reaction in low alkali cement leachates is minimal. (orig.)

  8. INL Results for Phases I and III of the OECD/NEA MHTGR-350 Benchmark

    Energy Technology Data Exchange (ETDEWEB)

    Gerhard Strydom; Javier Ortensi; Sonat Sen; Hans Hammer

    2013-09-01

    The Idaho National Laboratory (INL) Very High Temperature Reactor (VHTR) Technology Development Office (TDO) Methods Core Simulation group led the construction of the Organization for Economic Cooperation and Development (OECD) Modular High Temperature Reactor (MHTGR) 350 MW benchmark for comparing and evaluating prismatic VHTR analysis codes. The benchmark is sponsored by the OECD's Nuclear Energy Agency (NEA), and the project will yield a set of reference steady-state, transient, and lattice depletion problems that can be used by the Department of Energy (DOE), the Nuclear Regulatory Commission (NRC), and vendors to assess their code suits. The Methods group is responsible for defining the benchmark specifications, leading the data collection and comparison activities, and chairing the annual technical workshops. This report summarizes the latest INL results for Phase I (steady state) and Phase III (lattice depletion) of the benchmark. The INSTANT, Pronghorn and RattleSnake codes were used for the standalone core neutronics modeling of Exercise 1, and the results obtained from these codes are compared in Section 4. Exercise 2 of Phase I requires the standalone steady-state thermal fluids modeling of the MHTGR-350 design, and the results for the systems code RELAP5-3D are discussed in Section 5. The coupled neutronics and thermal fluids steady-state solution for Exercise 3 are reported in Section 6, utilizing the newly developed Parallel and Highly Innovative Simulation for INL Code System (PHISICS)/RELAP5-3D code suit. Finally, the lattice depletion models and results obtained for Phase III are compared in Section 7. The MHTGR-350 benchmark proved to be a challenging simulation set of problems to model accurately, and even with the simplifications introduced in the benchmark specification this activity is an important step in the code-to-code verification of modern prismatic VHTR codes. A final OECD/NEA comparison report will compare the Phase I and III

  9. Evaluate fundamental approaches to longwall dust control. Phase III report

    Energy Technology Data Exchange (ETDEWEB)

    Babbitt, C.; Bartlett, P.; Kelly, J.; Ludlow, J.; Mangolds, A.; Rajan, S.; Ruggieri, S.; Varga, E.

    1984-03-31

    The overall objective of the contract is to evaluate the effectiveness of available dust control technology for double-drum shearer longwall sections in a coordinated, systematic program at a few longwall test sections and to make the results available to the entire coal mining industry. This program is investigating nine different dust control techniques. These nine subprograms encompass a broad range of dust control measures ranging from administrative controls to new hardware. They span not only presently employed methods but also those recently adopted in the United States and those proposed for the future. This report documents the Phase III effort on each of the subprograms. For clarity, the report is divided in sections by subprogram as follows: Section 2, Subprogram A - passive barriers/spray air movers for dust control; Section 3, Subprogram B - practical aspects of deep cutting; Section 4, Subprogram C - stage loader dust control; Section 5, Subprogram D - longwall automation technology; Section 6, Subprogram E - longwall application of ventilation curtains; Section 7, Subprogram F - reversed drum rotation; Section 8, Subprogram G - reduction of shield generated dust; Section 9, Subprogram H - air canopies for longwalls; and Section 10, Subprogram I - mining practices. 43 figures, 11 tables.

  10. Brush Day & Night Phase III to Phase IV: ensuring that good oral health habits are sustainable.

    Science.gov (United States)

    Melo, Paulo; Fine, Charlotte; Malone, Sinead; Horn, Virginie

    2018-05-01

    Over the past 10 years, the FDI-Unilever Brush Day & Night partnership has significantly influenced the life of children worldwide through the implementation of school programmes for oral health education and prevention. This article reports the key facts and outcomes of Phase III of the partnership, and announces the launch of Phase IV. During Phase III, the expert advisors of the Brush Day & Night partnership conducted a longitudinal study to evaluate the impact of the '21 Day' programme in almost 8,000 children in 10 countries. Analysis revealed the effectiveness of the 21 Day programme in sustainably educating children to brush their teeth twice a day, with the greatest impact observed in children aged 7-9 years. With the launch of Phase IV, the Brush Day & Night partnership will continue to deliver its oral health school programme for 7-9 year-old children with a strengthened methodology, including randomized sampling and control groups. The scope of the evaluation will be broadened to include oral health-related quality of life indicators, and monitoring of the oral health knowledge of children's parents/carers. © 2018 FDI World Dental Federation.

  11. EXPERIMENTAL RESULTS OF THE NEPHELINE PHASE III STUDY

    Energy Technology Data Exchange (ETDEWEB)

    Fox, K.; Edwards, T.

    2009-11-09

    This study is the third phase in a series of experiments designed to reduce conservatism in the model that predicts the formation of nepheline, a crystalline phase that can reduce the durability of high level waste glass. A Phase I study developed a series of glass compositions that were very durable while their nepheline discriminator values were well below the current nepheline discriminator limit of 0.62, where nepheline is predicted to crystallize upon slow cooling. A Phase II study selected glass compositions to identify any linear effects of composition on nepheline crystallization and that were restricted to regions that fell within the validation ranges of the Defense Waste Processing Facility (DWPF) Product Composition Control System (PCCS) models. However, it was not possible to identify any linear effects of composition on chemical durability performance for this set of study glasses. The results of the Phase II study alone were not sufficient to recommend modification of the current nepheline discriminator. It was recommended that the next series of experiments continue to focus not only on compositional regions where the PCCS models are considered applicable (i.e., the model validation ranges), but also be restricted to compositional regions where the only constraint limiting processing is the current nepheline discriminator. Two methods were used in selecting glasses for this Phase III nepheline study. The first was based on the relationship of the current nepheline discriminator model to the other DWPF PCCS models, and the second was based on theory of crystallization in mineral and glass melts. A series of 29 test glass compositions was selected for this study using a combination of the two approaches. The glasses were fabricated and characterized in the laboratory. After reviewing the data, the study glasses generally met the target compositions with little issue. Product Consistency Test results correlated well with the crystallization analyses in

  12. CIM5 Phase III base process development results

    International Nuclear Information System (INIS)

    Witt, D.C.

    2000-01-01

    Integrated Demonstration Runs for the Am/Cm vitrification process were initiated in the Coupled 5-inch Cylindrical Induction Melter (CIM5) on 11/30/98 and completed on 12/9/98. Four successful runs at 60 wt% lanthanide loading were completed which met or exceeded all established criteria. The operating parameters used in these runs established the base conditions for the 5-inch Cylindrical Induction Melter (CIM5) process and were summarized in the 5-inch CIM design basis, SRT-AMC-99-OO01. (1) In subsequent tests, a total of fourteen CIM5 runs were performed using various power inputs, ramp rates and target temperatures to define the preferred processing conditions (2) Process stability and process flexibility were the key criteria used in assessing the results for each run. A preferred set of operating parameters was defined for the CIM5 batch process and these conditions were used to generate a pre-programmed, automatic processing cycle that was used for the last six CIM.5 runs (3) These operational tests were successfully completed in the January-February time frame and were summarized in SRT-AMC-99-00584. The recommended set of operating conditions defined in Runs No.1 through No.14 was used as the starting point for further pilot system runs to determine the robustness of the process, evaluate a bubbler, and investigate off-normal conditions. CIM5 Phase III Runs No.15 through No.60 were conducted utilizing the pre-programmed, automatic processing cycle to investigate system performance. This report summarizes the results of these tests and provides a recommendation for the base process as well as a processing modification for minimizing volume expansions if americium and/or curium are subject to a thermal reduction reaction like cerium. This document summarizes the results of the base process development tests conducted in the Am/Cm Pilot Facility located in Building 672-T

  13. Phase 0 and phase III transport in various organs: combined concept of phases in xenobiotic transport and metabolism.

    Science.gov (United States)

    Döring, Barbara; Petzinger, Ernst

    2014-08-01

    The historical phasing concept of drug metabolism and elimination was introduced to comprise the two phases of metabolism: phase I metabolism for oxidations, reductions and hydrolyses, and phase II metabolism for synthesis. With this concept, biological membrane barriers obstructing the accessibility of metabolism sites in the cells for drugs were not considered. The concept of two phases was extended to a concept of four phases when drug transporters were detected that guided drugs and drug metabolites in and out of the cells. In particular, water soluble or charged drugs are virtually not able to overcome the phospholipid membrane barrier. Drug transporters belong to two main clusters of transporter families: the solute carrier (SLC) families and the ATP binding cassette (ABC) carriers. The ABC transporters comprise seven families with about 20 carriers involved in drug transport. All of them operate as pumps at the expense of ATP splitting. Embedded in the former phase concept, the term "phase III" was introduced by Ishikawa in 1992 for drug export by ABC efflux pumps. SLC comprise 52 families, from which many carriers are drug uptake transporters. Later on, this uptake process was referred to as the "phase 0 transport" of drugs. Transporters for xenobiotics in man and animal are most expressed in liver, but they are also present in extra-hepatic tissues such as in the kidney, the adrenal gland and lung. This review deals with the function of drug carriers in various organs and their impact on drug metabolism and elimination.

  14. The role of technology in reducing health care costs. Phase II and phase III.

    Energy Technology Data Exchange (ETDEWEB)

    Cilke, John F.; Parks, Raymond C.; Funkhouser, Donald Ray; Tebo, Michael A.; Murphy, Martin D.; Hightower, Marion Michael; Gallagher, Linda K.; Craft, Richard Layne, II; Garcia, Rudy John

    2004-04-01

    In Phase I of this project, reported in SAND97-1922, Sandia National Laboratories applied a systems approach to identifying innovative biomedical technologies with the potential to reduce U.S. health care delivery costs while maintaining care quality. The effort provided roadmaps for the development and integration of technology to meet perceived care delivery requirements and an economic analysis model for development of care pathway costs for two conditions: coronary artery disease (CAD) and benign prostatic hypertrophy (BPH). Phases II and III of this project, which are presented in this report, were directed at detailing the parameters of telemedicine that influence care delivery costs and quality. These results were used to identify and field test the communication, interoperability, and security capabilities needed for cost-effective, secure, and reliable health care via telemedicine.

  15. Phase III Simplified Integrated Test (SIT) results - Space Station ECLSS testing

    Science.gov (United States)

    Roberts, Barry C.; Carrasquillo, Robyn L.; Dubiel, Melissa Y.; Ogle, Kathryn Y.; Perry, Jay L.; Whitley, Ken M.

    1990-01-01

    During 1989, phase III testing of Space Station Freedom Environmental Control and Life Support Systems (ECLSS) began at Marshall Space Flight Center (MSFC) with the Simplified Integrated Test. This test, conducted at the MSFC Core Module Integration Facility (CMIF), was the first time the four baseline air revitalization subsystems were integrated together. This paper details the results and lessons learned from the phase III SIT. Future plans for testing at the MSFC CMIF are also discussed.

  16. The coupling of thermochemistry and phase diagrams for group III-V semiconductor systems. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, T.J.

    1998-07-21

    The project was directed at linking the thermochemical properties of III-V compound semiconductors systems with the reported phase diagrams. The solid-liquid phase equilibrium problem was formulated and three approaches to calculating the reduced standard state chemical potential were identified and values were calculated. In addition, thermochemical values for critical properties were measured using solid state electrochemical techniques. These values, along with the standard state chemical potentials and other available thermochemical and phase diagram data, were combined with a critical assessment of selected III-V systems. This work was culminated with a comprehensive assessment of all the III-V binary systems. A novel aspect of the experimental part of this project was the demonstration of the use of a liquid encapsulate to measure component activities by a solid state emf technique in liquid III-V systems that exhibit high vapor pressures at the measurement temperature.

  17. Model validation studies of solar systems, Phase III. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Lantz, L.J.; Winn, C.B.

    1978-12-01

    Results obtained from a validation study of the TRNSYS, SIMSHAC, and SOLCOST solar system simulation and design are presented. Also included are comparisons between the FCHART and SOLCOST solar system design programs and some changes that were made to the SOLCOST program. Finally, results obtained from the analysis of several solar radiation models are presented. Separate abstracts were prepared for ten papers.

  18. Archform comparisons between skeletal class II and III malocclusions.

    Directory of Open Access Journals (Sweden)

    Wei Zou

    Full Text Available The purpose of this cross-sectional research was to explore the relationship of the mandibular dental and basal bone archforms between severe Skeletal Class II (SC2 and Skeletal Class III (SC3 malocclusions. We also compared intercanine and intermolar widths in these two malocclusion types. Thirty-three virtual pretreatment mandibular models (Skeletal Class III group and Thirty-five Skeletal Class II group pretreatment models were created with a laser scanning system. FA (the midpoint of the facial axis of the clinical crownand WALA points (the most prominent point on the soft-tissue ridgewere employed to produce dental and basal bone archforms, respectively. Gained scatter diagrams of the samples were processed by nonlinear regression analysis via SPSS 17.0. The mandibular dental and basal bone intercanine and intermolar widths were significantly greater in the Skeletal Class III group compared to the Skeletal Class II group. In both groups, a moderate correlation existed between dental and basal bone arch widths in the canine region, and a high correlation existed between dental and basal bone arch widths in the molar region. The coefficient of correlation of the Skeletal Class III group was greater than the Skeletal Class II group. Fourth degree, even order power functions were used as best-fit functions to fit the scatter plots. The radius of curvature was larger in Skeletal Class III malocclusions compared to Skeletal Class II malocclusions (rWALA3>rWALA2>rFA3>rFA2. In conclusion, mandibular dental and basal intercanine and intermolar widths were significantly different between the two groups. Compared with Skeletal Class II subjects, the mandibular archform was more flat for Skeletal Class III subjects.

  19. Comparison with experiment of COMETHE III-L fuel rod behaviour predictions

    International Nuclear Information System (INIS)

    Vliet, J. van; Billaux, M.

    1983-01-01

    A comparison is presented between experimental results and COMETHE III-L fuel rod behaviour predictions. The first part of the paper focuses on mechanical aspects, with as main experiments, AECL X-264 and Studsvik Interramp. The second part presents the results of a wide FGR benchmarking campaign, with a reference to previous COMETHE versions. It appears that the variance between experiment and calculation has decreased by a factor four when the III-J version was improved into the III-L version. As conclusion, some COMETHE III-L calculations are presented in order to illustrate its capability of predicting fuel rod performance limits. (author)

  20. Urban Ecosystem Health in Kathmandu (Nepal) - Phase III | CRDI ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    The two earlier phases of this project (003320 and 101277) led to the creation or strengthening of 18 local stakeholder groups and resulted in a new Animal Slaughtering and Meat Inspection Act, modification of the Nepal Food Act, modification of the Garbage Disposal Act, revisions to the Kathmandu Valley Housing Plan ...

  1. Research ICT Africa - Phase III | IDRC - International Development ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    During this phase, RIA will construct an African index of ICT policy and regulations; establish a network structure suitable for growth and the integration of North Africa; refine its policy influence and dissemination strategy; integrate its supply- and demand-side data and triangulate it with the telecommunication regulatory ...

  2. Research ICT Africa - Phase III | CRDI - Centre de recherches pour ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Launched in 2003, Research ICT Africa (RIA) has successfully conducted demand- and supply-side studies with a view to better understanding information and communication technology (ICT) access and usage in Africa. The network expanded over the first two phases of support (101584 and 103114) to include members ...

  3. Unraveling the Mystery of the Blue Fog: Structure, Properties, and Applications of Amorphous Blue Phase III.

    Science.gov (United States)

    Gandhi, Sahil Sandesh; Chien, Liang-Chy

    2017-12-01

    The amorphous blue phase III of cholesteric liquid crystals, also known as the "blue fog," are among the rising stars in materials science that can potentially be used to develop next-generation displays with the ability to compete toe-to-toe with disruptive technologies like organic light-emitting diodes. The structure and properties of the practically unobservable blue phase III have eluded scientists for more than a century since it was discovered. This progress report reviews the developments in this field from both fundamental and applied research perspectives. The first part of this progress report gives an overview of the 130-years-long scientific tour-de-force that very recently resulted in the revelation of the mysterious structure of blue phase III. The second part reviews progress made in the past decade in developing electrooptical, optical, and photonic devices based on blue phase III. The strong and weak aspects of the development of these devices are underlined and criticized, respectively. The third- and-final part proposes ideas for further improvement in blue phase III technology to make it feasible for commercialization and widespread use. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  4. Individualized Inservice Teacher Education (Project In-Step). Evaluation Report. Phase III.

    Science.gov (United States)

    Thurber, John C.

    This is a report on the third phase of Project IN-STEP, which was intended to develop a viable model for individualized, multi-media in-service teacher education programs. (Phase I and II are reported in ED 033 905, and ED 042 709). The rationale for Phase III was to see if the model could be successfully transferred to an area other than teaching…

  5. Comprehensive Evaluation of the Geothermal Resource Potential within the Pyramid Lake Paiute Reservation Phase III Report

    Energy Technology Data Exchange (ETDEWEB)

    Noel, Donna [Pyramid Lake Paiute Tribe, Nixon, NV (United States)

    2013-12-01

    This project integrated state-of-the-art exploration technologies with a geologic framework and reservoir modeling to ultimately determine the efficacy of future geothermal production within the PLPT reservation. The information gained during this study should help the PLPT to make informed decisions regarding construction of a geothermal power plant. Additional benefits included the transfer of new technologies and geothermal data to the geothermal industry and it created and/or preserved nearly three dozen jobs accordance with the American Recovery and Reinvestment Act of 2009. A variety of tasks were conducted to achieve the above stated objectives. The following are the tasks completed within the project: 1. Permitting 2. Shallow temperature survey 3. Seismic data collection and analysis 4. Fracture stress analysis 5. Phase I reporting Permitting 7. Shallow temperature survey 8. Seismic data collection and analysis 9. Fracture stress analysis 10. Phase I reporting 11. Drilling two new wells 12. Borehole geophysics 13. Phase II reporting 14. Well testing and geochemical analysis 15. Three-dimensional geologic model 16. Three-dimensional reservoir analysis 17. Reservation wide geothermal potential analysis 18. Phase III reporting Phase I consisted of tasks 1 – 5, Phase II tasks 6 – 8, and Phase III tasks 9 – 13. This report details the results of Phase III tasks. Reports are available for Phase I, and II as separate documents.

  6. Acute morbidity reduction using 3DCRT for prostate carcinoma; a randomised phase III study

    International Nuclear Information System (INIS)

    Koper, P.; Putten, W. van; Stroom, J.; Korevaar, G.; Heijmen, B.; Wijnmaalen, A.; Jansen, P.; Hanssens, P.; Griep, C.; Krol, A.; Samson, M.; Levendag, P.

    1997-01-01

    Purpose: A randomised phase III toxicity study (conventional vs conformal radiotherapy) was performed for prostatic carcinoma to study the effects on the (acute) morbidity of intestinal/rectosigmoid and bladder. The observed toxicity was compared with Dose Volume Histograms to reveal possible volume (reduction) effects. Methods: In the phase III study 266 T1-4 N0M0 prostate cancer patients were entered. Patients were randomised for conventional and conformal radiotherapy (total dose 66 Gy, minimum PTV dose 95% ICRU and a CTV-PTV margin of 10 mm in both study arms). The GTV was limited to the prostate only in T1 tumors. In all other patients the GTV was defined to be prostate and seminal vesicles for the complete treatment course. The CTV-PTV margin (10mm) was created by a automated program to ensure the minimum prescribed margin. The rectosigmoid was defined to be the rectum including the sigmoid within the Treatment Volume (ICRU). Acute toxicity was evaluated using the EORTC/RTOG morbidity score and weekly quality of life questionnaires. The radiation technique comparison was done by Dose volume Histogram analysis using the Area Under The Curve (AUC) for different dose levels. In this preliminary DVH analysis we present the data for the first 100 patients. Results: Patient and tumor characteristics were evenly distributed between both study groups. The maximum toxicity is reached at 75% of the tumordose (TD) (rectal grade I 59% grade II 26%, bladder grade I 48%, grade II 16% and grade III 1% [catheter for urinary retention]). Comparing both study arms there seems to be a reduction in intestinal morbidity (grade II and higher resp. 32% vs 19% p=0.02). Further analysis revealed a marked reduction in medication for anal symptoms; this accounts for a large part of the significant difference in intestinal toxicity (grade II conventional vs conformal rectosigmoid 18% vs 14% and anal 16% vs 8%). For bladder morbidity no difference for mobidity higher than grade I is

  7. Brazing of the Tore Supra actively cooled Phase III Limiter

    International Nuclear Information System (INIS)

    Nygren, R.E.; Walker, C.A.; Lutz, T.J.; Hosking, F.M.; McGrath, R.T.

    1993-01-01

    The head of the water-cooled Tore Supra Phase 3 Limiter is a bank of 14 round OFHC copper tubes, curved to fit the plasma radius, onto which several hundred pyrolytic graphite (PG) tiles and a lesser number of carbon fiber composite tiles are brazed. The small allowable tolerances for fitting the tiles to the tubes and mating of compound curvatures made the brazing and fabrication extremely challenging. The paper describes the fabrication process with emphasis on the procedure for brazing. In the fixturing for vacuum furnace brazing, the tiles were each independently clamped to the tube with an elaborate set of window frame clamps. Braze quality was evaluated with transient heating tests. Some rebrazing was necessary

  8. Phase III (full scale) agitated mixing test plan

    International Nuclear Information System (INIS)

    Ruff, D.T.

    1994-01-01

    Waste Receiving and Processing Facility Module 2A (WRAP 2A) is the proposed second module of the WRAP facility. This facility will provide the required treatment for contact Handled (CH) Low Level (LL) Mixed Waste (MW) to allow its permanent disposal. Solidification of a portion of this waste using a cement based grout has been selected in order to reduce the toxicity and mobility of the waste in the disposal site. Mixing of the waste with the cement paste and material handling constraints/requirements associated with the mixed material is, therefore, a key process in the overall treatment strategy. This test plan addresses Phase 3, Full Scale Testing. The objectives of these tests are to determine if there are scale-up issues associated with the mixing results obtained in Phase 1 and 2 mixing tests, verify the workability of mixtures resulting from previous formulation development efforts (Waste Immobilization Development [WID]), and provide a baseline for WRAP 2A mixing equipment design. To this end, the following objectives are of particular interest: determine geometric influence of mixing blade at full scale (i.e., size, type, and location: height/offset); determine if similar results in terms of mixing effectiveness and product quality are achievable at this scale; determine if vibration is as effective at this larger scale in fluidizing the mixture and aiding in cleaning the vessel; determine if baffles or sweeping blades are needed to aid in mixing at the larger size and for cleaning the vessel; and determine quality of the poured monolithic product and investigate exotherm and filling influences at this larger size

  9. Use of Geothermal Energy for Aquaculture Purposes - Phase III

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, W C; Smith, K C

    1981-09-01

    This project, financed by the Pacific Northwest Regional Commission (PNRC), was designed to provide information to evaluate the best methods to use for intensive aquaculture of freshwater prawns, Macrobrachium rosenbergii, using geothermal energy. The freshwater prawn is a tropical organism and is native to southeast Asia. Earlier projects at Oregon Institute of Technology have shown the feasibility of culturing this aquatic animal in geothermal water. This phase of the project was designed to investigate intensive culture of this animal as well as the advantages of growing rainbow trout, ornamental tropical fin fish, and mosquito fish, Gambusia affnis, for vector control using geothermal energy. The research data collected on the prawns was obtained from the stocking and sampling of two 0.2- ha (half-acre) ponds constructed as a part of the project. The ponds are equipped with recording monitors for temperature and flow. The geothermal energy used is the geothermal effluent from the Oregon Institute of Technology heating system. This water is of potable quality and ranges in temperature from 50 to 70oC. The geothermal water used in the ponds is controlled at 27oC, ± 2oC, by using thermostats and solenoid valves. A small building next to the ponds contains facilities for hatching larvae prawns and tanks for growing post-larvae prawns. The hatchery facility makes the project self-sustaining. The hatchery was obtained as part of an earlier PNRC project.

  10. Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

    Science.gov (United States)

    Takahashi, Fumihiro; Morita, Satoshi

    2018-02-08

    Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

  11. Durability of lightweight concrete : Phase II : wetting and drying tests, Phase III : freezing and thawing tests.

    Science.gov (United States)

    1966-12-01

    This report describes a laboratory research program on the durability of lightweight concrete. Two phases of a three phase study are covered by this report, while the remaining phase is still under study. The two phases being reported are Phase II - ...

  12. Remedial Action Report for Operable Units 6-05 and 10-04, Phase III

    Energy Technology Data Exchange (ETDEWEB)

    R. P. Wells

    2007-08-15

    This Phase III remedial action report addresses the remediation of lead-contaminated soils found at the Security Training Facility STF-02 Gun Range at the Idaho National Laboratory Site. Phase I, consisting of developing and implementing institutional controls at Operble Unit 10-04 sites and developing and implementing Idaho National Laboratory Site-wide plans for both institutional controls and ecological monitoring, was addressed in a previous report. Phase II will remediate sites contaminated with trinitrotoluene and Royal Demolition Explosive. Phase IV will remediate hazards from unexploded ordnance.

  13. Reversed phase partition chromatographic separation of Gd(III) on poly(Crown Ether) column

    International Nuclear Information System (INIS)

    Mahanwar, K.R.; Sabale, S.R.

    2014-01-01

    A simple method has been developed for the separation of Gd(III) in hippuric acid medium by using poly(dibenzo-18-crown-6) as stationary phase. The effect of hippuric acid concentration, different eluting agent, foreign ions etc was studied and the optimum conditions were established. Breakthrough capacity of poly(dibenzo-18-crown-6) for Gd(III) was found to be 0.572 ±0.01 mmolg -1 of crown polymer. The separation of Gd(III) from other elements in multicomponent mixtures has been achieved. The method was extended for determination of Gd(III) in real sample. The method is simple, rapid and selective with good reproducibility (approximately ± 2%). Crown ethers are widely used as complexing agent that can selectively capture metal cation in their cavity. This special feature shown by poly (dibenzo-18-crown-6) has been used in our laboratory for selective cation exchanger by column chromatography. No attempts were made for the separation of Gd(III) using hippuric acid media and column chromatography. The present communication describes a simple and sensitive method for the determination of Gd(III) using poly(dibenzo-18-crown-6) as stationary phase in hippuric acid medium. The proposed method affords an attractive feature as compared to the solvent extraction technique i.e. it is free from any organic diluents as an environmental concern

  14. Effects of PECS Phase III Application Training on Independent Mands in Young Children with Autism

    Science.gov (United States)

    Love, Jessica June

    2013-01-01

    The purpose of this study was to examine the effects of PECS phase III application training on independent mands in young children with autism. Participants were five children with autism ranging from ages 2 to 4 years old. A multiple baseline across participants was used to evaluate acquisition of independent correct mands across baseline and…

  15. SPSP Phase III Recruiting, Selecting, and Developing Secure Power Systems Professionals. Job Profiles

    Energy Technology Data Exchange (ETDEWEB)

    O' Neil, Lori Ross [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Conway, T. J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Tobey, D. H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Greitzer, Frank L. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Dalton, Angela C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Pusey, Portia K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-03-01

    The Secure Power Systems Professional Phase III final report was released last year which an appendix of Job Profiles. This new report is that appendix broken out as a standalone document to assist utilities in recruiting and developing Secure Power Systems Professionals at their site.

  16. SPSP Phase III Recruiting, Selecting, and Developing Secure Power Systems Professionals. Individual and Team Performance Guidelines

    Energy Technology Data Exchange (ETDEWEB)

    O' Neil, Lori Ross [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Conway, T. J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Tobey, D. H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Greitzer, Frank L. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Dalton, Angela C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Pusey, Portia K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-03-01

    The Secure Power Systems Professional Phase III final report was released last year which an appendix of Individual and Team Performance Guidelines. This new report is that appendix broken out as a standalone document to assist utilities in recruiting and developing Secure Power Systems Professionals at their site.

  17. Acceptance test procedure, 241-SY-101 Flexible Receiver System, Phase III testing

    International Nuclear Information System (INIS)

    Ritter, G.A.

    1994-01-01

    This Acceptance Test Procedure is for the 241-SY-101 Flexible Receiver System, Phase III Testing. This procedure will test the sealing integrity of the Flexible Receiver System to ensure that release of waste and aerosols will be minimized during the removal of the test mixer pump from tank SY-101

  18. Explorations of new phases in the Ga(III)/In(III)-Mo(VI)-Se(IV)/Te(IV)-O systems.

    Science.gov (United States)

    Kong, Fang; Hu, Chun-Li; Hu, Ting; Zhou, Yong; Mao, Jiang-Gao

    2009-07-07

    Systematic explorations of new phases in the Ga(III)/In(III)-Mo(VI)-Se(IV)/Te(IV)-O systems by hydrothermal syntheses or solid-state reactions at high-temperature led to four new quaternary compounds, namely, Ga(2)MoQ(2)O(10) (Q = Se, Te), In(2)Mo(2)Se(2)O(13)(H(2)O) and In(2)MoTe(2)O(10). Ga(2)MoQ(2)O(10) (Q = Se, Te) are isostructural and their structures feature a 3D network of gallium selenite/tellurite with 12-member ring tunnels along b-axis, the distorted MoO(6) octahedra are attached on the wall of the above tunnels. The structure of In(2)Mo(2)Se(2)O(13)(H(2)O) features a new pillared-layered architecture composed of 2D indium(III) selenite layers that are interconnected by Mo(2)O(10) dimers, forming 8-membered ring tunnels along the b-axis. The structure of In(2)MoTe(2)O(10) features a 2D indium oxide layer formed by corner- and edge-sharing InO(6) and InO(7) polyhedra with MoO(4) tetrahedra and TeO(n) (n = 4, 5) polyhedra hanging on both sides of the layer, there are weak interlayer Te-O bonds of 2.512 A. Results of optical diffuse reflectance spectrum measurements indicate that all four compounds are insulators, which are in agreement with results of band structure calculations based on DFT methods.

  19. Comparison report for CSNI International Standard Problem 12 (ROSA-III Run 912)

    International Nuclear Information System (INIS)

    Tasaka, Kanji; Anoda, Yoshinari; Kumamaru, Hiroshige; Nakamura, Hideo; Iriko, Masanori; Yonomoto, Taisuke; Shiba, Masayoshi

    1982-09-01

    ROSA-III Run 912 was identified as International Standard Problem 12 by the Committee on the Safety of Nuclear Installations. Run 912 simulated a 5% split break LOCA condition in a BWR at the pump suction in the recirculation line with the HPCS failure. Comparisons between the test data and the calculations by eight international participants were made and discussed. (author)

  20. Comparison of SAS3A and MELT-III predictions for a transient overpower hypothetical accident

    International Nuclear Information System (INIS)

    Wilburn, N.P.

    1976-01-01

    A comparison is made of the predictions of the two major codes SAS3A and MELT-III for the hypothetical unprotected transient overpower accident in the FFTF. The predictions of temperatures, fuel restructuring, fuel melting, reactivity feedbacks, and core power are compared

  1. Enantiomeric separation of iridium (III) complexes using HPLC chiral stationary phases based on amylose derivatives

    International Nuclear Information System (INIS)

    Kim, Hee Eun; Seo, Na Hyeon; Hyun, Myung Ho

    2016-01-01

    Cyclometalated iridium (III) complexes formed with three identical cyclometalating (C-N) ligands (homoleptic) or formed with two cyclometalating (C-N) ligands and one ancillary (LX) ligand (heteroleptic) have been known as highly phosphorescent materials and, thus, they have been utilized as efficient phosphorescent dopants in organic light emitting diodes (OLEDs) 1–3 or as effective phosphorescent chemosensors. 4–7 Cylometalated iridium (III) complexes are chiral compounds consisting of lambda (Λ, left-handed) and delta (Δ, right-handed) isomers. Racemic cyclometa- lated iridium (III) complexes emit light with no net polarization, but optically active cyclometalated iridium (III) complexes emit circularly polarized light. 8,9 Circularly polarized light can be used in various fields including highly efficient three dimensional electronic devices, photo nic devices for optical data storage, biological assays, and others. 8,9 In order to obtain optically active cylometalated iridium (III) complexes and to determine the enantiomeric composition of optically active cylometalated iridium (III) complexes, liquid chromatogr aphic enantiomer separation method on chiral stationary phases (CSPs) has been used. For example, Okamoto and coworkers first reported the high performance liquid chromatographic (HPLC) direct enantiomeric separation of two homoleptic cylometalated iridium (III) complexes on immobilized amylose tris(3,5- dimethylphenylcarbamate) (Chiralpak IA), coated cellulose tris(3,5-dimethylphenylcarbamate) (Chiralc el OD), and coated cellulose tris(4-methylbenzoate) (Chiralce l OJ). 10 Supercritical fluid chromatography (SFC) was also used by Bernhard and coworkers for the enantiomeric separation of cylometalated iridium (III) complexes on coated amylose tris(3,5-dimethylphenylcarbamate) (Chiralpak AD-H). 8 However, the general use of the HPLC method for the direct enantiomeric separation of homoleptic

  2. Enantiomeric separation of iridium (III) complexes using HPLC chiral stationary phases based on amylose derivatives

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hee Eun; Seo, Na Hyeon; Hyun, Myung Ho [Dept. of Chemistry and Chemistry Institute for Functional Materials, Pusan National University, Busan (Korea, Republic of)

    2016-12-15

    Cyclometalated iridium (III) complexes formed with three identical cyclometalating (C-N) ligands (homoleptic) or formed with two cyclometalating (C-N) ligands and one ancillary (LX) ligand (heteroleptic) have been known as highly phosphorescent materials and, thus, they have been utilized as efficient phosphorescent dopants in organic light emitting diodes (OLEDs) 1–3 or as effective phosphorescent chemosensors. 4–7 Cylometalated iridium (III) complexes are chiral compounds consisting of lambda (Λ, left-handed) and delta (Δ, right-handed) isomers. Racemic cyclometa- lated iridium (III) complexes emit light with no net polarization, but optically active cyclometalated iridium (III) complexes emit circularly polarized light. 8,9 Circularly polarized light can be used in various fields including highly efficient three dimensional electronic devices, photo nic devices for optical data storage, biological assays, and others. 8,9 In order to obtain optically active cylometalated iridium (III) complexes and to determine the enantiomeric composition of optically active cylometalated iridium (III) complexes, liquid chromatogr aphic enantiomer separation method on chiral stationary phases (CSPs) has been used. For example, Okamoto and coworkers first reported the high performance liquid chromatographic (HPLC) direct enantiomeric separation of two homoleptic cylometalated iridium (III) complexes on immobilized amylose tris(3,5- dimethylphenylcarbamate) (Chiralpak IA), coated cellulose tris(3,5-dimethylphenylcarbamate) (Chiralc el OD), and coated cellulose tris(4-methylbenzoate) (Chiralce l OJ). 10 Supercritical fluid chromatography (SFC) was also used by Bernhard and coworkers for the enantiomeric separation of cylometalated iridium (III) complexes on coated amylose tris(3,5-dimethylphenylcarbamate) (Chiralpak AD-H). 8 However, the general use of the HPLC method for the direct enantiomeric separation of homoleptic.

  3. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma

    NARCIS (Netherlands)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A.; Punt, Cornelis J. A.; Haanen, John B.; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L.; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A.; Dreno, Brigitte; Nathan, Paul D.; Mackiewicz, Jacek; Kirkwood, John M.; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-01-01

    In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with

  4. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

    NARCIS (Netherlands)

    Ribas, A.; Kefford, R.; Marshall, Martin; Punt, C.J.A.; Haanen, J.B.; Marmol, M.; Garbe, C.; Gogas, H.; Schachter, J.; Linette, G.; Lorigan, P.; Kendra, K.L.; Maio, M.; Trefzer, U.; Smylie, M.; McArthur, G.A.; Dreno, B.; Nathan, P.D.; Mackiewicz, J.; Kirkwood, J.M.; Gomez-Navarro, J.; Huang, B.; Pavlov, D.; Hauschild, A.

    2013-01-01

    PURPOSE: In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients

  5. Gas-phase infrared spectrum of phosphorus (III) oxycyanide, OPCN: experimental and theoretical investigations

    Science.gov (United States)

    Allaf, Abdul. W.; Kassem, M.; Alibrahim, M.; Boustani, Ihsan

    1999-03-01

    An attempt was made to observe the gas-phase infrared spectrum of Phosphorus (III) oxycyanide, OPCN for the first time. This molecule was produced by an on-line process using phosphorus (III) oxychloride, OPCl as precursor passed over heated AgCN. The products were characterised by the infrared spectra of their vapours. The low resolution gas-phase Fourier transform infrared spectrum shows two bands centered at 2165 and 1385 cm -1. These bands are assigned to, ν1 (CN stretch) and ν2 (OP stretch), respectively. Ab initio self-consistent-field (SCF) molecular orbital (MO) and Møller-Plesset second order perturbation theory (MP2) calculations were performed to determine the geometry, total energy and vibrational frequencies of OPCN.

  6. Gas-phase infrared spectrum of phosphorus (III) oxycyanide, OPCN: Experimental and theoretical and theoretical investigations

    International Nuclear Information System (INIS)

    Allaf, A.W.; Kassem, M.; Alibrahim, M.

    1999-01-01

    An attempt was made to observe the gas-phase infrared spectrum of phosphorus (III) oxycyanide, OPCN for the first time. This molecule was produced by on-line process using phosphorus (III) oxychloride, OPCI as precursor passed over heated Ag CN. The products were characterised by the infrared spectra of their vapours. The low resolution gas-phase Fourier transform infrared spectrum shows two bands at 2165 and 1385 cm -1 . These bands are assigned to ν 1 (C≡N stretch) and ν 2 (O=P stretch), respectively. Ab initio self-consistent-field (SCF) molecular orbital (MO) and Moeller - Plesset second order perturbation theory (MP2) calculations were performed to determine the geometry, total energy and vibrational frequencies of OPCN. (authors)

  7. Exploring the Photoreduction of Au(III) Complexes in the Gas-Phase

    Science.gov (United States)

    Marcum, Jesse C.; Kaufman, Sydney H.; Weber, J. Mathias

    2010-06-01

    We have used photodissociation spectroscopy to probe the electronic structure and photoreduction of Au(III) in gas-phase complexes containing Cl- and OH-. The gas-phase electronic spectrum of [AuCl_4]- closely resembles the aqueous solution spectrum, showing a lack of strong solvatochromic shifts. Substitution of Cl- ligands with OH- results in a strong blue shift, in agreement with ligand-field theory. Upon excitation, [AuCl_4]- can dissociate by loss of either one or two neutral Cl atoms, resulting in the reduction of gold from Au(III) to Au(II) and Au(I) respectively. The hydroxide substituted complex, [AuCl_2(OH)_2]-, demonstrates similar behavior but the only observable fragment channel is the loss of two neutral OH ligands, leading only to Au(I).

  8. Safety systems and safety analysis of the Qinshan phase III CANDU nuclear power plant

    International Nuclear Information System (INIS)

    Cai Jianping; Shen Sen; Barkman, N.

    1999-01-01

    The author introduces the Canadian nuclear reactor safety philosophy and the Qinshan Phase III CANDU NPP safety systems and safety analysis, which are designed and performed according to this philosophy. The concept of 'defence-in-depth' is a key element of the Canadian nuclear reactor safety philosophy. The design concepts of redundancy, diversity, separation, equipment qualification, quality assurance, and use of appropriate design codes and standards are adopted in the design. Four special safety systems as well as a set of reliable safety support systems are incorporated in the design of Qinshan phase III CANDU for accident mitigation. The assessment results for safety systems performance show that the fundamental safety criteria for public dose, and integrity of fuel, channels and the reactor building, are satisfied

  9. Japanese contributions to IAEA INTOR workshop, phase two A, part 2, chapter III: impurity control (engineering)

    International Nuclear Information System (INIS)

    Seki, Masahiro; Miki, Nobuharu; Shibutani, Yoji; Fujimura, Kaoru; Adachi, Jun-ichi; Sato, Kosuke; Fujii, Masaharu; Yamazaki, Seiichiro; Itoh, Shin-ichi.

    1985-07-01

    This report corresponds to the second half of Chapter III of Japanese contribution report to IAEA INTOR Workshop, Phase Two A, Part 2. Data base assessment are made on candidate materials for the divertor, limiter, and the first wall. Engineering trade-off studies are made for the high-recycling and low temperature conditions. The studies include material considerations, configuration, thermohydraulic and stress analysis, disruption, lifetime analysis, and tritium permeation. (author)

  10. The application and design of distributed control system in reactor shutdown system of Qinshan phase III

    International Nuclear Information System (INIS)

    Su Guoquan; Liu Wangtian; Yu Yijun; Xiong Weihua

    2006-03-01

    The design, commissioning and running of the reactor trip parameter monitoring system used in Qinshan Phase III are introduced. The applying technology of Distributed Control System realized trip parameter monitoring and realized the function of trip parameters quick data acquisitioning, transferring, saving, alarm, query. The applying of trip parameters monitoring system improved the abilities of plant status monitoring and event analyzing, and increased the security and economy of nuclear power plant. (authors)

  11. 200-ZP-1 phase II and III IRM groundwater pump and treat site safety plan

    International Nuclear Information System (INIS)

    St. John, C.H.

    1996-07-01

    This safety plan covers operations, maintenance, and support activities related to the 200-ZP-1 Phase II and III Ground Water Pump- and-Treat Facility. The purpose of the facility is to extract carbon tetrachloride contaminated groundwater underlying the ZP-1 Operable Unit; separate the contaminant from the groundwater; and reintroduce the treated water to the aquifer. An air stripping methodology is employed to convert volatile organics to a vapor phase for absorption onto granular activated carbon. The automated process incorporates a variety of process and safety features that shut down the process system in the event that process or safety parameters are exceeded or compromised

  12. Ultracompact electro-optic phase modulator based on III-V-on-silicon microdisk resonator.

    Science.gov (United States)

    Lloret, J; Kumar, R; Sales, S; Ramos, F; Morthier, G; Mechet, P; Spuesens, T; Van Thourhout, D; Olivier, N; Fédéli, J-M; Capmany, J

    2012-06-15

    A novel ultracompact electro-optic phase modulator based on a single 9 μm-diameter III-V microdisk resonator heterogeneously integrated on and coupled to a nanophotonic waveguide is presented. Modulation is enabled by effective index modification through carrier injection. Proof-of-concept implementation involving binary phase shift keying modulation format is assembled. A power imbalance of ∼0.6  dB between both symbols and a modulation rate up to 1.8 Gbps are demonstrated without using any special driving technique.

  13. Radiation therapy for ocular choroidal neovascularization (phase I/II study): preliminary report

    International Nuclear Information System (INIS)

    Sasai, Keisuke; Murata, Rumi; Mandai, Michiko; Takahashi, Masayo; Ogura, Yuichiro; Ngata, Yasushi; Nishimura, Yasumasa; Hiraoka, Masahiro

    1997-01-01

    Purpose/Objective: Choroidal neovascularization (CNV) is a major cause of severe loss of visual acuity in some ocular diseases such as age-related macular degeneration (ARMD) and angioid streaks. Laser photocoagulation has been used to treat patients with subfoveal neovascular lesions with well-demarcated boundaries. However, the treatment method is usually associated with a large decrease in visual acuity. Therefore, indications for this treatment are very limited. Recently, some investigators reported the effect of low dose irradiation on the sub retinal neovascular membranes in CNV. We conducted a Phase I/II study to determine the toxicity and efficacy of external photon beam radiotherapy in patients with CNV. Methods and Materials: Between April, 1994 and July, 1995, 36 patients with choroidal neovascularization (34 with ARMD and 2 with angioid streaks) were treated with radiation therapy. Treatment planning was performed using a CT simulator that enables real-time treatment planning from multiple CT slices. The clinical target volume that included the macula and optic disc received a dose of 10 Gy/5 fractions/1 week (first 18 eyes) or 20 Gy/10 fractions/2 weeks (last 18 eyes). All eyes were irradiated with a single lateral 6 MV photon beam, angled 10 degrees posteriorly to exclude the ipsilateral lens and the contralateral eye from the radiation field. The ipsilateral lens was irradiated with less than 10% of the total reference dose. The field size averaged 3.0 x 2.5 cm. Records of the 17 eyes with CNV referred to our hospital in 1993, which satisfied the eligibility criteria for this study, were retrospectively analyzed for comparison. Results: There was no significant acute morbidity. All patients were followed regularly by both ophthalmologists and radiation oncologists. Cataract formation after 1 year of the treatment was observed in one patient who had received a dose of 20 Gy. One patient who had received 20 Gy complained of transient dry-eye sensation

  14. The majority of patients with metastatic melanoma are not represented in pivotal phase III immunotherapy trials

    DEFF Research Database (Denmark)

    Donia, Marco; Kimper-Karl, Marie Louise; Høyer, Katrine Lundby

    2017-01-01

    BACKGROUND: Recent randomised phase III trials have led to the approval of several immune checkpoint inhibitors for unresectable or metastatic melanoma (MM). These trials all employed strict patient selection criteria, and it is currently unknown how large proportion of 'real-world' patients diag...... a huge knowledge gap regarding the usefulness of new immunotherapies in the 'real-world' patient population, and urge additional testing of known regimens in selected poor prognosis cohorts.......BACKGROUND: Recent randomised phase III trials have led to the approval of several immune checkpoint inhibitors for unresectable or metastatic melanoma (MM). These trials all employed strict patient selection criteria, and it is currently unknown how large proportion of 'real-world' patients...... in 2014, were included in the analysis. Seven pre-defined eligibility criteria, all used to select patients for enrolment in five recent randomised phase III immunotherapy trials, were analysed. RESULTS: Fifty-five percent of the total population with MM did not meet one or more eligibility criteria ('not...

  15. Conceptual design report for environmental, safety and health phase III FY-91 line item

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1988-09-01

    The Mound Facility (Mound), located in Miamisburg, Ohio, is a Department of Energy (DOE) development and production facility performing support work for DOE`s weapons and energy-related programs. EG&G Mound Applied Technologies (EG&G) is the Operating Contractor (OC) for this Government-Owned, Contractor-Operated (GOCO) facility. The work performed at Mound emphasizes nuclear energy and explosives technology. Mound is currently implementing an Environmental, Safety, and Health (ES&H) Program designed to protect its employees, the public, and the environment from adverse effects caused by the facility`s activities. Design has been completed, and construction is in progress for Phase I of this multiphase program. Phase II has been submitted for fiscal year (FY) 89 funding and Phase IV is being submitted as an FY 92 line item. This Conceptual Design Report (CDR) addresses Phase III of the ES&H program.

  16. Pre-Preliminary results from the phase III of the IAEA CRP: optimizing of reactor pressure vessel surveillance programmes and their analysis

    Energy Technology Data Exchange (ETDEWEB)

    Brumovsky, M; Gillemot, F; Kryukov, A; Levit, V

    1994-12-31

    This paper gives preliminary results and some conclusions from Phase III of the IAEA Coordinated Research Programme on ``Optimizing the Reactor Pressure Vessel Surveillance Programmes and their Analyses`` carried out during the last seven years in 15 member states. First analysis concerned: comparison of results from initial, un-irradiated materials condition, comparison of transition temperature shifts (from notch toughness testing) with respect to content of residual (P, Cu) and alloying (Ni) elements, type of material (base and weld metal), irradiation temperature (288 and 265 C), and type of fluence dependence. Special effort has been taken to the analysis of the behaviour of a chosen reference steel. (JRQ). 6 figs., 4 tabs.

  17. Comparison of catalytic ethylene polymerization in slurry and gas phase

    NARCIS (Netherlands)

    Daftaribesheli, Majid

    2009-01-01

    Polyethylene (PE) with the annual consumption of 70 million tones in 2007 is mostly produced in slurry, gas-phase or combination of both processes. This work focuses on a comparison between the slurry and gas phase processes. Why does PE produced in theses two processes can show extremely different

  18. Comparisons of ROSA-III and FIST BWR loss of coolant accident simulation tests

    International Nuclear Information System (INIS)

    Tasaka, Kanji; Suzuki, Mitsuhiro; Koizumi, Yasuo

    1985-10-01

    A common understanding and interpretation of BWR system response and the controlling phenomena in LOCA transients has been achieved through the evaluation and comparison of counterpart tests performed in the ROSA-III and FIST test facilities. These facilities, which are designed to simulate the thermal-hydraulic response of BWR systems, are operated respectively by the Japan Atomic Energy Research Institute (JAERI) and the General Electric Company. Comparison is made between three types of counterpart tests, each performed under similar tests conditions in the two facilities. They are large break, small break, and steamline break LOCA's. The system responses to these tests in each facility are quite similar. The sequence of events are similar, and the timing of these events are similar. Differences that do occur are due to minor differences in modeling objectives, facility scaling, and test conditions. Parallel channel flow interactions effects in the ROSA-III four channel (half length) core, although noticeable in the large break test, do not result in major differences with the single channel response in FIST. In the small break tests the timing of events is offset by the earlier ADS actuation in FIST. The steamline test responses are similar except there is no heatup in FIST, resulting from a different ECCS trip modeling. Overall comparisons between ROSA-III and FIST system responses in LOCA tests is very good. (author)

  19. Investigation of global particulate nitrate from the AeroCom phase III experiment

    Directory of Open Access Journals (Sweden)

    H. Bian

    2017-11-01

    Full Text Available An assessment of global particulate nitrate and ammonium aerosol based on simulations from nine models participating in the Aerosol Comparisons between Observations and Models (AeroCom phase III study is presented. A budget analysis was conducted to understand the typical magnitude, distribution, and diversity of the aerosols and their precursors among the models. To gain confidence regarding model performance, the model results were evaluated with various observations globally, including ground station measurements over North America, Europe, and east Asia for tracer concentrations and dry and wet depositions, as well as with aircraft measurements in the Northern Hemisphere mid-to-high latitudes for tracer vertical distributions. Given the unique chemical and physical features of the nitrate occurrence, we further investigated the similarity and differentiation among the models by examining (1 the pH-dependent NH3 wet deposition; (2 the nitrate formation via heterogeneous chemistry on the surface of dust and sea salt particles or thermodynamic equilibrium calculation including dust and sea salt ions; and (3 the nitrate coarse-mode fraction (i.e., coarse/total. It is found that HNO3, which is simulated explicitly based on full O3-HOx-NOx-aerosol chemistry by all models, differs by up to a factor of 9 among the models in its global tropospheric burden. This partially contributes to a large difference in NO3−, whose atmospheric burden differs by up to a factor of 13. The atmospheric burdens of NH3 and NH4+ differ by 17 and 4, respectively. Analyses at the process level show that the large diversity in atmospheric burdens of NO3−, NH3, and NH4+ is also related to deposition processes. Wet deposition seems to be the dominant process in determining the diversity in NH3 and NH4+ lifetimes. It is critical to correctly account for contributions of heterogeneous chemical production of nitrate on dust and sea salt, because this process

  20. Phase II and III the next generation of CLS beamline control and data acquisition systems

    International Nuclear Information System (INIS)

    Matias, E.; Beauregard, D.; Berg, R.; Black, G.; Boots, M.J.; Dolton, W.; Hunter, D.; Igarashi, R.; Liu, D.; Maxwell, D.; Miller, C.D.; Wilson, T.; Wright, G.

    2012-01-01

    The Canadian Light Source (CLS) is nearing the completion of its suite of Phase II Beamlines and in detailed design of its Phase III Beamlines. The paper presents an overview of the overall approach adopted by CLS in the development of beamline control and data acquisition systems. Building on the experience of our first phase of beamlines the CLS has continued to make extensive use of EPICS with EDM and QT based user interfaces. Increasing interpretive languages such as Python are finding a place in the beamline control systems. Web based environment such as ScienceStudio have also found a prominent place in the control system architecture as we move to tighter integration between data acquisition, visualization and data analysis. (authors)

  1. Contributions to reversed-phase column selectivity: III. Column hydrogen-bond basicity.

    Science.gov (United States)

    Carr, P W; Dolan, J W; Dorsey, J G; Snyder, L R; Kirkland, J J

    2015-05-22

    Column selectivity in reversed-phase chromatography (RPC) can be described in terms of the hydrophobic-subtraction model, which recognizes five solute-column interactions that together determine solute retention and column selectivity: hydrophobic, steric, hydrogen bonding of an acceptor solute (i.e., a hydrogen-bond base) by a stationary-phase donor group (i.e., a silanol), hydrogen bonding of a donor solute (e.g., a carboxylic acid) by a stationary-phase acceptor group, and ionic. Of these five interactions, hydrogen bonding between donor solutes (acids) and stationary-phase acceptor groups is the least well understood; the present study aims at resolving this uncertainty, so far as possible. Previous work suggests that there are three distinct stationary-phase sites for hydrogen-bond interaction with carboxylic acids, which we will refer to as column basicity I, II, and III. All RPC columns exhibit a selective retention of carboxylic acids (column basicity I) in varying degree. This now appears to involve an interaction of the solute with a pair of vicinal silanols in the stationary phase. For some type-A columns, an additional basic site (column basicity II) is similar to that for column basicity I in primarily affecting the retention of carboxylic acids. The latter site appears to be associated with metal contamination of the silica. Finally, for embedded-polar-group (EPG) columns, the polar group can serve as a proton acceptor (column basicity III) for acids, phenols, and other donor solutes. Copyright © 2015 Elsevier B.V. All rights reserved.

  2. Imprinted magnetic graphene oxide for the mini-solid phase extraction of Eu (III) from coal mine area

    Science.gov (United States)

    Patra, Santanu; Roy, Ekta; Madhuri, Rashmi; Sharma, Prashant K.

    2017-05-01

    The present work represents the preparation of imprinted magnetic reduced graphene oxide and applied it for the selective removal of Eu (III) from local coal mines area. A simple solid phase extraction method was used for this purpose. The material shows a very high adsorption as well as removal efficiency towards Eu (III), which suggest that the material have potential to be used in future for their real time applications in removal of Eu (III) from complex matrices.

  3. A new ion imprinted polymer based on Ru(III)-thiobarbituric acid complex for solid phase extraction of ruthenium(III) prior to its determination by ETAAS

    International Nuclear Information System (INIS)

    Zambrzycka, Elżbieta; Godlewska-Żyłkiewicz, Beata

    2014-01-01

    A new ruthenium ion imprinted polymer was prepared from the Ru(III) 2-thiobarbituric acid complex (the template), methacrylic acid or acrylamide (the functional monomers), and ethylene glycol dimethacrylate (the cross-linking agent) using 2,2′-azobisisobutyronitrile as the radical initiator. The ion imprinted polymer was characterized and used as a selective sorbent for the solid phase extraction of Ru(III) ions. The effects of type of functional monomer, sample volume, solution pH and flow rate on the extraction efficiency were studied in the dynamic mode. Ru(III) ion was quantitatively retained on the sorbents in the pH range from 3.5 to 10, and can be eluted with 4 mol L−1 aqueous ammonia. The affinity of Ru(III) for the ion imprinted polymer based on the acrylamide monomer is weaker than that for the polymer based on the methacrylic acid monomer, which therefore was used in interference studies and in analytical applications. Following extraction of Ru(III) ions with the imprint and their subsequent elution from the polymer with aqueous ammonia, Ru(III) was detected by electrothermal atomic absorption spectrometry with a detection limit of 0.21 ng mL −1 . The method was successfully applied to the determination of trace amounts of Ru(III) in water, waste, road dust and platinum ore (CRM SARM 76) with a reproducibility (expressed as RSD) below 6.4 %. (author)

  4. Development of a central data warehouse for statewide ITS and transportation data in Florida phase III : final report.

    Science.gov (United States)

    2009-12-15

    This report documents Phase III of the development and operation of a prototype for the Statewide Transportation : Engineering Warehouse for Archived Regional Data (STEWARD). It reflects the progress on the development and : operation of STEWARD sinc...

  5. On the determination of Zr(IV), Ce((III), Th(IV) and U(VI) in organic phase using arsenazo-I and arsenazo-III

    International Nuclear Information System (INIS)

    El-Sweify, F.H.; Kamel, M.M.; Shabana, R.

    1997-01-01

    Some organic extractants of different types, namely tridodecylamine (TDA), tricapryl methyl ammonium chloride (TCMA), di(2-ethylhexyl) phosphoric acid (HDEHP) and 1-[thenoyl-(2)]-3,3,3-trifluoroacetone (HTTA) in xylene have been used to study the extraction behaviour of coloured complexes of Zr(IV), Ce(III), Th(IV) and U(VI) from slightly acidic aqueous solutions of arsenazo-III. Spectrophotometric study for the determination of the aforementioned elements, as well as the colouring agents arsenazo-I and arsenazo-III in the organic phase has been carried out. Some factors affecting the spectrophotometric determination of these elements were studied. These factors were hydrogen ion concentration, concentration of the colouring agents in the aqueous phase and diluent type. Absorption spectra and standard curves are given. The molar extinction coefficients have been calculated. 10 figs

  6. Superior outcome of women with stage I/II cutaneous melanoma: Pooled analysis of four European organisation for research and treatment of cancer phase III trials

    NARCIS (Netherlands)

    A. Joosse (Arjen); S. Collette (Sandra); S. Suciu (Stefan); T.E.C. Nijsten (Tamar); F.J. Lejeune (Ferdy); U.R. Kleeberg (Ulrich); J.W.W. Coebergh (Jan Willem); A.M.M. Eggermont (Alexander); E.G.E. de Vries (Elisabeth)

    2012-01-01

    textabstractPurpose: Several studies observed a female advantage in the prognosis of cutaneous melanoma, for which behavioral factors or an underlying biologic mechanism might be responsible. Using complete and reliable follow-up data from four phase III trials of the European Organisation for

  7. Clinical effects of Angelica dahurica dressing on patients with I-II phase pressure sores.

    Science.gov (United States)

    Gong, Fen; Niu, Junzhi; Pei, Xing

    2016-11-02

    Angelica dahurica is a well-known traditional Chinese Medicine (TCM), while little information is available about its effects on pressure sores. We aimed to investigate the clinical effect of Angelica dahurica on patients with I-II phase pressure sores, as well as the underlying mechanism. Patients (n = 98) with phase I and phase II pressure sores were enrolled and randomly assigned to control and treated groups. In addition to holistic nursing, patients in the control group received compound clotrimazole cream, while patients in the treated group received continuous 4 weeks of external application of Angelica dahurica dressing. Therapeutic effect was recorded, along with the levels of interleukin-8 (IL-8), epidermal growth factor (EGF), transforming growth factor (TGF)-β, and vascular endothelial growth factor (VEGF). Besides, HaCaT cells were cultured with different concentrations of Angelica dahurica, and then cell viability, clone formation numbers, cell cycle, and levels of cyclin D1 and cyclin-dependent kinase (CDK) 2 were determined. The total effective rate in the treated group was significantly higher than in the control group. Levels of IL-8, EGF, TGF-β, and VEGF were statistically increased by Angelica dahurica. In addition, the cell viability and clone formation numbers were significantly upregulated by Angelica dahurica in a dose-dependent manner. Also, the percentage of cells in G0/G1 phase, and levels of cyclin D1 and CDK2 were significantly elevated. Our results suggest that Angelica dahurica may provide an effective clinical treatment for I-II phase pressure sores.

  8. Single-crystal neutron diffraction study of ammonium nitrate phase III

    International Nuclear Information System (INIS)

    Choi, C.S.; Prask, H.J.

    1982-01-01

    The crystal structure of ammonium nitrate phase III has been studied at room temperature by neutron diffraction using a single crystal containing 5% KNO 3 in solid-solution form. The space group is Pnma, with a = 7.6772 (4), b = 5.8208 (4), c = 7.1396 (5) A, Z = 4. The final residual after full-matrix least-squares refinement was R = 0.042 for 348 observed reflections. The ammonium ions are thermally disordered into two orientations, displaced by an angle of approximately 42 0 about an axis parallel to the c axis. (Auth.)

  9. SAFOD Phase III Core Sampling and Data Management at the Gulf Coast Repository

    Directory of Open Access Journals (Sweden)

    David Lockner

    2011-03-01

    Full Text Available The San Andreas Fault Observatory at Depth (SAFODproject is yielding new insight into the San Andreas Fault (Zoback et al., 2010; Zoback et al., this issue. SAFOD drilling started in 2002 with a pilot hole, and proceeded with three phrases of drilling and coring during the summers of 2004, 2005, and 2007 (Fig. 1. One key component of theproject is curation, sampling, and documentation of SAFOD core usage at the Integrated Ocean Drilling Program’s (IODP Gulf Coast Repository (GCR at Texas A&M University. We present here the milestones accomplished over the past two years of sampling Phase III core at the GCR.

  10. Investor Outlook: Focus on Upcoming LCA2 Gene Therapy Phase III Results.

    Science.gov (United States)

    Schimmer, Joshua; Breazzano, Steven

    2015-09-01

    Investor interest in gene therapy has increased substantially over the past few years, and the next major catalyst for the field is likely to be Spark Therapeutics's phase III trial for the treatment of visual impairment caused by RPE65 gene mutations (often referred to as Leber congenital amaurosis type 2, or LCA2, but may include other retinal disorders). Analysis of the approach from the basic genetics, underlying visual mechanisms, clinical data, and commercialization considerations helps frame investor expectations and the potential implications for the broader field.

  11. Stability considerations of permanent magnet quadrupoles for CESR phase-III upgrade

    Directory of Open Access Journals (Sweden)

    W. Lou

    1998-06-01

    Full Text Available The Cornell electron storage ring (CESR phase-III upgrade plan includes very strong permanent magnet quadrupoles in front of the cryostat for the superconducting quadrupoles and physically as close as possible to the interaction point. Together with the superconducting quadrupoles, they provide tighter vertical focusing at the interaction point. The quadrupoles are built with neodymium iron boron (NdFeB material and operate inside the 15 kG solenoid field. Requirements on the field quality and stability of these quadrupoles are discussed and test results are presented.

  12. Enginnering development of coal-fired high performance power systems phase II and III

    International Nuclear Information System (INIS)

    1998-01-01

    This report presents work carried out under contract DE-AC22-95PC95144 ''Engineering Development of Coal-Fired High Performance Systems Phase II and III.'' The goals of the program are to develop a coal-fired high performance power generation system (HIPPS) that is capable of: thermal efficiency (HHV) >47%; NOx, SOx, and particulates 65% of heat input; all solid wastes benign; cost of electricity <90% of present plants. Phase I, which began in 1992, focused on the analysis of various configurations of indirectly fired cycles and on technical assessments of alternative plant subsystems and components, including performance requirements, developmental status, design options, complexity and reliability, and capital and operating costs. Phase I also included preliminary R ampersand D and the preparation of designs for HIPPS commercial plants approximately 300 MWe in size. This phase, Phase II, involves the development and testing of plant subsystems, refinement and updating of the HIPPS commercial plant design, and the site selection and engineering design of a HIPPS prototype plant. Work reported herein is from: Task 2.2 HITAF Air Heaters; Task 6 HIPPS Commercial Plant Design Update

  13. Phase III Advanced Anodes and Cathodes Utilized in Energy Efficient Aluminum Production Cells; FINAL

    International Nuclear Information System (INIS)

    Christini, R.A.; Dawless, R.K.; Ray, S.P.; Weirauch, D.A. Jr.

    2001-01-01

    During Phase I of the present program, Alcoa developed a commercial cell concept that has been estimated to save 30% of the energy required for aluminum smelting. Phase ii involved the construction of a pilot facility and operation of two pilots. Phase iii of the Advanced Anodes and Cathodes Program was aimed at bench experiments to permit the resolution of certain questions to be followed by three pilot cells. All of the milestones related to materials, in particular metal purity, were attained with distinct improvements over work in previous phases of the program. NiO additions to the ceramic phase and Ag additions to the Cu metal phase of the cermet improved corrosion resistance sufficiently that the bench scale pencil anodes met the purity milestones. Some excellent metal purity results have been obtained with anodes of the following composition: Further improvements in anode material composition appear to be dependent on a better understanding of oxide solubilities in molten cryolite. For that reason, work was commissioned with an outside consultant to model the MeO - cryolite systems. That work has led to a better understanding of which oxides can be used to substitute into the NiO-Fe2O3 ceramic phase to stabilize the ferrites and reduce their solubility in molten cryolite. An extensive number of vertical plate bench electrolysis cells were run to try to find conditions where high current efficiencies could be attained. TiB2-G plates were very inconsistent and led to poor wetting and drainage. Pure TiB2 did produce good current efficiencies at small overlaps (shadowing) between the anodes and cathodes. This bench work with vertical plate anodes and cathodes reinforced the importance of good cathode wetting to attain high current efficiencies. Because of those conclusions, new wetting work was commissioned and became a major component of the research during the third year of Phase III. While significant progress was made in several areas, much work needs to be

  14. A prospective phase II trial of EGCG in treatment of acute radiation-induced esophagitis for stage III lung cancer

    International Nuclear Information System (INIS)

    Zhao, Hanxi; Xie, Peng; Li, Xiaolin; Zhu, Wanqi; Sun, Xindong; Sun, Xiaorong; Chen, Xiaoting; Xing, Ligang; Yu, Jinming

    2015-01-01

    Background: Acute radiation-induced esophagitis (ARIE) is one of main toxicities complicated by thoracic radiotherapy, influencing patients’ quality of life and radiotherapy proceeding seriously. It is difficult to be cured rapidly so far. Our phase I trial preliminarily showed that EGCG may be a promising strategy in the treatment of ARIE. Materials and methods: We prospectively enrolled patients with stage III lung cancer from the Shandong Tumor Hospital & Institute in China from January 2013 to September 2014. All patients received concurrent or sequential chemo-radiotherapy, or radiotherapy only. EGCG was administrated once ARIE appeared. EGCG was given with the concentration of 440 μmol/L during radiotherapy and additionally two weeks after radiotherapy. RTOG score, dysphagia and pain related to esophagitis were recorded every week. Results: Thirty-seven patients with stage IIIA and IIIB lung cancer were enrolled in this trial. In comparison to the original, the RTOG score in the 1st, 2nd, 3rd, 4th, 5th week after EGCG prescription and the 1st, 2nd week after radiotherapy decreased significantly (P = 0.002, 0.000, 0.000, 0.001, 0.102, 0.000, 0.000, respectively). The pain score of each week was significantly lower than the baseline (P = 0.000, 0.000, 0.000, 0.000, 0.006, 0.000, 0.000, respectively). Conclusion: This trial confirmed that the oral administration of EGCG is an effective and safe method to deal with ARIE. A phase III randomized controlled trial is expected to further corroborate the consequence of EGCG in ARIE treatment

  15. Evaluation of candidate magnetohydrodynamic materials for the U-02 Phase III test

    International Nuclear Information System (INIS)

    Marchant, D.D.; Bates, J.L.

    1978-06-01

    As part of a cooperative U.S.--U.S.S.R. program, electrode and insulator materials tested at the Westinghouse Electrode Systems Test Facility in Pittsburgh, Pennsylvania, were evaluated. From this evaluation materials will be selected for use in the third phase of tests being conducted in the U-02 magnetohydrodynamics test facility in the Soviet Union. Electrode and insulator materials were examined with both an optical microscope and a scanning electron microscope. The cathodes were found to behave differently from the anodes; most notably, the cathodes showed greater potassium interaction. The lanthanum chromite-based electrodes (excluding those fabricated by plasma-spraying) are recommended for testing in the U-02 Phase III test. Hotpressed, fused-grained MgO and sintered MgAl 2 O 4 are recommended as insulator materials. The electrode attachment techniques used in the Westinghouse Tests were inadequate and need to be modified for the U-02 test

  16. The third phase of the OECD/NEA TDB project: TDB III

    International Nuclear Information System (INIS)

    Mompean, F.J.; Illemassene, M.; Perrone, J.

    2005-01-01

    In 2003 with a foreseen duration of four years. The main objective of this new phase is to extend the existing critically reviewed database for elements of relevance in radioactive waste management, paying attention to the needs of the various national programmes. Following the decision by the Project Management Board (integrated by representatives of 16 organisations with responsibilities in radioactive waste management in 12 OECD member countries) the elements contemplated in this new phase are Th, Sn and Fe, with a higher priority being allocated to inorganic species and compounds. In addition to the corresponding review teams for these elements, an additional expert team has been constituted to prepare guidelines for the evaluation of thermodynamic data for solid solutions. As was the case in TDB Phase II, the basic project review methodology remains unaltered in TDB III. The Figure illustrates the relationship between the various TDB bodies, with an International Organisation, the OECD NEA, acting as Project Coordinator and linking the independent scientific teams and the project governing bodies. This organizational paradigm has proven successful with the recent completion of the five Phase II Reviews (Update, Ni, Se, Zr and Organic Ligands). The review and expert team activities were started in 2004 (except for Fe, being started in 2005) following an initiation stage. This preliminary stage was designed in order to tailor the team compositions to the existing literature for each element. The first reviews stemming from TDB III are scheduled to appear in published form in 2007. The successful completion of these objectives will add three further reports to the current series of nine volumes (dealing with the chemical thermodynamics of U, Np, Pu, Am, Tc, Ni, Se, Zr and compounds and complexes of these elements with oxalate, citrate, EDTA and isa). (authors)

  17. Comparison of catalytic ethylene polymerization in slurry and gas phase

    OpenAIRE

    Daftaribesheli, Majid

    2009-01-01

    Polyethylene (PE) with the annual consumption of 70 million tones in 2007 is mostly produced in slurry, gas-phase or combination of both processes. This work focuses on a comparison between the slurry and gas phase processes. Why does PE produced in theses two processes can show extremely different properties and extremely different reaction behaviour even if the same Ziegler-Natta (ZN) catalyst is used? Generally, it is known that the reason can be found in the differences of local condition...

  18. PHASE NOISE COMPARISON OF SHORT PULSE LASER SYSTEMS

    Energy Technology Data Exchange (ETDEWEB)

    Shukui Zhang; Stephen Benson; John Hansknecht; David Hardy; George Neil; Michelle D. Shinn

    2006-08-27

    This paper describes phase noise measurements of several different laser systems that have completely different gain media and configurations including a multi-kW free-electron laser. We will focus on state-of-the-art short pulse lasers, especially drive lasers for photocathode injectors. Phase noise comparison of the FEL drive laser, electron beam and FEL laser output also will be presented.

  19. Radiation therapy for ocular choroidal neovascularization (phase I/II study)

    International Nuclear Information System (INIS)

    Sasai, Keisuke; Murata, Rumi; Mandai, Michiko; Takahashi, Masayo; Hiraoka, Masahiro

    1996-01-01

    /2 weeks (last 18 eyes). All eyes were irradiated with a single lateral 6 MV photon beam, angled 10 degree posteriorly to exclude the ipsilateral lens and the contralateral eye from the radiation field. The ipsilateral lens was irradiated with less than 10% of the total reference dose. The field size averaged 3.0 x 2.5 cm. Records of the 17 eyes with CNV referred to our hospital in 1993, which satisfied the eligibility criteria for this study, were retrospectively analyzed for comparison. Results: There was no significant acute morbidity. All patients were followed regularly by both ophthalmologists and radiation oncologists. One patient treated with a dose of 20 Gy died due to intercurrent disease 2 months after irradiation. Median follow up periods for the group of patients receiving 10 Gy and for the group of patients receiving 20 Gy were 18 months, and 9 months, respectively. One patient who received 20 Gy complained of transient dry-eye sensation 2 months after treatment, but this disappeared spontaneously at the 4th month. Subjective symptoms, visual acuity and size of the neovascular membrane were evaluated 6 months after treatment in each group. In the group of patients irradiated with 10 Gy, subjective symptoms improved in 3 eyes, did not change in 10, and deteriorated in 5. In the 20 Gy group, 8 improved, 5 did not change, and 4 deteriorated. Although visual acuity was significantly decreased in the control group, patients of both irradiated groups did not show such a decrease in visual acuity. The size of the neovascular membrane in the control group progressed significantly. However, patients in the 20 Gy group showed significant regression of the membrane, although the 10 Gy group showed no significant change in size. Conclusions: This phase I/II study including a dose escalation study showed that radiation therapy seems to be useful for CNV. The dose of 20 Gy in 10 fractions was more useful in treating neovascular membranes than the dose of 10 Gy in 5

  20. DECOVALEX - Mathematical models of coupled T-H-M processes for nuclear waste repositories. Report of phase III

    International Nuclear Information System (INIS)

    Jing, L.; Rutqvist, J.; Stephansson, O.

    1995-12-01

    This report presents the methodologies and results of the field/laboratory experiments and mathematical modeling defined for the phase III of the project. Results from test cases 2-6 are given in separate chapters of the report (which have been indexed separately), and the last chapter discusses the lessons learned from the three phases of the DECOVALEX project

  1. ISP42 (PANDA Tests) - Open Phase Comparison Report

    International Nuclear Information System (INIS)

    2003-05-01

    PANDA is a large-scale facility, which has been constructed at the Paul Scherrer Institute (PSI) for the investigation of both overall dynamic response and the key phenomena of passive containment systems during the long-term heat removal phase for Advanced Light Water Reactors (ALWRs). Using a modular concept with a basic set of cylindrical vessels and connecting piping, the facility can be adapted to simulate different passive containment designs. Following a proposal, the OECD/NEA Committee on the Safety of Nuclear Installations approved, at its meeting on December 3-5, 1997, a new International Standard Problem (ISP) involving a test in the PANDA facility, based on a recommendation from the Principal Working Group 2 (PWG2) on System Behaviour. The main interest for this ISP is code validation in relation to a range of LWR and advanced LWR (ALWR) (mainly) containment issues that have been designated as important and involving thermalhydraulic phenomena. The ISP-PANDA test for defined six phases (A to F) was performed on 21/22 April 1998. Since the first part of ISP-42 was going to be conducted as a 'double- blind' or 'blind' exercise, the experimental data was locked. The 'blind' phase calculational results compared to experimental data are presented in the report entitled 'ISP-42 (PANDA Tests ) Blind Phase Comparison'. In the second part, the 'open' exercise has been conducted by providing the ISP-42 PANDA test data to the participants and by performing post-test analysis. The results of the 'open' phase are presented in the present report. 'Open' phase submissions, comparisons, and analyses for ISP-42 are based on the outcome of the results presented in the 'blind' phase report of ISP-42. The experimental data was distributed to all ISP-42 participants for their post-test calculations, 20 June 2000. 'Open' phase analyses of some of the ISP-42 participants, were completely received by the end of January 2001. There were 27 new submissions for different phases

  2. A comparison of recent results from HONDO III with the JSME nuclear shipping cask benchmark calculations

    International Nuclear Information System (INIS)

    Key, S.W.

    1985-01-01

    The results of two calculations related to the impact response of spent nuclear fuel shipping casks are compared to the benchmark results reported in a recent study by the Japan Society of Mechanical Engineers Subcommittee on Structural Analysis of Nuclear Shipping Casks. Two idealized impacts are considered. The first calculation utilizes a right circular cylinder of lead subjected to a 9.0 m free fall onto a rigid target, while the second calculation utilizes a stainless steel clad cylinder of lead subjected to the same impact conditions. For the first problem, four calculations from graphical results presented in the original study have been singled out for comparison with HONDO III. The results from DYNA3D, STEALTH, PISCES, and ABAQUS are reproduced. In the second problem, the results from four separate computer programs in the original study, ABAQUS, ANSYS, MARC, and PISCES, are used and compared with HONDO III. The current version of HONDO III contains a fully automated implementation of the explicit-explicit partitioning procedure for the central difference method time integration which results in a reduction of computational effort by a factor in excess of 5. The results reported here further support the conclusion of the original study that the explicit time integration schemes with automated time incrementation are effective and efficient techniques for computing the transient dynamic response of nuclear fuel shipping casks subject to impact loading. (orig.)

  3. Performance of Dutch children on the Bayley III: a comparison study of US and Dutch norms.

    Science.gov (United States)

    Steenis, Leonie J P; Verhoeven, Marjolein; Hessen, Dave J; van Baar, Anneloes L

    2015-01-01

    The Bayley Scales of Infant and Toddler Development-third edition (Bayley-III) are frequently used to assess early child development worldwide. However, the original standardization only included US children, and it is still unclear whether or not these norms are adequate for use in other populations. Recently, norms for the Dutch version of the Bayley-III (The Bayley-III-NL) were made. Scores based on Dutch and US norms were compared to study the need for population-specific norms. Scaled scores based on Dutch and US norms were compared for 1912 children between 14 days and 42 months 14 days. Next, the proportions of children scoring Dutch norms fluctuated around values based on US norms on all subtests. The extent of the deviations differed across ages and subtests. Differences in means were significant across all five subtests (p Dutch norms resulted in over-referral regarding gross motor skills, and under-referral regarding cognitive, receptive communication, expressive communication, and fine motor skills. The Dutch norms differ from the US norms for all subtests and these differences are clinically relevant. Population specific norms are needed to identify children with low scores for referral and intervention, and to facilitate international comparisons of population data.

  4. Comparison of the PLCS malfunction event analyses by using the CESEC III and MEDUSA codes

    International Nuclear Information System (INIS)

    Oh, Myung Taek; Park, Chan Eok; Kim, Shin Whan; Seo, Jong Tae

    2004-01-01

    The MEDUSA is a code developed by Korea Power Engineering Company (KOPEC) for non-LOCA and LOCA analysis, providing two-fluid, three-field representation of two-phase flow. In this paper, as an effort to verify the MEDUSA code, comparative simulation for Pressurizer Level Control System (PLCS) malfunction with loss of off-site power is performed for UCN 3 and 4 plants. The results by the MEDUSA are compared with those calculated by the CESEC-III, a licensing analysis code used for Korean Standard Nuclear Power Plant (KSNP)

  5. Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

    OpenAIRE

    Weinblatt, Michael E.; Baranauskaite, Asta; Niebrzydowski, Jaroslaw; Dokoupilova, Eva; Zielinska, Agnieszka; Jaworski, Janusz; Racewicz, Artur; Pileckyte, Margarita; Jedrychowicz‐Rosiak, Krystyna; Cheong, Soo Yeon; Ghil, Jeehoon; Sokolovic, S.; Mekic, M.; Prodanovic, N.; Gajic, B.

    2017-01-01

    Objective SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA). Methods In this phase III, randomized, double‐blind, parallel‐group study, patients with moderately to severely active RA despite treatment with methotrexate were randomized 1:1 to receive SB5 or reference ADA at a dosage of 40 mg subcutaneously every o...

  6. Impact of Dengue Vaccination on Serological Diagnosis: Insights From Phase III Dengue Vaccine Efficacy Trials.

    Science.gov (United States)

    Plennevaux, Eric; Moureau, Annick; Arredondo-García, José L; Villar, Luis; Pitisuttithum, Punnee; Tran, Ngoc H; Bonaparte, Matthew; Chansinghakul, Danaya; Coronel, Diana L; L'Azou, Maïna; Ochiai, R Leon; Toh, Myew-Ling; Noriega, Fernando; Bouckenooghe, Alain

    2018-04-03

    We previously reported that vaccination with the tetravalent dengue vaccine (CYD-TDV; Dengvaxia) may bias the diagnosis of dengue based on immunoglobulin M (IgM) and immunoglobulin G (IgG) assessments. We undertook a post hoc pooled analysis of febrile episodes that occurred during the active surveillance phase (the 25 months after the first study injection) of 2 pivotal phase III, placebo-controlled CYD-TDV efficacy studies that involved ≥31000 children aged 2-16 years across 10 countries in Asia and Latin America. Virologically confirmed dengue (VCD) episode was defined with a positive test for dengue nonstructural protein 1 antigen or dengue polymerase chain reaction. Probable dengue episode was serologically defined as (1) IgM-positive acute- or convalescent-phase sample, or (2) IgG-positive acute-phase sample and ≥4-fold IgG increase between acute- and convalescent-phase samples. There were 1284 VCD episodes (575 and 709 in the CYD-TDV and placebo groups, respectively) and 17673 other febrile episodes (11668 and 6005, respectively). Compared with VCD, the sensitivity and specificity of probable dengue definition were 93.1% and 77.2%, respectively. Overall positive and negative predictive values were 22.9% and 99.5%, respectively, reflecting the much lower probability of correctly confirming probable dengue in a population including a vaccinated cohort. Vaccination-induced bias toward false-positive diagnosis was more pronounced among individuals seronegative at baseline. Caution will be required when interpreting IgM and IgG data obtained during routine surveillance in those vaccinated with CYD-TDV. There is an urgent need for new practical, dengue-specific diagnostic algorithms now that CYD-TDV is approved in a number of dengue-endemic countries. NCT01373281 and NCT01374516.

  7. Objective Lightning Probability Forecasting for Kennedy Space Center and Cape Canaveral Air Force Station, Phase III

    Science.gov (United States)

    Crawford, Winifred C.

    2010-01-01

    The AMU created new logistic regression equations in an effort to increase the skill of the Objective Lightning Forecast Tool developed in Phase II (Lambert 2007). One equation was created for each of five sub-seasons based on the daily lightning climatology instead of by month as was done in Phase II. The assumption was that these equations would capture the physical attributes that contribute to thunderstorm formation more so than monthly equations. However, the SS values in Section 5.3.2 showed that the Phase III equations had worse skill than the Phase II equations and, therefore, will not be transitioned into operations. The current Objective Lightning Forecast Tool developed in Phase II will continue to be used operationally in MIDDS. Three warm seasons were added to the Phase II dataset to increase the POR from 17 to 20 years (1989-2008), and data for October were included since the daily climatology showed lightning occurrence extending into that month. None of the three methods tested to determine the start of the subseason in each individual year were able to discern the start dates with consistent accuracy. Therefore, the start dates were determined by the daily climatology shown in Figure 10 and were the same in every year. The procedures used to create the predictors and develop the equations were identical to those in Phase II. The equations were made up of one to three predictors. TI and the flow regime probabilities were the top predictors followed by 1-day persistence, then VT and Ll. Each equation outperformed four other forecast methods by 7-57% using the verification dataset, but the new equations were outperformed by the Phase II equations in every sub-season. The reason for the degradation may be due to the fact that the same sub-season start dates were used in every year. It is likely there was overlap of sub-season days at the beginning and end of each defined sub-season in each individual year, which could very well affect equation

  8. The Phase I/II BNCT Trials at the Brookhaven medical research reactor: Critical considerations

    International Nuclear Information System (INIS)

    Diaz, A.Z.

    2001-01-01

    A phase I/II clinical trial of boronophenylalanine-fructose (BPA-F) mediated boron neutron capture therapy (BNCT) for Glioblastoma Multiforme (GBM) was initiated at Brookhaven National Laboratory (BNL) in 1994. Many critical issues were considered during the design of the first of many sequential dose escalation protocols. These critical issues included patient selection criteria, boron delivery agent, dose limits to the normal brain, dose escalation schemes for both neutron exposure and boron dose, and fractionation. As the clinical protocols progressed and evaluation of the tolerance of the central nervous system (CNS) to BPA-mediated BNCT at the BMRR continued new specifications were adopted. Clinical data reflecting the progression of the protocols will be presented to illustrate the steps taken and the reasons behind their adoption. (author)

  9. Investor Outlook: Significance of the Positive LCA2 Gene Therapy Phase III Results.

    Science.gov (United States)

    Schimmer, Joshua; Breazzano, Steven

    2015-12-01

    Spark Therapeutics recently reported positive phase III results for SPK-RPE65 targeting the treatment of visual impairment caused by RPE65 gene mutations (often referred to as Leber congenital amaurosis type 2, or LCA2, but may include other retinal disorders), marking an important inflection point for the field of gene therapy. The results highlight the ability to successfully design and execute a randomized trial of a gene therapy and also reinforce the potentially predictive nature of early preclinical and clinical data. The results are expected to pave the way for the first approved gene therapy product in the United States and should sustain investor interest and confidence in gene therapy for many approaches, including retina targeting and beyond.

  10. Runaway electron damage to the Tore Supra Phase III outboard pump limiter

    International Nuclear Information System (INIS)

    Nygren, R.; Lutz, T.; Walsh, D.; Martin, G.; Chatelier, M.; Loarer, T.; Guilhem, D.

    1996-01-01

    Operation of the Phase III outboard pump limiter (OPL) in Tore Supra in 1994 was terminated prematurely when runaway electrons during the current decay following a disruption pierced leading edge tube on the electron side and caused a water leak. The location, about 20 mm outside the last closed flux surface during normal operation, and the infrared (IR) images of the limiter indicate that the runaways moved in large outward steps, i.e. tens of millimeters, in one toroidal revolution. For plasma (runaway) currents in the range of 155 to 250 kA, the drift orbits open to the outside. Basic trajectory computations suggest that such motion is possible under the conditions present for this experiment. Activation measurements made on sections of the tube to indicate the area of local damage are presented here. An understanding of this event may provide important guidance regarding the potential damage from runaways in future tokamaks

  11. Production circulator fabrication and testing for core flow test loop. Final report, Phase III

    Energy Technology Data Exchange (ETDEWEB)

    1981-05-01

    The performance testing of two production helium circulators utilizing gas film lubrication is described. These two centrifugal-type circulators plus an identical circulator prototype will be arranged in series to provide the helium flow requirements for the Core Flow Test Loop which is part of the Gas-Cooled Fast Breeder Reactor Program (GCFR) at the Oak Ridge National Laboratory. This report presents the results of the Phase III performance and supplemental tests, which were carried out by MTI during the period of December 18, 1980 through March 19, 1981. Specific test procedures are outlined and described, as are individual tests for measuring the performance of the circulators. Test data and run descriptions are presented.

  12. A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

    DEFF Research Database (Denmark)

    Vollmer, T L; Sorensen, P S; Selmaj, K

    2014-01-01

    The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFNβ)-1a (Avonex(®) reference arm). RRMS patients age 18-55 years with Expanded Disability Status Scale (EDSS) scores...... months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFNβ-1a (n = 447). ARR was not significantly...... reduced with laquinimod [-18 %, risk ratio (RR) = 0.82, 95 % CI 0.66-1.02; p = 0.075] vs. placebo. Laquinimod significantly reduced PBVC (28 %, p change in confirmed disability worsening with laquinimod measured...

  13. Integrated safety analysis of rolapitant with coadministered drugs from phase II/III trials

    DEFF Research Database (Denmark)

    Barbour, S; Smit, T.; Wang, X

    2017-01-01

    adverse events by use versus non-use of drug substrates of CYP2D6 or BCRP. Patients and methods: Patients were randomized to receive either 180 mg oral rolapitant or placebo approximately 1-2 hours before chemotherapy in combination with a 5-hydroxytryptamine type 3 RA and dexamethasone. Data...... cytochrome P450 (CYP) 3A4, but it does inhibit CYP2D6 and breast cancer resistance protein (BCRP). To analyze potential drug-drug interactions between rolapitant and concomitant medications, this integrated safety analysis of four double-blind, randomized phase II or III studies of rolapitant examined...... for treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) during cycle 1 were pooled across the four studies and summarized in the overall population and by concomitant use/non-use of CYP2D6 or BCRP substrate drugs. Results: In the integrated safety population, 828...

  14. Production circulator fabrication and testing for core flow test loop. Final report, Phase III

    International Nuclear Information System (INIS)

    1981-05-01

    The performance testing of two production helium circulators utilizing gas film lubrication is described. These two centrifugal-type circulators plus an identical circulator prototype will be arranged in series to provide the helium flow requirements for the Core Flow Test Loop which is part of the Gas-Cooled Fast Breeder Reactor Program (GCFR) at the Oak Ridge National Laboratory. This report presents the results of the Phase III performance and supplemental tests, which were carried out by MTI during the period of December 18, 1980 through March 19, 1981. Specific test procedures are outlined and described, as are individual tests for measuring the performance of the circulators. Test data and run descriptions are presented

  15. Direct disposal of spent fuel. Simulation of shaft transport. Phase III. Final report

    International Nuclear Information System (INIS)

    Filbert, W.; Heda, M.; Khamis, M.; Neydek, J.; Niehues, N.; Rissel, J.; Schrimpf, C.; Weber, W.; Fuchs, D.; Gerlach, A.; Langebrake, F.; Sindern, W.; Gasch, A.; Leicht, R.; Schwab, B.; Hecke, R. van; Kipka, P.; Simmich, K.; Weber, H.

    1994-01-01

    The aim of these demonstration tests was to verify the technical feasibility of a shaft hoisting equipment with a payload of 85 t as well as the safe transport of POLLUX-casks. In phase III of the project the components and the test stand were built, their proper functioning and reliability were tested to demonstrate that they are state-of-the-art. The following additional investigations were carried out: - Tests to fix operational disturbances and simulation tests for the new components to demonstrate their licensibility -Selection and lifetime tests of ropes and investigation of the present state-of-the-art of rope slighting under the conditions of the conceptual design of the shaft hoisting facility - Execution of a probabilistic safety analysis e.g. the determination of the release of radioactive material (result: probability [de

  16. The Qinshan phase III project-a successful model of sino-canadian cooperation

    International Nuclear Information System (INIS)

    Pang, S.H.H.; Alikhan, S.; Gu Jun

    2005-01-01

    The Qinshan Phase III (CANDU) Project, the largest-scale cooperative project between China and Canada, was completed in 2003 well in advance of the schedule and 10% under budget. The Third Qinshan (Phase III) Nuclear Power Plant (TQNPP) was built in record times: Unit 1 achieved commercial operation on December 31, 2002 and Unit 2 on July 20, 2003, 43 days and 115 days ahead of schedule respectively. Improvements in design and construction methods allowed Unit 1 to be constructed in 51.5 months from First Concrete to Criticality - a record in China for nuclear power plants. The key factors are project management and project management tools, quality assurance, construction methods, electronic documentation with configuration control that provides up-to-date on-line information, CADDS design linked with material management and control. New design and construction techniques were introduced by combining conventional AECL practices with working experiences in China. The most advanced tools and techniques for achieving optimum construction quality, schedule and cost were used. Successful application of advanced project management methods and tools has benefited TQNPC in its subsequent plant operation, and the Chinese contractors in advancing their capabilities in future nuclear projects in China as well as enhancing their opportunities internationally. Excellent co-operation and teamwork within the integrated TQNPC/AECL Commissioning Team with well documented QA program, process and procedures also contributed to the remarkable success of the Project. AECL's initial assessment, based on lessons learned, showed that the project schedule could readily be reduced to 66 months and the capital costs reduced by 25% for a replication project. AECL is building on this experience and successful results of TQNPP in its Advanced CANDU Reactor TM (ACR TM ) ** design. (authors)

  17. Phase III trial of high and low dose rate interstitial radiotherapy for early oral tongue cancer

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Teshima, Teruki; Murayama, Shigeyuki; Shimizutani, Kimishige; Fuchihata, Hajime; Furukawa, Souhei

    1996-01-01

    Purpose: Oral tongue carcinomas are highly curable with radiotherapy. In the past, patients with tongue carcinoma have usually been treated with low dose rate (LDR) interstitial radiation. This Phase III study was designed to compare the treatment results obtained with LDR with those obtained with high dose rate (HDR) interstitial radiotherapy for tongue carcinoma. Methods and Materials: The criteria for patient selection for the Phase III study were: (a) presence of a T1T2N0 tumor that could be treated with single-plane implantation, (b) localization of tumor at the lateral tongue border, (c) tumor thickness of 10 mm or less, (d) performance status between O and 3, and (e) absence of any severe concurrent disease. From April 1992 through December 1993, 15 patients in the LDR group (70 Gy/4 to 9 days) and 14 patients in the HDR group (60 Gy/10 fractions/6 days) were accrued. The time interval between two fractions of the HDR brachytherapy was more than 6 h. Results: Local recurrence occurred in two patients treated with LDR brachytherapy but in none of the patients treated with HDR. One- and 2-year local control rates for patients in the LDR group were both 86%, compared with 100% in the HDR group (p = 0.157). There were four patients with nodal metastasis in the LDR group and three in the HDR group. Local recurrence occurred in two of the four patients with nodal metastases in the LDR group. One- and 2-year nodal control rates for patients in the LDR group are were 85%, compared with 79% in the HDR group. Conclusion: HDR fractionated interstitial brachytherapy can be an alternative to traditional LDR brachytherapy for early tongue cancer and eliminate the radiation exposure for medical staffs

  18. Evaluating Intermittent Androgen-Deprivation Therapy Phase III Clinical Trials: The Devil Is in the Details.

    Science.gov (United States)

    Hussain, Maha; Tangen, Catherine; Higano, Celestia; Vogelzang, Nicholas; Thompson, Ian

    2016-01-20

    Intermittent androgen deprivation (IAD) has been widely tested in prostate cancer. However, phase III trials testing continuous androgen deprivation (CAD) versus IAD have reached inconclusive and seemingly contradictory results. Different design and conduct issues must be critically evaluated to better interpret the results. Seven published phase III trials were examined for prespecified design and outcomes. Treatment specifications; primary end point; superiority versus noninferiority design assumptions, including magnitude of assumed versus observed noninferiority margin (NIM); duration of follow-up; and quality-of-life (QOL) outcomes were considered in terms of the results and conclusions reported. Five trials had a superiority and three had a noninferiority primary hypothesis. Only three trials had a uniform population and overall survival (OS) end point. All trials observed better outcomes in terms of OS and progression-free survival (PFS) than assumed at time of study design, translating into prespecified NIMs or hazard ratios that reflected larger absolute differences in OS or PFS between arms. Lower-than-expected event rates also reduced statistical power for the trials. Other factors, including length of follow-up, cause of death, QOL, and primary end point, and their impact on trial interpretation are discussed. No trial to date has demonstrated survival superiority of IAD compared with CAD. Trials concluding IAD is noninferior to CAD were based on wide NIMs that included clinically important survival differences, not likely to be considered comparable by physicians or patients. Interim analyses relying on short follow-up and including a majority of non-prostate cancer deaths will favor a noninferiority conclusion and should be interpreted cautiously. Adequate follow-up is required to ensure capture of prostate cancer deaths in both superiority and noninferiority trials. © 2015 by American Society of Clinical Oncology.

  19. Unexpected Relationships and Inbreeding in HapMap Phase III Populations

    Science.gov (United States)

    Stevens, Eric L.; Baugher, Joseph D.; Shirley, Matthew D.; Frelin, Laurence P.; Pevsner, Jonathan

    2012-01-01

    Correct annotation of the genetic relationships between samples is essential for population genomic studies, which could be biased by errors or omissions. To this end, we used identity-by-state (IBS) and identity-by-descent (IBD) methods to assess genetic relatedness of individuals within HapMap phase III data. We analyzed data from 1,397 individuals across 11 ethnic populations. Our results support previous studies (Pemberton et al., 2010; Kyriazopoulou-Panagiotopoulou et al., 2011) assessing unknown relatedness present within this population. Additionally, we present evidence for 1,657 novel pairwise relationships across 9 populations. Surprisingly, significant Cotterman's coefficients of relatedness K1 (IBD1) values were detected between pairs of known parents. Furthermore, significant K2 (IBD2) values were detected in 32 previously annotated parent-child relationships. Consistent with a hypothesis of inbreeding, regions of homozygosity (ROH) were identified in the offspring of related parents, of which a subset overlapped those reported in previous studies (Gibson et al. 2010; Johnson et al. 2011). In total, we inferred 28 inbred individuals with ROH that overlapped areas of relatedness between the parents and/or IBD2 sharing at a different genomic locus between a child and a parent. Finally, 8 previously annotated parent-child relationships had unexpected K0 (IBD0) values (resulting from a chromosomal abnormality or genotype error), and 10 previously annotated second-degree relationships along with 38 other novel pairwise relationships had unexpected IBD2 (indicating two separate paths of recent ancestry). These newly described types of relatedness may impact the outcome of previous studies and should inform the design of future studies relying on the HapMap Phase III resource. PMID:23185369

  20. Encyclopedia of two-phase heat transfer and flow III macro and micro flow boiling and numerical modeling fundamentals

    CERN Document Server

    2018-01-01

    Set III of this encyclopedia is a new addition to the previous Sets I and II. It contains 26 invited chapters from international specialists on the topics of numerical modeling of two-phase flows and evaporation, fundamentals of evaporation and condensation in microchannels and macrochannels, development and testing of micro two-phase cooling systems for electronics, and various special topics (surface wetting effects, microfin tubes, two-phase flow vibration across tube bundles). The chapters are written both by renowned university researchers and by well-known engineers from leading corporate research laboratories. Numerous "must read" chapters cover the fundamentals of research and engineering practice on boiling, condensation and two-phase flows, two-phase heat transfer equipment, electronics cooling systems, case studies and so forth. Set III constitutes a "must have" reference together with Sets I and II for thermal engineering researchers and practitioners.

  1. Iodixanol in cerebral computed tomography: a randomized, double-blind, phase-III, parallel study with iodixanol and iohexol

    International Nuclear Information System (INIS)

    Doerfler, A.; Wanke, I.; Forsting, M.; Fiebach, J.; Sartor, K.; Henseke, P.

    1999-01-01

    Iodixanol is a new nonionic dimer, isotonic with blood at all clinically relevant concentrations. Iodixanol (270 mg I/ml) was compared in a double-blind, randomized, parallel-group, phase-III study to the monomeric nonionic iohexol (300 mg I/ml) for evaluation of safety, tolerability and radiographic efficacy during cerebral CT. One hundred adult patients scheduled to undergo contrast-enhanced cerebral CT were randomly allocated to receive either iodixanol or iohexol. All completed the trial. Safety was evaluated by recording discomfort and other adverse events, tolerance by assessing intensity and incidence of discomfort. Radiographic efficacy was assessed from the diagnostic information and the radiographic density. No serious adverse events occurred. One patient (2 %) in the iodixanol group and one patient (2 %) in the iohexol group experienced a transient reddening at the neck and lower neck-line, respectively. Both contrast agents were well tolerated. One patient (2 %) in the iodixanol group and two patients (4 %) in the iohexol group experienced a sensation of warmth (discomfort) in connection with the injection. No difference between the two contrast media were noted radiographically. This comparison between iodixanol and iohexol showed both contrast media to be safe, well-tolerated and efficacious for use in cerebral CT. (orig.)

  2. Acoustic Detection of Faults and Degradation in a High-Bypass Turbofan Engine during VIPR Phase III Testing

    Science.gov (United States)

    Boyle, Devin K.

    2017-01-01

    The Vehicle Integrated Propulsion Research (VIPR) Phase III project was executed at Edwards Air Force Base, California, by the National Aeronautics and Space Administration and several industry, academic, and government partners in the summer of 2015. One of the research objectives was to use external radial acoustic microphone arrays to detect changes in the noise characteristics produced by the research engine during volcanic ash ingestion and seeded fault insertion scenarios involving bleed air valves. Preliminary results indicate the successful acoustic detection of suspected degradation as a result of cumulative exposure to volcanic ash. This detection is shown through progressive changes, particularly in the high-frequency content, as a function of exposure to greater cumulative quantities of ash. Additionally, detection of the simulated failure of the 14th stage stability bleed valve and, to a lesser extent, the station 2.5 stability bleed valve, to their fully-open fail-safe positions was achieved by means of spectral comparisons between nominal (normal valve operation) and seeded fault scenarios.

  3. Phase III Drilling Operations at the Long Valley Exploratory Well (LVF 51-20)

    Energy Technology Data Exchange (ETDEWEB)

    Finger, J.T.; Jacobson, R.D.

    1999-06-01

    During July-September, 1998, a jointly funded drilling operation deepened the Long Valley Exploratory Well from 7178 feet to 9832 feet. This was the third major drilling phase of a project that began in 1989, but had sporadic progress because of discontinuities in tiding. Support for Phase III came from the California Energy Commission (CEC), the International Continental Drilling Program (ICDP), the US Geological Survey (USGS), and DOE. Each of these agencies had a somewhat different agenda: the CEC wants to evaluate the energy potential (specifically energy extraction from magma) of Long Valley Caldera; the ICDP is studying the evolution and other characteristics of young, silicic calderas; the USGS will use this hole as an observatory in their Volcano Hazards program; and the DOE, through Sandia, has an opportunity to test new geothermal tools and techniques in a realistic field environment. This report gives a description of the equipment used in drilling and testing; a narrative of the drilling operations; compiled daily drilling reports; cost information on the project; and a brief summary of engineering results related to equipment performance and energy potential. Detailed description of the scientific results will appear in publications by the USGS and other researchers.

  4. Performance of Dutch children on the Bayley III: a comparison study of US and Dutch norms.

    Directory of Open Access Journals (Sweden)

    Leonie J P Steenis

    Full Text Available The Bayley Scales of Infant and Toddler Development-third edition (Bayley-III are frequently used to assess early child development worldwide. However, the original standardization only included US children, and it is still unclear whether or not these norms are adequate for use in other populations. Recently, norms for the Dutch version of the Bayley-III (The Bayley-III-NL were made. Scores based on Dutch and US norms were compared to study the need for population-specific norms.Scaled scores based on Dutch and US norms were compared for 1912 children between 14 days and 42 months 14 days. Next, the proportions of children scoring < 1-SD and < -2 SD based on the two norms were compared, to identify over- or under-referral for developmental delay resulting from non-population-based norms.Scaled scores based on Dutch norms fluctuated around values based on US norms on all subtests. The extent of the deviations differed across ages and subtests. Differences in means were significant across all five subtests (p < .01 with small to large effect sizes (ηp2 ranging from .03 to .26. Using the US instead of Dutch norms resulted in over-referral regarding gross motor skills, and under-referral regarding cognitive, receptive communication, expressive communication, and fine motor skills.The Dutch norms differ from the US norms for all subtests and these differences are clinically relevant. Population specific norms are needed to identify children with low scores for referral and intervention, and to facilitate international comparisons of population data.

  5. Utility of DSM-5 section III personality traits in differentiating borderline personality disorder from comparison groups.

    Science.gov (United States)

    Bach, B; Sellbom, M; Bo, S; Simonsen, E

    2016-09-01

    Borderline Personality Disorder (BPD) is a highly prevalent diagnosis in mental health care and includes a heterogeneous constellation of symptoms. As the field of personality disorder (PD) research moves to emphasize dimensional traits in its operationalization, it is important to determine how the alternative DSM-5 Section III personality trait dimensions differentiates such features in BPD patients versus comparison groups. To date, no study has attempted such validation. The current study examined the utility of the DSM-5 trait dimensions in differentiating patients with the categorical DSM-IV/5 diagnosis of BPD (n=101) from systematically matched samples of other PD patients (n=101) and healthy controls (n=101). This was investigated using one-way ANOVA and multinomial logistic regression analyses. Results indicated that Emotional Lability, Risk Taking, and Suspiciousness uniquely differentiated BPD patients from other PD patients, whereas Emotional Lability, Depressivity, and Suspiciousness uniquely differentiated BPD patients from healthy controls. Emotional Lability is in particular a key BPD feature of the proposed Section III model, whereas Suspiciousness also augments essential BPD features. Provided that these findings are replicated cross-culturally in forthcoming research, a more parsimonious traits operationalization of BPD features is warranted. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  6. Intravitreal sirolimus for the treatment of geographic atrophy: results of a phase I/II clinical trial.

    Science.gov (United States)

    Petrou, Philip A; Cunningham, Denise; Shimel, Katherine; Harrington, Molly; Hammel, Keri; Cukras, Catherine A; Ferris, Frederick L; Chew, Emily Y; Wong, Wai T

    2014-12-18

    To investigate the safety and effects of intravitreal sirolimus for the potential treatment of geographic atrophy (GA). The study was a single-center, open-label, phase I/II trial enrolling six participants with bilateral GA treated with intravitreal sirolimus in only one randomly assigned eye, with the fellow eye as control. The primary efficacy outcome measure was the change in total GA area from baseline on color fundus photography (CFP); secondary outcomes included changes in GA area on fundus autofluorescence (FAF), visual acuity, central retinal thickness (CRT), and macular sensitivity from baseline. Although no systemic adverse events were attributed to treatment, two of six participants had ocular adverse events that were possibly associated. The treated eye of one participant developed abnormal paralesional changes on FAF that were associated with accelerated retinal thinning. This accelerated retinal thinning was also seen in the treated eye of a second participant. Because of concern that these events were associated with treatment, treatment was suspended. Comparisons of treated and fellow eyes for change in visual acuity, change in GA area, and change in CRT showed no evidence of treatment benefit and generally favored the untreated fellow eye. While paralesional FAF changes and rapid retinal thinning observed are potentially part of the natural course of GA, they may possibly be related to treatment. No general evidence of anatomical or functional benefit was detected in treated eyes. Further data on intravitreal sirolimus for GA treatment will be available from a larger phase II trial. (ClinicalTrials.gov number, NCT01445548.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.

  7. Bottlenecks in the development of topical analgesics: molecule, formulation, dose-finding, and phase III design

    Directory of Open Access Journals (Sweden)

    Keppel Hesselink JM

    2017-03-01

    Full Text Available Jan M Keppel Hesselink,1 David J Kopsky,2 Stephen M Stahl3 1Institute Neuropathic Pain, Bosch en Duin, the Netherlands; 2Institute Neuropathic Pain, Amsterdam, the Netherlands; 3University of California San Diego, La Jolla, CA, USA Abstract: Topical analgesics can be defined as topical formulations containing analgesics or co-analgesics. Since 2000, interest in such formulations has been on the rise. There are, however, four critical issues in the research and development phases of topical analgesics: 1 The selection of the active pharmaceutical ingredient. Analgesics and co-analgesics differ greatly in their mechanism of action, and it is required to find the most optimal fit between such mechanisms of action and the pathogenesis of the targeted (neuropathic pain. 2 Issues concerning the optimized formulation. For relevant clinical efficacy, specific characteristics for the selected vehicle (eg, cream base or gel base are required, depending on the physicochemical characteristics of the active pharmaceutical ingredient(s to be delivered. 3 Well-designed phase II dose-finding studies are required, and, unfortunately, such trials are missing. In fact, we will demonstrate that underdosing is one of the major hurdles to detect meaningful and statistically relevant clinical effects of topical analgesics. 4 Selection of clinical end points and innovatively designed phase III trials. End point selection can make or break a trial. For instance, to include numbness together with tingling as a composite end point for neuropathic pain seems stretching the therapeutic impact of an analgesic too far. Given the fast onset of action of topical analgesics (usually within 30 minutes, enrichment designs might enhance the chances for success, as the placebo response might decrease. Topical analgesics may become promising inroads for the treatment of neuropathic pain, once sufficient attention is given to these four key aspects. Keywords: topical, analgesics

  8. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial.

    Science.gov (United States)

    Blackwell, Kimberly; Donskih, Roman; Jones, C Michael; Nixon, Allen; Vidal, Maria J; Nakov, Roumen; Singh, Pritibha; Schaffar, Gregor; Gascón, Pere; Harbeck, Nadia

    2016-07-01

    Pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. In highly regulated markets, there are currently no approved biosimilars of pegfilgrastim. Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare proposed biosimilar LA-EP2006 with reference pegfilgrastim (Neulasta, Amgen) in early-stage breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy. A total of 308 patients were randomized to LA-EP2006 or reference pegfilgrastim. Each patient received TAC (intravenous docetaxel 75 mg/m(2), doxorubicin 50 mg/m(2), and cyclophosphamide 500 mg/m(2)) on day 1 of each cycle, for six or more cycles. Pegfilgrastim (LA-EP2006 or reference) was given subcutaneously (6 mg in 0.6 mL) on day 2 of each cycle. The primary endpoint was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with an absolute neutrophil count prevention of neutropenia in patients with early-stage breast cancer receiving TAC. The granulocyte colony-stimulating factor pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. Biosimilars are biologics with similar quality, safety, and efficacy to a reference product that may increase the affordability of treatment compared with their reference compounds. There are currently no approved biosimilars of pegfilgrastim in highly regulated markets. No previous phase III studies have been performed with LA-EP2006. PROTECT-2 was conducted to confirm the similarity of the proposed biosimilar LA-EP2006 to pegfilgrastim. Biosimilar pegfilgrastim (LA-EP2006) may benefit oncology patients by offering increased access to biological treatments that may improve clinical outcomes. This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred. ©AlphaMed Press.

  9. Comparison of phasing strategies for whole human genomes.

    Science.gov (United States)

    Choi, Yongwook; Chan, Agnes P; Kirkness, Ewen; Telenti, Amalio; Schork, Nicholas J

    2018-04-01

    Humans are a diploid species that inherit one set of chromosomes paternally and one homologous set of chromosomes maternally. Unfortunately, most human sequencing initiatives ignore this fact in that they do not directly delineate the nucleotide content of the maternal and paternal copies of the 23 chromosomes individuals possess (i.e., they do not 'phase' the genome) often because of the costs and complexities of doing so. We compared 11 different widely-used approaches to phasing human genomes using the publicly available 'Genome-In-A-Bottle' (GIAB) phased version of the NA12878 genome as a gold standard. The phasing strategies we compared included laboratory-based assays that prepare DNA in unique ways to facilitate phasing as well as purely computational approaches that seek to reconstruct phase information from general sequencing reads and constructs or population-level haplotype frequency information obtained through a reference panel of haplotypes. To assess the performance of the 11 approaches, we used metrics that included, among others, switch error rates, haplotype block lengths, the proportion of fully phase-resolved genes, phasing accuracy and yield between pairs of SNVs. Our comparisons suggest that a hybrid or combined approach that leverages: 1. population-based phasing using the SHAPEIT software suite, 2. either genome-wide sequencing read data or parental genotypes, and 3. a large reference panel of variant and haplotype frequencies, provides a fast and efficient way to produce highly accurate phase-resolved individual human genomes. We found that for population-based approaches, phasing performance is enhanced with the addition of genome-wide read data; e.g., whole genome shotgun and/or RNA sequencing reads. Further, we found that the inclusion of parental genotype data within a population-based phasing strategy can provide as much as a ten-fold reduction in phasing errors. We also considered a majority voting scheme for the construction of a

  10. Phase II study of imatinib mesylate and hydroxyurea for recurrent grade III malignant gliomas.

    Science.gov (United States)

    Desjardins, Annick; Quinn, Jennifer A; Vredenburgh, James J; Sathornsumetee, Sith; Friedman, Allan H; Herndon, James E; McLendon, Roger E; Provenzale, James M; Rich, Jeremy N; Sampson, John H; Gururangan, Sridharan; Dowell, Jeannette M; Salvado, August; Friedman, Henry S; Reardon, David A

    2007-05-01

    Recent reports demonstrate the activity of imatinib mesylate, an ATP-mimetic, tyrosine kinase inhibitor, plus hydroxyurea, a ribonucleotide reductase inhibitor, in patients with recurrent glioblastoma multiforme. We performed the current phase 2 study to evaluate this regimen among patients with recurrent WHO grade III malignant glioma (MG). Patients with grade III MG at any recurrence, received imatinib mesylate plus hydroxyurea (500 mg twice a day) orally on a continuous, daily schedule. The imatinib mesylate dose was 500 mg twice a day for patients on enzyme inducing anti-epileptic drugs (EIAEDs) and 400 mg once a day for those not on EIAEDs. Clinical assessments were performed monthly and radiographic assessments were obtained at least every 2 months. The primary endpoint was 6-month progression-free survival (PFS) rate. Thirty-nine patients were enrolled. All patients had progressive disease after prior radiotherapy and at least temozolomide-based chemotherapy. The median number of episodes of prior progression was 2 (range, 1-7) and the median number of prior treatment regimens was 3 (range, 1-8). With a median follow-up of 82.9 weeks, 24% of patients were progression-free at 6 months. The radiographic response rate was 10%, while 33% achieved stable disease. Among patients who achieved at least stable disease at first evaluation, the 6-month and 12-month PFS rates were 53% and 29%, respectively. The most common grade 3 or greater toxicities were hematologic and complicated less than 4% of administered courses. Imatinib mesylate plus hydroxyurea, is well tolerated and associated with anti-tumor activity in some patients with recurrent grade 3 MG.

  11. Robustness of phase retrieval methods in x-ray phase contrast imaging: A comparison

    International Nuclear Information System (INIS)

    Yan, Aimin; Wu, Xizeng; Liu, Hong

    2011-01-01

    Purpose: The robustness of the phase retrieval methods is of critical importance for limiting and reducing radiation doses involved in x-ray phase contrast imaging. This work is to compare the robustness of two phase retrieval methods by analyzing the phase maps retrieved from the experimental images of a phantom. Methods: Two phase retrieval methods were compared. One method is based on the transport of intensity equation (TIE) for phase contrast projections, and the TIE-based method is the most commonly used method for phase retrieval in the literature. The other is the recently developed attenuation-partition based (AP-based) phase retrieval method. The authors applied these two methods to experimental projection images of an air-bubble wrap phantom for retrieving the phase map of the bubble wrap. The retrieved phase maps obtained by using the two methods are compared. Results: In the wrap's phase map retrieved by using the TIE-based method, no bubble is recognizable, hence, this method failed completely for phase retrieval from these bubble wrap images. Even with the help of the Tikhonov regularization, the bubbles are still hardly visible and buried in the cluttered background in the retrieved phase map. The retrieved phase values with this method are grossly erroneous. In contrast, in the wrap's phase map retrieved by using the AP-based method, the bubbles are clearly recovered. The retrieved phase values with the AP-based method are reasonably close to the estimate based on the thickness-based measurement. The authors traced these stark performance differences of the two methods to their different techniques employed to deal with the singularity problem involved in the phase retrievals. Conclusions: This comparison shows that the conventional TIE-based phase retrieval method, regardless if Tikhonov regularization is used or not, is unstable against the noise in the wrap's projection images, while the AP-based phase retrieval method is shown in these

  12. Joint Operations 2030 - Phase III Report: The JO 2030 Capability Set (Operations interarmees 2030 - Rapport Phase III: L’ensemble capacitaire JO 2030)

    Science.gov (United States)

    2011-04-01

    Registry for EU and ul. Ostrobramska 109 NATO FRANCE 04-041 Warszawa Vojkova 55 O.N.E.R.A. (ISP) 1000 Ljubljana 29, Avenue de la Division...Ostrobramska 109 Dstl Knowledge and Information Streitkräfteamt / Abteilung III 04-041 Warszawa Services Fachinformationszentrum der Bundeswehr (FIZBw

  13. Microbial Reducibility of Fe(III Phases Associated with the Genesis of Iron Ore Caves in the Iron Quadrangle, Minas Gerais, Brazil

    Directory of Open Access Journals (Sweden)

    Ceth W. Parker

    2013-11-01

    Full Text Available The iron mining regions of Brazil contain thousands of “iron ore caves” (IOCs that form within Fe(III-rich deposits. The mechanisms by which these IOCs form remain unclear, but the reductive dissolution of Fe(III (hydroxides by Fe(III reducing bacteria (FeRB could provide a microbiological mechanism for their formation. We evaluated the susceptibility of Fe(III deposits associated with these caves to reduction by the FeRB Shewanella oneidensis MR-1 to test this hypothesis. Canga, an Fe(III-rich duricrust, contained poorly crystalline Fe(III phases that were more susceptible to reduction than the Fe(III (predominantly hematite associated with banded iron formation (BIF, iron ore, and mine spoil. In all cases, the addition of a humic acid analogue enhanced Fe(III reduction, presumably by shuttling electrons from S. oneidensis to Fe(III phases. The particle size and quartz-Si content of the solids appeared to exert control on the rate and extent of Fe(III reduction by S. oneidensis, with more bioreduction of Fe(III associated with solid phases containing more quartz. Our results provide evidence that IOCs may be formed by the activities of Fe(III reducing bacteria (FeRB, and the rate of this formation is dependent on the physicochemical and mineralogical characteristics of the Fe(III phases of the surrounding rock.

  14. A survey of Type III restriction-modification systems reveals numerous, novel epigenetic regulators controlling phase-variable regulons; phasevarions

    Science.gov (United States)

    Atack, John M; Yang, Yuedong; Jennings, Michael P

    2018-01-01

    Abstract Many bacteria utilize simple DNA sequence repeats as a mechanism to randomly switch genes on and off. This process is called phase variation. Several phase-variable N6-adenine DNA-methyltransferases from Type III restriction-modification systems have been reported in bacterial pathogens. Random switching of DNA methyltransferases changes the global DNA methylation pattern, leading to changes in gene expression. These epigenetic regulatory systems are called phasevarions — phase-variable regulons. The extent of these phase-variable genes in the bacterial kingdom is unknown. Here, we interrogated a database of restriction-modification systems, REBASE, by searching for all simple DNA sequence repeats in mod genes that encode Type III N6-adenine DNA-methyltransferases. We report that 17.4% of Type III mod genes (662/3805) contain simple sequence repeats. Of these, only one-fifth have been previously identified. The newly discovered examples are widely distributed and include many examples in opportunistic pathogens as well as in environmental species. In many cases, multiple phasevarions exist in one genome, with examples of up to 4 independent phasevarions in some species. We found several new types of phase-variable mod genes, including the first example of a phase-variable methyltransferase in pathogenic Escherichia coli. Phasevarions are a common epigenetic regulation contingency strategy used by both pathogenic and non-pathogenic bacteria. PMID:29554328

  15. Lapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trial

    DEFF Research Database (Denmark)

    Ravaud, Alain; Hawkins, Robert; Gardner, Jason P

    2008-01-01

    PURPOSE: Lapatinib is an orally reversible inhibitor of epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (HER-2) tyrosine kinases with demonstrated activity in patients with HER-2-positive breast cancer. In the current phase III open-label trial, lapatinib was comp...

  16. The Effects of PECS Teaching to Phase III on the Communicative Interactions between Children with Autism and Their Teachers

    Science.gov (United States)

    Carr, Deborah; Felce, Janet

    2007-01-01

    The study investigated the impact of mastery of the Picture Exchange Communication System (PECS) to Phase III, on the communications of children with autism. Children aged between 3 and 7 years, formed a PECS intervention group and a non-intervention control group. The intervention group received 15 h of PECS teaching over 5 weeks. Three 2-h…

  17. SPSP Phase III Recruiting, Selecting, and Developing Secure Power Systems Professionals: Behavioral Interview Guidelines by Job Roles

    Energy Technology Data Exchange (ETDEWEB)

    O' Neil, Lori Ross [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Conway, T. J. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Tobey, D. H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Greitzer, Frank L. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Dalton, Angela C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Pusey, Portia K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2015-03-01

    The Secure Power Systems Professional Phase III final report was released last year which an appendix of Behavioral Interview Guidelines by Job Roles. This new report is that appendix broken out as a standalone document to assist utilities in recruiting and developing Secure Power Systems Professionals at their site.

  18. Quantitative comparison of direct phase retrieval algorithms in in-line phase tomography

    International Nuclear Information System (INIS)

    Langer, Max; Cloetens, Peter; Guigay, Jean-Pierre; Peyrin, Francoise

    2008-01-01

    A well-known problem in x-ray microcomputed tomography is low sensitivity. Phase contrast imaging offers an increase of sensitivity of up to a factor of 10 3 in the hard x-ray region, which makes it possible to image soft tissue and small density variations. If a sufficiently coherent x-ray beam, such as that obtained from a third generation synchrotron, is used, phase contrast can be obtained by simply moving the detector downstream of the imaged object. This setup is known as in-line or propagation based phase contrast imaging. A quantitative relationship exists between the phase shift induced by the object and the recorded intensity and inversion of this relationship is called phase retrieval. Since the phase shift is proportional to projections through the three-dimensional refractive index distribution in the object, once the phase is retrieved, the refractive index can be reconstructed by using the phase as input to a tomographic reconstruction algorithm. A comparison between four phase retrieval algorithms is presented. The algorithms are based on the transport of intensity equation (TIE), transport of intensity equation for weak absorption, the contrast transfer function (CTF), and a mixed approach between the CTF and TIE, respectively. The compared methods all rely on linearization of the relationship between phase shift and recorded intensity to yield fast phase retrieval algorithms. The phase retrieval algorithms are compared using both simulated and experimental data, acquired at the European Synchrotron Radiation Facility third generation synchrotron light source. The algorithms are evaluated in terms of two different reconstruction error metrics. While being slightly less computationally effective, the mixed approach shows the best performance in terms of the chosen criteria.

  19. Assessing braze quality in the actively cooled Tore Supra phase III outboard pump limiter

    International Nuclear Information System (INIS)

    Hygren, R.; Lutz, T.; Miller, J.

    1994-01-01

    This paper discusses the assessment of quality of brazing of pyrolytic graphite (PG) armor brazed to copper tubes in Tore Supra's Phase III Outboard Pump Limiter (OPL). The limiter head is a bank of 14 water-cooled copper tubes with several hundred brazed PG tiles. Braze quality was first assessed through pre-service qualification testing of individual copper/tiles assemblies. The quality of brazes was evaluated using (non-destructive) transient heating (open-quotes hot waterclose quotes) tests performed in the high temperature, high pressure flow loop at Sandia's Plasma Materials Test Facility. The surface temperatures of tiles were monitored with an infra-red (IR) camera as water at 120 degrees C water at about 2.07 MPa (300 psi) passed through a tube assembly initially at 30 degrees C. For tiles with braze voids or cracks, the surface temperatures lagged behind those of adjacent well bonded tiles. Temperature lags were correlated with flaw sizes observed during repairs using a detailed 2-D heat transfer analyses. open-quotes Badclose quotes tiles, i.e., temperature lags of 10-20 degrees C depending upon tile's size, were easy to detect and, when removed, revealed braze voids of roughly 50% of the joint area. 11 of the 14 tubes were rebrazed after bad tiles were detected and removed. Three tubes were re-brazed twice

  20. Tier I ecological evaluation for phase III channel improvements to the John. F. Baldwin ship channel

    Energy Technology Data Exchange (ETDEWEB)

    Bienert, R.W.; Shreffler, D.K.; Word, J.Q.; Kohn, N.P. [Battelle/Marine Sciences Lab., Sequim, WA (United States)

    1994-05-01

    To assist the US Army Corps of Engineers (USACE) in determing whether the material from proposed dredging of the John F. Baldwin Ship Channel (JFBSC) is suitable for unrestricted, unconfined open-ocean disposal, Battelle/Marine Sciences Laboratory (MSL) prepared this report. Based on these findings, sediments that would be removed during Phase III improvements to the JFBSC fail to meet the three suitability criteria for open-ocean disposal. Firstly, fine-grained sediments comprise a significant fraction of the bottom material in some areas of the channel, and this material is not exposed to high current or wave energy. Dredged material from the JFBSC is not being proposed for beach nourishment; therefore the second criterion is not met. JFBSC sediments do not meet the third criterion because, although they may be substantially similar to substrates at several of the proposed disposal sites, they are from an area that historically has experienced loading of contaminants, which toxicology studies have shown have the potential to result in acute toxicity or significant bioaccumulation.

  1. SPIRIT: A seamless phase I/II randomized design for immunotherapy trials.

    Science.gov (United States)

    Guo, Beibei; Li, Daniel; Yuan, Ying

    2018-06-07

    Immunotherapy-treatments that enlist the immune system to battle tumors-has received widespread attention in cancer research. Due to its unique features and mechanisms for treating cancer, immunotherapy requires novel clinical trial designs. We propose a Bayesian seamless phase I/II randomized design for immunotherapy trials (SPIRIT) to find the optimal biological dose (OBD) defined in terms of the restricted mean survival time. We jointly model progression-free survival and the immune response. Progression-free survival is used as the primary endpoint to determine the OBD, and the immune response is used as an ancillary endpoint to quickly screen out futile doses. Toxicity is monitored throughout the trial. The design consists of two seamlessly connected stages. The first stage identifies a set of safe doses. The second stage adaptively randomizes patients to the safe doses identified and uses their progression-free survival and immune response to find the OBD. The simulation study shows that the SPIRIT has desirable operating characteristics and outperforms the conventional design. Copyright © 2018 John Wiley & Sons, Ltd.

  2. Solid phase extraction of Am (III) by resins impregnated with multiply diglycolamide-functionalized ligands

    International Nuclear Information System (INIS)

    Gujar, R.B.; Ansari, S.A.; Mohapatra, P.K.; Verboom, W.

    2016-01-01

    Solvent extraction studies with multiply diglycolamide-functionalized extractants such as tripodal diglycolamide (T-DGA) or diglycolamide-functionalized calix(4)arene (C4DGA) ligands have shown excellent results as compared to those of normal DGA ligands such as TODGA. A very high selectivity for Am(III) has been reported with these ligands with respect to U(VI) and Pu(IV). High selectivities and large extraction efficiencies of these ligands towards trivalent f elements were ascribed to a co-operative complexation mechanism. Furthermore, the extraction efficiency of these ligands increased several folds in ionic liquid medium as compared to paraffinic solvents. It was of interest, therefore, to prepare extraction chromatographic resins by impregnation of solvent systems containing these ligands in an ionic liquid. In the present work, solid phase extraction studies were carried out using these two multiply diglycolamide-functionalized extractants, viz. T-DGA (resin I) and C4DGA (resin-II) containing the ionic liquid C 4 mim. NTf 2 impregnated on Chromosorb-W

  3. Optimized FFTF Acceptance Test Program covering Phases III, IV, and V

    International Nuclear Information System (INIS)

    Wykoff, W.R.; Jones, D.H.

    1977-03-01

    A detailed review of Phases III, IV, and V of the FFTF Acceptance Test Program has been completed. The purpose of this review was to formulate that test sequence which not only meets requirements for safe, reliable and useful operation of the plant, but also results in the earliest prudent demonstration of full-power performance. A test sequence based on the underlying assumption that sodium flows into the secondary sodium storage tank (T-44) no later than August 31, 1978, is described in detail. A time-scale which allows extra time to put systems and equipment into operation the first time, debugging, and learning how to operate most effectively has been superimposed on the test sequence. Time is not included for major equipment malfunctions. This test plan provides the basis for coordinating the many and varied activities and interfaces necessary for successful and timely execution of the FFTF Acceptance Test Program. In this report, the need dates have been identified for presently scheduled test articles and standard core components

  4. Differences in Funding Sources of Phase III Oncology Clinical Trials by Treatment Modality and Cancer Type.

    Science.gov (United States)

    Jairam, Vikram; Yu, James B; Aneja, Sanjay; Wilson, Lynn D; Lloyd, Shane

    2017-06-01

    Given the limited resources available to conduct clinical trials, it is important to understand how trial sponsorship differs among different therapeutic modalities and cancer types and to consider the ramifications of these differences. We searched clinicaltrials.gov for a cross-sectional register of active, phase III, randomized controlled trials (RCTs) studying treatment-related endpoints such as survival and recurrence for the 24 most prevalent malignancies. We classified the RCTs into 7 categories of therapeutic modality: (1) chemotherapy/other cancer-directed drugs, (2) targeted therapy, (3) surgery, (4) radiation therapy (RT), (5) RT with other modalities, (6) multimodality therapy without RT, and (7) other. RCTs were categorized as being funded by one or more of the following groups: (1) government, (2) hospital/university, (3) industry, and (4) other. χ analysis was performed to detect differences in funding source distribution between modalities and cancer types. The percentage of multimodality trials (5%) and radiation RCTs (4%) funded by industry was less than that for chemotherapy (32%, Pfunding than any of the other modalities (Pfunded by industry if they also studied targeted therapy (Pfunded by industry than trials studying multimodality therapy or radiation. The impact of industry funding versus institutional or governmental sources of funding for cancer research is unclear and requires further study.

  5. Assessing braze quality in the actively cooled Tore Supra Phase III outboard pump limiter

    International Nuclear Information System (INIS)

    Nygren, R.E.; Lutz, T.L.; Miller, J.D.; McGrath, R.; Dale, G.

    1994-01-01

    The quality of brazing of pyrolytic graphite armor brazed to copper tubes in Tore Supra's Phase III Outboard Pump Limiter was assessed through pre-service qualification testing of individual copper/tile assemblies. The evaluation used non-destructive, hot water transient heating tests performed in the high-temperature, high-pressure flow loop at Sandia's Plasma Materials Test Facility. Surface temperatures of tiles were monitored with an infrared camera as water at 120 degrees C at about 2.07 MPa (300 psi) passed through a tube assembly initially at 30 degrees C. For tiles with braze voids or cracks, the surface temperatures tagged behind those of adjacent well-bonded tiles. Temperature tags were correlated with flaw sizes observed during repairs based upon a detailed 2-D heat transfer analyses. open-quotes Badclose quotes tiles, i.e., temperature tags of 10-20 degrees C depending upon tile's size, were easy to detect and, when removed, revealed braze voids of roughly 50% of the joint area. Eleven of the 14 tubes were rebrazed after bad tiles were detected and removed. Three tubes were rebrazed twice

  6. Growth, structure and phase transitions of epitaxial nanowires of III-V semiconductors

    International Nuclear Information System (INIS)

    Glas, F; Patriarche, G; Harmand, J C

    2010-01-01

    We review and illustrate the impact of TEM on the study of nanowires of non-nitride III-V semiconductors, with particular emphasis on the understanding of the thermodynamics and kinetics of their formation assisted by nano-sized catalyst particles. Besides providing basic information about the morphology of the nanowires and their growth rate as a function of diameter, TEM offers insights into the peculiar crystalline structure that they adopt. We discuss the formation of the unusual wurtzite hexagonal crystalline phase and that of planar stacking defects in these nanowires and show that they are kinetically controlled. We also demonstrate the transformation of wurtzite into cubic sphalerite upon epitaxial burying of the nanowires. Nanowires are particularly interesting in that they allow the fabrication of precisely positioned quantum dots with well-defined geometries. In this respect, we discuss the formation of strained quantum-size inclusions in nanowires, their critical dimensions and the kinetic and thermodynamic factors governing the changes of the crystalline structure that sometimes occur around a hetero-interface.

  7. SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

    International Nuclear Information System (INIS)

    Hurt, Christopher N; Nixon, Lisette S; Griffiths, Gareth O; Al-Mokhtar, Ruby; Gollins, Simon; Staffurth, John N; Phillips, Ceri J; Blazeby, Jane M; Crosby, Tom D

    2011-01-01

    and compare the overall survival of both groups. All patients randomised into Phase II will contribute to the Phase III comparison of overall survival. In addition to overall survival, Phase III of the study will also assess toxicity, health related quality of life and cost effectiveness. A detailed radiotherapy protocol and quality assurance procedure has been incorporated into this trial. ISRCTN: http://www.controlled-trials.com/ISRCTN47718479

  8. SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus

    Directory of Open Access Journals (Sweden)

    Staffurth John N

    2011-10-01

    stage will recruit a further 120 patients into each arm and compare the overall survival of both groups. All patients randomised into Phase II will contribute to the Phase III comparison of overall survival. In addition to overall survival, Phase III of the study will also assess toxicity, health related quality of life and cost effectiveness. A detailed radiotherapy protocol and quality assurance procedure has been incorporated into this trial. Trial registration ISRCTN: ISRCTN47718479

  9. Analysis of gas-liquid metal two-phase flows using a reactor safety analysis code SIMMER-III

    International Nuclear Information System (INIS)

    Suzuki, Tohru; Tobita, Yoshiharu; Kondo, Satoru; Saito, Yasushi; Mishima, Kaichiro

    2003-01-01

    SIMMER-III, a safety analysis code for liquid-metal fast reactors (LMFRs), includes a momentum exchange model based on conventional correlations for ordinary gas-liquid flows, such as an air-water system. From the viewpoint of safety evaluation of core disruptive accidents (CDAs) in LMFRs, we need to confirm that the code can predict the two-phase flow behaviors with high liquid-to-gas density ratios formed during a CDA. In the present study, the momentum exchange model of SIMMER-III was assessed and improved using experimental data of two-phase flows containing liquid metal, on which fundamental information, such as bubble shapes, void fractions and velocity fields, has been lacking. It was found that the original SIMMER-III can suitably represent high liquid-to-gas density ratio flows including ellipsoidal bubbles as seen in lower gas fluxes. In addition, the employment of Kataoka-Ishii's correlation has improved the accuracy of SIMMER-III for gas-liquid metal flows with cap-shape bubbles as identified in higher gas fluxes. Moreover, a new procedure, in which an appropriate drag coefficient can be automatically selected according to bubble shape, was developed. Through this work, the reliability and the precision of SIMMER-III have been much raised with regard to bubbly flows for various liquid-to-gas density ratios

  10. Long-Term Management Strategy for Dredged Material Disposal for Naval Facilities at Pearl Harbor, Hawaii Phase III - Analysis of Alternatives and Development of an LTMS

    National Research Council Canada - National Science Library

    Palermo, Michael

    2000-01-01

    This report documents Phase III of a three-phase study to develop a Long-Term Management Study for disposal of dredged material unsuitable for ocean disposal from Pearl Harbor Naval Complex for the next 30 years...

  11. Optimal scheme of postoperative chemoradiotherapy in rectal cancer: phase III prospective randomized trial

    International Nuclear Information System (INIS)

    Kim, Young Seok; Kim, Jong Hoon; Choi, Eun Kyung

    2002-01-01

    To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m 2 /day, leucovorin 20 mg/m 2 , IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% (ρ = 0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, ρ = 0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms (ρ = N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed

  12. A Multicenter Phase I/II Study of the BCNU Implant (Gliadel ® Wafer) for Japanese Patients with Malignant Gliomas

    Science.gov (United States)

    AOKI, Tomokazu; NISHIKAWA, Ryo; SUGIYAMA, Kazuhiko; NONOGUCHI, Naosuke; KAWABATA, Noriyuki; MISHIMA, Kazuhiko; ADACHI, Jun-ichi; KURISU, Kaoru; YAMASAKI, Fumiyuki; TOMINAGA, Teiji; KUMABE, Toshihiro; UEKI, Keisuke; HIGUCHI, Fumi; YAMAMOTO, Tetsuya; ISHIKAWA, Eiichi; TAKESHIMA, Hideo; YAMASHITA, Shinji; ARITA, Kazunori; HIRANO, Hirofumi; YAMADA, Shinobu; MATSUTANI, Masao

    2014-01-01

    Carmustine (BCNU) implants (Gliadel® Wafer, Eisai Inc., New Jersey, USA) for the treatment of malignant gliomas (MGs) were shown to enhance overall survival in comparison to placebo in controlled clinical trials in the United States and Europe. A prospective, multicenter phase I/II study involving Japanese patients with MGs was performed to evaluate the efficacy, safety, and pharmacokinetics of BCNU implants. The study enrolled 16 patients with newly diagnosed MGs and 8 patients with recurrent MGs. After the insertion of BCNU implants (8 sheets maximum, 61.6 mg BCNU) into the removal cavity, various chemotherapies (including temozolomide) and radiotherapies were applied. After placement, overall and progression-free survival rates and whole blood BCNU levels were evaluated. In patients with newly diagnosed MGs, the overall survival rates at 12 months and 24 months were 100.0% and 68.8%, and the progression-free survival rate at 12 months was 62.5%. In patients with recurrent MGs, the progression-free survival rate at 6 months was 37.5%. There were no grade 4 or higher adverse events noted due to BCNU implants, and grade 3 events were observed in 5 of 24 patients (20.8%). Whole blood BCNU levels reached a peak of 19.4 ng/mL approximately 3 hours after insertion, which was lower than 1/600 of the peak BCNU level recorded after intravenous injections. These levels decreased to less than the detection limit (2.00 ng/mL) after 24 hours. The results of this study involving Japanese patients are comparable to those of previous studies in the United States and Europe. PMID:24739422

  13. Utilization of modified corn silk as a biosorbent for solid-phase extraction of Cr(III) and chromium speciation.

    Science.gov (United States)

    Yu, Hongmei; Pang, Jing; Wu, Mei; Wu, Qiaoli; Huo, Cuixiu

    2014-01-01

    The ues of corn silk modified with diluted nitric acid (HNO3-MCS) as a novel biosorbent has been established for solid-phase extraction of Cr(III) and chromium speciation in water samples. The functional groups of the HNO3-MCS surface are favorable for the adsorption of Cr(III). Effective extraction conditions were optimized in both batch and column methods. At pH 3.0 - 6.0, a discrimination of Cr(III) and Cr(VI) is achieved on the HNO3-MCS surface. Cr(III) ions are retained onto the HNO3-MCS surface, however, the adsorption of Cr(VI) is negligible under the same conditions. The adsorption isotherm of HNO3-MCS for Cr(III) has been demonstrated in accordance with a linear form of the Langmuir equation, and the maximum adsorption capacity is 35.21 mg g(-1). The well fitted linear regression of the pseudo-second order model showed the indication of a chemisorption mechanism for the entire concentration range. Thermodynamic studies have shown that the adsorption process is spontaneous and endothermic. The adsorbed Cr(III) was quantitatively eluted by a nitric acid solution with detection by flame atomic absorption spectrometry (FAAS). With a sample volume of 30 mL, a detection limit (3σ) of 0.85 μg L(-1) and a precision of 2.0% RSD at the 40 μg L(-1) level were achieved. The concentration of Cr(III) could be accurately quantified within a linear range of 3 - 200 μg L(-1). After Cr(VI) has been reduced to Cr(III) with hydroxylamine hydrochloride, the total amount of chromium was obtained, and the content of Cr(VI) was given by subtraction. The procedure was validated by analyzing chromium in a certified reference material (GBW (E) 080039). It was also successfully applied for the speciation of chromium in wastewater samples.

  14. Study of complex formation of cobalt (II) and cobalt (III) in acrylamide aqueous solutions and in the phase of acrylamide hydrogel

    International Nuclear Information System (INIS)

    Ismailova, M.M.; Egorova, L.A.; Khamidov, B.O.

    1993-01-01

    Present article is devoted to study of complex formation of cobalt (II) and cobalt (III) in acrylamide aqueous solutions and in the phase of acrylamide hydrogel. The condition of cobalt in various rate of oxidation in acrylamide aqueous solutions was studied. The concentration conditions of stability of system Co(II)-Co(III) were defined. The composition of coordination compounds of cobalt (II) and cobalt (III) in acrylamide aqueous solutions and in the phase of acrylamide hydrogel was determined.

  15. How Accurately Do Consecutive Cohort Audits Predict Phase III Multisite Clinical Trial Recruitment in Palliative Care?

    Science.gov (United States)

    McCaffrey, Nikki; Fazekas, Belinda; Cutri, Natalie; Currow, David C

    2016-04-01

    Audits have been proposed for estimating possible recruitment rates to randomized controlled trials (RCTs), but few studies have compared audit data with subsequent recruitment rates. To compare the accuracy of estimates of potential recruitment from a retrospective consecutive cohort audit of actual participating sites and recruitment to four Phase III multisite clinical RCTs. The proportion of potentially eligible study participants estimated from an inpatient chart review of people with life-limiting illnesses referred to six Australian specialist palliative care services was compared with recruitment data extracted from study prescreening information from three sites that participated fully in four Palliative Care Clinical Studies Collaborative RCTs. The predominant reasons for ineligibility in the audit and RCTs were analyzed. The audit overestimated the proportion of people referred to the palliative care services who could participate in the RCTs (pain 17.7% vs. 1.2%, delirium 5.8% vs. 0.6%, anorexia 5.1% vs. 0.8%, and bowel obstruction 2.8% vs. 0.5%). Approximately 2% of the referral base was potentially eligible for these effectiveness studies. Ineligibility for general criteria (language, cognition, and geographic proximity) varied between studies, whereas the reasons for exclusion were similar between the audit and pain and anorexia studies but not for delirium or bowel obstruction. The retrospective consecutive case note audit in participating sites did not predict realistic recruitment rates, mostly underestimating the impact of study-specific inclusion criteria. These findings have implications for the applicability of the results of RCTs. Prospective pilot studies are more likely to predict actual recruitment. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  16. Diet and Respiratory Health in Children from 11 Latin American Countries: Evidence from ISAAC Phase III.

    Science.gov (United States)

    Cepeda, Alfonso Mario; Thawer, Sumaiyya; Boyle, Robert J; Villalba, Sara; Jaller, Rodolfo; Tapias, Elmy; Segura, Ana María; Villegas, Rodrigo; Garcia-Larsen, Vanessa

    2017-12-01

    The burden of childhood asthma and its risk factors is an important but neglected public health challenge in Latin America. We investigated the association between allergic symptoms and dietary intake in children from this region. As part of the International Study of Asthma and Allergies in Childhood (ISAAC) Phase III, questionnaire collected dietary intake was investigated in relation to risk of parental/child reported current wheeze (primary outcome) and rhino-conjunctivitis and eczema. Per-country adjusted logistic regressions were performed, and combined effect sizes were calculated with meta-analyses. 143,967 children from 11 countries had complete data. In children aged 6-7 years, current wheeze was negatively associated with higher fruit intake (adjusted odds ratio [aOR] 0.65; 95% CI 0.74, 0.97). Current rhino-conjunctivitis and eczema were statistically negatively associated with fruit intake (aOR 0.72; 95% CI 0.64, 0.82; and OR 0.64, 95% CI 0.56, 0.74, respectively). Vegetable intake was negatively associated with risk of symptoms in younger children, but these associations were attenuated in the 13-14 years old group. Fastfood/burger intake was positively associated with all three outcomes in the older children. A higher intake of fruits and vegetables was associated with a lower prevalence of allergic symptoms in Latin American children. Conversely, intake of fastfood was positively associated with a higher prevalence of wheeze in adolescents. Improved dietary habits in children might help reduce the epidemic of allergic symptoms in Latin America. Food interventions in asthmatic children are needed to evaluate the possible public health impact of a better diet on respiratory health.

  17. Combining dosimetry and toxicity: analysis of two UK phase III clinical trials

    International Nuclear Information System (INIS)

    Gulliford, Sarah L

    2014-01-01

    There are many advantages to performing a clinical trial when implementing a novel radiotherapy technique. The clinical trials framework enables the safety and efficacy of the 'experimental arm' to be tested and ensures practical support, rigorous quality control and data monitoring for participating centres. In addition to the clinical and follow-up data collected from patients within the trial, it is also possible to collect 3-D dosimetric information from the corresponding radiotherapy treatment plans. Analysing the combination of dosimetric, clinical and follow-up data enhances the understanding of the relationship between the dose delivered to both the target and normal tissue structures and reported outcomes and toxicity. Aspects of the collection, collation and analysis of data from two UK multicentre Phase III radiotherapy trials are presented here. MRC-RT01 dose-escalation prostate radiotherapy trial ISRCTN47772397 was one of the first UK multi-centre radiotherapy trials to collect 3-D dosimetric data. A number of different analysis methodologies were implemented to investigate the relationship between the dose distribution to the rectum and specific rectal toxicities. More recently data was collected from the PARSPORT trial (Parotid Sparing IMRT vs conventional head and neck radiotherapy) ISRCTN48243537. In addition to the planned analysis, dosimetric analysis was employed to investigate an unexpected finding that acute fatigue was more prevalent in the IMRT arm of the trial. It can be challenging to collect 3-D dosimetric information from multicentre radiotherapy trials. However, analysing the relationship between dosimetric and toxicity data provides invaluable information which can influence the next generation of radiotherapy techniques.

  18. A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients

    International Nuclear Information System (INIS)

    Chi, K.-H.; Chang, Y.-C.; Guo, W.-Y.; Leung, M.-J.; Shiau, C.-Y.; Chen, S.-Y; Wang, L.-W.; Lai, Y.-L.; Hsu, M.-M.; Lian, S.-L.; Chang, C.-H.; Liu, T.-W.; Chin, Y.-H.; Yen, S.-H.; Perng, C.-H.; Chen, Kuang Y.

    2002-01-01

    Purpose: To evaluate the role of adjuvant chemotherapy in locally advanced nasopharyngeal carcinoma (NPC) patients, we conducted a randomized Phase III trial comparing radiotherapy (RT) followed by adjuvant chemotherapy to RT alone in patients with advanced NPC. Methods and Materials: Between November 1994 and March 1999, 157 patients with Stage IV, M 0 (UICC/AJCC, 1992) advanced NPC disease were randomized to receive standard radiotherapy, as follows: 35-40 fractions, 1.8-2.0 Gy/fraction/day, 5 days/week, to a total dose 70-72 Gy with or without 9 weekly cycles of 24-h infusional chemotherapy (20 mg/m 2 cisplatin, 2,200 mg/m 2 5-fluorouracil, and 120 mg/m 2 leucovorin) after RT. Of 157 patients enrolled, 154 (77 radiotherapy, 77 combined therapy) were evaluable for survival and toxicity analysis. Results: With a median follow-up of 49.5 months, the 5-year overall survival and relapse-free survival rates were 60.5% vs. 54.5% (p = 0.5) and 49.5% vs. 54.4% (p = 0.38) for the radiotherapy-alone group and the combined radiotherapy and adjuvant chemotherapy group, respectively. The Cox regression showed that the hazard rates ratio of combined treatment to RT alone was 0.673 (p value = 0.232); the 95% confidence interval was 0.352 and 1.288, respectively. Patients who received combined treatment had a lower systemic relapse rate than radiotherapy-alone patients, according to relapse pattern analysis. The incidence of leukopenia (≥ Grade 3) occurred in 17 out of 819 (2.1%) cycles of weekly chemotherapy. No patient developed moderate to severe mucositis (≥ Grade 3). Conclusions: We conclude that adjuvant chemotherapy after RT for patients with advanced NPC has no benefit for overall survival or relapse-free survival

  19. Phase III study of ibuprofen versus placebo for radiation-induced genitourinary side effects

    International Nuclear Information System (INIS)

    Coleman, C. Norman; Kelly, Laura; Riese Daly, Nancy; Beard, Clair; Kaplan, Irving; Lamb, Carolyn; Propert, Kathleen; Manola, Judith

    2002-01-01

    Purpose: On the basis of our anecdotal clinical observations that nonsteroidal anti-inflammatory agents relieved dysuria during radiotherapy for patients with prostate cancer, we conducted a Phase III randomized trial of ibuprofen vs. placebo for patients who had an increase in acute urinary symptoms. Our in vitro and in vivo laboratory data with a higher concentration of ibuprofen than achievable in this study demonstrated radiosensitization. This study examined whether the inflammatory response within the prostate during radiotherapy would respond to the standard dose of ibuprofen as assessed by a symptom score. Methods and Materials: Patients were registered to the study and were followed weekly with a formal symptom assessment. A double-blind randomization to ibuprofen, 400 mg q.i.d., vs. placebo for 7 days was done at a time when the severity score increased. The symptom response was evaluated at the end of the week. Results: Between 1995 and 1998, 100 patients were entered, 28 did not have a sufficient change in symptom score to be randomized, and 19 were either unable to take ibuprofen or withdrew before randomization. Of the 53 patients randomized, 27 received placebo and 26 ibuprofen. No statistically significant differences were found between the placebo and ibuprofen groups between baseline and randomization or between randomization and the 1-week posttreatment assessment. Neither group had a change in symptom severity between randomization and the 1-week posttreatment evaluation. Conclusion: The standard anti-inflammatory dose of ibuprofen did not relieve the acute urinary or rectal symptoms during radiotherapy for prostate cancer. The nonsteroidal anti-inflammatory drugs are potential radiation sensitizers with the mechanism of action as yet unknown. Clinical trials of the cyclooxygenase inhibitors as radiation sensitizers should explore a range of doses and evaluate potential mechanisms of action, including cyclooxygenase inhibition and other non

  20. Steady-state heat and particle removal with the actively cooled Phase III outboard pump limiter in Tore Supra

    International Nuclear Information System (INIS)

    Nygren, R.; Koski, J.; Lutz, T.; McGrath; Miller, J.; Watkins, J.; Guilhem, D.; Chappuis, P.; Cordier, J.; Loarer, T.

    1995-01-01

    Tore Supra's Phase III outboard pump limiter (OPL) is a modular actively-cooled mid-plane limiter, designed for heat and particle removal during long pulse operation. During its initial operation in 1993, the OPL successfully removed about 1 MW of power during ohmicly heated shots of up to 10 s duration and reached (steady state) thermal equilibrium. The particle pumping of the Phase III OPL was found to be about 50% greater than the Phase II OPL which had a radial distance between the last closed flux surface and the entrance of the pumping throat of 3.5 cm compared with only 2.5 cm for the Phase III OPL. This paper gives examples of power distribution over the limiter from IR measurements of surface temperature and from extensively calorimetry (34 thermocouples and 10 flow meters) and compares the distributions with values predicted by a 3D model (HF3D) with a detailed magnetic configuration (e.g., includes field ripple). ((orig.))

  1. Motivation and participation in a phase III cardiac rehabilitation programme: an application of the health action process approach.

    Science.gov (United States)

    Dohnke, Birte; Nowossadeck, Enno; Müller-Fahrnow, Werner

    2010-10-01

    This longitudinal study extends the previous research on low participation rates and high dropout rates in phase III cardiac rehabilitation (CR) exercise programmes. It examines the correlates of motivation and participation 6 months after inpatient phase II CR (T1) and the predictors of dropout 6 months later (T2) using the health action process approach (HAPA). Risk perception, outcome expectancies, self-efficacy, intention (at T1), and participation (at T1 and T2) in relation to phase III CR programmes was assessed in 456 patients. Based on intention and participation at T1, patients were classified as nonintenders (56%), intenders (13%), or actors (31%). Group differences were confirmed in outcome expectancies and self-efficacy. By T2, 21% of T1 actors had dropped out. Dropouts and maintainers differed in intention and self-efficacy (at T1). Results are in line with the HAPA and suggest a perspective for tailoring motivational counselling to improve participation in phase III CR programmes.

  2. Ideal-MHD beta limits: scaling laws and comparison with Doublet III high-beta plasmas

    International Nuclear Information System (INIS)

    Bernard, L.C.; Bhadra, D.K.; Helton, F.J.; Lao, L.L.; Todd, T.N.

    1983-06-01

    Doublet III (DIII) recently has achieved a value for #betta#, the ratio of volume averaged plasma to magnetic pressure, of 4.5%. This #betta# value is in the range required for an economically attractive tokamak reactor, and also close to the relevant limit predicted by ideal-MHD theory. It is therefore of great interest to assess the validity of the theory by comparison with experiment and thus to have a basis for the prediction of future reactor performance. A large variety of plasma shapes have been obtained in DIII. These shapes can be divided into two classes: (1) limiter discharges, and (2) diverted discharges, which are of great interest because of their good confinement in the H-mode operation. We derive simple scaling laws from the variation of optimized ideal-MHD beta limits (#betta#/sub c/) with plasma shape parameters. The current profile is optimized for fixed plasma shapes, separately for the high-n (ballooning) and the low-n (kink) modes. Results are presented in the form of suitability normalized curves of #betta# versus poloidal beta, #betta#/sub p/, for both ballooning and kink modes in order to simultaneously compare all the DIII experimental data

  3. Remedial Design/Remedial Action Work Plan for Operable Units 6-05 and 10-04, Phase III

    Energy Technology Data Exchange (ETDEWEB)

    R. P. Wells

    2006-09-19

    The remedial design/remedial action for Operable Unit 6-05 (Waste Area Group 6) and Operable Unit 10-04 (Waste Area Group 10) - collectively called Operable Unit 10-04 has been divided into four phases. Phase I consists of developing and implementing institutional controls at Operable Unit 10-04 sites and developing and implementing Idaho National Laboratory-wide plans for both institutional controls and ecological monitoring. Phase II will remediate sites contaminated with trinitrotoluene and Royal Demolition Explosive. Phase III will remediate lead contamination at a gun range, and Phase IV will remediate hazards from unexploded ordnance. This Phase III remedial Design/Remedial Action Work Plan addresses the remediation of lead-contaminated soils found at the Security Training Facility (STF)-02 Gun Range located at the Idaho National Laboratory. Remediation of the STF-02 Gun Range will include excavating contaminated soils; physically separating copper and lead for recycling; returning separated soils below the remediation goal to the site; stabilizing contaminated soils, as required, and disposing of the separated soils that exceed the remediation goal; encapsulating and disposing of creosote-contaminated railroad ties and power poles; removing and disposing of the wooden building and asphalt pads found at the STF-02 Gun Range; sampling and analyzing soil to determine the excavation requirements; and when the remediation goals have been met, backfilling and contouring excavated areas and revegetating the affected area.

  4. TAILORING INORGANIC SORBENTS FOR SRS STRONTIUM AND ACTINIDE SEPARATIONS: MODIFIED MONOSODIUM TITANATE PHASE III FINAL REPORT

    Energy Technology Data Exchange (ETDEWEB)

    Taylor-Pashow, K.; Hobbs, D.

    2010-09-01

    This document provides a final report of Phase III testing activities for the development of modified monosodium titanate (mMST), which exhibits improved strontium and actinide removal characteristics compared to the baseline MST material. The activities included characterization of the crystalline phases present at varying temperatures, solids settling characteristics, quantification of the peroxide content; evaluation of the post-synthesis gas release under different conditions; the extent of desorption of {sup 85}Sr, Np, and Pu under washing conditions; and the effects of age and radiation on the performance of the mMST. Key findings and conclusions include the following. The peroxide content of several mMST samples was determined using iodometric titration. The peroxide content was found to decrease with age or upon extended exposure to elevated temperature. A loss of peroxide was also measured after exposure of the material to an alkaline salt solution similar in composition to the simulated waste solution. To determine if the loss of peroxide with age affects the performance of the material, Sr and actinide removal tests were conducted with samples of varying age. The oldest sample (4 years and 8 months) did show lower Sr and Pu removal performance. When compared to the youngest sample tested (1 month), the oldest sample retained only 15% of the DF for Pu. Previous testing with this sample indicated no decrease in Pu removal performance up to an age of 30 months. No loss in Np removal performance was observed for any of the aged samples, and no uptake of uranium occurred at the typical sorbent loading of 0.2 g/L. Additional testing with a uranium only simulant and higher mMST loading (3.0 g/L) indicated a 10% increase of uranium uptake for a sample aged 3 years and 8 months when compared to the results of the same sample measured at an age of 1 year and 5 months. Performance testing with both baseline-MST and mMST that had been irradiated in a gamma source to

  5. Waste retrieval sluicing system vapor sampling and analysis plan for evaluation of organic emissions, process test phase III

    International Nuclear Information System (INIS)

    SASAKI, L.M.

    1999-01-01

    This sampling and analysis plan identifies characterization objectives pertaining to sample collection, laboratory analytical evaluation, and reporting requirements for vapor samples obtained to address vapor issues related to the sluicing of tank 241-C-106. Sampling will be performed in accordance with Waste Retrieval Sluicing System Emissions Collection Phase III (Jones 1999) and Process Test Plan Phase III, Waste Retrieval Sluicing System Emissions Collection (Powers 1999). Analytical requirements include those specified in Request for Ecology Concurrence on Draft Strategy/Path Forward to Address Concerns Regarding Organic Emissions from C-106 Sluicing Activities (Peterson 1998). The Waste Retrieval Sluicing System was installed to retrieve and transfer high-heat sludge from tank 241-C-106 to tank 241-AY-102, which is designed for high-heat waste storage. During initial sluicing of tank 241-C-106 in November 1998, operations were halted due to detection of unexpected high volatile organic compounds in emissions that exceeded regulatory permit limits. Several workers also reported smelling sharp odors and throat irritation. Vapor grab samples from the 296-C-006 ventilation system were taken as soon as possible after detection; the analyses indicated that volatile and semi-volatile organic compounds were present. In December 1998, a process test (phase I) was conducted in which the pumps in tanks 241-C-106 and 241-AY-102 were operated and vapor samples obtained to determine constituents that may be present during active sluicing of tank 241-C-106. The process test was suspended when a jumper leak was detected. On March 7, 1999, phase I1 of the process test was performed; the sluicing system was operated for approximately 7 hours and was ended using the controlled shutdown method when the allowable amount of solids were transferred to 241-AY-102. The phase II test was successful, however, further testing is required to obtain vapor samples at higher emission levels

  6. Auditory phase and frequency discrimination: a comparison of nine procedures.

    Science.gov (United States)

    Creelman, C D; Macmillan, N A

    1979-02-01

    Two auditory discrimination tasks were thoroughly investigated: discrimination of frequency differences from a sinusoidal signal of 200 Hz and discrimination of differences in relative phase of mixed sinusoids of 200 Hz and 400 Hz. For each task psychometric functions were constructed for three observers, using nine different psychophysical measurement procedures. These procedures included yes-no, two-interval forced-choice, and various fixed- and variable-standard designs that investigators have used in recent years. The data showed wide ranges of apparent sensitivity. For frequency discrimination, models derived from signal detection theory for each psychophysical procedure seem to account for the performance differences. For phase discrimination the models do not account for the data. We conclude that for some discriminative continua the assumptions of signal detection theory are appropriate, and underlying sensitivity may be derived from raw data by appropriate transformations. For other continua the models of signal detection theory are probably inappropriate; we speculate that phase might be discriminable only on the basis of comparison or change and suggest some tests of our hypothesis.

  7. Novel concepts for the compression of large volumes of carbon dioxide-phase III

    Energy Technology Data Exchange (ETDEWEB)

    Moore, J. Jeffrey [Southwest Research Inst., San Antonio, TX (United States); Allison, Timothy C. [Southwest Research Inst., San Antonio, TX (United States); Evans, Neal D. [Southwest Research Inst., San Antonio, TX (United States); Moreland, Brian [Southwest Research Inst., San Antonio, TX (United States); Hernandez, Augusto J. [Southwest Research Inst., San Antonio, TX (United States); Day, Meera [Southwest Research Inst., San Antonio, TX (United States); Ridens, Brandon L. [Southwest Research Inst., San Antonio, TX (United States)

    2014-06-30

    and tested in a closed loop compressor facility using CO2 . Both test programs successfully demonstrated good performance and mechanical behavior. In Phase III, a pilot compression plant consisting of a multi-stage centrifugal compressor with cooled diaphragm technology has been designed, constructed, and tested. Comparative testing of adiabatic and cooled tests at equivalent inlet conditions shows that the cooled diaphragms reduce power consumption by 3-8% when the compressor is operated as a back-to-back unit and by up to 9% when operated as a straight-though compressor with no intercooler. The power savings, heat exchanger effectiveness, and temperature drops for the cooled diaphragm were all slightly higher than predicted values but showed the same trends.

  8. Analysis of Reasons for fluctuation in seal oil system on generator and countermeasures in Qinshan phase III project

    International Nuclear Information System (INIS)

    Jin Xiaodong

    2012-01-01

    Reasons for hydraulic differential fluctuations seal hydrogen oil on generator in Qinshan phase III project were analyzed, provide a basis for modifying Run method is to determine the causes and effects of seal oil flow changes and in the relationship between flow changes and hydraulic differential hydrogen oil changes according to reason Results were analyzed to adjust the running test, to verify the feasibility of running adjustment programs

  9. Stakeholder perspectives on the use of positron emission tomography in phase III oncology trials in the UK.

    Science.gov (United States)

    Rojas-Anaya, Hector; Skogen, Karoline; Miles, Kenneth Alan

    2012-06-01

    To identify factors that influence the use of PET in phase III oncology trials in the UK by evaluating stakeholder perspectives. A wide range of UK PET research stakeholders with a potential interest in the use of PET in phase III trials were identified and invited to participate. These UK PET research stakeholders were consulted using a semistructured questionnaire on their personal experience with and involvement in PET research, the role of PET in phase III oncology clinical trials and on the promotion of UK PET research and unmet clinical needs in oncology. Responses were analysed quantitatively and by qualitative content analysis of free-text responses. A total of 118 responses were received from a wide range of stakeholders representing several professional groups and working environments. Of these respondents, 49 (42%) were using PET in their research. There was the general perception that using PET in clinical research is beneficial in oncology. The two major barriers identified were poor availability of PET and perceived difficulties in funding of excess treatment costs (75% of respondents). Other factors included limited coverage of PET in training, uncertainty about developing imaging protocols or the status of tracers other than 18F-fluorodeoxyglucose, and low awareness of the role of PET in patient selection for therapeutic trials. Patient concerns about radiation were not perceived as a research barrier. Interventions that improve the availability and funding pathways for PET research scans and that increase researcher awareness could help promote the use of PET for phase III oncology trials in the UK.

  10. High Efficiency Quantum Dot III-V Multijunction Solar Cell for Space Power, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — We are proposing to utilize quantum dots to develop a super high-efficiency multijunction III-V solar cell for space. In metamorphic triple junction space solar...

  11. Twenty-seven years of phase III trials for patients with extensive disease small-cell lung cancer: disappointing results.

    Directory of Open Access Journals (Sweden)

    Isao Oze

    Full Text Available BACKGROUND: Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials. METHODS AND FINDINGS: We searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. RESULTS: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine-based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome. CONCLUSIONS AND SIGNIFICANCE: The survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.

  12. Broadband microwave photonic fully tunable filter using a single heterogeneously integrated III-V/SOI-microdisk-based phase shifter.

    Science.gov (United States)

    Lloret, Juan; Morthier, Geert; Ramos, Francisco; Sales, Salvador; Van Thourhout, Dries; Spuesens, Thijs; Olivier, Nicolas; Fédéli, Jean-Marc; Capmany, José

    2012-05-07

    A broadband microwave photonic phase shifter based on a single III-V microdisk resonator heterogeneously integrated on and coupled to a nanophotonic silicon-on-insulator waveguide is reported. The phase shift tunability is accomplished by modifying the effective index through carrier injection. A comprehensive semi-analytical model aiming at predicting its behavior is formulated and confirmed by measurements. Quasi-linear and continuously tunable 2π phase shifts at radiofrequencies greater than 18 GHz are experimentally demonstrated. The phase shifter performance is also evaluated when used as a key element in tunable filtering schemes. Distortion-free and wideband filtering responses with a tuning range of ~100% over the free spectral range are obtained.

  13. Preoperative hyperfractionated radiotherapy for locally advanced rectal cancers: a phase I-II trial

    International Nuclear Information System (INIS)

    Allal, Abdelkarim S.; Bieri, Sabine; Bruendler, Marie-Anne; Soravia, Claudio; Gertsch, Philippe; Bernier, Jacques; Morel, Philippe; Roth, Arnaud D.

    2002-01-01

    Purpose: To assess the toxicity, pathologic response rates, type of surgery, and oncologic results in a prospective Phase I-II trial using pure hyperfractionated radiotherapy (RT) preoperatively in locally advanced rectal cancer. Methods and Materials: Between September 1997 and April 2000, 50 patients with T3-T4 or N1 rectal cancers were treated preoperatively with 50 Gy (45 Gy to the pelvis and a 5-Gy tumor boost) in 40 fractions of 1.25 Gy during 4 weeks. The pretreatment tumor stage as determined by CT and endorectal ultrasonography (80% of patients) included 1 Stage T2 (2%), 45 T3 (90%), and 4 T4 (8%). Nodal involvement (N1) was documented in 26 patients (52%). Surgery was performed at a median interval of 45 days (range 26-114 days) after RT completion. Seventeen patients who presented with pT4 or pN1 and/or pM1 received 5-fluorouracil-based chemotherapy postoperatively. Results: All patients completed the RT schedule as planned. Severe acute toxicities included two Grade 3 skin reactions (4%) that did not require a break. The other acute toxicities were Grade 2 or less (skin, diarrhea, urinary, rectal tenesmus, and fatigue). A complete pathologic response was observed in 7 patients (14%), and microscopic residual cancer was found in 10 (20%). Of the 20 patients presenting with tumor located ≤6 cm from the anal verge, sphincter-saving surgery was performed in 14 (70%). At 3 years, the actuarial locoregional control rate was 90.5%, and the disease-free survival rate was 74.6%. At a median follow-up of 32 months, 4 patients (8%) presented with severe late complications (Grade 3-4) that might have been RT related (one rectovaginal fistula, two chronic perineal fistulas, and one bilateral ureteral stenosis). Conclusion: In locally advanced rectal cancer, preoperative hyperfractionated RT to a total dose of 50 Gy is feasible, with acceptable acute and late toxicity and an objective downstaging effect. In view of these results, this schedule might be used as a

  14. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1.

    Science.gov (United States)

    Smith, Matthew; De Bono, Johann; Sternberg, Cora; Le Moulec, Sylvestre; Oudard, Stéphane; De Giorgi, Ugo; Krainer, Michael; Bergman, Andries; Hoelzer, Wolfgang; De Wit, Ronald; Bögemann, Martin; Saad, Fred; Cruciani, Giorgio; Thiery-Vuillemin, Antoine; Feyerabend, Susan; Miller, Kurt; Houédé, Nadine; Hussain, Syed; Lam, Elaine; Polikoff, Jonathan; Stenzl, Arnulf; Mainwaring, Paul; Ramies, David; Hessel, Colin; Weitzman, Aaron; Fizazi, Karim

    2016-09-01

    Cabozantinib is an inhibitor of kinases, including MET and vascular endothelial growth factor receptors, and has shown activity in men with previously treated metastatic castration-resistant prostate cancer (mCRPC). This blinded phase III trial compared cabozantinib with prednisone in patients with mCRPC. Men with progressive mCRPC after docetaxel and abiraterone and/or enzalutamide were randomly assigned at a two-to-one ratio to cabozantinib 60 mg once per day or prednisone 5 mg twice per day. The primary end point was overall survival (OS). Bone scan response (BSR) at week 12 as assessed by independent review committee was the secondary end point; radiographic progression-free survival (rPFS) and effects on circulating tumor cells (CTCs), bone biomarkers, serum prostate-specific antigen (PSA), and symptomatic skeletal events (SSEs) were exploratory assessments. A total of 1,028 patients were randomly assigned to cabozantinib (n = 682) or prednisone (n = 346). Median OS was 11.0 months with cabozantinib and 9.8 months with prednisone (hazard ratio, 0.90; 95% CI, 0.76 to 1.06; stratified log-rank P = .213). BSR at week 12 favored cabozantinib (42% v 3%; stratified Cochran-Mantel-Haenszel P < .001). rPFS was improved in the cabozantinib group (median, 5.6 v 2.8 months; hazard ratio, 0.48; 95% CI, 0.40 to 0.57; stratified log-rank P < .001). Cabozantinib was associated with improvements in CTC conversion, bone biomarkers, and post-random assignment incidence of SSEs but not PSA outcomes. Grade 3 to 4 adverse events and discontinuations because of adverse events were higher with cabozantinib than with prednisone (71% v 56% and 33% v 12%, respectively). Cabozantinib did not significantly improve OS compared with prednisone in heavily treated patients with mCRPC and progressive disease after docetaxel and abiraterone and/or enzalutamide. Cabozantinib had some activity in improving BSR, rPFS, SSEs, CTC conversions, and bone biomarkers but not PSA outcomes. © 2016 by

  15. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial.

    Science.gov (United States)

    Cheng, Ann-Lii; Kang, Yoon-Koo; Lin, Deng-Yn; Park, Joong-Won; Kudo, Masatoshi; Qin, Shukui; Chung, Hyun-Cheol; Song, Xiangqun; Xu, Jianming; Poggi, Guido; Omata, Masao; Pitman Lowenthal, Susan; Lanzalone, Silvana; Yang, Liqiang; Lechuga, Maria Jose; Raymond, Eric

    2013-11-10

    Open-label, phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer. Patients were stratified and randomly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day. Primary end point was overall survival (OS). Early trial termination occurred for futility and safety reasons. A total of 1,074 patients were randomly assigned to the study (sunitinib arm, n = 530; sorafenib arm, n = 544). For sunitinib and sorafenib, respectively, median OS was 7.9 versus 10.2 months (hazard ratio [HR], 1.30; one-sided P = .9990; two-sided P = .0014); median progression-free survival (PFS; 3.6 v 3.0 months; HR, 1.13; one-sided P = .8785; two-sided P = .2286) and time to progression (TTP; 4.1 v 3.8 months; HR, 1.13; one-sided P = .8312; two-sided P = .3082) were comparable. Median OS was similar among Asian (7.7 v 8.8 months; HR, 1.21; one-sided P = .9829) and hepatitis B-infected patients (7.6 v 8.0 months; HR, 1.10; one-sided P = .8286), but was shorter with sunitinib in hepatitis C-infected patients (9.2 v 17.6 months; HR, 1.52; one-sided P = .9835). Sunitinib was associated with more frequent and severe adverse events (AEs) than sorafenib. Common grade 3/4 AEs were thrombocytopenia (29.7%) and neutropenia (25.7%) for sunitinib; hand-foot syndrome (21.2%) for sorafenib. Discontinuations owing to AEs were similar (sunitinib, 13.3%; sorafenib, 12.7%). OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib. OS was comparable in Asian and hepatitis B-infected patients. OS was superior in hepatitis C-infected patients who received sorafenib. Sunitinib-treated patients reported more frequent and severe toxicity.

  16. Clinical Signatures of Mucinous and Poorly Differentiated Subtypes of Colorectal Adenocarcinomas by a Propensity Score Analysis of an Independent Patient Database from Three Phase III Trials.

    Science.gov (United States)

    Kanda, Mitsuro; Oba, Koji; Aoyama, Toru; Kashiwabara, Kosuke; Mayanagi, Shuhei; Maeda, Hiromichi; Honda, Michitaka; Hamada, Chikuma; Sadahiro, Sotaro; Sakamoto, Junichi; Saji, Shigetoyo; Yoshikawa, Takaki

    2018-04-01

    Although colorectal cancer comprises several histological subtypes, the influences of histological subtypes on disease progression and treatment responses remain controversial. We sought to evaluate the prognostic relevance of mucinous and poorly differentiated histological subtypes of colorectal cancer by the propensity score weighting analysis of prospectively collected data from multi-institute phase III trials. Independent patient data analysis of a pooled database from 3 phase III trials was performed. An integrated database of 3 multicenter prospective clinical trials (the Japanese Foundation for Multidisciplinary Treatment of Cancer 7, 15, and 33) was the source of study data. Surgery alone or postoperative adjuvant chemotherapy was offered in patients with resectable colorectal cancer. To balance essential variables more strictly for the comparison analyses, propensity score weighting was conducted with the use of a multinomial logistic regression model. We evaluated the clinical signatures of mucinous and poorly differentiated subtypes with regard to postoperative survival, recurrence, and chemosensitivity. Of 5489 patients, 136 (2.5%) and 155 (2.8%) were pathologically diagnosed with poorly differentiated and mucinous subtypes. The poorly differentiated subtypes were associated with a poorer prognosis than the "others" group (HR, 1.69; 95% CI, 1.00-2.87; p = 0.051), particularly in the patient subgroup of adjuvant chemotherapy (HR, 2.16). Although the mucinous subtype had a marginal prognostic impact among patients with stage I to III colorectal cancer (HR, 1.33; 95% CI, 0.90-1.96), it was found to be an independent prognostic factor in the subpopulation of patients with stage II disease, being associated with a higher prevalence of peritoneal recurrence. The treatment regimens of postoperative chemotherapy are now somewhat outdated. Both mucinous and poorly differentiated subtypes have distinct clinical characteristics. Patients with the mucinous subtype

  17. Delta phase plutonium and its alloys with III B elements: a microscopic study

    International Nuclear Information System (INIS)

    Bouchet, J.

    2001-01-01

    The plutonium belongs to the actinides where it occupies a crucial place. In the actinide series the competition between the itinerant and local character of the f-electrons is responsible of its unique properties. The series can be divided into two sub-series: the light ( 90 Th- 94 Pu) and the heavy ( 95 Am and beyond) actinides with very different characteristics. The volume behavior of the light actinides is very similar to the one found for the transitions metals with a parabolic decrease of the volume as a function of atomic number. This trend can be explained by the itinerant character of the 5 f electrons which participate to the chemical bonding, and thus the light actinides are considered to form a 5 f transition series. The density functional theory in the local-density approximation (LDA) gives a good description of the ground state of the light actinides in agreement with experiment and a simple Friedel model can explain the parabolic decrease of the volumes. As for heavy actinides, the pattern is reversed: 5 f electrons are localized. This picture places plutonium as the link between the two series, at the transition from delocalized to localized states. The density functional theory within the local density approximation is a very crude approximation for these systems where the on-site interaction between f electrons is strong enough to overcome the kinetic energy. Equilibrium properties for the δ-phase of Pu have been calculated. Taking into account strong electron correlations in the 5 f shell, we show how the equilibrium volume and the bulk modulus are improved in comparison to previous results using the local density approximation (LDA) or the generalized gradient approximation (GGA). In addition, an augmentation of the orbital moment is observed due to the respect of Hund's rules, reducing the total magnetic moment. The stability of the δ-phase is explored and for the first time a positive value for the tetragonal shear constant is found. The

  18. Maxillary Transverse Comparison of Skeletal Class I and Class III Patient Populations Using Cone Beam Computed Tomography

    Science.gov (United States)

    2012-04-13

    dental compensations 5. Have fully erupted canines (no...expansion. Compendium 1996;17:170-178. 2. Basaran G, Hamamci N, Hamamci O. Comparison of Dental Arch Widths in Different Types of Malocclusions . World... Dental and Alveolar Arch Widths in Normal Occlusion and Class III Malocclusion . Angle Orthod 2005; 75:809- 813.   36. Vanarsdall, Transverse dimension and long-term stability, Semin Orthod 1999;5:171–180.

  19. Model for the ready definition and approximate comparison of alternative high voltage transmission systems. Phases II and III. Application to electric systems within the contiguous United States. [800 and 1200 kV; 400, 600, and 800 kV dc

    Energy Technology Data Exchange (ETDEWEB)

    1979-08-01

    Research on power delivery alternatives is reported. The first phase of this work was to develop a model of overhead transmission systems in the range of 362 to 1200 kV ac, and +-400 to +-800 kV dc. Such systems included transmission from generation to load and inter-connection of two large integrated systems, with and without the existence of an underlying lower voltage network in either case. This phase has been completed. The second and third phases involved application of the model to electric systems within selected regions of the US, and the entire US, respectively, dealing with real situations and including projected expansion to year 1987. The potential benefits and costs of using higher than existing transmission voltages were to be evaluated on this basis. Additionally, the most advantageous new voltage was to be determined taking into account direct and indirect benefits and costs. The results of the second and third phases are presented.

  20. Aerosol extinction profiles at 525 nm and 1020 nm derived from ACE imager data: comparisons with GOMOS, SAGE II, SAGE III, POAM III, and OSIRIS

    Directory of Open Access Journals (Sweden)

    F. Vanhellemont

    2008-04-01

    Full Text Available The Canadian ACE (Atmospheric Chemistry Experiment mission is dedicated to the retrieval of a large number of atmospheric trace gas species using the solar occultation technique in the infrared and UV/visible spectral domain. However, two additional solar disk imagers (at 525 nm and 1020 nm were added for a number of reasons, including the retrieval of aerosol and cloud products. In this paper, we present first comparison results for these imager aerosol/cloud optical extinction coefficient profiles, with the ones derived from measurements performed by 3 solar occultation instruments (SAGE II, SAGE III, POAM III, one stellar occultation instrument (GOMOS and one limb sounder (OSIRIS. The results indicate that the ACE imager profiles are of good quality in the upper troposphere/lower stratosphere, although the aerosol extinction for the visible channel at 525 nm contains a significant negative bias at higher altitudes, while the relative differences indicate that ACE profiles are almost always too high at 1020 nm. Both problems are probably related to ACE imager instrumental issues.

  1. Neighborhood crime and transit station access mode choice - phase III of neighborhood crime and travel behavior.

    Science.gov (United States)

    2015-08-01

    This report provides the findings from the third phase of a three-part study about the influences of neighborhood crimes on travel : mode choice. While previous phases found evidence that high levels of neighborhood crime discourage people from choos...

  2. The costs and effectiveness of large Phase III pre-licensure vaccine clinical trials.

    Science.gov (United States)

    Black, Steven

    2015-01-01

    Prior to the 1980s, most vaccines were licensed based upon safety and effectiveness studies in several hundred individuals. Beginning with the evaluation of Haemophilus influenzae type b conjugate vaccines, much larger pre-licensure trials became common. The pre-licensure trial for Haemophilus influenzae oligosaccharide conjugate vaccine had more than 60,000 children and that of the seven-valent pneumococcal conjugate vaccine included almost 38,000 children. Although trial sizes for both of these studies were driven by the sample size required to demonstrate efficacy, the sample size requirements for safety evaluations of other vaccines have subsequently increased. With the demonstration of an increased risk of intussusception following the Rotashield brand rotavirus vaccine, this trend has continued. However, routinely requiring safety studies of 20,000-50,000 or more participants has two major downsides. First, the cost of performing large safety trials routinely prior to licensure of a vaccine is very large, with some estimates as high at US$200 million euros for one vaccine. This high financial cost engenders an opportunity cost whereby the number of vaccines that a company is willing or able to develop to meet public health needs becomes limited by this financial barrier. The second downside is that in the pre-licensure setting, such studies are very time consuming and delay the availability of a beneficial vaccine substantially. One might argue that in some situations, this financial commitment is warranted such as for evaluations of the risk of intussusception following newer rotavirus vaccines. However, it must be noted that while an increased risk of intussusception was not identified in large pre-licensure studies, in post marketing evaluations an increased risk of this outcome has been identified. Thus, even the extensive pre-licensure evaluations conducted did not identify an associated risk. The limitations of large Phase III trials have also been

  3. Phase II study of ipilimumab in adolescents with unresectable stage III or IV malignant melanoma

    DEFF Research Database (Denmark)

    Geoerger, Birgit; Bergeron, Christophe; Gore, Lia

    2017-01-01

    BACKGROUND: Ipilimumab is approved for the treatment of advanced melanoma in adults; however, little information on the efficacy and safety of ipilimumab in younger patients is available. METHODS: Patients aged 12 to <18 years with previously treated or untreated, unresectable stage III or IV mal...

  4. Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders

    Science.gov (United States)

    2017-11-15

    Hurler Syndrome (MPS I); Hurler-Scheie Syndrome; Hunter Syndrome (MPS II); Sanfilippo Syndrome (MPS III); Krabbe Disease (Globoid Leukodystrophy); Metachromatic Leukodystrophy (MLD); Adrenoleukodystrophy (ALD and AMN); Sandhoff Disease; Tay Sachs Disease; Pelizaeus Merzbacher (PMD); Niemann-Pick Disease; Alpha-mannosidosis

  5. Enhanced Cr(VI) reduction and As(III) oxidation in ice phase: Important role of dissolved organic matter from biochar

    Energy Technology Data Exchange (ETDEWEB)

    Dong, Xiaoling [Department of Soil and Water Science, University of Florida, Gainesville, FL 32611 (United States); Ma, Lena Q., E-mail: lqma@ufl.edu [State Key Laboratory of Pollution Control and Resource Reuse, School of the Environment, Nanjing University, Jiangsu 210046 (China); Department of Soil and Water Science, University of Florida, Gainesville, FL 32611 (United States); Gress, Julia; Harris, Willie [Department of Soil and Water Science, University of Florida, Gainesville, FL 32611 (United States); Li, Yuncong [Soil and Water Science Department, Tropical Research and Education Center, University of Florida, Homestead, FL 33031-3314 (United States)

    2014-02-01

    Graphical abstract: - Highlights: • Biochar-derived dissolved organic matter (DOM) effectively reduced Cr(VI) and oxidized As(III). • Cr(VI) and As(III) could serve as a redox couple. • Cr(VI) and As(III) redox conversion was more effective in the ice phase than aqueous phase. • FTIR and ESR showed that biochar DOM served as both electron donor and acceptor. - Abstract: This study evaluated the impact of DOM from two biochars (sugar beet tailing and Brazilian pepper) on Cr(VI) reduction and As(III) oxidation in both ice and aqueous phases with a soil DOM as control. Increasing DOM concentration from 3 to 300 mg C L{sup −1} enhanced Cr(VI) reduction from 20% to 100% and As(III) oxidation from 6.2% to 25%; however, Cr(VI) reduction decreased from 80–86% to negligible while As(III) oxidation increased from negligible to 18–19% with increasing pH from 2 to 10. Electron spin resonance study suggested semiquinone radicals in DOM were involved in As(III) oxidation while Fourier transform infrared analysis suggested that carboxylic groups in DOM participated in both Cr(VI) reduction and As(III) oxidation. During Cr(VI) reduction, part of DOM (∼10%) was oxidized to CO{sub 2}. The enhanced conversion of Cr(VI) and As(III) in the ice phase was due to the freeze concentration effect with elevated concentrations of electron donors and electron acceptors in the grain boundary. Though DOM enhanced both Cr(VI) reduction and As(III)oxidation, Cr(VI) reduction coupled with As(III) oxidation occurred in absence of DOM. The role of DOM, Cr(VI) and/or As(III) in Cr and As transformation may provide new insights into their speciation and toxicity in cold regions.

  6. Comparison between MARCH-3 and MAAP-3 thermal-hydraulic results for a severe accident in a BWR system with MARK-III containment

    International Nuclear Information System (INIS)

    Barbucci, P.; Guidi, L.; Mariotti, G.

    1988-01-01

    A comparison between results provided by the Source Term Code Package and by the MAAP-3 code for a PWR with full pressure containment was presented. Thereafter the same two methodologies were used to analyse a severe accident sequence in a typical BWR power plant equipped with a General Electric BWR 6 reactor, rated at 2894 MWt, and a MARK-III type containment. As a reference sequence the TQUV was chosen. This sequence is characterized by a transient (T) with loss of feedwater (Q) and loss of all Emergency Core Cooling Systems, both at high pressure (U) and, after the intervention of the Automatic Depressurization System (ADS), at low pressure (V). After the vessel, failure two basic scenarios for the containment response were analysed: in the first one the pedestal is always dry, in the second one it is fully flooded. Typical limestone/common sand and basaltic concrete compositions were considered. In the following sections the obtained results will be shown with the main purpose to point out the different phenomenological models of the two codes rather than to look for the true plant response to such a severe accident. After the presentation of the most important physical models and of the main assumptions for the analyses (sects. 2 and 4), the comparison will be performed for the in-vessel phase, in section 3, and for the ex-vessel phase, in section 5

  7. ISP42 (PANDA Tests) - Blind Phase Comparison Report

    International Nuclear Information System (INIS)

    Luebbesmeyer, D.; Aksan, S.N.

    2003-05-01

    The International Standard Problem (ISP) No. 45 is part of the overall ISP program of the OECD/NEA and is dedicated to the behavior of heat-up and delayed reflood of fuel elements in nuclear reactors during a hypothetical accident. ISP-45 is related to the out-of-pile bundle quench experiment QUENCH-06, performed at Forschungszentrum Karlsruhe (FZK), Germany, on December 13, 2000. Special attention was paid to hydrogen production. To assess the ability of severe accident codes to simulate processes during core heat-up and reflood at temperatures above 2000 K, the behavior of the bundle during the whole experiment should be calculated on the basis of the necessary experimental initial and boundary conditions, but without knowing further experimental details. In this so-called blind phase 21 participants from 15 nations contributed with 8 different code systems (ATHLET-CD, ICARE/CATHARE, IMPACT/SAMPSON, GENFLO, MAAP, MELCOR, SCDAPSIM, SCDAP-3D). Additionally, posttest calculations using the in-house version SCDAP/RELAP5 mod3.2.irs are used for comparison. After the end of the blind phase all measured data were made available and the participants were invited to deliver a second calculation, where this knowledge could be used (so called open phase). In this report, results of the blind calculations are presented, analyzed, and compared to experimental data. During heat-up most results do not deviate significantly from one another, except as a consequence of some obvious user errors, so that a definition of a mainstream is justified. For the quench phase the lack of adequate hydraulic modeling becomes obvious: some participants could not match the observed cool-down rates, others had to use very fine meshes to compensate code deficiencies. To overcome this insufficiency some newly developed reflood models were used in MAAP and MELCOR. In QUENCH-06, oxide layers were thick enough to protect the cladding from melting and failure below 2200 K, so that no massive hydrogen

  8. A randomized phase III study of accelerated hyperfractionation versus standard in patients with unresected brain metastases: a report of the radiation therapy oncology group (RTOG) 9104

    International Nuclear Information System (INIS)

    Murray, Kevin J.; Scott, Charles; Greenberg, Harvey M.; Emami, Bahman; Seider, Michael; Vora, Nayana L.; Olson, Craig; Whitton, Anthony; Movsas, Benjamin; Curran, Walter

    1997-01-01

    Purpose: To compare 1-year survival and acute toxicity rates between an accelerated hyperfractionated (AH) radiotherapy (1.6 Gy b.i.d.) to a total dose of 54.4 Gy vs. an accelerated fractionation (AF) of 30 Gy in 10 daily fractions in patients with unresected brain metastasis. Methods and Materials: The Radiation Therapy Oncology Group (RTOG) accrued 445 patients to a Phase III comparison of accelerated hyperfractionation vs. standard fractionation from 1991 through 1995. All patients had histologic proof of malignancy at the primary site. Brain metastasis were measurable by CT or MRI scan and all patients had a Karnofsky performance score (KPS) of at least 70 and a neurologic function classification of 1 or 2. For AH, 32 Gy in 20 fractions over 10 treatment days (1.6 Gy twice daily) was delivered to the whole brain. A boost of 22.4 Gy in 14 fractions was delivered to each lesion with a 2-cm margin. Results: The average age in both groups was 60 years; nearly two-thirds of all patients had lung primaries. Of the 429 eligible and analyzable patients, the median survival time was 4.5 months in both arms. The 1-year survival rate was 19% in the AF arm vs. 16% in the AH arm. No difference in median or 1-year survival was observed among patients with solitary metastasis between treatment arms. Recursive partitioning analysis (RPA) classes have previously been identified and patients with a KPS of 70 or more, a controlled primary tumor, less than 65 years of age, and brain metastases only (RPA class I), had a 1-year survival of 35% in the AF arm vs. 25% in the AH arm (p = 0.95). In a multivariate model, only age, KPS, extent of metastatic disease (intracranial metastases only vs. intra- and extracranial metastases), and status of primary (controlled vs. uncontrolled) were statistically significant (at p < 0.05). Treatment assignment was not statistically significant. Overall Grade III or IV toxicity was equivalent in both arms, and one fatal toxicity at 44 days secondary

  9. Phasing-in Basel III capital and liquidity requirements in post-revolution Egypt

    Directory of Open Access Journals (Sweden)

    Monal Abdel-Baki

    2012-08-01

    Full Text Available The Basel Committee has introduced a new set of capital and liquidity requirements to be introduced by the global banking system during 2013 till January 2019. Egypt possesses a well-capitalised banking sector, yet it has been exposed to the devastating shock imposed by its popular revolution. Using the GMM method, the impact of introducing the new capital and liquidity requirements on the macroeconomic performance of the Egyptian economy is examined. The results reveal that Egyptian banks are motivated to enhance capital and liquidity ratios in the case of realizing high profits and favourable conditions at the individual banking level. On the other hand, negative macroeconomic performance and a poor business environment substantially deter the preparedness of Egyptian banks to meet the Basel III requirements. The analysis is timely given the need for compliance with Basel III as one of the requirements to raise the credit rating of the devastated economy.

  10. Baseline job satisfaction and stress among pharmacists and pharmacy technicians participating in the Fleetwood Phase III Study.

    Science.gov (United States)

    Lapane, Kate L; Hughes, Carmel M

    2004-11-01

    To provide baseline levels of job satisfaction and stress among members of the long-term care pharmacy team participating in the Fleetwood Phase III evaluation. Cross-sectional design; long-term care pharmacy provider in North Carolina (the implementation site of the large-scale Fleetwood Phase III study). All current pharmacy employees as of May/June 2002. None. Health Professional Stress Inventory and job satisfaction. Ninety-four percent (16/17) of consultant pharmacists were satisfied with their job, with 89% reporting they would definitely choose to be a pharmacist again. Seventy-five percent both of dispensing pharmacists and pharmacy technicians reported overall job satisfaction. Forty-one reported that they would not choose to be a pharmacist (pharmacy technician) again. The most frequently reported sources of stress among the dispensing pharmacists and pharmacy technicians were conflicts with non-work obligations (i.e., family, personal life) and the ability to perform duties with short staffing. In addition, inadequate pay and few opportunities for job advancement were often/frequent sources of stress among pharmacy technicians. More than one third of dispensing pharmacists also reported stress frequently because of fears of mistakes in patient treatment. Overall, consultants are very satisfied with their positions, although dispensing pharmacists and pharmacy technicians are less satisfied with their work. The reasons may be because of the different nature of each job, as well as staffing shortages. The extent to which the Fleetwood Model can improve job satisfaction and impact on stress will be evaluated once we resurvey the pharmacy team after the intervention period of the Fleetwood Phase III study.

  11. Evaluation of DCS III Transmission Alternatives. Phase 1A report. Appendix B. Regulatory Barriers.

    Science.gov (United States)

    1980-05-26

    Resolution DK). B.1.1.5 Importance of the RR in the DCS III Study. The ITU Radio Regulation offers a means to appraise viability of the alternatives to be...interference 466-1 483 Measurement of performance by means of signal 482 Measurement of noise in actual traffic 481 Table B.l-6. Communication Satellite...Economic and technical aspects of the choice of transmission systems GAS 5 Economic conditions and tel ecommunication development GAS 6 Economic and

  12. Zirconium metal-water oxidation kinetics. III. Oxygen diffusion in oxide and alpha Zircaloy phases

    International Nuclear Information System (INIS)

    Pawel, R.E.

    1976-10-01

    The reaction of Zircaloy in steam at elevated temperature involves the growth of discrete layers of oxide and oxygen-rich alpha Zircaloy from the parent beta phase. The multiphase, moving boundary diffusion problem involved is encountered in a number of important reaction schemes in addition to that of Zircaloy-oxygen and can be completely (albeitly ideally) characterized through an appropriate model in terms of oxygen diffusion coefficients and equilibrium concentrations for the various phases. Conversely, kinetic data for phase growth and total oxygen consumption rates can be used to compute diffusion coefficients. Equations are developed that express the oxygen diffusion coefficients in the oxide and alpha phases in terms of the reaction rate constants and equilibrium solubility values. These equations were applied to recent experimental kinetic data on the steam oxidation of Zircaloy-4 to determine the effective oxygen diffusion coefficients in these phases over the temperature range 1000--1500 0 C

  13. Whole Brain Radiotherapy and RRx-001: Two Partial Responses in Radioresistant Melanoma Brain Metastases from a Phase I/II Clinical Trial: A TITE-CRM Phase I/II Clinical Trial.

    Science.gov (United States)

    Kim, Michelle M; Parmar, Hemant; Cao, Yue; Pramanik, Priyanka; Schipper, Matthew; Hayman, James; Junck, Larry; Mammoser, Aaron; Heth, Jason; Carter, Corey A; Oronsky, Arnold; Knox, Susan J; Caroen, Scott; Oronsky, Bryan; Scicinski, Jan; Lawrence, Theodore S; Lao, Christopher D

    2016-04-01

    Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with RRx-001 and whole brain radiotherapy (WBRT) without neurologic or systemic toxicity in the context of a phase I/II clinical trial. RRx-001 is an reactive oxygen and reactive nitrogen species (ROS/RNS)-dependent systemically nontoxic hypoxic cell radiosensitizer with vascular normalizing properties under investigation in patients with various solid tumors including those with brain metastases. Metastatic melanoma to the brain is historically associated with poor outcomes and a median survival of 4 to 5 months. WBRT is a mainstay of treatment for patients with multiple brain metastases, but no significant therapeutic advances for these patients have been described in the literature. To date, candidate radiosensitizing agents have failed to demonstrate a survival benefit in patients with brain metastases, and in particular, no agent has demonstrated improved outcome in patients with metastatic melanoma. Kim et al. report two patients with melanoma metastases to the brain that responded to treatment with novel radiosensitizing agent RRx-001 and WBRT without neurologic or systemic toxicity in the context of a phase I/II clinical trial. Published by Elsevier Inc.

  14. Epidermal Growth Factor Receptor Variant III (EGFRvIII) Positivity in EGFR-Amplified Glioblastomas: Prognostic Role and Comparison between Primary and Recurrent Tumors.

    Science.gov (United States)

    Felsberg, Jörg; Hentschel, Bettina; Kaulich, Kerstin; Gramatzki, Dorothee; Zacher, Angela; Malzkorn, Bastian; Kamp, Marcel; Sabel, Michael; Simon, Matthias; Westphal, Manfred; Schackert, Gabriele; Tonn, Jörg C; Pietsch, Torsten; von Deimling, Andreas; Loeffler, Markus; Reifenberger, Guido; Weller, Michael

    2017-11-15

    Purpose: Approximately 40% of all glioblastomas have amplified the EGFR gene, and about half of these tumors express the EGFRvIII variant. The prognostic role of EGFRvIII in EGFR -amplified glioblastoma patients and changes in EGFRvIII expression in recurrent versus primary glioblastomas remain controversial, but such data are highly relevant for EGFRvIII-targeted therapies. Experimental Design: EGFR -amplified glioblastomas from 106 patients were assessed for EGFRvIII positivity. Changes in EGFR amplification and EGFRvIII status from primary to recurrent glioblastomas were evaluated in 40 patients with EGFR -amplified tumors and 33 patients with EGFR -nonamplified tumors. EGFR single-nucleotide variants (SNV) were assessed in 27 patients. Data were correlated with outcome and validated in 150 glioblastoma patients from The Cancer Genome Atlas (TCGA) consortium. Results: Sixty of 106 EGFR -amplified glioblastomas were EGFRvIII-positive (56.6%). EGFRvIII positivity was not associated with different progression-free or overall survival. EGFRvIII status was unchanged at recurrence in 35 of 40 patients with EGFR -amplified primary tumors (87.5%). Four patients lost and one patient gained EGFRvIII positivity at recurrence. None of 33 EGFR- nonamplified glioblastomas acquired EGFR amplification or EGFRvIII at recurrence. EGFR SNVs were frequent in EGFR -amplified tumors, but were not linked to survival. Conclusions: EGFRvIII and EGFR SNVs are not prognostic in EGFR -amplified glioblastoma patients. EGFR amplification is retained in recurrent glioblastomas. Most EGFRvIII-positive glioblastomas maintain EGFRvIII positivity at recurrence. However, EGFRvIII expression may change in a subset of patients at recurrence, thus repeated biopsy with reassessment of EGFRvIII status is recommended for patients with recurrent glioblastoma to receive EGFRvIII-targeting agents. Clin Cancer Res; 23(22); 6846-55. ©2017 AACR . ©2017 American Association for Cancer Research.

  15. Comparison of a polymeric pseudostationary phase in EKC with ODS stationary phase in RP-HPLC.

    Science.gov (United States)

    Ni, Xinjiong; Zhang, Min; Xing, Xiaoping; Cao, Yuhua; Cao, Guangqun

    2018-01-01

    Poly(stearyl methacrylate-co-methacrylic acid) (P(SMA-co-MAA)) was induced as pseudostationary phase (PSP) in electrokinetic chromatography (EKC). The n-octadecyl groups in SMA were the same as that in octadecylsilane (ODS) C18 column. Thus, the present work focused on the comparison of selectivity between polymeric PSP and ODS stationary phase (SP), and the effect of organic modifiers on the selectivity of polymeric PSP and ODS SP. 1-butanol could directly interacted with PSP as a Class I modifier, and improved both of the methylene selectivity and polar group selectivity. When the analysis times were similar, the polymeric PSP exhibited better methylene selectivity and polar group selectivity. Although the hydrophobic groups were similar, the substituted benzenes elution order was different between polymeric PSP and ODS SP. Linear solvation energy relationships (LSER) model analysis found that polymeric PSP and ODS SP exhibited two same key factors in selectivity: hydrophobic interaction and hydrogen bonding acidity. But polymeric PSP exhibited relatively strong n- and π-electrons interaction to the analytes. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  16. Quantitative comparisons of type III radio burst intensity and fast electron flux at 1 AU

    Science.gov (United States)

    Fitzenreiter, R. J.; Evans, L. G.; Lin, R. P.

    1976-01-01

    We compare the flux of fast solar electrons and the intensity of the type III radio emission generated by these particles at 1 AU. We find that there are two regimes in the generation of type III radiation: one where the radio intensity is linearly proportional to the electron flux, and the second regime, which occurs above a threshold electron flux, where the radio intensity is proportional to the approximately 2.4 power of the electron flux. This threshold appears to reflect a transition to a different emission mechanism.

  17. A comparison of FEMAXI-III code calculations with irradiation experiments

    International Nuclear Information System (INIS)

    Ito, K.; Sogame, M.; Ichikawa, M.; Nakajima, T.

    1981-01-01

    The FEMAXI-III code calculations were compared with in-pile diameter measurements in the Halden Boiling Water Reactor, in order to check the ability to analyse the pellet-cladding mechanical interaction. The results showed generally good agreement between calculations and measurements. The Studsvik INTER-RAMP Experiments were also analysed to examine the predictability of fuel rod failures. Good agreement was obtained between calculated and measured fission gas x release. The threshold stress to cause failure was estimated by means of FEMAXI-III. (author)

  18. Chromospheric oscillations observed with OSO 8. III. Average phase spectra for Si II

    International Nuclear Information System (INIS)

    White, O.R.; Athay, R.G.

    1979-01-01

    Time series of intensity and Doppler-shift fluctuations in the Si II emission lines lambda816.93 and lambda817.45 are Fourier analyzed to determine the frequency variation of phase differences between intensity and velocity and between these two lines formed 300 km apart in the middle chromosphere. Average phase spectra show that oscillations between 2 and 9 mHz in the two lines have time delays from 35 to 40 s, which is consistent with the upward propagation of sound wave at 8.6-7.5 km s -1 . In this same frequency band near 3 mHz, maximum brightness leads maximum blueshift by 60 0 . At frequencies above 11 mHz where the power spectrum is flat, the phase differences are uncertain, but approximately 65% of the cases indicate upward propagation. At these higher frequencies, the phase lead between intensity and blue Doppler shift ranges from 0 0 to 180 0 with an average value of 90 0 . However, the phase estimates in this upper band are corrupted by both aliasing and randomness inherent to the measured signals. Phase differences in the two narrow spectral features seen at 10.5 and 27 mHz in the power spectra are shown to be consistent with properties expected for aliases of the wheel rotation rate of the spacecraft wheel section

  19. Coping with missing data in phase III pivotal registration trials: Tolvaptan in subjects with kidney disease, a case study.

    Science.gov (United States)

    Ouyang, John; Carroll, Kevin J; Koch, Gary; Li, Junfang

    2017-07-01

    Missing data cause challenging issues, particularly in phase III registration trials, as highlighted by the European Medicines Agency (EMA) and the US National Research Council. We explore, as a case study, how the issues from missing data were tackled in a double-blind phase III trial in subjects with autosomal dominant polycystic kidney disease. A total of 1445 subjects were randomized in a 2:1 ratio to receive active treatment (tolvaptan), or placebo. The primary outcome, the rate of change in total kidney volume, favored tolvaptan (P outline the analyses undertaken to address the issue of missing data thoroughly. "Tipping point analyses" were performed to explore how extreme and detrimental outcomes among subjects with missing data must be to overturn the positive treatment effect attained in those subjects who had complete data. Nonparametric rank-based analyses were also performed accounting for missing data. In conclusion, straightforward and transparent analyses directly taking into account missing data convincingly support the robustness of the preplanned analyses on the primary and secondary endpoints. Tolvaptan was confirmed to be effective in slowing total kidney volume growth, which is considered an efficacy endpoint by EMA, and in lessening the decline in renal function in patients with autosomal dominant polycystic kidney disease. Copyright © 2017 John Wiley & Sons, Ltd.

  20. Predicting hypothetical willingness to participate (WTP) in a future phase III HIV vaccine trial among high-risk adolescents.

    Science.gov (United States)

    Giocos, Georgina; Kagee, Ashraf; Swartz, Leslie

    2008-11-01

    The present study sought to determine whether the Theory of Planned Behaviour predicted stated hypothetical willingness to participate (WTP) in future Phase III HIV vaccine trials among South African adolescents. Hierarchical logistic regression analyses showed that The Theory of Planned Behaviour (TPB) significantly predicted WTP. Of all the predictors, Subjective norms significantly predicted WTP (OR = 1.19, 95% C.I. = 1.06-1.34). A stepwise logistic regression analysis revealed that Subjective Norms (OR = 1.19, 95% C.I. = 1.07-1.34) and Attitude towards participation in an HIV vaccine trial (OR = 1.32, 95% C.I. = 1.00-1.74) were significant predictors of WTP. The addition of Knowledge of HIV vaccines and HIV vaccine trials, Perceived self-risk of HIV infection, Health-promoting behaviours and Attitudes towards HIV/AIDS yielded non-significant results. These findings provide support for the Theory of Reasoned Action (TRA) and suggest that psychosocial factors may play an important role in WTP in Phase III HIV vaccine trials among adolescents.

  1. Phase III trial of high- vs. low-dose-rate interstitial radiotherapy for early mobile tongue cancer

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko; Yoshida, Ken; Yoshioka, Yasuo; Shimamoto, Shigetoshi; Tanaka, Eiichi; Yamazaki, Hideya; Shimizutani, Kimishige; Teshima, Teruki; Furukawa, Souhei

    2001-01-01

    Purpose: Early mobile tongue cancer can be controlled with interstitial radiotherapy (ISRT). We carried out a Phase III trial to compare the treatment results of low-dose-rate (Ld) ISRT and high-dose-rate (HDR) ISRT for early mobile tongue cancer. Methods and Materials: From April 1992 through October 1996, 59 patients with cancer of the early mobile tongue were registered in this Phase III study. Eight patients were excluded from the evaluation because of violations of the requirements for this study. Of 51 eligible patients, 26 patients were treated with LDR-ISRT (70 Gy/4-9 days) and 25 patients with HDR-ISRT (60 Gy/10 fractions/1 week). For the hyperfractionated HDR-ISRT, the time interval between 2 fractions was more than 6 h. Results: Five-year local control rates of the LDR and HDR groups were 84% and 87% respectively. Nodal metastasis occurred in 6 patients in each group. Five-year nodal control rates of the LDR and HDR groups were 77% and 76%, respectively. Conclusion: Hyperfractionated HDR-ISRT for early mobile tongue cancer has the same local control compared with continuous LDR-ISRT. Hyperfractionated HDR-ISRT is an alternative treatment for continuous LDR-ISRT

  2. Novel solid phase extraction procedure for gold(III) on Dowex M 4195 prior to its flame atomic absorption spectrometric determination

    International Nuclear Information System (INIS)

    Tuzen, Mustafa; Saygi, Kadriye O.; Soylak, Mustafa

    2008-01-01

    A method for solid phase extraction (SPE) of gold(III) using Dowex M 4195 chelating resin has been developed. The optimum experimental conditions for the quantitative sorption of gold(III), pH, effect of flow rates, eluent types, sorption capacity and the effect of diverse ions on the sorption of gold(III) have been investigated. The chelating resin can be reused for more than 100 cycles of sorption-desorption without any significant change in sorption of gold(III) ions. The recovery values for gold(III) and detection limit (LOD) of gold were greater than 95% and 1.61 μg L -1 , respectively. The preconcentration factor was 31. The relative standard deviation of the method was -1 . The proposed method has been applied for the determination of gold(III) in some real samples including water, soil and sediment samples

  3. Liquid plugs bouncing against a solid basis, comparison of SIMMER-III and PLEXUS results

    International Nuclear Information System (INIS)

    Maschek, W.; Arnecke, G.; Flad, M.

    1995-01-01

    The SIMMER III code is being tested by application to problems of reactor accidents. The fluid dynamics/thermohydraulics part of the code can be applied also to evaporation/condensation, melt, and freezing phenomena. For a liquid plug bouncing against a solid basis, the momentum transfer is calculated. PLEXUS results turn out to be in significant disagreement with the SIMMER calculations. (orig.)

  4. Comparison of WAIS-III Short Forms for Measuring Index and Full-Scale Scores

    Science.gov (United States)

    Girard, Todd A.; Axelrod, Bradley N.; Wilkins, Leanne K.

    2010-01-01

    This investigation assessed the ability of the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III) short forms to estimate both index and IQ scores in a large, mixed clinical sample (N = 809). More specifically, a commonly used modification of Ward's seven-subtest short form (SF7-A), a recently proposed index-based SF7-C and eight-subtest…

  5. Performance of Dutch Children on the Bayley III: A Comparison Study of US and Dutch Norms

    NARCIS (Netherlands)

    Steenis, Leonie J. P.; Verhoeven, Marjolein; Hessen, Dave J.; Van Baar, Anneloes L.

    2015-01-01

    Background The Bayley Scales of Infant and Toddler Development-third edition (Bayley-III) are frequently used to assess early child development worldwide. However, the original standardization only included US children, and it is still unclear whether or not these norms are adequate for use in other

  6. First-principles interatomic potentials for transition-metal aluminides. III. Extension to ternary phase diagrams

    International Nuclear Information System (INIS)

    Widom, Mike; Al-Lehyani, Ibrahim; Moriarty, John A.

    2000-01-01

    Modeling structural and mechanical properties of intermetallic compounds and alloys requires detailed knowledge of their interatomic interactions. The first two papers of this series [Phys. Rev. B 56, 7905 (1997); 58, 8967 (1998)] derived first-principles interatomic potentials for transition-metal (TM) aluminides using generalized pseudopotential theory (GPT). Those papers focused on binary alloys of aluminum with first-row transition metals and assessed the ability of GPT potentials to reproduce and elucidate the alloy phase diagrams of Al-Co and Al-Ni. This paper addresses the phase diagrams of the binary alloy Al-Cu and the ternary systems Al-Co-Cu and Al-Co-Ni, using GPT pair potentials calculated in the limit of vanishing transition-metal concentration. Despite this highly simplifying approximation, we find rough agreement with the known low-temperature phase diagrams, up to 50% total TM concentration provided the Co fraction is below 25%. Full composition-dependent potentials and many-body interactions would be required to correct deficiencies at higher Co concentration. Outside this troublesome region, the experimentally determined stable and metastable phases all lie on or near the convex hull of a scatter plot of energy versus composition. We verify, qualitatively, reported solubility ranges extending binary alloys into the ternary diagram in both Al-Co-Cu and Al-Co-Ni. Finally, we reproduce previously conjectured transition-metal positions in the decagonal quasicrystal phase. (c) 2000 The American Physical Society

  7. First-principles interatomic potentials for transition-metal aluminides. III. Extension to ternary phase diagrams

    Science.gov (United States)

    Widom, Mike; Al-Lehyani, Ibrahim; Moriarty, John A.

    2000-08-01

    Modeling structural and mechanical properties of intermetallic compounds and alloys requires detailed knowledge of their interatomic interactions. The first two papers of this series [Phys. Rev. B 56, 7905 (1997); 58, 8967 (1998)] derived first-principles interatomic potentials for transition-metal (TM) aluminides using generalized pseudopotential theory (GPT). Those papers focused on binary alloys of aluminum with first-row transition metals and assessed the ability of GPT potentials to reproduce and elucidate the alloy phase diagrams of Al-Co and Al-Ni. This paper addresses the phase diagrams of the binary alloy Al-Cu and the ternary systems Al-Co-Cu and Al-Co-Ni, using GPT pair potentials calculated in the limit of vanishing transition-metal concentration. Despite this highly simplifying approximation, we find rough agreement with the known low-temperature phase diagrams, up to 50% total TM concentration provided the Co fraction is below 25%. Full composition-dependent potentials and many-body interactions would be required to correct deficiencies at higher Co concentration. Outside this troublesome region, the experimentally determined stable and metastable phases all lie on or near the convex hull of a scatter plot of energy versus composition. We verify, qualitatively, reported solubility ranges extending binary alloys into the ternary diagram in both Al-Co-Cu and Al-Co-Ni. Finally, we reproduce previously conjectured transition-metal positions in the decagonal quasicrystal phase.

  8. Gene expression of transporters and phase I/II metabolic enzymes in murine small intestine during fasting

    Directory of Open Access Journals (Sweden)

    van der Meijde Jolanda

    2007-08-01

    Full Text Available Abstract Background Fasting has dramatic effects on small intestinal transport function. However, little is known on expression of intestinal transport and phase I/II metabolism genes during fasting and the role the fatty acid-activated transcription factor PPARα may play herein. We therefore investigated the effects of fasting on expression of these genes using Affymetrix GeneChip MOE430A arrays and quantitative RT-PCR. Results After 24 hours of fasting, expression levels of 33 of the 253 analyzed transporter and phase I/II metabolism genes were changed. Upregulated genes were involved in transport of energy-yielding molecules in processes such as glycogenolysis (G6pt1 and mitochondrial and peroxisomal oxidation of fatty acids (Cact, Mrs3/4, Fatp2, Cyp4a10, Cyp4b1. Other induced genes were responsible for the inactivation of the neurotransmitter serotonin (Sert, Sult1d1, Dtd, Papst2, formation of eicosanoids (Cyp2j6, Cyp4a10, Cyp4b1, or for secretion of cholesterol (Abca1 and Abcg8. Cyp3a11, typically known because of its drug metabolizing capacity, was also increased. Fasting had no pronounced effect on expression of phase II metabolic enzymes, except for glutathione S-transferases which were down-regulated. Time course studies revealed that some genes were acutely regulated, whereas expression of other genes was only affected after prolonged fasting. Finally, we identified 8 genes that were PPARα-dependently upregulated upon fasting. Conclusion We have characterized the response to fasting on expression of transporters and phase I/II metabolic enzymes in murine small intestine. Differentially expressed genes are involved in a variety of processes, which functionally can be summarized as a increased oxidation of fat and xenobiotics, b increased cholesterol secretion, c increased susceptibility to electrophilic stressors, and d reduced intestinal motility. This knowledge increases our understanding of gut physiology, and may be of relevance

  9. Solid phase extraction of Am(III) and Cm(III) from acidic feeds using tetraethyl diglycolamide (TEDGA) in ionic liquid

    NARCIS (Netherlands)

    Gujar, R.B.; Ansari, S.A.; Mohapatra, P.K.; Leoncini, Andrea; Verboom, Willem

    2016-01-01

    Solvent extraction of Am(III) and Cm(III) with several diglycolamide ligands in an ionic liquid, [C4mim][Tf2N] was investigated from nitric acid medium. Based on the encouraging extraction behaviour with N,N,N′,N′-tetraethyldiglycolamide (TEDGA), extraction chromatographic studies were carried out

  10. Phase I/II trial of concurrent use of S-1 and radiation therapy for T2 glottic cancer

    International Nuclear Information System (INIS)

    Nakayama, Meijin; Hayakawa, Kazushige; Okamoto, Makito; Niibe, Yuzuru; Ishiyama, Hiromichi; Kotani, Shouko

    2010-01-01

    A Phase I/II study of S-1 combined radiation therapy was conducted in patients with Stage II (T2N0) glottic cancer. The purpose of the Phase I study was to identify the maximum tolerated dose, the recommended dose and the dose limiting toxicity. The objectives in the phase II study were to estimate the local control and the overall survival, and the incidence of adverse events. In Phase I, S-1 was administered orally in a split-course fashion as two doses of 40 mg/m 2 , for a total daily dose of 80 mg/m 2 . The course involved a 2-week rest after a 2-week administration (Level 1) and a 1-week rest after a 3-week administration (Level 2). Radiation therapy was administered in 2-Gy daily (total 60-Gy) standard fractionation. Seven patients were enrolled in the Phase I, and 19 in the Phase II study. Mucositis was the most common toxicity encountered. All 26 patients completed radiation therapy without delay. The overall response rate was 100% (26/26) with all patients showing a complete response. One patient developed a local recurrence 28 months after the treatment. The 3-year local control and overall survival rates were 94.7 and 85.4%, respectively (limited to 22 patients from Level 2). The use of S-1 at 80 mg/m 2 per day in a split-course with 1-week rest during the course of radiation therapy was safe and effective for Stage II glottic cancer. The treatment strategy employing orally available S-1 proved to be beneficial over the conventional injection of antitumor agents for maintaining the patients' quality of life. (author)

  11. Engineering development of coal-fired high performance power systems, Phase II and III

    Energy Technology Data Exchange (ETDEWEB)

    None

    1999-04-01

    The goals of the program are to develop a coal-fired high performance power generation system (HIPPS) that is capable of: thermal efficiency (HHV) {ge} 47%, NOx, SOx, and particulates {le} 10% NSPS (New Source Performance Standard) coal providing {ge} 65% of heat input, all solid wastes benign, and cost of electricity {le} 90% of present plants. Phase 1, which began in 1992, focused on the analysis of various configurations of indirectly fired cycles and on technical assessments of alternative plant subsystems and components, including performance requirements, developmental status, design options, complexity and reliability, and capital and operating costs. Phase 1 also included preliminary R and D and the preparation of designs for HIPPS commercial plants approximately 300 MWe in size. This phase, Phase 2, involves the development and testing of plant subsystems, refinement and updating of the HIPPS commercial plant design, and the site selection and engineering design of a HIPPS prototype plant. Work reported herein is from: Task 2.1 HITAC Combustors; Task 2.2 HITAF Air Heaters; Task 6 HIPPS Commercial Plant Design Update.

  12. Postoperative opioid sparing with injectable hydroxypropyl-β-cyclodextrin-diclofenac: pooled analysis of data from two Phase III clinical trials

    Directory of Open Access Journals (Sweden)

    Gan TJ

    2016-12-01

    Full Text Available Tong J Gan,1 Neil Singla,2 Stephen E Daniels,3 Douglas A Hamilton,4,5 Peter G Lacouture,6,7 Christian RD Reyes,8 Daniel B Carr4,9 1Department of Anesthesiology, Stony Brook University, NY, 2Lotus Clinical Research, LLC, Pasadena, CA, 3Premier Research, Austin, TX, 4Javelin Pharmaceuticals, Inc., Cambridge, MA, 5New Biology Ventures, LLC, San Mateo, CA, 6Magidom Discovery, LLC, St Augustine, FL, 7Department of Emergency Medicine, Brown University School of Medicine, Providence, RI, 8Hospira Inc., Lake Forest, IL, 9Department of Anesthesiology, Tufts Medical Center, Boston, MA, USA Purpose: Use of nonopioid analgesics (including nonsteroidal anti-inflammatory drugs for postoperative pain management can reduce opioid consumption and potentially prevent opioid-related adverse events. This study examined the postoperative opioid-sparing effect of repeated-dose injectable diclofenac formulated with hydroxypropyl-β-cyclodextrin (HPβCD-diclofenac. Patients and methods: Pooled data from two double-blind, randomized, placebo- and active comparator-controlled Phase III trials were analyzed. Patients received HPβCD-diclofenac, placebo, or ketorolac by intravenous injection every 6 hours for up to 5 days following abdominal/pelvic or orthopedic surgery. Rescue opioid use was evaluated from the time of first study drug administration to up to 120 hours following the first dose in the overall study population and in subgroups defined by baseline pain severity, age, and HPβCD-diclofenac dose. Results: Overall, 608 patients received ≥1 dose of study medication and were included in the analysis. While 93.2% of patients receiving placebo required opioids, the proportion of patients requiring opioids was significantly lower for patients receiving HPβCD-diclofenac (18.75, 37.5, or 50 mg or ketorolac (P<0.005 for all comparisons. Mean cumulative opioid dose and number of doses were significantly lower among patients receiving HPβCD-diclofenac versus placebo

  13. Comparison between Hybrid III dummy and cadaver knee response in frontal impact

    OpenAIRE

    MASSON, Catherine; CAVALLERO, Claude

    2003-01-01

    Lower limb injuries frequently occur during car accidents. The purpose of this work was to compare the response of the hybrid iii lower limb with the response of cadaver lower limb subjected to similar impacts. These experiments were performed with the objective to evaluate the biofidelity, repeatability and response characteristics of the knee-femur-pelvis HIII dummy. The tests have examined the dynamic response of the knee-femur-pelvis complex to sub injury simple pendulum impacts. The expe...

  14. [Comparison of the effects of phosphodiesterase III inhibitors, milrinone and olprinone, in infant corrective cardiac surgery].

    Science.gov (United States)

    Sakimura, Shotaro; Yoshino, Jun; Izumi, Kaoru; Jimi, Nobuo; Sumiyoshi, Rieko; Mizuno, Keiichiro

    2013-05-01

    Clinical characteristics of phosphodiesterase (PDE) III inhibitors, milrinone and olprinone, is not fully understood in infants. We therefore retrospectively examined the hemodynamics, metabolism, and oxygenation of two different PDE III inhibitors in infants undergoing radical correction of ventricular septal defect with pulmonary hypertension. Twenty-six infants with pulmonary hypertension undergoing ventricular septum defect repair were retrospectively allocated to milrinone group (n= 13)and olprinone group(n=13). Hemodynamic parameters, acid-base balance, oxygenation and postoperative mechanical ventilation period were compared between the two groups at induction of anesthesia, weaning from cardiopulmonary bypass and the end of the surgery. The patients' mean age was 4.4 +/- 2.5 months. Demographic data were almost similar between the two groups. Milrinone and olprinone were administered at the rates of 0.5 and 0.3 microg x kg-1 x min-1 at the end of surgery, respectively. Hemodynamic variables, acid-base balance, Pao2 /FIo2 ratio and mechanical ventilation period were not significantly different between the two groups. No adverse side effects were observed during the study period. The effects of the PDE III inhibitors, milrinone and olprinone, on hemodynamic parameters, acid-base balance and oxygenation were similar in these infants. Both milrinone and olprinone could be used safely in infant cardiac surgery.

  15. Photoluminescence Polarization Anisotropy in a Single Heterostructured III-V Nanowire with Mixed Crystal Phases

    International Nuclear Information System (INIS)

    Moses, A. F.; Hoang, T. B.; Ahtapodov, L.; Dheeraj, D. L.; Fimland, B. O.; Weman, H.; Helvoort, A. T. J. van

    2011-01-01

    Low temperature (10 K) micro-photoluminescence (μ-PL) of single GaAs/AlGaAs core-shell nanowires with single GaAsSb inserts were measured. The PL emission from the zinc blende GaAsSb insert is strongly polarized along the nanowire axis while the PL emission from the wurtzite GaAs nanowire is perpendiculary polarized to the nanowire axis. The result indicates that the crystal phase, through the optical selection rules, has significant effect on the polarization of the PL from NWs besides the dielectric mismatch. The analysis of the PL results based on the electronic structure of these nanowires supports the correlation between the crystal phase and the PL emission.

  16. Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

    Science.gov (United States)

    Chudnoff, Scott G; Nichols, John E; Levie, Mark

    2015-01-01

    To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). Thirteen clinical study centers in the United States, Europe, and Australia. A total of 518 previously fertile women seeking permanent contraception. The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during

  17. Phase I-II study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer

    International Nuclear Information System (INIS)

    Huijts, Charlotte M; Santegoets, Saskia J; Eertwegh, Alfons J van den; Pijpers, Laura S; Haanen, John B; Gruijl, Tanja D de; Verheul, Henk M; Vliet, Hans J van der

    2011-01-01

    For patients with metastatic renal cell cancer (mRCC) who progressed on vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor therapy, the orally administered mammalian target of rapamycin (mTOR) inhibitor everolimus has been shown to prolong progression free survival. Intriguingly, inhibition of mTOR also promotes expansion of immunosuppressive regulatory T cells (Tregs) that can inhibit anti-tumor immune responses in a clinically relevant way in various tumor types including RCC. This study intends to investigate whether the antitumor efficacy of everolimus can be increased by preventing the detrimental everolimus induced expansion of Tregs using a metronomic schedule of cyclophosphamide. This phase I-II trial is a national multi-center study of different doses and schedules of low-dose oral cyclophosphamide in combination with a fixed dose of everolimus in patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase inhibitor containing treatment regimen. In the phase I part of the study the optimal Treg-depleting dose and schedule of metronomic oral cyclophosphamide when given in combination with everolimus will be determined. In the phase II part of the study we will evaluate whether the percentage of patients progression free at 4 months of everolimus treatment can be increased from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in the phase I part). In addition to efficacy, we will perform extensive immune monitoring with a focus on the number, phenotype and function of Tregs, evaluate the safety and feasibility of the combination of everolimus and cyclophosphamide, perform monitoring of selected angiogenesis parameters and analyze everolimus and cyclophosphamide drug levels. This phase I-II study is designed to determine whether metronomic cyclophosphamide can be used to counter the mTOR inhibitor everolimus induced Treg expansion in patients with metastatic renal cell

  18. Phase I-II study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer

    Directory of Open Access Journals (Sweden)

    Huijts Charlotte M

    2011-11-01

    Full Text Available Abstract Background For patients with metastatic renal cell cancer (mRCC who progressed on vascular endothelial growth factor (VEGF receptor tyrosine kinase inhibitor therapy, the orally administered mammalian target of rapamycin (mTOR inhibitor everolimus has been shown to prolong progression free survival. Intriguingly, inhibition of mTOR also promotes expansion of immunosuppressive regulatory T cells (Tregs that can inhibit anti-tumor immune responses in a clinically relevant way in various tumor types including RCC. This study intends to investigate whether the antitumor efficacy of everolimus can be increased by preventing the detrimental everolimus induced expansion of Tregs using a metronomic schedule of cyclophosphamide. Methods/design This phase I-II trial is a national multi-center study of different doses and schedules of low-dose oral cyclophosphamide in combination with a fixed dose of everolimus in patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase inhibitor containing treatment regimen. In the phase I part of the study the optimal Treg-depleting dose and schedule of metronomic oral cyclophosphamide when given in combination with everolimus will be determined. In the phase II part of the study we will evaluate whether the percentage of patients progression free at 4 months of everolimus treatment can be increased from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in the phase I part. In addition to efficacy, we will perform extensive immune monitoring with a focus on the number, phenotype and function of Tregs, evaluate the safety and feasibility of the combination of everolimus and cyclophosphamide, perform monitoring of selected angiogenesis parameters and analyze everolimus and cyclophosphamide drug levels. Discussion This phase I-II study is designed to determine whether metronomic cyclophosphamide can be used to counter the mTOR inhibitor everolimus

  19. Preoperative chemoradiotherapy in locally advanced gastric cancer, a phase I/II feasibility and efficacy study

    Energy Technology Data Exchange (ETDEWEB)

    Trip, Anouk K. [Department of Radiation Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Poppema, Boelo J. [Department of Medical Oncology, University Medical Centre Groningen (Netherlands); Berge Henegouwen, Mark I. van [Department of Surgical Oncology, Academic Medical Centre – University of Amsterdam (Netherlands); Siemerink, Ester [Department of Internal Medicine, Ziekenhuisgroep Twente, Hengelo (Netherlands); Beukema, Jannet C. [Department of Radiation Oncology, University Medical Centre Groningen (Netherlands); Verheij, Marcel [Department of Radiation Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Plukker, John T.M. [Department of Surgical Oncology, University Medical Centre Groningen (Netherlands); Richel, Dick J. [Department of Medical Oncology, Academic Medical Centre – University of Amsterdam (Netherlands); Hulshof, Maarten C.C.M. [Department of Radiation Oncology, Academic Medical Centre – University of Amsterdam (Netherlands); Sandick, Johanna W. van [Department of Surgical Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Cats, Annemieke [Department of Gastroenterology and Hepatology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Jansen, Edwin P.M. [Department of Radiation Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Hospers, Geke A.P., E-mail: g.a.p.hospers@umcg.nl [Department of Medical Oncology, University Medical Centre Groningen (Netherlands)

    2014-08-15

    Objectives: This study was initiated to investigate the feasibility and efficacy of preoperative radiotherapy with weekly paclitaxel and carboplatin in locally advanced gastric cancer. Methods: In a prospective study, patients with locally advanced gastric cancer stage IB-IV(M0) were treated with chemoradiotherapy followed by surgery 4–6 weeks after the last irradiation. Chemoradiotherapy consisted of radiation to a total dose of 45 Gy given in 25 fractions of 1.8 Gy, combined with concurrent weekly carboplatin and paclitaxel. Results: Between December 2007 and January 2012, 25 patients with cT3 (64%) or cT4 (36%) gastric cancer were included. One patient discontinued concurrent chemotherapy in the 4th week due to toxicity, but completed radiotherapy. Another patient discontinued chemoradiotherapy after the 3rd week due to progressive disease. Grade III adverse events of chemoradiotherapy were: gastrointestinal 12%, haematological 12% and other 8%. All patients, except one who developed progressive disease, were operated. Surgical complications were: general/infectious 48%, anastomotic leakage 12%, and bowel perforation 8%. Postoperative mortality was 4%. Microscopically radical resection rate was 72%. Pathological complete response rate was 16% and near complete response rate 24%. Conclusions: In this study, preoperative chemoradiotherapy for patients with locally advanced gastric cancer was associated with manageable toxicity and encouraging pathological response rates.

  20. Preoperative chemoradiotherapy in locally advanced gastric cancer, a phase I/II feasibility and efficacy study

    International Nuclear Information System (INIS)

    Trip, Anouk K.; Poppema, Boelo J.; Berge Henegouwen, Mark I. van; Siemerink, Ester; Beukema, Jannet C.; Verheij, Marcel; Plukker, John T.M.; Richel, Dick J.; Hulshof, Maarten C.C.M.; Sandick, Johanna W. van; Cats, Annemieke; Jansen, Edwin P.M.; Hospers, Geke A.P.

    2014-01-01

    Objectives: This study was initiated to investigate the feasibility and efficacy of preoperative radiotherapy with weekly paclitaxel and carboplatin in locally advanced gastric cancer. Methods: In a prospective study, patients with locally advanced gastric cancer stage IB-IV(M0) were treated with chemoradiotherapy followed by surgery 4–6 weeks after the last irradiation. Chemoradiotherapy consisted of radiation to a total dose of 45 Gy given in 25 fractions of 1.8 Gy, combined with concurrent weekly carboplatin and paclitaxel. Results: Between December 2007 and January 2012, 25 patients with cT3 (64%) or cT4 (36%) gastric cancer were included. One patient discontinued concurrent chemotherapy in the 4th week due to toxicity, but completed radiotherapy. Another patient discontinued chemoradiotherapy after the 3rd week due to progressive disease. Grade III adverse events of chemoradiotherapy were: gastrointestinal 12%, haematological 12% and other 8%. All patients, except one who developed progressive disease, were operated. Surgical complications were: general/infectious 48%, anastomotic leakage 12%, and bowel perforation 8%. Postoperative mortality was 4%. Microscopically radical resection rate was 72%. Pathological complete response rate was 16% and near complete response rate 24%. Conclusions: In this study, preoperative chemoradiotherapy for patients with locally advanced gastric cancer was associated with manageable toxicity and encouraging pathological response rates

  1. SAMICS validation. SAMICS support study: Phase III. Final report, Jet Propulsion Laboratory

    Energy Technology Data Exchange (ETDEWEB)

    1979-03-01

    The purpose of SAMICS is to provide a consistent basis for estimating solar cell array costs and comparing production technology costs. The user of SAMICS provides detailed process information for calculating direct costs. To these are added indirect and overhead expenses. Although thorough documentation of direct processes requires a significant initial effort, the process gives SAMICS its primary strength. A complete accounting of direct process resource requirements establishes an audit trail that will help to monitor the realism of assumptions before production and to later identify variations from forecasted operating parameters after production begins. The purpose for this review were the following: (a) to test the computational validity of the computer model by comparison with preliminary hand calculations based on conventional cost estimating techniques; (b) to review and improve the accuracy of the cost relationships being used by the model; and (c) to provide an independent verification to users of the model's value in decision making for allocation of research and development funds and for investment in manufacturing capacity. The conclusion is that the SAMICS model is a flexible, accurate, and useful tool for managerial decision making. The comparison of model results with calculations shows close correlation. This report provides the basis for conclusions. It also contains recommendations for increasing the usefulness of SAMICS. (WHK)

  2. High-pressure single-crystal elasticity study of CO{sub 2} across phase I-III transition

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Jin S., E-mail: zhang72@illinois.edu; Bass, Jay D. [Department of Geology, University of Illinois, Urbana-Champaign, Illinois 61801 (United States); Shieh, Sean R. [Departments of Earth Sciences and Physics and Astronomy, University of Western Ontario, London, Ontario N6A 5B7 (Canada); Dera, Przemyslaw [Hawaii Institute of Geophysics and Planetology, University of Hawaii at Manoa, Honolulu, Hawaii 96822 (United States); Prakapenka, Vitali [Center for Advanced Radiation Sources, University of Chicago, Chicago, Illinois 60637 (United States)

    2014-04-07

    Sound velocities and elastic moduli of solid single-crystal CO{sub 2} were measured at pressures up to 11.7(3) GPa by Brillouin spectroscopy. The aggregate adiabatic bulk modulus (K{sub S}), shear modulus (G), and their pressure derivatives for CO{sub 2} Phase I are K{sub S0} = 3.4(6) GPa, G{sub 0} = 1.8(2) GPa, (dK{sub S}/dP){sub 0} = 7.8(3), (dG/dP){sub 0} = 2.5(1), (d{sup 2}K{sub S}/dP{sup 2}){sub 0} = −0.23(3) GPa{sup −1}, and (d{sup 2}G/dP{sup 2}){sub 0} = −0.10(1) GPa{sup −1}. A small increase of elastic properties was observed between 9.8(1) and 10.5(3) GPa, in agreement with the CO{sub 2} I-III transition pressure determined from previous x-ray diffraction experiments. Above the transition pressure P{sub T}, we observed a mixture dominated by CO{sub 2}-I, with minor CO{sub 2}-III. The CO{sub 2}-I + III mixture shows slightly increased sound velocities compared to pure CO{sub 2}-I. Elastic anisotropy calculated from the single-crystal elasticity tensor exhibits a decrease with pressure beginning at 7.9(1) GPa, which is lower than P{sub T}. Our results coincide with recent X-ray Raman observations, suggesting that a pressure-induced electronic transition is related to local structural and optical changes.

  3. Liquid-liquid extraction of ruthenium(III) thiocyanate with hexamethylphosphoramide: direct spectrophotometric determination in the organic phase

    International Nuclear Information System (INIS)

    Mitra, B.K.; Pal, B.K.; Chowdhury, R.P.

    1982-01-01

    Ru(III) thiocyanate has been extracted with hexamethylphosphoramide(HMPA) in methyl isobutyl ketone (MIBK). Thus the extractability, sensitivity and selectivity are improved over the simple binary Ru(III) thiocyanate system in spectrophotometric determination of ruthenium in the organic phase. The maximum colour develops on the steam bath, at the acidity range of 1.5 - 2.5 M with HCl and ammonium thiocyanate concentration range of 0.25 - O.5 M. The colour is completely extractable in MIBK when 1.5 - 3.0 ml HMPA is used and show maximum absorbance at 570 nm. The colour system obeys Beer's law for 0.7 - 13 μg Ru/ml and the optimum concentration range is 2 - 13 μg/ml. The molar absorptivity and sensitivity are 6940 l . mole -1 cm -1 and 0.0145 μg/cm 2 respectively. The percent relative error is 2.72%. The method is very simple and does not require oxidation and subsequent distillation. The method can be applied in the presence of osmium. (Author)

  4. BEMUSE Phase III Report - Uncertainty and Sensitivity Analysis of the LOFT L2-5 Test

    International Nuclear Information System (INIS)

    Bazin, P.; Crecy, A. de; Glaeser, H.; Skorek, T.; Joucla, J.; Probst, P.; Chung, B.; Oh, D.Y.; Kyncl, M.; Pernica, R.; Macek, J.; Meca, R.; Macian, R.; D'Auria, F.; Petruzzi, A.; Perez, M.; Reventos, F.; Fujioka, K.

    2007-02-01

    This report summarises the various contributions (ten participants) for phase 3 of BEMUSE: Uncertainty and Sensitivity Analyses of the LOFT L2-5 experiment, a Large-Break Loss-of-Coolant-Accident (LB-LOCA). For this phase, precise requirements step by step were provided to the participants. Four main parts are defined, which are: 1. List and uncertainties of the input uncertain parameters. 2. Uncertainty analysis results. 3. Sensitivity analysis results. 4. Improved methods, assessment of the methods (optional). 5% and 95% percentiles have to be estimated for 6 output parameters, which are of two kinds: 1. Scalar output parameters (First Peak Cladding Temperature (PCT), Second Peak Cladding Temperature, Time of accumulator injection, Time of complete quenching); 2. Time trends output parameters (Maximum cladding temperature, Upper plenum pressure). The main lessons learnt from phase 3 of the BEMUSE programme are the following: - for uncertainty analysis, all the participants use a probabilistic method associated with the use of Wilks' formula, except for UNIPI with its CIAU method (Code with the Capability of Internal Assessment of Uncertainty). Use of both methods has been successfully mastered. - Compared with the experiment, the results of uncertainty analysis are good on the whole. For example, for the cladding temperature-type output parameters (1. PCT, 2. PCT, time of complete quenching, maximum cladding temperature), 8 participants out of 10 find upper and lower bounds which envelop the experimental data. - Sensitivity analysis has been successfully performed by all the participants using the probabilistic method. All the used influence measures include the range of variation of the input parameters. Synthesis tables of the most influential phenomena and parameters have been plotted and participants will be able to use them for the continuation of the BEMUSE programme

  5. Oxidation of Cr(III)-Fe(III) Mixed-phase Hydroxides by Chlorine: Implications on the Control of Hexavalent Chromium in Drinking Water.

    Science.gov (United States)

    Chebeir, Michelle; Liu, Haizhou

    2018-05-17

    The occurrence of chromium (Cr) as an inorganic contaminant in drinking water is widely reported. One source of Cr is its accumulation in iron-containing corrosion scales of drinking water distribution systems as Cr(III)-Fe(III) hydroxide, i.e., FexCr(1-x)(OH)3(s), where x represents the Fe(III) molar content and typically varies between 0.25 and 0.75. This study investigated the kinetics of inadvertent hexavalent chromium Cr(VI) formation via the oxidation of FexCr(1-x)(OH)3(s) by chlorine as a residual disinfectant in drinking water, and examined the impacts of Fe(III) content and drinking water chemical parameters including pH, bromide and bicarbonate on the rate of Cr(VI) formation. Data showed that an increase in Fe(III) molar content resulted in a significant decrease in the stoichiometric Cr(VI) yield and the rate of Cr(VI) formation, mainly due to chlorine decay induced by Fe(III) surface sites. An increase in bicarbonate enhanced the rate of Cr(VI) formation, likely due to the formation of Fe(III)-carbonato surface complexes that slowed down the scavenging reaction with chlorine. The presence of bromide significantly accelerated the oxidation of FexCr(1-x)(OH)3(s) by chlorine, resulting from the catalytic effect of bromide acting as an electron shuttle. A higher solution pH between 6 and 8.5 slowed down the oxidation of Cr(III) by chlorine. These findings suggested that the oxidative conversion of chromium-containing iron corrosion products in drinking water distribution systems can lead to the occurrence of Cr(VI) at the tap, and the abundance of iron, and a careful control of pH, bicarbonate and bromide levels can assist the control of Cr(VI) formation.

  6. Reversed phase chromatographic behaviour of Pu (III), Pu (IV) and Pu (VI) in presence of α-hydroxyisobutyric acid

    International Nuclear Information System (INIS)

    Jaison, P.G.; Telmore, V.M.; Kumar, Pranaw

    2016-01-01

    Understanding the aqueous chemistry of plutonium is important in process conditions as well as in environmental conditions. Since plutonium possesses multiple oxidation states which can coexist in solution, a reliable method for the identification of these oxidation states is essential to understand its physical and chemical processes. The identification of plutonium oxidation states is conventionally determined through a series of liquid-liquid extraction procedures using selective extractants. Spectroscopic and laser based techniques also have been used for the identification of its oxidation state in solutions. Liquid chromatographic behavior of different oxidation states of Pu and other actinide ions is reported to correlate their retention behaviour with stability constants. Objective of the present work is to study the reversed phase chromatography behavior of the three oxidation states of plutonium viz. Pu(III), Pu(IV) and Pu(VI) in presence of á-hydroxyisobutyric acid (HIBA) as an eluent

  7. Should positive phase III clinical trial data be required before proton beam therapy is more widely adopted? No

    International Nuclear Information System (INIS)

    Suit, Herman; Kooy, Hanne; Trofimov, Alexei; Farr, Jonathan; Munzenrider, John; DeLaney, Thomas; Loeffler, Jay; Clasie, Benjamin; Safai, Sairos; Paganetti, Harald

    2008-01-01

    Purpose: Evaluate the rationale for the proposals that prior to a wider use of proton radiation therapy there must be supporting data from phase III clinical trials. That is, would less dose to normal tissues be an advantage to the patient? Methods: Assess the basis for the assertion that proton dose distributions are superior to those of photons for most situations. Consider the requirements for determining the risks of normal tissue injury, acute and remote, in the examination of the data from a trial. Analyze the probable cost differential between high technology photon and proton therapy. Evaluate the rationale for phase III clinical trials of proton vs photon radiation therapy when the only difference in dose delivered is a difference in distribution of low LET radiation. Results: The distributions of biological effective dose by protons are superior to those by X-rays for most clinical situations, viz. for a defined dose and dose distribution to the target by protons there is a lower dose to non-target tissues. This superiority is due to these physical properties of protons: (1) protons have a finite range and that range is exclusively dependent on the initial energy and the density distribution along the beam path; (2) the Bragg peak; (3) the proton energy distribution may be designed to provide a spread out Bragg peak that yields a uniform dose across the target volume and virtually zero dose deep to the target. Importantly, proton and photon treatment plans can employ beams in the same number and directions (coplanar, non-co-planar), utilize intensity modulation and employ 4D image guided techniques. Thus, the only difference between protons and photons is the distribution of biologically effective dose and this difference can be readily evaluated and quantified. Additionally, this dose distribution advantage should increase the tolerance of certain chemotherapeutic agents and thus permit higher drug doses. The cost of service (not developmental) proton

  8. Can harmonized regulation overcome intra-European differences? Insights from a European Phase III stem cell trial.

    Science.gov (United States)

    Hauskeller, Christine

    2017-09-01

    Harmonized regulation of research with human stem cells in Europe has shaped innovation in regenerative medicine. Findings from a Phase III academic clinical trial of an autologous cell procedure illustrate the obstacles that a multinational trial faces. A typology of the obstacles encountered, may help other teams embarking upon trials. The findings throw light on the situation of clinician-scientists in clinical innovation, as the expertise to run scientific trials is very complex. The innovation route of clinical translation takes insufficient account of the interdependencies between multiple social and cultural factors from outside the laboratory and the clinic. For ethical reasons, however, academic and business routes to stem cell treatments ought to be enabled by the regulators. Suggestions arise, how academics can prepare for trials, that academic research needs better institutional support and that new models of medical innovation may need to be developed for regenerative medicine.

  9. Avelumab (anti-PD-L1) in platinum-resistant/refractory ovarian cancer: JAVELIN Ovarian 200 Phase III study design.

    Science.gov (United States)

    Pujade-Lauraine, Eric; Fujiwara, Keiichi; Dychter, Samuel S; Devgan, Geeta; Monk, Bradley J

    2018-03-27

    Avelumab is a human anti-PD-L1 checkpoint inhibitor with clinical activity in multiple solid tumors. Here, we describe the rationale and design for JAVELIN Ovarian 200 (NCT02580058), the first randomized Phase III trial to evaluate the role of checkpoint inhibition in women with ovarian cancer. This three-arm trial is comparing avelumab administered alone or in combination with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory recurrent ovarian, fallopian tube or peritoneal cancer. Eligible patients are not preselected based on PD-L1 expression and may have received up to three prior lines of chemotherapy for platinum-sensitive disease, but none for resistant disease. Overall survival and progression-free survival are primary end points, and secondary end points include biomarker evaluations and pharmacokinetics.

  10. OECD/NEA expert group on uncertainty analysis for criticality safety assessment: Results of benchmark on sensitivity calculation (phase III)

    Energy Technology Data Exchange (ETDEWEB)

    Ivanova, T.; Laville, C. [Institut de Radioprotection et de Surete Nucleaire IRSN, BP 17, 92262 Fontenay aux Roses (France); Dyrda, J. [Atomic Weapons Establishment AWE, Aldermaston, Reading, RG7 4PR (United Kingdom); Mennerdahl, D. [E Mennerdahl Systems EMS, Starvaegen 12, 18357 Taeby (Sweden); Golovko, Y.; Raskach, K.; Tsiboulia, A. [Inst. for Physics and Power Engineering IPPE, 1, Bondarenko sq., 249033 Obninsk (Russian Federation); Lee, G. S.; Woo, S. W. [Korea Inst. of Nuclear Safety KINS, 62 Gwahak-ro, Yuseong-gu, Daejeon 305-338 (Korea, Republic of); Bidaud, A.; Sabouri, P. [Laboratoire de Physique Subatomique et de Cosmologie LPSC, CNRS-IN2P3/UJF/INPG, Grenoble (France); Patel, A. [U.S. Nuclear Regulatory Commission (NRC), Washington, DC 20555-0001 (United States); Bledsoe, K.; Rearden, B. [Oak Ridge National Laboratory ORNL, M.S. 6170, P.O. Box 2008, Oak Ridge, TN 37831 (United States); Gulliford, J.; Michel-Sendis, F. [OECD/NEA, 12, Bd des Iles, 92130 Issy-les-Moulineaux (France)

    2012-07-01

    The sensitivities of the k{sub eff} eigenvalue to neutron cross sections have become commonly used in similarity studies and as part of the validation algorithm for criticality safety assessments. To test calculations of the sensitivity coefficients, a benchmark study (Phase III) has been established by the OECD-NEA/WPNCS/EG UACSA (Expert Group on Uncertainty Analysis for Criticality Safety Assessment). This paper presents some sensitivity results generated by the benchmark participants using various computational tools based upon different computational methods: SCALE/TSUNAMI-3D and -1D, MONK, APOLLO2-MORET 5, DRAGON-SUSD3D and MMKKENO. The study demonstrates the performance of the tools. It also illustrates how model simplifications impact the sensitivity results and demonstrates the importance of 'implicit' (self-shielding) sensitivities. This work has been a useful step towards verification of the existing and developed sensitivity analysis methods. (authors)

  11. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting.

    Science.gov (United States)

    Uc, Ergun Y; Doerschug, Kevin C; Magnotta, Vincent; Dawson, Jeffrey D; Thomsen, Teri R; Kline, Joel N; Rizzo, Matthew; Newman, Sara R; Mehta, Sonya; Grabowski, Thomas J; Bruss, Joel; Blanchette, Derek R; Anderson, Steven W; Voss, Michelle W; Kramer, Arthur F; Darling, Warren G

    2014-07-29

    To (1) investigate effects of aerobic walking on motor function, cognition, and quality of life in Parkinson disease (PD), and (2) compare safety, tolerability, and fitness benefits of different forms of exercise intervention: continuous/moderate intensity vs interval/alternating between low and vigorous intensity, and individual/neighborhood vs group/facility setting. Initial design was a 6-month, 2 × 2 randomized trial of different exercise regimens in independently ambulatory patients with PD. All arms were required to exercise 3 times per week, 45 minutes per session. Randomization to group/facility setting was not feasible because of logistical factors. Over the first 2 years, we randomized 43 participants to continuous or interval training. Because preliminary analyses suggested higher musculoskeletal adverse events in the interval group and lack of difference between training methods in improving fitness, the next 17 participants were allocated only to continuous training. Eighty-one percent of 60 participants completed the study with a mean attendance of 83.3% (95% confidence interval: 77.5%-89.0%), exercising at 46.8% (44.0%-49.7%) of their heart rate reserve. There were no serious adverse events. Across all completers, we observed improvements in maximum oxygen consumption, gait speed, Unified Parkinson's Disease Rating Scale sections I and III scores (particularly axial functions and rigidity), fatigue, depression, quality of life (e.g., psychological outlook), and flanker task scores (p improvements on the flanker task and quality of life (p improves aerobic fitness, motor function, fatigue, mood, executive control, and quality of life in mild to moderate PD. This study provides Class IV evidence that in patients with PD, an aerobic exercise program improves aerobic fitness, motor function, fatigue, mood, and cognition. © 2014 American Academy of Neurology.

  12. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

    Science.gov (United States)

    Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

    2010-08-01

    A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

  13. A quality assurance audit: phase iii trial of maximal androgen deprivation in prostate cancer (TROG 96.01)

    International Nuclear Information System (INIS)

    Steigler, A.; Kovacev, O.; Denham, J.; Lamb, D.; North, J.

    2000-01-01

    In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme. Copyright (1999) Blackwell Science Pty Ltd

  14. Phase I/II trial of weekly docetaxel and concomitant radiotherapy for squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    Fujii, Masato; Tsukuda, Mamoru; Kubota, Akira; Kida, Akinori; Okami, Kenji

    2003-01-01

    Docetaxel (DOC) is one of the most promising drugs for head and neck cancer (HNSCC). A phase I/II trial of concurrent DOC and radiation for HNSCC was conducted to estimate the recommended dose schedule of DOC, and then to evaluate the therapeutic benefit based on the response and toxicity of the recommended dose schedule. Patients with squamous cell carcinomas of the head and neck were entered. All the patients received radiation with 2.0 Gy single daily fractions up to 60 Gy. DOC was administered weekly for 6 consecutive weeks during radiotherapy. Dose-limiting toxicities, grade 3/4 mucositis and grade 3 pain, manifested in four patients in level 2, and that dose of DOC, 15 mg/m 2 , was considered the maximum tolerated dose (MTD). The recommended dose was decided as 10 mg/m 2 . The phase II study was conducted using DOC at 10 mg/m 2 . Thirty-nine patients with stage II, III or IV were registered, and 35 patients were eligible, 32 patients were evaluable for the response and 34 patients for the toxicity. The overall response rate was 96.9%. The prognoses of the complete response (CR) patients were statistically better than for the partial response (PR) patients. Grade 3 or 4 adverse events consisted of lymphopenia in 64.7%, mucositis in 41.2% and anorexia in 20.6% of the patients. Thirty-two of the 35 eligible patients showed high compliance of over 90%, and their toxicities were manageable. Even low-dose DOC shows a strong effect on HNSCC in combination with radiation, with high survival rates in CR patients. The effect on survival will be assessed by further follow-up. (author)

  15. A quality assurance audit: phase III trial of maximal androgen deprivation in prostate cancer (TROG 96.01).

    Science.gov (United States)

    Steigler, A; Mameghan, H; Lamb, D; Joseph, D; Matthews, J; Franklin, I; Turner, S; Spry, N; Poulsen, M; North, J; Kovacev, O; Denham, J

    2000-02-01

    In 1997 the Trans-Tasman Radiation Oncology Group (TROG) performed a quality assurance (QA) audit of its phase III randomized clinical trial investigating the effectiveness of different durations of maximal androgen deprivation prior to and during definitive radiation therapy for locally advanced carcinoma of the prostate (TROG 96.01). The audit reviewed a total of 60 cases from 15 centres across Australia and New Zealand. In addition to verification of technical adherence to the protocol, the audit also incorporated a survey of centre planning techniques and a QA time/cost analysis. The present report builds on TROG's first technical audit conducted in 1996 for the phase III accelerated head and neck trial (TROG 91.01) and highlights the significant progress TROG has made in the interim period. The audit provides a strong validation of the results of the 96.01 trial, as well as valuable budgeting and treatment planning information for future trials. Overall improvements were detected in data quality and quantity, and in protocol compliance, with a reduction in the rate of unacceptable protocol violations from 10 to 4%. Audit design, staff education and increased data management resources were identified as the main contributing factors to these improvements. In addition, a budget estimate of $100 per patient has been proposed for conducting similar technical audits. The next major QA project to be undertaken by TROG during the period 1998-1999 is an intercentre dosimetry study. Trial funding and staff education have been targeted as the key major issues essential to the continued success and expansion of TROG's QA programme.

  16. Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma

    Science.gov (United States)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A.; Punt, Cornelis J.A.; Haanen, John B.; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L.; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A.; Dreno, Brigitte; Nathan, Paul D.; Mackiewicz, Jacek; Kirkwood, John M.; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-01-01

    Purpose In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients and Methods Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). Results In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. Conclusion This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma. PMID:23295794

  17. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

    Science.gov (United States)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A; Punt, Cornelis J A; Haanen, John B; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A; Dreno, Brigitte; Nathan, Paul D; Mackiewicz, Jacek; Kirkwood, John M; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-02-10

    In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.

  18. Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies.

    Science.gov (United States)

    Rockstroh, Jürgen K; Teppler, Hedy; Zhao, Jing; Sklar, Peter; Miller, Michael D; Harvey, Charlotte M; Strohmaier, Kim M; Leavitt, Randi Y; Nguyen, Bach-Yen T

    2011-07-17

    We evaluated the long-term efficacy of raltegravir according to HIV-1 subtype (B and non-B) using data from three phase III studies in treatment-experienced (BENCHMRK-1 and 2) and treatment-naive (STARTMRK) HIV-infected patients. HIV-1 subtypes were identified from baseline plasma specimens using genotypic data of the PhenoSense GT test (Monogram Biosciences, South San Francisco, California, USA). Non-B subtypes were combined for the current analyses due to small numbers of each specific subtype. An observed failure approach was used (only discontinuations due to lack of efficacy were treated as failures). Resistance evaluation was performed in patients with documented virologic failure. Seven hundred and forty-three patients received raltegravir and 519 received comparator (efavirenz in STARTMRK; optimized background therapy in BENCHMRK). Non-B subtype virus (A, A/C, A/D, A/G, A1, AE, AG, B/G, BF, C, D, D/F, F, F1, G, and complex) was isolated at baseline in 98 (13%) raltegravir recipients and 62 (12%) comparator recipients. Subtypes AE and C were most common, isolated in 41 and 43 patients, respectively. The proportion of raltegravir recipients achieving HIV RNA less than 50 copies/ml was similar between non-B and B subtypes (STARTMRK: 94.5 vs. 88.7%; BENCHMRK-1 and 2: 66.7 vs. 60.7%); change in CD4 cell count also was similar between non-B and B subtypes (STARTMRK: 243 vs. 221 cells/μl; BENCHMRK-1 and 2: 121 vs. 144 cells/μl). Phenotypic resistance to raltegravir in non-B virus was associated with integrase mutations observed previously in subtype B virus. In phase III studies in treatment-naive and treatment-experienced patients, raltegravir showed comparable and potent clinical efficacy against B and non-B HIV-1 subtypes.

  19. Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial.

    Science.gov (United States)

    Zhang, Wei; Kong, Yujia; Jiang, Zhiwei; Li, Chanjuan; Wang, Ling; Xia, Jielai

    2016-04-02

    Human enterovirus 71 (EV71) is a causative agent of hand, foot, and mouth disease (HFMD). In a previous phase III trial in children, a human diploid cell-based inactivated EV71 vaccine elicited EV71 specific immune responses and protection against EV71 associated HFMD. This study aimed to assess the factors influencing the severity of adverse events observed in this previous trial. This was a randomized, double-blinded, placebo-controlled, phase III clinical trial of a human diploid vaccine carried out in 12,000 children in Guangxi Zhuang Autonomous Region, China (ClinicalTrials.gov: NCT01569581). Solicited events were recorded for 7 days and unsolicited events were reported for 28 days after each injection. Age trend analysis of adverse reaction was conducted in each treatment group. Multiple logistic regression models were built to identify factors influencing the severity of adverse reactions. Fewer solicited adverse reactions were observed in older participants within the first 7 days after vaccination (P < 0.0001), except local pain and pruritus. More severe adverse reactions were observed after the initial injection than after the booster injection. Serious cold or respiratory tract infections (RTI) were observed more often in children aged 6-36 months than in older children. Only the severity of local swelling was associated with body mass index. Children with throat discomfort before injection had a higher risk of serious cold or RTI. These results indicated that the human diploid cell-based vaccine achieved a satisfactory safety profile.

  20. Calibration artefacts in radio interferometry - III. Phase-only calibration and primary beam correction

    Science.gov (United States)

    Grobler, T. L.; Stewart, A. J.; Wijnholds, S. J.; Kenyon, J. S.; Smirnov, O. M.

    2016-09-01

    This is the third installment in a series of papers in which we investigate calibration artefacts. Calibration artefacts (also known as ghosts or spurious sources) are created when we calibrate with an incomplete model. In the first two papers of this series, we developed a mathematical framework which enabled us to study the ghosting mechanism itself. An interesting concomitant of the second paper was that ghosts appear in symmetrical pairs. This could possibly account for spurious symmetrization. Spurious symmetrization refers to the appearance of a spurious source (the antighost) symmetrically opposite an unmodelled source around a modelled source. The analysis in the first two papers indicates that the antighost is usually very faint, in particular, when a large number of antennas are used. This suggests that spurious symmetrization will mainly occur at an almost undetectable flux level. In this paper, we show that phase-only calibration produces an antighost that is N-times (where N denotes the number of antennas in the array) as bright as the one produced by phase and amplitude calibration and that this already bright ghost can be further amplified by the primary beam correction.

  1. Left ventricular diastolic dyssynchrony assessed with phase analysis of gated myocardial perfusion SPECT: a comparison with tissue Doppler imaging

    International Nuclear Information System (INIS)

    Boogers, Mark J.; Veltman, Caroline E.; Chen, Ji; Garcia, Ernest V.; Bommel, Rutger J. van; Mooyaart, Eline A.Q.; Wall, Ernst E. van der; Schalij, Martin J.; Bax, Jeroen J.; Delgado, Victoria; Younis, Imad Al; Hiel, Bernies van der; Dibbets-Schneider, Petra

    2011-01-01

    The aim of the current study was to evaluate the feasibility of phase analysis on gated myocardial perfusion SPECT (GMPS) for the assessment of left ventricular (LV) diastolic dyssynchrony in a head-to-head comparison with tissue Doppler imaging (TDI). The population consisted of patients with end-stage heart failure of New York Heart Association functional class III or IV with a reduced LV ejection fraction of ≤35%. LV diastolic dyssynchrony was calculated using TDI as the maximal time delay between early peak diastolic velocities of two opposing left ventricle walls (diastolic mechanical delay). Significant LV diastolic dyssynchrony was defined as a diastolic mechanical delay of >55 ms on TDI. Furthermore, phase analysis on GMPS was performed to evaluate LV diastolic dyssynchrony; diastolic phase standard deviation (SD) and histogram bandwidth (HBW) were used as markers of LV diastolic dyssynchrony. A total of 150 patients (114 men, mean age 66.0 ± 10.4 years) with end-stage heart failure were enrolled. Both diastolic phase SD (r = 0.81, p 55 ms) showed significantly larger diastolic phase SD (68.1 ± 13.4 vs. 40.7 ± 14.0 , p < 0.01) and diastolic HBW (230.6 ± 54.3 vs. 129.0 ± 55.6 , p < 0.01) as compared to patients without LV diastolic dyssynchrony on TDI (≤55 ms). Finally, phase analysis on GMPS showed a good intra- and interobserver reproducibility for the determination of diastolic phase SD (ICC 0.97 and 0.88) and diastolic HBW (ICC 0.98 and 0.93). Phase analysis on GMPS showed good correlations with TDI for the assessment of LV diastolic dyssynchrony. (orig.)

  2. Probing the magnetic moments of [Mn{sup III}{sub 6}Cr{sup III}]{sup 3+} single-molecule magnets—A cross comparison of XMCD and spin-resolved electron spectroscopy

    Energy Technology Data Exchange (ETDEWEB)

    Helmstedt, Andreas, E-mail: helmstedt.andreas@gmail.com [Faculty of Physics, Bielefeld University, Universitätsstr. 25, 33615 Bielefeld (Germany); Dohmeier, Niklas; Müller, Norbert; Gryzia, Aaron; Brechling, Armin; Heinzmann, Ulrich [Faculty of Physics, Bielefeld University, Universitätsstr. 25, 33615 Bielefeld (Germany); Hoeke, Veronika; Krickemeyer, Erich; Glaser, Thorsten [Faculty of Chemistry, Bielefeld University, Universitätsstr. 25, 33615 Bielefeld (Germany); Leicht, Philipp; Fonin, Mikhail [Fachbereich Physik, Universität Konstanz, Universitätsstr. 10, 78457 Konstanz (Germany); Tietze, Thomas [Max Planck Institute for Intelligent Systems, Heisenbergstr. 3, 70569 Stuttgart (Germany); Joly, Loïc [Institut de Physique et Chimie des Matériaux de Strasbourg, UMR 7504, CNRS-Université de Strasbourg, BP 43, 23 rue du Loess, F-67034 Strasbourg Cedex 2 (France); Kuepper, Karsten [Institut für Festkörperphysik, Universität Ulm, 89069 Ulm (Germany)

    2015-01-15

    Highlights: • [Mn{sup III}{sub 6}Cr{sup III}]{sup 3+} single-molecule magnets are investigated. • XMCD and spin-resolved electron spectroscopy (SPES) results are compared. • A simple sum rule evaluation is performed for comparison. • Differences between SPES and XMCD results are discussed. • Influences of the magnetic field on the Mn L edge absorption are observed. - Abstract: Single-molecule magnets (SMM) of the [Mn{sup III}{sub 6}Cr{sup III}]{sup 3+} structural type prepared on Si and gold-coated glass substrates have been investigated by spin-resolved electron spectroscopy (SPES) and X-ray magnetic circular dichroism (XMCD) at the Mn L{sub 3,2} edge and in addition by XMCD at the Cr L{sub 3,2} edge using synchrotron radiation. Differences between the two methods are discussed. Despite its severe limitations for 3d transition metals, a spin sum rule evaluation is nevertheless performed for the Mn{sup III} centres in the [Mn{sup III}{sub 6}Cr{sup III}]{sup 3+} SMM to provide a simple means of comparing XMCD and spin-resolved electron spectroscopy results.

  3. Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: Clinical Phase I/II trials

    International Nuclear Information System (INIS)

    Chen Zhinan; Mi Li; Xu Jing

    2006-01-01

    Purpose: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine ( 131 I) metuximab injection (Licartin), a novel 131 I-labeled HAb18G/CD147-specific monoclonal antibody F(ab') 2 fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. Methods and Materials: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. Results: No life-threatening toxic effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p 131 I) metuximab injection is safe and active for HCC patients

  4. A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

    Science.gov (United States)

    Murakami, Naoya; Kato, Shingo; Nakano, Takashi; Uno, Takashi; Yamanaka, Takeharu; Sakurai, Hideyuki; Yoshimura, Ryoichi; Hiratsuka, Junichi; Kuroda, Yuki; Yoshio, Kotaro; Itami, Jun

    2016-08-17

    This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients. Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT. The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique. UMIN000019081 ; Registration date: 2015/9/30.

  5. Phase III clinical evaluation of gadoteridol injection: Experience in pediatric neuro-oncologic MR imaging

    International Nuclear Information System (INIS)

    Debatin, J.F.; Nadel, S.N.; Gray, L.; Trotter, P.; Friedman, H.S.; Hockenberger, B.; Oakes, W.J.

    1992-01-01

    Twenty-two pediatric patients with known CNS neoplasms underwent magnetic resonance (MR) imaging before and after intravenous injection of 0.1 mmol/kg gadoteridol injection as part of a Phase IIIB open label multicenter clinical trial. Intravenous adminstration of this neutral, nonionic contrast agent was found to be safe in children. No clinically relevant changes in vital signs or laboratory values were attributed to the administration of gadoteridol injection. There were no systemic complaints. The imaging characteristics of gadoteridol in pediatric CNS disease appeared similar to those of gadopentetate dimeglumine. The very low toxicity, inherent to this nonionic low osmolal paramagnetic contrast formulation may allow administration of increased doses at increased infusion rates for an increased number of indications with improved sensitivity. (orig.)

  6. Effects of induction docetaxel, platinum, and fluorouracil chemotherapy in patients with stage III or IVA/B nasopharyngeal cancer treated with concurrent chemoradiation therapy: Final results of 2 parallel phase 2 clinical trials.

    Science.gov (United States)

    Kong, Lin; Zhang, Youwang; Hu, Chaosu; Guo, Ye; Lu, Jiade J

    2017-06-15

    The effects of docetaxel, platinum, and fluorouracil (TPF) induction chemotherapy plus concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal cancer (NPC) are unclear. This study examined the long-term outcomes of the addition of this regimen to CCRT for stage III and IVA/B NPC. Two parallel, single-arm phase 2 trials were performed synchronously to evaluate the efficacy and toxicity of TPF-based induction chemotherapy in patients with stage III or IVA/B NPC. The induction chemotherapy, which preceded standard intensity-modulated radiation therapy/platinum-based chemoradiation, consisted of 3 cycles of docetaxel (75 mg/m 2 on day 1), cisplatin (75 mg/m 2 on day 1), and a continuous infusion of fluorouracil (500 mg/m 2 /d on days 1-5) every 4 weeks. The primary endpoint for both trials was 5-year overall survival (OS). Between January 2007 and July 2010, 52 eligible patients with stage III NPC and 64 eligible patients with nonmetastatic stage IV NPC were accrued to the 2 trials. With a median follow-up of 67 months, the 5-year OS, progression-free survival, distant metastasis-free survival, and local progression-free survival (LPFS) rates were all improved in comparison with historical benchmarks for patients with stage III or IVA/IVB NPC. Multivariate analyses indicated that T and N classifications (T1/T2 vs T3/T4 and N3 vs N0-N2) were the only significant prognosticators for OS. The number of induction chemotherapy cycles was the only significant prognostic factor for predicting LPFS. TPF-based induction chemotherapy appears to significantly improve outcomes in comparison with historical data when it is administered before CCRT for locoregionally advanced NPC. A phase 3 trial is currently being performed to confirm this benefit. Cancer 2017;123:2258-2267. © 2017 American Cancer Society. © 2017 American Cancer Society.

  7. Phase II and III Clinical Studies of Diphtheria-Tetanus-Acellular Pertussis Vaccine Containing Inactivated Polio Vaccine Derived from Sabin Strains (DTaP-sIPV).

    Science.gov (United States)

    Okada, Kenji; Miyazaki, Chiaki; Kino, Yoichiro; Ozaki, Takao; Hirose, Mizuo; Ueda, Kohji

    2013-07-15

    Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP). A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered 3 times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received either Formulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. The OPV or OPV placebo was orally administered twice between primary and booster immunizations. Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). All adverse reactions were clinically acceptable. DTaP-sIPV was shown to be a safe and immunogenic vaccine. JapicCTI-121902 for Phase II study, JapicCTI-101075 for Phase III study (http://www.clinicaltrials.jp/user/cte_main.jsp).

  8. Institute for High Heat Flux Removal (IHHFR). Phases I, II, and III

    Energy Technology Data Exchange (ETDEWEB)

    Boyd, Ronald D. [Prairie View A& M Univ., TX (United States)

    2014-08-31

    The IHHFR focused on interdisciplinary applications as it relates to high heat flux engineering issues and problems which arise due to engineering systems being miniaturized, optimized, or requiring increased high heat flux performance. The work in the IHHFR focused on water as a coolant and includes: (1) the development, design, and construction of the high heat flux flow loop and facility; (2) test section development, design, and fabrication; and, (3) single-side heat flux experiments to produce 2-D boiling curves and 3-D conjugate heat transfer measurements for single-side heated test sections. This work provides data for comparisons with previously developed and new single-side heated correlations and approaches that address the single-side heated effect on heat transfer. In addition, this work includes the addition of single-side heated circular TS and a monoblock test section with a helical wire insert. Finally, the present work includes: (1) data base expansion for the monoblock with a helical wire insert (only for the latter geometry), (2) prediction and verification using finite element, (3) monoblock model and methodology development analyses, and (4) an alternate model development for a hypervapotron and related conjugate heat transfer controlling parameters.

  9. SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

    Science.gov (United States)

    Song, Mi-Kyung; Unruh, Mark L; Manatunga, Amita; Plantinga, Laura C; Lea, Janice; Jhamb, Manisha; Kshirsagar, Abhijit V; Ward, Sandra E

    2018-01-01

    Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. ClinicalTrials.govNCT03138564, registered 05/01/2017. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. The EORTC module for quality of life in patients with thyroid cancer: phase III.

    Science.gov (United States)

    Singer, Susanne; Jordan, Susan; Locati, Laura D; Pinto, Monica; Tomaszewska, Iwona M; Araújo, Cláudia; Hammerlid, Eva; Vidhubala, E; Husson, Olga; Kiyota, Naomi; Brannan, Christine; Salem, Dina; Gamper, Eva M; Arraras, Juan Ignacio; Ioannidis, Georgios; Andry, Guy; Inhestern, Johanna; Grégoire, Vincent; Licitra, Lisa

    2017-04-01

    The purpose of the study was to pilot-test a questionnaire measuring health-related quality of life (QoL) in thyroid cancer patients to be used with the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire EORTC QLQ-C30. A provisional questionnaire with 47 items was administered to patients treated for thyroid cancer within the last 2 years. Patients were interviewed about time and help needed to complete the questionnaire, and whether they found the items understandable, confusing or annoying. Items were kept in the questionnaire if they fulfilled pre-defined criteria: relevant to the patients, easy to understand, not confusing, few missing values, neither floor nor ceiling effects, and high variance. A total of 182 thyroid cancer patients in 15 countries participated ( n  = 115 with papillary, n  = 31 with follicular, n  = 22 with medullary, n  = 6 with anaplastic, and n  = 8 with other types of thyroid cancer). Sixty-six percent of the patients needed 15 min or less to complete the questionnaire. Of the 47 items, 31 fulfilled the predefined criteria and were kept unchanged, 14 were removed, and 2 were changed. Shoulder dysfunction was mentioned by 5 patients as missing and an item covering this issue was added. To conclude, the EORTC quality of life module for thyroid cancer (EORTC QLQ-THY34) is ready for the final validation phase IV. © 2017 Society for Endocrinology.

  11. Post-treatment resistance analysis of hepatitis C virus from phase II and III clinical trials of ledipasvir/sofosbuvir.

    Science.gov (United States)

    Wyles, David; Dvory-Sobol, Hadas; Svarovskaia, Evguenia S; Doehle, Brian P; Martin, Ross; Afdhal, Nezam H; Kowdley, Kris V; Lawitz, Eric; Brainard, Diana M; Miller, Michael D; Mo, Hongmei; Gane, Edward J

    2017-04-01

    Ledipasvir/sofosbuvir combination treatment in phase III clinical trials resulted in sustained viral suppression in 94-99% of patients. This study characterized drug resistance in treatment failures, which may help to inform retreatment options. We performed NS5A and NS5B deep sequencing of hepatitis C virus (HCV) from patients infected with genotype (GT) 1 who participated in ledipasvir/sofosbuvir phase II and III clinical trials. Fifty-one of 2144 (2.4%) (42 GT1a and 9 GT1b) treated patients met the criteria for resistance analysis due to virologic failure following the end of treatment. The majority of patients with virologic failure (38 of 51; 74.5%) had detectable ledipasvir-specific resistance-associated substitutions (RASs) at the time of virologic failure (1% deep sequencing cut-off). The percent of patients with NS5A RASs at virologic failure were 37.5%, 66.7%, 94.7% and 100% in patients treated for 6, 8, 12 and 24weeks, respectively. The common substitutions detected at failure were Q30R/H, and/or Y93H/N in GT1a and Y93H in GT1b. At failure, 35.3% (18/51) of virologic failure patients' viruses had two or more NS5A RASs and the majority of patients harbored NS5A RASs conferring a 100-1000-fold (n=10) or >1000-fold (n=23) reduced susceptibility to ledipasvir. One patient in a phase II study with a known ledipasvir RAS at baseline (L31M) developed the S282T sofosbuvir (NS5B) RAS at failure. In GT1 HCV-infected patients treated with ledipasvir/sofosbuvir±ribavirin, virologic failure was rare. Ledipasvir resistance in NS5A was selected or enhanced in most patients with virologic failure, one of whom also developed resistance to sofosbuvir. Clinical studies have shown that combination treatment with ledipasvir/sofosbuvir efficiently cures most patients with genotype 1 hepatitis C infection. For the few patients failing treatment, we show that resistance to ledipasvir was observed in most patients, whereas resistance to sofosbuvir was less common. This has

  12. Phase-coherent transport and spin-orbit-coupling in III/V-semiconductor nanowires

    International Nuclear Information System (INIS)

    Estevez Hernandez, Sergio

    2009-01-01

    Semiconductor nanowires fabricated by a bottom-up approach are not only interesting for the realization of future nanoscaled devices but also appear to be very attractive model systems to tackle fundamental questions concerning the transport in strongly confined systems. In order to avoid the problem connected with carrier depletion, narrowband gap semiconductors, i.e., InAs or InN, or core-shell Nanowires, i.e., GaAs/AlGaAs, are preferred. The underlying reason is that in InAs or InN the Fermi-level pinning in the conduction band results in a carrier accumulation at the surface. In fact, the tubular topology of the surface electron gas opens up the possibility to observe unconventional quantum transport phenomena. When the phase-coherence length in the nanowire is comparable to its dimensions the conductance fluctuates if a magnetic field is applied or if the electron concentration is changed by means of a gate electrode. These so-called universal conductance fluctuations being in the order of e 2 /h originate from the fact that in small disordered samples, electron interference effects are not averaged out. In this work are analyzed universal conductance fluctuations to study the quantum transport properties in InN, InAs and GaAs/AlGaAs nanowires. With the use of a magnetic field and a back-gate electrode the universal conductance fluctuations and localizations effects were analyzed. Since InN and InAs are narrow band gap semiconductors, one naturally expects spin-orbit coupling effects. Because this phenomena is of importance for spin electronic applications. However, owing to the cylindrical symmetry of the InN and InAs nanowires, the latter effect was observable and actually be used to determine the strength of spin-orbit coupling. In order to clearly separate the weak antilocalization effect from the conductance fluctuations, the averaging of the magnetoconductance at different gate voltages was essential. The low-temperature quantum transport properties of

  13. NOVEL CONCEPTS RESEARCH IN GEOLOGIC STORAGE OF CO2 PHASE III

    Energy Technology Data Exchange (ETDEWEB)

    Neeraj Gupta

    2006-01-23

    As part of the Department of Energy's (DOE) initiative on developing new technologies for storage of carbon dioxide in geologic reservoirs, Battelle has been investigating the feasibility of CO{sub 2} sequestration in the deep saline reservoirs in the Ohio River Valley region. In addition to the DOE, the project is being sponsored by American Electric Power (AEP), BP, The Ohio Coal Development Office (OCDO) of the Ohio Air Quality Development Authority, Schlumberger, and Battelle. The main objective of the project is to demonstrate that CO{sub 2} sequestration in deep formations is feasible from engineering and economic perspectives, as well as being an inherently safe practice and one that will be acceptable to the public. In addition, the project is designed to evaluate the geology of deep formations in the Ohio River Valley region in general and in the vicinity of AEP's Mountaineer Power Plant in particular, in order to determine their potential use for conducting a long-term test of CO{sub 2} disposal in deep saline formations. The current technical progress report summarizes activities completed for the October through December 2005 period of the project. As discussed in the following report, the main field activity was reservoir testing in the Copper Ridge ''B-zone'' in the AEP No.1 well. In addition reservoir simulations were completed to assess feasibility of CO{sub 2} injection for the Mountaineer site. These reservoir testing and computer simulation results suggest that injection potential may be substantially more than anticipated for the Mountaineer site. Work also continued on development of injection well design options, engineering assessment of CO{sub 2} capture systems, permitting, and assessment of monitoring technologies as they apply to the project site. Overall, the current design feasibility phase project is proceeding according to plans.

  14. Treatment of geographic atrophy with subconjunctival sirolimus: results of a phase I/II clinical trial.

    Science.gov (United States)

    Wong, Wai T; Dresner, Samuel; Forooghian, Farzin; Glaser, Tanya; Doss, Lauren; Zhou, Mei; Cunningham, Denise; Shimel, Katherine; Harrington, Molly; Hammel, Keri; Cukras, Catherine A; Ferris, Frederick L; Chew, Emily Y

    2013-04-26

    To investigate the safety and effects of subconjunctival sirolimus, an mTOR inhibitor and immunosuppressive agent, for the treatment of geographic atrophy (GA). The study was a single-center, open-label phase II trial, enrolling 11 participants with bilateral GA; eight participants completed 24 months of follow-up. Sirolimus (440 μg) was administered every 3 months as a subconjunctival injection in only one randomly assigned eye in each participant for 24 months. Fellow eyes served as untreated controls. The primary efficacy outcome measure was the change in the total GA area at 24 months. Secondary outcomes included changes in visual acuity, macular sensitivity, central retinal thickness, and total drusen area. The study drug was well tolerated with few symptoms and related adverse events. Study treatment in study eyes was not associated with structural or functional benefits relative to the control fellow eyes. At month 24, mean GA area increased by 54.5% and 39.7% in study and fellow eyes, respectively (P = 0.41), whereas mean visual acuity decreased by 21.0 letters and 3.0 letters in study and fellow eyes, respectively (P = 0.03). Substantial differences in mean changes in drusen area, central retinal thickness, and macular sensitivity were not detected for all analysis time points up to 24 months. Repeated subconjunctival sirolimus was well-tolerated in patients with GA, although no positive anatomic or functional effects were identified. Subconjunctival sirolimus may not be beneficial in the prevention of GA progression, and may potentially be associated with effects detrimental to visual acuity. (ClinicalTrials.gov number, NCT00766649.).

  15. EERC Center for Biomass Utilization 2008-2010. Phases I-III

    Energy Technology Data Exchange (ETDEWEB)

    Zygarlicke, Christopher J. [Univ. of North Dakota, Grand Forks, ND (United States); Hurley, John P. [Univ. of North Dakota, Grand Forks, ND (United States); Auich, Ted R. [Univ. of North Dakota, Grand Forks, ND (United States); Folkedahl, Bruce C. [Univ. of North Dakota, Grand Forks, ND (United States); Strege, Josua R. [Univ. of North Dakota, Grand Forks, ND (United States); Patel, Nikhil M. [Univ. of North Dakota, Grand Forks, ND (United States); Swanson, Michael L. [Univ. of North Dakota, Grand Forks, ND (United States); Martin, Christopher L [Univ. of North Dakota, Grand Forks, ND (United States); Olson, Edwin S. [Univ. of North Dakota, Grand Forks, ND (United States); Oster, Benjamin G. [Univ. of North Dakota, Grand Forks, ND (United States); Stanislowski, Joshua J. [Univ. of North Dakota, Grand Forks, ND (United States); Nyberg, Carolyn M. [Univ. of North Dakota, Grand Forks, ND (United States); Wocken, Chad A. [Univ. of North Dakota, Grand Forks, ND (United States); Pansegrau, Paul D. [Univ. of North Dakota, Grand Forks, ND (United States)

    2015-07-30

    The U.S. Department of Energy (DOE) Energy Information Administration (EIA) projects nonhydro renewable electric energy increases of 140% and liquid transportation biofuels growing by 32,200 barrels a day between 2012 and 2040 (U.S. Energy Information Administration, 2014). This is the EIA base case scenario, and this outlook could be a low estimate depending on the many assumptions involved in making such projections, not the least of which are climate change and the resultant legislation. The climate change postulate is based on increasing levels of CO2 being introduced into the atmosphere through anthropogenic activity such as fossil fuel combustion for energy use. Renewable energy, and biomass conversion to energy in particular, is a net-zero CO2 emission generator. When biomass is converted to energy, it emits CO2; however, this CO2 is balanced in a cycle where the production of biomass removes CO2 from the atmosphere for growth and then releases it back into the atmosphere to be taken up by new growth of biomass feedstocks for energy. In comparison, fossil fuels are examples of CO2 that has been removed from the atmosphere and sequestered and which, when converted to energy, is a new addition to the atmospheric levels of CO2, which has been linked to climate change. While recent advances in technology used for extracting oil and gas from tight formations have increased the availability of fossil fuels for energy, the end game needs to focus on providing sustainable energy sources for the United States as well as the world. If, in the future, legislation is enacted that places a fee on atmospheric CO2 emissions, this may make the use of biomass for energy more economically attractive, increasing its use. Research that focuses on the future sustainability of energy production is part of the answer to bringing about game-changing technologies that can provide energy in a

  16. A direct comparison of protein structure in the gas and solution phase: the Trp-cage

    DEFF Research Database (Denmark)

    Patriksson, Alexandra; Adams, Christopher M; Kjeldsen, Frank

    2007-01-01

    Molecular dynamics simulations of zwitterions of the Trp-cage protein in the gas phase show that the most stable ion in vacuo has preserved the charge locations acquired in solution. A direct comparison of the gas and solution-phase structures reveals that, despite the similarity in charge location...

  17. Phase I/II Study of Metastatic Melanoma Patients Treated with Nivolumab Who Had Progressed after Ipilimumab.

    Science.gov (United States)

    Weber, Jeffrey; Gibney, Geoffrey; Kudchadkar, Ragini; Yu, Bin; Cheng, Pingyan; Martinez, Alberto J; Kroeger, Jodie; Richards, Allison; McCormick, Lori; Moberg, Valerie; Cronin, Heather; Zhao, Xiuhua; Schell, Michael; Chen, Yian Ann

    2016-04-01

    The checkpoint inhibitor nivolumab is active in patients with metastatic melanoma who have failed ipilimumab. In this phase I/II study, we assessed nivolumab's safety in 92 ipilimumab-refractory patients with unresectable stage III or IV melanoma, including those who experienced grade 3-4 drug-related toxicity to ipilimumab. We report long-term survival, response duration, and biomarkers in these patients after nivolumab treatment (3 mg/kg) every 2 weeks for 24 weeks, then every 12 weeks for up to 2 years, with or without a multipeptide vaccine. The response rate for ipilimumab-refractory patients was 30% (95% CI, 21%-41%). The median duration of response was 14.6 months, median progression-free survival was 5.3 months, and median overall survival was 20.6 months, when patients were followed up for a median of 16 months. One- and 2-year survival rates were 68.4% and 31.2%, respectively. Ipilimumab-naïve and ipilimumab-refractory patients showed no significant difference in survival. The 21 patients with prior grade 3-4 toxicity to ipilimumab that was managed with steroids tolerated nivolumab well, with 62% (95% CI, 38%-82%) having complete or partial responses or stabilized disease at 24 weeks. High numbers of myeloid-derived suppressor cells (MDSC) were associated with poor survival. Thus, survival and long-term safety were excellent in ipilimumab-refractory patients treated with nivolumab. Prior grade 3-4 immune-related adverse effects from ipilimumab were not indicative of nivolumab toxicities, and patients had a high overall rate of remission or stability at 24 weeks. Prospectively evaluating MDSC numbers before treatment could help assess the expected benefit of nivolumab. ©2016 American Association for Cancer Research.

  18. Phase I study of cisplatin, vinorelbine, and concurrent thoracic radiotherapy for unresectable stage III non-small cell lung cancer

    International Nuclear Information System (INIS)

    Sekine, Ikuo

    2004-01-01

    To determine the recommended phase II dose of vinorelbine in combination with cisplatin and thoracic radiotherapy (TRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC), 18 patients received cisplatin (80 mg/m 2 ) on day 1 and vinorelbine (20 mg/m 2 in level 1, and 25 mg/m 2 in level 2) on days 1 and 8 every 4 weeks for 4 cycles. TRT consisted of a single dose of 2 Gy once daily for 3 weeks followed by a rest of 4 days, and then the same TRT for 3 weeks to a total dose of 60 Gy. Fifteen (83%) patients received 60 Gy of TRT and 14 (78%) patients received 4 cycles of chemotherapy. Ten (77%) of 13 patients at level 1 and all 5 patients at level 2 developed grade 3-4 neutropenia. Four (31%) patients at level 1 and 3 (60%) patients at level 2 developed grade 3-4 infection. None developed ≥grade 3 esophagitis or lung toxicity. Dose-limiting toxicity was noted in 33% of the patients in level 1 and in 60% of the patients in level 2. The overall response rate (95% confidence interval) was 83% (59-96%) with 15 partial responses. The median survival time was 30.4 months, and the 1-year, 2-year, and 3-year survival rates were 72%, 61%, and 50%, respectively. In conclusion, the recommended dose is the level 1 dose, and this regimen is feasible and promising in patients with stage III NSCLC. (author)

  19. A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients.

    Science.gov (United States)

    Floege, Jürgen; Covic, Adrian C; Ketteler, Markus; Rastogi, Anjay; Chong, Edward M F; Gaillard, Sylvain; Lisk, Laura J; Sprague, Stuart M

    2014-09-01

    Efficacy of PA21 (sucroferric oxyhydroxide), a novel calcium-free polynuclear iron(III)-oxyhydroxide phosphate binder, was compared with that of sevelamer carbonate in an open-label, randomized, active-controlled phase III study. Seven hundred and seven hemo- and peritoneal dialysis patients with hyperphosphatemia received PA21 1.0-3.0 g per day and 348 received sevelamer 4.8-14.4 g per day for an 8-week dose titration, followed by 4 weeks without dose change, and then 12 weeks maintenance. Serum phosphorus reductions at week 12 were -0.71 mmol/l (PA21) and -0.79 mmol/l (sevelamer), demonstrating non-inferiority of, on average, three tablets of PA21 vs. eight of sevelamer. Efficacy was maintained to week 24. Non-adherence was 15.1% (PA21) vs. 21.3% (sevelamer). The percentage of patients that reported at least one treatment-emergent adverse event was 83.2% with PA21 and 76.1% with sevelamer. A higher proportion of patients withdrew owing to treatment-emergent adverse events with PA21 (15.7%) vs. sevelamer (6.6%). Mild, transient diarrhea, discolored feces, and hyperphosphatemia were more frequent with PA21; nausea and constipation were more frequent with sevelamer. After 24 weeks, 99 hemodialysis patients on PA21 were re-randomized into a 3-week superiority analysis of PA21 maintenance dose in 50 patients vs. low dose (250 mg per day (ineffective control)) in 49 patients. The PA21 maintenance dose was superior to the low dose in maintaining serum phosphorus control. Thus, PA21 was effective in lowering serum phosphorus in dialysis patients, with similar efficacy to sevelamer carbonate, a lower pill burden, and better adherence.

  20. Statistical comparison of the geometry of second-phase particles

    Energy Technology Data Exchange (ETDEWEB)

    Benes, Viktor, E-mail: benesv@karlin.mff.cuni.cz [Charles University in Prague, Faculty of Mathematics and Physics, Department of Probability and Mathematical Statistics, Sokolovska 83, 186 75 Prague 8-Karlin (Czech Republic); Lechnerova, Radka, E-mail: radka.lech@seznam.cz [Private College on Economical Studies, Ltd., Lindnerova 575/1, 180 00 Prague 8-Liben (Czech Republic); Klebanov, Lev [Charles University in Prague, Faculty of Mathematics and Physics, Department of Probability and Mathematical Statistics, Sokolovska 83, 186 75 Prague 8-Karlin (Czech Republic); Slamova, Margarita, E-mail: slamova@vyzkum-kovu.cz [Research Institute for Metals, Ltd., Panenske Brezany 50, 250 70 Odolena Voda (Czech Republic); Slama, Peter [Research Institute for Metals, Ltd., Panenske Brezany 50, 250 70 Odolena Voda (Czech Republic)

    2009-10-15

    In microscopic studies of materials, there is often a need to provide a statistical test as to whether two microstructures are different or not. Typically, there are some random objects (particles, grains, pores) and the comparison concerns their density, individual geometrical parameters and their spatial distribution. The problem is that neighbouring objects observed in a single window cannot be assumed to be stochastically independent, therefore classical statistical testing based on random sampling is not applicable. The aim of the present paper is to develop a test based on N-distances in probability theory. Using the measurements from a few independent windows, we consider a two-sample test, which involves a large amount of information collected from each window. An application is presented consisting in a comparison of metallographic samples of aluminium alloys, and the results are interpreted.

  1. Statistical comparison of the geometry of second-phase particles

    International Nuclear Information System (INIS)

    Benes, Viktor; Lechnerova, Radka; Klebanov, Lev; Slamova, Margarita; Slama, Peter

    2009-01-01

    In microscopic studies of materials, there is often a need to provide a statistical test as to whether two microstructures are different or not. Typically, there are some random objects (particles, grains, pores) and the comparison concerns their density, individual geometrical parameters and their spatial distribution. The problem is that neighbouring objects observed in a single window cannot be assumed to be stochastically independent, therefore classical statistical testing based on random sampling is not applicable. The aim of the present paper is to develop a test based on N-distances in probability theory. Using the measurements from a few independent windows, we consider a two-sample test, which involves a large amount of information collected from each window. An application is presented consisting in a comparison of metallographic samples of aluminium alloys, and the results are interpreted.

  2. Randomised phase I/II study to evaluate carbon ion radiotherapy versus fractionated stereotactic radiotherapy in patients with recurrent or progressive gliomas: The CINDERELLA trial

    International Nuclear Information System (INIS)

    Combs, Stephanie E; Wick, Wolfgang; Debus, Jürgen; Burkholder, Iris; Edler, Lutz; Rieken, Stefan; Habermehl, Daniel; Jäkel, Oliver; Haberer, Thomas; Haselmann, Renate; Unterberg, Andreas

    2010-01-01

    Treatment of patients with recurrent glioma includes neurosurgical resection, chemotherapy, or radiation therapy. In most cases, a full course of radiotherapy has been applied after primary diagnosis, therefore application of re-irradiation has to be applied cauteously. With modern precision photon techniques such as fractionated stereotactic radiotherapy (FSRT), a second course of radiotherapy is safe and effective and leads to survival times of 22, 16 and 8 months for recurrent WHO grade II, III and IV gliomas. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the GBM cell line as well as the endpoint analyzed. Protons, however, offer an RBE which is comparable to photons. First Japanese Data on the evaluation of carbon ion radiation therapy for the treatment of primary high-grade gliomas showed promising results in a small and heterogeneous patient collective. In the current Phase I/II-CINDERELLA-trial re-irradiation using carbon ions will be compared to FSRT applied to the area of contrast enhancement representing high-grade tumor areas in patients with recurrent gliomas. Within the Phase I Part of the trial, the Recommended Dose (RD) of carbon ion radiotherapy will be determined in a dose escalation scheme. In the subsequent randomized Phase II part, the RD will be evaluated in the experimental arm, compared to the standard arm, FSRT with a total dose of 36 Gy in single doses of 2 Gy. Primary endpoint of the Phase I part is toxicity. Primary endpoint of the randomized part II is survival after re-irradiation at 12 months, secondary endpoint is progression-free survival. The Cinderella trial is the first study to evaluate carbon ion

  3. Comparison of Schwinger and Kohn variational phase shift calculations

    International Nuclear Information System (INIS)

    Callaway, I.

    1980-01-01

    Numerical calculations of the l = 0 phase shift for an attractive Yukawa potential are reported using Schwinger and Kohn (type) variational methods. Accurate values can be obtained from both procedures, but when the same basis set of short range functions is used, the Kohn procedure gives superior results. (orig.)

  4. Motivations to participate in a Phase I/II HIV vaccine trial: A descriptive study from Dar es Salaam, Tanzania

    Directory of Open Access Journals (Sweden)

    E. A. M. Tarimo

    2016-02-01

    Full Text Available Abstract Background The search for an efficacious HIV vaccine is a global priority. To date only one HIV vaccine trial (RV144 has shown modest efficacy in a phase III trial. With existing different HIV-1 subtypes and frequent mutations, multiple trials are needed from different geographical sites particularly in sub-Saharan Africa where most HIV infections occur. Thus, motivations to participate in HIV vaccine trials among Tanzanians need to be assessed. This paper describes the motives of Police Officers who showed great interest to volunteer in HIVIS-03 in Dar es Salaam, Tanzania. Methods A descriptive cross-sectional study was conducted among Police Officers who showed interest to participate in the HIVIS-03, a phase I/II HIV vaccine trial in Dar es Salaam. Prior to detailed training sessions about HIV vaccine trials, the potential participants narrated their individual motives to participate in the trial on a piece of paper. Descriptive analysis using content approach and frequency distributions were performed. Results Of the 265 respondents, 242 (91.3 % provided their socio-demographic characteristics as well as reasons that would make them take part in the proposed trial. Majority, (39.7 %, cited altruism as the main motive. Women were more likely to volunteer due to altruism compared to men (P < 0.01. Researchers’ explanations about HIV/AIDS vaccine studies motivated 15.3 %. More men (19.6 % than women (1.7 % were motivated to volunteer due to researchers’ explanations (P < 0.001. Also, compared to other groups, those unmarried and educated up to secondary level of education were motivated to volunteer due to researchers’ explanation (P < 0.05. Other reasons were: desire to become a role model (18.6 %; to get knowledge for educating others (14.0 %; to cooperate with researchers in developing an HIV vaccine (9.5 %; to get protection against HIV infection (7.0 %, and severity of the disease within families (6.2

  5. Successful completion of the Qinshan phase III nuclear power plant-a successful model for Chinese-Canadian cooperation

    International Nuclear Information System (INIS)

    Peng Xiaoxing

    2004-01-01

    This report documents Qinshan CANDU project construction and commissioning experience as well as management strategies and approaches that contributed to the successful completion of the project. The Qinshan phase III (CANDU) nuclear power plant was built in record times: Unit 1 achieved commercial operation on December 31, 2002 and Unit 2 on July 24, 2003, 43 days and 112 days ahead of schedule respectively. The reference plant design is the Wolsong 3 and 4 CANDU-6 units in the Republic of Korea. Improvements in design and construction methods allowed Unit 1 to be constructed in 51.5 Months from First Concrete to Criticality-a record in China for nuclear power plants. The key factors are project management and project management tools, quality assurance, construction methods (including open top construction, heavy lifts and modularization), electronic documentation with configuration control that provides up-to-date on-line information, CADDS design linked with material management, specialized material control including bar coding, and planning. The introduction of new design and construction techniques was achieved by combining conventional AECL practices with working experiences in China. The most advanced tools and techniques for achieving optimum construction quality, schedule and cost were used. Successful application of advanced project management methods and tools will benefit TQNPC in operation of the station, and the Chinese contractors in advancing their capabilities in future nuclear projects in China and enhancing their opportunities internationally. TQNPC's participation in Quality surveillance (QS) activities of nuclear steam plant (NSP) and Balance of Plant (BOP) offshore equipment benefited TQNPC in acquiring knowledge of specific equipment manufacturing processes, which can be applied to similar activities in China. China has established the capability of manufacturing CANDU fuel and becoming self-reliant in fuel supply. Excellent co-operation and

  6. Melphalan, prednisone, thalidomide and defibrotide in relapsed/refractory multiple myeloma: results of a multicenter phase I/II trial.

    Science.gov (United States)

    Palumbo, Antonio; Larocca, Alessandra; Genuardi, Mariella; Kotwica, Katarzyna; Gay, Francesca; Rossi, Davide; Benevolo, Giulia; Magarotto, Valeria; Cavallo, Federica; Bringhen, Sara; Rus, Cecilia; Masini, Luciano; Iacobelli, Massimo; Gaidano, Gianluca; Mitsiades, Constantine; Anderson, Kenneth; Boccadoro, Mario; Richardson, Paul

    2010-07-01

    Defibrotide is a novel orally bioavailable polydisperse oligonucleotide with anti-thrombotic and anti-adhesive effects. In SCID/NOD mice, defibrotide showed activity in human myeloma xenografts. This phase I/II study was conducted to identify the most appropriate dose of defibrotide in combination with melphalan, prednisone and thalidomide in patients with relapsed and relapsed/refractory multiple myeloma, and to determine its safety and tolerability as part of this regimen. This was a phase I/II, multicenter, dose-escalating, non-comparative, open label study. Oral melphalan was administered at a dose of 0.25 mg/kg on days 1-4, prednisone at a dose of 1.5 mg/kg also on days 1-4 and thalidomide at a dose of 50-100 mg/day continuously. Defibrotide was administered orally at three dose-levels: 2.4, 4.8 or 7.2 g on days 1-4 and 1.6, 3.2, or 4.8 g on days 5-35. Twenty-four patients with relapsed/refractory multiple myeloma were enrolled. No dose-limiting toxicity was observed. In all patients, the complete response plus very good partial response rate was 9%, and the partial response rate was 43%. The 1-year progression-free survival and 1-year overall survival rates were 34% and 90%, respectively. The most frequent grade 3-4 adverse events included neutropenia, thrombocytopenia, anemia and fatigue. Deep vein thrombosis was reported in only one patient. This combination of melphalan, prednisone and thalidomide together with defibrotide showed anti-tumor activity with a favorable tolerability. The maximum tolerated dose of defibrotide was identified as 7.2 g p.o. on days 1-4 followed by 4.8 g p.o. on days 5-35. Further trials are needed to confirm the role of this regimen and to evaluate the combination of defibrotide with new drugs.

  7. Comparison of electrical and optical characteristics in gas-phase and gas-liquid phase discharges

    Energy Technology Data Exchange (ETDEWEB)

    Qazi, H. I. A.; Li, He-Ping, E-mail: liheping@tsinghua.edu.cn; Zhang, Xiao-Fei; Bao, Cheng-Yu [Department of Engineering Physics, Tsinghua University, Beijing 100084 (China); Nie, Qiu-Yue [School of Electrical Engineering and Automation, Harbin Institute of Technology, Harbin, Heilongjiang Province 150001 (China)

    2015-12-15

    This paper presents an AC-excited argon discharge generated using a gas-liquid (two-phase) hybrid plasma reactor, which mainly consists of a powered needle electrode enclosed in a conical quartz tube and grounded deionized water electrode. The discharges in the gas-phase, as well as in the two-phase, exhibit two discharge modes, i.e., the low current glow-like diffuse mode and the high current streamer-like constrict mode, with a mode transition, which exhibits a negative resistance of the discharges. The optical emission spectral analysis shows that the stronger diffusion of the water vapor into the discharge region in the two-phase discharges boosts up the generation of OH (A–X) radicals, and consequently, leads to a higher rotational temperature in the water-phase plasma plume than that of the gas-phase discharges. Both the increase of the power input and the decrease of the argon flow rate result in the increase of the rotational temperature in the plasma plume of the water-phase discharge. The stable two-phase discharges with a long plasma plume in the water-phase under a low power input and gas flow rate may show a promising prospect for the degradation of organic pollutants, e.g., printing and dyeing wastewater, in the field of environmental protection.

  8. Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy

    DEFF Research Database (Denmark)

    Herrstedt, Jørn; Apornwirat, Wichit; Shaharyar, Ahmed

    2009-01-01

    PURPOSE: The purpose of this phase III trial was to evaluate the efficacy and safety of regimens containing casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting during the first cycle in patients receiving moderately emetogenic chemo...

  9. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy

    DEFF Research Database (Denmark)

    Bellmunt, Joaquim; von der Maase, Hans; Mead, Graham M

    2012-01-01

    The combination of gemcitabine plus cisplatin (GC) is a standard regimen in patients with locally advanced or metastatic urothelial cancer. A phase I/II study suggested that a three-drug regimen that included paclitaxel had greater antitumor activity and might improve survival....

  10. Phase III trial of cetuximab with continuous or intermittent fluorouracil, leucovorin, and oxaliplatin (Nordic FLOX) versus FLOX alone in first-line treatment of metastatic colorectal cancer

    DEFF Research Database (Denmark)

    Tveit, Kjell Magne; Guren, Tormod; Glimelius, Bengt

    2012-01-01

    The NORDIC-VII multicenter phase III trial investigated the efficacy of cetuximab when added to bolus fluorouracil/folinic acid and oxaliplatin (Nordic FLOX), administered continuously or intermittently, in previously untreated metastatic colorectal cancer (mCRC). The influence of KRAS mutation...

  11. Bortezomib before and after high-dose therapy in myeloma : Long-term results from the phase III HOVON-65/GMMGHD-4 trial

    NARCIS (Netherlands)

    Goldschmidt, H.; Lokhorst, H. M.; Mai, E. K.; van der Holt, B.; Blau, I. W.; Zweegman, S.; Weisel, K. C.; Vellenga, E.; Pfreundschuh, M.; Kersten, M. J.; Scheid, C.; Croockewit, S.; Raymakers, R.; Hose, D.; Potamianou, A.; Jauch, A.; Hillengass, J.; Stevens-Kroef, M.; Raab, M. S.; Broijl, A.; Lindemann, H. W.; Bos, G. M. J.; Brossart, P.; Kooy, M. van Marwijk; Ypma, P.; Duehrsen, U.; Schaafsma, R. M.; Bertsch, U.; Hielscher, T.; Jarari, Le; Salwender, H. J.; Sonneveld, P.

    The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical

  12. Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMGHD-4 trial

    NARCIS (Netherlands)

    Goldschmidt, H.; Lokhorst, H. M.; Mai, E. K.; van der Holt, B.; Blau, I. W.; Zweegman, S.; Weisel, K. C.; Vellenga, E.; Pfreundschuh, M.; Kersten, M. J.; Scheid, C.; Croockewit, S.; Raymakers, R.; Hose, D.; Potamianou, A.; Jauch, A.; Hillengass, J.; Stevens-Kroef, M.; Raab, M. S.; Broijl, A.; Lindemann, H. W.; Bos, G. M. J.; Brossart, P.; van Marwijk Kooy, M.; Ypma, P.; Duehrsen, U.; Schaafsma, R. M.; Bertsch, U.; Hielscher, T.; Jarari, Le; Salwender, H. J.; Sonneveld, P.

    2018-01-01

    The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical

  13. Effects of recombinant human granulocyte colony-stimulating factor on leucopenia in zidovudine-treated patients with AIDS and AIDS related complex, a phase I/II study

    NARCIS (Netherlands)

    van der Wouw, P. A.; van Leeuwen, R.; van Oers, R. H.; Lange, J. M.; Danner, S. A.

    1991-01-01

    Twelve male patients, eight with the acquired immunodeficiency syndrome (AIDS) and four with AIDS related complex (ARC), who had zidovudine associated neutropenia (less than 1 x 10(9) neutrophils/l) were treated with recombinant human granulocyte colony-stimulating factor (G-CSF) in a phase I/II

  14. Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non-Hodgkin's Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study

    NARCIS (Netherlands)

    van Oers, Marinus H. J.; van Glabbeke, Martine; Giurgea, Livia; Klasa, Richard; Marcus, Robert E.; Wolf, Max; Kimby, Eva; van 't Veer, Mars; Vranovsky, Andrej; Holte, Harald; Hagenbeek, Anton

    2010-01-01

    Purpose In 2006, we published the results of the European Organisation for Research and Treatment of Cancer phase III trial EORTC 20981 on the role of rituximab in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma (FL). At that time, the median follow-up for the

  15. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies : Challenges and opportunities

    NARCIS (Netherlands)

    van Leeuwen, M.L.; Efficace, F.; Fosså, S.D.; Bolla, M.; de Giorgi, U.; De Wit, R.; Holzner, B.; van de Poll-Franse, L.; White, J.; Collette, L.; Osanto, S.; Aaronson, N.K.; European Organisation for Research and Treatment of Cancer Quality of Life Group; Genito-Urinary Cancers Group, The

    2014-01-01

    Objectives In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting

  16. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: Challenges and opportunities

    NARCIS (Netherlands)

    van Leeuwen, M.; Efficace, F.; Fosså, S.D.; Bolla, M.; De Giorgi, U.; de Wit, R; Holzner, B.; van de Poll-Franse, L.V.; van Poppel, H.; White, J.; Collette, L.; Osanto, S.; Aaronson, N.K.

    2014-01-01

    Objectives: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting

  17. Comparison of normal and phase stepping shearographic NDE

    Science.gov (United States)

    Andhee, A.; Gryzagoridis, J.; Findeis, D.

    2005-05-01

    The paper presents results of non-destructive testing of composite main rotor helicopter blade calibration specimens using the laser based optical NDE technique known as Shearography. The tests were performed initially using the already well established near real-time non-destructive technique of Shearography, with the specimens perturbed during testing for a few seconds using the hot air from a domestic hair dryer. Subsequent to modification of the shearing device utilized in the shearographic setup, phase stepping of one of the sheared images to be captured by the CCD camera was enabled and identical tests were performed on the composite main rotor helicopter blade specimens. Considerable enhancement of the images manifesting or depicting the defects on the specimens is noted suggesting that phase stepping is a desirable enhancement technique to the traditional Shearographic setup.

  18. Comparison of multihardware parallel implementations for a phase unwrapping algorithm

    Science.gov (United States)

    Hernandez-Lopez, Francisco Javier; Rivera, Mariano; Salazar-Garibay, Adan; Legarda-Sáenz, Ricardo

    2018-04-01

    Phase unwrapping is an important problem in the areas of optical metrology, synthetic aperture radar (SAR) image analysis, and magnetic resonance imaging (MRI) analysis. These images are becoming larger in size and, particularly, the availability and need for processing of SAR and MRI data have increased significantly with the acquisition of remote sensing data and the popularization of magnetic resonators in clinical diagnosis. Therefore, it is important to develop faster and accurate phase unwrapping algorithms. We propose a parallel multigrid algorithm of a phase unwrapping method named accumulation of residual maps, which builds on a serial algorithm that consists of the minimization of a cost function; minimization achieved by means of a serial Gauss-Seidel kind algorithm. Our algorithm also optimizes the original cost function, but unlike the original work, our algorithm is a parallel Jacobi class with alternated minimizations. This strategy is known as the chessboard type, where red pixels can be updated in parallel at same iteration since they are independent. Similarly, black pixels can be updated in parallel in an alternating iteration. We present parallel implementations of our algorithm for different parallel multicore architecture such as CPU-multicore, Xeon Phi coprocessor, and Nvidia graphics processing unit. In all the cases, we obtain a superior performance of our parallel algorithm when compared with the original serial version. In addition, we present a detailed comparative performance of the developed parallel versions.

  19. Everolimus for Previously Treated Advanced Gastric Cancer: Results of the Randomized, Double-Blind, Phase III GRANITE-1 Study

    Science.gov (United States)

    Ohtsu, Atsushi; Ajani, Jaffer A.; Bai, Yu-Xian; Bang, Yung-Jue; Chung, Hyun-Cheol; Pan, Hong-Ming; Sahmoud, Tarek; Shen, Lin; Yeh, Kun-Huei; Chin, Keisho; Muro, Kei; Kim, Yeul Hong; Ferry, David; Tebbutt, Niall C.; Al-Batran, Salah-Eddin; Smith, Heind; Costantini, Chiara; Rizvi, Syed; Lebwohl, David; Van Cutsem, Eric

    2013-01-01

    Purpose The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer. Patients and Methods Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety. Results Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months with everolimus and 4.3 months with placebo (hazard ratio, 0.90; 95% CI, 0.75 to 1.08; P = .124). Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms, respectively (hazard ratio, 0.66; 95% CI, 0.56 to 0.78). Common grade 3/4 adverse events included anemia, decreased appetite, and fatigue. The safety profile was similar in patients enrolled in Asia versus ROW. Conclusion Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy. The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers. PMID:24043745

  20. Current Practices in the Treatment of Alzheimer Disease: Where is the Evidence After the Phase III Trials?

    Science.gov (United States)

    Ehret, Megan J; Chamberlin, Kevin W

    2015-08-01

    The purpose of this systematic review was to review the current place in therapy of the 4 medications, donepezil, rivastigmine, galantamine, and memantine, approved for the treatment of Alzheimer disease (AD) since the publication of Phase III trials. A systematic literature search of MEDLINE and EMBASE was conducted for articles published in the past 10 years. The search was performed using the following Medical Subject Headings and text key words: Alzheimer's disease, treatment, donepezil, galantamine, rivastigmine, memantine, dementia of the Alzheimer's type, and dementia. Studies that evaluated new doses, indications, and dose formulations remain a large part of the current literature. Donepezil gained approval for the treatment of severe AD and became available in a 23-mg/d dose formulation. Rivastigmine became available in a patch formulation. Memantine became available as an extended-release capsule. Use of a combination product formulation was recently approved, memantine extended release/donepezil. Controversy among clinicians remains regarding when to initiate therapy, appropriate duration of therapy, and how and when to discontinue the treatment of AD. Only drugs that affect cholinergic function have shown consistent, but modest, clinical effects, even in late-phase trials. There is a need for a better appreciation of the various risk factors and drug targets for the treatment of AD. The wide range of targets makes it unlikely that affecting only 1 of those targets (eg, cholinergic function or N-methyl-d-aspartate) will lead to a more than minimally effective treatment option, regardless of when a treatment is started and discontinued. There is substantial opportunity for the continued growth and development of drugs and clinical trial expansion for the treatment of AD. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

  1. Resource Use and Costs of Dengue: Analysis of Data from Phase III Efficacy Studies of a Tetravalent Dengue Vaccine.

    Science.gov (United States)

    El Fezzazi, Hanna; Branchu, Marie; Carrasquilla, Gabriel; Pitisuttithum, Punnee; Perroud, Ana Paula; Frago, Carina; Coudeville, Laurent

    2017-12-01

    A tetravalent dengue vaccine (CYD-TDV) has recently been approved in 12 countries in southeast Asia and Latin America for individuals aged 9-45 years or 9-60 years (age indication approvals vary by country) living in endemic areas. Data on utilization of medical and nonmedical resources as well as time lost from school and work were collected during the active phase of two phase III efficacy studies performed in 10 countries in the Asia-Pacific region and Latin America (NCT01373281; NCT01374516). We compared dengue-related resource utilization and costs among vaccinated and nonvaccinated participants. Country-specific unit costs were derived from available literature. There were 901 virologically confirmed dengue episodes among participants aged ≥ 9 years ( N = 25,826): corresponding to 373 episodes in the CYD-TDV group ( N = 17,230) and 528 episodes in the control group ( N = 8,596). Fewer episodes in the CYD-TDV group resulted in hospitalization than in the control group (7.0% versus 13.3%; P = 0.002), but both had a similar average length of stay of 4 days. Overall, a two-thirds reduction in resource consumption and missed school/work days was observed in the CYD-TDV group relative to the control group. The estimated direct and indirect cost (2014 I$) associated with dengue episodes per participant in the CYD-TDV group was 73% lower than in the control group (I$6.72 versus I$25.08); representing a saving of I$I8.36 (95% confidence interval [CI]:17.05-19.78) per participant with vaccination. This is the first study providing information on dengue costs among vaccinated individuals and direct confirmation that vaccination has the potential to reduce dengue illness costs.

  2. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial.

    Science.gov (United States)

    Wells, Samuel A; Robinson, Bruce G; Gagel, Robert F; Dralle, Henning; Fagin, James A; Santoro, Massimo; Baudin, Eric; Elisei, Rossella; Jarzab, Barbara; Vasselli, James R; Read, Jessica; Langmuir, Peter; Ryan, Anderson J; Schlumberger, Martin J

    2012-01-10

    There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC (ClinicalTrials.gov NCT00410761).

  3. Column Chromatography Of Co(II), Zn(II) And Eu(III) Using Pistachio Shell And Different Mobile Phases

    International Nuclear Information System (INIS)

    Abdel-Fattah, A.A.

    2009-01-01

    Pistachio shell particles (0.5-1 mm) have been applied as the stationary phase for studying the column chromatography of Co(II), Zn(II) and Eu(III) at room temperature; 26 + - 1 oC. This solid sorbent has been characterized by thermogravimetric analysis, infra-red spectroscopy and X-ray diffraction. Its surface area and percent of swelling have been also determined. Different eluting agents have been used for eluting the sorbed elements. The elution curves have been done from which the distribution coefficients (K d ), number of theoretical plates (N) and heights equivalent to theoretical plates (H) have been determined. Column performance studies have been conducted for a representative system under certain experimented conditions and Van Deemter equation has been applied. Thermodynamic studies have been applied and thermodynamic functions ( δG 0 ,δH 0 andδ S 0 ) have been calculated for this representative system by determining K d at three different room temperatures (18, 26 and 37 + - 1o C).

  4. Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.

    Science.gov (United States)

    Yoshino, Takayuki; Komatsu, Yoshito; Yamada, Yasuhide; Yamazaki, Kentaro; Tsuji, Akihito; Ura, Takashi; Grothey, Axel; Van Cutsem, Eric; Wagner, Andrea; Cihon, Frank; Hamada, Yoko; Ohtsu, Atsushi

    2015-06-01

    In the international, phase III, randomized, double-blind CORRECT trial, regorafenib significantly prolonged overall survival (OS) versus placebo in patients with metastatic colorectal cancer (mCRC) that had progressed on all standard therapies. This post hoc analysis evaluated the efficacy and safety of regorafenib in Japanese and non-Japanese subpopulations in the CORRECT trial. Patients were randomized 2 : 1 to regorafenib 160 mg once daily or placebo for weeks 1-3 of each 4-week cycle. The primary endpoint was OS. Outcomes were assessed using descriptive statistics. One hundred Japanese and 660 non-Japanese patients were randomized to regorafenib (n = 67 and n = 438) or placebo (n = 33 and n = 222). Regorafenib had a consistent OS benefit in the Japanese and non-Japanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.43-1.51) and 0.77 (95 % CI 0.62-0.94), respectively. Regorafenib-associated hand-foot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the non-Japanese subpopulation, but were generally manageable. Regorafenib appears to have comparable efficacy in Japanese and non-Japanese subpopulations, with a manageable adverse-event profile, suggesting that this agent could potentially become a standard of care in patients with mCRC.

  5. Column Chromatography Of Co(II), Zn(II) And Eu(III) Using Pistachio Shell And Different Mobile Phases

    Energy Technology Data Exchange (ETDEWEB)

    Abdel-Fattah, A A [Nuclear Chemistry Department, Radioisotopes Production Division, Hot Laboratories Centre, Atomic Energy Authority, Cairo (Egypt)

    2009-07-01

    Pistachio shell particles (0.5-1 mm) have been applied as the stationary phase for studying the column chromatography of Co(II), Zn(II) and Eu(III) at room temperature; 26{sup +}-{sup 1}oC. This solid sorbent has been characterized by thermogravimetric analysis, infra-red spectroscopy and X-ray diffraction. Its surface area and percent of swelling have been also determined. Different eluting agents have been used for eluting the sorbed elements. The elution curves have been done from which the distribution coefficients (K{sub d}), number of theoretical plates (N) and heights equivalent to theoretical plates (H) have been determined. Column performance studies have been conducted for a representative system under certain experimented conditions and Van Deemter equation has been applied. Thermodynamic studies have been applied and thermodynamic functions ( {delta}G{sup 0} ,{delta}H{sup 0} and{delta} S{sup 0}) have been calculated for this representative system by determining K{sub d} at three different room temperatures (18, 26 and 37{sup +}-{sup 1o}C)

  6. Survival and human papillomavirus in oropharynx cancer in TAX 324: a subset analysis from an international phase III trial.

    Science.gov (United States)

    Posner, M R; Lorch, J H; Goloubeva, O; Tan, M; Schumaker, L M; Sarlis, N J; Haddad, R I; Cullen, K J

    2011-05-01

    The association between human papillomavirus (HPV) and overall survival (OS) in oropharynx cancer (OPC) was retrospectively examined in TAX 324, a phase III trial of sequential therapy for locally advanced head and neck cancer. Accrual for TAX 324 was completed in 2003 and data updated through 2008. Pretherapy tumor biopsies were studied by PCR for human papillomavirus type 16 and linked to OS, progression-free survival (PFS) and demographics. Of 264 patients with OPC, 111 (42%) had evaluable biopsies; 56 (50%) were HPV+ and 55 (50%) were HPV-. HPV+ patients were significantly younger (54 versus 58 years, P = 0.02), had T1/T2 primary cancers (49% versus 20%, P = 0.001), and had a performance status of zero (77% versus 49%, P = 0.003). OS and PFS were better for HPV+ patients (OS, hazard ratio = 0.20, P < 0.0001). Local-regional failure was less in HPV+ patients (13% versus 42%, P = 0.0006); at 5 years, 82% of HPV+ patients were alive compared with 35% of HPV- patients (P < 0.0001). HPV+ OPC has a different biology compared with HPV- OPC; 5-year OS, PFS, and local-regional control are unprecedented. These results support the possibility of selectively reducing therapy and long-term morbidity in HPV+ OPC while preserving survival and approaching HPV- disease with more aggressive treatment.

  7. "cART intensification by the HIV-1 Tat B clade vaccine: progress to phase III efficacy studies".

    Science.gov (United States)

    Cafaro, Aurelio; Sgadari, Cecilia; Picconi, Orietta; Tripiciano, Antonella; Moretti, Sonia; Francavilla, Vittorio; Pavone Cossut, Maria Rosaria; Buttò, Stefano; Cozzone, Giovanni; Ensoli, Fabrizio; Monini, Paolo; Ensoli, Barbara

    2018-02-01

    In spite of its success at suppressing HIV replication, combination antiretroviral therapy (cART) only partially reduces immune dysregulation and loss of immune functions. These cART-unmet needs appear to be due to persistent virus replication and cell-to-cell transmission in reservoirs, and are causes of increased patients' morbidity and mortality. Up to now, therapeutic interventions aimed at cART-intensification by attacking the virus reservoir have failed. Areas covered: We briefly review the rationale and clinical development of Tat therapeutic vaccine in cART-treated subjects in Italy and South Africa (SA). Vaccination with clade-B Tat induced cross-clade neutralizing antibodies, immune restoration, including CD4 + T cell increase particularly in low immunological responders, and reduction of proviral DNA. Phase III efficacy trials in SA are planned both in adult and pediatric populations. Expert commentary: We propose the Tat therapeutic vaccine as a pathogenesis-driven intervention that effectively intensifies cART and may lead to a functional cure and provide new perspectives for prevention and virus eradication strategies.

  8. Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

    Science.gov (United States)

    Bridoux, Valérie; Moutel, Grégoire; Schwarz, Lilian; Michot, Francis; Herve, Christian; Tuech, Jean-Jacques

    2014-10-01

    Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

  9. Nature of the Blue-Phase-III endash isotropic critical point: An analogy with the liquid-gas transition

    International Nuclear Information System (INIS)

    Anisimov, M.A.; Agayan, V.A.; Collings, P.J.

    1998-01-01

    The analogy with the liquid-gas critical point is analyzed to clarify the nature of the pretransitional behavior of physical properties in the vicinity of the Blue-Phase-III endash isotropic transition in chiral liquid crystalline systems. The analogy is unusual: temperature serves as the ordering field and entropy plays the role of the order parameter. Both mean field and parametric equations of state are formulated in terms of scaling fields. The scaling fields are linear combinations of the physical fields, which are temperature and chirality. It is shown that mixing of the physical field variables naturally leads to a strong asymmetry with respect to the transition temperature in the behavior of the physical properties that cannot be described by simple power laws. While the mean field theory gives a good description of the experimental data, the scaling theory, if one incorporates mixing of the field variables, gives even better agreement with the experimental data, placing this transition in the same universality class as the three-dimensional Ising model. copyright 1998 The American Physical Society

  10. Myocardial perfusion imaging with Technetium-99m Sestamibi and Thallium-201. Results of the phase III clinical trial

    International Nuclear Information System (INIS)

    Giering, L.; Haber, S.; Joseph, J.L.; Neacy, W.

    1998-01-01

    Full text: Technetium-99m-Sestamibi (MIBI) has been compared to 201 TI and coronary angiography in a large Phase III clinical trial to assess diagnostic accuracy. Exercise and rest planar (P) and SPECT (S) MIBI, and exercise and redistribution thallium-201 studies were performed in 150 healthy volunteers and 396 patients (379 males; mean age 51.3 years). Prior myocardial infarction was present in 50% of the patients. Sensitivity and specificity for angiographically defined cardiovascular diseases - CAD (>70% stenosis) for planar imaging was 90.3% and 81.3% for MIBI and 91.6% and 50.0% for 201 TI. Agreement was 88.7% MIBI and 84.0% for 201 TI. For SPECT imaging, sensitivity and specificity were 95.1% and 46.0% for MIBI and 92.3% and 39.7% for 201 TI. Agreement was 80.0% for MIBI and 76.1% for 201 TI. Tomographic normality rates were 91.4% and 92.9% for MIBI and 201 TI. Agreement for characterisation of defect type by MIBI and 201 TI SPECT was 82.5%. In females, sensitivity was comparable for both agents. Specificity of MIBI planar and SPECT imaging was higher then for 201 TI (P: 90.9% v. 66.7%; S: 76.2% v. 61.9%). The improved imaging characteristics of MIBI results in better diagnostic confidence when interpreting myocardial perfusion studies especially in women and obese patients

  11. Tank vapor sampling and analysis data package for tank 241-C-106 waste retrieval sluicing system process test phase III

    Energy Technology Data Exchange (ETDEWEB)

    LOCKREM, L.L.

    1999-08-13

    This data package presents sampling data and analytical results from the March 28, 1999, vapor sampling of Hanford Site single-shell tank 241-C-106 during active sluicing. Samples were obtained from the 296-C-006 ventilation system stack and ambient air at several locations. Characterization Project Operations (CPO) was responsible for the collection of all SUMMATM canister samples. The Special Analytical Support (SAS) vapor team was responsible for the collection of all triple sorbent trap (TST), sorbent tube train (STT), polyurethane foam (PUF), and particulate filter samples collected at the 296-C-006 stack. The SAS vapor team used the non-electrical vapor sampling (NEVS) system to collect samples of the air, gases, and vapors from the 296-C-006 stack. The SAS vapor team collected and analyzed these samples for Lockheed Martin Hanford Corporation (LMHC) and Tank Waste Remediation System (TWRS) in accordance with the sampling and analytical requirements specified in the Waste Retrieval Sluicing System Vapor Sampling and Analysis Plan (SAP) for Evaluation of Organic Emissions, Process Test Phase III, HNF-4212, Rev. 0-A, (LMHC, 1999). All samples were stored in a secured Radioactive Materials Area (RMA) until the samples were radiologically released and received by SAS for analysis. The Waste Sampling and Characterization Facility (WSCF) performed the radiological analyses. The samples were received on April 5, 1999.

  12. Randomized Phase III and Extension Studies of Naldemedine in Patients With Opioid-Induced Constipation and Cancer.

    Science.gov (United States)

    Katakami, Nobuyuki; Harada, Toshiyuki; Murata, Toru; Shinozaki, Katsunori; Tsutsumi, Masakazu; Yokota, Takaaki; Arai, Masatsugu; Tada, Yukio; Narabayashi, Masaru; Boku, Narikazu

    2017-12-01

    Purpose Opioid-induced constipation (OIC) is a frequent and debilitating adverse effect (AE) of opioids-common analgesics for cancer pain. We investigated the efficacy and safety of a peripherally acting μ-opioid receptor antagonist, naldemedine (S-297995), for OIC, specifically in patients with cancer. Patients and Methods This phase III trial consisted of a 2-week, randomized, double-blind, placebo-controlled study (COMPOSE-4) and an open-label, 12-week extension study (COMPOSE-5). In COMPOSE-4, eligible adults with OIC and cancer were randomly assigned on a 1:1 basis to receive once-daily oral naldemedine 0.2 mg or placebo. The primary end point was the proportion of spontaneous bowel movement (SBM) responders (≥ 3 SBMs/week and an increase of ≥ 1 SBM/week from baseline). The primary end point of COMPOSE-5 was safety. Results In COMPOSE-4, 193 eligible patients were randomly assigned to naldemedine (n = 97) or placebo (n = 96). The proportion of SBM responders in COMPOSE-4 was significantly greater with naldemedine than with placebo (71.1% [69 of 97 patients] v 34.4% [33 of 96 patients]; P opioid withdrawal and had no notable impact on opioid-mediated analgesia. Conclusion Once-daily oral naldemedine 0.2 mg effectively treated OIC and was generally well tolerated in patients with OIC and cancer.

  13. Classification of criticality calculations with correlation coefficient method and its application to OECD/NEA burnup credit benchmarks phase III-A and II-A

    International Nuclear Information System (INIS)

    Okuno, Hiroshi

    2003-01-01

    A method for classifying benchmark results of criticality calculations according to similarity was proposed in this paper. After formulation of the method utilizing correlation coefficients, it was applied to burnup credit criticality benchmarks Phase III-A and II-A, which were conducted by the Expert Group on Burnup Credit Criticality Safety under auspices of the Nuclear Energy Agency of the Organisation for Economic Cooperation and Development (OECD/NEA). Phase III-A benchmark was a series of criticality calculations for irradiated Boiling Water Reactor (BWR) fuel assemblies, whereas Phase II-A benchmark was a suite of criticality calculations for irradiated Pressurized Water Reactor (PWR) fuel pins. These benchmark problems and their results were summarized. The correlation coefficients were calculated and sets of benchmark calculation results were classified according to the criterion that the values of the correlation coefficients were no less than 0.15 for Phase III-A and 0.10 for Phase II-A benchmarks. When a couple of benchmark calculation results belonged to the same group, one calculation result was found predictable from the other. An example was shown for each of the Benchmarks. While the evaluated nuclear data seemed the main factor for the classification, further investigations were required for finding other factors. (author)

  14. Novel solid phase extraction procedure for gold(III) on Dowex M 4195 prior to its flame atomic absorption spectrometric determination

    Energy Technology Data Exchange (ETDEWEB)

    Tuzen, Mustafa [Gaziosmanpasa University, Faculty of Science and Arts, Chemistry Department, 60250 Tokat (Turkey)], E-mail: mtuzen@gop.edu.tr; Saygi, Kadriye O. [Gaziosmanpasa University, Faculty of Science and Arts, Chemistry Department, 60250 Tokat (Turkey); Soylak, Mustafa [Erciyes University, Faculty of Science and Arts, Chemistry Department, 38039 Kayseri (Turkey)

    2008-08-15

    A method for solid phase extraction (SPE) of gold(III) using Dowex M 4195 chelating resin has been developed. The optimum experimental conditions for the quantitative sorption of gold(III), pH, effect of flow rates, eluent types, sorption capacity and the effect of diverse ions on the sorption of gold(III) have been investigated. The chelating resin can be reused for more than 100 cycles of sorption-desorption without any significant change in sorption of gold(III) ions. The recovery values for gold(III) and detection limit (LOD) of gold were greater than 95% and 1.61 {mu}g L{sup -1}, respectively. The preconcentration factor was 31. The relative standard deviation of the method was <5%. The adsorption capacity of the resin was 8.1 mg g{sup -1}. The proposed method has been applied for the determination of gold(III) in some real samples including water, soil and sediment samples.

  15. A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412].

    Science.gov (United States)

    Lang, Reinhold; Baumann, Petra; Schmoor, Claudia; Odermatt, Erich K; Wente, Moritz N; Jauch, Karl-Walter

    2015-01-01

    Intra-abdominal surgical intervention can cause the development of intra-peritoneal adhesions. To reduce this problem, different agents have been tested to minimize abdominal adhesions; however, the optimal adhesion prophylaxis has not been found so far. Therefore, the A-Part(®) Gel was developed as a barrier to diminish postsurgical adhesions; the aim of this randomized controlled study was a first evaluation of its safety and efficacy. In this prospective, controlled, randomized, patient-blinded, monocenter phase I-II study, 62 patients received either the hydrogel A-Part-Gel(®) as an anti-adhesive barrier or were untreated after primary elective median laparotomy. Primary endpoint was the occurrence of peritonitis and/or wound healing impairment 28 ± 10 days postoperatively. As secondary endpoints anastomotic leakage until 28 days after surgery, adverse events and adhesions were assessed until 3 months postoperatively. A lower rate of wound healing impairment and/or peritonitis was observed in the A-Part Gel(®) group compared to the control group: (6.5 vs. 13.8 %). The difference between the two groups was -7.3%, 90 % confidence interval [-20.1, 5.4 %]. Both treatment groups showed similar frequency of anastomotic leakage but incidence of adverse events and serious adverse events were slightly lower in the A-Part Gel(®) group compared to the control. Adhesion rates were comparable in both groups. A-Part Gel(®) is safe as an adhesion prophylaxis after abdominal wall surgery but no reduction of postoperative peritoneal adhesion could be found in comparison to the control group. This may at least in part be due to the small sample size as well as to the incomplete coverage of the incision due to the used application. NCT00646412.

  16. Note: Comparison of grazing incidence small angle x-ray scattering of a titania sponge structure at the beamlines BW4 (DORIS III) and P03 (PETRA III)

    International Nuclear Information System (INIS)

    Rawolle, M.; Körstgens, V.; Ruderer, M. A.; Metwalli, E.; Guo, S.; Müller-Buschbaum, P.; Herzog, G.; Benecke, G.; Schwartzkopf, M.; Buffet, A.; Perlich, J.; Roth, S. V.

    2012-01-01

    Grazing incidence small angle x-ray scattering (GISAXS) is a powerful technique for morphology investigation of nanostructured thin films. GISAXS measurements at the newly installed P03 beamline at the storage ring PETRA III in Hamburg, Germany, are compared to the GISAXS data from the beamline BW4 at the storage ring DORIS III, which had been used extensively for GISAXS investigations in the past. As an example, a titania thin film sponge structure is investigated. Compared to BW4, at beamline P03 the resolution of larger structures is slightly improved and a higher incident flux leads to a factor of 750 in scattered intensity. Therefore, the acquisition time in GISAXS geometry is reduced significantly at beamline P03.

  17. Comparison of different configurations of Phase Doppler Analyser

    Directory of Open Access Journals (Sweden)

    Zaremba Matouš

    2016-01-01

    Full Text Available A phase Doppler anemometry (PDA technique is widely used in experimental fluid mechanics to measure size and velocity of particles in the fluid flow. Even though this method is common in experimental fluid mechanics, there are only few techniques that might serve for the purpose of the evaluation of the PDA system. To examine results of the PDA visualizations techniques are usually used. However, this approach suffers from several aspects. Mainly, it is difficult to determine the exact position of the measurement volume of PDA system. Then it is complicated to determine which particles are passing through the measuring volume. Another way how to examine performance of the PDA system is to use two PDA systems simultaneously. By using one laser for both systems we can avoid previously mentioned aspects. In our experiments, we use fiber based PDA system and classical PDA system both made by Dantec Dynamics. The aim of this paper is to compare results from various configurations and highlight crucial parameters that influence measurements.

  18. Comparison of different configurations of Phase Doppler Analyser

    Science.gov (United States)

    Zaremba, Matouš; Malý, Milan; Jedelský, Jan; Jícha, Miroslav

    2016-03-01

    A phase Doppler anemometry (PDA) technique is widely used in experimental fluid mechanics to measure size and velocity of particles in the fluid flow. Even though this method is common in experimental fluid mechanics, there are only few techniques that might serve for the purpose of the evaluation of the PDA system. To examine results of the PDA visualizations techniques are usually used. However, this approach suffers from several aspects. Mainly, it is difficult to determine the exact position of the measurement volume of PDA system. Then it is complicated to determine which particles are passing through the measuring volume. Another way how to examine performance of the PDA system is to use two PDA systems simultaneously. By using one laser for both systems we can avoid previously mentioned aspects. In our experiments, we use fiber based PDA system and classical PDA system both made by Dantec Dynamics. The aim of this paper is to compare results from various configurations and highlight crucial parameters that influence measurements.

  19. Tolerance and Acceptance Results of a Palladium-103 Permanent Breast Seed Implant Phase I/II Study

    International Nuclear Information System (INIS)

    Pignol, Jean-Philippe; Rakovitch, Eileen; Keller, Brian M.; Sankreacha, Raxa; Chartier, Carole

    2009-01-01

    Purpose: To test, in a prospective Phase I/II trial, a partial breast irradiation technique using a 103 Pd permanent breast seed implant (PBSI) realized in a single 1-h procedure under sedation and local freezing. Methods and Materials: Eligible patients had infiltrating ductal carcinoma ≤3 cm in diameter, surgical margin ≥2 mm, no extensive intraductal component, no lymphovascular invasion, and negative lymph nodes. Patients received a permanent seed implant, and a minimal peripheral dose of 90 Gy was prescribed to the clinical target volume, with a margin of 1.5 cm. Results: From May 2004 to April 2007, 67 patients received the PBSI treatment. The procedure was well tolerated, with 17% of patients having significant pain after the procedure. Only 1 patient (1.5%) had an acute skin reaction (Grade 3 according to the National Cancer Institute Common Toxicity Criteria). The rates of acute moist desquamation, erythema, and indurations were 10.4%, 42%, and 27%, respectively. At 1 year the rate of Grade 1 telangiectasia was 14%. The rate of skin reaction decreased from 65% to 28% when skin received less than the 85% isodose. According to a Radiation Therapy Oncology Group questionnaire, 80-90% of patients were very satisfied with their treatment, and the remainder were satisfied. One patient (1.5%) developed an abscess, which resolved after the use of antibiotics. There was no recurrence after a median follow-up of 32 months (range, 11-49 months). Conclusions: The feasibility, safety, and tolerability of PBSI compares favorably with that of external beam and other partial breast irradiation techniques.

  20. Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

    Energy Technology Data Exchange (ETDEWEB)

    Mimura, Hidefumi, E-mail: mimura@marianna-u.ac.jp [St. Marianna University School of Medicine, Department of Radiology (Japan); Arai, Yasuaki, E-mail: arai-y3111@mvh.biglobe.ne.jp [National Cancer Center Hospital, Department of Diagnostic Radiology (Japan); Yamakado, Koichiro, E-mail: yama@clin.medic.mie-u.ac.jp [Mie University School of Medicine, Department of Interventional Radiology (Japan); Sone, Miyuki, E-mail: msone@me.com; Takeuchi, Yoshito, E-mail: yotake62@qg8.so-net.ne.jp [National Cancer Center Hospital, Department of Diagnostic Radiology (Japan); Miki, Tsuneharu, E-mail: tmiki@koto.kpu-m.ac.jp [Kyoto Prefectural University of Medicine, Department of Urology (Japan); Gobara, Hideo, E-mail: gobara@cc.okayama-u.ac.jp [Okayama University Medical School, Department of Radiology (Japan); Sakuhara, Yusuke, E-mail: yusaku@med.hokudai.ac.jp [Hokkaido University School of Medicine, Department of Diagnostic and Interventional Radiology (Japan); Yamamoto, Takanobu, E-mail: tyamamot@tcc.pref.tochigi.lg.jp [Tochigi Cancer Center, Department of Radiology (Japan); Sato, Yozo, E-mail: ysato@aichi-cc.jp [Aichi Cancer Center Hospital, Department of Diagnostic and Interventional Radiology (Japan); Kanazawa, Susumu, E-mail: susumu@cc.okayama-u.ac.jp [Okayama University Medical School, Department of Radiology (Japan)

    2016-05-15

    PurposeThis multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.MethodsThirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.ResultsThe RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).ConclusionThe current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

  1. Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

    International Nuclear Information System (INIS)

    Mimura, Hidefumi; Arai, Yasuaki; Yamakado, Koichiro; Sone, Miyuki; Takeuchi, Yoshito; Miki, Tsuneharu; Gobara, Hideo; Sakuhara, Yusuke; Yamamoto, Takanobu; Sato, Yozo; Kanazawa, Susumu

    2016-01-01

    PurposeThis multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.MethodsThirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.ResultsThe RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).ConclusionThe current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

  2. PREVENTION OF CONVERSION TO ABNORMAL TCD WITH HYDROXYUREA IN SICKLE CELL ANEMIA: A PHASE III INTERNATIONAL RANDOMIZED CLINICAL TRIAL

    Science.gov (United States)

    Hankins, Jane S.; McCarville, M. Beth; Rankine-Mullings, Angela; Reid, Marvin E.; Lobo, Clarisse L.C.; Moura, Patricia G.; Ali, Susanna; Soares, Deanne; Aldred, Karen; Jay, Dennis W.; Aygun, Banu; Bennett, John; Kang, Guolian; Goldsmith, Jonathan C.; Smeltzer, Matthew P.; Boyett, James M.; Ware, Russell E.

    2015-01-01

    Children with sickle cell anemia (SCA) and conditional transcranial Doppler (TCD) ultrasound velocities (170-199 cm/sec) may develop stroke. However, with limited available clinical data, the current standard of care for conditional TCD velocities is observation. The efficacy of hydroxyurea in preventing conversion from conditional to abnormal TCD (≥200 cm/sec), which confers a higher stroke risk, has not been studied prospectively in a randomized trial. Sparing Conversion to Abnormal TCD Elevation (SCATE #NCT01531387) was an NHLBI-funded Phase III multicenter international clinical trial comparing alternative therapy (hydroxyurea) to standard care (observation) to prevent conversion from conditional to abnormal TCD velocity in children with SCA. SCATE enrolled 38 children from the United States, Jamaica, and Brazil [HbSS (36), HbSβ0-thalassemia (1), and HbSD (1), median age 5.4 years (range, 2.7-9.8)]. Due to slow patient accrual and administrative delays, SCATE was terminated early. In an intention-to-treat analysis, the cumulative incidence of abnormal conversion was 9% (95% CI 0 to 35%) in the hydroxyurea arm and 47% (95% CI 6 to 81%) in observation arm at 15 months (p=0.16). In post-hoc analysis according to treatment received, significantly fewer children on hydroxyurea converted to abnormal TCD velocities, compared to observation (0% versus 50%, p=0.02). After a mean of 10.1 months, a significant change in mean TCD velocity was observed with hydroxyurea treatment (−15.5 versus +10.2 cm/sec, p=0.02). No stroke events occurred in either arm. Hydroxyurea reduces TCD velocities in children with SCA and conditional velocities. PMID:26414435

  3. Prevention of conversion to abnormal transcranial Doppler with hydroxyurea in sickle cell anemia: A Phase III international randomized clinical trial.

    Science.gov (United States)

    Hankins, Jane S; McCarville, Mary Beth; Rankine-Mullings, Angela; Reid, Marvin E; Lobo, Clarisse L C; Moura, Patricia G; Ali, Susanna; Soares, Deanne P; Aldred, Karen; Jay, Dennis W; Aygun, Banu; Bennett, John; Kang, Guolian; Goldsmith, Jonathan C; Smeltzer, Matthew P; Boyett, James M; Ware, Russell E

    2015-12-01

    Children with sickle cell anemia (SCA) and conditional transcranial Doppler (TCD) ultrasound velocities (170-199 cm/sec) may develop stroke. However, with limited available clinical data, the current standard of care for conditional TCD velocities is observation. The efficacy of hydroxyurea in preventing conversion from conditional to abnormal TCD (≥200 cm/sec), which confers a higher stroke risk, has not been studied prospectively in a randomized trial. Sparing Conversion to Abnormal TCD Elevation (SCATE #NCT01531387) was a National Heart, Lung, and Blood Institute-funded Phase III multicenter international clinical trial comparing alternative therapy (hydroxyurea) to standard care (observation) to prevent conversion from conditional to abnormal TCD velocity in children with SCA. SCATE enrolled 38 children from the United States, Jamaica, and Brazil [HbSS (36), HbSβ(0) -thalassemia (1), and HbSD (1), median age = 5.4 years (range, 2.7-9.8)]. Because of the slow patient accrual and administrative delays, SCATE was terminated early. In an intention-to-treat analysis, the cumulative incidence of abnormal conversion was 9% (95% CI = 0-35%) in the hydroxyurea arm and 47% (95% CI = 6-81%) in observation arm at 15 months (P = 0.16). In post hoc analysis according to treatment received, significantly fewer children on hydroxyurea converted to abnormal TCD velocities when compared with observation (0% vs. 50%, P = 0.02). After a mean of 10.1 months, a significant change in mean TCD velocity was observed with hydroxyurea treatment (-15.5 vs. +10.2 cm/sec, P = 0.02). No stroke events occurred in either arm. Hydroxyurea reduces TCD velocities in children with SCA and conditional velocities. © 2015 Wiley Periodicals, Inc.

  4. Safety and tolerability of tegaserod in patients with chronic constipation: pooled data from two phase III studies.

    LENUS (Irish Health Repository)

    Quigley, Eamonn M M

    2012-02-03

    BACKGROUND & AIMS: Studies show that tegaserod effectively relieves the symptoms of chronic constipation\\/idiopathic constipation (CC). This pooled analysis assessed the safety and tolerability of tegaserod in a large dataset of CC patients. METHODS: Adverse event (AE) data were pooled from 2 double-blind, placebo-controlled phase III trials of 12 weeks\\' duration. Post hoc analysis was conducted for the most frequent AEs (incidence, >or=3%). RESULTS: Eight hundred eighty-one, 861, and 861 patients received tegaserod 6 mg twice a day, 2 mg twice a day, or placebo, respectively. Most AEs were mild\\/moderately severe. AE incidence was similar for the tegaserod 6 mg and 2 mg twice a day (57.1% and 56.3%, respectively) and placebo groups (59.6%) and most frequent in the gastrointestinal system (tegaserod 6 mg twice a day, 25.8%; 2 mg twice a day, 22.5%; placebo, 24.6%). Headache, the most common AE, was slightly more frequent in the placebo group (tegaserod 6 mg twice a day, 11.0%; 2 mg twice a day, 10.1%; placebo, 13.2%). Diarrhea (generally transient and resolved with continued treatment) was the only AE with a statistically significant difference between groups (tegaserod 6 mg twice a day 6.6% vs placebo 3.0%, P=.0005). Serious AE incidence (1.4% overall) was comparable across treatment groups, although abdominal surgery was less common in the combined tegaserod (0.5%) than the placebo group (1.0%). Discontinuation as a result of AEs was slightly higher in tegaserod 6 mg twice a day patients (5.7%; 2 mg twice a day, 3.3%; placebo, 3.7%), mainly because of diarrhea. Laboratory and electrocardiogram parameters were comparable across groups. CONCLUSIONS: Tegaserod is well tolerated by patients with CC during 12 weeks of treatment.

  5. Dosimetric explanations of fatigue in head and neck radiotherapy: An analysis from the PARSPORT Phase III trial

    International Nuclear Information System (INIS)

    Gulliford, Sarah L.; Miah, Aisha B.; Brennan, Sinead; McQuaid, Dualta; Clark, Catharine H.; Partridge, Mike; Harrington, Kevin J.; Morden, James P.; Hall, Emma; Nutting, Christopher M.

    2012-01-01

    Background: An unexpected finding from the phase III parotid sparing radiotherapy trial, PARSPORT (ISRCTN48243537, CRUK/03/005), was a statistically significant increase in acute fatigue for those patients who were treated with intensity-modulated radiotherapy (IMRT) compared to standard conventional radiotherapy (CRT). One possible explanation was the difference in dose to central nervous system (CNS) structures due to differing beam portals. Using data from the trial, a dosimetric analysis of individual CNS structures was performed. Method: Dosimetric and toxicity data were available for 67 patients (27 CRT, 40 IMRT). Retrospective delineation of the posterior fossa, brainstem, cerebellum, pituitary gland, pineal gland, hypothalamus, hippocampus and basal ganglia was performed. Dosimetry was reviewed using summary statistics and dose–volume atlases. Results: A statistically significant increase in maximum and mean doses to each structure was observed for patients who received IMRT compared to those who received CRT. Both maximum and mean doses were significantly higher for the posterior fossa, brainstem and cerebellum for the 42 patients who reported acute fatigue of Grade 2 or higher (p ⩽ 0.01) compared to the 25 who did not. Dose–volume atlases of the same structures indicated that regions representing larger volumes and higher doses to each structure were consistent with a higher incidence of acute fatigue. There was no association between the dose distribution and acute fatigue for the other structures tested. Conclusions: The excess fatigue reported in the IMRT arm of the trial may, at least in part, be attributed to the dose distribution to the posterior fossa, cerebellum and brainstem. Future studies that modify dose delivery to these structures may allow us to test the hypothesis that radiation-induced fatigue is avoidable.

  6. A phase I/II study of Docetaxel/TS-1 with radiation for esophageal cancer patients. Step 1

    International Nuclear Information System (INIS)

    Matsumoto, Hideo; Hirai, Toshihiro; Hirabayashi, Youko

    2006-01-01

    The therapy 5-fluorouracil (FU) and cisplatin (CDDP) with radiation is thought to be the standard therapy for esophageal cancer patients by now. However, the therapy is associated with a comparatively high incidence of gastrointestinal disorders and requires hospitalization. We have proposed a new regimen of Docetaxel and TS-1 with radiation for maintaining of QOL and improving outcome. Step 1 of the clinical phase I/II study was conducted for 10 cases from May 2004 to March 2006. Treatment could be accomplished in all cases, and no treatment-related deaths or adverse events of grade 4 were observed in any case. As for hematotoxicity, one case had leucopenia of grade 3 and neutropenia of grade 2. As for non-hematotoxic adverse events, anorexia of grade 3 was recognized in one case of level 3. The response rate evaluated by RECIST was 66% (CR in 2 cases, PR in 4 cases,) and the rate based on the Guide Lines for the Clinical and Pathologic Studies on Carcinoma of Esophagus by the Japanese Society for Esophageal Cancer was 70% (CR in 3 cases, PR in 4 cases). We assumed that the recommended dosage of TXT was 30 mg/m 2 and that of TS-1 was 60 mg/m 2 with radiotherapy of 60 Gy. This combination therapy may be recommended because of fewer adverse events and a higher responsive rate than the standard therapies. We intend to continue this study to step 2 and 3, and to reveal the response rate and adverse events for more esophageal cancer patients. (author)

  7. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies.

    Science.gov (United States)

    Bugarski-Kirola, Dragana; Blaettler, Thomas; Arango, Celso; Fleischhacker, Wolfgang W; Garibaldi, George; Wang, Alice; Dixon, Mark; Bressan, Rodrigo A; Nasrallah, Henry; Lawrie, Stephen; Napieralski, Julie; Ochi-Lohmann, Tania; Reid, Carol; Marder, Stephen R

    2017-07-01

    There is currently no standard of care for treatment of negative symptoms of schizophrenia, although some previous results with glutamatergic agonists have been promising. Three (SunLyte [WN25308], DayLyte [WN25309], and FlashLyte [NN25310]) phase III, multicenter, randomized, 24-week, double-blind, parallel-group, placebo-controlled studies evaluated the efficacy and safety of adjunctive bitopertin in stable patients with persistent predominant negative symptoms of schizophrenia treated with antipsychotics. SunLyte met the prespecified criteria for lack of efficacy and was declared futile. Key inclusion criteria were age ≥18 years, DSM-IV-TR diagnosis of schizophrenia, score ≥40 on the sum of the 14 Positive and Negative Syndrome Scale negative symptoms and disorganized thought factors, unaltered antipsychotic treatment, and clinical stability. Following a 4-week prospective stabilization period, patients were randomly assigned 1:1:1 to bitopertin (5 mg and 10 mg [DayLyte] and 10 mg and 20 mg [FlashLyte]) or placebo once daily for 24 weeks. The primary efficacy end point was mean change from baseline in Positive and Negative Syndrome Scale negative symptom factor score at week 24. The intent-to-treat population in DayLyte and FlashLyte included 605 and 594 patients, respectively. At week 24, mean change from baseline showed improvement in all treatment arms but no statistically significant separation from placebo in Positive and Negative Syndrome Scale negative symptom factor score and all other end points. Bitopertin was well tolerated. These studies provide no evidence for superior efficacy of adjunctive bitopertin in any of the doses tested over placebo in patients with persistent predominant negative symptoms of schizophrenia. Copyright © 2017. Published by Elsevier Inc.

  8. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria.

    Directory of Open Access Journals (Sweden)

    Vera Halpern

    Full Text Available This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection.This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV acquisition. Study participants were randomized 1:1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events.The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10 than on placebo (13, a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3-1.8; p = 0.56. Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5-1.1; p = 0.19 for the combined STI outcome. Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported.Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV.ClinicalTrials.gov NCT00120770.

  9. Phase I-II study of multiple daily fractions for palliation of advanced head and neck malignancies.

    Science.gov (United States)

    Paris, K J; Spanos, W J; Lindberg, R D; Jose, B; Albrink, F

    1993-03-15

    To assess palliation of advance head and neck malignancies with the use of rapid hyper fractionation studies similar to the RTOG 85-02. 37 patients with 39 lesions were entered into the non-randomized Phase I-II protocol, between 1984 and 1991. Previously untreated malignancies were present in 24 lesions, primary recurrent diseases in six patients, metastasis to the head and neck in five patients and skin primaries in the remaining two cases. At presentation 15 of 37 patients (or 17 of 39 lesions) were in operable due to poor medical status, eight patients were considered technically in operable due to extent of disease, 10 patients had distant metastasis and four patients refused surgery. The protocol uses twice a day fraction (370 cGy per fraction) for 2 consecutive days totalling 1,480 cGy per course. Three courses were given at 3-week intervals for a final tumor dose of 4,440 cGy in twelve fraction over 8-9 weeks. Eleven of 39 lesions had complete response; 19 lesions had partial response; 4 lesions had no response; 3 lesions progressed under treatment. Response could not be assessed in two patients. The average survival after completion of therapy was 4.5 months ranging from 2 weeks to 31 months. Palliation was achieved in 33 of 39 lesions. The acute reactions were minimal and no late or long term complications were noted. The absence of significant complications with reasonable response in the high rate of palliation suggests that this rapid hyper fractionation palliation study should be studied for further evaluation.

  10. Implementation of a Novel Adherence Monitoring Strategy in a Phase III, Blinded, Placebo-Controlled, HIV-1 Prevention Clinical Trial.

    Science.gov (United States)

    Husnik, Marla J; Brown, Elizabeth R; Marzinke, Mark; Livant, Edward; Palanee-Phillips, Thesla; Hendrix, Craig W; Matovu Kiweewa, Flavia; Nair, Gonasagrie; Soto-Torres, Lydia E; Schwartz, Katie; Hillier, Sharon L; Baeten, Jared M

    2017-11-01

    Placebo-controlled HIV-1 prevention trials of pre-exposure prophylaxis (PrEP) have not generally used concurrent measurement of adherence because of the potential risk of unblinding. However, several pre-exposure prophylaxis trials for HIV-1 prevention among women failed to show effectiveness because of low product adherence. Evaluation of product adherence objectively during a study provides the opportunity for strengthening adherence activities at sites having low adherence. During MTN-020/ASPIRE, a phase III, placebo-controlled trial of the dapivirine intravaginal ring, we implemented an adherence monitoring system. Monitoring began in quarter 1 (Q1) 2013 and continued through the conclusion of the trial. Blood plasma was collected quarterly and tested for dapivirine concentrations while maintaining blinding among study team members involved in participant management. Dapivirine concentrations >95 pg/mL, reflecting >8 hours of continuous use, were assessed as signaling product use. Study leadership monitored results on a monthly basis and provided feedback to site investigators. Experiences were shared across sites to motivate staff and counsel participants to strive toward higher adherence levels. An upward trend in adherence was observed (P dapivirine >95 pg/mL increased from 63% in Q1 2013 to 84% by Q1 2015. Ongoing drug level testing as a marker of adherence in MTN-020/ASPIRE demonstrates the feasibility of real-time adherence monitoring while maintaining study blinding at the level of participants, sites, and study leadership. This approach is novel for large-scale effectiveness studies for HIV-1 prevention.

  11. Evaluation of Angiopoietin-2 as a biomarker in gastric cancer: results from the randomised phase III AVAGAST trial

    Science.gov (United States)

    Hacker, Ulrich T; Escalona-Espinosa, Laura; Consalvo, Nicola; Goede, Valentin; Schiffmann, Lars; Scherer, Stefan J; Hedge, Priti; Van Cutsem, Eric; Coutelle, Oliver; Büning, Hildegard

    2016-01-01

    Background: In the phase III AVAGAST trial, the addition of bevacizumab to chemotherapy improved progression-free survival (PFS) but not overall survival (OS) in patients with advanced gastric cancer. We studied the role of Angiopoietin-2 (Ang-2), a key driver of tumour angiogenesis, metastasis and resistance to antiangiogenic treatment, as a biomarker. Methods: Previously untreated, advanced gastric cancer patients were randomly assigned to receive bevacizumab (n=387) or placebo (n=387) in combination with chemotherapy. Plasma collected at baseline and at progression was analysed by ELISA. The role of Ang-2 as a prognostic and a predictive biomarker of bevacizumab efficacy was studied using a Cox proportional hazards model. Logistic regression analysis was applied for correlations with metastasis. Results: Median baseline plasma Ang-2 levels were lower in Asian (2143 pg ml−1) vs non-Asian patients (3193 pg ml−1), P<0.0001. Baseline plasma Ang-2 was identified as an independent prognostic marker for OS but did not predict bevacizumab efficacy alone or in combination with baseline VEGF. Baseline plasma Ang-2 correlated with the frequency of liver metastasis (LM) at any time: Odds ratio per 1000 pg ml−1 increase: 1.19; 95% CI 1.10–1.29; P<0.0001 (non-Asians) and 1.37; 95% CI 1.13–1.64; P=0.0010 (Asians). Conclusions: Baseline plasma Ang-2 is a novel prognostic biomarker for OS in advanced gastric cancer strongly associated with LM. Differences in Ang-2 mediated vascular response may, in part, account for outcome differences between Asian and non-Asian patients; however, data have to be further validated. Ang-2 is a promising drug target in gastric cancer. PMID:27031850

  12. Oral minocycline for the treatment of diabetic macular edema (DME): results of a phase I/II clinical study.

    Science.gov (United States)

    Cukras, Catherine A; Petrou, Philip; Chew, Emily Y; Meyerle, Catherine B; Wong, Wai T

    2012-06-22

    Inflammation contributes significantly to the pathogenesis of diabetic macular edema (DME). In particular, retinal microglia demonstrate increased activation and aggregation in areas of DME. Study authors investigated the safety and potential efficacy of oral minocycline, a drug capable of inhibiting microglial activation, in the treatment of DME. A single-center, prospective, open-label phase I/II clinical trial enrolled five participants with fovea-involving DME who received oral minocycline 100 mg twice daily for 6 months. Main outcome measurements included best-corrected visual acuity (BCVA), central retinal subfield thickness (CST), and central macular volume using spectral domain optical coherence tomography (SD-OCT) and late leakage on fluorescein angiography (FA). Findings indicated that the study drug was well tolerated and not associated with significant safety issues. In study eyes, mean BCVA improved continuously from baseline at 1, 2, 4, and 6 months by +1.0, +4.0, +4.0, and +5.8 letters, respectively, while mean retinal thickness (CST) on OCT decreased by -2.9%, -5.7%, -13.9, and -8.1% for the same time points. At month 6, mean area of late leakage on FA decreased by -34.4% in study eyes. Mean changes in contralateral fellow eyes also demonstrated similar trends. Improvements in outcome measures were not correlated with concurrent changes in systemic factors. In this pilot proof-of-concept study of DME, minocycline as primary treatment was associated with improved visual function, central macular edema, and vascular leakage, comparing favorably with historical controls from previous studies. Microglial inhibition with oral minocycline may be a promising therapeutic strategy targeting the inflammatory etiology of DME. (ClinicalTrials.gov number, NCT01120899.).

  13. Active surveillance for intussusception in a phase III efficacy trial of an oral monovalent rotavirus vaccine in India.

    Science.gov (United States)

    John, Jacob; Kawade, Anand; Rongsen-Chandola, Temsunaro; Bavdekar, Ashish; Bhandari, Nita; Taneja, Sunita; Antony, Kalpana; Bhatnagar, Veereshwar; Gupta, Arun; Kabra, Madhulika; Kang, Gagandeep

    2014-08-11

    Post licensure studies have identified an increased risk of intussusception following vaccination with currently licensed rotavirus vaccines, raising safety concerns generic to all rotavirus vaccines. We describe the surveillance for intussusception in a phase III clinical trial with an oral monovalent rotavirus vaccine developed from the neonatal 116E strain. Using broad screening criteria and active surveillance, the incidence of intussusception between 6 weeks and 2 years of age was measured in 4532 children who received three doses of vaccine and 2267 children who received a placebo in the clinical trial. Possible intussusceptions were evaluated with a screening ultrasonogram. An independent intussusception case adjudication committee reviewed all intussusceptions and graded them on Brighton Collaboration criteria for diagnostic certainty. We identified twenty-three intussusceptions on ultrasound from 1361 evaluated sentinel events. Eleven were of level 1 diagnostic certainty as determined by the independent intussusception case adjudication committee. None required surgical intervention, and the earliest identified intussusception was at 36 days following the third dose in a placebo recipient. Among vaccine recipients the first event of intussusception occurred 112 days after the third dose. The incidence of ultrasound-diagnosed intussusception was 200/100,000 child-years (95% CI, 120, 320) among those receiving the vaccine and 141/100,000 child-years (95% CI, 50, 310) among those receiving the placebo. The incidence rate of confirmed intussusception among vaccine recipients was 94/100,000 child-years (95% CI, 41, 185) and 71/100,000 child-years (95% CI, 15, 206) among those receiving the placebo. In this licensure study, 23 cases of intussusception were identified through an active surveillance system, but there was no temporal association with rotavirus vaccination. The use of active surveillance with broad criteria intended for ensuring safety of children

  14. Phase II/III Study of Radiofrequency Ablation Combined with Cytokine-Induced Killer Cells Treating Colorectal Liver Metastases

    Directory of Open Access Journals (Sweden)

    Xiaodong Li

    2016-11-01

    Full Text Available Purpose: This phase II/III, non-randomized clinical trial aimed to determine the efficacy and safety of the combination of radiofrequency ablation (RFA and cytokine-induced killer (CIK cells transfusion for patients with colorectal liver metastases (CRLMs. Experimental Design: A total of 60 eligible patients with CRLMs were enrolled and divided into Group A (RFA alone, n = 30 and Group B (RFA plus CIK, n = 30, and following enzyme-linked immunosorbent spot assay was performed in 8 patients with CEA > 50 ng/mL pre-RFA and 7 days post-RFA and CIK treatment, respectively. Results: The median progression-free survival (PFS times of Group A and Group B were 18.5 months and 23 months, respectively (P = 0.0336. The 3-year progression-free rates were 13.3% in Group A and 20.3% in Group B, respectively. The median overall survival time was 43 months in Group A, and not reached in Group B. The 3-year survival rates were 64.6% in Group A and 81.0% in Group B, respectively (P = 0.1187. Among the 8 patients with CEA > 50ng/mL, 6 had increase of circulating CEA-specific T cells after RFA (P = 0.010. After CIK cell therapy, the number of CEA-specific T cells increased in all the 8 patients comparing with that pre-treatment (P = 0.001 and in 7 patients comparing with that post-RFA (P = 0.028. Conclusions: We firstly confirm that the combination of RFA and CIK cells boosts CEA-specific T cell response and shows to be an efficacious and safe treatment modality for patients with CRLMs.

  15. An overview of the MIZ-1 borehole investigations during phase I/II. MIZ-1 progress report 03-01

    International Nuclear Information System (INIS)

    Ota, Kunio; Takeuchi, Shinji; Ikeda, Koki

    2004-05-01

    Surface-based investigations have now been carried out, in a step-by-step fashion, with the main aims of the development of conceptual models of the geological environment and the enhancement of the understanding of the undisturbed deep geological environment before excavation of the shafts and experimental drifts. The MIZ-1 borehole investigation programme was launched in December 2002, as a step of the field investigations at the MIU Construction Site. The overall goals of the MIZ-1 borehole investigations are to characterise the geological environment from the surface to over 1,000 m depth in the crystalline basement, to establish baseline conditions before excavation of the shafts and experimental drifts, and to provide a deep borehole for observing hydraulic responses during the shaft and drift excavation and experiments in the drifts during the Construction and the Operation Phases. The borehole is planned to be drilled in an overall south-westerly direction from the north-eastern area of the MIU Site. The planned inclination varies from vertical at shallower depths to 12deg from vertical at greater depths down to 1,350 m along the borehole length, which will be achieved by controlled directional drilling. In MIZ-1 Phase I/II (from March to May 2003), the borehole was drilled vertically, through the entire sedimentary formations, down to 123.00 m in the uppermost part of the Toki granite at the MIU Construction Site. The new method of wireline core drilling with a downhole motor was introduced for the drilling. Planned geological, geophysical and hydrochemical investigations and complementary hydraulic and hydrochemical monitoring were performed. In addition, as a complete loss of drilling fluid was encountered at 115.85 m along the borehole length, modified work procedures resulted in the execution of hydraulic tests with groundwater sampling, from necessity, in that section and of further drilling work. The local QC system was applied to all the

  16. Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT).

    Science.gov (United States)

    Carvajal, Richard D; Piperno-Neumann, Sophie; Kapiteijn, Ellen; Chapman, Paul B; Frank, Stephen; Joshua, Anthony M; Piulats, Josep M; Wolter, Pascal; Cocquyt, Veronique; Chmielowski, Bartosz; Evans, T R Jeffry; Gastaud, Lauris; Linette, Gerald; Berking, Carola; Schachter, Jacob; Rodrigues, Manuel J; Shoushtari, Alexander N; Clemett, Delyth; Ghiorghiu, Dana; Mariani, Gabriella; Spratt, Shirley; Lovick, Susan; Barker, Peter; Kilgour, Elaine; Lai, Zhongwu; Schwartz, Gary K; Nathan, Paul

    2018-04-20

    Purpose Uveal melanoma is the most common primary intraocular malignancy in adults with no effective systemic treatment option in the metastatic setting. Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective MEK1/2 inhibitor with a short half-life, which demonstrated single-agent activity in patients with metastatic uveal melanoma in a randomized phase II trial. Methods The Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) study was a phase III, double-blind trial ( ClinicalTrial.gov identifier: NCT01974752) in which patients with metastatic uveal melanoma and no prior systemic therapy were randomly assigned (3:1) to selumetinib (75 mg twice daily) plus dacarbazine (1,000 mg/m 2 intravenously on day 1 of every 21-day cycle) or placebo plus dacarbazine. The primary end point was progression-free survival (PFS) by blinded independent central radiologic review. Secondary end points included overall survival and objective response rate. Results A total of 129 patients were randomly assigned to receive selumetinib plus dacarbazine (n = 97) or placebo plus dacarbazine (n = 32). In the selumetinib plus dacarbazine group, 82 patients (85%) experienced a PFS event, compared with 24 (75%) in the placebo plus dacarbazine group (median, 2.8 v 1.8 months); the hazard ratio for PFS was 0.78 (95% CI, 0.48 to 1.27; two-sided P = .32). The objective response rate was 3% with selumetinib plus dacarbazine and 0% with placebo plus dacarbazine (two-sided P = .36). At 37% maturity (n = 48 deaths), analysis of overall survival gave a hazard ratio of 0.75 (95% CI, 0.39 to 1.46; two-sided P = .40). The most frequently reported adverse events (selumetinib plus dacarbazine v placebo plus dacarbazine) were nausea (62% v 19%), rash (57% v 6%), fatigue (44% v 47%), diarrhea (44% v 22%), and peripheral edema (43% v 6%). Conclusion In patients with metastatic uveal melanoma, the combination of selumetinib plus dacarbazine had a tolerable safety

  17. Time to Angiographic Reperfusion and Clinical Outcome after Acute Ischemic Stroke in the Interventional Management of Stroke Phase III (IMS III) Trial: A Validation Study

    Science.gov (United States)

    Khatri, Pooja; Yeatts, Sharon D.; Mazighi, Mikael; Broderick, Joseph P.; Liebeskind, David S.; Demchuk, Andrew M.; Amarenco, Pierre; Carrozzella, Janice; Spilker, Judith; Foster, Lydia D.; Goyal, Mayank; Hill, Michael D.; Palesch, Yuko Y.; Jauch, Edward C.; Haley, E. Clarke; Vagal, Achala; Tomsick, Thomas A.

    2014-01-01

    BACKGROUND The IMS III Trial did not demonstrate clinical benefit of the endovascular approach compared to IV rt-PA alone for moderate or severe ischemic strokes (NIHSS≥8) enrolled within three hours of stroke onset. Late reperfusion of tissue that is no longer salvageable may be one explanation, as suggested by prior exploratory studies showing an association between time to reperfusion and good clinical outcome. We sought to validate this relationship in the large-scale IMS III trial, and consider its implications for future endovascular trials. METHODS The analysis consisted of the endovascular cohort with proximal arterial occlusions in the anterior circulation that achieved angiographic reperfusion (TICI 2–3) during the endovascular procedure (within 7 hours from the onset of symptoms). Logistic regression was used to model good clinical outcome (90-day modified Rankin 0–2) as a function of the time to reperfusion, and prespecified variables were considered for adjustment. FINDINGS Among 240 proximal vessel occlusions, angiographic reperfusion (TICI 2–3) was achieved in 182 (76%). Mean time to reperfusion was 325 minutes (range 180–418 minutes). Longer time for reperfusion was associated with a decreased likelihood of good clinical outcome (RR [95% CI] for every 30 minute delay: unadjusted 0·85 [0·77–0·94]; adjusted 0·88 [0·80–0·98]). INTERPRETATION We confirm that delay in time to angiographic reperfusion leads to a decreased likelihood of good clinical outcome. Achieving rapid reperfusion may be critical for the successes of future acute endovascular trials. FUNDING: NIH/NINDS (study sponsor), Genentech Inc. (study drug - intra-arterial t-PA), EKOS Corp. (device), Concentric Inc. (device), Cordis Neurovascular, Inc. (device), and Boehringer Ingelheim (European Investigator Meeting support). PMID:24784550

  18. Phase transition temperatures of Sn-Zn-Al system and their comparison with calculated phase diagrams

    Czech Academy of Sciences Publication Activity Database

    Smetana, B.; Zlá, S.; Kroupa, Aleš; Žaludová, M.; Drápala, J.; Burkovič, R.; Petlák, D.

    2012-01-01

    Roč. 110, č. 1 (2012), s. 369-378 ISSN 1388-6150 R&D Projects: GA MŠk(CZ) OC08053 Institutional support: RVO:68081723 Keywords : Sn-Zn-Al system * DTA * phase transition temperatures Subject RIV: BJ - Thermodynamics Impact factor: 1.982, year: 2012

  19. Structural systematics of rare earth complexes. III. Structural characterization of lanthanoid (III) picrate hydrates: gadolinium picrate dodecahydrate - an x-ray-induced phase modifications? - and some general aspects of structural chemistry of lanthanoid picrates

    International Nuclear Information System (INIS)

    Harrowfield, J.M.; Weimin, Lu; Brian, W.S.; White, A.H.

    1994-01-01

    In the course of the previous studies (Parts I and II), an unusual result was observed in the case of the structure determination of hydrated gadolinium(III) picrate. Midway through data collection, the monoclinic P2 1 /c phase modification (X-ray-induced?) to a similar cell more nearly resembling that of the La→Pr structure type recorded previously, with no loss of crystal integrity, and with useful data sets being obtained on both forms. Redetermination of the structure with a fresh sample yielded no reproduction of the anomaly. These results are recorded and discussed, together with an overview of the consequences of the data of Parts I-III in relation to those of other literature in the field. 13 refs., 4 tabs., 1 fig

  20. Comparison of liquid and supercritical fluid chromatography mobile phases for enantioselective separations on polysaccharide stationary phases.

    Science.gov (United States)

    Khater, Syame; Lozac'h, Marie-Anne; Adam, Isabelle; Francotte, Eric; West, Caroline

    2016-10-07

    Analysis and production of enantiomerically pure compounds is a major topic of interest when active pharmaceutical ingredients are concerned. Enantioselective chromatography has become a favourite both at the analytical and preparative scales. High-performance liquid chromatography (HPLC) and supercritical fluid chromatography (SFC) are dominating the scene and are often seen as complementary techniques. Nowadays, for economic and ecologic reasons, SFC may be preferred over normal-phase HPLC (NPLC) as it allows significant reductions in solvent consumption. However, the transfer of NPLC methods to SFC is not always straightforward. In this study, we compare the retention of achiral molecules and separation of enantiomers under supercritical fluid (carbon dioxide with ethanol or isopropanol) and liquid normal-phase (heptane with ethanol or isopropanol) elution modes with polysaccharide stationary phases in order to explore the differences between the retention and enantioseparation properties between the two modes. Chemometric methods (namely quantitative structure-retention relationships and discriminant analysis) are employed to compare the results obtained on a large set of analytes (171 achiral probes and 97 racemates) and gain some understanding on the retention and separation mechanisms. The results indicate that, contrary to popular belief, carbon dioxide - solvent SFC mobile phases are often weaker eluents than liquid mobile phases. It appears that SFC and NPLC elution modes provide different retention mechanisms. While some enantioseparations are unaffected, facilitating the transfer between the two elution modes, other enantioseparations may be drastically different due to different types and strength of interactions contributing to enantioselectivity. Copyright © 2016 Elsevier B.V. All rights reserved.

  1. Adjuvant whole abdominal intensity modulated radiotherapy (IMRT) for high risk stage FIGO III patients with ovarian cancer (OVAR-IMRT-01) – Pilot trial of a phase I/II study: study protocol

    International Nuclear Information System (INIS)

    Rochet, Nathalie; Jensen, Alexandra D; Sterzing, Florian; Munter, Marc W; Eichbaum, Michael H; Schneeweiss, Andreas; Sohn, Christof; Debus, Juergen; Harms, Wolfgang

    2007-01-01

    The prognosis for patients with advanced epithelial ovarian cancer remains poor despite aggressive surgical resection and platinum-based chemotherapy. More than 60% of patients will develop recurrent disease, principally intraperitoneal, and die within 5 years. The use of whole abdominal irradiation (WAI) as consolidation therapy would appear to be a logical strategy given its ability to sterilize small tumour volumes. Despite the clinically proven efficacy of whole abdominal irradiation, the use of radiotherapy in ovarian cancer has profoundly decreased mainly due to high treatment-related toxicity. Modern intensity-modulated radiation therapy (IMRT) could allow to spare kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose. The OVAR-IMRT-01 study is a single center pilot trial of a phase I/II study. Patients with advanced ovarian cancer stage FIGO III (R1 or R2< 1 cm) after surgical resection and platinum-based chemotherapy will be treated with whole abdomen irradiation as consolidation therapy using intensity modulated radiation therapy (IMRT) to a total dose of 30 Gy in 1.5 Gy fractions. A total of 8 patients will be included in this trial. For treatment planning bone marrow, kidneys, liver, spinal cord, vertebral bodies and pelvic bones are defined as organs at risk. The planning target volume includes the entire peritoneal cavity plus pelvic and para-aortic node regions. The primary endpoint of the study is the evaluation of the feasibility of intensity-modulated WAI and the evaluation of the study protocol. Secondary endpoint is evaluation of the toxicity of intensity modulated WAI before continuing with the phase I/II study. The aim is to explore the potential of IMRT as a new method for WAI to decrease the dose to kidneys, liver, bone marrow while covering the peritoneal cavity with a homogenous dose, and to implement whole abdominal intensity-modulated radiotherapy into the adjuvant multimodal

  2. Zwitterion-functionalized polymer microspheres as a sorbent for solid phase extraction of trace levels of V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II) prior to their determination by ICP-MS.

    Science.gov (United States)

    Jia, Xiaoyu; Gong, Dirong; Zhao, Junyi; Ren, Hongyun; Wang, Jiani; Zhang, Xian

    2018-03-19

    This paper describes the preparation of zwitterion-functionalized polymer microspheres (ZPMs) and their application to simultaneous enrichment of V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II) from environmental water samples. The ZPMs were prepared by emulsion copolymerization of ethyl methacrylate, 2-diethylaminoethyl methacrylate and triethylene glycol dimethyl acrylate followed by modification with 1,3-propanesultone. The components were analyzed by elemental analyses as well as Fourier transform infrared spectroscopy, and the structures were characterized by scanning electron microscopy and transmission electron microscopy. The ZPMs were packed into a mini-column for on-line solid-phase extraction (SPE) of the above metal ions. Following extraction with 40 mM NH 4 NO 3 and 0.5 M HNO 3 solution, the ions were quantified by ICP-MS. Under the optimized conditions, the enrichment factors (from a 40 mL sample) are up to 60 for the ions V(V), As(III), Sb(III) and Hg(II), and 55 for Cr(III) and Sn(IV). The detection limits are 1.2, 3.4, 1.0, 3.7, 2.1 and 1.6 ng L -1 for V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II), respectively, and the relative standard deviations (RSDs) are below 5.2%. The feasibility and accuracy of the method were validated by successfully analyzing six certified reference materials as well as lake, well and river waters. Graphical abstract Zwitterion-functionalized polymer microspheres (ZPMs) were prepared and packed into a mini-column for on-line solid-phase extraction (SPE) via pump 1. Then V(V), Cr(III), As(III), Sn(IV), Sb(III) and Hg(II) ions in environmental waters were eluted and submitted to ICP-MS via pump 2.

  3. Virtual reality exercise on a home-based phase III cardiac rehabilitation program, effect on executive function, quality of life and depression, anxiety and stress: a randomized controlled trial.

    Science.gov (United States)

    Vieira, Ágata; Melo, Cristina; Machado, Jorge; Gabriel, Joaquim

    2018-02-01

    To analyse the effect of a six-month home-based phase III cardiac rehabilitation (CR) specific exercise program, performed in a virtual reality (Kinect) or conventional (booklet) environment, on executive function, quality of life and depression, anxiety and stress of subjects with coronary artery disease. A randomized controlled trial was conducted with subjects, who had completed phase II, randomly assigned to intervention group 1 (IG1), whose program encompassed the use of Kinect (n = 11); or intervention group 2 (IG2), a paper booklet (n = 11); or a control group (CG), only subjected to the usual care (n = 11). The three groups received education on cardiovascular risk factors. The assessed parameters, at baseline (M0), 3 (M1) and 6 months (M2), were executive function, control and integration in the implementation of an adequate behaviour in relation to a certain objective, specifically the ability to switch information (Trail Making Test), working memory (Verbal Digit Span test), and selective attention and conflict resolution ability (Stroop test), quality of life (MacNew questionnaire) and depression, anxiety and stress (Depression, Anxiety and Stress Scale 21). Descriptive and inferential statistical measures were used, significance level was set at .05. The IG1 revealed significant improvements, in the selective attention and conflict resolution ability, in comparison with the CG in the variable difference M0 - M2 (p = .021) and in comparison with the IG2 in the variable difference M1 - M2 and M0 - M2 (p = .001 and p = .002, respectively). No significant differences were found in the quality of life, and depression, anxiety and stress. The virtual reality format had improved selective attention and conflict resolution ability, revealing the potential of CR, specifically with virtual reality exercise, on executive function. Implications for Rehabilitation In cardiac rehabilitation, especially in phase III, it is

  4. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials

    DEFF Research Database (Denmark)

    Petersen, Lone K; Restrepo, Jaime; Moreira, Edson D

    2017-01-01

    BACKGROUND: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody...... responses was assessed. METHODS: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized...... as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1. RESULTS: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined...

  5. A phase III trial of zoladex and flutamide versus orchiectomy in the treatment of patients with advanced carcinoma of the prostate

    DEFF Research Database (Denmark)

    Iversen, P; Christensen, M G; Friis, E

    1990-01-01

    In a multicenter Phase III trial 264 patients with advanced prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex supplemented by flutamide. Presently, median follow-up time is 30 months. A small difference in objective response was recorded in favor of the co......In a multicenter Phase III trial 264 patients with advanced prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex supplemented by flutamide. Presently, median follow-up time is 30 months. A small difference in objective response was recorded in favor...... of the combination therapy, whereas no statistically significant difference was found in subjective response to therapy, time to progression, and overall survival. Adverse effects were more commonly encountered in the pharmacologically treated patients. It is concluded that the combination of zoladex plus flutamide...... is not clinically superior to orchiectomy in the treatment of patients with advanced carcinoma of the prostate....

  6. Concurrent chemoradiotherapy in locally advanced carcinoma of the uterine cervix: a phase I/II prospective study

    International Nuclear Information System (INIS)

    Kang, One Chul; Choi, Eun Kyung; Chung, Weon Kuu; Kim, Jong Hoon; Chang, Hye Sook; Kim, Yong Man; Kim, Young Tak; Nam, Joo Hyun; Mok, Jung Eun; Lee, Moo Song

    1998-01-01

    Prospective, single arm. Phase I/II clinical trial was performed to assess the efficacy and toxicity of the concurrent chemotherapy and definitive radiotherapy (RT) in patients with previously untreated locally advanced carcinoma of the uterine cervix. From May 1992 to January 1997, a total of 73 patients with advanced cervical carcinoma were entered on the protocol but 5 patients were excluded in analysis because of patients' refusal of treatment. Their ages ranged from 31 to 77 years, median 58 years. The international Federation of Gynecology and Obstetrics (FIGO) stage distribution was as follows: IIB 46, IIIA 2, IIIB 15 and IVA 5. RT consisted of external beam irradiation to 4, 140-5, 040 cGy/23-28 fractions plus high dose rate intracavitary treatments to deliver a dose of 30-35 Gy to point A in 6-7 fractions. During the intracavitary treatments parametrial boost was delivered for point B dose of 60 Gy in stage IIB and 65 Gy in stage IIIB. Two cycles of concurrent 5-fluorouracil and cisplatin (FP) chemotherapy (5-fluorouracil 1,000 mg/m 2 /day continuous infusion for 4 days, day 1-4, 29-32 and cisplatin 20 mg/m 2 /dy intravenous bolus for 3 days, day 1-3, 29-31) administered starting on day 1 of 1 of RT. The median follow-up was 24 months (range 4-68+). Sixty-four patients were evaluable for survival rate in this protocol: The 5-year actuarial and disease-free survival rate were 52% and 64%, respectively. The 5-year actuarial survival for stage IIB and II+IVA patients were 58% and 36%, respectively. The 5-year disease-free survival rate for stage IIB and III+IVA patients were 71% and 46%, respectively. Of the 68 patients evaluated for patterns of failure, overall recurrence rate was 27.9% (19/68): local failure in 5.9% (4/68), distant metastasis in 10.3% (7/68) and both in 11.8% (8/68). Of the 64 patients evaluated for response at one month after the completion of treatment, the complete response rate was 78% (50/64). Concurrent chemoradiation appear to be a

  7. Preliminary results of a phase I/II study of HDR brachytherapy alone for T1/T2 breast cancer

    International Nuclear Information System (INIS)

    Wazer, David E.; Berle, Lisa; Graham, Roger; Chung, Maureen; Rothschild, Janice; Graves, Theresa; Cady, Blake; Ulin, Kenneth; Ruthazer, Robin; DiPetrillo, Thomas A.

    2002-01-01

    Purpose: To investigate the feasibility, toxicity, cosmetic outcome, and local control of high-dose-rate (HDR) brachytherapy alone without whole breast external beam irradiation for early-stage breast carcinoma. Methods and Materials: Between June 1997 and August 1999, 32 women diagnosed with a total of 33 AJCC Stage I/II breast carcinomas underwent surgical breast excision and postoperative irradiation using HDR brachytherapy interstitial implantation as part of a multi-institutional clinical Phase I/II protocol. Eligible patients included those with T1, T2, N0, N1 (≤3 nodes positive), and M0 tumors of nonlobular histologic features with negative surgical margins, no extracapsular lymph node extension, and a negative postexcision mammogram. Brachytherapy catheters were placed at the initial excision, reexcision, or either sentinel or full-axillary sampling. Direct visualization, surgical clips, and ultrasound and/or CT scan assisted in the delineation of the target volume, defined as the excision cavity plus a 2-cm margin. High-activity 192 Ir (3-10 Ci) was used to deliver 340 cGy/fraction, 2 fractions/d, for 5 consecutive days, to a total dose of 34 Gy to the target volume. Source position and dwell times were calculated using standard volume optimization techniques. Results: The median follow-up of all patients was 33 months, and the mean patient age was 63 years. The mean tumor size was 1.3 cm, and 55% had an extensive intraductal component. Three patients had positive axillary nodes. Two patients experienced moderate perioperative pain that required narcotic analgesics. No peri- or postoperative infections occurred. No wound healing problems and no significant skin reactions related to the implant developed. The Radiation Therapy Oncology Group late radiation morbidity scoring scheme was applied to the entire 33-case cohort. In the assessment of the skin, 30 cases were Grade 0-1 and 3 cases were Grade 2. Subcutaneous toxicity was scored as 11 patients with

  8. Effect of silodosin on specific urinary symptoms associated with benign prostatic hyperplasia: analysis of international prostate symptom scores in 2 phase III clinical studies

    OpenAIRE

    Gittelman, Marc C; Marks, Leonard S; Hill, Lawrence A; Volinn, Weining; Hoel, Gary

    2010-01-01

    Marc C Gittelman1, Leonard S Marks2, Lawrence A Hill3, Weining Volinn3, Gary Hoel31South Florida Medical Research, Aventura, Florida, USA; 2University of California at Los Angeles and Urological Sciences Research Foundation, Los Angeles, California, USA; 3Watson Laboratories, Salt Lake City, Utah, USAPurpose: Pooled results from 2 randomized, placebo-controlled, US phase III studies (NCT00224107, NCT00224120) showed that silodosin, a uroselective α-blocker, significantly improved In...

  9. The Combination Process for Preparative Separation and Purification of Paclitaxel and 10-Deacetylbaccatin III Using Diaion® Hp-20 Followed by Hydrophilic Interaction Based Solid Phase Extraction

    Science.gov (United States)

    Shirshekanb, Mahsa; Rezadoost, Hassan; Javanbakht, Mehran; Ghassempour, Ali Reza

    2017-01-01

    There is no other naturally occurring defense agent against cancer that has a stronger effect than paclitaxel, commonly known under the brand name of Taxol®. The major drawback for the more widespread use of paclitaxel and its precious precursor, 10-deacetylbaccatin III (10-DAB III), is that they require large-scale extraction from different parts of yew trees (Taxus species), cell cultures, taxane-producing endophytic fungi, and Corylus species. In our previous work, a novel online two-dimensional heart-cut liquid chromatography process using hydrophilic interaction/ reversed-phase chromatography was used to introduce a semi-preparative treatment for the separation of polar (10-deacetylbaccatin III) and non-polar (paclitaxel) taxanes from Taxus baccata L. In this work, a combination of the absorbent (Diaion® HP-20) and a silica based solid phase extraction is utilized as a new, efficient, and cost effective method for large-scale production of taxanes. This process avoids the technical problem of two-dimensional preparative liquid chromatography. The first stage of the process involves discarding co-extractive polar compounds including chlorophylls and pigments using a non-polar synthetic hydrophobic absorbent, Diaion® HP-20. Extract was then loaded on to a silica based hydrophilic interaction solid phase extraction (silica 40-60 micron). Taxanes was eluted using a mixture of water and methanol at the optimized ratio of 70:30. Finally, the fraction containing taxanes was applied to semi-preparative reversed phase HPLC. The results revealed that using this procedure, paclitaxel and 10-DAB III could be obtained at 8 and 3 times more, respectively than by the traditional method of extraction. PMID:29552048

  10. The Combination Process for Preparative Separation and Purification of Paclitaxel and 10-Deacetylbaccatin III Using Diaion® Hp-20 Followed by Hydrophilic Interaction Based Solid Phase Extraction.

    Science.gov (United States)

    Shirshekanb, Mahsa; Rezadoost, Hassan; Javanbakht, Mehran; Ghassempour, Ali Reza

    2017-01-01

    There is no other naturally occurring defense agent against cancer that has a stronger effect than paclitaxel, commonly known under the brand name of Taxol ® . The major drawback for the more widespread use of paclitaxel and its precious precursor, 10-deacetylbaccatin III (10-DAB III), is that they require large-scale extraction from different parts of yew trees ( Taxus species), cell cultures, taxane-producing endophytic fungi, and Corylus species. In our previous work, a novel online two-dimensional heart-cut liquid chromatography process using hydrophilic interaction/ reversed-phase chromatography was used to introduce a semi-preparative treatment for the separation of polar (10-deacetylbaccatin III) and non-polar (paclitaxel) taxanes from Taxus baccata L. In this work, a combination of the absorbent (Diaion ®  HP-20) and a silica based solid phase extraction is utilized as a new, efficient, and cost effective method for large-scale production of taxanes. This process avoids the technical problem of two-dimensional preparative liquid chromatography. The first stage of the process involves discarding co-extractive polar compounds including chlorophylls and pigments using a non-polar synthetic hydrophobic absorbent, Diaion ®  HP-20. Extract was then loaded on to a silica based hydrophilic interaction solid phase extraction (silica 40-60 micron). Taxanes was eluted using a mixture of water and methanol at the optimized ratio of 70:30. Finally, the fraction containing taxanes was applied to semi-preparative reversed phase HPLC. The results revealed that using this procedure, paclitaxel and 10-DAB III could be obtained at 8 and 3 times more, respectively than by the traditional method of extraction.

  11. Analysis of Regional Timelines To Set Up a Global Phase III Clinical Trial in Breast Cancer: the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Experience

    OpenAIRE

    Metzger-Filho, Otto; Azambuja, Evandro de; Bradbury, Ian; Saini, Kamal S.; Bines, Jose; Simon, Sergio D. [UNIFESP; Van Dooren, Veerle; Aktan, Gursel; Pritchard, Kathleen I.; Wolff, Antonio C.; Smith, Ian; Jackisch, Christian; Lang, Istvan; Untch, Michael; Boyle, Frances

    2013-01-01

    Purpose. This study measured the time taken for setting up the different facets of Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO), an international phase III study being conducted in 44 participating countries.Methods. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected i...

  12. Opioid Patient Controlled Analgesia (PCA) use during the Initial Experience with the IMPROVE PCA Trial: A Phase III Analgesic Trial for Hospitalized Sickle Cell Patients with Painful Episodes

    OpenAIRE

    Dampier, Carlton D.; Smith, Wally R.; Kim, Hae-Young; Wager, Carrie Greene; Bell, Margaret C.; Minniti, Caterina P.; Keefer, Jeffrey; Hsu, Lewis; Krishnamurti, Lakshmanan; Mack, A. Kyle; McClish, Donna; McKinlay, Sonja M.; Miller, Scott T.; Osunkwo, Ifeyinwa; Seaman, Phillip

    2011-01-01

    Opioid analgesics administered by patient-controlled analgesia (PCA) are frequently used for pain relief in children and adults with sickle cell disease (SCD) hospitalized for persistent vaso-occlusive pain, but optimum opioid dosing is not known. To better define PCA dosing recommendations, a multi-center phase III clinical trial was conducted comparing two alternative opioid PCA dosing strategies (HDLI-higher demand dose with low constant infusion or LDHI- lower demand dose and higher const...

  13. Solvent phase characterisation of lanthanide(3) and americium(3) complexes with malonamide (tema) and ter-pyridine ligands by EXAFS: comparison with single crystals

    International Nuclear Information System (INIS)

    Den Auwer, C.; Presson, M.T.; Grigoriev, M.; Madic, C.; Nierlich, M.; Thuery, P.; David, F.; Hubert, S.; Drew, M.G.B.; Hudson, M.J.; Iveson, P.B.; Russell, M.L.

    2002-01-01

    In order to develop molecules that will be good candidates for the extractive separation of the various elements contained within nuclear fuels, 4f and 5f molecular chemistry has been the subject of numerous studies. Thus, to better understand the ligand to cation interaction and to fine tune the theoretical models, precise knowledge about the cation co-ordination sphere must be obtained. More precisely, both structural and electronic data must be acquired in order to define the role of the cation frontier orbitals within the complex. To do so, various structural probes must be used, from vibrational and nuclear techniques to X-ray spectroscopies. In the field of actinide solvent extraction, the species of interest are in the solvent phase and both solid state diffraction methods and solvent phase X-ray absorption spectroscopy have become of primary importance lately. A number of Ln(III) and Am(III) complexes of the type M(NO 3 ) 3 L 1,2 (where M is either Ln 3+ or Am 3+ and L is either the 2,2',6',2 - ter-pyridine (Tpy) or the N,N,N',N' tetraethyl-malonamide (TEMA) ligand) have been crystallographically characterised in the solid state. In order to obtain structural information in the solvent phase, EXAFS L III edge measurements have been performed on the cation (DCI ring at the LURE facility). The overall contraction (-0.05 Angstrom) of the cation co-ordination sphere from Nd 3+ to Lu 3+ reflects the decrease in the lanthanide ionic radii. With the TEMA ligand, this steric constraint generates the elongation of one nitrate bond, leading to one formally monodendate nitrate for the late Ln ions. Comparison is made with the Tpy ligand. In the case of Am 3+ cation, comparison with isostructural Nd 3+ shows that similar co-ordination spheres are obtained, either with the TEMA or the Tpy ligands. (authors)

  14. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

    Directory of Open Access Journals (Sweden)

    Nativ Ofer

    2012-11-01

    Full Text Available Abstract Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10, and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC-controlled Phase I/II study (N = 7 in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10: All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7: Hemostatic success at 10 min (primary endpoint was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial

  15. Project 8, Phase III Design: Placing an eV-Scale Limit on the Neutrino Mass using Cyclotron Radiation Emission Spectroscopy

    Science.gov (United States)

    Oblath, Noah; Project 8 Collaboration

    2016-09-01

    We report on the design concept for Phase III of the Project 8 experiment. In the third phase of Project 8 we aim to place a limit on the neutrino mass that is similar to the current limits set by tritium beta-decay experiments, mν radioastronomy will be employed to search for and track electron signals in the fiducial volume. This talk will present the quantitative design concept for the phased-array receiver, and illustrate how we are progressing towards the Phase IV experiment, which will have sensitivity to the neutrino mass scale allowed by the inverted mass hierarchy. This work is supported by the DOE Office of Science Early Career Research Program, and the Laboratory Directed Research and Development Program at Pacific Northwest National Laboratory.

  16. Whole brain radiotherapy after local treatment of brain metastases in melanoma patients - a randomised phase III trial

    International Nuclear Information System (INIS)

    Fogarty, Gerald; Shivalingam, Brindha; Dhillon, Haryana; Thompson, John F; Morton, Rachael L; Vardy, Janette; Nowak, Anna K; Mandel, Catherine; Forder, Peta M; Hong, Angela; Hruby, George; Burmeister, Bryan

    2011-01-01

    Cerebral metastases are a common cause of death in patients with melanoma. Systemic drug treatment of these metastases is rarely effective, and where possible surgical resection and/or stereotactic radiosurgery (SRS) are the preferred treatment options. Treatment with adjuvant whole brain radiotherapy (WBRT) following neurosurgery and/or SRS is controversial. Proponents of WBRT report prolongation of intracranial control with reduced neurological events and better palliation. Opponents state melanoma is radioresistant; that WBRT yields no survival benefit and may impair neurocognitive function. These opinions are based largely on studies in other tumour types in which assessment of neurocognitive function has been incomplete. This trial is an international, prospective multi-centre, open-label, phase III randomised controlled trial comparing WBRT to observation following local treatment of intracranial melanoma metastases with surgery and/or SRS. Patients aged 18 years or older with 1-3 brain metastases excised and/or stereotactically irradiated and an ECOG status of 0-2 are eligible. Patients with leptomeningeal disease, or who have had previous WBRT or localised treatment for brain metastases are ineligible. WBRT prescription is at least 30 Gy in 10 fractions commenced within 8 weeks of surgery and/or SRS. Randomisation is stratified by the number of cerebral metastases, presence or absence of extracranial disease, treatment centre, sex, radiotherapy dose and patient age. The primary endpoint is the proportion of patients with distant intracranial failure as determined by MRI assessment at 12 months. Secondary end points include: survival, quality of life, performance status and neurocognitive function. Accrual to previous trials for patients with brain metastases has been difficult, mainly due to referral bias for or against WBRT. This trial should provide the evidence that is currently lacking in treatment decision-making for patients with melanoma brain

  17. A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer

    International Nuclear Information System (INIS)

    Newton, Robert U; Taaffe, Dennis R; Spry, Nigel; Gardiner, Robert A; Levin, Gregory; Wall, Bradley; Joseph, David; Chambers, Suzanne K; Galvão, Daniel A

    2009-01-01

    targeting bone density, cardiovascular function, lean and fat mass, physical function and falls risk as primary study endpoints. In terms of advancement of prostate cancer care, we expect dissemination of the knowledge gained from this project to reduce fracture risk, improve physical and functional ability, quality of life and ultimately survival rate in this population. A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer; ACTRN12609000200280

  18. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial

    Energy Technology Data Exchange (ETDEWEB)

    Hamstra, Daniel A., E-mail: Daniel.Hamstra@gmail.com [Texas Oncology, Texas Center for Proton Therapy, Irving, Texas (United States); Mariados, Neil [Associated Medical Professionals of NY, PLLC, Syracuse, New York (United States); Sylvester, John [21st Century Oncology, Inc, Lakewood Ranch, East Bradenton, Florida (United States); Shah, Dhiren [Western New York Urology Associates, LLC, Doing Business as Cancer Care of WNY, Cheektowaga, New York (United States); Karsh, Lawrence [The Urology Center of Colorado, Denver, Colorado (United States); Hudes, Richard [Chesapeake Urology Associates, Doing Business as Chesapeake Urology Research Associates (The Prostate Center), Owings Mills, Maryland (United States); Beyer, David [Arizona Oncology Services Foundation, Phoenix, Arizona (United States); Kurtzman, Steven [Urological Surgeons of Northern California Inc, Campbell, California (United States); Bogart, Jeffrey [The Research Foundation of State University of New York/State University of New York Upstate Medical University, Syracuse, New York (United States); Hsi, R. Alex [Peninsula Cancer Center, Poulsbo, Washington (United States); Kos, Michael [Urology Nevada, Reno, Nevada (United States); Ellis, Rodney [University Hospitals Case Medical Center, Cleveland, Ohio (United States); Logsdon, Mark [Sutter Health Sacramento Sierra Region, Doing Business as Sutter Institute for Medical Research, Sacramento, California (United States); Zimberg, Shawn [Advanced Radiation Centers of New York, Lake Success, New York (United States); Forsythe, Kevin [Oregon Urology Institute, Springfield, Oregon (United States); Zhang, Hong [University of Rochester, Rochester, New York (United States); Soffen, Edward [CentraState Medical Center, Freehold, New Jersey (United States); Francke, Patrick [Carolina Regional Cancer Center, LLC, 21st Century Oncology, Inc, Myrtle Beach, South Carolina (United States); Mantz, Constantine [21st Century Oncology, Inc, Fort Meyers, Florida (United States); and others

    2017-04-01

    Purpose: SpaceOAR, a Food and Drug Administration–approved hydrogel intended to create a rectal–prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years. Methods and Materials: Cumulative (Common Terminology Criteria for Adverse Events, version 4.0) toxicity was evaluated using the log-rank test. Quality of life (QOL) was examined using the Expanded Prostate Cancer Index Composite (EPIC), and the mean changes from baseline in the EPIC domains were tested using repeated measures models. The proportions of men with minimally important differences (MIDs) in each domain were tested using repeated measures logistic models with prespecified thresholds. Results: The 3-year incidence of grade ≥1 (9.2% vs 2.0%; P=.028) and grade ≥2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade ≥1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade ≥2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05) meeting the threshold for a MID. The control group had a 3.9-point greater decline in urinary QOL compared with the spacer group at 3 years (P<.05), but the difference did not meet the MID threshold. At 3 years, more men in the control group than in the spacer group had experienced a MID decline in bowel QOL (41% vs 14%; P=.002) and urinary QOL (30% vs 17%; P=.04). Furthermore, the control group were also more likely to have experienced large declines (twice the MID) in bowel QOL (21% vs 5%; P=.02) and urinary QOL (23% vs 8%; P=.02). Conclusions: The benefit of a hydrogel spacer in

  19. Intravitreal Sirolimus for Noninfectious Uveitis: A Phase III Sirolimus Study Assessing Double-masKed Uveitis TReAtment (SAKURA).

    Science.gov (United States)

    Nguyen, Quan Dong; Merrill, Pauline T; Clark, W Lloyd; Banker, Alay S; Fardeau, Christine; Franco, Pablo; LeHoang, Phuc; Ohno, Shigeaki; Rathinam, Sivakumar R; Thurau, Stephan; Abraham, Abu; Wilson, Laura; Yang, Yang; Shams, Naveed

    2016-11-01

    To evaluate the efficacy and safety of intravitreal sirolimus in the treatment of noninfectious uveitis (NIU) of the posterior segment (i.e., posterior, intermediate, or panuveitis). Phase III, randomized, double-masked, active-controlled, 6-month study with intravitreal sirolimus. Adults with active NIU of the posterior segment (intermediate, posterior, or panuveitis), defined as a vitreous haze (VH) score >1+. Subjects discontinued NIU medications before baseline, except for systemic corticosteroids, which were allowed only for those already receiving them at baseline and were rapidly tapered after baseline per protocol. Intravitreal sirolimus assigned 1:1:1 at doses of 44 (active control), 440, or 880 μg, administered on Days 1, 60, and 120. The primary efficacy outcome was the percentage of subjects with VH 0 response at Month 5 (study eye) without use of rescue therapy. Secondary outcomes at Month 5 were VH 0 or 0.5+ response rate, corticosteroid tapering success rate (i.e., tapering to a prednisone-equivalent dosage of ≤5 mg/day), and changes in best-corrected visual acuity (BCVA). Adverse events during the double-masked treatment period are presented. A total of 347 subjects were randomized. Higher proportions of subjects in the intravitreal sirolimus 440 μg (22.8%; P = 0.025) and 880 μg (16.4%; P = 0.182) groups met the primary end point than in the 44 μg group (10.3%). Likewise, higher proportions of subjects in the 440 μg (52.6%; P = 0.008) and 880 μg (43.1%; P = 0.228) groups achieved a VH score of 0 or 0.5+ than in the 44 μg group (35.0%). Mean BCVA was maintained throughout the study in each dose group, and the majority of subjects receiving corticosteroids at baseline successfully tapered off corticosteroids (44 μg [63.6%], 440 μg [76.9%], and 880 μg [66.7%]). Adverse events in the treatment and active control groups were similar in incidence, and all doses were well tolerated. Intravitreal sirolimus 440 μg demonstrated a significant

  20. Peptide receptor radionuclide therapy with {sup 177}Lu-DOTATATE: the IEO phase I-II study

    Energy Technology Data Exchange (ETDEWEB)

    Bodei, Lisa; Grana, Chiara M.; Baio, Silvia M.; Lombardo, Dario; Chinol, Marco; Paganelli, Giovanni [European Institute of Oncology, Division of Nuclear Medicine, Milan (Italy); Cremonesi, Marta; Ferrari, Mahila E. [European Institute of Oncology, Division of Medical Physics, Milan (Italy); Fazio, Nicola [European Institute of Oncology, Division of Medical Oncology, Milan (Italy); Iodice, Simona [European Institute of Oncology, Division of Epidemiology and Biostatistics, Milan (Italy); Bartolomei, Mirco [European Institute of Oncology, Division of Nuclear Medicine, Milan (Italy); M. Bufalini Hospital, Division of Nuclear Medicine, Cesena, FC (Italy); Sansovini, Maddalena [Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Unit of Radiometabolic Medicine, Meldola, FC (Italy)

    2011-12-15

    Peptide receptor radionuclide therapy (PRRT) is used in tumours expressing type 2 somatostatin receptors (sst{sub 2}), mainly neuroendocrine. The aim of this prospective phase I-II study was to evaluate the toxicity and efficacy of {sup 177}Lu-DOTATATE in multiple cycles. Fifty-one consecutive patients with unresectable/metastatic sst{sub 2}-positive tumours, divided into two groups, received escalating activities (3.7-5.18 GBq/cycle, group 1; 5.18-7.4 GBq/cycle, group 2) of {sup 177}Lu-DOTATATE. Cumulative activities ranged from 3.7 to 29.2 GBq (median 26.4 GBq in median 6 cycles, group 1, 21 patients) and 5.55 to 28.9 GBq (median 25.2 GBq in 4 cycles, group 2, 30 patients), based on dosimetry. No major acute or delayed renal or haematological toxicity occurred (one grade 3 leukopenia and thrombocytopenia). Cumulative renal absorbed doses were 8-37 Gy (9-41 Gy bioeffective doses). A median decrease of creatinine clearance of 21.7% 6 months after PRRT, 23.9% after 1 year and 27.6% after 2 years was observed. Higher losses (>20%) occurred in patients with risk factors for renal toxicity, particularly hypertension and diabetes. Cumulative bone marrow doses were <1.5 Gy. Blood elements showed a progressive mild drop during cycles and recovered during follow-up (median 30 months). Thirty-nine patients were progressive at enrolment. Partial and complete responses occurred in 15 of 46 (32.6%) assessable patients. The median time to progression was 36 months. Overall survival was 68% at 36 months. Non-responders and patients with extensive tumour involvement had lower survival. {sup 177}Lu-DOTATATE was well tolerated up to 29 GBq cumulative activity (up to 7.4 GBq/cycle). The maximum tolerated dose/cycle was not reached. However, considering the individual bone marrow function and the presence of risk factors for kidney toxicity, it seems safer to divide cumulative activities into lower activity cycles. (orig.)

  1. Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial

    International Nuclear Information System (INIS)

    Hamstra, Daniel A.; Mariados, Neil; Sylvester, John; Shah, Dhiren; Karsh, Lawrence; Hudes, Richard; Beyer, David; Kurtzman, Steven; Bogart, Jeffrey; Hsi, R. Alex; Kos, Michael; Ellis, Rodney; Logsdon, Mark; Zimberg, Shawn; Forsythe, Kevin; Zhang, Hong; Soffen, Edward; Francke, Patrick; Mantz, Constantine

    2017-01-01

    Purpose: SpaceOAR, a Food and Drug Administration–approved hydrogel intended to create a rectal–prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years. Methods and Materials: Cumulative (Common Terminology Criteria for Adverse Events, version 4.0) toxicity was evaluated using the log-rank test. Quality of life (QOL) was examined using the Expanded Prostate Cancer Index Composite (EPIC), and the mean changes from baseline in the EPIC domains were tested using repeated measures models. The proportions of men with minimally important differences (MIDs) in each domain were tested using repeated measures logistic models with prespecified thresholds. Results: The 3-year incidence of grade ≥1 (9.2% vs 2.0%; P=.028) and grade ≥2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade ≥1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade ≥2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05) meeting the threshold for a MID. The control group had a 3.9-point greater decline in urinary QOL compared with the spacer group at 3 years (P<.05), but the difference did not meet the MID threshold. At 3 years, more men in the control group than in the spacer group had experienced a MID decline in bowel QOL (41% vs 14%; P=.002) and urinary QOL (30% vs 17%; P=.04). Furthermore, the control group were also more likely to have experienced large declines (twice the MID) in bowel QOL (21% vs 5%; P=.02) and urinary QOL (23% vs 8%; P=.02). Conclusions: The benefit of a hydrogel spacer in

  2. Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial.

    Science.gov (United States)

    Glina, Sidney; Fonseca, Gilvan N; Bertero, Eduardo B; Damião, Ronaldo; Rocha, Luíz C A; Jardim, Carlos R F; Cairoli, Carlos E; Teloken, Cláudio; Torres, Luiz O; Faria, Geraldo E; da Silva, Marcelo B; Pagani, Eduardo

    2010-05-01

    This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. Expanding information on LC efficacy and safety. International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. LC showed a satisfactory efficacy-safety profile for oral therapy of ED.

  3. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC).

    Science.gov (United States)

    Pearce, Neil; Aït-Khaled, Nadia; Beasley, Richard; Mallol, Javier; Keil, Ulrich; Mitchell, Ed; Robertson, Colin

    2007-09-01

    Phase I of the International Study of Asthma and Allergies in Childhood (ISAAC) was designed to allow worldwide comparisons of the prevalence of asthma symptoms. In phase III the phase I survey was repeated in order to assess changes over time. The phase I survey was repeated after an interval of 5-10 years in 106 centres in 56 countries in children aged 13-14 years (n = 304,679) and in 66 centres in 37 countries in children aged 6-7 years (n = 193,404). The mean symptom prevalence of current wheeze in the last 12 months changed slightly from 13.2% to 13.7% in the 13-14 year age group (mean increase of 0.06% per year) and from 11.1% to 11.6% in the 6-7 year age group (mean increase of 0.13% per year). There was also little change in the mean symptom prevalence of severe asthma or the symptom prevalence measured with the asthma video questionnaire. However, the time trends in asthma symptom prevalence showed different regional patterns. In Western Europe, current wheeze decreased by 0.07% per year in children aged 13-14 years but increased by 0.20% per year in children aged 6-7 years. The corresponding findings per year for the other regions in children aged 13-14 years and 6-7 years, respectively, were: Oceania (-0.39% and -0.21%); Latin America (+0.32% and +0.07%); Northern and Eastern Europe (+0.26% and +0.05%); Africa (+0.16% and +0.10%); North America (+0.12% and +0.32%); Eastern Mediterranean (-0.10% and +0.79%); Asia-Pacific (+0.07% and -0.06%); and the Indian subcontinent (+0.02% and +0.06%). There was a particularly marked reduction in current asthma symptom prevalence in English language countries (-0.51% and -0.09%). Similar patterns were observed for symptoms of severe asthma. However, the percentage of children reported to have had asthma at some time in their lives increased by 0.28% per year in the 13-14 year age group and by 0.18% per year in the 6-7 year age group. These findings indicate that international differences in asthma symptom prevalence

  4. The Systems Approach to Functional Job Analysis. Task Analysis of the Physician's Assistant: Volume II--Curriculum and Phase I Basic Core Courses and Volume III--Phases II and III--Clinical Clerkships and Assignments.

    Science.gov (United States)

    Wake Forest Univ., Winston Salem, NC. Bowman Gray School of Medicine.

    This publication contains a curriculum developed through functional job analyses for a 24-month physician's assistant training program. Phase 1 of the 3-phase program is a 6-month basic course program in clinical and bioscience principles and is required of all students regardless of their specialty interest. Phase 2 is a 6 to 10 month period of…

  5. A phase I study of postoperative concurrent radiotherapy and oral doxifluridine and leucovorin for II/III stage rectal cancer

    International Nuclear Information System (INIS)

    Jin Jing; Li Yexiong; Tang Yuan; Wang Weihu; Wang Shulian; Song Yongwen; Liu Yueping; Yu Zihao; Liu Xinfan

    2008-01-01

    Objective: A phase I study was conducted to determine the maximal tolerated dose (MTD) and the dose-limiting toxicity (DLT) of chemotherapy of oral doxifluridine (5-dFUR) and leucovorin with concurrent standard radiotherapy(RT) as adjuvant treatment in patients with rectal cancer. Methods: Patients aged 18-75 years old, Kamofsky scored ≥70%, stage II/III rectal cancer after curative surgery were eligible. Total RT dose was delivered as DT 50 Gy in the fraction of 2.0 Gy per day for 5 weeks to the pelvic area. 5-dFUR was administered concurrently with radiotherapy in escalating doses, and oral leucovorin was administered in a fixed dose of 30 mg/(m 2 ·d), both 3 times daily, from the 1 st day of RT to the last day. The DLTs included grade 3 or grade 4 hematologic and nonhematologie toxicity. Results: From Aug. 2005 to Mar. 2007, 16 patients were enrolled at the following dose levels: 450 mg/(m 2 ·d) (3 patients), 550 mg/(m 2 ·d) (6 patients) and 650 mg/(m 2 ·d) (7 patients). Diarrhea, neutropenia and nausea/vomit were the most common side effects although all neutropenia was less grade 3. The DLT was observed in 1 patient at 550 mg/(m 2 ·d) (grade 4 diarrhea), but none in the following 3 patients at the same dose level. At 650 mg/(m 2 ·d) level, the first patient quitted the study due to a severe abdominal cramp pain in the 3rd week of RT. In the following 3 enrolled patients, one suffered grade 3 abdominal cramp pain, diarrhea, fatigue, nausea/vomit and grade 2 neutropenia and fever. Grade 3 diarrhea was also observed in all the additional 3 patients at 650 mg/(m 2 ·d) dose level. So the dose escalation was ended up to 650 mg/(m 2 ·d). Four of 16 patients didn't complete the scheduled concurrent chemoradiotherapy due to severe side effects, including 1 at 550 mg/(m 2 ·d) dose level, and 3 at 650 mg/(m 2 ·d). The DLTs were observed as grade 3/4 diarrhea, grade 3 abdominal cramp pain, fatigue and nausea/vomit. Conclusions: Diarrhea is the most common and

  6. Calorimetric comparison of the interactions between salivary proteins and Streptococcus mutans with and without antigen I/II

    NARCIS (Netherlands)

    Xu, C.P.; Belt-Gritter, van de B.; Busscher, H.J.; Mei, van der H.C.; Norde, W.

    2007-01-01

    Antigen I/II can be found on streptococcal cell surfaces and is involved in their interaction with salivary proteins. In this paper, we determine the adsorption enthalpies of salivary proteins to Streptococcus mutans LT11 and S. mutans IB03987 with and without antigen I/II, respectively, using

  7. Calorimetric comparison of the interactions between salivary proteins and Streptococcus mutans with and without antigen I/II

    NARCIS (Netherlands)

    Xu, Chun-Ping; Belt-Gritter, van de Betsy; Busscher, Henk J.; van der Mei, Henny C.; Norde, Willem

    2007-01-01

    Antigen I/II can be found on streptococcal cell surfaces and is involved in their interaction with salivary proteins. In this paper, we determine the adsorption enthalpies of salivary proteins to Streptococcus mutans LT 11 and S. mutans IB03987 with and without antigen I/II, respectively, using

  8. Comparison of GC stationary phases for the separation of fatty acid methyl esters in biodiesel fuels.

    Science.gov (United States)

    Goding, Julian C; Ragon, Dorisanne Y; O'Connor, Jack B; Boehm, Sarah J; Hupp, Amber M

    2013-07-01

    The fatty acid methyl ester (FAME) content of biodiesel fuels has traditionally been determined using gas chromatography with a polar stationary phase. In this study, a direct comparison of the separation of FAMEs present in various biodiesel samples on three polar stationary phases and one moderately polar stationary phase (with comparable column dimensions) was performed. Retention on each column was based on solubility in and polarity of the phase. Quantitative metrics describing the resolution of important FAME pairs indicate high resolution on all polar columns, yet the best resolution, particularly of geometric isomers, is achieved on the cyanopropyl column. In addition, the separation of four C18 monounsaturated isomers was optimized and the elution order determined on each column. FAME composition of various biodiesel fuel types was determined on each column to illustrate (1) chemical differences in biodiesels produced from different feedstocks and (2) chemical similarities in biodiesels of the same feedstock type produced in different locations and harvest seasons.

  9. Interlaboratory comparison exercise for the determination of uranium by potentiometric titration (first phase)

    International Nuclear Information System (INIS)

    Verdingh, V.; Le Duigou, Y.

    1991-01-01

    Upon request of the Esarda working group on low-enriched uranium conversion and fuel fabrication plants an interlaboratory comparison was organized, to assess the precision and accuracy concerning the determination of uranium by the potentiometric titration method. This report presents the results of the first phase of this exercise (pure uranyl-nitrate solutions). The solutions used in this intercomparison have been certified for their uranium content by the CBNM, Geel. Comparison of the laboratory results with the certified values shows excellent, good and fairly good agreement for many of the participating laboratories. 10 tabs., 5 figs., 10 refs

  10. Interfacial Area and Interfacial Transfer in Two-Phase Flow Systems (Volume III. Chapters 11-14)

    Energy Technology Data Exchange (ETDEWEB)

    Guo, T.; Park, J.; Kojasoy, G.

    2003-03-15

    Experiments were performed on horizontal air-water bubbly two-phase flow, axial flow, stratified wavy flow, and annular flow. Theoretical studies were also undertaken on interfacial parameters for a horizontal two-phase flow.

  11. A novel solid phase extraction procedure on Amberlite XAD-1180 for speciation of Cr(III), Cr(VI) and total chromium in environmental and pharmaceutical samples

    International Nuclear Information System (INIS)

    Narin, Ibrahim; Kars, Ayse; Soylak, Mustafa

    2008-01-01

    Due to the toxicity of chromium, species depend on their chemical properties and bioavailabilities, speciation of chromium is very important in environmental samples. A speciation procedure for chromium(III), chromium(VI) and total chromium in environmental samples is presented in this work, prior to flame atomic absorption spectrometric determination of chromium. The procedure is based on the adsorption of Cr(III)-diphenylcarbazone complex on Amberlite XAD-1180 resin. After oxidation of Cr(III), the developed solid phase extraction system was applied to determinate the total chromium. Cr(III) was calculated as the difference between the total Cr content and the Cr(VI) content. The analytical conditions for the quantitative recoveries of Cr(VI) on Amberlite XAD-1180 resin were investigated. The effects of some alkaline, earth alkaline, metal ions and also some anions were also examined. Preconcentration factor was found to be 75. The detection limits (LOD) based on three times sigma of the blank (N: 21) for Cr(VI) and total chromium were 7.7 and 8.6 μg/L, respectively. Satisfactory results for the analysis of total chromium in the stream sediment (GBW7310) certified reference material for the validation of the presented method was obtained. The procedure was applied to food, water and pharmaceutical samples successfully

  12. Phase-coherent transport and spin-orbit-coupling in III/V-semiconductor nanowires; Phasenkohaerenter Transport und Spin-Bahn-Wechselwirkung in III/V-Halbleiternanodraehten

    Energy Technology Data Exchange (ETDEWEB)

    Estevez Hernandez, Sergio

    2009-10-16

    Semiconductor nanowires fabricated by a bottom-up approach are not only interesting for the realization of future nanoscaled devices but also appear to be very attractive model systems to tackle fundamental questions concerning the transport in strongly confined systems. In order to avoid the problem connected with carrier depletion, narrowband gap semiconductors, i.e., InAs or InN, or core-shell Nanowires, i.e., GaAs/AlGaAs, are preferred. The underlying reason is that in InAs or InN the Fermi-level pinning in the conduction band results in a carrier accumulation at the surface. In fact, the tubular topology of the surface electron gas opens up the possibility to observe unconventional quantum transport phenomena. When the phase-coherence length in the nanowire is comparable to its dimensions the conductance fluctuates if a magnetic field is applied or if the electron concentration is changed by means of a gate electrode. These so-called universal conductance fluctuations being in the order of e{sup 2}/h originate from the fact that in small disordered samples, electron interference effects are not averaged out. In this work are analyzed universal conductance fluctuations to study the quantum transport properties in InN, InAs and GaAs/AlGaAs nanowires. With the use of a magnetic field and a back-gate electrode the universal conductance fluctuations and localizations effects were analyzed. Since InN and InAs are narrow band gap semiconductors, one naturally expects spin-orbit coupling effects. Because this phenomena is of importance for spin electronic applications. However, owing to the cylindrical symmetry of the InN and InAs nanowires, the latter effect was observable and actually be used to determine the strength of spin-orbit coupling. In order to clearly separate the weak antilocalization effect from the conductance fluctuations, the averaging of the magnetoconductance at different gate voltages was essential. The low-temperature quantum transport properties

  13. Differences and Comparisons of the Properties and Reactivities of Iron(III)–hydroperoxo Complexes with Saturated Coordination Sphere

    Science.gov (United States)

    Faponle, Abayomi S; Quesne, Matthew G; Sastri, Chivukula V; Banse, Frédéric; de Visser, Sam P

    2015-01-01

    Heme and nonheme monoxygenases and dioxygenases catalyze important oxygen atom transfer reactions to substrates in the body. It is now well established that the cytochrome P450 enzymes react through the formation of a high-valent iron(IV)–oxo heme cation radical. Its precursor in the catalytic cycle, the iron(III)–hydroperoxo complex, was tested for catalytic activity and found to be a sluggish oxidant of hydroxylation, epoxidation and sulfoxidation reactions. In a recent twist of events, evidence has emerged of several nonheme iron(III)–hydroperoxo complexes that appear to react with substrates via oxygen atom transfer processes. Although it was not clear from these studies whether the iron(III)–hydroperoxo reacted directly with substrates or that an initial O–O bond cleavage preceded the reaction. Clearly, the catalytic activity of heme and nonheme iron(III)–hydroperoxo complexes is substantially different, but the origins of this are still poorly understood and warrant a detailed analysis. In this work, an extensive computational analysis of aromatic hydroxylation by biomimetic nonheme and heme iron systems is presented, starting from an iron(III)–hydroperoxo complex with pentadentate ligand system (L52). Direct C–O bond formation by an iron(III)–hydroperoxo complex is investigated, as well as the initial heterolytic and homolytic bond cleavage of the hydroperoxo group. The calculations show that [(L52)FeIII(OOH)]2+ should be able to initiate an aromatic hydroxylation process, although a low-energy homolytic cleavage pathway is only slightly higher in energy. A detailed valence bond and thermochemical analysis rationalizes the differences in chemical reactivity of heme and nonheme iron(III)–hydroperoxo and show that the main reason for this particular nonheme complex to be reactive comes from the fact that they homolytically split the O–O bond, whereas a heterolytic O–O bond breaking in heme iron(III)–hydroperoxo is found. PMID:25399782

  14. Recovery of Unrelated Donors of Peripheral Blood Stem Cells versus Bone Marrow: A Prespecified Analysis from the Phase III BMT CTN Protocol 0201

    Science.gov (United States)

    Burns, Linda J.; Logan, Brent R.; Chitphakdithai, Pintip; Miller, John P.; Drexler, Rebecca; Spellman, Stephen; Switzer, Galen E.; Wingard, John R.; Anasetti, Claudio; Confer, Dennis L.

    2016-01-01

    We report a comparison of time to recovery, side effects, and change in blood counts from baseline to post-donation of unrelated donors who participated in the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) phase III randomized, multicenter trial (0201) in which donor/recipient pairs were randomized to either peripheral blood stem cell (PBSC) or bone marrow (BM) donation. Of the entire cohort, 262 donated PBSC and 264 donated BM; 372 (71%) donors were from domestic and 154 (29%) from international centers (145 German and 9 Canadian). PBSC donors recovered in less time with a median time to recovery of 1 week compared to 2.3 weeks for BM donors. The number of donors reporting full recovery was significantly greater for donors of PBSC than of BM at 1, 2, and 3 weeks and 3 months post-donation. Multivariate analysis showed that PBSC donors were more likely to recover at any time post donation compared to BM donors (HR 2.08 [95% CI 1.73–2.50], pdonor and donation in more recent years. Donors of BM were more likely to report grade 2–4 skeletal pain, body symptoms and fatigue at 1 week post donation. In logistic regression analysis of domestic donors only in which toxicities at peri-collection time points (day 5 filgrastim for PBSC donors and day 2 post-collection of BM donors) could be analyzed, no variable was significantly associated with grade 2–4 skeletal pain, including product donated (BM vs PBSC, OR 1.13 [95% CI 0.74–1.74], p=0.556). Blood counts were impacted by product donated, with mean change from baseline to post-donation being greater for white blood cells, neutrophils, mononuclear cells and platelets in PBSC donors whereas BM donors experienced a greater mean change in hemoglobin. This analysis provided an enhanced understanding of donor events as product donated was independent of physician bias or donor preference. PMID:27013014

  15. Double-phase Tc-99m tetrofosmin parathyroid scan in hyperparathyroidism: comparison with ultrasonography

    International Nuclear Information System (INIS)

    Kim, In Soo; Kim, Sang Yoon; Zeon, Seok Kil; Won, Kyoung Sook

    2004-01-01

    This study was performed to evaluate the utility of double-phase Tc-99m Tetrofosmin(TF) parathyroid scan in the detection of pathologic lesions of primary hyperparathyroidism, and comparison with the ultrasonography(US). The double phase TF parathyroid scan of the anterior neck including upper mediastinum with 800 MBq TF were acquired at ten minutes (early phase) and at two hours (delayed phase) after radiopharmaceutical injection, in 24 consecutive patients under the clinical impression of primary hyperparathyroidism and hypercalcaemia. The images were evaluated for abnormal focal areas of increased tracer localization in the anterior neck and superior mediastinum in early phase, and visualization of parathyroid gland radioactivity after wash-out of the thyroid gland radioactivity in delayed phase. US of the anterior neck including upper mediastinum was performed by a diagnostic radiologist in 24 consecutive patients, within one week before or after the scan. The findings of double phase TF parathyroid scan and US were compared with the pathologic results. Ten of 24 patients were surgically explored and pathologic results showed eight adenomas and two hyperplasia. The double phase TF parathyroid scan showed positive findings in seven patients of eight adenomas and one patient of two hyperplasia patients. US image showed positive findings in six patients of eight adenomas and no positive findings of two hyperplasia. The sensitivity of the double phase TF scan for detection of the causes of the primary hyperparathyroidism was 80% and US was 60%. The double phase Tc-99m Tetrofosmin parathyroid scan showed higher sensitivity in detection of the pathologic lesions of primary hyperparathyroidism than ultrasonography

  16. The PACOVAR-trial: A phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer

    International Nuclear Information System (INIS)

    Eichbaum, Michael; Fersis, Nikos; Schmidt, Marcus; Wallwiener, Markus; Schneeweiss, Andreas; Sohn, Christof; Mayer, Christine; Eickhoff, Regina; Bischofs, Esther; Gebauer, Gerhard; Fehm, Tanja; Lenz, Florian; Fricke, Hans-Christian; Solomayer, Erich

    2011-01-01

    The prognosis of patients with recurrent, platinum-resistant epithelial ovarian cancer (EOC) is poor. There is no standard treatment available. Emerging evidence suggests a major role for antiangiogenic treatment modalities in EOC, in particular in combination with the metronomic application of low dose chemotherapy. The novel, investigational oral antiangiogenic agent pazopanib targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR) and c-kit is currently being studied in different tumour types and is already used as first line therapy in recurrent renal cell carcinoma. A combined therapy consisting of pazopanib and metronomic oral cyclophosphamide may offer a well-tolerable treatment option to patients with recurrent, pretreated EOC. This study is designed as a multicenter phase I/II trial evaluating the optimal dose for pazopanib (phase I) as well as activity and tolerability of a combination regimen consisting of pazopanib and metronomic cyclophosphamide in the palliative treatment of patients with recurrent, platinum-resistant, pre-treated ovarian cancer (phase II). The patient population includes patients with histologically or cytologically confirmed diagnosis of EOC, cancer of the fallopian tube or peritoneal cancer which is platinumresistant or -refractory. Patients must have measurable disease according to RECIST criteria and must have failed available standard chemotherapy. Primary objectives are determination of the optimal doses for pazopanib (phase I) and the overall response rate according to RECIST criteria (phase II). Secondary objectives are time to progression, overall survival, safety and tolerability. The treatment duration is until disease progression or intolerability of study drug regimen (with a maximum of 13 cycles up to 52 weeks per subject). The current phase I/II trial shall clarify the potential of the multitargeting antiangiogenic tyrosinkinaseinhibitor GW 786034 (pazopanib) in

  17. Technical Note: Validation of Odin/SMR limb observations of ozone, comparisons with OSIRIS, POAM III, ground-based and balloon-borne instruments

    Directory of Open Access Journals (Sweden)

    F. Jégou

    2008-06-01

    Full Text Available The Odin satellite carries two instruments capable of determining stratospheric ozone profiles by limb sounding: the Sub-Millimetre Radiometer (SMR and the UV-visible spectrograph of the OSIRIS (Optical Spectrograph and InfraRed Imager System instrument. A large number of ozone profiles measurements were performed during six years from November 2001 to present. This ozone dataset is here used to make quantitative comparisons with satellite measurements in order to assess the quality of the Odin/SMR ozone measurements. In a first step, we compare Swedish SMR retrievals version 2.1, French SMR ozone retrievals version 222 (both from the 501.8 GHz band, and the OSIRIS retrievals version 3.0, with the operational version 4.0 ozone product from POAM III (Polar Ozone Atmospheric Measurement. In a second step, we refine the Odin/SMR validation by comparisons with ground-based instruments and balloon-borne observations. We use observations carried out within the framework of the Network for Detection of Atmospheric Composition Change (NDACC and balloon flight missions conducted by the Canadian Space Agency (CSA, the Laboratoire de Physique et de Chimie de l'{}Environnement (LPCE, Orléans, France, and the Service d'Aéronomie (SA, Paris, France. Coincidence criteria were 5° in latitude×10° in longitude, and 5 h in time in Odin/POAM III comparisons, 12 h in Odin/NDACC comparisons, and 72 h in Odin/balloons comparisons. An agreement is found with the POAM III experiment (10–60 km within −0.3±0.2 ppmv (bias±standard deviation for SMR (v222, v2.1 and within −0.5±0.2 ppmv for OSIRIS (v3.0. Odin ozone mixing ratio products are systematically slightly lower than the POAM III data and show an ozone maximum lower by 1–5 km in altitude. The comparisons with the NDACC data (10–34 km for ozonesonde, 10–50 km for lidar, 10–60 for microwave instruments yield a good agreement within −0.15±0.3 ppmv for the SMR data and −0.3±0.3 ppmv

  18. Room temperature ionic liquids enhanced the speciation of Cr(VI) and Cr(III) by hollow fiber liquid phase microextraction combined with flame atomic absorption spectrometry

    International Nuclear Information System (INIS)

    Zeng, Chujie; Lin, Yao; Zhou, Neng; Zheng, Jiaoting; Zhang, Wei

    2012-01-01

    Highlights: ► First reported enhancement effect of RTILs in HF-LPME for the speciation of chromium. ► The addition of RTILs led to 3.5 times improvement of the sensitivity of Cr(VI). ► The proposed method is a simplicity, sensitivity, low cost, green method. - Abstract: A new method for the speciation of Cr(VI) and Cr(III) based on enhancement effect of room temperature ionic liquids (RTILs) for hollow fiber liquid phase microextraction (HF-LPME) combined with flame atomic absorption spectrometry (FAAS) was developed. Room temperature ionic liquids (RTILs) and diethyldithiocarbamate (DDTC) were used enhancement reagents and chelating reagent, respectively. The addition of room temperature ionic liquids led to 3.5 times improvement in the determination of Cr(VI). In this method, Cr(VI) reacts with DDTC yielding a hydrophobic complex, which is subsequently extracted into the lumen of hollow fiber, whereas Cr(III) is remained in aqueous solutions. The extraction organic phase was injected into FAAS for the determination of Cr(VI). Total Cr concentration was determined after oxidizing Cr(III) to Cr(VI) in the presence of KMnO 4 and using the extraction procedure mentioned above. Cr(III) was calculated by subtracting of Cr(VI) from the total Cr. Under optimized conditions, a detection limit of 0.7 ng mL −1 and an enrichment factor of 175 were achieved. The relative standard deviation (RSD) was 4.9% for Cr(VI) (40 ng mL −1 , n = 5). The proposed method was successfully applied to the speciation of chromium in natural water samples with satisfactory results.

  19. Room temperature ionic liquids enhanced the speciation of Cr(VI) and Cr(III) by hollow fiber liquid phase microextraction combined with flame atomic absorption spectrometry

    Energy Technology Data Exchange (ETDEWEB)

    Zeng, Chujie, E-mail: cjzeng@126.com [Department of Chemistry and Material, Yulin Normal College, Yulin, Guangxi 537000 (China); Lin, Yao; Zhou, Neng; Zheng, Jiaoting; Zhang, Wei [Department of Chemistry and Material, Yulin Normal College, Yulin, Guangxi 537000 (China)

    2012-10-30

    Highlights: Black-Right-Pointing-Pointer First reported enhancement effect of RTILs in HF-LPME for the speciation of chromium. Black-Right-Pointing-Pointer The addition of RTILs led to 3.5 times improvement of the sensitivity of Cr(VI). Black-Right-Pointing-Pointer The proposed method is a simplicity, sensitivity, low cost, green method. - Abstract: A new method for the speciation of Cr(VI) and Cr(III) based on enhancement effect of room temperature ionic liquids (RTILs) for hollow fiber liquid phase microextraction (HF-LPME) combined with flame atomic absorption spectrometry (FAAS) was developed. Room temperature ionic liquids (RTILs) and diethyldithiocarbamate (DDTC) were used enhancement reagents and chelating reagent, respectively. The addition of room temperature ionic liquids led to 3.5 times improvement in the determination of Cr(VI). In this method, Cr(VI) reacts with DDTC yielding a hydrophobic complex, which is subsequently extracted into the lumen of hollow fiber, whereas Cr(III) is remained in aqueous solutions. The extraction organic phase was injected into FAAS for the determination of Cr(VI). Total Cr concentration was determined after oxidizing Cr(III) to Cr(VI) in the presence of KMnO{sub 4} and using the extraction procedure mentioned above. Cr(III) was calculated by subtracting of Cr(VI) from the total Cr. Under optimized conditions, a detection limit of 0.7 ng mL{sup -1} and an enrichment factor of 175 were achieved. The relative standard deviation (RSD) was 4.9% for Cr(VI) (40 ng mL{sup -1}, n = 5). The proposed method was successfully applied to the speciation of chromium in natural water samples with satisfactory results.

  20. Adsorption of As(III), As(V) and Cu(II) on zirconium oxide immobilized alginate beads in aqueous phase.

    Science.gov (United States)

    Kwon, Oh-Hun; Kim, Jong-Oh; Cho, Dong-Wan; Kumar, Rahul; Baek, Seung Han; Kurade, Mayur B; Jeon, Byong-Hun

    2016-10-01

    A composite adsorbent to remove arsenite [As(III)], arsenate [As(V)], and copper [Cu(II)] from aqueous phase was synthesized by immobilizing zirconium oxide on alginate beads (ZOAB). The composition (wt%) of ZOAB (Zr-34.0; O-32.7; C-21.3; Ca-1.0) was confirmed by energy dispersive X-ray (EDX) analysis. Sorption studies were conducted on single and binary sorbate systems, and the effects of contact time, initial adsorbate concentration, and pH on the adsorption performance of ZOAB (pHPZC = 4.3) were monitored. The sorption process for As(III)/As(V) and Cu(II) reached an equilibrium state within 240 h and 24 h, respectively, with maximum sorption capacities of 32.3, 28.5, and 69.9 mg g(-1), respectively. The addition of Cu(II) was favorable for As(V) sorption in contrast to As(III). In the presence of 48.6 mg L(-1) Cu(II), the sorption capacity of As(V) increased from 1.5 to 3.8 mg g(-1) after 240 h. The sorption data for As(III)/As(V) and Cu(II) conformed the Freundlich and Langmuir isotherm models, respectively. The adsorption of As(III), As(V), and Cu(II) followed pseudo second order kinetics. The effect of arsenic species on Cu(II) sorption was insignificant. The results of present study demonstrated that the synthesized sorbent could be useful for the simultaneous removal of both anionic and cationic contaminants from wastewaters. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Frequency transfer via a two-way optical phase comparison on a multiplexed fiber network.

    Science.gov (United States)

    Calosso, C E; Bertacco, E; Calonico, D; Clivati, C; Costanzo, G A; Frittelli, M; Levi, F; Mura, A; Godone, A

    2014-03-01

    We performed a two-way remote optical phase comparison on optical fiber. Two optical frequency signals were launched in opposite directions in an optical fiber and their phases were simultaneously measured at the other end. In this technique, the fiber noise is passively canceled, and we compared two optical frequencies at the ultimate 10(-21) stability level. The experiment was performed on a 47 km fiber that is part of the metropolitan network for Internet traffic. The technique relies on the synchronous measurement of the optical phases at the two ends of the link, which is here performed by digital electronics. This scheme offers some advantages with respect to active noise cancellation schemes, as the light travels only once in the fiber.

  2. Comparison of nonpolar III-nitride vertical-cavity surface-emitting lasers with tunnel junction and ITO intracavity contacts

    KAUST Repository

    Leonard, J. T.

    2016-03-01

    We report on the lasing of III-nitride nonpolar, violet, vertical-cavity surface-emitting lasers (VCSELs) with III-nitride tunnel-junction (TJ) intracavity contacts and ion implanted apertures (IIAs). The TJ VCSELs are compared to similar VCSELs with tin-doped indium oxide (ITO) intracavity contacts. Prior to analyzing device results, we consider the relative advantages of III-nitride TJs for blue and green emitting VCSELs. The TJs are shown to be most advantageous for violet and UV VCSELs, operating near or above the absorption edge for ITO, as they significantly reduce the total internal loss in the cavity. However, for longer wavelength III-nitride VCSELs, TJs primarily offer the advantage of improved cavity design flexibility, allowing one to make the p-side thicker using a thick n-type III-nitride TJ intracavity contact. This offers improved lateral current spreading and lower loss, compare to using ITO and p-GaN, respectively. These aspects are particularly important for achieving high-power CW VCSELs, making TJs the ideal intracavity contact for any III-nitride VCSEL. A brief overview of III-nitride TJ growth methods is also given, highlighting the molecular-beam epitaxy (MBE) technique used here. Following this overview, we compare 12 mu m aperture diameter, violet emitting, TJ and ITO VCSEL experimental results, which demonstrate the significant improvement in differential efficiency and peak power resulting from the reduced loss in the TJ design. Specifically, the TJ VCSEL shows a peak power of similar to 550 mu W with a threshold current density of similar to 3.5 kA/cm(2), while the ITO VCSELs show peak powers of similar to 80 mu W and threshold current densities of similar to 7 kA/cm

  3. Comparison of nonpolar III-nitride vertical-cavity surface-emitting lasers with tunnel junction and ITO intracavity contacts

    KAUST Repository

    Leonard, J. T.; Young, E. C.; Yonkee, B. P.; Cohen, D. A.; Shen, Chao; Margalith, T.; Ng, Tien Khee; Denbaars, S. P.; Ooi, Boon S.; Speck, J. S.; Nakamura, S.

    2016-01-01

    We report on the lasing of III-nitride nonpolar, violet, vertical-cavity surface-emitting lasers (VCSELs) with III-nitride tunnel-junction (TJ) intracavity contacts and ion implanted apertures (IIAs). The TJ VCSELs are compared to similar VCSELs with tin-doped indium oxide (ITO) intracavity contacts. Prior to analyzing device results, we consider the relative advantages of III-nitride TJs for blue and green emitting VCSELs. The TJs are shown to be most advantageous for violet and UV VCSELs, operating near or above the absorption edge for ITO, as they significantly reduce the total internal loss in the cavity. However, for longer wavelength III-nitride VCSELs, TJs primarily offer the advantage of improved cavity design flexibility, allowing one to make the p-side thicker using a thick n-type III-nitride TJ intracavity contact. This offers improved lateral current spreading and lower loss, compare to using ITO and p-GaN, respectively. These aspects are particularly important for achieving high-power CW VCSELs, making TJs the ideal intracavity contact for any III-nitride VCSEL. A brief overview of III-nitride TJ growth methods is also given, highlighting the molecular-beam epitaxy (MBE) technique used here. Following this overview, we compare 12 mu m aperture diameter, violet emitting, TJ and ITO VCSEL experimental results, which demonstrate the significant improvement in differential efficiency and peak power resulting from the reduced loss in the TJ design. Specifically, the TJ VCSEL shows a peak power of similar to 550 mu W with a threshold current density of similar to 3.5 kA/cm(2), while the ITO VCSELs show peak powers of similar to 80 mu W and threshold current densities of similar to 7 kA/cm

  4. Magnetic solid-phase extraction combined with graphite furnace atomic absorption spectrometry for speciation of Cr(III) and Cr(VI) in environmental waters.

    Science.gov (United States)

    Jiang, Hong-mei; Yang, Ting; Wang, Yan-hong; Lian, Hong-zhen; Hu, Xin

    2013-11-15

    A new approach of magnetic solid phase extraction (MSPE) coupled with graphite furnace atomic absorption spectrometry (GFAAS) has been developed for the speciation of Cr(III) and Cr(VI) using zincon-immobilized silica-coated magnetic Fe3O4 nanoparticles (Zincon-Si-MNPs) as the MSPE absorbent. Cr(III) was quantitatively reserved on the absorbent at pH 9.1 while total Cr was reserved at pH 6.5. The absorbed Cr species were eluted by using 2 mol/L HCl and detected by GFAAS. The concentration of Cr(VI) could be calculated by subtracting Cr(III) from total Cr. All the parameters affecting the separation and extraction efficiency of Cr species such as pH, extraction time, concentration and volume of eluent, sample volume and influence of co-existing ions were systematically examined and the optimized conditions were established accordingly. The detection limit (LOD) of the method was 0.016 and 0.011 ng mL(-1) for Cr(III) and Cr(VI), respectively, with the enrichment factor of 100 and 150. The precisions of this method (Relative standard deviation, RSD, n=7) for Cr(III) and Cr(VI) at 0.1 ng mL(-1) were 6.0% and 6.2%, respectively. In order to validate the proposed method, a certified reference material of environmental water was analyzed, and the result of Cr speciation was in good agreement with the certified value. This MSPE-GFAAS method has been successfully applied for the speciation of Cr(III) and Cr(VI) in lake and tap waters with the recoveries of 88-109% for the spiked samples. Moreover, the MSPE separation mechanism of Cr(III) and Cr(VI) based on their adsorption-desorption on Zincon-Si-MNPs has been explained through various spectroscopic characterization. © 2013 Elsevier B.V. All rights reserved.

  5. Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

    Directory of Open Access Journals (Sweden)

    Tania Crucitti

    2010-10-01

    Full Text Available Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS [1].In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL, responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL.Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented.Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors

  6. Alterations in the Rate of Limb Movement Using a Lower Body Positive Pressure Treadmill Do Not Influence Respiratory Rate or Phase III Ventilation

    OpenAIRE

    Michael J. Buono; Marissa Burnsed-Torres; Bethany Hess; Kristine Lopez; Catherine Ortiz; Ariel Girodo; Karen Lolli; Brett Bloom; David Bailey; Fred W. Kolkhorst

    2015-01-01

    The purpose of this study was to determine the effect of alterations in rate of limb movement on Phase III ventilation during exercise, independent of metabolic rate, gait style, and treadmill incline. Subjects completed five submaximal exercise bouts on a lower body positive pressure treadmill (AlterG P 200). The percent body weight for the five exercise bouts was 100, 87, 75, 63, and 50% and each was matched for carbon dioxide production (V CO2 ). Naturally, to match the V CO2 while reducin...

  7. Parameters for calculation of nuclear reactions of relevance to non-energy nuclear applications (Reference Input Parameter Library: Phase III). Summary report of the first research coordination meeting

    International Nuclear Information System (INIS)

    Capote Noy, R.

    2004-08-01

    A summary is given of the First Research Coordination Meeting on Parameters for Calculation of Nuclear Reactions of Relevance to Non-Energy Nuclear Applications (Reference Input Parameter Library: Phase III), including a critical review of the RIPL-2 file. The new library should serve as input for theoretical calculations of nuclear reaction data at incident energies up to 200 MeV, as needed for energy and non-energy modern applications of nuclear data. Technical discussions and the resulting work plan of the Coordinated Research Programme are summarized, along with actions and deadlines. Participants' contributions to the RCM are also attached. (author)

  8. International key comparison of measurements of neutron source emission rate (1999-2005): CCRI(III)-K9.AmBe

    Energy Technology Data Exchange (ETDEWEB)

    Roberts, N.J.; Jones, L.N. [National Physical Laboratory (NPL), Teddington, (United Kingdom); Wang, Z.; Liu, Y.; Wang, Q.; Chen, X.; Luo, H.; Rong, C. [China Institute of Atomic Energy (CIAE), Beijing (China); Kralik, M. [Czech Metrology Institute (CMI), Praha, (Czech Republic); Park, H.; Choi, K.O. [Korea Research Institute of Standards and Science (KRISS), Daejeon, (Korea, Republic of); Pereira, W.W.; Da Fonseca, E.S. [National Laboratory of Metrology of Ionizing Radiation (LNMRI), Rio de Janeiro, (Brazil); Cassette, P. [Laboratoire National Henri Becquerel (LNE-LNHB), Paris, (France); Dewey, M.S. [National Institute of Standards and Technology (NIST), Gaithersburg, MD, (United States); Moiseev, N.N.; Kharitonov, I.A. [D I Mendeleyev Institute for Metrology (VNIIM), St Petersburg, (Russian Federation)

    2011-07-01

    Section III (neutron measurements) of the Comite Consultatif des Rayonnements Ionisants, CCRI, conducted a key comparison of primary measurements of the neutron emission rate of an {sup 241}Am-Be({alpha},n) radionuclide source. A single {sup 241}Am-Be({alpha},n) source was circulated to all the participants between 1999 and 2005. Eight laboratories participated - the CIAE (China), CMI (Czech Republic), KRISS (Republic of Korea), LNMRI (Brazil), LNE-LNHB (France), NIST (USA), NPL (UK) and the VNIIM (Russian Federation) - with the NPL making their measurements at the start and repeating them near the end of the exercise to verify the stability of the source. Each laboratory reported the emission rate into 4{pi} sr together with a detailed uncertainty budget. All participants used the manganese bath technique, with the VNIIM also making measurements using an associated particle technique. The CMI, KRISS, VNIIM, and later the NPL, also measured the anisotropy of the source although this was not a formal part of the comparison. The first draft report was released in May 2006 and having been discussed and modified by the participants and subsequently reviewed by the CCRI(III), the present paper is now the final report of the comparison. (authors)

  9. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials.

    Science.gov (United States)

    Lodise, Thomas P; Anzueto, Antonio R; Weber, David J; Shorr, Andrew F; Yang, Min; Smith, Alexander; Zhao, Qi; Huang, Xingyue; File, Thomas M

    2015-02-01

    The primary driver of health care costs for patients with community-acquired pneumonia (CAP) is the hospital length of stay (LOS). Unfortunately, hospital LOS comparisons are difficult to make from phase III CAP trials because of their structured designs and prespecified treatment durations. However, an opportunity still exists to draw inferences about potential LOS differences between treatments through the use of surrogates for hospital discharge. The intent of this study was to quantify the time to a clinical response, a proxy for the time to discharge readiness, among hospitalized CAP patients who received either ceftaroline or ceftriaxone in two phase III CAP FOCUS clinical trials. On the basis of the Infectious Diseases Society of America and American Thoracic Society CAP management guidelines and recent FDA guidance documents for community-acquired bacterial pneumonia, a post hoc adjudication algorithm was constructed a priori to compare the time to a clinical response, a proxy for the time to discharge readiness, between patients who received ceftaroline or ceftriaxone. Overall, 1,116 patients (ceftaroline, n=562; ceftriaxone, n=554) from the pooled FOCUS trials met the selection criteria for this analysis. Kaplan-Meier analyses showed that ceftaroline was associated with a shorter time, measured in days, to meeting the clinical response criteria (P=0.03). Of the patients on ceftaroline, 61.0, 76.1, and 83.6% achieved a clinical response by days 3, 4, and 5, compared to 54.3, 69.8, and 79.3% of the ceftriaxone-treated patients. In the Cox regression, ceftaroline was associated with a shorter time to a clinical response (HR, 1.16, P=0.02). The methodology employed here provides a framework to draw comparative effectiveness inferences from phase III CAP efficacy trials. (The FOCUS trials whose data were analyzed in this study have been registered at ClinicalTrials.gov under registration no. NCT00621504 and NCT00509106.). Copyright © 2015, American Society

  10. Comparison of outcomes in patients with stage III versus limited stage IV non-small cell lung cancer

    International Nuclear Information System (INIS)

    Cheruvu, Praveena; Metcalfe, Su K; Metcalfe, Justin; Chen, Yuhchyau; Okunieff, Paul; Milano, Michael T

    2011-01-01

    Standard therapy for metastatic non small cell lung cancer (NSCLC) includes palliative systemic chemotherapy and/or radiotherapy. Recent studies of patients with limited metastases treated with curative-intent stereotactic body radiation therapy (SBRT) have shown encouraging survival. We hypothesized that patients treated with SBRT for limited metastases have comparable outcomes with those treated with curative-intent radiation for Stage III NSCLC. We retrospectively reviewed the records of NSCLC patients treated with curative-intent radiotherapy at the University of Rochester from 2000-2008. We identified 3 groups of patients with NSCLC: stage III, stage IV, and recurrent stage IV (initial stage I-II). All stage IV NSCLC patients treated with SBRT had ≤ 8 lesions. Of 146 patients, 88% had KPS ≥ 80%, 30% had > 5% weight loss, and 95% were smokers. The 5-year OS from date of NSCLC diagnosis for stage III, initial stage IV and recurrent stage IV was 7%, 14%, and 27% respectively. The 5-year OS from date of metastatic diagnosis was significantly (p < 0.00001) superior among those with limited metastases (≤ 8 lesions) versus stage III patients who developed extensive metastases not amenable to SBRT (14% vs. 0%). Stage IV NSCLC is a heterogeneous patient population, with a selected cohort apparently faring better than Stage III patients. Though patients with limited metastases are favorably selected by virtue of more indolent disease and/or less bulky disease burden, perhaps staging these patients differently is appropriate for prognostic and treatment characterization. Aggressive local therapy may be indicated in these patients, though prospective clinical studies are needed

  11. Comparison of VNEM to measured data from Ringhals unit 3. (Phase 3)

    International Nuclear Information System (INIS)

    Tsuiki, M.; Mullet, S.

    2011-01-01

    1. PWR. Comparisons have been made of a PWR core simulator CYGNUS with VNEM neutronics module to the measured data obtained from Ringhals unit 3 NPP through the cycle 1A (core average burnup = 0 through 10,507MWD/MT). The results can be summarized as: core eigenvalue = 0.99937 +/- 0.00086 before intermediate 5 months shutdown core eigenvalue = 0.99647 +/- 0.00029 after intermediate 5 months shutdown. The reason of core eigenvalue drop after the intermediate shutdown is estimated to be the build-up of fissile elements during the long shutdown. A calculation model to track some important isotopes in addition to Xe135 and Sm149 (these isotopes are tracked in the present version of CYGNUS) has to be implemented. As for the comparison of the neutron detector readings, the agreement was excellent throughout the cycle 1A as observed in Phase 1 and 2 (2008, 2009). The burnup tilt effect was not observed during the cycle 1A. The verification of the burnup tilt model of CYGNUS will be performed in the next phase of the project. 2. BWR. A preliminary 2D numerical benchmarking was performed for BWR cores. The problems were generated imitating the NEACRP MOX PWR 2D benchmark problems. The results of comparisons of VNEM to a reference transport code (FCM2D), based on the method of characteristics, were as good as those obtained in the case of PWR cores for similar benchmarking. (Author)

  12. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  13. Solution and gas phase evidence of anion binding through the secondary bonding interactions of a bidentate bis-antimony(iii) anion receptor.

    Science.gov (United States)

    Qiu, J; Song, B; Li, X; Cozzolino, A F

    2017-12-20

    The solution and gas phase halide binding to a bis-antimony(iii) anion receptor was studied. This new class of anion receptors utilizes the strong Sb-centered secondary bonding interactions (SBIs) that are formed opposite to the polar Sb-O primary bond. 1 H NMR titration data were fitted statistically to binding models and solution-phase binding energetics were extracted, while the formation of anion-to-receptor complexes was observed using ESI-MS. Density functional theory calculations suggest that their affinity towards binding halide anions is mitigated by the strong explicit solvation effect in DMSO, which gives insights into future designs that circumvent direct solvent binding and are anticipated to yield tighter and perhaps more selectivity in anion binding.

  14. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia.

    Science.gov (United States)

    Roboz, Gail J; Montesinos, Pau; Selleslag, Dominik; Wei, Andrew; Jang, Jun-Ho; Falantes, Jose; Voso, Maria T; Sayar, Hamid; Porkka, Kimmo; Marlton, Paula; Almeida, Antonio; Mohan, Sanjay; Ravandi, Farhad; Garcia-Manero, Guillermo; Skikne, Barry; Kantarjian, Hagop

    2016-02-01

    Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged ≥55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.

  15. Ammonia control in children with urea cycle disorders (UCDs); Phase 2 comparison of sodium phenylbutyrate and glycerol phenylbutyrate☆

    OpenAIRE

    Lichter-Konecki, Uta; Diaz, G.A.; Merritt, J.L.; Feigenbaum, A.; Jomphe, C.; Marier, J.F.; Beliveau, M.; Mauney, J.; Dickinson, K.; Martinez, A.; Mokhtarani, M.; Scharschmidt, B.; Rhead, W.

    2011-01-01

    Twenty four hour ammonia profiles and correlates of drug effect were examined in a phase 2 comparison of sodium phenylbutyrate (NaPBA) and glycerol phenylbutyrate (GPB or HPN-100), an investigational drug being developed for urea cycle disorders (UCDs).

  16. Comprehensive analysis of published phase I/II clinical trials between 1990-2010 in osteosarcoma and Ewing sarcoma confirms limited outcomes and need for translational investment

    Directory of Open Access Journals (Sweden)

    van Maldegem Annemiek M

    2012-01-01

    Full Text Available Abstract Background High grade primary bone sarcomas are rare cancers that affect mostly children and young adults. Osteosarcoma and Ewing sarcoma are the most common histological subtypes in this age group, with current multimodality treatment strategies achieving 55-70% overall survival. As there remains an urgent need to develop new therapeutic interventions, we have reviewed published phase I/II trials that have been reported for osteosarcoma and Ewing sarcoma in the last twenty years. Results We conducted a literature search for clinical trials between 1990 and 2010, either for trials enrolling bone sarcoma patients as part of a general sarcoma indication or trials specifically in osteosarcoma and Ewing sarcoma. We identified 42 clinical trials that fulfilled our search criteria for general sarcoma that enrolled these patient groups, and eight and twenty specific trials for Ewing and osteosarcoma patients, respectively. For the phase I trials which enrolled different tumour types our results were incomplete, because the sarcoma patients were not mentioned in the PubMed abstract. A total of 3,736 sarcoma patients were included in these trials over this period, 1,114 for osteosarcoma and 1,263 for Ewing sarcoma. As a proportion of the worldwide disease burden over this period, these numbers reflect a very small percentage of the potential patient recruitment, approximately 0.6% for Ewing sarcoma and 0.2% for osteosarcoma. However, these data show an increase in recent activity overall and suggest there is still much room for improvement in the current trial development structures. Conclusion Lack of resources and commercial investment will inevitably limit opportunity to develop sufficiently rapid improvements in clinical outcomes. International collaboration exists in many well founded co-operative groups for phase III trials, but progress may be more effective if there were also more investment of molecular and translational research into

  17. Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

    Directory of Open Access Journals (Sweden)

    Brafman-Kennedy Barbara

    2011-05-01

    Full Text Available Abstract Background Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS seeks to improve the care of breathless patients with advanced disease (regardless of cause through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed. This paper presents the protocol for Phase III. Methods/Design Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks and one for patients with non-malignant disease (intervention delivered over four weeks. The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol and one for patients with non-malignant conditions (eight week protocol. Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only. The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10. The trial includes economic evaluation. Analysis will be on an intention to treat basis. Discussion This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast

  18. The structure of the blue luminescent delta-phase of tris(8-hydroxyquinoline)aluminium(III) (Alq3).

    Science.gov (United States)

    Cölle, Michael; Dinnebier, Robert E; Brütting, Wolfgang

    2002-12-07

    The existence of the facial isomer in the delta-phase of Alq3 is proven by X-ray structural analysis, revealing that both the different molecular structure and the weaker overlap of the pi-orbitals of hydroxyquinoline ligands belonging to neighboring Alq3 molecules as compared to other phases (alpha, beta) are likely to be the origin of the significantly different optical properties of delta-Alq3.

  19. Comparison between RELAP5 versions for a two-phase natural circulation analysis

    Energy Technology Data Exchange (ETDEWEB)

    Braz Filho, Francisco A.; Ribeiro, Guilherme B.; Sabundjian, Gaianê; Caldeira, Alexandre D., E-mail: fbraz@ieav.cta.br, E-mail: gbribeiro@ieav.cta.br, E-mail: alexdc@ieav.cta.br, E-mail: gdjian@ipen.br [Instituto de Estudos Avançados (IEAv), São José dos Campos, SP (Brazil). Div. de Energia Nuclear; Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2017-11-01

    RELAP5 is one of the most used numerical tools to predict thermal-hydraulic and neutronic phenomena in nuclear reactors. RELAP5-3D is the latest version of this software family, but RELAP5-mod3 is still widely used in Brazilian research institutes and it is also used as benchmark for several nuclear applications. Among these applications, the use of passive heat transfer mechanisms, such as natural circulation, has drawn attention of several studies, especially after the Fukushima-Daiichi accident. Considering this aforementioned aspect, this study proposes a comparison of RELAP5-3D and RELAP5-mod3 versions, focusing on a two-phase natural circulation loop. For comparison purposes, an experimental data set is part of the analysis. Results showed that during the single-phase regime, the temperature difference between versions is negligible. However, when the two-phase flow regime takes place, different wavelengths and amplitudes of flow instabilities were obtained for each version. When compared to the experimental data set, the RELAP5-3D version provided the best prediction results. (author)

  20. Determination of As(III) and total inorganic As in water samples using an on-line solid phase extraction and flow injection hydride generation atomic absorption spectrometry

    Energy Technology Data Exchange (ETDEWEB)

    Sigrist, Mirna, E-mail: msigrist@fiq.unl.edu.ar [Laboratorio Central, Facultad de Ingenieria Quimica, Universidad Nacional del Litoral, Santiago del Estero 2654-Piso 6, (3000) Santa Fe (Argentina); Albertengo, Antonela; Beldomenico, Horacio [Laboratorio Central, Facultad de Ingenieria Quimica, Universidad Nacional del Litoral, Santiago del Estero 2654-Piso 6, (3000) Santa Fe (Argentina); Tudino, Mabel [Laboratorio de Analisis de Trazas, Departamento de Quimica Inorganica, Analitica y Quimica Fisica/INQUIMAE, Facultad de Ciencias Exactas y Naturales, Pabellon II, Ciudad Universitaria (1428), Buenos Aires (Argentina)

    2011-04-15

    A simple and robust on-line sequential injection system based on solid phase extraction (SPE) coupled to a flow injection hydride generation atomic absorption spectrometer (FI-HGAAS) with a heated quartz tube atomizer (QTA) was developed and optimized for the determination of As(III) in groundwater without any kind of sample pretreatment. The method was based on the selective retention of inorganic As(V) that was carried out by passing the filtered original sample through a cartridge containing a chloride-form strong anion exchanger. Thus the most toxic form, inorganic As(III), was determined fast and directly by AsH{sub 3} generation using 3.5 mol L{sup -1} HCl as carrier solution and 0.35% (m/v) NaBH{sub 4} in 0.025% NaOH as the reductant. Since the uptake of As(V) should be interfered by several anions of natural occurrence in waters, the effect of Cl{sup -}, SO{sub 4}{sup 2-}, NO{sub 3}{sup -}, HPO{sub 4}{sup 2-}, HCO{sub 3}{sup -} on retention was evaluated and discussed. The total soluble inorganic arsenic concentration was determined on aliquots of filtered samples acidified with concentrated HCl and pre-reduced with 5% KI-5% C{sub 6}H{sub 8}O{sub 6} solution. The concentration of As(V) was calculated by difference between the total soluble inorganic arsenic and As(III) concentrations. Detection limits (LODs) of 0.5 {mu}g L{sup -1} and 0.6 {mu}g L{sup -1} for As(III) and inorganic total As, respectively, were obtained for a 500 {mu}L sample volume. The obtained limits of detection allowed testing the water quality according to the national and international regulations. The analytical recovery for water samples spiked with As(III) ranged between 98% and 106%. The sampling throughput for As(III) determination was 60 samples h{sup -1}. The device for groundwater sampling was especially designed for the authors. Metallic components were avoided and the contact between the sample and the atmospheric oxygen was carried to a minimum. On-field arsenic species

  1. Determination of As(III) and total inorganic As in water samples using an on-line solid phase extraction and flow injection hydride generation atomic absorption spectrometry

    International Nuclear Information System (INIS)

    Sigrist, Mirna; Albertengo, Antonela; Beldomenico, Horacio; Tudino, Mabel

    2011-01-01

    A simple and robust on-line sequential injection system based on solid phase extraction (SPE) coupled to a flow injection hydride generation atomic absorption spectrometer (FI-HGAAS) with a heated quartz tube atomizer (QTA) was developed and optimized for the determination of As(III) in groundwater without any kind of sample pretreatment. The method was based on the selective retention of inorganic As(V) that was carried out by passing the filtered original sample through a cartridge containing a chloride-form strong anion exchanger. Thus the most toxic form, inorganic As(III), was determined fast and directly by AsH 3 generation using 3.5 mol L -1 HCl as carrier solution and 0.35% (m/v) NaBH 4 in 0.025% NaOH as the reductant. Since the uptake of As(V) should be interfered by several anions of natural occurrence in waters, the effect of Cl - , SO 4 2- , NO 3 - , HPO 4 2- , HCO 3 - on retention was evaluated and discussed. The total soluble inorganic arsenic concentration was determined on aliquots of filtered samples acidified with concentrated HCl and pre-reduced with 5% KI-5% C 6 H 8 O 6 solution. The concentration of As(V) was calculated by difference between the total soluble inorganic arsenic and As(III) concentrations. Detection limits (LODs) of 0.5 μg L -1 and 0.6 μg L -1 for As(III) and inorganic total As, respectively, were obtained for a 500 μL sample volume. The obtained limits of detection allowed testing the water quality according to the national and international regulations. The analytical recovery for water samples spiked with As(III) ranged between 98% and 106%. The sampling throughput for As(III) determination was 60 samples h -1 . The device for groundwater sampling was especially designed for the authors. Metallic components were avoided and the contact between the sample and the atmospheric oxygen was carried to a minimum. On-field arsenic species separation was performed through the employ of a serial connection of membrane filters and

  2. Wave hindcast studies using SWAN nested in WAVEWATCH III - comparison with measured nearshore buoy data off Karwar, eastern Arabian Sea

    Digital Repository Service at National Institute of Oceanography (India)

    Amrutha, M.M.; SanilKumar, V.; Sandhya, K.G.; Nair, T.M.B; Rathod, J.L.

    Waves in the nearshore waters (~15 m water-depth) of eastern Arabian Sea were simulated using SWAN nested in WAVEWATCH III (WW3) for the year 2014. The sensitivity of the numerical wave model WW3 towards different source term (ST) packages...

  3. Flow injection microfluidic device with on-line fluorescent derivatization for the determination of Cr(III) and Cr(VI) in water samples after solid phase extraction

    Energy Technology Data Exchange (ETDEWEB)

    Peng, Guilong [Key Laboratory of Eco-Environment of Three Gorges Region of Ministry of Education, Chongqing University, Chongqing, 400045 (China); Department of Chemistry, Beijing Key Laboratory of Microanalytical Methods and Instrumentation, Tsinghua University, Beijing, 100084 (China); He, Qiang, E-mail: heqiang0980@163.com [Key Laboratory of Eco-Environment of Three Gorges Region of Ministry of Education, Chongqing University, Chongqing, 400045 (China); Lu, Ying [Department of Mathematics and Physics, Armed Police College, Chengdu, 610213 (China); Huang, Jing [Research Center for Advanced Computation, College of Science, Xihua University, Chengdu, 610039 (China); Lin, Jin-Ming, E-mail: jmlin@mail.tsinghua.edu.cn [Department of Chemistry, Beijing Key Laboratory of Microanalytical Methods and Instrumentation, Tsinghua University, Beijing, 100084 (China)

    2017-02-22

    In this paper, a rapid and simple method using magnetic multi-walled carbon nanotubes (MWCNTS), as a solid-phase extraction (SPE) sorbent, was successfully developed for extraction and preconcentration trace amounts of Cr(III) in water samples. The synthesized magnetic-MWCNTs nanocomposite was characterized by scanning electron microscopy (SEM), transmission electron microscopy (TEM), Fourier transform infrared spectroscopy (FT-IR), X-ray photoelectron spectroscopy (XPS) and X-ray diffraction (XRD). A rhodamine derivative (R1) was synthesized and characterized as a highly selective and sensitive fluorescent derivatizing agent for Cr(III). After SPE procedure, Cr(III) analysis was performed by flow injection microfluidic chip with on-line fluorescent derivatization and laser-induced fluorescence (LIF) spectroscopy detection. The parameters, which affected the efficiency of the developed method were investigated and optimized. Under the optimized conditions, the method exhibited a linear dynamic range of 0–10.0 nM, with a detection limit of 0.094 nM and an enrichment factor of 38. Furthermore, real water samples were analyzed and good recoveries were obtained from 91.0 to 101.6%. - Graphical abstract: Flow injection microfluidic device with on-line fluorescent derivatization and detection coupled to LIF. - Highlights: • A highly selective and sensitive derivatizing reagent for Cr(III) was synthesized and characterized. • The magnetic-MWCNTs nanocomposite as a SPE sorbent was successfully synthesized and characterized. • A new portable detection system was developed for microfluidic chip FIA platform.

  4. Alterations in the rate of limb movement using a lower body positive pressure treadmill do not influence respiratory rate or phase III ventilation.

    Science.gov (United States)

    Buono, Michael J; Burnsed-Torres, Marissa; Hess, Bethany; Lopez, Kristine; Ortiz, Catherine; Girodo, Ariel; Lolli, Karen; Bloom, Brett; Bailey, David; Kolkhorst, Fred W

    2015-01-01

    The purpose of this study was to determine the effect of alterations in rate of limb movement on Phase III ventilation during exercise, independent of metabolic rate, gait style, and treadmill incline. Subjects completed five submaximal exercise bouts on a lower body positive pressure treadmill (AlterG P 200). The percent body weight for the five exercise bouts was 100, 87, 75, 63, and 50% and each was matched for carbon dioxide production (V CO2 ). Naturally, to match the V CO2 while reducing the body weight up to 50% of normal required a significant increase in the treadmill speed from 3.0 ± 0.1 to 4.1 ± 0.2 mph, which resulted in a significant (P body weight) to 133 ± 6 at 4.1 mph (i.e., 50% of body weight). The most important finding was that significant increases in step frequency did not significantly alter minute ventilation or respiratory rate. Such results do not support an important role for the rate of limb movement in Phase III ventilation during submaximal exercise, when metabolic rate, gait style, and treadmill incline are controlled.

  5. Facilitating the implementation of the American College of Surgeons/Association of Program Directors in Surgery phase III skills curriculum: training faculty in the assessment of team skills.

    Science.gov (United States)

    Hull, Louise; Arora, Sonal; Stefanidis, Dimitrios; Sevdalis, Nick

    2015-11-01

    Effective teamwork is critical to safety in the operating room; however, implementation of phase III of the American College of Surgeons (ACS) and Association of Program Directors in Surgery (APDS) Curriculum that focuses on team-based skills remains worryingly low. Training and assessing the complexities of teamwork is challenging. The objective of this study was to establish guidelines and recommendations for training faculty in assessing/debriefing team skills. A multistage survey-based consensus study was completed by 108 experts responsible for training and assessing surgical residents from the ACS Accredited Educational Institutes. Experts agreed that a program to teach faculty to assess team-based skills should include training in the recognition of teamwork skills, practice rating these skills, and training in the provision of feedback/debriefing. Agreement was reached that faculty responsible for conducting team-based skills assessment should be revalidated every 2 years and stringent proficiency criteria should be met. Faculty development is critical to ensure high-quality, standardized training and assessment. Training faculty to assess team-based skills has the potential to facilitate the effective implementation of phase III of the ACS and APDS Curriculum. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Alterations in the Rate of Limb Movement Using a Lower Body Positive Pressure Treadmill Do Not Influence Respiratory Rate or Phase III Ventilation

    Directory of Open Access Journals (Sweden)

    Michael J. Buono

    2015-01-01

    Full Text Available The purpose of this study was to determine the effect of alterations in rate of limb movement on Phase III ventilation during exercise, independent of metabolic rate, gait style, and treadmill incline. Subjects completed five submaximal exercise bouts on a lower body positive pressure treadmill (AlterG P 200. The percent body weight for the five exercise bouts was 100, 87, 75, 63, and 50% and each was matched for carbon dioxide production (VCO2. Naturally, to match the VCO2 while reducing the body weight up to 50% of normal required a significant increase in the treadmill speed from 3.0±0.1 to 4.1±0.2 mph, which resulted in a significant (P<0.05 increase in the mean step frequency (steps per minute from 118±10 at 3 mph (i.e., 100% of body weight to 133±6 at 4.1 mph (i.e., 50% of body weight. The most important finding was that significant increases in step frequency did not significantly alter minute ventilation or respiratory rate. Such results do not support an important role for the rate of limb movement in Phase III ventilation during submaximal exercise, when metabolic rate, gait style, and treadmill incline are controlled.

  7. Simultaneous determination of Cr(iii) and Cr(vi) using reversed-phased ion-pairing liquid chromatography with dynamic reaction cell inductively coupled plasma mass spectrometry

    Science.gov (United States)

    Wolf, R.E.; Morrison, J.M.; Goldhaber, M.B.

    2007-01-01

    A method for the simultaneous determination of Cr(iii) and Cr(vi) species in waters, soil leachates and synthetic bio-fluids is described. The method uses reversed-phase ion-pairing liquid chromatography to separate the chromium species and a dynamic reaction cell (DRC??) equipped ICP-MS for detection of chromium. Separation of the chromium species is carried out in less than 2 min. Cr(iii) is complexed with ethylenediaminetetraacetic acid (EDTA) prior to separation by mixing samples with the mobile phase containing 2.0 mM tetrabutylammonium hydroxide (TBAOH), 0.5 mM EDTA (dipotassium salt), and 5% (vol/vol) methanol, adjusted to pH 7.6. The interfering 40Ar 12C+ background peak at mass 52 was reduced by over four orders of magnitude to less than 200 cps by using 0.65 mL min-1 ammonia as a reaction gas and an RPq setting on the DRC of 0.75. Method detection limits (MDLs) of 0.09 ??g L-1 for Cr(iii) and 0.06 ??g L-1 for Cr(vi) were obtained based on peak areas at mass 52 for 50 ??L injections of low level spikes. Reproducibility at 2 ??g L-1 was 3% RSD for 5 replicate injections. The tolerance of the method to various levels of common cations and anions found in natural waters and to matrix constituents found in soil leachates and simulated gastric and lung fluids was tested by performing spike recovery calculations for a variety of samples. ?? The Royal Society of Chemistry.

  8. Comparison of twin-fluid atomizers using a phase Doppler analyser

    Energy Technology Data Exchange (ETDEWEB)

    Zaremba, Matouš, E-mail: y116215@stud.fme.vutbr.cz, E-mail: y145527@stud.fme.vutbr.cz, E-mail: jedelsky@fme.vutbr.cz, E-mail: jicha@fme.vutbr.cz; Malý, Milan, E-mail: y116215@stud.fme.vutbr.cz, E-mail: y145527@stud.fme.vutbr.cz, E-mail: jedelsky@fme.vutbr.cz, E-mail: jicha@fme.vutbr.cz; Jedelský, Jan, E-mail: y116215@stud.fme.vutbr.cz, E-mail: y145527@stud.fme.vutbr.cz, E-mail: jedelsky@fme.vutbr.cz, E-mail: jicha@fme.vutbr.cz; Jícha, Miroslav, E-mail: y116215@stud.fme.vutbr.cz, E-mail: y145527@stud.fme.vutbr.cz, E-mail: jedelsky@fme.vutbr.cz, E-mail: jicha@fme.vutbr.cz [Brno University of technology, Technická 2896/2, 616 69 Brno (Czech Republic)

    2014-08-06

    The quality of atomization is crucial in combustion processes, especially in cases of highly viscous fuels. Twin-fluid atomizers have been developed for atomizing heavy and waste fuels and they have undergone significant development in the last decades. Nevertheless, in order to design an atomizer for a given industrial application, a comparison of different atomizers at similar operating conditions is required. This paper focuses on the description and comparison of two internally mixed twin-fluid atomizers at the same operating regime. The Y-jet and the Inverse-effervescent atomizers were examined. The phase-Doppler analyzer was used to measure the velocity and size of droplets in a radial profile in the spray. Data were sorted out into classes with respect to the droplet size and the motion analysis was done for both atomizers.

  9. Comparison of cardiovascular risk factors in maintenance hemodialysis patients based on phase angle of bioimpedance analysis

    Science.gov (United States)

    Muzasti, R. A.; Lubis, H. R.

    2018-03-01

    Mortality and morbidity rate, especially from cardiovascular disease in hemodialysis patients in Indonesia is still quite high. One of indicator to assess the predictive value of mortality is the phase angle (PhA) of bioimpedance analysis (BIA) scan examination. Determining the comparison of BMI and laboratory data as cardiovascular risk factors in hemodialysis patients based on PhA.A cross-sectional analytical study was done on 155 outpatientsin RasyidaRenal Hospital, Medan in 2016. Patients were two groups, namely PhAcardiovascular risk factors of hemodialysis patients were determined by age, BMI, and hemoglobin.

  10. A Phase I-II dose escalation study of fixed-dose rate gemcitabine, oxaliplatin and capecitabine every two weeks in advanced cholangiocarcinomas

    DEFF Research Database (Denmark)

    Lassen, Ulrik V; Jensen, Lars Henrik; Sorensen, Morten

    2011-01-01

    (O) and capecitabine (C), and evaluate the safety and efficacy of this regimen in patients with advanced cholangiocarcinoma (CC). Methods. In the Phase I part of the study a dose-escalation schedule of FDR G, O and C, administered every two weeks, was performed in patients with solid tumours...... and no other treatments or advanced CC. In the Phase II part response rate, toxicity, progression-free survival (PFS) and overall survival was evaluated in patients with newly diagnosed advanced CC. Results. Thirty-six patients entered the Phase I part and G 1 000 mg/m(2) day 1 and 15, O 60 mg/m(2) day 1...... and 15, and C 1 000 mg/m(2) BID day 1-7 and day 15-21 were established as MTD. In the Phase II part, 41 patients with advanced CC were included. Overall response rate was 34% and 51% had stable disease, resulting in a clinical benefit rate of 85%. Grade III and IV adverse events were rare. Median...

  11. Phase I/II study of azacitidine and capecitabine/oxaliplatin (CAPOX) in refractory CIMP-high metastatic colorectal cancer: evaluation of circulating methylated vimentin.

    Science.gov (United States)

    Overman, Michael J; Morris, Van; Moinova, Helen; Manyam, Ganiraju; Ensor, Joe; Lee, Michael S; Eng, Cathy; Kee, Bryan; Fogelman, David; Shroff, Rachna T; LaFramboise, Thomas; Mazard, Thibault; Feng, Tian; Hamilton, Stanley; Broom, Bradley; Lutterbaugh, James; Issa, Jean-Pierre; Markowitz, Sanford D; Kopetz, Scott

    2016-10-11

    Hypermethylation of promoter CpG islands (CIMP) has been strongly implicated in chemotherapy resistance and is implicated in the pathogenesis of a subset of colorectal cancers (CRCs) termed CIMP-high. This phase I/II study in CRC (phase II portion restricted to CIMP-high CRC), treated fluoropyrimidine/oxaliplatin refractory patients with azacitidine (75 mg/m2/day subcutaneously D1-5) and CAPOX (capecitibine and oxaliplatin) every three weeks. Twenty-six patients (pts) were enrolled in this study: 15 pts (12 treated at MTD) in phase I and 11 pts in phase II. No dose limiting toxicities were observed. A total of 14 pts were CIMP-high. No responses were seen. CIMP-high status did not correlate with efficacy endpoints [stable disease (SD) or progression-free survival (PFS)] or baseline vimentin methylation level. Changes in vimentin methylation over time did not correlate with efficacy outcomes. Baseline methylated vimentin correlated with tumor volume (PCIMP-high pts, but no objective responses. Serum methylated vimentin may be associated with benefit from a regimen including a hypomethylation agent, although this study is not able to separate a potential prognostic or predictive role for the biomarker.

  12. Experimental comparison of chiral metal-organic framework used as stationary phase in chromatography.

    Science.gov (United States)

    Xie, Sheng-Ming; Zhang, Mei; Fei, Zhi-Xin; Yuan, Li-Ming

    2014-10-10

    Chiral metal-organic frameworks (MOFs) are a new class of multifunctional material, which possess diverse structures and unusual properties such as high surface area, uniform and permanent cavities, as well as good chemical and thermal stability. Their chiral functionality makes them attractive as novel enantioselective adsorbents and stationary phases in separation science. In this paper, the experimental comparison of a chiral MOF [In₃O(obb)₃(HCO₂)(H₂O)] solvent used as a stationary phase was investigated in gas chromatography (GC), high-performance liquid chromatography (HPLC) and capillary electrochromatography (CEC). The potential relationship between the structure and components of chiral MOFs with their chiral recognition ability and selectivity are presented. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. Comparison of Concussion Rates Between NCAA Division I and Division III Men's and Women's Ice Hockey Players.

    Science.gov (United States)

    Rosene, John M; Raksnis, Bryan; Silva, Brie; Woefel, Tyler; Visich, Paul S; Dompier, Thomas P; Kerr, Zachary Y

    2017-09-01

    Examinations related to divisional differences in the incidence of sports-related concussions (SRC) in collegiate ice hockey are limited. To compare the epidemiologic patterns of concussion in National Collegiate Athletic Association (NCAA) ice hockey by sex and division. Descriptive epidemiology study. A convenience sample of men's and women's ice hockey teams in Divisions I and III provided SRC data via the NCAA Injury Surveillance Program during the 2009-2010 to 2014-2015 academic years. Concussion counts, rates, and distributions were examined by factors including injury activity and position. Injury rate ratios (IRRs) and injury proportion ratios (IPRs) with 95% confidence intervals (CIs) were used to compare concussion rates and distributions, respectively. Overall, 415 concussions were reported for men's and women's ice hockey combined. The highest concussion rate was found in Division I men (0.83 per 1000 athlete-exposures [AEs]), followed by Division III women (0.78/1000 AEs), Division I women (0.65/1000 AEs), and Division III men (0.64/1000 AEs). However, the only significant IRR was that the concussion rate was higher in Division I men than Division III men (IRR = 1.29; 95% CI, 1.02-1.65). The proportion of concussions from checking was higher in men than women (28.5% vs 9.4%; IPR = 3.02; 95% CI, 1.63-5.59); however, this proportion was higher in Division I women than Division III women (18.4% vs 1.8%; IPR = 10.47; 95% CI, 1.37-79.75). The proportion of concussions sustained by goalkeepers was higher in women than men (14.2% vs 2.9%; IPR = 4.86; 95% CI, 2.19-10.77), with findings consistent within each division. Concussion rates did not vary by sex but differed by division among men. Checking-related concussions were less common in women than men overall but more common in Division I women than Division III women. Findings highlight the need to better understand the reasons underlying divisional differences within men's and women's ice hockey and the

  14. The change in weight perception of weight status among the overweight: comparison of NHANES III (1988–1994 and 1999–2004 NHANES

    Directory of Open Access Journals (Sweden)

    Starke-Reed Pamela

    2008-02-01

    Full Text Available Abstract Objectives This study seeks to determine whether perception of weight status among the overweight has changed with the increasing overweight/obesity prevalence. Methods The perception of weight status was compared between overweight participants (BMI between 25.0–29.9 kg/m2 from NHANES III (1988–1994 and overweight participants from NHANES 1999–2004. Perception of weight status was assessed by asking participants to classify their weight as about the right weight, underweight or overweight. Comparisons were made across age groups, genders, race/ethnicities and various income levels. Results Fewer overweight people during the NHANES 1999–2004 survey perceived themselves as overweight when compared to overweight people during the NHANES III survey. The change in distortion between the survey periods was greatest among persons with lower income, males and African-Americans. Conclusion The increase in overweight/obesity between the survey years (NHANES III and NHANES 1999–2004 has been accompanied with fewer overweight people perceiving themselves as overweight.

  15. Comparison of solid and liquid-phase bioassays using ecoscores to assess contaminated soils

    Energy Technology Data Exchange (ETDEWEB)

    Lors, Christine [Universite Lille Nord de France, 1bis rue Georges Lefevre, 59044 Lille Cedex (France); Ecole des Mines de Douai, LGCgE-MPE-GCE, 941 rue Charles-Bourseul, 59500 Douai (France); Centre National de Recherche sur les Sites et Sols Pollues, 930 Boulevard Lahure, BP 537, 59505 Douai Cedex (France); Ponge, Jean-Francois, E-mail: ponge@mnhn.fr [Museum National d' Histoire Naturelle, Departement Ecologie et Gestion de la Biodiversite, CNRS UMR 7179, 4 Avenue du Petit-Chateau, 91800 Brunoy (France); Martinez Aldaya, Maite [Museum National d' Histoire Naturelle, Departement Ecologie et Gestion de la Biodiversite, CNRS UMR 7179, 4 Avenue du Petit-Chateau, 91800 Brunoy (France); Damidot, Denis [Universite Lille Nord de France, 1bis rue Georges Lefevre, 59044 Lille Cedex (France); Ecole des Mines de Douai, LGCgE-MPE-GCE, 941 rue Charles-Bourseul, 59500 Douai (France)

    2011-10-15

    Bioassays on aqueous and solid phases of contaminated soils were compared, belonging to a wide array of trophic and response levels and using ecoscores for evaluating ecotoxicological and genotoxicological endpoints. The method was applied to four coke factory soils contaminated mainly with PAHs, but also to a lesser extent by heavy metals and cyanides. Aquatic bioassays do not differ from terrestrial bioassays when scaling soils according to toxicity but they are complementary from the viewpoint of ecological relevance. Both aquatic and terrestrial endpoints are strongly correlated with concentrations of 3-ring PAHs. This evaluation procedure allows us to propose a cost-effective battery which embraces a wide array of test organisms and response levels: it includes two rapid bioassays (Microtox) and springtail avoidance), a micronucleus test and three bioassays of a longer duration (algal growth, lettuce germination and springtail reproduction). This battery can be recommended for a cost-effective assessment of polluted/remediated soils. - Highlights: > Comparison of liquid- and solid-phase bioassays on contaminated soils, using ecoscores. > Complementarity of liquid- and solid-phase bioassays for the evaluation of environmental hazards. > Proposal for a restricted battery of 5 most sensitive tests. > Use of this restricted battery for a cost-effective assessment of polluted/remediated soils. - Aqueous and solid phases of contaminated soils give similar results in terms of toxicity but are complementary for the evaluation of environmental hazards by ecoscores.

  16. Comparison of solid and liquid-phase bioassays using ecoscores to assess contaminated soils

    International Nuclear Information System (INIS)

    Lors, Christine; Ponge, Jean-Francois; Martinez Aldaya, Maite; Damidot, Denis

    2011-01-01

    Bioassays on aqueous and solid phases of contaminated soils were compared, belonging to a wide array of trophic and response levels and using ecoscores for evaluating ecotoxicological and genotoxicological endpoints. The method was applied to four coke factory soils contaminated mainly with PAHs, but also to a lesser extent by heavy metals and cyanides. Aquatic bioassays do not differ from terrestrial bioassays when scaling soils according to toxicity but they are complementary from the viewpoint of ecological relevance. Both aquatic and terrestrial endpoints are strongly correlated with concentrations of 3-ring PAHs. This evaluation procedure allows us to propose a cost-effective battery which embraces a wide array of test organisms and response levels: it includes two rapid bioassays (Microtox) and springtail avoidance), a micronucleus test and three bioassays of a longer duration (algal growth, lettuce germination and springtail reproduction). This battery can be recommended for a cost-effective assessment of polluted/remediated soils. - Highlights: → Comparison of liquid- and solid-phase bioassays on contaminated soils, using ecoscores. → Complementarity of liquid- and solid-phase bioassays for the evaluation of environmental hazards. → Proposal for a restricted battery of 5 most sensitive tests. → Use of this restricted battery for a cost-effective assessment of polluted/remediated soils. - Aqueous and solid phases of contaminated soils give similar results in terms of toxicity but are complementary for the evaluation of environmental hazards by ecoscores.

  17. Santé de l'écosystème urbain à Katmandou, au Népal - phase III ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Les deux phases antérieures de ce projet (nos 003320 et 101277) ont permis la création et le renforcement de 18 groupes locaux ainsi que l'élaboration d'une nouvelle loi sur ... Assistance in synthesis and documentation of health, environment and development outcomes in urban eco-health project, Katmandu : report.

  18. "Brief Report: Increase in Production of Spoken Words in Some Children with Autism after PECS Teaching to Phase III"

    Science.gov (United States)

    Carr, Deborah; Felce, Janet

    2007-01-01

    The context for this work was an evaluation study [Carr, D., & Felce, J. A. (in press)] of the early phases of the Picture Exchange Communication System (PECS) [Frost, L. A., & Bondy, A. S. (1994). "The picture exchange communication system training manual." Cherry Hill, NJ: Pyramid Educational Consultants, Inc.; Frost, L. A., & Bondy, A. S.…

  19. Comparison of incisor inclination in patients with Class III malocclusion treated with orthognathic surgery or orthodontic camouflage.

    Science.gov (United States)

    Troy, Beth A; Shanker, Shiva; Fields, Henry W; Vig, Katherine; Johnston, William

    2009-02-01

    Reports comparing Class III patients treated by camouflage and those treated by orthognathic surgery are not numerous. The purpose of this study was to compare the dental and skeletal values of Class III patients treated with these methods against normative data and over the course of treatment. Thirty-three surgical and 39 camouflage Class III patients were selected from a graduate orthodontic clinic and regional private practices, and lateral cephalograms were digitized. Skeletal and dental values were obtained, and mean and efficacy evaluations referenced to ethnic norms were calculated. At pretreatment, the surgery patients had more severe skeletal discrepancies and more compensated incisors. During presurgical orthodontic treatment, most of the surgery group's mandibular incisors were significantly decompensated, although half of the maxillary incisors remained compensated. The surgical move improved 90% of these patients but to only 60% to 65% of the norm. The camouflage group was compensated at pretreatment, and they became more compensated in the end. After treatment, there were no differences between the incisor positions of the 2 groups. There was no statistical difference in incisor inclination and position between the Class III surgical and camouflage groups after treatment; there was a significant difference in the pretreatment and posttreatment incisor inclination and position compared with normative values for both the surgical and the camouflage groups; the maxillary and mandibular incisors were not adequately decompensated in the surgical group, but significant improvement in mandibular incisor position and axial inclination was achieved presurgically. The outcome of the surgical correction was limited by the inadequate presurgical orthodontic incisor decompensation, and orthodontic compensation of incisors occurred postsurgically to achieve an optimal occlusal result.

  20. Surface decoration of amine-rich carbon nitride with iron nanoparticles for arsenite (As{sup III}) uptake: The evolution of the Fe-phases under ambient conditions

    Energy Technology Data Exchange (ETDEWEB)

    Georgiou, Y., E-mail: yiannisgeorgiou@hotmail.com [Physics Department, University of Ioannina, Ioannina 45110 (Greece); Mouzourakis, E., E-mail: emouzou@cc.uoi.gr [Physics Department, University of Ioannina, Ioannina 45110 (Greece); Bourlinos, A.B., E-mail: bourlino@cc.uoi.gr [Physics Department, University of Ioannina, Ioannina 45110 (Greece); Regional Centre of Advanced Technologies and Materials, Faculty of Science, Department of Physical Chemistry and Experimental Physics, Palacky University in Olomouc, 77146 (Czech Republic); Zboril, R., E-mail: radek.zboril@upol.cz [Regional Centre of Advanced Technologies and Materials, Faculty of Science, Department of Physical Chemistry and Experimental Physics, Palacky University in Olomouc, 77146 (Czech Republic); Karakassides, M.A., E-mail: mkarakas@cc.uoi.gr [Department of Materials Science and Engineering, University of Ioannina, Ioannina 45110 (Greece); Douvalis, A.P., E-mail: adouval@uoi.gr [Physics Department, University of Ioannina, Ioannina 45110 (Greece); Bakas, Th., E-mail: tbakas@cc.uoi.gr [Physics Department, University of Ioannina, Ioannina 45110 (Greece); Deligiannakis, Y., E-mail: ideligia@cc.uoi.gr [Physics Department, University of Ioannina, Ioannina 45110 (Greece)

    2016-07-15

    Highlights: • Novel hybrid based on carbon nitride and iron nanoparticles (gC{sub 3}N{sub 4}-rFe). • gC{sub 3}N{sub 4}-rFe superior As{sup III} sorbent(76.5 mg g{sup −1}). • Surface complexation modeling of As{sup III} adsorption. • Dual mode EPR,monitoring of Fe{sup 2+} and Fe{sup 3+} evolution. - Abstract: A novel hybrid material (gC{sub 3}N{sub 4}-rFe) consisting of amine-rich graphitic carbon nitride (gC{sub 3}N{sub 4}), decorated with reduced iron nanoparticles (rFe) is presented. XRD and TEM show that gC{sub 3}N{sub 4}-rFe bears aggregation-free Fe-nanoparticles (10 nm) uniformly dispersed over the gC{sub 3}N{sub 4} surface. In contrast, non-supported iron nanoparticles are strongly aggregated, with non-uniform size distribution (20–100 nm). {sup 57}Fe-Mössbauer spectroscopy, dual-mode electron paramagnetic resonance (EPR) and magnetization measurements, allow a detailed mapping of the evolution of the Fe-phases after exposure to ambient O{sub 2}. The as-prepared gC{sub 3}N{sub 4}-rFe bears Fe{sup 2+} and Fe° phases, however only after long exposure to ambient O{sub 2}, a Fe-oxide layer is formed around the Fe° core. In this [Fe°/Fe-oxide] core-shell configuration, the gC{sub 3}N{sub 4}-rFe hybrid shows enhanced As{sup III} uptake capacity of 76.5 mg g{sup −1}, i.e., ca 90% higher than the unmodified carbonaceous support, and 300% higher than the non-supported Fe-nanoparticles. gC{sub 3}N{sub 4}-rFe is a superior As{sup III} sorbent i.e., compared to its single counterparts or vs. graphite/graphite oxide or activated carbon analogues (11–36 mg g{sup −1}). The present results demonstrate that the gC{sub 3}N{sub 4} matrix is not simply a net that holds the particles, but rather an active component that determines particle formation dynamics and ultimately their redox profile, size and surface dispersion homogeneity.

  1. Comparison of Separation of Seed Oil Triglycerides Containing Isomeric Conjugated Octadecatrienoic Acid Moieties by Reversed-Phase HPLC

    OpenAIRE

    Anh Van Nguyen; Victor Deineka; Lumila Deineka; Anh Vu Thi Ngoc

    2017-01-01

    Relative retention analysis and increment approach were applied for the comparison of triglycerides (TGs) retention of a broad set of plant seed oils with isomeric conjugated octadecatrienoic acids (CLnA) by reversed-phase HPLC for “propanol-2-acetonitrile” mobile phases and Kromasil 100-5C18 stationary phase with diode array detection (DAD) and mass spectrometric (MS) detection. The subjects of investigation were TGs of seed oils: Calendula officinalis, Catalpa ovata, Jacaranda mimosifolia, ...

  2. Direct comparison of phase-sensitive vibrational sum frequency generation with maximum entropy method: case study of water.

    Science.gov (United States)

    de Beer, Alex G F; Samson, Jean-Sebastièn; Hua, Wei; Huang, Zishuai; Chen, Xiangke; Allen, Heather C; Roke, Sylvie

    2011-12-14

    We present a direct comparison of phase sensitive sum-frequency generation experiments with phase reconstruction obtained by the maximum entropy method. We show that both methods lead to the same complex spectrum. Furthermore, we discuss the strengths and weaknesses of each of these methods, analyzing possible sources of experimental and analytical errors. A simulation program for maximum entropy phase reconstruction is available at: http://lbp.epfl.ch/. © 2011 American Institute of Physics

  3. Santé de l'écosystème urbain à Katmandou, au Népal - phase III ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Les deux phases antérieures de ce projet (nos 003320 et 101277) ont permis la création et le renforcement de 18 groupes locaux ainsi que l'élaboration d'une nouvelle loi sur l'abattage des animaux et l'inspection des viandes, des amendements à la loi sur l'inspection des aliments et à la loi sur l'enlèvement des ordures ...

  4. Comparison between phase shift derived and exactly calculated nucleon--nucleon interaction matrix elements

    International Nuclear Information System (INIS)

    Gregersen, A.W.

    1977-01-01

    A comparison is made between matrix elements calculated using the uncoupled channel Sussex approach to second order in DWBA and matrix elements calculated using a square well potential. The square well potential illustrated the problem of the determining parameter independence balanced with the concept of phase shift difference. The super-soft core potential was used to discuss the systematics of the Sussex approach as a function of angular momentum as well as the relation between Sussex generated and effective interaction matrix elements. In the uncoupled channels the original Sussex method of extracting effective interaction matrix elements was found to be satisfactory. In the coupled channels emphasis was placed upon the 3 S 1 -- 3 D 1 coupled channel matrix elements. Comparison is made between exactly calculated matrix elements, and matrix elements derived using an extended formulation of the coupled channel Sussex method. For simplicity the potential used is a nonseparable cut-off oscillator. The eigenphases of this potential can be made to approximate the realistic nucleon--nucleon phase shifts at low energies. By using the cut-off oscillator test potential, the original coupled channel Sussex method of determining parameter independence was shown to be incapable of accurately reproducing the exact cut-off oscillator matrix elements. The extended Sussex method was found to be accurate to within 10 percent. The extended method is based upon more general coupled channel DWBA and a noninfinite oscillator wave function solution to the cut-off oscillator auxiliary potential. A comparison is made in the coupled channels between matrix elements generated using the original Sussex method and the extended method. Tables of matrix elements generated using the original uncoupled channel Sussex method and the extended coupled channel Sussex method are presented for all necessary angular momentum channels

  5. Microbial Mineral Transformations at the Fe(II)/Fe(III) Redox Boundary for Solid Phase Capture of Strontium and Other Metal/Radionuclide Contaminants

    International Nuclear Information System (INIS)

    Ferris, F.G.; Roden, E.E.

    2000-01-01

    The migration of 90 Sr in groundwater is a significant environmental concern at former nuclear weapons production sites in the US and abroad. Although retardation of 90 Sr transport relative to mean groundwater velocity is known to occur in contaminated aquifers, Sr 2+ does not sorb as strongly to iron oxides and other mineral phases as do other metal-radionuclides contaminants. Thus, some potential exists for extensive 90 Sr migration from sources of contamination. Chemical or biological processes capable of retarding or immobilizing Sr 2+ in groundwater environments are of interest from the standpoint of understanding controls on subsurface Sr 2+ migration. In addition, it may be possible to exploit such processes for remediation of subsurface Sr contamination. In this study the authors examined the potential for the solid phase sorption and incorporation of Sr 2+ into carbonate minerals formed during microbial Fe(III) oxide reduction as a first step toward evaluating whether this process could be used to promote retardation of 90 Sr migrations in anaerobic subsurface environments. The demonstration of Sr 2+ capture in carbonate mineral phases formed during bacterial HFO reduction and urea hydrolysis suggests that microbial carbonate mineral formation could contribute to Sr 2+ retardation in groundwater environments. This process may also provide a mechanism for subsurface remediation of Sr 2+ and other divalent metal contaminants that form insoluble carbonate precipitates

  6. Integrated Sensing & Controls for Coal Gasification - Development of Model-Based Controls for GE's Gasifier & Syngas Cooler. Topical Rerport for Phase III

    Energy Technology Data Exchange (ETDEWEB)

    Kumar, Aditya

    2011-02-17

    This Topical Report for the final Phase III of the program summarizes the results from the Task 3 of the program. In this task, the separately designed extended Kalman Filter (EKF) and model predictive controls (MPC) with ideal sensing, developed in Phase II, were integrated to achieve the overall sensing and control system for the gasification section of an IGCC plant. The EKF and MPC algorithms were updated and re-tuned to achieve closed-loop system stability as well as good steady-state and transient control response. In particular, the performance of the integrated EKF and MPC solution was tested extensively through multiple simulation studies to achieve improved steady-state as well as transient performance, with coal as well as coal-petcoke blended fuel, in the presence of unknown modeling errors as well as sensor errors (noise and bias). The simulation studies demonstrated significant improvements in steady state and transient operation performance, similar to that achieved by MPC with ideal sensors in Phase II of the program.

  7. A phase I/II exploratory clinical trial for intracordal injection of recombinant hepatocyte growth factor for vocal fold scar and sulcus.

    Science.gov (United States)

    Hirano, Shigeru; Kawamoto, Atsuhiko; Tateya, Ichiro; Mizuta, Masanobu; Kishimoto, Yo; Hiwatashi, Nao; Kawai, Yoshitaka; Tsuji, Takuya; Suzuki, Ryo; Kaneko, Mami; Naito, Yasushi; Kagimura, Tatsuo; Nakamura, Tatsuo; Kanemaru, Shin-Ichi

    2018-04-01

    Vocal fold scar and sulcus are intractable diseases with no effective established treatments. Hepatocyte growth factor (HGF) has preclinically proven to have potent antifibrotic and regenerative effects on vocal fold scar. The current Phase I/II clinical trial aims to examine the safety and effectiveness of intracordal injection of a recombinant human HGF drug for patients with vocal fold scar or sulcus. This is an open-label, dose-escalating, first-in-human clinical trial. Eighteen patients with bilateral vocal fold scar or sulcus were enrolled and divided into three groups: Step I received 1 μg of HGF per vocal fold; Step II received 3 μg of HGF; and Step III received 10 μg of HGF. Injections were administered once weekly for 4 weeks. The protocol treatment was performed starting with Step I and escalating to Step III. Patients were followed for 6 months post-treatment. Local and systemic safety aspects were examined as primary endpoints, and therapeutic effects were assessed as secondary endpoints using voice handicap index-10; maximum phonation time; vocal fold vibratory amplitude; grade, rough, breathy, asthenic, strained scale; and jitter. The results indicated no serious drug-related adverse events in either the systemic or local examinations. In whole-subject analysis, voice handicap index-10, vocal fold vibratory amplitude, and grade, rough, breathy, asthenic, strained scale were significantly improved at 6 months, whereas maximum phonation time and jitter varied. There were no significant differences in phonatory data between the step groups. In conclusion, intracordal injection of a recombinant human HGF drug was safe, feasible, and potentially effective for human patients with vocal fold scar or sulcus. Copyright © 2017 John Wiley & Sons, Ltd.

  8. COMPARISON OF A HEAD MOUNTED IMPACT MEASUREMENT DEVICE TO THE HYBRID III ANTHROPOMORPHIC TESTING DEVICE IN A CONTROLLED LABORATORY SETTING.

    Science.gov (United States)

    Schussler, Eric; Stark, David; Bolte, John H; Kang, Yun Seok; Onate, James A

    2017-08-01

    Reports estimate that 1.6 to 3.8 million cases of concussion occur in sports and recreation each year in the United States. Despite continued efforts to reduce the occurrence of concussion, the rate of diagnosis continues to increase. The mechanisms of concussion are thought to involve linear and rotational head accelerations and velocities. One method of quantifying the kinematics experienced during sport participation is to place measurement devices into the athlete's helmet or directly on the athlete's head. The purpose of this research to determine the accuracy of a head mounted device for measuring the head accelerations experienced by the wearer. This will be accomplished by identifying the error in Peak Linear Acceleration (PLA), Peak Rotational Acceleration (PRA) and Peak Rotational Velocity (PRV) of the device. Laboratory study. A helmeted Hybrid III 50th percentile male headform was impacted via a pneumatic ram from the front, side, rear, front oblique and rear oblique at speeds from 1.5 to 5 m/s. The X2 Biosystems xPatch® (Seattle, WA) sensor was placed on the headform's right side at the approximate location of the mastoid process. Measures of PLA, PRA, PRV from the xPatch ® and Hybrid III were analyzed for Root Mean Square Error (RMSE), and Absolute and Relative Error (AE, RE). Seventy-six impacts were analyzed. All measures of correlation, fixed through the origin, were found to be strong: PLA R 2 =0.967 pstandard yet above the average error of testing devices in both PLA and PRA, but a low error in PRV. PLA measures from the xPatch® system demonstrated a high level of correlation with the PLA data from the Hybrid III mounted data collection system. 3.

  9. GILT - A randomised phase III study of oral vinorelbine and cisplatin with concomitant radiotherapy followed by either consolidation therapy with oral vinorelbine and cisplatin or best supportive care alone in stage III non-small cell lung cancer

    Energy Technology Data Exchange (ETDEWEB)

    Flentje, Michael [University Hospital Wuerzburg, Dept. of Radiotherapy, Wuerzburg (Germany); Huber, Rudolf M. [University Hospital Munich, Member of the German Center for Lung Research (DZL CPC-M), Munich (Germany); Engel-Riedel, Walburga [University Hospital Merheim, Dept. of Pneumonology, Cologne (Germany); Andreas, Stefan [Dept. of Pneumonology, Immenhausen (Germany); Kollmeier, Jens [Helios Emil-von-Behring Hospital, Berlin (Germany); Staar, Susanne [Municipal Hospital Bremen-Mitte, Bremen (Germany); Dickgreber, Nicolas [University Hospital Hannover, Hannover (Germany); Vaissiere, Nathalie; Almeida, Cecilia de [Institut de Recherche Pierre Fabre, Boulogne (France); Edlich, Birgit [Pierre Fabre Pharma GmbH, Freiburg (Germany); Fietkau, Rainer [University Hospital Erlangen, Erlangen (Germany)

    2016-04-15

    Concurrent chemoradiotherapy (CRT) is considered standard for inoperable stage III non-small cell lung cancer (NSCLC). Consolidation chemotherapy (CC) following CRT is intended to further improve outcomes, yet studies have shown discordant results. This phase III study assessed CRT followed by best supportive care (BSC) or consolidation with oral vinorelbine and cisplatin. Patients received two cycles of oral vinorelbine (50 mg/m{sup 2} days 1, 8 and 15) + cisplatin (20 mg/m{sup 2} days 1-4) q4w + radiotherapy (RT; 66 Gy). Patients with at least stable disease (SD) were randomised to either two cycles oral vinorelbine (60-80 mg/m{sup 2} days 1 and 8) + cisplatin (80 mg/m{sup 2} day 1) q3w + BSC or BSC alone. Primary endpoint was progression-free survival (PFS). A total of 279 patients were enrolled for CRT and 201 patients were randomised to CC or BSC. Both CRT and CC were well tolerated, with limited radiation-mediated grade 3/4 toxicities (CRT/CC/BSC: oesophagitis-related events 12.9 %/3.1 %/0 %; grade 3 pneumonitis 0 %/0 %/2 %) and chemotherapy-mediated grade 3/4 toxicities (CRT/CC: neutropenia 11.2 %/22.1 %; leukopenia 18.3 %/26.7 %; grade 3 nausea 5.0 %/2.3 %, grade 3 vomiting 3.2 %/3.5 %). Median PFS from randomisation was 6.4 (5.0-8.7) and 5.5 (3.8-7.4) months in the CC and BSC arms (hazard ratio, HR = 0.93 [0.69-1.26]; p = 0.63), respectively; median overall survival (OS) 20.8 (13.5-25.3) and 18.5 (13.6-24.7) months, respectively. Consolidation chemotherapy after concurrent CRT did not prolong PFS or OS. Concurrent RT with oral vinorelbine and cisplatin demonstrated a favourable safety profile and represents a suitable treatment regimen for inoperable stage III NSCLC. (orig.) [German] Simultane Radiochemotherapie (CRT) wird als Standardtherapie beim inoperablen Stadium III des nicht-kleinzelligen Lungenkarzinoms (NSCLC) angesehen. Konsolidierende Chemotherapie (CC) nach der CRT zielt darauf ab, das Therapieergebnis zu verbessern, allerdings zeigen Studien

  10. Phase I-II study of lenalidomide and alemtuzumab in refractory chronic lymphocytic leukemia (CLL): effects on T cells and immune checkpoints.

    Science.gov (United States)

    Winqvist, Maria; Mozaffari, Fariba; Palma, Marzia; Eketorp Sylvan, Sandra; Hansson, Lotta; Mellstedt, Håkan; Österborg, Anders; Lundin, Jeanette

    2017-01-01

    This phase I-II study explored safety, immunomodulatory and clinical effects of lenalidomide (weeks 1-16) and alemtuzumab (weeks 5-16) in 23 patients with refractory chronic lymphocytic leukemia. Most patients had Rai stage III/IV disease and were heavily pretreated (median 4 prior therapies), and 61% had del(17p)/del(11q). Eleven of 19 evaluable patients (58%) responded, with a median response duration of 12 months (1-29+); time to progression was short in non-responders. Lenalidomide had a narrow therapeutic dose range, 2.5 mg/day was not efficient, and maximum tolerated dose was 5 mg/day. Grade 3-4 neutropenia and thrombocytopenia occurred in 84 and 55%, 30% had febrile neutropenia, and CMV-reactivation requiring valganciclovir occurred in 30% of patients. The frequency of proliferating (Ki67 + ) CD8 + T cells was increased at week 4, with further increase in both the CD4 + and CD8 + subsets (p cells increased at week 4 as the frequency of effector memory cells increased in the CD8 + subset (p cells decreased in both the CD8 + and CD4 + subsets (p regulatory T cells was reduced (p T cells decreased, and effector memory T cells increased (p T cells increased at 30-week follow-up (p T cells, including increased proliferative activity and cytotoxic potential.

  11. Novel corrosion experiments using the wire beam electrode: (III) Measuring electrochemical corrosion parameters from both the metallic and electrolytic phases

    International Nuclear Information System (INIS)

    Tan, Yong-Jun; Liu, Tie; Aung, Naing Naing

    2006-01-01

    The wire beam electrode (WBE) and the scanning reference electrode technique (SRET) have been applied in a novel combination to measure, for the first time, electrochemical parameters simultaneously from both the metallic and electrolytic phases of a corroding metal surface. The objective of this work is to demonstrate the application of this combined WBE-SRET method in obtaining unique information on localised corrosion mechanism, by investigating typical corrosion processes occurring over a mild steel WBE surface exposed to the classic Evans solution. The WBE method was used to map current and potential distributions in the metallic phase, and the SRET was used to map current or potential distribution in the electrolytic phase. It has been found that the combined WBE-SRET method is able to gain useful information on macro-cell electrochemical corrosion processes that involve macro-scale separation of anodes and cathodes. In such macro-cell corrosion systems, maps measured using WBE and SRET were found to correlate with each other and both methods were able to detect the locations of anodic sites. However the movement of the scanning probe during SRET measurements was found to affect the SRET detection of cathodic sites. In micro-cell corrosion systems where the separation of anodic and cathodic sites were less distinct, SRET measurement was found to be insensitive in detecting anodic and cathodic sites, while the WBE method was still able to produce results that correlated well with observed corrosion behaviour. Results obtained from this work suggest that the WBE-SRET method is applicable for understanding the initiation, propagation and electrochemical behaviour of localised corrosion anodes and cathodes, and also their dependence on externally controllable variables, such as solution pH changes and the existence of surface coatings

  12. On some derived compounds of fluorides of Cerium III or IV: defined compounds and non stoichiometric phases

    International Nuclear Information System (INIS)

    Besse, Jean-Pierre

    1968-01-01

    This research study addresses the study of rare earth fluorides. It reports the preparation and study of new fluoro-cerates (IV) in order to complete the set of already known compounds (ammonium fluoro-cerate, and alkaline earth compounds), the study of binary CeF 3 binary systems, monovalent and divalent fluorides, and CeF 3 -NF 2 -N'F ternary systems, and the study of non stoichiometric phases in CeF 3 oxides, sulphides and selenides [fr

  13. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations.

    LENUS (Irish Health Repository)

    Sequist, Lecia V

    2013-09-20

    The LUX-Lung 3 study investigated the efficacy of chemotherapy compared with afatinib, a selective, orally bioavailable ErbB family blocker that irreversibly blocks signaling from epidermal growth factor receptor (EGFR\\/ErbB1), human epidermal growth factor receptor 2 (HER2\\/ErbB2), and ErbB4 and has wide-spectrum preclinical activity against EGFR mutations. A phase II study of afatinib in EGFR mutation-positive lung adenocarcinoma demonstrated high response rates and progression-free survival (PFS).

  14. Crystal growth of pure substances: Phase-field simulations in comparison with analytical and experimental results

    Science.gov (United States)

    Nestler, B.; Danilov, D.; Galenko, P.

    2005-07-01

    A phase-field model for non-isothermal solidification in multicomponent systems [SIAM J. Appl. Math. 64 (3) (2004) 775-799] consistent with the formalism of classic irreversible thermodynamics is used for numerical simulations of crystal growth in a pure material. The relation of this approach to the phase-field model by Bragard et al. [Interface Science 10 (2-3) (2002) 121-136] is discussed. 2D and 3D simulations of dendritic structures are compared with the analytical predictions of the Brener theory [Journal of Crystal Growth 99 (1990) 165-170] and with recent experimental measurements of solidification in pure nickel [Proceedings of the TMS Annual Meeting, March 14-18, 2004, pp. 277-288; European Physical Journal B, submitted for publication]. 3D morphology transitions are obtained for variations in surface energy and kinetic anisotropies at different undercoolings. In computations, we investigate the convergence behaviour of a standard phase-field model and of its thin interface extension at different undercoolings and at different ratios between the diffuse interface thickness and the atomistic capillary length. The influence of the grid anisotropy is accurately analyzed for a finite difference method and for an adaptive finite element method in comparison.

  15. Comparison of measured and computed phase functions of individual tropospheric ice crystals

    International Nuclear Information System (INIS)

    Stegmann, Patrick G.; Tropea, Cameron; Järvinen, Emma; Schnaiter, Martin

    2016-01-01

    Airplanes passing the incuda (lat. anvils) regions of tropical cumulonimbi-clouds are at risk of suffering an engine power-loss event and engine damage due to ice ingestion (Mason et al., 2006 [1]). Research in this field relies on optical measurement methods to characterize ice crystals; however the design and implementation of such methods presently suffer from the lack of reliable and efficient means of predicting the light scattering from ice crystals. The nascent discipline of direct measurement of phase functions of ice crystals in conjunction with particle imaging and forward modelling through geometrical optics derivative- and Transition matrix-codes for the first time allow us to obtain a deeper understanding of the optical properties of real tropospheric ice crystals. In this manuscript, a sample phase function obtained via the Particle Habit Imaging and Polar Scattering (PHIPS) probe during a measurement campaign in flight over Brazil will be compared to three different light scattering codes. This includes a newly developed first order geometrical optics code taking into account the influence of the Gaussian beam illumination used in the PHIPS device, as well as the reference ray tracing code of Macke and the T-matrix code of Kahnert. - Highlights: • A GO code for shaped beams and non-spherical particles has been developed. • The code has been validated against exact Mie results. • Measured and computed phase functions for a single ice crystal have been compared. • The comparison highlights differences in the backscattering region.

  16. EXPERIMENTAL COMPARISON OF HOMODYNE DEMODULATION ALGORITHMS FOR PHASE FIBER-OPTIC SENSOR

    Directory of Open Access Journals (Sweden)

    M. N. Belikin

    2015-11-01

    Full Text Available Subject of Research. The paper presents the results of experimental comparative analysis of homodyne demodulation algorithms based on differential cross multiplying method and on arctangent method under the same conditions. The dependencies of parameters for the output signals on the optical radiation intensity are studied for the considered demodulation algorithms. Method. The prototype of single fiber optic phase interferometric sensor has been used for experimental comparison of signal demodulation algorithms. Main Results. We have found that homodyne demodulation based on arctangent method provides greater (by 7 dB at average signal-to-noise ratio of output signals over the frequency band of acoustic impact from 100 Hz to 500 Hz as compared to differential cross multiplying algorithms. We have demonstrated that no change in the output signal amplitude occurs for the studied range of values of the optical pulses amplitudes. Obtained results indicate that the homodyne demodulation based on arctangent method is most suitable for application in the phase fiber-optic sensors. It provides higher repeatability of their characteristics than the differential cross multiplying algorithm. Practical Significance. Algorithms of interferometric signals demodulation are widely used in phase fiber-optic sensors. Improvement of their characteristics has a positive effect on the performance of such sensors.

  17. Gemcitabine and paclitaxel associated pneumonitis in non-small cell lung cancer: report of a phase I/II dose-escalating study.

    Science.gov (United States)

    Thomas, A L; Cox, G; Sharma, R A; Steward, W P; Shields, F; Jeyapalan, K; Muller, S; O'Byrne, K J

    2000-12-01

    The aim of this phase I/II dose escalating study was to establish the maximum tolerated dose (MTD) of gemcitabine and paclitaxel given in combination in non-small cell lung cancer (NSCLC). 12 patients with stage IIIB and IV NSCLC received paclitaxel administered intravenously over 1 h followed by gemcitabine given over 30 min on days 1, 8 and 15 every 28 days. Pneumonitis was the principal side-effect observed with 4 patients affected. Of these, 1 experienced grade 3 toxicity after one cycle of treatment and the others had grade 2 toxicity. All 4 cases responded to prednisolone. No other significant toxicities were observed. Of the 8 evaluable patients, 3 had a partial response and 2 had minor responses. The study was discontinued due to this dose-limiting toxicity. The combination of paclitaxel and gemcitabine shows promising antitumour activity in NSCLC, however, this treatment schedule may predispose to pneumonitis.

  18. Phase III double-blind evaluation of an aloe vera gel as a prophylactic agent for radiation-induced skin toxicity

    International Nuclear Information System (INIS)

    Williams, Maureen S.; Burk, Mary; Loprinzi, Charles L.; Hill, Mary; Schomberg, Paula J.; Nearhood, Kim; O'Fallon, Judith R.; Laurie, John A.; Shanahan, Thomas G.; Moore, Randy L.; Urias, Rodolfo E.; Kuske, Robert R.; Engel, Roland E.; Eggleston, William D.

    1996-01-01

    Purpose: Considerable pilot data and clinical experience suggested that an aloe vera gel might help to prevent radiation therapy-induced dermatitis. Methods and Materials: Two Phase III randomized trials were conducted. The first one was double blinded, utilized a placebo gel, and involved 194 women receiving breast or chest wall irradiation. The second trial randomized 108 such patients to aloe vera gel vs. no treatment. Skin dermatitis was scored weekly during both trials both by patients and by health care providers. Results: Skin dermatitis scores were virtually identical on both treatment arms during both of the trials. The only toxicity from the gel was rare contact dermatitis. Conclusions: This dose and schedule of an aloe vera gel does not protect against radiation therapy-induced dermatitis

  19. Randomized phase III trial of concurrent chemoradiotherapy vs accelerated hyperfractionation radiotherapy in locally advanced head and neck cancer

    International Nuclear Information System (INIS)

    Chitapanarux, Imjai; Kamnerdsupaphon, Pimkhuan; Pukanhapan, Nantaka; Tharavichitkul, Ekkasit; Vongtama, Roy

    2013-01-01

    The aim of this study was to compare the efficacy and safety of concurrent chemoradiotherapy (CCRT) vs accelerated hyperfractionation with concomitant boost (CCB) as a primary treatment for patients with Stage III-IV squamous cell carcinoma of head and neck (SCCHN). A total of 85 non-metastatic advanced SCCHN patients were accrued from January 2003 to December 2007. Of these, 48 and 37 patients received CCRT and CCB, respectively. The patients were randomized to receive either three cycles of carboplatin and 5-fluorouracil plus conventional radiotherapy (CCRT, 66 Gy in 6.5 weeks) or hybrid accelerated radiotherapy (CCB, 70 Gy in 6 weeks). The primary endpoint was determined by locoregional control rate. The secondary endpoints were overall survival and toxicity. With a median follow-up of 43 months (range, 3-102), the 5-year locoregional control rate was 69.6% in the CCRT arm vs 55.0% in the CCB arm (P = 0.184). The 5-year overall survival rate was marginally significantly different (P = 0.05): 76.1% in the CCRT arm vs 63.5% in the CCB arm. Radiotherapy treatment interruptions of more than three days were 60.4% and 40.5% in the CCRT arm and CCB arm, respectively. The median total treatment time was 55.5 days in the CCRT arm and 49 days in the CCB arm. The rate of Grade 3 - 4 acute mucositis was significantly higher in the CCB arm (67.6% vs 41.7%, P = 0.01), but no high grade hematologic toxicities were found in the CCB arm (27.2% vs 0%). CCRT has shown a trend of improving outcome over CCB irradiation in locoregionally advanced head and neck cancer. (author)

  20. A Phase III placebo-controlled trial of oral pilocarpine in patients undergoing radiotherapy for head-and-neck cancer

    International Nuclear Information System (INIS)

    Warde, Padraig; O'Sullivan, Brian; Aslanidis, Julie; Kroll, Barbaranne; Lockwood, Gina; Waldron, John; Payne, David; Bayley, Andrew; Ringash, Jolie; Kim, John; Liu, F.-F.; Maxymiw, Walter; Sprague, Shelley; Cummings, Bernard J.

    2002-01-01

    Purpose: To test the hypothesis that the use of oral pilocarpine during and after radiotherapy (RT) for head-and-neck cancer would reduce the symptoms of post-RT xerostomia. Methods and Materials: One hundred thirty patients were randomized in a double-blind method to receive either pilocarpine (5-mg tablets) or placebo three times daily starting on Day 1 of RT and continuing for 1 month after treatment. The eligibility criteria included a planned dose of >50 Gy as radical or postoperative RT for head-and-neck cancer, with at least 50% of both parotid glands included in the treatment fields. The primary outcome measure was the severity of xerostomia as assessed by a patient-completed linear analog scale 3 months after RT. Secondary outcome measures included quality of life during therapy (as assessed by the McMaster University Head-and-Neck Questionnaire) and severity of mucositis during RT (as assessed using Radiation Therapy Oncology Group scales). Results: No difference was observed between the pilocarpine-treated patients and the placebo group in the severity of xerostomia score as assessed by linear analog scale at baseline and 1, 3, and 6 months after treatment (repeated measures analysis, p=0.92). No difference was apparent in the severity of mucositis during RT; 56.3% of patients receiving pilocarpine had Grade III/IV mucositis compared with 50.8% treated with placebo. No difference in quality of life was noted between the treatment groups during or after RT. The questionnaire score at 3 months after RT was 5.0 (SD 1.0). in the pilocarpine group and 4.9 (SD 0.9) in the placebo group. Conclusion: We were unable to detect a beneficial effect of pilocarpine on RT-induced xerostomia when administered during RT for head-and-neck cancer

  1. A phase III multicenter trail of radiosensitizing effect and safety of sodium glycididazole in thoracic esophageal squamous carcinoma

    International Nuclear Information System (INIS)

    Qin Shangbin; Wang Yadi; Yang Junquan; Wang Xiaohu; Li Haibin; Yang Zhiyong; Yu Hong; Li Xueying; Gao Xianshu

    2012-01-01

    Objective: To evaluate the efficacy and clinical safety glycididazole (CMNa) in thoracic esophageal squamous carcinoma. Methods: From June 1, 2008 to October 13, 2009, 66 pathologically proved thoracic esophageal squamous carcinoma (stage II a -III, stage IV with metastases only in supraclavicular lymph nodes, by AJCC 6 th ed) were randomized into radiotherapy plus CMNa (A) or radiotherapy plus placebo (B) group. Radiotherapy was given by conventional schedule: 1.8-2.0 Gy per fraction, 5 times per week to a total dose of 66 Gy/6.6-7.2 w. CMNa was given intravenously 800 mg/m 2 3 times a week in solution of 100 ml saline within 30 minutes. Radiotherapy was started 30-60 minutes after completion of infusion. Patients of Group B received placebo in saline solution. A total of 66 patients were enrolled (Group A: 32; Group B: 34), and four patients were unanalyzable, remaining 31 patients in each Group. Baseline factors were balanced. Results: Follow-up rate was 97%. Group A vs. Group B: the overall response rate was 93.5% vs. 67.7% (χ 2 =6.61, P=0.01), 2-year overall survival was 39.9% vs. 29.9% (χ 2 = 0.62, P=0.433), 2-year cancer specific survival was 43.1% vs. 26.8% (χ 2 = 0.30, P=0.878), and 2-year progression-free survival was 30.1% vs. 27.9% (χ 2 = 0.02, P=0.586). No severe side effects observed. All patients tolerated CMNa infusion well. Conclusions: CMNa is tolerable and effective as a hypoxic radiosensitizer, and its combination with radiotherapy can improve short term effect. However, survival is not improved within our follow-up period. (authors)

  2. Pharmacokinetic monitoring and dose modification of etanidazole in the RTOG 85-27 phase III head and neck trial

    International Nuclear Information System (INIS)

    Riese, Nancy E.; Buswell, Lori; Noll, Lisa; Pajak, Thomas F.; Stetz, JoAnn; Lee, D.J.; Coleman, C. Norman

    1997-01-01

    Purpose: To prospectively evaluate the pharmacokinetic monitoring and drug dose adjustment of Etanidazole (Eta) in patients treated on the RTOG randomized trial for Stage III and IV head and neck cancer. Methods and Materials: From June, 1986 to October, 1991, 521 patients were randomized to conventional RT alone or RT plus Eta. The primary goal was to determine whether the addition of Eta to conventional radiation therapy improves local-regional control and tumor-free survival. Of the 264 patients who received Eta, 233 had their drug exposure calculated and the Eta dose and schedule adjusted accordingly to prevent the occurrence of serious peripheral neuropathy. Drug exposure was assessed using the area under the curve (AUC) for a single treatment that was calculated by the integral over time of the serum concentration of Eta. The total drug exposure (total-AUC) was estimated by multiplying the AUC by the number of drug administrations. Results: Eighteen percent of patients developed Grade I and 6% developed Grade II peripheral neuropathy. There was no Grade 3 or 4 peripheral neuropathy. There is a trend for an increased risk of neuropathy by single dose AUC. The minimal difference in incidence of neuropathy by single-dose AUC was due to the use of dose and schedule modification for patients with the higher values. Conclusions: The pharmacokinetics investigated in this study confirm previous work that monitoring Eta levels, with dose adjustment, allows it to be used safely in the clinic. In a subset analysis there was a statistically significant improvement in local-regional control and survival rates for patients with N0 and N1 disease, that will require confirmation (14). However, the clinical efficacy of Eta in this trial proved to be of little overall benefit

  3. Comparison of the Tight Rope Technique and Clavicular Hook Plate for the Treatment of Rockwood Type III Acromioclavicular Joint Dislocation.

    Science.gov (United States)

    Cai, Leyi; Wang, Te; Lu, Di; Hu, Wei; Hong, Jianjun; Chen, Hua

    2018-06-01

    Acromioclavicular joint dislocation is one of the most common shoulder problems and may lead to instability or degenerative changes. The aim of this study was to compare the clinical outcomes of the Tight Rope system and clavicular hook plate for Rockwood type III acromioclavicular joint dislocation in adults. This was a prospective, randomized study in a hospital setting. From January 2012 to December 2014, 69 patients with type III injury were reviewed. Patients were randomly divided into two groups: Group A was treated using the TightRope system and Group B with the clavicular hook plate. All participants were followed up for 12 months. Clinical outcomes, radiological results and postoperative complications were recorded. The length of incision was significantly shorter in Goup A than that in Group B. The blood loss of surgery was significantly less in the Group A. Significant difference could be found between the two groups regarding the Visual Analogue Scale scores one day after surgery, at the 3 and 12 months follow-up. There were no differences according to the improvement of the Constant-Murley score and the coracoclavicular distance between the groups. The two groups have similar clinical and radiological outcomes. Both treatments could relieve the pain of dislocation, improve the function of Acromioclavicular joint and rectify the coracoclavicular distance measured in plain films. However, the TightRope system exhibited some advantages in terms of length of incision, blood loss of surgery, the pain postoperatively and no need for a second surgery.

  4. Comparison of Serum Autoantibodies to Desmogleins I, III in Patients with Oral Lichen Planus and Healthy Controls.

    Science.gov (United States)

    Gholizadeh, Narges; Khoini Poorfar, Hossein; TaghaviZenouz, Ali; Vatandoost, Masoumeh; Mehdipour, Masoumeh

    2015-01-01

    Lichen planus is a mucocutaneous disease which is relatively common and in 30-70% of patients, mucosal lesions can be seen and known as a precancerous lesion but its etiology is not completely understood. Desmogleins I and III are the main desmosomal transmembrane proteins. These proteins have been identified as the autoantigen of the autoimmune disease. The aim of this study was evaluation of serum autoantibodies against desmogleins Ι, ΙΙΙ in oral lichen planus . We attempted to determine the etiology of this disease with evaluation of these serum factors. Thirty-five patients with oral lichen planus and 35 healthy controls were recruited and tested for serum autoantibodies against desmogleins Ι, ΙΙΙ and indirect immunofluorescence also performed. Data were analyzed by statistical-analytical methods (Independent sample t -test) with using the SPSS.15 software. Serum autoantibody against desmoglein Ι had no significant difference in the two groups ( P =0.31 ) but significant increase in serum autoantibody to desmoglein ΙΙΙ was found in patients with oral lichen planus ( P =0.00) . It seems that autoantibody against desmoglein III has a significant role in the pathogenesis of oral lichen planus.

  5. Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine

    Directory of Open Access Journals (Sweden)

    Carter Terrell

    2011-08-01

    Full Text Available Abstract Background A pivotal phase III study of the RTS,S/AS01 malaria candidate vaccine is ongoing in several research centres across Africa. The development and establishment of quality systems was a requirement for trial conduct to meet international regulatory standards, as well as providing an important capacity strengthening opportunity for study centres. Methods Standardized laboratory methods and quality assurance processes were implemented at each of the study centres, facilitated by funding partners. Results A robust protocol for determination of parasite density based on actual blood cell counts was set up in accordance with World Health Organization recommendations. Automated equipment including haematology and biochemistry analyzers were put in place with standard methods for bedside testing of glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic microbiology testing were also provided or upgraded alongside health care infrastructure in some centres. External quality assurance assessment of all major laboratory methods was established and method qualification by each laboratory demonstrated. The resulting capacity strengthening has ensured laboratory evaluations are conducted locally to the high standards required in clinical trials. Conclusion Major efforts by study centres, together with support from collaborating parties, have allowed standardized methods and robust quality assurance processes to be put in place for the phase III evaluation of the RTS, S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with continuous commitment from research centre staff, have been the key elements behind the successful implementation of quality processes. It is expected these activities will culminate in healthcare benefits for the subjects and communities participating in these trials. Trial registration Clinicaltrials.gov NCT00866619

  6. Expression profiling of blood samples from an SU5416 Phase III metastatic colorectal cancer clinical trial: a novel strategy for biomarker identification

    Directory of Open Access Journals (Sweden)

    Smolich Beverly D

    2003-02-01

    Full Text Available Abstract Background Microarray-based gene expression profiling is a powerful approach for the identification of molecular biomarkers of disease, particularly in human cancers. Utility of this approach to measure responses to therapy is less well established, in part due to challenges in obtaining serial biopsies. Identification of suitable surrogate tissues will help minimize limitations imposed by those challenges. This study describes an approach used to identify gene expression changes that might serve as surrogate biomarkers of drug activity. Methods Expression profiling using microarrays was applied to peripheral blood mononuclear cell (PBMC samples obtained from patients with advanced colorectal cancer participating in a Phase III clinical trial. The PBMC samples were harvested pre-treatment and at the end of the first 6-week cycle from patients receiving standard of care chemotherapy or standard of care plus SU5416, a vascular endothelial growth factor (VEGF receptor tyrosine kinase (RTK inhibitor. Results from matched pairs of PBMC samples from 23 patients were queried for expression changes that consistently correlated with SU5416 administration. Results Thirteen transcripts met this selection criterion; six were further tested by quantitative RT-PCR analysis of 62 additional samples from this trial and a second SU5416 Phase III trial of similar design. This method confirmed four of these transcripts (CD24, lactoferrin, lipocalin 2, and MMP-9 as potential biomarkers of drug treatment. Discriminant analysis showed that expression profiles of these 4 transcripts could be used to classify patients by treatment arm in a predictive fashion. Conclusions These results establish a foundation for the further exploration of peripheral blood cells as a surrogate system for biomarker analyses in clinical oncology studies.

  7. Expression profiling of blood samples from an SU5416 Phase III metastatic colorectal cancer clinical trial: a novel strategy for biomarker identification

    International Nuclear Information System (INIS)

    DePrimo, Samuel E; Wong, Lily M; Khatry, Deepak B; Nicholas, Susan L; Manning, William C; Smolich, Beverly D; O'Farrell, Anne-Marie; Cherrington, Julie M

    2003-01-01

    Microarray-based gene expression profiling is a powerful approach for the identification of molecular biomarkers of disease, particularly in human cancers. Utility of this approach to measure responses to therapy is less well established, in part due to challenges in obtaining serial biopsies. Identification of suitable surrogate tissues will help minimize limitations imposed by those challenges. This study describes an approach used to identify gene expression changes that might serve as surrogate biomarkers of drug activity. Expression profiling using microarrays was applied to peripheral blood mononuclear cell (PBMC) samples obtained from patients with advanced colorectal cancer participating in a Phase III clinical trial. The PBMC samples were harvested pre-treatment and at the end of the first 6-week cycle from patients receiving standard of care chemotherapy or standard of care plus SU5416, a vascular endothelial growth factor (VEGF) receptor tyrosine kinase (RTK) inhibitor. Results from matched pairs of PBMC samples from 23 patients were queried for expression changes that consistently correlated with SU5416 administration. Thirteen transcripts met this selection criterion; six were further tested by quantitative RT-PCR analysis of 62 additional samples from this trial and a second SU5416 Phase III trial of similar design. This method confirmed four of these transcripts (CD24, lactoferrin, lipocalin 2, and MMP-9) as potential biomarkers of drug treatment. Discriminant analysis showed that expression profiles of these 4 transcripts could be used to classify patients by treatment arm in a predictive fashion. These results establish a foundation for the further exploration of peripheral blood cells as a surrogate system for biomarker analyses in clinical oncology studies

  8. The Value of Botox-A in Acute Radiation Proctitis: Results From a Phase I/II Study Using a Three-Dimensional Scoring System

    International Nuclear Information System (INIS)

    Vuong, Te; Waschke, Kevin; Niazi, Tamim; Richard, Carole; Parent, Josee; Liberman, Sender; Mayrand, Serge; Loungnarath, Rasmy; Stein, Barry; Devic, Slobodan

    2011-01-01

    Purpose: Acute radiation proctitis (ARP) is a common side effect of pelvic radiotherapy, and its management is challenging in daily practice. The present phase I/II study evaluates the safety and efficacy of the botulinum toxin A (BTX-A) in ARP treatment for rectal cancer patients undergoing neoadjuvant high-dose-rate endorectal brachytherapy (HDREBT). Methods and Materials: Fifteen patients, treated with neoadjuvant HDREBT, 26-Gy in 4 fractions, received the study treatment that consisted of a single injection of BTX-A into the rectal wall. The injection was performed post-HDREBT and prior to the development of ARP. The control group, 20 such patients, did not receive the BTX-A injection. Both groups had access to standard treatment with hydrocortisone rectal aerosol foam (Cortifoam) and anti-inflammatory and narcotic medication. The ARP was clinically evaluated by self-administered daily questionnaires using visual analog scores to document frequency and urgency of bowel movements, rectal burning/tenesmus, and pain symptoms before and after HDREBT. Results: At the time of this analysis, there was no observed systemic toxicity. Patient compliance with the self-administered questionnaire was 100% from week 1 to 4, 70% during week 5, and 40% during week 6. The maximum tolerated dose was established at the 100-U dose level, and noticeable mean differences were observed in bowel frequency (p = 0.016), urgency (p = 0.007), and pain (p = 0.078). Conclusions: This study confirms the feasibility and efficacy of BTX-A intervention at 100-U dose level for study patients compared to control patients. A phase III study with this dose level is planned to validate these results.

  9. DAPPA grafted polymer: an efficient solid phase extractant for U(VI), Th(IV) and La(III) from acidic waste streams and environmental samples.

    Science.gov (United States)

    Raju, Ch Siva Kesava; Subramanian, M S

    2005-07-15

    A new class of polymeric resin has been synthesized by grafting Merrifield chloromethylated resin with (dimethyl amino-phosphono-methyl)-phosphonic acid (MCM-DAPPA), for the preconcentration of U(VI), Th(IV) and La(III) from both acidic wastes and environmental samples. The various chemical modification steps involved during grafting process are characterized by FT-IR spectroscopy, (31)P and (13)C-CPMAS (cross-polarized magic angle spin) NMR spectroscopy and CHNS/O elemental analysis. The water regain capacity data for the grafted polymer are obtained from thermo-gravimetric (TG) analysis. The influence of various physico-chemical parameters during the quantitative extraction of metal ions by the resin phase are studied and optimized by both static and dynamic methods. The significant feature of this grafted polymer is its ability to extract both actinides and lanthanides from high-level acidities as well as from near neutral conditions. The resin shows very high sorption capacity values of 2.02, 0.89 and 0.54mmolg(-1) for U(VI), 1.98, 0.63 and 0.42mmolg(-1) for Th(IV) and 1.22, 0.39 and 0.39mmolg(-1) for La(III) under optimum pH, HNO(3) and HCl concentration, respectively. The grafted polymer shows faster phase exchange kinetics (99.5% recovery using 1M (NH(4))(2)CO(3), as eluent. The developed grafted resin has been successfully applied in extracting Th(IV) from high matrix monazite sand, U(VI) from sea water and also U(VI) and Th(IV) from simulated nuclear spent fuel mixtures. The analytical data obtained from triplicate measurements are within 3.9% R.S.D. reflecting the reproducibility and reliability of the developed method.

  10. Clinical impact of tumor location on the colon cancer survival and recurrence: analyses of pooled data from three large phase III randomized clinical trials.

    Science.gov (United States)

    Aoyama, Toru; Kashiwabara, Kosuke; Oba, Koji; Honda, Michitaka; Sadahiro, Sotaro; Hamada, Chikuma; Maeda, Hiromichi; Mayanagi, Shuhei; Kanda, Mitsuro; Sakamoto, Junichi; Saji, Shigetoyo; Yoshikawa, Takaki

    2017-11-01

    The aim of the present study was to determine whether or not the overall survival (OS) and disease-free survival (DFS) were affected by the tumor location in patients who underwent curative resection for colon cancer in a pooled analysis of three large phase III studies performed in Japan. In total, 4029 patients were included in the present study. Patients were classified as having right-side colon cancer (RC) if the primary tumor was located in the cecum, ascending colon, hepatic flexure or transverse colon, and left-side colon cancer (LCC) if the tumor site was within the splenic flexure, descending colon, sigmoid colon or recto sigmoid junction. The risk factors for the OS and DFS were analyzed. In the present study, 1449 patients were RC, and 2580 were LCC. The OS rates at 3 and 5 years after surgery were 87.6% and 81.6% in the RC group and 91.5% and 84.5% in the LCC group, respectively. Uni- and multivariate analyses showed that RRC increased the risk of death by 19.7% (adjusted hazard ratio = 1.197; 95% confidence interval, 1.020-1.408; P = 0.0272). In contrast, the DFS was similar between the two locations. The present study confirmed that the tumor location was a risk factor for the OS in patients who underwent curative treatment for colon cancer. Tumor location may, therefore, need to be considered a stratification factor in future phase III trials of colon cancer. © 2017 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  11. Analysis of regional timelines to set up a global phase III clinical trial in breast cancer: the adjuvant lapatinib and/or trastuzumab treatment optimization experience.

    Science.gov (United States)

    Metzger-Filho, Otto; de Azambuja, Evandro; Bradbury, Ian; Saini, Kamal S; Bines, José; Simon, Sergio D; Dooren, Veerle Van; Aktan, Gursel; Pritchard, Kathleen I; Wolff, Antonio C; Smith, Ian; Jackisch, Christian; Lang, Istvan; Untch, Michael; Boyle, Frances; Xu, Binghe; Baselga, Jose; Perez, Edith A; Piccart-Gebhart, Martine

    2013-01-01

    This study measured the time taken for setting up the different facets of adjuvant lapatinib and/or trastuzumab treatment optimization (ALTTO), an nternational phase III study being conducted in 44 participating countries. Time to regulatory authority (RA) approval, time to ethics committee/institutional review board (EC/IRB) approval, time from study approval by EC/IRB to first randomized patient, and time from first to last randomized patient were prospectively collected in the ALTTO study. Analyses were conducted by grouping countries into either geographic regions or economic classes as per the World Bank's criteria. South America had a significantly longer time to RA approval (median: 236 days, range: 21-257 days) than Europe (median: 52 days, range: 0-151 days), North America (median: 26 days, range: 22-30 days), and Asia-Pacific (median: 62 days, range: 37-75 days). Upper-middle economies had longer times to RA approval (median: 123 days, range: 21-257 days) than high-income (median: 47 days, range: 0-112 days) and lower-middle income economies (median: 57 days, range: 37-62 days). No significant difference was observed for time to EC/IRB approval across the studied regions (median: 59 days, range 0-174 days). Overall, the median time from EC/IRB approval to first recruited patient was 169 days (range: 26-412 days). This study highlights the long time intervals required to activate a global phase III trial. Collaborative research groups, pharmaceutical industry sponsors, and regulatory authorities should analyze the current system and enter into dialogue for optimizing local policies. This would enable faster access of patients to innovative therapies and enhance the efficiency of clinical research.

  12. Beaver Valley Unit 1, United States of America, 2007. Annex III. Description of Selected Open Phase Events

    International Nuclear Information System (INIS)

    2016-01-01

    On 27 Nov. 2007, during a non-routine walkdown of the off-site switchyard to investigate line voltage differences, the licensee discovered that the Phase A conductor of a 138 kV off-site power circuit of the Beaver Valley Power Station Unit 1 had broken off in the switchyard. This break occurred between the off-site feeder breaker and the line running on-site to the A train system station service transformer, located inside the site security fence. The terminal broke on the switchyard side of a revenue-metering current transformer/voltage transformer installed in 2006 to track the station’s power usage through this line. During normal power operation, no appreciable current goes through this 138 kV line because the unit generator normally powers the station buses (loads). The licensee determined that the break on the 138 kV Phase A had occurred 26 days earlier and, therefore, had not been restored within 72 h as required by technical specifications.

  13. Comparison of the WAIS-III and WISC-IV in 16-Year-Old Special Education Students

    Science.gov (United States)

    Gordon, Shirley; Duff, Simon; Davidson, Terry; Whitaker, Simon

    2010-01-01

    Background: Previous research with earlier versions of the WISC and WAIS has demonstrated that when administered to people who have intellectual disabilities, the WAIS produced higher IQ scores than the WISC. The aim of this study was to examine whether these differences still exist. A comparison of the Wechsler Adult Intelligence Scale-Third…

  14. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT in patients with advanced ovarian cancer stage FIGO III - The OVAR-IMRT-02 Study

    Directory of Open Access Journals (Sweden)

    Eichbaum Michael H

    2011-01-01

    Full Text Available Abstract Background The prognosis for patients with advanced FIGO stage III epithelial ovarian cancer remains poor despite the aggressive standard treatment, consisting of maximal cytoreductive surgery and platinum-based chemotherapy. The median time to recurrence is less than 2 years, with a 5-years survival rate of -20-25%. Recurrences of the disease occur mostly intraperitoneally. Ovarian cancer is a radiosensitive tumor, so that the use of whole abdominal radiotherapy (WAR as a consolidation therapy would appear to be a logical strategy. WAR used to be the standard treatment after surgery before the chemotherapy era; however, it has been almost totally excluded from the treatment of ovarian cancer during the past decade because of its high toxicity. Modern intensity-modulated radiation therapy (IMRT has the potential of sparing organs at risk like kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose. Our previous phase I study showed for the first time the clinical feasibility of intensity-modulated WAR and pointed out promising results concerning treatment tolerance. The current phase-II study succeeds to the phase-I study to further evaluate the toxicity of this new treatment. Methods/design The OVAR-IMRT-02 study is a single-center one arm phase-II trial. Thirty seven patients with optimally debulked ovarian cancer stage FIGO III having a complete remission after chemotherapy will be treated with intensity-modulated WAR as a consolidation therapy. A total dose of 30 Gy in 20 fractions of 1.5 Gy will be applied to the entire peritoneal cavity including the liver surface and the pelvic and para-aortic node regions. Organ at risk are kidneys, liver (except the 1 cm-outer border, heart, vertebral bodies and pelvic bones. Primary endpoint is tolerability; secondary objectives are toxicity, quality of life, progression-free and overall survival. Discussion Intensity-modulated WAR provides

  15. Phase II study evaluating consolidation whole abdominal intensity-modulated radiotherapy (IMRT) in patients with advanced ovarian cancer stage FIGO III - The OVAR-IMRT-02 Study

    International Nuclear Information System (INIS)

    Rochet, Nathalie; Debus, Juergen; Kieser, Meinhard; Sterzing, Florian; Krause, Sonja; Lindel, Katja; Harms, Wolfgang; Eichbaum, Michael H; Schneeweiss, Andreas; Sohn, Christof

    2011-01-01

    The prognosis for patients with advanced FIGO stage III epithelial ovarian cancer remains poor despite the aggressive standard treatment, consisting of maximal cytoreductive surgery and platinum-based chemotherapy. The median time to recurrence is less than 2 years, with a 5-years survival rate of -20-25%. Recurrences of the disease occur mostly intraperitoneally. Ovarian cancer is a radiosensitive tumor, so that the use of whole abdominal radiotherapy (WAR) as a consolidation therapy would appear to be a logical strategy. WAR used to be the standard treatment after surgery before the chemotherapy era; however, it has been almost totally excluded from the treatment of ovarian cancer during the past decade because of its high toxicity. Modern intensity-modulated radiation therapy (IMRT) has the potential of sparing organs at risk like kidneys, liver, and bone marrow while still adequately covering the peritoneal cavity with a homogenous dose. Our previous phase I study showed for the first time the clinical feasibility of intensity-modulated WAR and pointed out promising results concerning treatment tolerance. The current phase-II study succeeds to the phase-I study to further evaluate the toxicity of this new treatment. The OVAR-IMRT-02 study is a single-center one arm phase-II trial. Thirty seven patients with optimally debulked ovarian cancer stage FIGO III having a complete remission after chemotherapy will be treated with intensity-modulated WAR as a consolidation therapy. A total dose of 30 Gy in 20 fractions of 1.5 Gy will be applied to the entire peritoneal cavity including the liver surface and the pelvic and para-aortic node regions. Organ at risk are kidneys, liver (except the 1 cm-outer border), heart, vertebral bodies and pelvic bones. Primary endpoint is tolerability; secondary objectives are toxicity, quality of life, progression-free and overall survival. Intensity-modulated WAR provides a new promising option in the consolidation treatment of

  16. PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer

    International Nuclear Information System (INIS)

    Owadally, Waheeda; Hurt, Chris; Timmins, Hayley; Parsons, Emma; Townsend, Sarah; Patterson, Joanne; Hutcheson, Katherine; Powell, Ned; Beasley, Matthew; Palaniappan, Nachi; Robinson, Max; Jones, Terence M.; Evans, Mererid

    2015-01-01

    Human papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. The study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology g